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2025 Medical Device Industry Report
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…
Three Insights on Medtech Product Development
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…
Enhancing Compliance Through Quality Risk Management
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…
AI in Medical Device Manufacturing
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…
How Testing Automation Reduces Risk and Elevates Quality Assurance
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…
Common Mistakes in ISO 27001 Implementation
4C Consulting
ISO 27001 is a globally recognized standard for establishing, implementing, maintaining, and improving an information security management system (ISMS). Successfully implementing ISO 27001 can provide tremendous benefits, such as ensuring data security, building trust with customers, and meeting…
Medical Device Compliance
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…
Critical Aspects of Quality Management Systems
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…
Real-World Data and Real-World Evidence
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…
How Technology Supports ALCOA Principles
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…
Equipping Doctors With AI Assistants
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…
Healthcare Cybersecurity
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…
AI-Powered Risk Assessment Revolutionizes Pharma Product Development
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…
How AI Can Help Revolutionize the Patient Experience
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…
Ten Tips for Passing 21 CFR Audits
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…
Avoid the ‘Blockbuster Effect’ in Life Sciences With Preventive Quality
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.”…
Ramping Up Productivity With Bulk-Bag Discharge Upgrades
Del Williams
In food processing, bulk-bag discharge systems are used to transfer food ingredients such as flour, sugar, and spices from bulk bags to mixing and blending equipment. However, when not designed or installed properly, bulk discharge systems can become a production bottleneck. Complicating the issue…
What FDA QSR and ISO 13485 Harmonization Means for Medical Device Companies
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…
Twelve Strategies for Successful CAPA Management
Stephanie Ojeda
There’s no question about it: Should an auditor or inspector visit your facility, one thing that will certainly be under the microscope is your corrective and preventive action (CAPA) system. CAPA management is a recurring theme in U.S. Food and Drug Administration (FDA) warning letters, a fact…
Data Management and Reporting in FDA-Regulated Clinical Trials
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…
Fundamentals of Telemedicine Equipment
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…
Your Future Medications Could Be Personalized on a 3D Printer
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…
QMSR and the End of DMR, DHR, and DHF
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…
The Power of Change Management Tools
Stephanie Ojeda
Look through even a few FDA warning letters and you’re likely to find violations related to change management. For instance, a recent warning letter from the U.S. Food and Drug Administration cited a pharmaceutical manager for changing drug components without justification. Another noted a lack of…
Tech-Enabled Healthcare
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…
What Is a Class III Medical Device in the US?
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…
Guide to Choosing the Right Training Management Software
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…
Why You Need a Digital Solution for Your APQR
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…
A Baldrige Award-Winning Nonprofit Highlights Organizational Resilience
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…
How to Build Flexibility Into Medical Equipment Inventories
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…
Medical Device Recalls Outpace All Industries
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…
Conflict Among Hospital Staff Could Compromise Care
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…
New NIST Database Helps Monitor ‘Forever Chemicals’
NIST
Stain-resistant clothing, fast-food wrappers, and extreme weather gear such as certain jackets and pants—these products get many of their desirable features from a class of manufactured chemicals called per- and polyfluoroalkyl substances (PFAS). But there’s a major downside: Researchers have found…
Nine Strategies for Effective Internal Audits
Stephanie Ojeda
As U.S. Supreme Court Justice Louis D. Brandeis famously wrote, “Sunlight is said to be the best of disinfectants.” In the field of quality, internal audits are the equivalent of sunlight. Like spring cleaning, internal audits provide the opportunity to bring process issues into the open before…
How to Use the Turtle Diagram for Better Internal Audits
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…
The Hidden ROI of Complaint Management
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…
The Impact of AI on Quality Operations
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…
Four Scary Life Science Quality Management Stories
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…
FDA Inspections on the Rise
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…
In Pursuit of Quality Excellence
ComplianceQuest
Today’s quality leaders in the life sciences industry have nearly impossible charters. Long-term trends and sudden black swan events in combination can hinder an organization’s ability to exert control over product quality. Globalization, labor shortages and strikes, outsourcing, just-in-time…
Innovation and the Future of Life Sciences
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…
