All Features
John O'Kelly
Warehouses are the backbone of supply chains, ensuring that goods move efficiently from suppliers to consumers. However, the physical demands of warehouse work—heavy lifting, repetitive motions, and prolonged standing—can take a toll on employees, leading to fatigue, injuries, and long-term strain…
ISO
How do health and safety incidents affect your business? If a worker is injured or becomes ill, what kind of disruption does it cause? Is your productivity affected? What’s the effect on other workers in terms of workload or psychological health and well-being?
People are the foundation of every…
IDS Imaging Development Systems
The slit-lamp examination is one of the most important diagnostic techniques in ophthalmology. It enables a detailed examination of the anterior, middle, and posterior segments of the eye. Ophthalmologists can use it to recognize the smallest changes, anomalies, or damage. This procedure is used…
Matt McFarlane
The medical device industry is growing. Data from KPMG predict that global annual sales will rise by 5% per year to reach just under $800 billion by 2030. New technology, new opportunities, and, as always, the promise of improving patient outcomes around the world are major drivers of growth within…
Etienne Nichols
Have you ever wondered what your medtech company looks like from the point of view of a U.S. Food and Drug Administration investigator? Well, this is your chance to find out.
Greenlight Guru invited Vincent Cafiso, a former FDA investigator, to the Global Medical Device Podcast to share his…
Stephanie Ojeda
Quality risk management (QRM) has become a crucial tool for ensuring regulatory compliance worldwide. It plays a central role in ISO management system standards and regulations, as well as the EU Medical Device Regulation (MDR/IVDR), FDA 21 CFR 820, and ICH Q10 in the pharmaceutical and biotech…
Stephanie Ojeda
In April 2018, the U.S. Food and Drug Administration (FDA) approved the first artificial intelligence-powered diagnostic system, a software program used to detect diabetes-related vision loss.
Since then, the industry has seen explosive growth of AI in medical device manufacturing, which is…
Ilana J. Sprongl
Back in 2023, only 15% of businesses had adopted AI-augmented software testing tools. By 2027, that number is expected to leap to 80%. The reason behind this rapid adoption is clear. The complexity of modern software and products is skyrocketing, and with it, the risks associated with quality…
Etienne Nichols
Compliance with industry regulations and standards is a fundamental part of medtech. Without proper medical device compliance, companies risk patient harm, litigation, and reputational damage.
Fortunately, compliance with medical device regulations and standards is not an impossible task. A…
Victoria Alestra
In regulated industries like pharmaceuticals, medical devices, and food manufacturing, compliance is crucial for operational excellence. A validated quality management system (QMS) is key to maintaining this compliance. Let’s explore how QMS software streamlines validation and ensures regulatory…
Chris Rush
While clinical trials are the gold standard for generating clinical data to use as evidence of your medical device’s safety and effectiveness, they are by no means the only way to gather clinical evidence.
Real-world data (RWD), which typically come from routine healthcare delivery or…
Stephanie Ojeda
In the highly regulated world of life sciences, data integrity isn’t optional; it’s essential. The ALCOA principles—attributable, legible, contemporaneous, original, and accurate—provide a foundational framework for ensuring data are reliable and trustworthy.
With the rise of digital…
Joshua Zable
Everyone has their own favorite graph type or visual tool. I’m not ready to declare this my favorite yet, but this oldie but goodie has got to get more time and attention. That’s right: I’m talking about control charts with stages, also sometimes called before/after control charts.
If you’re not…
Zach Winn
Most doctors go into medicine because they want to help patients. But today’s healthcare system requires that they spend hours each day on other work—searching through electronic health records (EHRs), documenting, coding and billing, gaining prior authorization, and evaluating services—that often…
Sachin Waiker
‘Clinician burnout is a critical issue to understand and address,” says Mohsen Bayati, a professor of operations, information, and technology at Stanford Graduate School of Business. The condition is thought to affect nearly half of all U.S. doctors, at a cost of about $4.6 billion annually due to…
ISO
Cybersecurity has become increasingly critical in the digital age as organizations across all sectors face growing threats from cybercriminals.
Imagine that hackers breached a small healthcare practice through “phishing”—sending a scam email and gaining access to sensitive patient data, including…
Saurabh Joshi Shripad
Before the ICH Harmonized Tripartite Guideline Q9—“Quality risk management”—was introduced in 2005, the pharmaceutical industry was evolving but lacked a structured, scientific, and systematic approach. Various stakeholders, including the industry, regulators, and patient rights groups, recognized…
Laura Velásquez Herrera
With its roots in compassion and humanity, the healthcare sector might seem an unlikely place for artificial intelligence (AI) to play a big role. Yet as we look deeper into the complex processes that build our medical systems, we uncover a multitude of ways that AI could revolutionize patient care…
James Chan
The U.S. Food and Drug Administration (FDA) is the country’s chief agency for regulating the manufacture, marketing, and distribution of critical consumer goods including food, cosmetics, medical devices, biological products, and pharmaceuticals. The FDA provides direct oversight of the businesses…
Jennifer King
Many people don’t realize just how long AI has been around in the healthcare industry—and are surprised to find out that it’s something that’s been relied on for 50 years already.
MYCIN, a computer-based model with machine learning capabilities, was developed by a team of researchers at Stanford…
Robyn Coward, Brian Brooks
This year, the Medical Device Innovation Consortium held an Excellence in Quality Summit where it was promised that participants would receive a “unique opportunity to learn adoptable cutting-edge practices to maximize the impact of investing in quality across [their] total product life cycle.”…
Etienne Nichols
On Jan. 31, 2024, the U.S. Food and Drug Administration (FDA) released its final rule for the new Quality Management System Regulation (QMSR).
The new QMSR is the result of aligning the current good manufacturing practice (cGMP) requirements of the FDA’s quality system regulation (QSR) with the…
Chris Rush
Ensuring the accuracy and security of clinical data, as well as compliance with good clinical practice (GCP), will in large part determine the success of your study and regulatory submission to the U.S. Food and Drug Administration (FDA). Data management and reporting are essential practices when…
Mike King
Historically, the sensitive nature of personal and company proprietary information held in life sciences quality management systems (QMS) has been a factor for quality management teams’ reluctance to adopt AI. Add to that the complex global regulatory environment and the penalties of noncompliance…
ISO
When a patient comes into a clinic or hospital, healthcare practitioners have all the tools at their disposal to conduct thorough examinations. However, when they see a patient online, they may lack the necessary equipment to conduct the visit properly. One reason for this is that virtual care…
Gleb Tsipursky
Many employees are unaware that they can leverage the Americans with Disabilities Act (ADA) to request work-from-home (WFH) accommodations based on mental health conditions. This knowledge gap has the potential to reshape the “return to office” (RTO) landscape, creating both opportunities and…
Lawrence Goodman
Here are just a few potential advantages of 3D drug printing—a new system for manufacturing drugs and treatments onsite at pharmacies, healthcare facilities, and other remote locations: chocolate-flavored pills for children who hate taking medicine; several drugs combined into one daily pill for…
Etienne Nichols
If you’re a medtech professional who’s been working with the quality system regulation (QSR) in the United States, then you’re probably familiar with the three terms the U.S. Food and Drug Administration uses for record-keeping requirements: 1) device master record (DMR), a compilation of records…
Bruce Hamilton
As years roll on, I’m noticing more parts of me breaking down: Teeth, eyes, knees, cardiovascular, stomach—the list keeps getting longer, as does the list of docs I see. I’m blessed to be living in an area with the world’s finest medical care and lucky that healthcare innovation (and Medicare) have…
Veronica Muzquiz Edwards
Health connects each one of us to one another. No matter where we are in the world, who we are, or what we do, the state of our health is a key determinant in our quality of life. Simply put, it’s our most valuable asset.
Individual health crises can be disastrously grim, and if not addressed…
Gabriel Popkin
They’re called per- and polyfluoroalkyl substances, or PFAS, a group of thousands of compounds that contain a chemical bond between fluorine and carbon. That bond has proved to be one of the most stable and unbreakable known to chemistry—a fact baked into the common nickname “forever chemicals,”…
Rob Moorey
Equipment failures in healthcare can have serious consequences, including delays in diagnosis or treatment, scheduling disruptions, and patient safety risks. Health systems should empower clinical engineering teams with technology that helps identify potential failures. This will allow health…
Jessica Rector
Burnout is affecting every industry, company, and role. There are no exceptions.
Leaders often find themselves in the trenches, navigating through the chaos and driving their teams toward success. However, amidst the pursuit of goals and objectives, burnout remains a lurking enemy that can…
Etienne Nichols
In the United States, the Food and Drug Administration (FDA) is the federal agency tasked with regulating the medical device market and ensuring the safety and effectiveness of all devices for patients.
The FDA classifies medical devices by risk into three categories: Class I, Class II, and Class…
Stephanie Ojeda
An analysis of U.S. Food and Drug Administration (FDA) warning letters by the Food and Drug Law Institute reveals a perhaps not-so-surprising link between training gaps and FDA violations.
It’s one of several factors motivating companies to switch to automated training management software. The…
Aman Pandey
In the dynamic landscape of the life sciences industry, ensuring compliance with good manufacturing practices (GMP) is imperative to guarantee the safety, efficacy, and quality of pharmaceutical products.
One critical aspect of GMP is the analytical product quality review (APQR), an essential…
Morehouse Instrument Co.
In the healthcare sector, precision isn’t just a requirement. It’s a necessity where the margins for error are perilously thin, and the consequences of inaccuracy can be grave. At the heart of this precision lies the unassuming yet critical load cell, a device whose reliability is foundational to…
Dawn Bailey
The Center for Organ Recovery & Education (CORE), a 2019 Baldrige Award recipient, is a nonprofit organ procurement organization (OPO) in Pittsburgh with a federally designated service area encompassing a population of 5.5 million in western Pennsylvania, West Virginia, and one county in New…
Patrick Gale
Medical equipment is a necessary yet substantial investment for any health system. Making strategic decisions about these assets can be daunting in the face of shifting patient demand, financial uncertainty, and fast-changing cybersecurity risks.
Because clinical assets account for an average of…
Mike Figliuolo
If you have kids, you know the nauseating feeling of one of them going down for the count and having to rush them to the emergency room. I had that grim experience recently. What I learned from that ER visit is businesses can make very strong statements about how little they care about their…
Jones Loflin
When we talk about a lack of work-life balance, stress, or burnout, one of the things we’re actually saying to ourselves is that we feel we have no control over the outcome or our future. It can feel like the line between work and life has blurred into one big, overwhelming blob.
It’s time for a…
Alonso Diaz, Maria DiBari
The U.S. Food and Drug Administration (FDA) emphasizes the importance of being prepared for device recalls.
FDA product recalls are on the rise in the post-pandemic era. There has been a clear upward trend from 2021 through 2023, and medical devices ranked the highest of all product types. (See…
Maggie Overfelt
Michele Gelfand finds inspiration for new projects all around her: taking in the banter in a boardroom, speaking with taxi drivers when traveling, observing the interactions between physicians and nurses during an unexpected trip to the doctor. The idea for one of her most recent papers was sparked…
Jamie Bihary
An internal audit can be an overwhelming prospect, especially if you’re new to a company or internal auditing in general.
The MedTech space is huge, and even the standards that are meant to help, like ISO 13485:2016, cover a lot of ground.
So, if you’re part of the audit team in your company, and…
Stephanie Ojeda
Formal complaint management is a requirement in regulated industries such as medical device and pharmaceuticals under U.S. Food and Drug Administration (FDA) and other international regulations.
The FDA mandates that medical device companies, for example, designate a formal unit for managing…
Michael King
In the ever-evolving life-sciences industry, market share is fiercely contested and companies must continuously optimize their operations to maintain their competitive edge.
Modern technologies and intelligence-driven solutions are revolutionizing how organizations work, empowering them to elevate…
Meg Sinclair
At Qualio, our mission is to help life science companies embed robust digitized quality to get their critical products to market at rapid speed and keep them there. And because the Qualio+ team combines over a century of collective quality and regulatory experience from within the life science…
Kristi McDermott
Technology has reshaped the healthcare industry, empowering clinicians, technicians, and executives to better serve patients and achieve their goals. However, technology doesn’t eliminate the need for human oversight and management. Healthcare technology will continue to advance at a rapid pace in…
Alonso Diaz, Maria DiBari
Inspections by the U.S. Food and Drug Administration (FDA) are on the rise after the nation has recovered from the Covid-19 pandemic. Domestic inspections showed a drop in 2020 due to state health guidelines around quarantine.
The rise has more than doubled within three years of post-pandemic…
Scott A. Hindle, Douglas C. Fair
So far in this series our focus has remained on statistical process control (SPC) in manufacturing. We’ve alternated between more traditional uses of SPC that remain relevant in this digital era and discussing uses of SPC and its related techniques that are enabled by the marvels of modern…
Kari Miller
Traditionally, quality management in the pharmaceutical industry has strayed away from artificial intelligence (AI) for fear of setting it loose with such sensitive information. They have been cautious of implementing an additional element of intelligence into their process. But will organizations…
Brad Jobe
Artificial intelligence (AI) has the potential to reshape the healthcare industry. There is a massive amount of healthcare data available for AI to process. Nearly one-third of the world’s data volume is generated by the healthcare industry, and the volume of big data is projected to increase…
Jón Bergsteinsson
Clinical investigations play an important role in your journey of bringing a medical device to market. While the relevant standards are often perceived as difficult and complex, having a good grasp of them makes the process less confusing.
Understanding ISO 14155:2020 is essential. It’s a guide to…
Rob Moorey
Growing medical equipment inventories and increasing technical complexity are demanding more than ever from the clinical engineering teams responsible for maintaining clinical assets. Simultaneously, a shrinking talent pool of biomedical equipment technicians (BMETs) could lead to large staffing…
Stephanie Ojeda
In December 2023, the U.S. Food and Drug Administration (FDA) expects to issue its long-awaited overhaul of its Quality System Regulation (QSR). The biggest change is that the new Quality Management System Regulation (QMSR) will harmonize with ISO 13485 for medical device quality management. With…
Steve Thompson
If you’ve ever enjoyed the experience of an audit or inspection, then you know it’s about as much fun as having your wisdom teeth extracted. As painful as audits and inspections may be, they are necessary to bring needed medical products to market and monitor them to protect consumers and patients…
ISO
Healthcare administrators find themselves at the fore of a demanding and transformative field, where the pursuit of excellence in patient care is nonnegotiable. In a health industry landscape facing evolving regulations, escalating costs, and an increasing emphasis on patient outcomes, the need for…
Stephanie Hinton
If you’re conducting a clinical investigation of a medical device in a European Union member state, you will be required to submit a clinical investigation report (CIR) along with a summary of the CIR to that member state.
The European Union Medical Device Regulation (EU MDR) lists this as one of…
Kelley Jacobsen
In the wake of the Covid-19 pandemic, medical device supply chains are one of the top priorities for health system leaders. Amid supply chain disruptions during the pandemic, hospitals scrambled to find enough devices to keep up with unprecedented demand. The global crisis revealed gaps in standard…
Etienne Nichols
Supply chain management is crucial to any medtech company’s ability to deliver safe, effective, and high-quality devices to their customers.
But as anyone in the industry can tell you, consistently getting the products and services you need to manufacture your devices is harder than it sounds. In…
Chris Bush
Untitled Document
The U.N. recognizes privacy as a fundamental human right, and nowhere is this more important than in medical data. That’s why both the U.S. and the EU have regulations in place that govern the collection, storage, and use of patient data in healthcare.
In the U.S., there is the…
Jennifer Chu
Getting blood test results can take anywhere from a day to a week, depending on what a test is targeting. The same goes for tests of water pollution and food contamination. And in most cases, the wait time has to do with time-consuming steps in sample processing and analysis.
Now, MIT engineers…
NIST
Magnetic resonance imaging (MRI) machines can clearly view non-bony parts of the body—soft tissue such as the brain, muscles, and ligaments—as well as detect tumors, making it possible to diagnose many diseases and other conditions. However, the powerful magnets in conventional MRI machines make…
Lindsey Walker
In the quickly changing industrial landscape, firms continue to place a high premium on safety. Innovative approaches to improving industrial safety have been made possible by technological advancements. One particularly revolutionary option is computerized maintenance management system (CMMS)…
Etienne Nichols
On Feb. 23, 2022, the U.S. Food and Drug Administration (FDA) released its proposed rule for the new Quality Management System Regulation (QMSR). The proposed QMSR will be the result of aligning the current good manufacturing practice (cGMP) requirements of the FDA’s Quality System Regulation (QSR…
Etienne Nichols
Amedical device company is expected to deliver innovative, life-changing devices while ensuring compliance and achieving true quality. This task bears loads of responsibility—all of which must be kept and documented within your quality management system (QMS).
A QMS contains everything that…
Aaron Smith
A successful company can’t run without happy and motivated employees. One way you can achieve that is by improving your employees’ uptime. Uptime refers to your employees’ freedom to pursue personal and occupational growth without the burden of preventable injuries. Here is everything you need to…
Stephanie Ojeda
Design controls are a frequent citation in 483 observations and warning letters from the U.S. Food and Drug Administration (FDA). In fact, the agency has noted a large proportion of past recalls that could have been prevented with design controls.
FDA guidance also makes an explicit link between…
Gleb Tsipursky
The unemployment rate is surprisingly low, at 3.7%, shocking economists who expected a slowdown in hiring and rising unemployment rate. Frontline work, such as healthcare, led job growth. Frontline workers are in high demand, and the competition for their services is fierce. Yet wage growth cooled…
Etienne Nichols
The goal of your MedTech company’s supplier management process should be to ensure a consistent supply of high-quality parts and components that conform to your specifications.
But achieving that goal is easier said than done, and it depends heavily on whether you take a risk-based approach to…
Stephanie Ojeda
Effective complaint handling is fundamental to life-sciences quality management, with implications for operations, product design, risk management, and more.
It’s also critical to ISO 9001, FDA Quality System Regulation (QSR), and EU Medical Device Regulation (MDR) compliance.
Manufacturers that…
Michael King
Medical companies work in an environment of ever-increasing challenge and complexity. Global regulations continue to evolve with advancements in technology and variations in requirements from country to country. This brings unavoidable technical complexity to daily tasks of quality and regulatory…
Mike Morini
Following the turmoil of the pandemic, many salaried employees have had the opportunity to work remotely and enjoy newfound flexibility in their day-to-day work lives. For many, the ability to be more in control over where and when they work has been life-changing, enabling them to find better work…
Silke von Gemmingen
Rigid endoscopes are used in medical diagnostics and therapy to examine body cavities and hollow organs, and to perform minimally invasive procedures. To avoid risks for patients and medical staff, it’s essential that the devices function perfectly. Reliable quality testing is intended above all to…
Melissa Phillips
The levels of contaminants in our food supply are, generally, decreasing. That’s the good news.
But we still need to measure those contaminants and make sure our food is safe. And measuring tiny things (and big things) is what we do best here at NIST.
In our food safety program, we’re studying all…
Etienne Nichols
Medical device companies must have established risk management processes that comply with ISO 14971. It doesn’t matter whether you’re developing medical devices in the U.S., EU, Canada, or elsewhere. Every international regulatory agency you’ve ever heard of accepts ISO 14971.
ISO 14971 is a good…
Ophir Ronen
From the health histories of patients to the effectiveness of different healthcare services, hospitals are sitting on a treasure trove of historical data. Unfortunately, most of these data go unused, often because they are so difficult to store or format for actionable use.
Due to inconsistencies…
Martin Cottam
It’s tempting to attribute the increased profile now given to occupational health and safety (OH&S) to the Covid-19 pandemic. But while in many organizations the pandemic shone a spotlight on OH&S management, there are other issues that will keep OH&S at the fore throughout the next…
Matthew M. Lowe
Change of any kind often requires a catalyst. This is particularly true in a business environment where the rule of thumb is to do things the way they’ve always been done. And when you’re working in a regulated industry, processes tend to get more locked in because compliance is at stake.
That was…
Michael Glickman
Artificial intelligence (AI) is revolutionizing the healthcare industry by enhancing decision-making capabilities, improving quality of care, and reducing costs. In the age of supercomputers and technological advancement, the health sector generates vast amounts of data, which AI can process and…
Kari Miller
Life science organizations depend on quality management systems (QMS) to improve products, minimize risks, ensure patient safety, and support regulatory compliance. When companies use a horizontal QMS that is not purpose-built for the life science industry, they must execute additional steps to…
Etienne Nichols
I have a bold opinion: The corrective and preventive action (CAPA) process is the second-most important component of your quality management system (QMS). (If you want to know what I think is No. 1, shoot me an email.) As you build medical devices, a well-defined CAPA program provides a framework…
Grant Ramaley
As of 2023, more than 27,000 medical device QMS certificates have been issued worldwide, providing confidence in medical devices. From cardiac stents to simple dental tools used to correct teeth, the healthcare systems of the world have come to rely on ISO 13485 to provide critical support to world…
Donald J. Wheeler, Al Pfadt
In memory of Al Phadt, Ph.D.
This article is a reprint of a paper Al and I presented several years ago. It illustrates how the interpretation and visual display of data in their context can facilitate discovery. Al’s integrated approach is a classic example not only for clinical practitioners but…
Etienne Nichols
On Dec. 9, 2022, the U.S. Food and Drug Administration (FDA) issued a new draft guidance, “Content of Human Factors Information in Medical Device Marketing Submissions,” that provides recommendations for the inclusion of human-factors information in marketing submissions.
The drafted guidance is…
Trupti Dhere
The healthcare industry is known for rapidly adopting advanced technologies that offer improved treatment for various diseases. Consequently, digital twin technology in healthcare has gained popularity during the past few years, owing to the range of advantages it offers.
Digital twin technology…
Etienne Nichols
In a highly regulated industry like medical technology, manufacturing processes must undergo either process verification or process validation to ensure they’re consistently producing the correct result. The question is, which one should you use?
Verification and validation are two different…
Liza Dzhezhora
Having appeared in the early 2000s, connected health technologies have gradually become a game changer in the healthcare industry. Healthcare providers that have embraced smart medical IoT solutions reduce costs, improve patient experience, and ensure preventive care.