Report Details Conveying Systems in Food and Beverage Industry
Del Williams
To provide food processors with insight into the industry’s current challenges and opportunities, Cablevey Conveyors, a global specialty conveyor manufacturer, and Automated Handling Solutions, a service-focused subsidiary of Cablevey, have released results from an annual proprietary survey…
The Importance of a Document Management System
Stephanie Ojeda
There’s an old saying in regulated industries: If it isn’t documented, it didn’t happen. In the past, maintaining fully compliant documentation meant handling a mountain of paper, which created extra work—and hidden risks—from a quality perspective. Today, document management has become the…
The Ultimate Guide to ISO 14155:2020 for Medical Devices
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…
Risk Management in ISO 13485
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…
Validation Life Cycle Management Speeds Auditing, Facilitates Regulatory Inspections
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…
Health Systems Need More Insight Into Inventory, Supply Chain
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…
Tiny Magnetic Beads Could Help to Quickly Detect Pathogens
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…
Build Your Culture of Quality With These Four Foundational Principles of Quality 4.0
Matthew M. Lowe
Let’s start with a definition of Industry 4.0, keeping in mind that we’re rapidly approaching Industry 5.0. Industry 4.0 is an era marked by enhanced digitization and the increased connectivity of smart technologies. Where Industry 5.0 is more values-driven, it will require the technology of…
What FDA QSR and ISO 13485 Harmonization Means
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…
Five Necessary Steps to Maintain a Reliable CAPA Process
Kari Miller
Since 2010, citations for insufficient corrective action and preventive action (CAPA) procedures have been at the top of the list of the most common issues within the U.S. Food and Drug Administration (FDA) inspections, particularly for the medical device industry. Issues can occur while…
Fifteen Questions to Ask QMS Software Vendors in the Medical Device Industry
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…
Linking Design Controls and Risk Management in the QMS
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…
Embracing AI-Driven Technology to Augment Quality and Regulatory Activities
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…
Studying Food Safety Through Measurement
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…
Overcoming Blockers to Digital Quality Management
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…
How a Purpose-Built eQMS Improves Compliance in Life Science Organizations
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…
Five Foundational Steps of a CAPA Quality Process
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…
IAF CertSearch Team Identifies 20,000 Fake or Fraudulent ISO QMS Certs
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…
Process Verification vs. Process Validation
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…
Top Five Challenges for Medical Device Integration
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…
Going Beyond Dust Hazard Analysis
Del Williams
For owners and operators in the agricultural and food-processing industries, Jan. 1, 2022, was the deadline for completing a dust hazard analysis (DHA) for existing facilities in accordance with Chapter 7 of the National Fire Protection Association’s Standard 61 (2020) for the Prevention of Fires…
How to Prioritize Cybersecurity Risks in Medical Devices
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…
Protect Against Food Recalls With the Right Conveyor System
Del Williams
With the threat of contamination from harmful pathogens such as salmonella, listeria, and e. coli a continual concern, food processors are seeking to protect not only the public but also their companies’ bottom lines from the massive costs, reputational damage, and greater regulatory scrutiny…
EU Regulation Is Driving Medical Device Manufacturers From EU Market
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…
Migrating Your QMS From Paper to AI
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…
Food Expiration Dates Don’t Have Much Science Behind Them
Jill Roberts
Florida’s outbreak of listeria has so far led to at least one death, 22 hospitalizations, and an ice cream recall since January 2022. Humans get sick with listeria infections, called listeriosis, from eating soil-contaminated food, undercooked meat, or dairy products that are raw or unpasteurized.…
How Pharma Quality Leaders Navigate Shifts and Instigate Change
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…
Food Processing: Automatic Scraper Strainers Protect Critical Membrane Systems
Del Williams
The use of membrane technology as a processing and separation method in the food industry is gaining wide application for demineralization, desalination, stabilization, separation, deacidification, purification, and reducing microbial load. Perhaps the most obvious application for membrane…
Four Factors to Consider When Buying an Ultra-Low Temperature Freezer
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…
The Value of Risk-Based Supplier Inspections in Pharma Quality Management
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…
Staying Ahead of ICH E6(R3) Good Clinical Practice Guidelines
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…
How Healthcare Software Development Enhances the Medical Industry
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…
Four Steps to Accelerating Discoveries in Life Sciences
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…
What FDA QSR and ISO 13485 Harmonization Means for Medical Device Companies
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…
How Do You Know You’re Getting What You Pay For at the Grocery Store?