The trend is not fading away…
Scott Trevino
Nearly a quarter of surveyed healthcare cyberattack victims experienced increased mortality rates following a data breach, and more than half reported poorer patient outcomes due to longer hospital stays and delayed procedures. Healthcare has faced the highest average data breach cost—more than $10…
Amy Brown
Listening to customers is critical for healthcare organizations to ensure they’re delivering high-quality care to their patients. Sure, the traditional methodology of doing so via surveys can increase customer retention and profitability. But much like evolving from analog to digital, there’s a…
Gleb Tsipursky
One of the key stakeholders in stakeholder capitalism is the employee. You could argue that the employee is the key stakeholder, because without employees you’d have no stakeholders at all. This is why employers need to stay aware of today’s health environment and its effect on their employees.…
In a press statement released on Jan. 6, 2023, the European Commission reported the adoption of a proposal to allow more time to certify medical devices to mitigate the risk of shortages. The proposal introduces a longer transition period to adapt to new rules, as foreseen under the Medical Devices…
Bhushan Avsatthi
The very nature of healthcare construction and its specific infrastructural and functional needs pose significant challenges to the architectural, engineering, and construction (AEC) sector. Crucial hospital spaces such as operation theaters and critical care centers need fail-proof connections to…
Angie Basiouny
In the hustle of a busy hospital emergency department, teams of doctors and nurses react quickly to determine whether a patient needs to be admitted, referred, or released. Providing such complex care requires a high degree of skill and seamless teamwork, the kind that usually comes from years of…
Doug Folsom
Unpatched vulnerabilities remain a target of cyberattacks, and an ever-present risk for healthcare organizations. Medical devices pose an additional burden because patches are frequently unavailable for medical devices. So, dealing with the potential threat isn’t usually straightforward. The stakes…
Dirk Dusharme @ Quality Digest
In 2010 a medical device scandal in France set the stage for a new European Union medical device regulation that, according to most experts in the medical device community, may cause more damage than the problem it was intended to address. An unreasonable deadline, lack of notified bodies to…
Alex Waddell, Diki Tsering, Peter Bragge, Paul Kellner
Emergency medical workers, already at increased risk for burnout compared to other professions, continue to be challenged by the fallout of Covid-19.
Stretched to the breaking point by increased workloads, highly contagious and acutely ill patients, and limited resources, workers’ risk factors for…
James Gaines, Knowable Magazine
In 2004, the United States’ Defense Advanced Research Projects Agency (DARPA) dangled a $1 million prize for any group that could design an autonomous car that could drive itself through 142 miles of rough terrain from Barstow, California, to Primm, Nevada. Thirteen years later, the U.S. Department…
Jon Speer
Medical device product development and risk management are often treated as entirely separate processes. Sure, there is usually acknowledgement and understanding that these two processes are related. But it is important to realize that product development and risk management share more than that.…
Dirk Dusharme @ Quality Digest
Every company wants to succeed, but not all can say they meet the current requirements to do that. More than a focus on capital, business plans, or staff, a successful business in 2022 must operate digitally. Yet for the 45 percent of small and medium-sized businesses (SMBs) that still rely on…
Laurie Flynn
AStanford Medicine-led study has found that borrowing certain billing- and insurance-related procedures from other countries could lead to policies that drastically lower healthcare costs in the U.S.
The new study, published in the August edition of Health Affairs, compares costs of healthcare…
Bendta Schroeder
The first step in choosing the appropriate treatment for a cancer patient is to identify their specific type of cancer, including determining the primary site: the organ or part of the body where the cancer begins.
In rare cases, the cancer’s origin can’t be determined, even with extensive testing…
Dwayne Duncum
The workplace has changed forever, having gone through a revolution similar to the Industrial Revolution. Our workplaces are diverse, complex, and frequently changing. If we take any lesson from the Covid pandemic, it’s that the way we work, where we work, and how we work have fundamentally shifted…
Etienne Nichols
I know what you’re thinking. You’ve got a medical device prototype that the FDA has categorized as Class I. You’re ready to push forward to manufacturing or marketing the device, since there are no formal requirements for design controls. “So why would I waste time on design controls?”
The fact is…
Catherine Barzler
Falls are a serious public health issue that result in tens of thousands of deaths annually while racking up billions of dollars in healthcare costs. Although there has been extensive research into the biomechanics of falls, most current approaches study how the legs, joints, and muscles act…
Jennifer Chu
Ultrasound imaging is a safe and noninvasive window into the body’s workings, providing clinicians with live images of a patient’s internal organs. To capture these images, trained technicians manipulate ultrasound wands and probes to direct sound waves into the body. These waves reflect back out…
Grant Ramaley
The FDA Quality System Regulation (QSR) 21 CFR Part 820 was written in 1997 to harmonize with ISO 13485:1996. The goal was to relieve some of the burden of manufacturers having to meet two different criteria, the FDA’s and ISO 13485.
But by 2003, ISO 13485 had changed so significantly that the FDA…
Claudine Mangen
Work has become an around-the-clock activity, courtesy of the pandemic and technology that makes us reachable anytime, anywhere. Throw in expectations to deliver fast and create faster, and it becomes hard to take a step back.
Not surprising, many of us are feeling burned out. Burnout—which often…
Gregory Way
Drugs don’t always behave exactly as expected. While researchers may develop a drug to perform one specific function that may be tailored to work for a specific genetic profile, sometimes the drug might perform several other functions outside of its intended purpose.
This concept of drugs having…
Adam Zewe
Physicians often query a patient’s electronic health record for information that helps them make treatment decisions, but the cumbersome nature of these records hampers the process. Research has shown that even when a doctor has been trained to use an electronic health record (EHR), finding an…
Karina Montoya
Close to 9 million people in India suffer from hepatitis C. If left untreated, the virus leads to cirrhosis or liver damage, which eventually causes death from organ failure or cancer. On average, a 50-year-old man in India with asymptomatic liver damage who doesn’t receive treatment is expected to…
Tom Rish
Your design history file (DHF) is one of the most critical components of your QMS. That’s because the DHF should contain all the product development documentation for a specific medical device. Its purpose is to show regulatory bodies and internal stakeholders that you appropriately followed the…
Patricia Santos-Serrao
The pharmaceutical industry has seen significant upheaval and disruption during the past several years. These changes are due in part to the impacts of Covid—for example, interruptions in the supply chain and overwhelming market demand for shortened production times.
They are also being driven by…
Mike John
This article has been republished with permission from Medical Plastics News.
While ISO 13485 sets the standard for quality management systems (QMS) in medical device manufacturing, metrology is often treated as an afterthought and used simply to validate products and detect defects at the end of…
Gleb Tsipursky
The pandemic has made organizations aware of the need for a new C-suite leader, the CHO, or chief health officer. This has been driven by recognizing the importance of employee health for engagement, productivity, and risk management, along with lowering healthcare insurance costs. At the same time…
Ann Brady
Safer food, better health: This was the theme of World Food Safety Day (June 7, 2022), and it’s obvious, is it not, that access to safe food is vital for life and health? The challenge in today’s world is how to achieve this. Global food systems, already under pressure before the pandemic, are now…
Jamie Steiner
Ultra-low temperature freezers became popular due to the storage of Covid-19 vaccines, but they have been important components of laboratories for many years. There’s a lot, however, to think about—quality, productivity, maintenance, different types of technology, warranties, etc. And if you end up…
Prashant Yadav
During the past two and a half years, we’ve seen unparalleled innovation and private-public collaboration in the global fight against Covid-19. The rapid development and rollout of new vaccines, diagnostic tests, and therapeutics have saved millions of lives.
However, these developments haven’t…
David Stevens
The United States has more than 6,000 hospitals, and each one has thousands, if not tens of thousands, of clinical assets, such as imaging machines, ventilators, and IV pumps. Managing this equipment becomes a mighty task when hospital staff must handle the monitoring, repair, and maintenance of…
Kari Miller
Quality management is essential to the growth and performance of any organization. It’s a valuable resource in the effort to ensure that products and services satisfy the highest quality requirements and deliver positive customer results.
Pharmaceutical manufacturers must ensure that the…
William A. Levinson
Quality-related data collection is useful, but statistics can also deliver misleading and even dysfunctional results when incomplete. This is often the case when information is collected only from surviving people or products, extremely satisfied or dissatisfied customers, or propagators of bad…
The Un-Comfort Zone With Robert Wilson
In a recent column, I wrote about the power of suggestion. I stated, “When our subconscious mind is exposed to a constantly repeated message, it’s going to penetrate unless we are cognizant of it.” Becoming conscious of indoctrinating media messages is important, but recognizing your own internal…
Merilee Kern
Since the dawn of civilization, humans have used natural remedies for their healing properties. Some of the same treatments are still used by billions around the world, based largely on anecdotal evidence and lore. Clinical research on natural treatments is lacking due to costly clinical trials,…
Duxin Sun
When you hear the word “nanomedicine,” it might call to mind scenarios like those in the 1966 movie Fantastic Voyage. The film portrays a medical team and robotic submarine shrunk to microscopic size to travel through a man’s body to clear a blood clot in his brain.
Nanomedicine has not reached…
Dario Lirio
By now, it’s no secret that good clinical practice (GCP) guidelines used by FDA inspectors are expanding. These GCP guidelines are developed by the International Conference on Harmonization. The ICH last revised its GCP document, called ICH E6(R2), in 2016. It will be releasing a new version in…
Alexander Khomich
The digital transformation of healthcare is under the influence of trending technologies, from IoT devices to AI algorithms. Some healthcare providers are just getting acquainted with innovations. Others (93%, according to Accenture) are already actively implementing and creating software solutions…
Gary Shorter
Predictive and prescriptive insights driven by data analytics have risen to prominence as tools that can help research teams cut the time, complexity, and cost of clinical trials. At the same time, these insights can enhance the quality of a study and accelerate new drugs to market. But to uncover…
NIST
Tiny biological computers made of DNA could revolutionize the way we diagnose and treat a slew of diseases, once the technology is fully fleshed out. However, a major stumbling block for these DNA-based devices, which can operate in both cells and liquid solutions, has been how short-lived they are…
Knowledge at Wharton
More than a half-million healthcare workers in the United States have quit their jobs in recent months, driven to the breaking point by the Covid-19 pandemic. But greater use of technology could help save jobs by reducing the kinds of inefficiency and stress that lead to burnout for many hospital…
NIST
To combat Covid-19 amid supply shortages in 2020, healthcare facilities across the United States resorted to disinfecting personal protective equipment (PPE), such as N95 masks, for reuse with methods such as ultraviolet (UV) light. But questions lingered about the safety and efficacy of these…
NIST
Researchers at the National Institute of Standards and Technology (NIST) have discovered a potential source of error when using acoustic waves to measure the properties of fluids such as blood. Their discovery raises the possibility of more accurate diagnostic tests for certain types of blood…
Edmund Andrews
Seems everybody has a horror story about health insurance: Kafkaesque debates with robotic agents about what is and isn’t covered. Huge bills from a doctor you didn’t know was “out of network.” Reimbursements that take months to process.
It’s no secret that healthcare in the United States is…
Theodoros Evgeniou, Ludo Van der Heyden
Technology has always been a double-edged sword. While it’s been a major force for progress, it has also been abused and caused harm. From water power to Fordism, history shows that technology is neither good nor bad by itself. It can, of course, be both, depending on how it’s used.…
Wade Schroeder
On May 12, 2021, President Biden signed the Executive Order on Improving the Nation’s Cybersecurity. Among other items in the order was a requirement that every vendor that supplies the federal government with software must provide a software bill of materials (SBOM) with their product.
Given that…
Dennis Fridrich
As the number of networked medical devices grows, so too will online threats and vulnerabilities. In this era of interconnectivity, healthcare systems must prioritize medical device security and patient safety.
The heightened risk is drawing the attention of federal regulators, who warn that “it…
Etienne Nichols
On February 23, 2022, the FDA released its proposed rule for the new Quality Management System Regulation (QMSR). The proposed QMSR will be the result of aligning the current good manufacturing practice (cGMP) requirements of the FDA’s Quality System Regulation (QSR) with the international…
Aliyah Kovner
To combat a pandemic, science needs to move quickly. With safe and effective vaccines now widely available, and a handful of promising Covid-19 treatments coming soon, there’s no doubt that many aspects of biological research have been successfully accelerated during the past two years.
Now,…
Duxin Sun
It takes 10 to 15 years and around $1 billion to develop one successful drug. Despite these significant investments in time and money, 90 percent of drug candidates in clinical trials fail. Whether because they don’t adequately treat the condition they’re meant to target or the side effects are too…
Violetta Njunina
According to the CDC, approximately one out of six Americans are diagnosed with foodborne diseases each year. Out of this, about 128,000 are hospitalized, and as many as 3,000 lose their lives.
These sorry statistics show why food safety is paramount and why more effort should be put into reducing…
Scott Trevino
The pandemic promises ongoing challenges for healthcare providers in 2022 as they cope with nursing shortages and cybersecurity threats amid shifts previously underway for the industry. How they manage their clinical assets, however, can present opportunities to overcome those challenges while…
Maggie Overfelt
Machine learning has the potential to drastically improve efficiency and the quality of care in hospitals by tackling hard-to-predict problems like ICU occupancy or which patients are likely to be readmitted.
Yet, a big barrier to any technology working optimally is getting full buy-in from its…
Sankesh Abbhi
Life science organizations play a vital role in healthcare’s technology revolution, with a key focus on identifying the right opportunities to scale digital transformation. Currently, life sciences leaders are leaning into areas such as automation, which was discussed at length at ArisGlobal’s…
Grant Ramaley
The IAF Medical Device Working Group has updated one of the most important documents that supports the medical device quality system ISO 13485. IAF MD9:2022—“Application of ISO/IEC 17021-1 in the field of medical device quality management systems (ISO 13485)” provides the mandatory requirements for…
Rodney Rohde
Medical laboratory professionals form the backbone of healthcare and the public health system. They conduct some 13 billion laboratory medicine tests annually in the United States. As of February 2022, these individuals had also performed more than 900 million Covid-19 tests and counting during the…
Bill Marler
Although the announcement, “FDA Proposes Changes to Food Safety Modernization Act Rule to Enhance Safety of Agricultural Water Used on Produce,” is a bit to fully digest in one sitting, I’m intrigued by the FDA’s focus on pre-harvest risk assessment of water risk as opposed to water testing for…
Kari Miller
In the medtech space, all roads lead to quality. Unlike pharma, which looks at safety and quality separately, all of the information around risk and vigilance to inform product improvement will be housed within a medtech company’s quality management system (QMS).
The primary goal of post-market…
Prashant Yadav, Antoine Désir
The pandemic has seen an unprecedented global effort to accelerate the development of safe and effective vaccines as well as a rapid expansion of vaccine manufacturing capacity. However, challenges in further scaling up vaccine manufacturing capacity to meet higher-than-expected demand, and the…
John Colmers, Sherry Glied, Knowable Magazine
This story was originally published by Knowable Magazine.
The way the United States typically finances hospitals isn’t working. The coronavirus laid this bare, along with many other long-standing societal problems.
Before Covid-19, most hospitals were operating on a standard “fee-for-service”…
Dawn Bailey
‘We didn’t get here on our own,” said Brian Dieter, president and CEO of Baldrige Award-recipient Mary Greeley Medical Center (MGMC), speaking at the 32nd Baldrige Quest for Excellence Conference. “We think we are very much better as a result of having learned from [other Baldrige Award recipients…
Rich Tree
Following any tech transfer project, the subsequent startup of the manufacturing line is almost always full of challenges. The goal is to start up as soon as possible once the project is completed but also to achieve steady-state throughput as quickly as possible after the startup begins. This type…
Dirk Dusharme @ Quality Digest
Like it or not, work-from-home (WFH) is here to stay. This is not just a perk that employers might offer, but a requirement on which many employees, current and future, are demanding. According to several surveys, between 30 and 50 percent of employees surveyed said they would leave their jobs if…
Jay Arthur—The KnowWare Man
There are many control chart rules to detect special causes (i.e., out-of-control conditions). Although most of these rules are clear, the one that seems to befuddle most people is the rule about trends. Is it six points (including the first point), six points (excluding the first point), or seven…
Taran March @ Quality Digest
In regulated industries, every step of the production process must be verified to some sort of guidance or standard. What this comes down to, practically speaking, is an enormous amount of time and effort spent on actions outside the sphere of production. Every day of production seems to create a…
Ravi Anupindi
Inoculating the planet from Covid-19 presents an unprecedented logistical challenge like none we’ve seen before. Mobilizing for a world war may be the closest comparison, but in this case, the enemy is invisible and everywhere.
Some of the vaccines require super-cold storage at virtually all…
Sara Adams
Designing, developing, and getting your medical device approved and onto the market is a huge accomplishment—but it isn’t the end of your responsibilities.
For the European Union (EU) market, the European Commission (EC) requires manufacturers to perform ongoing postmarket surveillance (PMS)…
Dawn Bailey
‘What would be important to you in the care of your daughter?” John Chessare, president and CEO of Baldrige Award-recipient GBMC HealthCare (GBMC), asked a virtual Quest for Excellence conference audience.
“The No. 1 answer is always that people want the best possible health outcome for their…
Boris Babic, Sara Gerke, Theodoros Evgeniou, I. Glenn Cohen
For many of us, our electronic device can be a communications lifeline, entertainment system, and professional networking hub. If trends continue, it may become our health advisor as well.
Direct-to-consumer (DTC) medical apps are a growing segment of the $10 billion market for healthcare…
Zach Winn
This story was originally published by MIT News.
For small healthcare groups like dentist’s offices, one sick staff member can mean a day’s worth of cancelled appointments. Such offices can either continue short-staffed, which could negatively affect patient care, or reschedule appointments,…
Tom Siegfried, Knowable Magazine
This story was originally published by Knowable Magazine.
From the earliest days of their evolution, guts and brains have been the best of friends.
It’s a mutually beneficial relationship. Guts prepare nourishment for delivery to the brain. And brains guide the behaviors needed to fill the gut…
Saligrama Agnihothri
Health-tracking devices and apps are becoming part of everyday life. More than 300,000 mobile phone applications claim to help with managing diverse personal health issues, from monitoring blood glucose levels to conceiving a child.
But so far the potential for health-tracking apps to improve…
Dawn Bailey
The spirit of service—for a small clinic started in 1913 to provide free care to Los Angeles (LA)—lives today in the servant-leader aspirations of 2019 Baldrige Award recipient Adventist Health White Memorial (AHWM), a 353-bed, safety-net hospital.
The community of two million people that AHWM…
Clare Naden
Travel and tourism took a beating during the Covid-19 pandemic, with borders closed, airlines grounded, and many establishments shut for months. Now as the industry attempts to recover in this new context, constantly changing rules and regulations are making it a far-from-simple task. What’s more,…
Adrian Hernandez, C. Michael White
T
he U.S. Food and Drug Administration (FDA) regularly inspects manufacturing facilities to ensure that drugs meet rigorous quality standards. These standards are vital to protect patients from drugs that are incorrectly dosed, contaminated, or ineffective.
But over the past few years, tens of…
Gleb Tsipursky
When the Covid pandemic swept through the country last year, companies rapidly transitioned employees to working from home (WFH). However, this shift led to growing challenges of WFH burnout and Zoom fatigue.
Unfortunately, organizations treat these issues as day-to-day challenges, instead of…
Jon Speer
Demonstrating identification and traceability in all quality system processes is a must for medical device companies to comply with FDA regulations. To satisfy this compliance need, companies will need to connect related processes within their quality system to close the loop between related pre-…
Wade Schroeder
Medical-device usability testing and validation are critical tasks leading up to a medical device’s debut on the market. “Usability” looks at how the user interacts with your device and forms a key component of overall risk management and safety.
If there’s any “spoiler alert” to this article, it’…
Ariane Ollier-Malaterre, Knowable Magazine
This story was originally published by Knowable Magazine.
Working from home—formally known as telework—is here to stay. A 2021 survey of approximately 30,000 Americans concluded that, after the pandemic, 20 percent of all work days may continue to take place at home, vs. just 5 percent before.…
David L. Chandler
This story was originally published by MIT News.
Two MIT professors have proposed a new approach to estimating the risks of exposure to Covid-19 under different indoor settings. The guideline they developed suggests a limit for exposure time, based on the number of people, the size of the space,…
Jon Speer
The medical device technical file is a must-have document for devices to be sold in the European Union (EU) marketplace. The file contains detailed information about your medical device, its design, intended use claims, composition, and clinical evaluations. It’s essentially an “everything you must…
Janet Woodcock, Judy McMeekin
During the past year, the U.S. Food and Drug Administration’s (FDA) approach to foreign and domestic inspections for food and medical products has been both risk-based and deliberate. The Covid-19 pandemic required us to rework our business operations so that we could carry out our public health…
Edmund Andrews
Seems everybody has a horror story about health insurance: Kafkaesque debates with robotic agents about what is and isn’t covered. Huge bills from a doctor you didn’t know was “out of network.” Reimbursements that take months to process.
It’s no secret that healthcare in the United States is…
Graham Freeman
Here’s an unfortunate truth: The story of the Covid-19 pandemic is one of epic quality failures in almost every area imaginable. Although there have been some admirable successes, such as the food and beverage organizations that have ensured the continued safe delivery of food supplies to most…
Gleb Tsipursky
Have you or your employees been feeling work-from-home burnout (WFH) and Zoom fatigue these past months despite the supposed convenience of working from home and using video conferences to meet?
Due to the computer-based nature of their work, many quality professionals have been in the privileged…
Rita Men
Ending the pandemic depends on achieving herd immunity, estimated at 70 percent or even 80 percent to 90 percent of a population. With some 30 percent of Americans telling pollsters they have no interest in getting vaccinated, that’s cutting it a bit close. The numbers are even worse in many other…
Sharona Hoffman
Artificial intelligence holds great promise for improving human health by helping doctors make accurate diagnoses and treatment decisions. It can also lead to discrimination that can harm minorities, women, and economically disadvantaged people.
The question is, when healthcare algorithms…
Dave Klumpe
Recent surveys point to increasing frustration and, frankly, exhaustion among nurses across the country. Although attending to patients during the pandemic has exacerbated the challenges of the profession, nursing shortages have been reported on for well over a decade. It is incumbent on hospitals…
Tinglong Dai, Christopher Tang, Ho-Yin Mak
More than 50 million Americans have received at least one dose of either the Pfizer or Moderna Covid-19 vaccine. So far, Americans have been largely brand-agnostic, but that’s about to change as the Johnson & Johnson vaccine rolls out.
The vaccine has been hailed as a game changer. It requires…
Anne Trafton
In the era of social distancing, using robots for some healthcare interactions is a promising way to reduce in-person contact between healthcare workers and sick patients. However, a key question that needs to be answered is how patients will react to a robot entering the exam room.
Researchers…
Ryan E. Day
In an article published by Quality Digest, Julias DeSilva addresses recent declines in ISO certification and poses the question, “Does quality matter anymore?” His conclusion is that even if you don’t get certified, you will still gain from a well-implemented management system. But what do…
Clare Naden
It’s been about a year since the Covid-19 pandemic turned our world upside down, and that includes the world in which we work. Certainty has hung up its hat, normality looks unlikely to return, and unpredictability is here to stay for the long term. How can organizations manage in this context, and…
Denis Bergeron
From the earliest days of radioactivity research, radiation and cancer therapy have gone together like peas and carrots. But Zach Levine covered peas and carrots in an earlier blog post, so I will focus on radiation and cancer therapy.
Shortly after Wilhelm Röntgen discovered the high-energy…
Gleb Tsipursky
Stakeholder engagement is one of the more critical aspects of leadership, whether you’re a team leader or a member of a cross-functional team trying to lead team members to focus on quality. Stakeholders can be anyone from your colleagues to suppliers to business partners, and your relationship…
Clare Naden
Never have we been more acutely aware of the importance of reliability when it comes to laboratory testing. As the ongoing Covid-19 pandemic has highlighted, the development of accurate diagnostic tests plays an important role in outbreak management.
Whether a laboratory develops its own test…
Maria Church
Sometimes work seems like, well, work. It’s not the fun, fulfilling, or rewarding kind of work that we look forward to tackling but the life-sucking, drudgery kind of work. What to do when work drains the soul and seems like a waste of a life? Find the meaning in the work you do, and you will find…
Sheronda Jeffries
Since the beginning of the coronavirus outbreak, UK officials have seized millions of substandard face masks at Heathrow Airport. These masks could have put millions at risk for contracting or spreading the Covid-19 virus.
Industry and governmental organizations including the Therapeutic Goods…
Stephen M. Hahn, Amy P. Abernethy
During a short period of time, our society has seen a rapid increase in the interest and availability of cannabidiol (CBD) products and other products derived from cannabis. However, we still have a limited understanding of the safety profile of CBD and many other cannabis-derived compounds,…
Gleb Tsipursky
Should quality professionals be worried about the new Covid strains originating in the United Kingdom, South Africa, and elsewhere, and recently identified in the United States?
Authorities have focused on downplaying concerns about vaccine effectiveness against these new variants. While some…
Richard Harpster
As someone who has helped companies in a wide variety of industries for the last 30 years solve many problems using risk-based thinking, I cannot think of an issue that I have worked on that is more important than preventing the spread of Covid-19. With three high-risk people in my home, I have…
Jane Bianchi
Let’s pretend, for a moment, that you’re a primary care physician and you refer one of your patients to another doctor for a colonoscopy. Will the patient follow through? If not, how will your team know to remind him or her? If the patient does receive a colonoscopy, will your team be alerted so…
Bahar Aliakbarian
The two major U.S. developers of the early Covid-19 vaccines are Pfizer/BioNTech and Moderna. They both developed mRNA vaccines, a relatively new type of vaccine. A major supply-chain issue is the temperature requirement for these vaccines.
The Pfizer vaccine needs to be stored at between –112° F…
Sanjay Mishra
As the weather cools, the number of infections of the Covid-19 pandemic are rising sharply. Hamstrung by pandemic fatigue, economic constraints, and political discord, public health officials have struggled to control the surging pandemic. But now, a rush of interim analyses from pharmaceutical…
Nader Moayeri
I am part of a grassroots effort at the National Institute of Standards and Technology (NIST) that is developing an exposure notification system for pandemics in general, though we hope it could be used in at least a limited fashion during the current Covid-19 pandemic. We are fortunate at NIST to…
Steve McCarthy
The ideal of proactive quality has been the holy grail of chief quality officers in the life sciences industry for at least five years, but few, if any, have realized the vision. Industry has since set out a clear definition of the milestones a medical product manufacturer would need to meet in…
Grant Ramaley
IEC 60601-1: “Medical electrical equipment,” edition 3.1, is the base medical-device standard to ensure “basic safety and essential performance” of medical electrical equipment. It is used by medical device regulators but also recognized by some other regulatory authorities as a regulatory…
Rich Press
Researchers at the National Institute of Standards and Technology (NIST) have produced synthetic gene fragments from SARS-CoV-2, the virus that causes Covid-19. This material, which is noninfectious and safe to handle, can help manufacturers produce more accurate and reliable diagnostic tests for…
Merilee Kern
As Covid-19 rages on, warning sirens have sounded of late amid a flurry of headlines surrounding ultraviolet C (UVC) light device-safety issues. Rightfully so, as the current pandemic has ushered in a veritable wild west of UVC gadget deployments with subpar consumer safeguards, instructions, or…
Tinglong Dai, Guihua Wang, Ronghuo Zheng
The Covid-19 pandemic has crippled the airline industry. Passenger numbers are down more than two-thirds from last year, and airlines have been canceling flights and shutting down routes.
It’s frustrating for travelers, but for patients on organ transplant waiting lists, the loss of flights can…
Jeb Banner
As the current pandemic unfolds, organizations’ boards of directors—especially in the healthcare industry—must continue leading and guiding. But gathering board members for in-person meetings is no longer an option.
In response, board engagement has gone digital. Planning, hosting, and following up…
Donald J. Wheeler
On Sept. 29, 2020, the recorded worldwide death toll from Covid-19 reached 1 million. Six days earlier the United States reached 200,000 Covid-related deaths. So how did the United States with only 4 percent of the world’s population manage to capture 20 percent of the world’s deaths in this…
Gleb Tsipursky
Although deeply fulfilling, establishing and growing a quality-oriented startup poses serious dangers for the mental health of quality leaders. During the expansion stage, a founder will often face brutally long work weeks, pressure from different sources to manage the startup while raising funding…
Jon Speer
Risk can mean many different things depending on the situation. Flying on an airplane, biking on a busy road, driving in a car—all of these involve some level of risk.
Although risk is a variable we encounter in everyday life, it means something uniquely different to the medical device industry.…
Jennifer Mallow
Covid-19 has led to a boom in telehealth, with some healthcare facilities seeing an increase in its use by as much as 8,000 percent. This shift happened quickly and unexpectedly, and has left many people asking whether telehealth is really as good as in-person care.
During the last decade, I’ve…
Donald J. Wheeler
This article tracks the progression of Covid-19 over the past six months on a state-by-state basis and provides a framework for interpreting these curves by including curves for seven other countries. While 52 states and territories are covered here, it turns out that there are just three basic…
Thomas R. Cutler
About one in two U.S. adults has a musculoskeletal disorder, costing an estimated $213 billion each year in treatment and lost wages, according to a report from the United States Bone and Joint Initiative. Musculoskeletal disorders (MSD) are injuries and conditions to the bones, muscles, and joints…
Jon Speer
Imagine you’re a patient going in for any medical procedure. You probably think very little about the risks of the medical device being used on you. Generally, patients trust clinicians’ expertise and seldom wonder if the products being used have undergone rigorous testing and are proven to be safe…
Jennifer Lauren Lee
While awaiting full access to their labs due to Covid-19 restrictions, scientists at the National Institute of Standards and Technology (NIST) have taken this rare opportunity to report the technical details of pioneering research they conducted on the disinfection of drinking water using…
Stephen M. Hahn, Anand Shah
Americans may be surprised to learn that many 21st-century medical products are still being manufactured using technologies commonly employed since the middle of the last century. These manufacturing platforms are not dynamic and can increase the risk of shortages, limit flexibility during an…
Donald J. Wheeler
In past articles I have used graphs to provide perspective on how the Covid-19 pandemic is progressing around the world. In this article I shall update some of those graphs and use these historical data to make projections on what may be expected in the United States in the fall.
The worldwide…
William A. Levinson
Face masks and respirators may well offer the only way to return to an even remotely normal living and working style in the second half of 2020, which means they will play a vital role in any kind of economic recovery. This article’s purpose is to discuss what we know about respiratory protection,…
Bob Holmes, Knowable Magazine
This story was originally published by Knowable Magazine.
Infectious disease expert Anthony Fauci. Coronavirus response coordinator Deborah Birx. County health officials across the United States. The Covid-19 pandemic has led to the emergence of a new set of household names: those in the media…
Donald J. Wheeler
Since the start of the Covid pandemic I have received many questions about how to analyze the Covid numbers using process behavior charts. Various schemes have been proposed and used. This column will discuss appropriate ways of analyzing data from epidemics and pandemics.
Now to be clear, in this…
Lola Butcher, Knowable Magazine
This story was originally published by Knowable Magazine.
In February 2020, the month before Covid-19 hit Boston, Partners Healthcare, the huge health system that includes Massachusetts General Hospital, treated 1,600 patients via video visits. By April, the number of patients seeking care through…
Donald J. Wheeler
With data that come along one number at a time, it is easy to get lost in the details. To see the big picture, it helps to use a time-series graph that will draw your eye in the direction that your mind wants to go. These simple graphs reveal how the values are changing over time and thereby place…
Greg Hutchins
My recent epiphany was that the lens for all work and even for everyday living during the next few years will be risk-based. Why do I make this case?
In January 2020, my company was selected to participate in the largest pitch fest in the Northwest, TechfestNW, which was originally scheduled for…
Katherine McCormick
To detect a virus, you need to already know intimate details about it. You need to design a test particular to that virus: one that finds and copies only a specific, identifying piece of its genetic material.
But Mauricio Terrones and his collaborators at Penn State University think they’ve found…
Elizabeth Tippett
If you’re among the tens of millions of people returning to work or preparing to do so after months sheltering in place, you may be worried it will put you and your family at increased risk of exposure to Covid-19.
The dilemma may be especially stark for the millions of Americans who can expect…
Farhana Ahmad
When Intelex developed its return-to-work program, we decided the best approach would be a phased one. Similar to the concept of continuous deployment, breaking down the plan to allow individuals to quickly process, adapt, and execute practices and procedures makes it more manageable for employers…
Kayla Wiles
A new laser treatment method could potentially turn any metal surface into a rapid bacteria killer just by giving it a different texture, researchers say. In a new study, they demonstrated that this technique allows the surface of copper to immediately kill off superbugs such as MRSA.
“Copper has…
Katherine Harmon Courage, Knowable Magazine
This story was originally published by Knowable Magazine.
From mask wearing to physical distancing, individuals wield a lot of power in how the coronavirus outbreak plays out. Behavioral experts reveal what might be prompting people to act—or not.
With many states and towns lifting strict stay-at…
Matthew Staymates
As a fluid dynamicist and mechanical engineer at the National Institute of Standards and Technology (NIST), I’ve devoted much of my career to helping others see things that are often difficult to detect. I’ve shown the complex flow of air that occurs when a dog sniffs. I’ve helped develop ways to…
Donald J. Wheeler
The daily Covid-19 pandemic values tell us how things have changed from yesterday, and give us the current totals, but they are difficult to understand simply because they are only a small piece of the puzzle. This article will present a global perspective on the pandemic and show where the United…
William A. Levinson
The U.S. House of Representatives has passed the HEROES Act (Health and Economic Recovery Omnibus Emergency Solutions Act)1 which will, if approved by the Senate and president, require OSHA to develop a standard for workplace protection against Covid-19.
Under section 120302 the legislation says…
Leigh Turner
Given the death, suffering, social disruption and economic devastation caused by Covid-19, there is an urgent need to quickly develop therapies to treat this disease and prevent the spread of the virus.
But the U.S. Food and Drug Administration (FDA), charged with the task of evaluating and…
Maggie Pavlick
Masks, gowns, and other personal protective equipment (PPE) are essential for protecting healthcare workers. However, the textiles and materials used to make such items can absorb and carry viruses and bacteria, inadvertently spreading the disease the wearer sought to contain.
When the coronavirus…
Thomas Hellwig
The Covid-19 world is marked by a high degree of uncertainty and existential fear, a dearth of social interaction, the convergence of professional and personal space, a lack of physical activity, and an obsessive focus on hygiene and social distancing. For professionals, this amounts to a toxic…
Jessica Reiner
For more than 20 years, a class of man-made, potentially cancer-causing chemicals called per- and polyfluoroalkyl substances (PFAS) has commonly been found in humans and the environment. These chemicals are used in a variety of industries and can be found in many consumer products, such as food…
Dirk Dusharme @ Quality Digest
Around the world, local agencies and institutions have scrambled to find personal protective equipment (PPE) to protect their essential employees from Covid-19. Not just healthcare workers, but also the men and women who to work to keep our cities and counties up and running, from emergency…
Stanley Chao
‘Can you help me source PPEs from China?” asks a caller on the phone. I have received dozens of these inquiries since March from local governments, medical clinics, and mom-and-pop shops after hospitals and first responders began reporting massive shortages of N95 masks, latex gloves, and surgical…
Quality Digest
It’s easy to assume that something as simple as a mask wouldn’t pose much of a risk. Essentially, it’s just a covering that goes over your nose and mouth.
But masks are more than just stitched-together cloth. Medical-grade masks use multiple layers of nonwoven material, usually polypropylene,…
Grant Ramaley
The International Accreditation Forum (IAF), the association of conformity assessment accreditation bodies worldwide, held an emergency meeting after confirming what appears to be an outbreak in the use of fake ISO 13485 certificates. ISO 13485 is a quality management system standard particular to…
Carrie Van Daele
Crossing the street or stepping backward when you encounter another person has already become a habit, as has a routine elbow bump, instead of a handshake.
And that is definitely what is needed during a health crisis. But when the time is right, as a society we must bounce back to social…
Gleb Tsipursky
So many companies are shifting their employees to working from home to address the Covid-19 coronavirus pandemic. Yet they’re not considering the potential quality disasters that can occur as a result of this transition.
An example of this is what one of my coaching clients experienced more than a…
Sangeet Paul Choudary
The digitization of patient data and the adoption of cloud-based healthcare management systems have created efficiencies and new business models across the value chain. Advancements in AI provide superior decision support systems to doctors, while connected devices enable the remote delivery of…
Jon Speer
Historically, risk management has been a complex and polarizing subject, with various stakeholders assigning different values on the probability and severity of harm. In the medical device industry, risk management’s high importance has led to the publication of standards such as ISO 14971,…
Alan Rudolph, Raymond Goodrich
We [Alan Rudolph and Raymond Goodrich] are both biotechnology researchers and are currently seeking to repurpose an existing medical manufacturing platform to quickly develop a vaccine candidate for Covid-19.
This process is used for the treatment of blood products such as plasma, platelets, and…
Amber Dance, Knowable Magazine
This story was originally published by Knowable Magazine.
As Covid-19 cases fill the hospitals, among the sickest and most likely to die are those whose bodies react in a signature, catastrophic way. Immune cells flood and attack the lungs they should be protecting. Blood vessels leak; the blood…
Jay Arthur—The KnowWare Man
Story update 5/6/2020: The charts and some data have been updated to reflect the data available on the date this article was published.
During the Covid-19 stay-at-home order in Colorado, I've become increasingly frustrated by Covid-19 charts. Most of what I see are cumulative column charts, which…
Donald J. Wheeler, Al Pfadt
Each day we receive data that seek to quantify the Covid-19 pandemic. These daily values tell us how things have changed from yesterday, and give us the current totals, but they are difficult to understand simply because they are only a small piece of the puzzle. And like pieces of a puzzle, data…
William A. Levinson
The phrase “flatten the curve” means to slow the transmission of the coronavirus (Covid-19) in order to spread the total number of cases out over a longer period of time. This will avoid overwhelming the healthcare system.1 The model is accurate as presented throughout the internet, but it also…
Clinton Ballew
Telehealth services have become even more critical in caring for patients as the Covid-19 pandemic quickly evolves. To temporarily remove barriers to practice telehealth, the federal government and many states have made sweeping changes in telehealth waiver provisions.
As HORNE continues to…
Eric Stoop
According to the National Safety Council, the rate of preventable workplace fatalities per 100,000 workers has flattened or risen slightly since 2009 after decades of steady improvement in occupational safety.
Companies conducting layered process audits (LPAs) can help get the United States get…
James Anderton
While healthcare professionals globally struggle to contain the Covid-19 pandemic, acute care patients are taxing ICU units worldwide. Critical to the care needed for the most serious cases is breathing support through mechanical ventilators. In Italy, the worst-hit nation in Europe, the lack of…
Donald J. Wheeler, Al Pfadt, Kathryn J. Whyte
This article is an update to “Tracking Covid-19” that Al Pfadt, Kathryn Whyte, and I wrote last week. In that article we summarized what is known about Covid-19, what has already happened, and what is to be expected based on the analysis of the data and the epidemiological models.
Over the past…
Donald J. Wheeler, Al Pfadt, Kathryn J. Whyte
Based on the professional literature available, there are some inconvenient truths about Covid-19 that are not always considered in the chorus of confusion that exists today. Here we summarize what is known, what has already happened, and what is to be expected based on the analysis of the data and…
Ryan E. Day
Although Covid-19 shelter-in-home edicts usually use the terms “essential” and “nonessential,” most business owners think of doing business as essential for survival. Many organizations don’t have the resources to temporarily suspend business. They must find new ways to get it done.
In a Think…
Gleb Tsipursky
The Covid-19 coronavirus has developed into a widespread pandemic. With growing outbreaks of diagnosed cases in all 50 states, and vastly larger numbers of undiagnosed cases, there’s serious cause for concern. Yet quality professionals who follow the official advice on Covid-19 coronavirus prep…
David Pride
‘That escalated quickly!” is a common trope used in popular culture to describe when a situation gets out of hand before you’ve even had a chance to think about it. We don’t often use this trope in medicine, but I can think of nothing better to describe what has been going on in the United States…
Kevin Meyer
A couple weeks ago a consultant friend of mine, who coincidentally focuses his practice on lean in healthcare, was complaining about issues with his healthcare providers. It’s a story we hear often: doctors running late, very short and often superficial consultations, a rush to diagnosis, and a…
Sriram Chandrasekaran
Imagine you’re a fossil hunter. You spend months in the heat of Arizona digging up bones only to find that what you’ve uncovered is from a previously discovered dinosaur.
That’s how the search for antibiotics has panned out recently. The relatively few antibiotic hunters out there keep finding…
Sheng Lin-Gibson, Vijay Srinivasan
Biopharmaceuticals, also known as biological drugs or biologics, are manufactured from living organisms, or contain living organisms that have been genetically engineered to prevent or treat diseases. Biologics are chemically and structurally complex, and often highly heterogeneous; therefore,…
Peter Dizikes
Given the complexities of healthcare, do basic statistics used to rank hospitals really work well? A study co-authored by MIT economists indicates that some fundamental metrics do, in fact, provide real insight about hospital quality.
“The results suggest a substantial improvement in health if you…
Anne Trafton
After a patient has a heart attack or stroke, doctors often use risk models to help guide their treatment. These models can calculate a patient’s risk of dying based on factors such as the patient’s age, symptoms, and other characteristics.
While these models are useful in most cases, they do not…
Kelvin Lee
Biopharmaceutical manufacturing uses living cells to produce therapies that treat diseases like cancer, diabetes, and autoimmune disorders. Manufacturing medicine using biology presents different challenges from the traditional chemical manufacturing processes that stamp out identical pressed pills…
Clinton Ballew
Legislative support is growing for the reimbursement of care delivery via telemedicine. The Centers for Medicare and Medicaid Services (CMS) and the Office of Inspector General have recently made final and proposed rule changes to stimulate greater use and access for telemedicine delivery. These…
Dirk Dusharme @ Quality Digest
What a year.
No matter your job, your industry, or your political beliefs, this year has been a heck of a ride. The (still ongoing) trade war with China, manufacturing gains (and losses), the 737 MAX, Hong Kong riots, North Korea, Brexit, impeachment. What a mixed bag of ups and downs that has…
As usual with Quality Digest’s diverse audience, this year’s top stories covered a wide range of topics applicable to quality professionals. From hardware to software, from standards to risk management, from China trade to FDA regulations. It’s always fun to see what readers gravitate to, and this…
Anat Amit-Eyal
Eric, a 40-something married father of three, runs a successful startup. Given his demanding career, he and his wife decided she would be a stay-at-home mum. Eric believed the attention he devoted to his family was adequate, and that he had fully harmonized his work as CEO and life as a family man…
Michael Millenson
In late November 1999, a TV producer called me about an alarming report that 44,000 to 98,000 Americans were being killed each year by preventable errors in hospitals, and another 1 million were being injured. Could that be true? Based on my research, I replied, the estimate seemed low.
The “To…
The QA Pharm
Weekly CGMP Quiz 1: Part 210 & 211 Subpart A General Provisions. Use with your team for training credit!
This is the first of eleven quizzes on CGMPs that will appear weekly on QA Pharm. Try it yourself, and use it as a discussion tool for your staff groups. Also, each quiz will have one…
Heather Thompson
Software as a medical device (SaMD) is a growing sector in medical device technology. Through the use of artificial intelligence and machine learning, SaMD has the power to influence health on a global scale as well as allow for personalization in medicine and life-saving therapies.
Medical device…
The company Grace Science was born through an inversion of the normal business sequence. Typically, if an entrepreneur launches a startup and it succeeds, the founders will create a nonprofit, declaring, “We want to give back.” In this case, the nonprofit spawned the startup.
The company’s…
Boris Liedtke
In May 2019, a California jury found Monsanto’s weed killer, Roundup, to be a “substantial factor” in the cancer suffered by a couple and ordered the U.S. agrochemical company to pay them $2 billion in damages. This was the third and largest verdict against Monsanto, now owned by German…
Lola Butcher, Knowable Magazine
Any patient scheduled for surgery hopes, and maybe assumes, that his surgeon will do a high-quality job. Surgeons know better. Nearly three decades of research have made clear that some hospitals and surgeons have significantly better outcomes than others.
Exactly how to measure the quality of a…
David Moser
Technology companies are frequently driven by their engineering processes. Of course product quality is regarded as most important, and that quality can be tested and measured with numbers and data. Such companies also frequently align their core identity with the engineering that belies their…
Jon Speer
When it comes to making medical devices, quality is key. That’s a concept that nearly every medical device professional agrees with, but what does it mean? Why is quality so important, and how should it be pursued? These are the questions that medtech executives and company stakeholders should be…
Samantha Maragh
I didn’t understand what people were asking me when I was a kid. The question would come in several different forms. Sometimes it was, “What are you?” Other times it was, “Where are you from?” I would answer with things I knew to be true, like, “I’m a girl,” or, “I’m a person,” or, “I’m from…
Daniel Hess
We all expect hospitals to be open and operating when we need them, but extreme weather events like hurricanes are a strain on resources and pose significant challenges for hospitals.
Closing a hospital is an extreme action, but several hospitals in Florida, Georgia, and South Carolina did just…
Sharona Hoffman
A career as a physician has traditionally been considered to be among the best vocations that talented students can pursue. That may no longer be the case. All too many doctors report that they are unhappy, frustrated, and even prepared to leave the profession.
That should worry all of us. The…
Peter Rose
On May 26, 2020, the new European Union Medical Device Regulation (MDR) will finally take effect. By that date, all Class I manufacturers wishing to continue their trading activities within the EU market must have effectively completed the transition from the previous medical device directive and…
Michael D. Williams
As I spoke recently with colleagues at a conference in Florence, Italy, about healthcare innovation, a fundamental truth resurfaced in my mind: the U.S. healthcare industry is just that. An industry, an economic force, Big Business. It is a vehicle for returns on investment first and the success of…
David L. Chandler
As a cucumber plant grows, it sprouts tightly coiled tendrils that seek out supports to pull the plant upward. This ensures the plant receives as much sunlight exposure as possible. Now, researchers at MIT have found a way to imitate this coiling-and-pulling mechanism to produce contracting fibers…
Sarah Webb, Knowable Magazine
This story was originally published by Knowable Magazine.
What you see in the image below is a lobe of a liver, times two. On the right, a flesh-and-blood one, removed from a transplant donor; and on the left, one created from plastic to represent bile ducts, arteries, and veins, which were laid…
Grant Ramaley
Although the “new approach” to regulating medical devices has always given more urgency to higher-risk medical devices, this is not the case for the European Medical Device Regulation (MDR). Class 1 medical devices must fully comply with the regulation by May 26, 2020, or be shut out of the region…
Jon Speer
This notion of risk-based processes within quality systems is something that has become part of our formal lexicon following the release of ISO 13485:2016, the globally harmonized standard for medical device quality management systems (QMS).