NIST
Whether it’s bananas, olives, potato salad, or cereal, many products are priced according to their weight. That weight is likely determined on a scale tested and certified by a specially trained state or local inspector. Weights and measures underpin approximately half of the United States gross…
Ninety Percent of Drugs Fail Clinical Trials
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…
Important Factors in Implementing an Effective HACCP
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…
What Should Really Trigger a CAPA?
Sara Adams
Corrective and preventive action (CAPA) is often a thorn in the side of medical device manufacturers. Problems with CAPA top the list of reasons for 483s and warning letters from the FDA year after year, and many companies struggle to identify when they should even initiate a CAPA. When companies…
Shifting Auditor Competency in the Supply Chain: The Impact of New IAF MD9:2022
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…
Is the FDA Creating a HACCP Program for Produce?
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…
Boosting Vaccine Production Needs the Right Degree of Flexibility
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…
Reporting All Biosafety Errors Could Improve Labs Worldwide
David Gillum, Kathleen Vogel, Rebecca Moritz
The origin of SARS-CoV-2 remains a mystery. One theory is that the coronavirus that causes Covid-19 was transmitted from animals to humans—a fairly common occurrence. Another is that it came from a laboratory accident—a more infrequent circumstance. Around the world, scientists conduct many kinds…
What Is Blockchain 2.0, and Why Should Food Manufacturers Care?
Julia Canale
Believe it or not, the technology that brought you Bitcoin is beginning to make waves in the food manufacturing industry. This technology, called blockchain, is a digital ledger maintained across several computers, then linked through a peer-to-peer network. The system's design makes it difficult…
Operational Readiness: The Precursor to Operational Excellence
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…
Inspection and Compliance in One Reliable Package
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…
Risk Management for Medical Devices
Wade Schroeder
As more medical devices using network-connection technology are developed, cybersecurity will continue to grow in importance and focus among regulators and manufacturers. Many connected devices store or transmit patient data for which there is an expectation of both privacy and accuracy. Any sort…
The FDA’s Weak Drug Manufacturing Oversight Is a Potentially Deadly Problem
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…
How Food Processors Can Improve FDA Compliance and Productivity at the Same Time
Del Williams
To meet increasingly strict compliance standards, such as the Food Safety Modernization Act (FSMA) and Global Food Safety Initiative (GFSI), food processors now regularly use adenosine triphosphate (ATP) testing to monitor equipment surfaces for microbial growth. Add to this the need to minimize…
Closed-Loop Traceability for FDA Compliance
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-…
How to Build Medical-Device Usability Testing and Validation Into Your Quality System
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’…
How Does Analytical Testing Improve Food Quality?
Emily Newton
Food manufacturers must carry out numerous specific processes to check that the foods they produce and distribute are safe for consumers. Analytical testing plays a vital role in meeting that goal. Here’s a look at how such examinations raise food quality and purchaser trust. Checking foods for…
FDA’s Ongoing Use of Inspectional Tools During the Covid-19 Pandemic
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…
Food Safety Management System Certification Schemes, Highly Effective, But… What a Bunch of Them!
Esteve Garriga
There are many important issues to be considered in the food industry, such as consumer tastes, environmental impact, and economic aspects, but the most important is food safety. Although current food safety management system (FSMS) certification schemes around the world are highly effective, I…
Medical Laboratory Testing: How Can We Trust the Results?
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…
More Must Be Done to Promote IAF CertSearch
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…
Better Data for Use and Safety Profile of Cannabidiol (CBD) Products
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,…
How Risk-Based Thinking Could Prevent Thousands of Covid-19 Deaths
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…
Fine-Tuning Remote Audits During Covid-19
Natalie Weber
Unlike Covid-19, remote audits aren’t unprecedented. Remote audits didn’t start with the pandemic, although it has forced more companies to use them than previously. At MasterControl, we’ve been doing remote audits for years for our international customers. It saves time and expense, and it’s every…
Unannounced Audits
Jon Speer
The medical device industry is one that requires preparation. Unlike less regulated industries, there’s an expectation in the industry around the possibility that an inspector or auditor can show up without notice and stop a business in its tracks. That’s why, when Greenlight Guru released its “…
IEC 60601-1:2020 Edition 3.2 Launches. Prepare for Impact!