Well before these risk-based processes became a quality…
Matthew M. Lowe
While most business sectors have welcomed the efficiencies and benefits that cloud technologies and software-as-a-service (SaaS) offerings bring, the life sciences industry has been slow to embrace external cloud networks. Merely a decade ago, in fact, an International Data Corp. survey showed that…
Jon Speer
The European Medical Device Regulation (MDR) is a new set of regulations that governs the production and distribution of medical devices in Europe, and compliance with the regulation is mandatory for medical device companies that want to sell their products in the European marketplace.
If your…
AssurX
Last month an investigative report revealed that the U.S. Food and Drug Administration (FDA) has millions of “hidden” serious injury and malfunctions reports on medical devices. According to the report from Kaiser Health News, “Since 2016, at least 1.1 million incidents have flowed into the…
Matthew M. Lowe
Despite the life science industry’s infatuation with modernity and trend chasing, even its most forward-thinking organizations have struggled to fully digitize and integrate their operations.
Yet, while the industry lags behind most other sectors in implementing business-streamlining digital…
Robyn Metcalf
In an outbreak that has now run for more than 28 months, at least 279 people across 41 states have fallen ill with multidrug-resistant Salmonella infections linked to raw turkey products. Federal investigators are still trying to determine the cause. In response to food company recalls, more than …
NIST
A new measurement approach proposed by scientists at the National Institute of Standards and Technology (NIST) could lead to a better way to calibrate computed tomography (CT) scanners, potentially streamlining patient treatment by improving communication among doctors.
The approach, detailed in…
Bruce Hamilton
Last February I had the opportunity to observe healthcare providers up close and personal at one the world’s premier hospitals. “Who Cares for the Caregivers?” was written from the perspective of a patient in a cardiac step-down unit, sympathetically watching caregivers as they grappled with many…
Shobhendu Prabhakar
Historically, conventional wisdom among business managers was that the higher the quality, the higher the cost. This perception still holds true today among a few business managers. Common sense also tells us the same thing, i.e., to create higher quality products or services, organizations will…
Hubert Gatignon
Health and economics are linked in more ways than just health insurance. When we look past the obvious, research shows us how brain scans, the gig economy, or even hospital queues are all part of the expanding domain of health economics.
Recently, professors and researchers from the Sorbonne…
Jon Speer
You arrive at work one morning, and there are FDA inspectors sitting in your waiting area. If you are lucky, you may be notified ahead of time that they’re coming, but otherwise, the US. Food and Drug Administration (FDA) is fully within its rights to show up unannounced at any time.
Because of…
Taran March @ Quality Digest
Life science companies are no strangers to data, so it would be easy to assume they are adept at making innovative use of huge amounts. Not necessarily. A tradition of rigorous scientific method and clinical trial hasn’t prepared them for the shifting inundation of big data or all its baffling…
Dirk Dusharme @ Quality Digest
For centuries, medical procedures, prescriptions, and other medical interventions have been based largely on experience—what is known about a set of symptoms. The doctor looks at those symptoms, tests you in various ways (blood tests, X-rays, MRIs), and interprets the results based on experience…
Zach Y. Brown
Imagine there was a store where there were no prices on items, and you never knew what you’d pay until you’d picked out your purchases and were leaving the shop. You might be skeptical that the store would have any incentive to offer reasonable prices.
This exact situation has become the norm in U…
Stephen McCarthy
I am thrilled to introduce Quality Digest’s special report, “Unlocking the Future of Life Sciences.” This series explores the last several decades of quality management within the life sciences industry. It begins with the genesis of early regulations, shows us how that led to the current state of…
Mike Richman
Great quality is pretty much the same everywhere, but the cost of poor quality is not equivalent from industry to industry. For example, it’s conceivable (but I hope not probable) that this article may turn out to be a real bomb, or worse, a complete snoozer. What’s the cost of that poor quality?…
Quality Digest
Within the life science industry, federal and industry regulations have prompted the need for compliance, and that trend has only increased in magnitude and complexity. Along with that has come technological solutions to enable both compliance and efficiency, without which life science…
Laurel Thoennes @ Quality Digest
Compliance to U.S. Food and Drug Administration (FDA) regulations has come a long way in the past 30 years. Here are the main changes. Have they affected your business?
1988: Food and Drug Administration ActOfficially establishes the FDA as an agency of the Department of Health and Human Services…
Dirk Dusharme @ Quality Digest
As the United States struggles with rising healthcare costs, reducing the amount of money pharmaceutical companies spend dealing with regulation, while at the same time meeting drug safety requirements, would seem to be competing interests.
The goal of any honest pharmaceutical company is to make…
Taran March @ Quality Digest
It’s been a year and a month since Stephen McCarthy switched C suites, moving from Johnson & Johnson, where he served as vice president of quality system shared services, to Sparta Systems, where he’s now vice president of digital innovation. His focus has switched as well.
At J&J, he…
Graham Freeman
Many industries have no clear boundary between safety and quality culture. In fact, they are often closely integrated. Quality failures and nonconformances that require rework have been correlated with increased accidents and recordable injury rates in manufacturing organizations. These injuries…
Teresa Purzner
Developmental biologist Matthew Scott and I went from purely basic biological research in our lab at Stanford University, to discovering a target for drug development, to identifying a drug for a pediatric brain cancer called medulloblastoma, to a clinical trial—all within five years and for just $…
Manfred Kets de Vries, Katharina Balazs
The global wellness industry is doing superbly, thank you very much. In recent years, it grew a healthy 12.8 percent, becoming a $4.2 trillion market. Whether the lives of wellness consumers are improving at a comparable rate is another matter altogether.
Wellness products and services run the…
Dirk Dusharme @ Quality Digest
In this episode we look at lessons learned (or not) from GE, the difference between ISO and FDA “requirements,” and this year's Baldridge recipients.
“GE’s Lessons Won’t Determine Whether You Succeed or Fail”
Does the success or failure of GE’s CEO really matter that much when it comes to how most…
Ryan E. Day
BioBridge Global (BBG) is a parent organization for four subsidiary organizations, three of which are involved in production activities, and they’re all around regenerative medicine, including blood components, clinical laboratory testing, and cell and tissue therapies. Organizations in the life…
Taran March @ Quality Digest
These days, even regulatory agencies must innovate if they expect to keep pace with the speed of doing business. The U.S. Food and Drug Administration is no exception, and this year especially it has challenged itself to find ways to enhance efficiency and update old regulations. Quality Digest has…
Dirk Dusharme @ Quality Digest
The Dec. 31, 2018 deadline looms for medical device companies that sell their devices in Canada. On that day, any company that sells medical devices to Canada will either need to hold an MDSAP certificate or show proof that they are on track to be MDSAP certified, or they won’t be able to sell…
Mike Richman
The future is the ultimate abstraction; anyone who has ever attempted to discern the nature of tomorrow by looking at the yesterdays leading up to today knows that prediction is a fool’s errand. That’s the unfortunate reality for weather forecasters, stockbrokers, sports bookmakers, political…
Ryan E. Day
One of the unique aspects of Finch Therapeutics is that although its product does not fall easily into any regulated category and thus is not FDA-approved, the company has been working closely with the agency for at least five years. The FDA has broad jurisdiction to regulate all health products,…
Matthew M. Lowe
Life science companies play a major role in the global economy, with revenues expected to reach a staggering $1.5 trillion by 2020.1 Such a rosy forecast is likely to attract innovators and encourage current industry players to blaze new trails. Whether new or established, life science companies…
The Un-Comfort Zone With Robert Wilson
Last year I was invited to give a lecture on critical thinking to the U.S. Navy. I opened my presentation with a story I’d read in Reader’s Digest magazine as a child. It’s an old story you may have heard before, but it’s a perfect introduction to the importance of critical thinking. Here’s how it…
Mike Richman
IMTS was a blast, but it was great to be back home in lovely Northern California this week. On this episode of QDL, we covered the skills that workers need and the innovations that organizations want. Plus, we brought you a live interview with author Mark Graban, and one on tape from Burt Mason of…
Rip Stauffer
I must admit, right up front, that this is not a totally unbiased review. I first became aware of Davis Balestracci in 1998, when I received the American Society for Quality (ASQ) Statistics Division Special Publication, Data “Sanity”: Statistical Thinking Applied to Everyday Data. At the time, I…
Bita Kash, Stephen L. Jones
Can you imagine a future where the question, “Did you bring a copy of your test results?” becomes entirely unnecessary? That could happen, but the methods that most healthcare providers use to exchange healthcare information are little different than they were 5,000 years ago, when physicians…
Knowledge at Wharton
‘How is it that in the middle of a relatively small town of about 125,000 people in Minnesota, you’ve got the No. 1-rated healthcare system probably in the world?”
The question was put to Jeffrey Bolton—the Mayo Clinic’s chief administrative officer—by Larry Jameson, executive vice president of…
Grant Ramaley
The Dental Trade Alliance learned from its members in February 2018 that the Canadian Health Ministry (“Health Canada”) had contacted the Standards Council of Canada (SCC) and the British Standards Institution (BSI). Health Canada had ordered these certification bodies to stop issuing ISO 13485…
Richard Pazdur
During the past decade, advances in understanding of cancer biology have led to the development of targeted treatments that are more effective than the chemotherapies of the past century. These therapies are demonstrating response rates large in magnitude or response durations prolonged in early…
Manfred Kets de Vries
A certain amount of stress is needed for us to function effectively. Stress is very much a part of the human condition. We all face disappointments, setbacks, losses and pain. But to live a rich and meaningful life, we must learn to deal in a constructive way with life’s challenges.
Stress evolved…
Sally Davies
It’s hard to believe that modern Western doctors, with their multimillion-dollar hospitals and high-tech gadgets, have much in common with their ancient counterparts. Up to the 19th century, doctors usually occupied a fairly low status in society. Doctors these days generally enjoy better working…
Scott Gottlieb
There’s new technology that can improve drug quality, address shortages of medicines, lower drug costs, and bring pharmaceutical manufacturing back to the United States. At the U.S. Food and Drug Administration (FDA), we’re focused on propelling these innovations, collectively referred to as…
Leonard L. Berry, D. Kirk Hamilton
We spend much of our time in buildings, and they can have a profound effect on our well-being, for better or for worse. As long ago as 1943, Winston Churchill told Britain’s House of Commons that “we shape our buildings, and afterwards our buildings shape us.”
Research is showing that effective…
Vanessa Burrows, Suzanne Junod, John Swann
During the early 20th century, Americans were inundated with ineffective and dangerous drugs, as well as adulterated and deceptively packaged foods.
A cosmetic eyelash and eyebrow dye called Lash Lure, for example, which promised women that it would help them “radiate personality,” in fact…
Rob Matheson
Medical image registration is a common technique that involves overlaying two images, such as magnetic resonance imaging (MRI) scans, to compare and analyze anatomical differences in great detail. If a patient has a brain tumor, for instance, doctors can overlap a brain scan from several months ago…
J. B. Silvers, Mark Votruba
The new healthcare venture formed by Amazon, Berkshire Hathaway, and JPMorgan Chase announced June 20, 2018, that Harvard professor and well-known author Atul Gawande would be the company’s CEO. The idea for the new company is to innovate by cutting costs from the healthcare system, starting with…
Sharona Hoffman
On June 12, 2018, the American Medical Association announced that drug shortages pose an urgent public health crisis. This crisis should be of concern to all Americans.
The Food and Drug Administration (FDA) defines a drug shortage as a “period of time when the demand or projected demand for a…
Janet Woodcock
The staff of the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) always tries to utilize cutting-edge science and up-to-date process management, befitting our stature as the global “gold standard” in drug regulation. Maintaining that standard requires us to…
Mohammad Jalali
Like any large company, a modern hospital has hundreds, even thousands, of workers using countless computers, smartphones, and other electronic devices that are vulnerable to security breaches, data thefts, and ransomware attacks. But hospitals are unlike other companies in two important ways. They…
Bruce Hamilton
Last month I joined Eric Buhrens, CEO at Lean Enterprise Institute (LEI), to host a leadership team from Tel Aviv’s Sourasky Medical Center. They were on a study mission to many of Boston’s fine hospitals and were winding up their week with a visit to LEI. Early in the discussion, one of our guests…
Jon Speer
“I wish there was a way for the FDA to give me a heads-up about my stuff, prior to submission….”
That sentiment was really the basis behind the U.S. Food and Drug Administration’s (FDA) presubmission tool, as I was discussing recently with medical-device quality assurance and regulatory affiars…
Ryan E. Day
So, the Quality Digest team is considering a transition to working remotely for the most part. I and two other associates already do. In part one of this series, I outlined my ad-hoc attempt at creating a computer work space at home. The result was not very pretty.
As I said in part one, my home…
Marin Hedin
Limiting first-year medical residents to 16-hour work shifts, compared to “flexing” them to allow for some longer shifts, generally makes residents more satisfied with their training and work-life balance. It also makes their training directors more dissatisfied with curtailed educational…
Knowledge at Wharton
America’s healthcare system has been on the examining table lately: from the tortuous battle over the Affordable Care Act, to Senator Bernie Sanders’ bill to allow low-cost prescription drugs in from Canada, to the intriguing announcement in January that Amazon, Berkshire Hathaway, and JPMorgan…
Mike Richman
During this past Friday’s episode of Quality Digest Live, our weekly web TV show, QD editor in chief Dirk Dusharme and I covered stories about the gig economy and the skills gap and workforce shortages within manufacturing, especially as it relates to metrology, which is the science of measurement…
Chad Kymal
ISO 45001 is the much-anticipated, first ISO-based international occupational health and safety (OH&S) standard. The International Organization for Standardization (ISO) has tried twice and failed in the past to create an international OH&S management system standard. Although there are a…
Malvina Eydelman
The U.S. Food and Drug Administration’s (FDA) Breakthrough Devices Program is beginning to show important results for patients since it was established in late 2016 under the 21st Century Cures Act to help patients gain timely access to breakthrough technologies.
Consider Second Sight Medical…
Ian Setliff, Amyn Murji
The current 2017–2018 flu season is a bad one. Hospitalization rates are now higher than in recent years at the same point, and infection rates are still rising. The best line of defense is the seasonal influenza vaccine. But H3N2 viruses, like the one that’s infecting many people this year, are…
Mary Beth O’Leary
Matt Bianchi had a problem. As chief of the division of sleep medicine at Massachusetts General Hospital, he needed a better way to diagnose sleep disorders. Typically, a patient seeking a diagnosis needs to come into a sleep lab and be attached to a number of devices. This setting is hardly…
Davis Balestracci
The Individuals chart is the “Swiss Army knife” of control charts. It usually approximates the supposedly “correct” chart under most conditions, and its use is much easier to understand and explain. It can also save you a major side trip into the swamp of unnecessary calculation minutiae,…
Morten Wendelbo, Christine Crudo Blackburn
Flu season in the United States typically peaks in February, but this year’s outbreak is already one of the worst on record. As of Jan. 6, 2018, 20 children have died from the flu, and overall mortality caused by the virus is already double that of last year’s.
One reason the flu is so severe…
AssurX
Recent FDA warning letters indicate that many drug manufacturers do not have their manufacturing in a state of current good manufacturing practices (CGMPs) control. During the first half of 2017, the FDA cited adulterated products and insanitary conditions as the two most common violations in drug…
Wendy Wood
Employers have a stake in their staff’s health. It’s not just a matter of keeping health insurance premiums in check which is a consideration in countries without universal healthcare. It’s also about maximizing employee engagement and productivity, and even happiness.
Promoting health habits is…
Michael Armstrong, Kenneth Klassen
Patients often wait weeks or months for medical appointments. Canada’s Fraser Institute recently reported that Canadians typically wait 10 weeks to see specialists. Long wait times are one reason Canada ranks behind other developed countries in healthcare quality.
In the United States, waits are…
Scott Gottlieb, Jeffrey Shuren
In recent days, the U.S. Food and Drug Administration (FDA) has committed to several new policies that will modernize the agency’s approach to regulation in the medical device system.
For instance, we announced our intention to propose an alternate approach to the traditional 510(k) clearance…
Rob Matheson
Liquid-liquid separation and chemical extraction are key processes in drug manufacturing and many other industries, including oil and gas, fragrances, food, wastewater filtration, and biotechnology.
Three years ago, MIT spinout Zaiput Flow Technologies launched a novel continuous-flow liquid-…
Jon Speer
Complaint handling continues to be one of the biggest reasons medical device companies receive 438s and warning letters from the U.S. Food and Drug Administration (FDA). Companies have a lot going on once a medical device has reached the market, and it can be challenging to keep up with…
Eric Cooper
You’re in the market to build a new house. Would you tell the builder what you’re looking for, or would you just tell him to build “something?” If the latter, what’s the likelihood that the house you end up with is going to be what you want? Documenting your requirements should be obvious, right…
Mike Richman
During last Friday’s episode of Quality Digest Live, we looked at the far-reaching implications of a prospective merger, previewed our latest webinar with DNV, considered the importance of fun at work, and inspected some interesting stereo microscopes from Vision Engineering. Here’s a closer look…
Sharona Hoffman
CVS operates 9,700 pharmacies and 1,000 MinuteClinics. A decade ago, it also purchased Caremark and now operates CVS/Caremark, a pharmacy benefits manager (PBM), a type of business that administers drug-benefit programs for health plans. CVS/Caremark is one of the three largest PBMs in the United…
Scott Gottlieb
Twice a year the federal government publishes the Unified Agenda of Federal Regulatory and Deregulatory Actions (Unified Agenda), which provides the American public with insight into regulations under development or review throughout the federal government. For the U.S. Food and Drug…
Jenna Gallegos, Jean Peccoud
Biology is becoming increasingly digitized. Researchers use computers to analyze DNA, operate lab equipment and store genetic information. But new capabilities also mean new risks, and biologists remain largely unaware of the potential vulnerabilities that come with digitizing biotechnology.
The…
Quality Transformation With David Schwinn
I was recently reminded of a fundamental statement about continual improvement. In Out of the Crisis (Massachusetts Institute Center for Advanced Engineering, 1986), W. Edwards Deming stated, “I should estimate that in my experience, most troubles and most possibilities for improvement add up to…
Lou Valdez, Dara Corrigan, Peter Stein
Regulatory experts from around the world, including the Food and Drug Administration (FDA), gathered recently to discuss issues such as regenerative medical products, international collaboration to fight antimicrobial resistance (AMR), and developing strategies to combat substandard or falsified…
Patrick Horine
Readmission of patients within 30 days of discharge is one of the most serious issues plaguing healthcare delivery in the United States. No one wants to go to the hospital, let alone return shortly after being discharged; readmissions also hurt hospital bottom lines.
Readmissions cost hospitals $…
Mike Richman
During last Friday’s episode of QDL, we examined the potential of quality thinking to improve outcomes for people’s health, manufacturing, and workplace efficiency. Let’s take a look:
“World Toilet Day” ISO truly has a standard (or at least a standard in development) for everything. World Toilet…
Jay Desai
The presidential symposium at this year’s annual meeting of the Child Neurology Society of America in early October in Kansas City raised many eyebrows: The first presentation focused on burnout rates among neurologists around the country.
Many of my colleagues felt that this was an inappropriate…
Jon Speer
What exactly is a risk-based quality management system (QMS)? This is a timely topic to get into. In 2016, ISO 13485—“Medical devices”—“Quality management systems” was updated, and one of the key concepts presented is the idea of a risk-based QMS.
Historically, regulations have almost exclusively…
Grant Ramaley
I have written previously about the Medical Device Single Audit Program (MDSAP) created by the International Medical Device Regulators Forum (IMDRF). MDSAP is viewed as a single audit covering the United States, Canada, Brazil, Australia, and Japan. The intent was to establish one medical-device…
Davis Balestracci
During the early 1990s, I was president of the Twin Cities Deming Forum. I had a wonderful board to work with, one of whom was Doug Augustine, our self-appointed provocateur. Doug was a 71-year-old retired Lutheran minister, and we all loved him because he always pulled us right back to earth with…
The QA Pharm
If I could summarize in one page the most important lessons I have learned in pharmaceutical quality assurance over the last 40 years, this is it.
When it comes to putting a procedure into written words, it doesn’t mean the words will be effective in getting people to follow the procedure.
The…
Dirk Dusharme @ Quality Digest
Our Oct. 27, 2017, episode of QDL looked at Ford, autonomous cars, and changes to FDA compassionate use rules.
“Ford Plans $14B in Cost Cuts as Part of New CEO’s Strategy”
Ford Motor Co’'s new CEO plans to cut $14 billion in costs, drop some car models, and focus the company’s resources on…
Scott Gottlieb
The FDA has a long history of supporting patient access to investigational new treatments. This includes working with drug and device companies through the clinical trial process that may lead to FDA approval of the treatment. We also offer expanded access programs that provide investigational…
Mike Richman
We cover a wide range of topics on QDL most weeks, but our latest episode, from Friday, Oct. 20, 2017, provided a steady drumbeat of technological detail. Here’s what we chatted about:
“Energy Harvested from Evaporation Could Power Much of U.S., Says Study” Renewal sources of energy like solar…
Ken Kingery
The first in-car measurements of exposure to pollutants that cause oxidative stress during rush-hour commutes has turned up potentially alarming results. The levels of some forms of harmful particulate matter inside car cabins was found to be twice as high as previously believed.
Most traffic…
Jon Speer
How confident are you when it comes to design validation? Does this always involve clinical evaluation, or not? We’ve found that, like many other terms in medical device development, the two can end up getting confused. When do you use one or the other?
There tends to be a lack of clarity out…
Dirk Dusharme @ Quality Digest
Our Oct. 13, 2017, episode of Quality Digest Live looked at edge computing for natural disasters, medical records, and zero defects.
“New Research May Improve Communications During Natural Disasters”
Could edge computing help communications during disasters?
“How Health Care Leaders Should…
Ann Cleland
|nids=22799|quantity=1-->
If your hospital or clinic uses a Windows 7-based version of a Siemens PET/CT or SPECT system, it could be vulnerable to attack by a relatively low-skill hacker, according to a July 26, 2017, security advisory from the company.
The Industrial Control System Cyber…
Anna Abram
We’re at a moment of extraordinary opportunity to improve public health. New innovations are giving us fundamentally better ways to address disease. Some of the same technology is providing consumers with a broader selection of foods that can improve peoples’ diets and products that can expand…
Patricia Morrill
Do all employees in healthcare understand how their jobs link to patients in some way? If they do, then they are more likely to know the importance of service excellence.
Does every leader, physician, and employee know the statistic that preventable medical errors are the third leading cause of…
Dirk Dusharme @ Quality Digest
Our Sept. 8, 2017, episode of QDL examined a different way to conduct clinical trials, discussed fixing problems before they occur, and in the aftermath of Hurricane Harvey looked at resources for building a more resilient and sustainable infrastructure.
“A Better Way to Design Clinical Trials”
A…
Greg Anderson
In part one of this series, I described the Centers for Medicare and Medicaid Services (CMS) Innovation Center and its mission to test innovative payment and delivery models, and to implement the Medicare Access and Children's Health Insurance Program (CHIP) Reauthorization Act (MACRA) Quality…
Stephen Chick
Value has found a place at the heart of healthcare innovation. For money-conscious governments and other actors in the system, it’s not enough that a new treatment be beneficial and safe. It also needs to be cost effective.
This emphasis on value is even changing the profile of the pharmaceutical…
Thomas Cronin
We humans are uncommonly visual creatures. And those of us endowed with normal sight are used to thinking of our eyes as vital to how we experience the world.
Vision is an advanced form of photoreception—that is, light sensing. But we also experience other more rudimentary forms of photoreception…
Amie Whittington
As discussed in my previous article, the Internal Revenue Service (IRS) is ramping up compliance audits of governmental hospitals that are exempt under section 501(c)3. However, the IRS isn’t the only one monitoring your tax-exempt hospital. Other organizations have started policing these…
Dirk Dusharme @ Quality Digest
Our August 11, 2017, episode of QDL looked at the role of technology in after-market service, stairs that help you up, Fidget Cubes, and more.
“Climbing Stairs Just Got Easier With Energy-Recycling Steps”
These stairs actually help you go up.
“The Curious Case of the Fidget Cube”
How a product…
Greg Anderson
The Affordable Care Act created the CMS Innovation Center to allow Medicare and Medicaid programs to test innovative payment and delivery models that improve patient care and lower healthcare costs.
The Innovation Center organizes models into seven categories. Some models are based on payment…
Gerald Friedman
It’s easier than ever to buy stuff. You can purchase almost anything on Amazon with a click, and it is only slightly harder to find a place to stay in a foreign city on Airbnb. So why can’t we pay for healthcare the same way?
My research into the economics of healthcare suggests we should be able…
AssurX
Three recent warning letters from the Center for Device and Radiological Health (CDRH) offer a glimpse into ongoing medical-device inspection investigative focus. CAPA noncompliance is a top concern.
Inadequate corrective actions
An FDA investigation was conducted from January to February 2017 at…
Scott Gottlieb
It is incumbent upon the U.S. Food and Drug Administration (FDA) to ensure that we have the right policies in place to promote and encourage safe and effective innovation that can benefit consumers, and adopt regulatory approaches to enable the efficient development of these technologies. By…
InfinityQS
On Jan. 1, 2017, Philadelphia became one of the first U.S. cities to pass a tax ($0.15 per oz) on sugary drinks, including artificially sweetened beverages, such as diet soda. In California, San Francisco, Albany, Berkeley, and Oakland have joined Philadelphia in this initiative, as well as…
Claire McCluskie
With ISO 13485:2016—“Medical devices—Quality management systems—Requirements for regulatory purposes” published and being implemented, many medical device customers are experiencing some uncertainty about the effect that one of the standard’s key changes might have on their business: computer…
Amie Whittington
Is your governmental hospital exempt under Section 501(c)3? If you have a 403(b) plan, the answer is yes, but even if you don’t, you need to check.
The Internal Revenue Service (IRS) is ramping up compliance audits of governmental hospitals that are exempt under 501(c)3 (dual status). The…
Ian Haydon
There’s a revolution happening in biology, and its name is CRISPR. CRISPR (pronounced “crisper”) is a powerful technique for editing DNA. It has received an enormous amount of attention in the scientific and popular press, largely based on the promise of what this powerful gene-editing technology…
Erin Connelly
For a long time, medieval medicine has been dismissed as irrelevant. This time period is popularly referred to as the “Dark Ages,” which erroneously suggests that it was unenlightened by science or reason. However, some medievalists and scientists are now looking back to history for clues to…
AssurX
The Advanced Medical Technology Association (AdvaMed) wants the U.S. Food and Drug Administration (FDA) to understand that medical device manufacturers need clarity on the FDA’s heightened focus on real-world evidence (RWE).
Responding to the Center for Devices and Radiological Health’s (CDRH’s…
Wesley McGrew
Last month, the WannaCry ransomware attack hit more than150 countries and infected tens of thousands of systems worldwide. Among those victimized were England’s National Health Service, automobile manufacturers, and government systems. The worm’s ominous red ransom screen, informing the user that…
AssurX
The FDA’s Center for Devices and Radiological Health (CDRH) provided a glowing self-assessment in a recent report. The CDRH met its 2016 strategic objectives for several initiatives pertaining to medical device manufacturers.
The CDRH continues to put a premium on quality when it assesses a…
Rob Mitchum
People have touted the potential of big data and computation in medicine for what feels like decades, promising more effective and personalized treatments, new research discoveries, and smarter clinical predictions. But only recently have these technologies made it to the clinic, where they can…
Brooke Pierce
As high deductibles and escalating costs drive patients to take a more active role in their healthcare, providers are waking up to the fact that they need to pay attention to what buyers want. But uncovering those consumer insights and using them to drive organizational strategy remains a…
Dirk Dusharme @ Quality Digest
In last week’s Quality Digest Live: design digital assistance instead of digital assistants, how to make better beer, and closed-loop manufacturing.
“How Digital Media Will Bring Out Our Best Selves in the Workplace”
To improve the workplace, maybe we need a fewer digital assistants and lot more…
Laurel Thoennes @ Quality Digest
Traffic crawled. Ahead of me was a pickup, its bumper thick with stickers. From the one most cracked and faded, I saw the word “welfare.” Just before the driver switched lanes, I made out the rest: “Work harder—there are millions on welfare depending on you.” That triggered a memory so vivid I no…
Azadeh Shoaibi
The word “prism” might make you think of a triangular piece of glass that separates white light into a rainbow of colors. But at the U.S. Food and Drug Administration (FDA), it means a powerful, computer-based system that separates critical bits of information from vast streams of healthcare data…
Brenda Stodart, Renu Lal
It is well known that small business is vital to the success of the U.S. economy. Less known, though, is how instrumental it has been to the growth and innovation in drug development.
We may think of the pharmaceutical industry in terms of giant corporations, but the fact is that there are…
Mike Richman
On our most recent episode of QDL from this past Fri., April 14, 2017, we took a close look at innovation and engineering. Here’s a quick recap:
“SAE Institute Creates Webisodes to Benefit STEM Education” This piece demonstrates the good work that the San Jose, California, campus of the SAE…
Michael Causey
The FDA has made it abundantly clear that it expects medical device manufacturers and other life sciences firms to have strong cybersecurity management programs. Since the FDA hasn’t always been clear on what it expects on a granular level, the Common Vulnerability Scoring System can provide much-…
Greg Anderson
The most astute executives in health systems are rightfully concerned about compliance risks in physician contracting. Among these risks are that a transaction or an arrangement between a hospital and a physician are consistent with fair market value (FMV) and are commercially reasonable (CR) as…
AssurX
Quality management, always an FDA focus during inspections, could become even more important in 2017 as FDA priorities take shape.
In December 2016, Director Janet Woodcock laid out some of the broader goals for 2017 around the same time Congress approved the epic 21st Century Cures Act. If all…
Michael Causey
Former FDA Chairman Robert Califf, M.D., stepped down on Jan. 20, 2017, and it’s not always easy to predict what the Center for Drug Evaluation and Research (CDER), or any FDA agency, will accomplish under a new chairman. Efforts at quality management could be affected by what appears to be an…
William A. Levinson
‘Sitting is the new smoking” is a common new adage. James Levin, M.D., of the Mayo Clinic explains, “Too much sitting also seems to increase the risk of death from cardiovascular disease and cancer.” He adds that sitting for four rather than two hours a day in front of a TV screen increases the…
Tom Scaletta
Quality improvement initiatives are a mainstay for hospital care teams. They can also offer a fresh approach for raising patient satisfaction scores. To achieve maximum effectiveness, however, they require timely patient feedback.
Nowhere is this truer, perhaps, than in the high-volume/short-…
Jon Speer
If you’re in the business of developing medical devices, then risk and risk management become terms synonymous with your daily operations. Your overall task is to bring a device to market that not only provides a needed function to a patient, but is also proven to be safe to use—maybe even used by…
Greg Anderson
Like it or not, the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) is here. MACRA created the new Quality Payment Program, comprised of two pathways to higher quality: the Merit-Based Incentive Payment System (MIPS) and the Advanced Alternative Payment Models (Advanced APMs). MACRA…
Laura Gillenwater
I recently had the privilege of attending the Health Care Advisory Board’s National Meeting in St. Louis. One of the topics that really struck me was the last presentation about the importance of building a consumer-focused organization and increasing consumer loyalty.
We hear so much about the…
Anna Nagurney
When we talk about supply chains, we may conjure up images of manufacturing plants, warehouses, trucks, and shipping docks. There is another, truly unique supply chain for a product vitally important to healthcare and life, and it is very volatile at the moment: the blood supply chain.
Human…
Katherine Watts
While at the National MACRA MIPS/APM Summit in Washington, D.C., I heard much discussion centered on how to create and implement strategies that pay physicians fairly, while controlling spending in the Medicare program. It’s a question we’ve wrestled with for almost 20 years and a challenge we…
Robert M. Califf, Nina L. Hunter
About a year ago, we shared with you our combination product review, Intercenter Consult Process Study Report, developed by the U.S. Food and Drug Administration’s (FDA) Office of Planning. The report findings were derived from focus group studies with reviewers from the FDA’s different centers…
Dara Corrigan
For FDA professionals focused on drug quality and safety, the rapid increase in imported drugs from nations where we devote limited inspection resources is of great concern. One way to address this concern would be to create an expanded inspectorate, one where investigators and inspectors from the…
Davis Balestracci
Those of you familiar with W. Edwards Deming know that his Funnel Experiment ultimately shows that a process in control delivers the best results if left alone. Funnel Rule No. 4, also known as a “random walk”—i.e., making, doing, or building your next iteration based on the previous one—has been…
Vijay Iyer
As the director of the structural heart team at Kaleida Health’s Gates Vascular Institute in Buffalo, New York, I perform minimally invasive, endovascular surgeries to repair structural defects of the heart. I specialize in valve replacements, clip procedures, and other structural heart treatments…
AssurX
Life sciences companies around the world should make sure their corrective and preventive action (CAPA) plans are in good shape before a Food and Drug Administration (FDA) inspector comes calling. Looking at a deep pool of letters issued this year domestically and internationally, it’s clear the…
Suzanne Schwartz
During National Cybersecurity Awareness Month, which took place in October, the public and industry were encouraged to understand the importance of cybersecurity and to be vigilant when it comes to the technology we rely on every day, including helping patients remain confident in the safety of…
Joel Bradbury
Healthcare professionals have a long history of caring for their patients and improving the quality of their services. During the Crimean War (1853–1856), British nurse Florence Nightingale realized that the mortality rate of soldiers was far too high. A visionary statistician as well as a…
Michael Causey
It’s time to get your compliance programs in order to meet some looming international regulatory compliance demands, experts including former Food and Drug Administration officials say. Having a firm grip on quality management processes—especially document management and change control—will be…
Brooke Pierce
When Congress passed the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), “risk” moved front and center as a feature of provider reimbursement models. These days, terms such as “at risk” and “risk-based” are used more and more, but what do they really mean? And why should healthcare…
Michael Causey
The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) Director Jeff Shuren outlined the agency’s ambitious 2017 goals at an important session that was part of the conference of the Regulatory Affairs Professionals Society that was held Sept. 18, 2016, in San…
Since the launch of the Patient-Focused Drug Development (PFDD) program as part of the fifth authorization of the Prescription Drug User Fee Act, the U.S. Food and Drug Administration (FDA) has worked intensively to explore ways to enhance the patient’s voice in drug development. Recently the FDA…
During the past year, my email inbox has been consistently pinged by law firms advertising seminars and workshops that promise to help medical professionals understand what is noteworthy for 3D-printed medical products, ranging from regulatory to IP concerns. Some of these have been quite alarming…
Kade Moody
Is the following statement true or false? The new revenue recognition standard will have only a minimal effect on my accounting practices and policies. I hope that statement is true for your organization, but I think for many healthcare systems, the answer is false.
If you have already started…
Andrew Maynard
In 2014, more than 32,000 people were killed in car crashes in the United States. In 2012, more than 2 million Americans visited the emergency room as a result of car crashes. An estimated 94 percent of the crashes that caused these injuries and fatalities are attributable to human choice or error…
GBMP
Ellis Medicine is a 438-bed community and teaching healthcare system serving New York’s capital region. With four main campuses, five additional service locations, more than 3,300 employees, and more than 700 medical staff, Ellis Medicine offers an extensive array of inpatient and outpatient…
The Un-Comfort Zone With Robert Wilson
Over the years, I’ve beaten myself up over business breakdowns, lost relationships, and countless other failures. I would only look at what I’d done wrong and where I was at fault. And, of course, this would only make me feel worse.
People would tell me, “Rob, you need to love yourself.” Wow,…
Christine Schaefer
Every year a new cohort of Baldrige Executive Fellows gains intensive knowledge about leading organizations to excellence through cross-sector, peer-to-peer learning hosted at the sites of Baldrige Award recipients. Every Baldrige Fellow completes a capstone project as part of the executive…
Anthony Harris
The proliferation of Accountable Care Organizations (ACO), spurred by the healthcare industry’s shift from fee-for-service to pay-for-performance, has focused healthcare executives’ attention on clinical outcome metrics. Yet the greatest barriers—individual clinician practices—remain difficult to…
While commanding four vessels sailing between England and India in 1601, Capt. James Lancaster performed one of the great experiments in medical history. Each of the seamen on just one ship—his own, of course—was required to sip three teaspoons of lemon juice per day. By the midpoint of the voyage…
Knowledge at Wharton
Steve Klasko, president of Thomas Jefferson University and CEO of Jefferson Health, is the co-author of We Can Fix Healthcare (Mary Ann Lieber Inc., 2016) with Wharton adjunct professor Gregory P. Shea and Michael Hoad. In the book, the authors propose 12 disruptive transformations to the…
William A. Levinson
Clause 6.1 of ISO 9001:2015 requires “Actions to address risks and opportunities” first with regard to section 4.1, “Understanding the organization and its context” and second in section 4.2, “Understanding the needs and expectations of interested parties.” As 4.2 goes on to say, the latter are…
The rising price for the EpiPen, a drug delivery system that is crucial for persons experiencing potentially life-threatening allergic reactions, has resulted in outrage. The price increase, from about $94 for a two-pack of injectable epinephrine to more than $600 in just nine years, has members…
Greg Anderson
Government and commercial insurers are transforming payment systems from a fee-for-service reimbursement model to arrangements that include incentives for quality, outcomes, improved patient satisfaction, and reduced cost.
In the fee-for-service environment, hospitals, physicians, and other…
Brooke Pierce
Think back to your last car, truck, or SUV purchase. What did you want to know before spending so much money?
More than likely, you first wanted to know the price range of the type of car you were considering. You might have also wanted to know what features were standard on the various makes and…
John Maxwell
Have you ever considered the time investment required of some of the world’s greatest achievements?
• It took 26 months to build the Eiffel Tower. • It took Da Vinci four years to paint the Mona Lisa. • It took Michelangelo four years to paint the ceiling of the Sistine Chapel. • It took Leo…
Thinh Nguyen, Rachel E. Sherman
One question that product sponsors often ask the U.S. Food and Drug Administration (FDA) is whether their medical product will be regulated as a drug, a device, a biologic, or as a combination product—and in the case of the latter, which FDA component will regulate it.
One way sponsors may…
Jon Speer
Did you know that during the first six months of 2015, 69 percent of 510(k) submissions were rejected the first time? And that up to 75 percent of first-time 510(k) submissions are regularly sent back? I heard this and thought it was a crazy statistic. Is it really that high?
Then I spoke with a…
Davis Balestracci
I hope this little diversion into design of experiments (DOE) that I’ve explored in my last few columns has helped clarify some things that may have been confusing. Even if you don’t use DOE, there are still some good lessons about understanding the ever-present, insidious, lurking cloud of…
MIT News
Ever waited way too long at your doctor’s office for an appointment to start? Those long waits may soon be over. A schedule-optimizing software developed by MIT spinout Arsenal Health gets more patients seen more quickly and could soon be used by thousands of healthcare providers across the…
John Elliott
In 1978, REO Speedwagon released the single “Roll with the Changes,” a song that never fails to give me an adrenaline rush, especially as I run or bike. I think it’s pertinent to what healthcare professionals are experiencing since health reform became law in 2010 and the Centers for Medicare…
Mark Graban
Given all of the problems that exist in our American healthcare system, it’s encouraging that most healthcare organizations are endorsing or practicing some form of process improvement or operational excellence strategy. Under the banner of different labels and using different combinations of…
ISO
The global food industry has never faced more challenges. From tainted dairy products to contaminated beef, high-profile cases crop up regularly to dent consumer confidence, while leading companies work hard to reclaim lost faith. So how trustworthy is your food?
Food safety is something we tend…
Patrick Runkel
It’s been called a “demographic watershed.” During the next 15 years alone, the worldwide population of individuals aged 65 and older is projected to increase more than 60 percent, from 617 million to about 1 billion, according to a U.S. Census Bureau report.
Increasingly, countries are asking…
Jon Speer
Design controls and risk management processes should be tools to ensure that medical devices are designed, developed, and manufactured to be safe and effective, and to address indications for use, too.
All too often, however, design controls and risk management are viewed as a pile of “stuff”…
Katherine Watts
The HORNE Healthcare team has been blogging recently about the necessary business model changes we think are inevitable to healthcare transformation. We’ve focused on the macro level, urging healthcare organizations to take action. Although I believe our advice is sound for large systems, I am…
Sam Sharter
The tragic shooting in Orlando brought dozens of victims to emergency rooms. Even now, several of those people are still clinging to life. Many across the nation are praying for them and the other victims. Without quick response and high-quality emergency medical care, many more than the 49 already…
Johns Hopkins University
More than one-third of Americans say they don’t have enough time in their day to get things done, and the majority of Americans who report not having enough spare time also say they battle stress, reports the Johns Hopkins Health Review.
Busyness is a badge of honor for those who equate a packed…
Patrick Runkel
What does the eyesight of a homeless person have in common with complications from dental anesthesia? Or with reducing side-effects from cancer? Or monitoring artificial hip implants?
These are all subjects of recently published studies that use statistical analyses in Minitab to improve…
Mike Figliuolo
Work is a convenient excuse for not taking care of yourself. Not exercising, poor diet, and stress are a bad combination. You’ve got to make time for you. Work will always be there when you get back.
Just over a year ago, I had a heart attack. My second heart attack. Yep. Two. The first one…
Jennifer Marshall
For as long as we have had automobiles, we have had traffic accidents. Even the vehicles that we depend on to take care of us in the event of an accident—ambulances—get into accidents nearly every day. Because ambulances are basically a small emergency room on wheels, the occupants in the back are…
Rachel E. Sherman, Robert M. Califf
In an earlier article, we discussed a pair of concepts—interoperability and connectivity—that are essential prerequisites for creating a successful national system for evidence generation (or “EvGen”). Here, we take a look at how we would apply these constructs as we go about building such a…
Brooke Pierce
The healthcare industry is in a state of constant change, and with change comes opportunity. With the passage of the Affordable Care Act (ACA) and the Medicare Access and CHIP Reauthorization Act (MACRA), healthcare providers are, or will be, paid differently for their services. No longer can they…
Taran March @ Quality Digest
They sound like words and have a mysterious dignity rolling off the tongue. Their meanings seem both apparent and elusive. If an alien delegation landed on Earth, words like these might feature in their formal greetings. They are the most expensively researched neologisms in use around the globe.…
Grant Ramaley
The Quality System Regulation (QSR) 21 CFR Part 820, aka FDA current Good Manufacturing Practices (cGMP) for Medical Devices, is what regulatory professionals should be referencing in their quality system procedures. Part 820 embodies all the major parts of the FDA quality system that are shared…
Tonianne DeMaria
“It is a common experience that a problem difficult at night is resolved in the morning after the committee of sleep has worked on it.” —John Steinbeck
In Personal Kanban (Modus Cooperandi Press, 2011), Jim Benson and I discuss how workflow should be optimized for throughput, not capacity. Work…
Lawrence Yu
If we used a time machine to transport a pharmaceutical scientist from the 1960s into a current pharmaceutical production plant, it might be surprising to learn that he would already be familiar with most of the processes and production techniques being used. That’s because not much has changed in…
Norman A. Paradis
The last few months have witnessed the unraveling of the remarkable life sciences company Theranos, culminating in the news that federal regulators may ban Theranos founder Elizabeth Holmes from the blood-testing industry for at least two years. The company is also facing a federal criminal…
Rachel E. Sherman, Robert M. Califf
Across the clinical research enterprise, there is a growing awareness of serious shortfalls in the current model for generating the scientific evidence that supports medical product evaluation and clinical care decisions. As a result the FDA seeks to modernize methods and satisfy expectations…
Jon Speer
If you’re still using failure mode and effects analysis (FMEA) as your methodology to capture medical-device risk management activities, then your risk management process is out of date. Let me tell you why.
Here’s the definition of “risk management” as defined in ISO 14971:2007—“Medical devices—…
Ken Miller
Please pardon me, but I feel a little like a modern-day Paul Revere alerting you to the start of the second wave of Health Insurance Portability and Accountability (HIPAA) compliance audits.
Last week, Jocelyn Samuels, director of the Health and Human Services’ Office of Civil Rights (OCR),…
Kimberly Watson-Hemphill, Kristine Nissen Bradley
Editor’s note: This is an excerpt from the new book, Innovating Lean Six Sigma, by Kimberly Watson-Hemphill and Kristine Nissen Bradley.
Like every company, healthcare businesses do their work through processes, and any process can be studied and improved using basic lean Six Sigma methods. Figure…
Duke University
Evidence on the safety and effectiveness of medical devices is difficult to coordinate and assess, despite the critical role medical devices play in diagnosing and treating patients.
A new report from the planning board for a national medical device evaluation system (NMDES) describes how the…
NIST
Researchers at the National Institute of Standards and Technology (NIST) have developed the first widely useful standard for magnetic resonance imaging (MRI) of the breast, a method used to identify and monitor breast cancer.
The NIST instrument—a “phantom”—will help standardize MRIs of breast…
NIST
I
n the age-old struggle between humans and microbes, bacteria seem to be regaining the offensive. Only about a dozen classes of chemicals protect us from the myriad pathogens that populate our environment. Numerous agencies have warned that evolved resistance could soon render common antibiotics…
J.D. Power and Associates
According to the recently released J.D. Power 2016 Member Health Plan Study, critical factors of health plan member satisfaction are highest in areas of the country that have more competition between different health plans.
On a nationwide basis, member satisfaction with their health plans has…
Eston Martz
There’s plenty of noisy disagreement about the state of healthcare, but when you look beyond the controversies, a great deal of common ground exists.
Many agree that the way we’ve been doing things is wasteful and inefficient, when healthcare should be delivered as efficiently and effectively as…
NIST
Medical implants and spacecraft can suddenly go dead, often for the same reason: cracks in ceramic capacitors, which are devices that store electric charge in electronic circuits. These cracks, at first harmless and often hidden, can start conducting electricity, depleting batteries or shorting…
ISO
With medical devices ranging from simple needles to life-saving high-tech implants, ensuring the highest possible level of safety is one of the industry’s greatest priorities. Here, as the chair of the ISO technical committee for quality management and related general aspects for medical devices,…
Katherine Watts
Bundled payments. Volume-to-value. Cost accounting. Process improvement. Patient engagement. Population health. Organizational leadership. These are more than just the newest industry buzzwords: They’re the trends that will compel the healthcare industry to transform its business model. They will…
Ken Miller
I wrote last month about the need to increase security for imaging devices in hospitals. The devices I cited store both personal and medical information about patients and should be subject to standard security measures. Very often they are not.
Last month the U.S. Food and Drug Administration (…
James Brewton
The healthcare industry is under pressure to improve performance across strategic measures of performance, including delivery cost, operating revenue, employee engagement, patient safety, patient experience, and patient outcomes. A growing number of organizations turn to innovation as a way to…
Greg Anderson
A s the market gradually moves toward value-based reimbursement, hospital payments to physicians have also been in transition from purely productivity-based pay to incentives based in part on quality, patient experience, and efficiency of care. This shift has taken place in employment,…
Brandon Henning
Although the FDA’s Food Safety Modernization Act (FSMA) was passed in 2011, the reality is that the rules that went along with the law—and that truly define how it will be executed and regulated—are just now being finalized. Enforcement of these rules should really ramp up in 2016 and 2017.
Will…
Katherine Watts
It amazes me how seemingly disparate ideas, when considered together, can create new ways of seeing the world. Bear with me for a minute, and I’ll share an insight I’ve received lately based on two seemingly unrelated ideas.
Here’s the first idea: New York Times bestselling author Bruce Feiler…
Stephen Ostroff
In this third and final article reflecting on the FDA’s work to protect and promote public health during 2015, we’ll take a look at our achievements in food, antimicrobial resistance, and tobacco product regulation. In part one I shared the FDA’s 2015 accomplishments in medical product innovation…
Stephen Ostroff
In my first look back on the FDA’s 2015 accomplishments, I focused on our achievements in medical product innovation and our constant drive to make available safe, effective, and innovative products. Because the FDA’s responsibility covers the entire life cycle of products, in the second part of…
Stephen Ostroff
Since March 2015 it’s been my pleasure to serve as the Food and Drug Administration’s (FDA) Acting Commissioner. The FDA has broad responsibilities, and I’d like to share some important accomplishments during 2015.
Tasked with overseeing products that account for about 20 cents of the consumer…
Russ King
As medical science has advanced, products submitted for FDA review are using increasingly complex formulations, including unique and creative combinations of drugs, biologics, and devices. Because of this complexity, combination products, by definition, may require intercenter consultations with…
Michael Causey
Medical device warning letters and domestic inspections continue to show a slow decline, according to a new report issued by the U.S. Food and Drug Administration (FDA). The number of medical device-related warning letters dipped to 121 during calendar year (CY) 2014, compared to 144 during the…
Has your organization secured all its electronic healthcare records (EHR)? If not, don’t wait to put the proper policies and procedures in place. If you’ve already secured your EHR, then make sure that you’re ready for an audit by the Office for Civil Rights (OCR).
I recently wrote that the OCR…
Healthcare reform has undoubtedly created more integrated delivery and payment models based on a culture of quality-focused and cost-efficient clinical management. In one example, many healthcare systems have begun implementing clinical co-management arrangements (“CCMAs”) to accomplish the…
Taran March @ Quality Digest
As a sort of character-building exercise, I recently opened an unsolicited email from my health insurance provider. I was intent on doing a quick purge of sham, spam, and flimflam, and I figured this one would be no different. But I also know I’m biased against health insurers, so I decided to set…
Russ King
The path to medical device commercialization requires FDA approval, which most often means filing a premarketing notification, also known as a 510(k). The FDA has specific criteria for accepting a 510(k), and it just released its new acceptance policy. This new standard, which will be effective…
Patrick Stone
The corner drug store isn’t currently affected by many drug shortages; instead, the pain is being inflicted on a vulnerable group of patients in hospitals today. The U.S. Food and Drug Administration (FDA) “officially” list the shortage of drug products as less than 200; however, the pharma…
NIST
A newly released study comparing 34 U.S. healthcare organizations that received the Baldrige National Quality Award with their 153 geographically closest competitors found that the Baldrige Award recipients matched or exceeded their competitors’ measures of healthcare quality and outperformed them…
Russ King
The FDA just issued a Safety Communication on the cybersecurity vulnerabilities of the Hospira Symbiq Infusion System, which is a computerized pump designed for the continuous delivery of general infusion therapy for a broad patient population. The pump is mostly used in hospitals or other acute…
Michael Causey
A new Government Accounting Office (GAO) report, designed to shed light on what effect the medical device tax will have on the industry in the future, might have done a better job of taking us under the industry’s financial hood.
The GAO, the nonpartisan counting-house arm of the federal…
Michael Causey
Although medical-industry trade groups and many House and Senate members are lined up on one side, determined to repeal the medical device tax, the other side might have the final ace: A veto threat by President Obama.
Not so fast, say opponents who want to eliminate the 2.3-percent excise tax on…
Michael Causey
If you’ve got six months—and nerves of steel—here’s some good news: You have a 61-percent chance of getting your medical device approved by the Food and Drug Administration (FDA). That’s one nugget of interesting data to be found in a recent Emergo Group report that analyzed some 15,000 device…
Thomas Prewitt Jr.
Big data seem to be all the rage in healthcare, but from the perspective of a frontline clinician, they miss the mark. The clinical enterprise is the realm of small data. That’s because small data are directly related to patient care.
Examples of small data include: • Missed clinic appointments…
Alex Morris, Jon Speer
In the medical device industry, one absolute—which shows no signs of abating—is the need to maintain documentation.
We’re talking documentation to demonstrate you have a compliant quality management system, that you design and develop products to meet design controls, and that you’re addressing…
Michael Causey
We, and others, like to take the FDA to task for missing deadlines or behaving in ways that are sometimes difficult to fathom. So it’s only fair to give equal space to something when they seem to get it right. Take the agency’s Unique Device Identification System (UDI).
Readers of this column…
Alexandra Brown
Being a hospital leader is more difficult than ever in today’s changing healthcare environment. It can be easy to stray off course while dealing with regulatory compliance and financial constraints. It’s vital that a leader remembers he is responsible for one of the most precious and fragile…
Russ King
IEC 62304, the international standard that defines software development life-cycle requirements for medical device software, was developed from the perspective that product testing alone is insufficient to ensure patient safety. It provides a common framework for medical device manufacturers to…
Akhilesh Gulati
The dynamics of the healthcare environment are changing rapidly. Small primary care practices are confronting a host of regulatory, technological, and practice challenges, not the least of which is patient expectation and evaluation. The challenges are all exaggerated by social media, where…
Jim Bevier
A simple calculation—available time divided by demand—known as takt time, is a fuzzy concept for many people in healthcare. That’s understandable when you consider a hospital is open 24 hours a day, and you never know how many people are going to show up at the door. Let’s look at two concepts…
Thomas Prewitt Jr.
One of our major problems with healthcare reform is that we are doing it from the top down.
At the top, a bloated bureaucracy works in an environmental context of regulations and finance that seems to be focused on what is best for government and payers. The perils of out-of-control costs have…
ASQ
Strengthening communication between caregivers and patients should be a top priority for reducing healthcare costs and improving patient experience, according to a new poll of U.S. healthcare quality improvement professionals conducted by ASQ, the world’s largest network of quality resources and…
Alexandra Brown
Physician alignment is vital to driving the changes necessary in our shifting healthcare environment. On the hospital side, physicians are the frontline experts needed to increase quality and decrease cost. It’s impossible for a hospital system to take on important projects like fall prevention,…
Patrick Stone
The U.S. Food and Drug Administration (FDA) has a “Plain Jane” version of its Pharmaceuticals FY 2015 Action Plan. In this article, however, let’s look at some interesting wrinkles not necessarily contained in the document.
This “Plain Jane” action plan, taken straight from the document, reads as…
Jon Speer
When people talk about U.S. Food and Drug Administration (FDA) design controls, they often place a lot of emphasis on inputs and outputs, verification, transfer, and the design history file. All good things, of course; without them, you won’t meet FDA requirements for your design controls. The…
Alexandra Brown
Why is it easier for many hospitals to justify investing in capital equipment, new buildings, and service lines rather than in quality improvement? There are three major reasons.
Many hospital systems don’t know their real costs
It’s been said that the first step in fixing a problem is realizing…
Larry Spears
If you’ve been in the life science industry for awhile, you know it never gets easier but instead more complicated year after year. For example, unique device identification (UDI) requirements, combination product rules, and updated electronic medical device reporting (eMDR) requirements add to…
Kelly Kuchinski
Nestlé USA has officially announced its plans to replace the artificial flavors and colors in its chocolate candy products with natural ingredients. This decision will affect more than 250 chocolate bars across 10 brands. The first three modified candy bars—Baby Ruth, Butterfinger, and Crunch—will…
Alexandra Brown
Hospital leaders are feeling increasing pressure to find ways to thrive in our changing healthcare system. A C-suite that is removed from daily hospital operations is a liability in this era of process improvement and hands-on progress.
Here are four characteristics hospital leaders need to move…
The QA Pharm
At the risk of sounding like a pharmaceutical quality assurance heretic, standard operating procedures (SOPs) often don’t work as intended. In fact, they can do more harm than good by giving a false sense of security: “We must be OK; we have procedures for that.”
Having procedures is certainly…
Alexandra Brown
A big challenge facing academic medical centers is how to maintain a focus on patient care in an artificially divided environment.
Most academic medical centers were developed in a system with abundant resources, cost-based reimbursement, and a traditional academic departmental structure. This…
Thomas Prewitt Jr.
As we begin the journey to value-based healthcare, the relationships between a hospital and its medical staff are changing. For decades, these relationships were straightforward: Doctors admitted patients to the hospital, performed procedures and delivered therapies, and at some point, sent the…
Michael Causey
Sometimes it’s nice to be told what the U.S. Food and Drug Administration (FDA) isn’t going to do. The agency issued a guidance last month that should make anyone building or working with a medical device data system (MDDS) happy and relieved. Can you hear the collective sigh?
FDA defines MDDS as…
Dawn Keller
Juvenile idiopathic scoliosis. That was the diagnosis given to my then 8-year-old daughter last January. In short, it means that she’s young (under 10), she exhibits an abnormal amount of spinal curvature, and there’s no identified cause (aside from some bad luck).
Emilia’s X-rays indicated an S-…
As more physicians are integrating their patient electronic medical records (EMRs) with third-party patient portals, they’re looking for clarifications on many issues to stay within the various regulations boundaries and to be meaningful use-attested. It can be difficult to differentiate fact from…
Michael Causey
Scholars still debate how long it took to build the Great Wall of China, but it’s generally agreed it was built in stages between the 5th century B.C. and the 16th century A.D. The Great Pyramid of Giza took about 20 years to construct, according to ancient historians, but it must be remembered…
Michael Causey
The next time you want a cheeseburger, you might consider hopping a plane and flying to Germany. Or France. Or New Zealand. Basically, anywhere but the United States of America.
Almost across the board, the United States ranks at the bottom (“regressive”) for produce traceability programs as…
Tripp Babbitt
In my last column I wrote about the seven perspectives that pollute customers and culture. These perspectives rule the design of our organizations. They are inherent to our work cultures and thinking. They put us on autopilot as we toil in our everyday work. The first step to change that is to…
Michael Causey
A
s expected, the FDA is shifting more of its regulatory focus toward medical device reporting (MDR). In an Oct. 1, 2014, letter, the agency’s Baltimore district office hit Baltimore-based Electronic Development Labs for not having a MDR procedure. Bad idea. The company may not have recovered very…
Alexandra Brown
My husband and I both like to run. I run about three miles once or twice a week—if the weather’s not too bad, and if I don’t have something else going on. Keith, on the other hand, runs half marathons.
Keith goes for long runs on the weekends for three to four hours at a time and shorter runs…
Jeff Mazik
If you have been procrastinating on setting up electronic submissions for your adverse event reports to the FDA, you might want to reconsider that decision. Earlier this year, the FDA published its final rule on MedWatch/eMDR reporting.
Although not much has changed in this final rule in regards…
Margaret A. Hamburg
I recently wrapped up a jam-packed, five-day visit to China, a fascinating country with a dramatically growing economy and an increasingly significant effect on the products that U.S. citizens consume. Indeed, a key reason for my trip is the important and growing collaboration between the FDA and…
Gary Minks
Medical device manufacturers seeking global access for their products can face significant challenges in meeting the regulatory requirements of multiple target markets. The approval process can be even more time-consuming when individual regulatory authorities require an independent audit of a…
Michael Causey
After years of decline, medical device approvals by the FDA have finally begun to hit the gas pedal, according to an interesting report from the California Healthcare Institute (CHI) and Boston Consulting Group (BCG).
In hindsight, it appears the FDA hit bottom in 2010 when approval times…
The QA Pharm
Responding to FDA 483 observations was my focus in part 1 of this series. Responses lead to commitments, and commitments lead to changes that are intended to prevent recurrence of the underlying problem that led to the observation.
Here, I’ll share my views on getting the work done to fulfill…
Dave Cranmer
Some things are just meant to be, apparently. Sept. 23, 2014, marked an interesting waypoint in the career of someone concerned about standards of measurement, because on that day, I became a standard reference human.
Having started working for the (then) National Bureau of Standards (NBS) almost…
Johns Hopkins University
A weekend design challenge to develop new protective gear for health workers fighting Ebola drew students, faculty, and clinicians from across Johns Hopkins University and beyond, along with $25,000 in state seed grants to support further development of the best ideas.
Jhpiego, a nonprofit global…
The QA Pharm
This three-part series will discuss how to respond to the U.S. Food and Drug Administration’s Form 483 (FDA 483), which is issued at the conclusion of an inspection to document potential violations to the Federal Food, Drug, and Cosmetic Act. We’ll look at how to assess the work needed to address…
Quality Digest
BioCision was founded in 2007 by Rolf Ehrhardt and Brian Schryver when they realized, having spent many years in the clinical and laboratory environment, that there were critical unmet needs in the handling of temperature-sensitive biospecimens and biologics.
The rapid adoption of their first…
Alexandra Brown
The past five to 10 years, hospitals and physician offices have been in a mad dash to implement electronic health records (EHRs) to meet governmental regulatory requirements. Now that most projects are either complete or well on their way, what are we doing with all of the data that EHRs promised…
Katherine Watts
Healthcare in 2014 is in a state of flux. The Affordable Care Act (ACA) health insurance exchange marketplace opened in October of 2013 with a rough start, and it has still not gained traction. Meanwhile, Medicare and Medicaid are squeezing reimbursement, and there is a growing population paired…
Barry Plunkett
Leadership at healthcare organizations is being tested like never before. The move away from a fee-for-service model to a patient-outcome-based model means management has to get clinical-care teams collaborating in a whole new way.
Your leadership style and the culture you help create within your…
Michael Causey
Well, boys and girls, Halloween is approaching. Although it’s fun to don a Dracula (or Miley Cyrus) costume and get some yucks faux-scaring folks, the FDA is acting like a responsible parent by setting up a medical-device cybersecurity public workshop, “Collaborative Approaches for Medical Device…
The QA Pharm
Oftentimes pharma has a split personality. One personality loathes firefighting, and the other needs a burning platform to justify doing anything that requires spending money.
Go figure.
This becomes evident in our industry when some companies can’t part with a pittance of their billion-dollar…
Tamar June
The landmark Food Safety Modernization Act (FSMA) just keeps getting more and more important. Earlier this month, the Food and Drug Administration (FDA) unveiled four proposed amendments that will likely make a tough law even tougher.
The FSMA, signed into law in January 2011, is designed to…
Alexandra Brown
As a physician, I enjoy listening to nonphysicians tell me how to motivate doctors. I don’t mean this in a totally snarky way (well, maybe just a little). These conversations often highlight the chasm that exists between physicians and administration.
What’s the most common motivator people throw…
Russ King
Food and Drug Administration (FDA) medical device recalls are on the rise. An increasingly active FDA coupled with an increase of medical device software components is adding up to new challenges for manufacturers. It’s important to understand how the FDA uses IEC 62304, an international standard…
Whitney Andrews
Medical device manufacturers are facing mounting pressure to better manage the quality of their supply chain. One approach they’ve taken to improve risk management and increase efficiency is to partner with suppliers who are ISO 13485 certified.
ISO 13485 is an internationally recognized quality…
Thomas Prewitt Jr.
I am concerned about the rush to consolidation we are seeing in the hospital industry. It seems all too tidy and easy, and if there is anything I have learned from my 30+ years in clinical medicine, it is that nothing in healthcare is easy.
Larger hospitals began acquiring smaller hospitals in…
Taha A. Kass-Hout, Jeffrey Shuren
In addition to food and drugs, the FDA has regulatory oversight of tens of thousands of medical devices ranging from bandages and prosthetics to heart valves and robotics. These products are used by millions of Americans, and they are essential, well-performing tools of modern healthcare, but…
Michael Causey
Medical device manufacturers would be well-advised to address any risk with potential home-use products during their design phase, according to an August 2014 guidance from the FDA.
As the agency notes, “Failure to adequately consider potentially hazardous situations during the design of home-use…
Dawn Bailey
In a recent column, I shared insights from the 2013 Baldrige Award recipients’ leaders as they fielded questions related to their journeys to excellence. There was so much thoughtful reflection that it couldn’t fit into just one column.
More answers to questions follow:
How did you convey to…
Carly Barry
Via Christi Health, the largest provider of healthcare in Kansas, operates a Center for Clinical Excellence that’s made up of a team of quality practitioners; all have had lean and Six Sigma training. I recently had the opportunity to talk with the team about the types of projects they’re working…
The QA Pharm
After nearly 20 years helping the biopharmaceutical industry to regulatory enforcement by implementing an operational and sustainable quality management system, I have come to the conclusion—at the most fundamental level—that there are three quintessential elements required for success. I call…
Russ King
The FDA recently released a new draft guidance document for medical device data systems (MDDS). The FDA defines MDDS as “hardware or software products that transfer, store, convert formats and display medical device data. An MDDS does not modify data, and it does not control the functions or…
Howard Sklamberg
Since July 9, 2012, when President Obama signed the Food and Drug Administration Safety and Innovation Act (FDASIA), a group of colleagues and I have had an urgent mission: implement Title VII of the statute. This section gave the FDA new authority to better protect the global drug supply chain,…
Christine Schaefer
In the Baldrige Health Care Criteria for Performance Excellence, category three, concerning customer focus, asks how your organization engages its patients and other customers for long-term marketplace success. The related self-assessment questions cover how your organization listens to the voice…
Michael Causey
If someone out in there in the wild wonderful world of the web takes a potshot at your drug or device, the first thing to do is take a deep breath and think. Any crisis communications executive worth her salt will tell you it’s often best to let the attacker eat silence rather than draw more…
AAFP
For the 11th consecutive year, the Agency for Healthcare Research and Quality has released complementary reports that assess the U.S. healthcare system’s performance in the areas of healthcare quality, access, and disparities in care.
The two reports—the 2013 National Healthcare Quality Report and…
Robert Fangmeyer
What does healthcare in the United States need? Well, according to a report released May 29, 2014, by the President’s Council of Advisors on Science and Technology (PCAST), U.S. healthcare organizations need “systems engineering.”
In their letter to President Obama, PCAST co-chairs John Holdren…
Not knowing the answer to the question posed in the title of this article has led many medical device manufacturers to undertake expensive and unnecessary retesting of their previously certified products.
In Annex 1 of the “Medical Device Directive 93/42/EEC—Essential Requirements—Section 2,” the…
Enterprise Innovation Institute at Georgia Tech
Two major noncommercial health information technology organizations are working together in a new vendor-neutral health IT innovation network designed to stimulate development of new ideas and shorten the time required to bring new solutions into practice.
The Department of Veterans Affairs (VA)…
Kelly Kuchinski
Editor’s note: A webinar on this topic will held on May 29, 2014, at 2:00 p.m. Eastern / 11:00 a.m. Pacific. Register here.
Food and beverage manufacturers have seen a considerable number of changes over the last decade. Mergers and acquisitions have expanded the footprint of many food and beverage…
University of Arizona
To keep hospitalized patients safer, University of Arizona (UA) researchers are working on new technology that involves a small, wearable sensor that measures a patient’s activity, heart rate, wakefulness, and other biometrics—data that can predict a fall before it happens.
More than 500,000…
Ryan E. Day
Last month I, along with millions of other people around the world, celebrated Easter. For myself, a religious observance, for others a celebration of seasonal renewal. I think for most people, Easter is a time that elicits reflection on what matters most in the world. The state of the global…
Grant Ramaley
Congress has mandated that every two years the FDA will have inspected nearly every medical device manufacturer on planet Earth that sells to the United States. This isn’t happening. Some have the illusory hope that the Medical Device Single Audit Program (MDSAP) will remedy this.
There just aren…
Dawn Bailey
In health care settings, clinical integration is a fairly new concept that means coordinating patient care across conditions, providers, settings, and time to achieve care that is safe, timely, effective, efficient, equitable, and patient-focused.
According to Becker’s Hospital Review, “clinical…
The QA Pharm
There are many instances when a pharmaceutical quality management system (QMS) must be improved in part or as a whole. In some cases improvements are made in response to regulatory inspection observations. In other cases they are made when new company standards are deployed to remain current with…
Steve George
The implementation of the Affordable Care Act (ACA) will stress a healthcare system that is already under the strain of an aging baby boomer population. New patients are expected to flood the system starting in early 2014, part of the 25 million uninsured Americans projected to get health coverage…
Margaret A. Hamburg
As my busy and productive trip to India drew to a close, I had the opportunity for one final meeting and one last memory with a group of some of the country’s most extraordinary women. The occasion was a women’s roundtable in Mumbai, organized by the Confederation of Indian Industry (CII).
It…
Margaret A. Hamburg
We all know that just as every person is different, so too is every disease and every drug. And so we weren’t surprised by the results of a new study published in the Journal of the American Medical Association.
The study found that the FDA used a range of clinical trial evidence when approving…
Mike Figliuolo
PowerPoint is the devil’s instrument, and when you use it, you risk becoming a musician in his demonic orchestra. All of us are required to give presentations in some form or fashion at various points in our careers. If you’d like to succeed in those efforts, there are three things you should never…
Dirk Dusharme @ Quality Digest
This past November, three winners of the 2013 Malcolm Baldrige National Quality awards were announced, one in education and two in healthcare. Quality Digest Daily is fortunate that one of the winners, Sutter Davis Hospital (SDH) is practically in our back yard. This gave us an opportunity to meet…
Arun Hariharan
Last week, I accompanied my father to an eye hospital to get his eye examined for a suspected cataract. The hospital examined his eye and confirmed the presence of a cataract. They recommended surgically implanting an artificial lens in his eye—a fairly common procedure these days for cataract…
Gerry Cronin
At GBMP’s recent Northeast Shingo Prize Conference in Hyannis, Massachusetts, the Center for Comparative Medicine (CCM) displayed adaptations of lean to biomedical research in its Community of Lean Lounge. Conference attendees were drawn in by the wacky display of dangerous animals and props, but…
Grant Ramaley
Many of us have heard horror stories about ISO certificates that were fakes, or of medical-device quality system audits being performed by persons who were not competent. A recent report published by the European Commission found that two out of 11 notified bodies were performing so inadequately,…
Patrick Stone
The Food and Drug Administration’s (FDA) “Food Police” will be in full force to secure budget funds for food safety initiatives for FY 2014 as mandated by Congress. More than half of the operating funds will be earmarked for food work.
International food inspections will surely be a focus area…
Stewart Anderson
A recent news story here in Ontario detailed how health officials were reviewing the results of 3,500 CT scans and mammograms at two Toronto-area hospitals because of potential errors caused by a radiologist’s “performance issue.” Although the results of that review are still pending, the story…
Paul Naysmith
Arecent call with an old colleague from Europe got me wondering about a question that few are conscious of: Who is the customer of your quality document? Oh boy, did we have an interesting discussion about quality systems.
My friend was developing and reinvigorating his employer’s quality system,…
MIT News
Moore’s Law predicts that every two years the cost of computing will fall by half. That’s one reason why tomorrow’s gadgets may be better, and cheaper, too. But in American hospitals and doctors’ offices, a very different law seems to hold sway: Every 13 years, spending on U.S. healthcare doubles…
Gallup
Hospitals are facing ever-increasing pressure to evaluate and cut costs. This isn’t surprising. Medical supplies represent as much as 30 percent of an average hospital’s total operating expenses. Regulatory and economic changes, and initiatives such as value-based purchasing, are also pushing…
Michael Causey
School bells have sounded the death knell of summer across the land. But as we’ve noted before, the U.S. Food and Drug Administration (FDA) didn’t take much time off to enjoy surf and sand. The agency capped a busy season last week by issuing a new guidance aimed at investigational review boards (…
Bakul Patel
For medical devices, the term “interoperability” refers to the ability of various devices to interact, and for electronic health record systems to talk to each other using a common vocabulary. It is similar to the concept of “plug and play” computer attachments such as a web cam or mouse, which…
The QA Pharm
Editor’s note: This is the second in a five-part series exploring issues that affect management’s ability to detect the warning signals of current good manufacturing practice (cGMP) compliance problems in the pharmaceutical industry.
In part one of this series, I discussed the management…
Christine Tremblay
Most people are surprised to learn that more than half of small medical practices are still using handwritten paper charts to collect and store demographic and clinical information about patients. Although every medical office has computers, many doctors never touch them.
Other professions have…
Patrick Stone
How often do we see Health Insurance Portability and Accountability (HIPAA) violations issued because a regulated entity did not secure the electronic records at the hospital and small clinics? Large-scale security breaches and, sometimes, reports of illegal sales of electronic medical records by…
Knowledge at Wharton
When you overhear a person five spots ahead of you at the coffee shop ordering a mocha light decaf, no whip, one pump, it might be enough to make you abandon your place in line and walk out. But what if the context is different and what’s at stake isn’t a hand-crafted drink, but your health—or…
John Roth
In an earlier article, I explained how the Food and Drug Administration’s (FDA) Office of Criminal Investigation (OCI) works when a small portion of the industry fails to adequately respond to regulatory action. For Abbott Laboratories and Amgen, the price for regulatory malfeasance was high: $1.4…
Gallup
If you’re a hospital leader, the safety of your patients and your employees might be keeping you up at night. That’s because senior management is accountable for creating and maintaining a safe environment for hospital staff and patients. You’re right to be concerned. Research has shown that the…
Quality Digest
On March 28, 2013, the world lost a person whom many consider to be a major contributor to the world of industrial statistics: George E. P. Box. Relatively unknown outside the world of statistics, Box was certainly very well known by those who have studied or practiced industrial statistics.
His…
Harry Hertz
According to a recent PBS report based on information from the Organization for Economic Co-operation and Development (OECD), the United States’ healtcare expenditures are 2.5 times greater than that of the most developed nations around the world. Depending on which report you read, our healthcare…
Matthew E. May
Recently I had a conversation with a friend who was upset about some directional shifts and a looming job shuffle within his company. As I listened to the lament, I recognized that the changes he described focused on the symptoms of the issue. All of his reactions and proposed courses of action…
Davis Balestracci
The 24th Institute for Healthcare Improvement (IHI) Annual Forum took place on Dec. 9–12, 2012. It is probably the leading health care improvement event in the world. I have presented there for 20 consecutive years and watched it evolve from barely 1,000 attendees to well over 5,000. What’s changed…
Margaret A. Hamburg
Every year, millions of products regulated by the Food and Drug Administration (FDA) flood into the United States from 150 countries. Ensuring these products are safe and effective can be daunting task. It was heartening for me to sign two cooperative arrangements with some of our international…
Matthew E. May
I remember when I first discovered the work of Mark Graban. The year was 2008, and I was preparing to speak to the Massachusetts Hospital Association, an audience of about 400 hospital CEOs and administrators. They wanted me to tie my work with Toyota to healthcare, which I had no firsthand…
Jay Arthur—The KnowWare Man
The United States spends $2.5 trillion for healthcare. Healthcare spending is expected to reach $4.5 trillion by the end of the decade. With Obamacare becoming a reality, we need to find a way cut the cost of healthcare to help pay for these increasing costs. The Institute of Medicine (IOM)…
University of Michigan
At hospital shift changes, doctors and nurses exchange crucial information about the patients they’re handing over—or at least they strive to. In reality, they might not spend enough time talking about the toughest cases, according to a study led by the University of Michigan.
These quick but…
Johns Hopkins University
Computational medicine, a fast-growing method of using computer models and sophisticated software to figure out how disease develops—and how to thwart it—has begun to leap off the drawing board and land in the hands of doctors who treat patients for heart ailments, cancer, and other illnesses.…
Gallup
The rising cost of healthcare in the United States coupled with the absence of return on investment for Americans’ health is an important concern for many leaders across the country. And as many health systems adopt new strategies to reduce patient readmission rates and improve Hospital Consumer…
Michael Causey
There are two things right now that get relatively bipartisan support in Washington, D.C. The first is that a major league baseball team in D.C. won a pennant for the first time since we stopped huddling around our radios for entertainment. [Editor’s note: The Nationals lost in the first round of…
Tefen Management Consulting
One of the many hidden challenges in hospital systems is to ensure required supplies are readily available and in the right quantity. Significant manpower is invested in material management so that patients receive care without interruption. An optimized supply system that uses modern technology…
Tefen Management Consulting
When a medical institution aspires toward excellence and patient safety, quality enhancement proves to be a key factor essential to the process.
It goes without saying that there are countless risks in the healthcare system, and that it is always a priority to minimize these. There is nothing new…
Institute of Medicine
America’s healthcare system has become too complex and costly to continue business as usual, according to the report, “Best Care at Lower Cost: The Path to Continuously Learning Health Care in America” from the Institute of Medicine.
Inefficiencies, an overwhelming amount of data, and other…
Tracey Lynn King, Brian A. Stockhoff, Mary Beth Edmond
Editor’s note: This is the third of a three-part series on quality in healthcare. Part one described the Juran Model for Patient Safety, and part two identified elements of a patient safety officer program.
With between 44,000 to 98,000 patients dying each year in hospitals as a result of medical…
Mike Roberts
Adverse food safety events can have disastrous effects on branding and profitability. Because information today can go viral in a matter of hours, companies in the food and beverage industry are faced with increasing pressures to operate seamlessly, with little or no room for error…
Mary Beth Edmond, Jonathan Flanders
Editor's note: Part one of this three-part series on patient safety, "Establishing a Patient Safety Culture," offered an overview of the Juran Model for Patient Safety. Part Two takes a closer look at Juran's patient safety curriculum and certification.
It has been 22 years since the Institute of…
Mary Beth Edmond, Jonathan Flanders
Ensuring patient safety is one of the most vital and challenging roles in health care. Public reporting of preventable medical errors has forced hospitals to report their medical error numbers accurately and to improve the quality of care. Organizations such as the Institute of Medicine recommend…
Patrick Stone
Speed up approval for new health care products and minimize a major drug shortage. Sounds good so far, right? Let’s hope lawmakers get this right with a new bill designed to speed delivery and avert shortages of life-saving medicines.
Throughout the Food and Drug Administration’s (FDA) history,…
Alberto Gutierrez
During the next few months, manufacturers of certain in vitro diagnostic and radiology products may start to notice they are getting decisions on their premarket notification submissions, aka 510(k), sooner than expected. This will be due to a six-month pilot program called Triage, launched…
Mark Graban
As the Supreme Court debates the fate of “Obama Care,” we should recall the formal name of the law: the Patient Protection and Affordable Care Act (PPACA). Most of the public debate has been about the cost of health care, losing sight of the urgent need to fix the ongoing crisis of quality and…
Michael Causey
While calling it one of the more “egregious” examples he’s seen or heard about, Fisher Wallace Labs (FWL) CEO Chip Fisher said the Food and Drug Administration’s (FDA) attempt to “force its own agenda” over dissenting science or how its own advisory boards vote on medical device classification is…
Banner Medical
Banner Medical is committed to an ambitious approach to quality assurance, one developed specifically for the evolving, critical needs of the medical device industry. The company believes this investment achieves multiple payoffs—in relationship-building with customers, in risk mitigation, and in…
Michael Causey
Predicting things on Capitol Hill is never easy, especially as the election campaign “silly season” enters the picture, but it’s beginning to look like medical device companies should expect heavier regulation in 2012, and that will only increase if President Obama is reelected in November.
The…
Davis Balestracci
In my March 7, 2012, column, “An Elegantly Simple but Counterintuitive Approach to Analysis,” I suggested the necessity to formally assess the stability of the process producing any data—a step not usually taught in most academic statistics courses. This is done by plotting the data in their…
Christine Forcier
The global demand for medical devices has been steady in traditional markets despite the economic downturn and even increasing in some emerging markets. For medical device manufacturers seeking access to new markets, conformity with regulatory requirements is most often a prerequisite. Those who…
Grant Ramaley
One of the greatest challenges that I have in discussing standards is trying to put things in a context so that all people affected by them can understand how they matter. So I want to start with a simple picture and a remarkable snapshot in time. It shows how small medical-device companies are…
Guidon Performance Solutions LLC
Industry experts at Guidon Performance Solutions’ Second Annual Virtual Healthcare Summit agreed that health care organizations’ ability to survive their increasingly demanding and changing environment will require a new agility and adaptability. Consensus from the speakers signaled that most…
Stanford News Service
For 50 years, scientists searched for the secret to making tiny implantable devices that could travel through the bloodstream. Engineers at Stanford University have demonstrated just such a device. Powered without wires or batteries, it can propel itself though the bloodstream and is small enough…
Texas A and M News and Information Services
In an era of soaring medical costs, providing health care to employees at or near their workplace is gaining new momentum, according to an article in the Winter 2012 issue of MIT Sloan Management Review.
A 2011 study by the professional-services company Towers Watson and the nonprofit National…
Dale Hallerberg
There are substantial changes in the third edition of IEC 60601-1, and understanding all aspects of them is the key to turning the standard into a benefit for medical-device manufacturers.
This article explains the philosophy behind the major changes in the standard, how these changes will affect…
Mark R. Hamel
During a recent trip to the great state of Texas, I heard some down-home wisdom: “Before you season your food, why don’t you taste it first?” The person who uttered that question was not talking about food. Rather, he was challenging someone who was a little too hell-bent on changing something…
News-Medical.Net
Japanese vehicle manufacturer, Toyota, is well-known for developing the principles of lean manufacturing. Research published in the International Journal of Technology Management suggests that the lean approach might also be beneficial to medical procedures, making hospitals more efficient and…
Davis Balestracci
I recently attended the annual forum of the Institute for Healthcare Improvement (IHI), which is probably the leading health improvement organization in the world. The forum has grown from under 100 attendees in 1989 to almost 6,000 this year—half of whom were there for the first time—with now…
UC Berkeley NewsCenter
A nurse refuses to help an ailing alcoholic who is upset to find a hospital detox unit closed. A hospital clerk brushes off a deceased woman’s grieving family as they try to pay her bills and claim her belongings. A charge nurse keeps the mother of gunshot victim from seeing her son, saying the…
Mark Graban
To improve quality, the most effective hospitals and leaders focus on processes and systems, instead of just lecturing and cajoling their employees and physicians to do better. W. Edwards Deming famously stated that the problem with posters and exhortations was that “they take no account of the…
William A. Levinson
Hospital-acquired infections, ventilator-acquired pneumonia, patient falls, and similar events are (hopefully) rare enough to promote discussion of control charts for rare events. A Google search will, for example, turn up the application of u charts to falls per 1,000 patient days (u being…
William A. Conway M.D.
As a 2011 recipient of the Malcolm Baldrige National Quality Award, the Henry Ford Health System in Detroit has achieved recognition as a top-performing organization for excellence in innovation, efficiency, and quality improvement. The highest priority of our quality improvement work is to…
As You Sow
A first-of-its-kind framework released Dec. 6, 2011, offers recommendations to food and food packaging companies on how to identify and evaluate nanomaterials in products. Not only is this technology unregulated and untested for its implications on public health but companies may not even be…
ASQ
(ASQ: Milwaukee, WI) -- The results of ASQ’s 25th annual Salary Survey show strong average salaries for quality professionals in 2011 and fewer lay-offs as companies continue to see the value of quality and its positive impact on an organization.
The survey results also show that experience…
Bill Kalmar
The 2011 Malcolm Baldrige National Quality Award winners were announced last week, and for the first time, three recipients are in the health care category.
The recipients of the 2011 Baldrige Award are:
• Concordia Publishing House, St. Louis (nonprofit)
• Henry Ford Health System, Detroit (…
Stanford News Service
A readily portable miniature microscope weighing less than 2 grams and tiny enough to balance on your fingertip has been developed by Stanford University researchers. The scope is designed to see fluorescent markers, such as dyes, commonly used by medical and biological researchers studying the…
The Advisory Board Co.
In our current health care environment, hospitals face increasing urgency to strengthen relationships with physicians. Among the concerns are an aging population driving increased demand for health care (as well as a growing Medicare population), reimbursement reductions and changes, and…
The Ohio State University
Drugs produced in offshore manufacturing plants—even those run by U.S. manufacturers—pose a greater quality risk than those prepared in the mainland United States, a new study suggests.
Researchers found that drugs produced at plants located in Puerto Rico that are owned and operated by U.S…
When the Japanese word kaizen entered the language of quality improvement via Masaaki Imai’s seminal book, Kaizen: The Key to Japan’s Competitive Success, (McGraw-Hill/Irwin, 1986), the author defined kaizen as “ongoing improvement involving everyone.” In a 2011 video posted on YouTube, Imai…
Mark R. Hamel
First, the introduction. This post was earnestly written by my friend, Jeff Fuchs. He’s the director of the Maryland World Class Consortia, a lean nonprofit assistance organization in the mid-Atlantic. He’s also president of Neovista Consulting, which works with large and small organizations on…
Davis Balestracci
Finally, the medical industry is putting aside its “We’re medicine; we’re different” mindset and taking a more practical look at quality improvement. Bravo! Although an element of physician culture remains convinced that improvement is all about outcomes and double-blind clinical trials, the…
American College of Surgeons
The American College of Surgeons (ACS) has set a goal to enlist at least 1,000 hospitals into its respected National Surgical Quality Improvement Program (ACS NSQIP). The commitment is part of the ACS Inspiring Quality initiative, an effort to raise awareness of proven models of quality…
William A. Levinson
Dr. Gary Brandeland’s article, “The Day Joy Died,” which appeared in the Oct. 20, 2006, edition of Modern Medicine, underscores the primitive nature of quality thinking—and more specifically, safety thinking—in hospitals. Although I’m not going to give formal engineering advice about medical…
Bill Kalmar
Sseems the Diet Police are once again running rampant in our nation. It has been said that close to 30 percent of Michigan residents are overweight, and thus there is a movement afoot to curtail our eating habits, not only in that state but also nationally. Believe it or not, there is some…
Davis Balestracci
After reading Joe De Feo’s July 8, 2011, Quality Digest Daily article, “A Positive Prognosis: Transforming Health Care in America,” I took another look at the wonderful book, Escape Fire (Jossey-Bass, 2003), a compendium of Dr. Donald Berwick’s inspiring plenary speeches at the Institute for…
Joseph A. DeFeo
In the U.S. health care system, quality and safety have developed into strategically important issues. Progress is being made at the local level, even if it is slow and doesn’t get much of the public’s attention. Health care improvement has certainly come a long way since the early 1990s, when an…
Dennis Payton
With the explosive growth in imported goods to the United States, what is the Food and Drug Administration (FDA) doing toward maintaining a level of service inspection that ensures the best protection of the public health? One option is to partner with the countries exporting the supplies. Perhaps…
Don Sayre
There is a new international standard published June 9, 2011, that might just warrant your attention. This standard’s purpose is help organizations follow a systematic approach to improving energy performance, including energy efficiency, energy use, and consumption. It applies to variables that…
Mayo Clinic
“We can do better” was the underlying takeaway message from the 15th annual Mayo Clinic Quality Conference. This year’s theme was “Creating and Paying for Value in Health Care.”
The conference, held May 3–4, 2011, in Rochester, Minnesota, drew about 1,000 people to hear national leaders in…
Mike Richman
Last month I wrote an article entitled “Being Comfortable in a World of Never-Ending Change.” Editor in Chief Dirk Dusharme and I also covered this story on the April 29th edition of Quality Digest Live (QDL). QDL, by the way, is our live video show wrap-up of the week’s top industry news and…
Bruce Hamilton
About six years ago I was meeting with a clinical team to kick off an early improvement effort at their hospital. We began with a reflection on the problems with traditional business management practices. To break the ice, I played a short clip from an I Love Lucy episode that has now become a…
Mike Chamberlain
According to the National Center for Health Care (NCHC), emergency department (ED) crowding has been a concern in U.S. hospitals for more than a decade. The Centers for Disease Control and Prevention (CDC) report the number of visits to EDs rose 19 percent from 1995 to 2005, even as the number of…
This is one of the first questions that executives always ask me. Because it is a broad question, the answer is often challenging. I usually respond with a few examples that have been gathered in Juran Institute’s 20-year benchmarking practice database, such as Company A is this, and Company B is…
American Sentinel University
Critical care units at St. Joseph’s Hospital Health Center in Syracuse, New York, were faced with a formidable task. They had applied to receive the Beacon Award for Critical Care Excellence, a distinction given only to the top intensive care units in the United States. One of the components on…
Mike Richman
Welcome to Quality Digest Daily 2.0! This new format represents a significant re-imaging of our flagship brand (the industry’s only daily newsletter), which we first launched nearly two years ago. I hope you notice that we’ve added more video content to the newsletter as well as greater editorial…
Danita Johnson Hughes Ph.D.
Read this. It won’t be a waste of time.
Time gets lost. People kill time. Time flies. It gets wasted. Time weighs heavy on our hands. We spend time. Time passes. It drags on or it hurries by. Those behind bars are said to be doing time. Sometimes, we have no time left; we’re out of time.…
In business there’s a saying: Time is money. The more time it takes for something to get done, the more money is wasted. Companies that can figure out a way to compress the time it takes for something to happen can realize significant cost savings and also get their products into the market faster…
Pierre Huot
If a manufacturer were to ask its clients how they evaluated goods or services, the three most common metrics would be goods at a fair price, on-time delivery, and quality. Ask which could be most valuable and in all likelihood the most significant response would be quality. When included in the…
Georgia Institute of Technology
Researchers from the Georgia Institute of Technology have created a new sampling device that could prevent thousands of people worldwide from dying of pneumonia each year.
Called PneumoniaCheck, the device created at Georgia Tech, is a solution to the problem of diagnosing pneumonia, which is a…
Claudia Jackson
Twitter is not at all what I expected. After a few months, I now use Twitter to improve my knowledge in health care quality, expand my professional network, and save time. Through Twitter, I’ve connected with an amazing variety of people, including health care providers, marketing pros, e-patients…
Barbara A. Cleary
A young man in PQ Systems' hometown survived a dramatic auto accident last summer in which police-captured video footage of his spectacular, airborne vehicle was broadcast throughout the nation. That was just the beginning of his problems, for during his hospitalization, his medical records were…
A new year always brings new hope, new plans, and new perspectives. While looking ahead is the most direct route to progress, looking back is essential to understanding the present. After all, the past creates the consequences that will shape the future.
With this in mind, the editors of…
Mike Richman
A recent article appearing in the Quality Digest Daily e-newsletter (“Why Lean? Why Now?” by Dean Bliss http://www.qualitydigest.com/inside/health-care-news/why-lean-why-now.html) discusses the value of lean in a health care setting. In his editorial, Bliss writes about the manufacturing origins…
It is no secret that the health care industry is undergoing revolutionary changes. Are you responding by re-evaluating your approach to process improvement? In a world where doing more work with fewer resources is the norm rather than the exception, now is the right time to update your own work…
Mark Graban
Lean thinkers see the waste in health care when they are at the hospital gemba. I think this is true whether you are a lean person who is new to health care or if you’re a long-time hospital person who has learned lean. Experts (doctors) ranging from John Toussaint to Patricia Gabow to Don Berwick…
Melanoma is one of the less common types of skin cancer, but it accounts for the majority of skin cancer deaths (about 75%). The five-year survival rate for early-stage melanoma is high (98%), but the rate drops precipitously if the cancer is detected late or there is recurrence.
So a great…
The QA Pharm
One of the regulatory responsibilities of the quality control department is the release decision for drug batches into the market. When I was first given that responsibility early in my quality assurance (QA) career, it was impressed upon me to not count the cost of the batch when making that…
National Association for Healthcare Quality
The Toyota Production System and U.S. health care improvement share a long history. What lessons can health care leaders learn from Toyota’s recent production troubles? A few experts recently discussed this on WIHI, an audio program sponsored by the Institute for Healthcare Improvement (IHI). Here…
Michele DeMeo
A surgical technician prepares her back table for the next laparoscopic surgery. Instruments are removed from their containers and packages, and placed neatly on the back table. Chemical indicators show that sets and instruments are sterilized; the patient is prepped. The surgeon begins the…
(Academy Leadership Publishing: King of Prussia, PA) -- When news headlines trumpet story after story about fiscal mismanagement, unchecked greed, massive bankruptcies, and rampant downsizing, it’s hard to believe there’s any good news about the business world. Indeed, it’s almost impossible not…
Tony Shaw
A woman in Southern California’s Inland Empire, age 53, is suffering from an unidentified neurological disorder. It started as an odd numbness in her left arm, and now she feels an uncomfortable, persistent tingling and prickling pain from the bottom of her feet to the top of her eyebrows. She…
Leaders of quality assurance programs must be able to generate interest and commitment without burdening clinical and administrative staff with an activity they neither understand nor believe in.
Hospital accreditation has been defined as “A self-assessment and external peer assessment process…
NIST
The U.S. Department of Veterans Affairs Cooperative Studies Program (VACSP) Clinical Research Pharmacy Coordinating Center (the Center) is a federal government organization that supports multicenter clinical trials targeting current health issues for America’s veterans. Located in Albuquerque, New…
Georgia Institute of Technology
The cross-functional team at Piedmont Newnan was made up of employees that deal with the process daily. For this process improvement project, they focused on case carts, which are used for pulling together all supplies needed for surgical procedures.
Pam Murphy, a…
Knowledge at Wharton
Toyota’s legendary lean processes didn’t come out of nowhere. They were forged by the fire of urgency in post-World War II Japan when resources were scarce. Toyota innovated—and continued to innovate. Today, the Toyota Production System is the most respected manufacturing and inventory control…
redOrbit
With a silicone rubber “stick on” sheet containing dozens of miniature, powerful lenses, engineers at Harvard are one step closer to putting the capacity of a large laboratory into a microsized package.
The marriage of high-performance optics with microfluidics could prove the perfect match for…
Mark Graban
When I was in Sweden recently, we had a lot of good discussion about the lean concept of “standardized work.”
There was much agreement from different presenters at the lean laboratories conference, and from the hospital people we visited, concerning standardized work—that it isn’t a robotic…
The Un-Comfort Zone With Robert Wilson
On a summer weekend in 1977, my friend Tony and I made plans to go water-skiing. When he picked me up there were two people in the car that I did not know. He introduced his new girlfriend, Sue, and her brother, Bubba.
Bubba was the quintessential redneck. Within minutes of getting on the boat…
Jane Martinsons
With or without health care reform, health care quality professionals know that change is already a new reality for U.S. health care, transforming the industry, their own organizations, and their professional roles on what seems a daily basis.
“With all the changes that we’re facing in health…
The Un-Comfort Zone With Robert Wilson
In the early 1970s I was a young teenager who was completely caught up in the Zeitgeist. I admired the long-haired rebels and radicals who were engaged in protesting the establishment and developing the counter-culture. I didn’t really know what any of that meant, but to me it was all about…
H. James Harrington
The world is changing so fast today that it is almost impossible to keep up with the latest trends in your own profession. If you are not spending at least two hours per day updating yourself in your chosen profession, you probably are behind the current state of the art. It has been estimated that…
Mike Micklewright
Can you imagine producing products with a tremendous amount of variation? I’m sure many of you know this all too well. I mean, here you’re trying to produce the same products, trying to ensure consistency, and many of the products you produce have different shades of color, many function…
Georgia Institute of Technology
To improve customer satisfaction, enhance the quality of services and reduce costs, Peach Regional Medical Center has worked with the Georgia Institute of Technology to adopt process improvement techniques traditionally used by the manufacturing industry. Already, Peach Regional Medical Center’s…
John G. Miller
Outstanding means being superior, striking, exceptional, clearly noticeable—essentially, to stand out. People are attracted to outstanding organizations. They want to buy from them, sell to them, invest in them, volunteer at them, and work for them. And as we close out the first decade of the 21st…
WILLIAM SCHERKENBACH
I’ve spent most of the past two years living in China where I have learned much on how enterprise is managed over there. Many people have said that this century belongs to Asia. That may be, but they have a lot to learn and change before that happens. They cannot depend on cheap rote labor to…
Malcolm Chisholm
I have just finished rereading Walter A. Shewhart's 1939 book Statistical Method from the Viewpoint of Quality Control (Dover Publications, 1986). Mine is the 1986 edition, which has a foreword by W. Edwards Deming. Shewhart, a Bell Labs man, pioneered quality control and was a major inspiration…
Bill Kalmar
Several years ago, I penned a column entitled, “Nurse, I’m Ready for My Cappuccino!” The article was an interview with Gerard van Grinsven, the new CEO and president of the Henry Ford West Bloomfield Hospital, which was to be located in a Detroit suburb. At the time of my interview, Van Grinsven…
Mike Richman
Here at Quality Digest, we get a lot of mail: Some of it’s critical, some of it’s praiseworthy, some of it’s cantankerous, and some of it’s challenging. All of it is insightful. And then, every once in awhile, something comes along that simply... well...
The following was sent to us from a…
GKS Global Services
Didrick Medical Inc. is a small privately owned company located in Naples, Florida, that designs and fabricates active-function artificial finger prostheses, called the X-Finger, for partial finger amputees. The owner refined the design for more than six years before he took it to the marketplace…
Georgia Institute of Technology
(Georgia Tech Enterprise Innovation Institute: Atlanta) -- Debbie Guzman, laboratory director at Athens Regional Medical Center, says that implementing lean principles in a health care setting is especially challenging. Traditionally used in manufacturing, lean refers to an operational strategy…
When I started Productivity Inc. Press in 1979, quality of work life (QWL) was a very popular symbol for American unionism. Unions wanted workers to have a quality of work life, however, I don’t believe they understood what quality of work life really meant. The unions wanted workers to have a…
National Committee for Quality Assurance
(NCQA: Washington) -- “The State of Health Care Quality 2009,” an annual report, now in its 13th year, provided by the National Committee for Quality Assurance (NCQA), finds that the quality of U.S. health care was virtually stagnant in 2008, a disturbing slowdown after a decade of improvements.…
Michelle LaBrosse
A couple of years ago, I was featured on CNN pouring out the contents of my backpack. The story was about how I ran my business, virtually, from wherever I was with the trusty items carried on my back.
As you might imagine, there were all the usual suspects: my laptop, iPhone, digital camera,…
Jim Jubelirer
Story update 10/23/2009: The link to the prerecorded webinar mentioned at the end of the article has been corrected.
The U.S. economy runs on service. From front-line service in transactional industries such as retail, banking, hospitality and food service, to technical support for high-tech…
Steve Arbogast
A quality management system is a framework of processes and procedures that are used to ensure that an organization can fulfill all tasks required to achieve its goals, strategies, and objectives.
The majority of businesses around the world have some sort of well-defined quality management…
Ten years after the Institute of Medicine released its influential report "To Err Is Human" (www.iom.edu/en/Reports/1999/To-Err-is-Human-Building-A-Safer-Health-System.aspx), hospital care still has many safety problems, and the quality of care remains lower than it should be in many institutions…
In 2005, according to a BBC News report at the time, operating rooms all over the United Kingdom were thrown into chaos and operations canceled due to broken, missing, or dirty surgical instruments. The Royal College of Surgeons called for a national audit of decontamination units, following a…
Andrea Kabcenell
What if hospital leaders had an easier, more streamlined way to chart an improvement path for their organizations? Imagine a list of key processes that could—if implemented reliably—lower mortality, reduce harm, lessen delays, create a better patient experience, and lower costs. This possibility…
GKS Global Services
In this case study of reverse engineering and rapid prototyping we will look at a company that developed an initial prototype of an anti-snoring device based on many years of research in the field of dentistry. The company’s main dental advisor is a pioneering dentist in the research and…
Bill Kalmar
Regular readers of my column know that I abhor surveys that don’t provide some type of incentive or discount on a future purchase for completing the survey. I realize that I may have discussed this subject ad nauseam, but have you noticed that every store, restaurant, gas station, doctor’s office…
Georgia Institute of Technology
Radio frequency identification (RFID) systems are widely used for applications that include inventory management, package tracking, toll collection, passport identification, and airport luggage security. More recently, these systems have found their way into medical environments to track patients…
A
n emergency response organization differs substantially from our usual public health organization for day-to-day business. However, as the spring 2009 H1N1 (also referred to as swine flu) outbreak highlighted, usual public health processes are fundamental for effectively responding to a…
Dirk Dusharme @ Quality Digest
All the talk of health care reform has resulted in many hospitals turning to lean Six Sigma to help improve efficiency and aid in cost cutting. However, health care efficiency expert Ron Wince contends that many of these facilities are not applying the tools properly and therefore will not reap…
Matthew J. Savage
As companies downsize, they cut down on the number of employees, or move, or close, and thousands find themselves without jobs in a highly competitive job market that they never anticipated. A 55-year-old former NCR systems engineer is in line for jobs along with whiz-bang new college graduates,…
The Un-Comfort Zone With Robert Wilson
“Writing is not a job; it’s a hobby!” thundered my father when I told him my plans for college. “You need to get a profession: Medicine, law, engineering, or accounting.”
I cheerlessly acquiesced and enrolled in a pre-med program, but at the end of my first year, after struggling through…
Chris Hardee
As moviegoers, we have all seen a wide range of animation—from early Disney features, such as “Snow White,” to Japanese anime, and Pixar’s “Toy Story,” to an assortment of recent blockbusters that seamlessly integrate animation with real actors. With each release, the movie magic gets more amazing…
Donald J. Wheeler
Following my article on Leptokurtophobics (Do You Have Leptokurtophobia?) it was almost inevitable that we should hear from one. We were fortunate to have someone as articulate as Forrest Breyfogle III to write the response. However, rather than offering a critique of the points raised in my…
Mark Graban
A couple of Sundays ago, I read this New York Times article about Apple's "App Store" for the iPhone and iPod Touch (I've been a pretty happy iPhone user for the past three months after switching over from BlackBerry).
I'm going to try to use this example to teach about two concepts that can be…
Bill Kalmar
The band “Chicago” sang those words about "time" decades ago. The second line “Does anybody really care?” seems to sum up what is still in vogue today, especially in the workplace. Just as with vacations where workers are reluctant to leave for fear that someone will discover that their job is…
David C. Crosby
When I say quality manager, of course I’m talking about the department he or she manages as well.
I’ve been in the “quality business” for fifty years now. That’s right, fifty years. Much of my career—from source inspector to quality engineer, to corporate director of quality—was spent in other…
Georgia Institute of Technology
In 2008, Children’s Healthcare of Atlanta saw more than 170,000 patients across all three of its three emergency departments. That kind of volume demands an effective and efficient process, and staff spent the past three years developing a master facility plan to do just that. However, moving into…
Davis Balestracci
Click here to read part 1 of this series.
Analytic statistical methods are in very strong contrast with what is normally taught in most statistics textbooks, which describe the problem as one of “accepting” or “rejecting” hypotheses. In the real world of quality improvement, we must look for…
The New Yorker magazine featured a cartoon showing a discussion between a salesman and his sales manager. The despondent salesman asked, “I know you’re always telling us to sell the sizzle and not the steak, Mr. Bollinger, but just what is the sizzle of a 90º elbow, flexible-copper fitting?”…
Donald J. Wheeler
Some authors recommend that you have to wait until you have the range chart “in control” before you can compute the limits for the average chart or the X chart. Why this is not true will be the subject of this column.
To illustrate the issues we will once again use the NB10 data. The 100 values are…
H. James Harrington
I often get assignments at organizations where I am required to take aside a group of people, either within the building facility or off campus, to focus on issues or problems. Typically these groups spend a considerable amount of time to summarize and present a well-defined problem. The next step…
David C. Crosby
The most important element in producing a quality product or service is the attitude of the people doing the work—not only the worker—but the attitude of all levels of management. Employee attitude about the product, about the work, about the boss, and about the company will pretty well determine…
Minitab LLC
A $1 billion annual budget may sound ample, but a few years ago, the costs of services ranging from law enforcement to cleaning county buildings had squeezed the government of Erie County, New York, to its limit. Residents faced a painful choice: raise taxes or slash services. But Chris Collins,…
Dale Hershfield
Twitter is the latest new thing. Want to follow John McCain or Al Gore throughout their day? Easy. Just sign up to receive their tweets. While their tweets may provide insights, or just entertainment (Ashton Kutcher and 50 Cent also tweet), does Twitter have value for business management?
The…
Laurel Thoennes @ Quality Digest
“You can put your clothes back on,” the doctor says as he walks out. Before you know it, he’s back and you’re still hopping around the cold floor, aiming for your pant leg and with your sweater on backward. There’s no time for embarrassment, because the doctor declares that you need surgery. You…
Craig Cochran
When I first got into quality, I really hated verifying the effectiveness of actions taken to correct a problem. After all, I was young and inexperienced. All of the people whose actions I was verifying were older, wiser, and more experienced than I was. Who was I to say that their actions were…
Geoff Bilau
Geoff Bilau, senior writer for the International Association for Plumbing and Mechanical Officials (IAPMO) Group, was awarded first place for his paper by the American National Standards Institute (ANSI) for describing the importants of quality standards and accreditation.
--Editor
I
t was…
James Odom
Charles Kettering, the famous inventor, once said: “A problem well stated is a problem half solved.” This implies that a good portion of problem solving should be devoted to a thorough understanding of what’s going on before any corrective action steps are taken.
In many cases, too much time is…
Bill Kalmar
None of us, I suspect, are fond of visiting our physician, making an unexpected trip to the hospital emergency room, or undergoing an operation. From time to time, we hear about the unanticipated results of a botched operation where the wrong leg was removed or an incorrect diagnosis resulted in…
Lysosomal storage disorders may not sound as dire as diseases such as cancer or Alzheimer’s, but to the people that suffer from them, life can be a nightmare. In fact, three of the primary disorders in this category—Gaucher’s Disease, Fabry Disease, and Pompe Disease—aren’t only characterized by a…
Nancy Fullbright
Alan Kent, president and CEO of Meadows Regional Medical Center in Vidalia, Ga., was a champion for implementing lean principles in the hospital’s emergency department. Photo by Gary Meek Emergency rooms in the United States aren’t known for their…
Patrice L. Spath
Measurements of patient care continuity should encompass all of the components of health care delivery—structure, process, and outcome. “Structure” in health care delivery refers to the way a health care entity organizes itself and sets up operations. Health care structures include elements such…
Wini Hayes
A well-respected surgical group requests a new surgical device that they swear will revolutionize how surgery is performed in your hospital. The price tag is well into seven figures, with significant annual maintenance and training costs. A competing hospital is advertising to consumers that they…
The use of drug product is widespread and touches all aspects of our daily lives without our knowing it. From aspirin to cardiac medicine and from hormones in animal feed to over-the-counter dietary supplements, these products are used every day. What they all have in common are specific government…
Carolyn Clancy
Choosing a hospital that scores well on quality can make it easier and safer for you to recover from a serious event, such as heart surgery, or a routine one, such as having a baby. Doing a little homework before you choose a hospital can do more than give you peace of mind.
As a physician, let…
Carolyn Clancy
Walk into many stores and you’re bound to be impressed by the quality of digital cameras, TVs, cell phones, and other consumer electronics. Every year the quality of these devices improves by leaps and bounds, and consumers often pay less as products improve.
I wish the same could be said about the…
Walk into many stores and you’re bound to be impressed by the quality of digital cameras, TVs, cell phones, and other consumer electronics. Every year the quality of these devices improves by leaps and bounds, and consumers often pay less as products improve.I wish the same could be said about the…
A thorny question lies at the heart of meaningful health care reform. How much is human life worth? New research from Wharton and Stanford based on Medicare kidney-dialysis data shows that the average figure—$129,090 per additional year of quality life—is higher than prior studies have shown.…
Carolyn M. Clancy M.D.
If you’ve ever watched the popular “MythBusters” program on the Discovery Channel, you know that many supposed truths are based on old, incomplete, or simply incorrect information.The same can be said about beliefs about the quality of health care in America. How many times have you heard that more…
Patricia C. La Londe
Cardinal Health Alaris Products, which makes pumps and disposables used during infusions, was in critical shape in the late 1990s and needed to address improvement on all fronts. The prescription included improvements in customer satisfaction and in the company’s finances, which required the…
Bill Kalmar
Advancing into that mystical category of “senior citizen” brings with it certain perks. Simultaneously becoming a senior citizen, retiring, and joining the ranks of Social Security recipients is a financial trifecta.I retired in 2003, and when I made that phone call to add my name to the millions…
Mike Richman
Dr. Tomas Gonzalez, senior vice president and chief quality officer for Valley Baptist Health System of Harlingen, Texas, is a busy man. Not only does he direct quality process improvement at Valley Baptist’s two hospitals, he’s also a physician and a certified Master Black Belt. Valley Baptist…
The cost of poor quality in health care ranges from 30 to 60 cents of every health care dollar. Until recently, however, there have been few financial consequences for health care providers’ failure to address the underlying root causes. This article describes Medicare’s new policy of not…
Georgia Institute of Technology
Research reported recently in the journal Advanced Materials describes a potentially promising strategy for encouraging the regeneration of damaged central nervous system cells known as neurons.The technique would use a biodegradable polymer containing a chemical group that mimics the…
Abby Vogel
Tushar Sathe holds a vial of dual-function beads embedded with iron oxide and 600 nanometer emission quantum dots, while Shuming Nie looks on. The other vials contain beads embedded with quantum dots that emit light at other wavelengths. photo by Gary Meek…
Georgia Institute of Technology
For people with impaired mobility and reduced ability to sense injury, the risk is high for pressure ulcers that can develop when they sit or recline in one position too long or wear a poorly-fitted prostheses for an extended period.
Clinical data collection helps drive the researchers’…
This figure shows the 3-dimensional dose distribution of the prostate upon completion of implanted seeds. Based on patient tests, Lee’s inverse planning system uses 15% fewer seeds. Photo by Eva Lee A California medical software company has launched…
CardioMEMS engineer Michael Fonseca uses a laser to separate pressure sensors in the company’s clean room facility in the ATDC Biosciences Center located at Georgia Tech’s Environmental Science and Technology Building. Photo by Gary Meek After…
Georgia Tech student Ashley Palmer, Ph.D., conducted experiments to validate a new cartilage-imaging technique developed by associate professors Marc Levenston and Robert Guldberg in the Georgia Tech School of Mechanical Engineering. On the computer…
Despite the best efforts of pharmaceutical manufacturers, drug labeling is one of the greatest challenges in clinical trials, involving a complex, time-consuming process to meet strict regulatory requirements and obtain wide-ranging approvals from individual countries. That labels must…
Researchers Mark Prausnitz and Robyn Schlicher use a confocal microscope to study cells whose membranes have been opened by the application of ultrasound. Georgia Tech Photo: Gary Meek Researchers have shown how ultrasound energy can…
James M. Anderson
An ABC News/Washington Post survey in 2003 found that for the first time, 54 percent of Americans were dissatisfied with the overall quality of health care in the United States. In 2006, the Commonwealth Fund released results of an international survey that measured 37 areas of quality…
Research engineer Phil Santangelo works in professor Gang Bao’s cell culture facility in the Wallace H. Coulter Department of Biomedical Engineering at Georgia Tech and Emory University in Atlanta. Photo courtesy of: Phil Santangelo…
John Toon
Georgia Tech professor Zhong Lin Wang holds a sample nanowire array that can be used to power nanometer scale devices. Georgia Tech Photo: Gary Meek Researchers have developed a new technique for powering nanometer-scale devices…
T. J. Becker
In our increasingly wireless world, the air is chock-full of electromagnetic signals carrying data from one place to another. Yet, while new wireless technologies advance our options in security, commerce and entertainment, they also produce interference that may cause problems for…
Georgia Tech postdoctoral fellow Jean-Francois Masson holds a microelectrode modified with a biosensing layer capable of measuring adenosine triphosphate (ATP), a chemical involved in energy transport in humans. It’s of interest to medical…
A worsening epidemic of sophisticated antimalarial drug counterfeiting in Southeast Asia and Africa is increasing the likelihood of drug-resistant parasites, which yield false-positive results on screening tests and risk the lives of hundreds of thousands of malaria patients—mostly…
Jane M. Sanders
A newly developed family of biodegradable polymers has shown potential for use in intracellular delivery and sustained release of therapeutic drugs to the acidic environments of tumors, inflammatory tissues and intracellular vesicles that hold foreign matter. These polymers have several…
Tom Solon
Advancements in diabetes treatments By any measure, diabetes is a huge health problem. Approximately 16 million people in the United States have diabetes, and it’s a leading cause of associated medical conditions such as blindness, circulatory problems and digestive disorders. While…
Christopher Werner
Although conventional homogenization has served the needs of the dairy industry and other industries for more than a century, the producers of pharmaceutical, personal care, chemical and food products are increasingly turning to high-shear fluid processing when highly precise processing is required…
Jerry Fireman
Diagnostic Hybrids Inc. manufactures discrete units of mammalian cell cultures and diagnostic reagents—such as antibodies—that are used to grow, isolate and type viruses. The company faced complex information-management challenges because of its many different product offerings, complex…
According to the Institute of Medicine, there are approximately 100,000 people per year killed in the Unites States because of medical errors. There are 100,000 families in despair because they have lost a loved one too soon. This also means that 100,000 medical professionals are losing…
Avoiding blood trauma is a concern when pumping cardiac patients’ blood during surgery. With this in mind, a medical-device manufacturer decided to reuse the flow-path geometry of an existing arterial filter that had been proven safe and effective in many patients. The problem was…
William L. Roper
A revolution is working its way through America’s health care systems. Like many great revolutions, it’s about empowerment and the creation of a new paradigm. It won’t happen overnight, but the forces at work are irresistible and will bring new hope and new responsibilities. The agent…
Tim Postema
The Dutch public health care system is being transformed in various ways. With an increasing focus on efficiency and consumer driven care, health institutions in The Netherlands are forced to critically evaluate their actions and processes. With recent political developments creating a more liberal…
Marlo Brooke
The groundswell of radio frequency identification devices (RFID) in health care may be clouded by the stomping of Wal-Mart, but the biotechnology and pharmaceutical industries are quietly becoming one of the top innovators and users of RFID, and they’ll likely outpace other market segments in the…
Optimizing biological assay conditions is a demanding process that scientists face every day. The requirement is to develop high-quality, robust assays that work across a wide range of biological conditions. The demand is to do this within a short development time frame. To overcome these obstacles…
Laura Smith
In hopes of cutting administrative costs and streamlining the amount of time it takes to get new drugs to consumers, eight global pharmaceutical manufacturers have formed a coalition, SAFE-BioPharma, to support the widespread adoption of the new global digital identity standard, Secure Access for…
Tamar June
Companies struggling to comply with the FDA’s myriad electronic recordkeeping regulations should take a deep breath and follow it up with a long, careful look at the FDA’s actual GxP and 21 CFR Part 11 rules. After a careful reading of the admittedly long and sometimes dry rules, it should become…
Tamar June
If you are thinking of CFR 21 Part 11 compliance in terms of what the FDA may or may not require, you are missing a huge opportunity to make your business more efficient, nimble and ultimately profitable by improving the quality of your operation and its products. That’s the consensus of dozens of…
BSI
More than a decade ago, Osteoimplant Technology Inc. provided the orthopedic prosthesis for a complete hip replacement for Mikhail Lavrovsky, one of the most famous lead dancers with the Bolshoi Ballet. He was able to dance with the replacement and continued to make appearances around the world.…
Tamar June
If you are thinking of CFR 21 Part 11 compliance in terms of what the FDA may or may not require, you are missing a huge opportunity to make your business more efficient, nimble and ultimately profitable by improving the quality of your operation and its products. That’s the consensus of dozens of…
Quality Digest
Our BioMed Community is under Construction. Check back soon. Our launch date will be Jan. 26, 2005