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…
Four Essential Processes in Medical Device Risk Management
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.…
Evidence-Based Ergonomic Risk Analysis for Environmental Health and Safety
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…
Investing in Advanced Manufacturing to Support Public Health Preparedness
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…
Compliant Steam Filtration Is Key to Food and Beverage Safety
Del Williams
Approximately 48 million people in the United States (one in six) get sick, 128,000 are hospitalized, and 3,000 die each year from foodborne diseases, according to the Centers for Disease Control and Prevention. Consequently, the FDA Food Safety Modernization Act (FSMA) is transforming the nation’s…
Could Pressure for Covid-19 Drugs Lead the FDA to Lower Its Standards?
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…
Fake PPE on the Rise: Don’t Get Fooled
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…
This Time, It’s Not All China’s Fault
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…
The Problem With Fake N95 Masks
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,…
Possible Cure for Outbreak of Fake Certificates From Covid-19 Pandemic
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…
How to Prevent Failure When Shifting to Working From Home
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…
Five Ways to Stay on Top of Manufacturing Quality Management While Under Pressure
Jason Chester
Even in the midst of the pandemic, product safety and quality remain critical. For many manufacturers, complex quality management systems and procedures stand in the way of agile responses and effective operational optimization. Cloud technology provides the means to dramatically simplify quality…
Waiting for the Covid-19 Peak
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…
Using Layered Process Audits to Close the Loop on Safety
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…
Three Myths Engineers Believe About Quality
Jon Speer
Successfully run medical device companies are cross-functional. From product development, manufacturing, quality, and regulatory compliance, to marketing and sales, every business operation works together to produce and sell medical devices that improve the lives of end users. Still, many medical…
FDA Form 483 Observations and Warning Letters: What’s the Difference?
Jon Speer
If you’re a medical device company manufacturing Class II or Class III devices, you can expect to have the U.S. Food and Drug Administration (FDA) turning up for an inspection. It’s what happens after that inspection that we’re concerned with in this article. The unfortunate truth of the matter is…
Critical Data Elements and Data Quality
Rupa Mahanti
We are currently living in the digital age and are drowning in an ocean of data. Organizations have a large number of data entities and data elements, and a large volume of data corresponding to the same, and they continue to amass more and more data with each passing day. With the large amount of…
Manufacturing Standards for Biopharmaceuticals
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,…
Handling Product Recalls and Product Liability Lawsuits
Randall Goodden
The manufacturing industry, stock market, and new product development have really taken off in the past four years, and there’s a lot of focus now on moving offshore manufacturing back into the United States. With all of this growth, it is also apparent that many manufacturing corporations are…
Quality Is Everything
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…
Quality Digest Top Stories for 2019
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…
Weekly Quizzes for Current Good Manufacturing Practices Training Credit
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…
FDA’s Fast-Track Model for Software As a Medical Device Requires a Cuture of Quality
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 Food Safety Modernization Act in a Nutshell
Dileep Thatte
According to information from the Centers for Disease Control and Prevention (CDC), every year 48 million people in the United States get sick, 128,000 are hospitalized, and 3,000 die from foodborne diseases. That means one in six people in the United States get sick from contaminated food every 12…
Big Food Is Ripe for a Revolution
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…
Five Tips From Medtech Executives on the Value of Quality
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…
Six Ways to Improve Product Quality in Food Manufacturing
Steven Brand
The food industry is evolving rapidly, with consumers demanding quality, authenticity, and transparency from food manufacturers. And they’re not just demanding it; they’re “voting with their dollars,” supporting companies that align with their personal beliefs. To keep up with consumer demand—and…
Wake-Up Call: Class I Manufacturers, Get an Early Start on EU MDR Compliance
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…
Transforming Quality Operational Data Into Business Insights
Stephen McCarthy
In our constantly evolving, data-rich universe, collecting, interpreting, and understanding process data can be tricky. But it is increasingly important if we want to maintain sustainable quality across product development and manufacturing processes. This challenge is particularly evident in the…
Global Regulatory Harmonization
Jennifer Lopez
Globalization of the medical device market as well as its supporting supply chains continues to increase year after year. This has forced regulatory bodies to grapple with finding a way to narrow the gap between international and domestic regulation. In spring 2018 the United States Food and Drug…
FDA to Sunset Alternative Summary Reporting Program
The FDA has announced an end to the alternative summary reporting (ASR) program for medical device manufacturers and will make the data publicly accessible. The ASR program originally launched in 2000 when device manufacturers sought an “alternative summary” reporting exemption. ASR permitted…
Will New EU Medical Device Regulation Hit Tongue Depressors Before Defibrillators?
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…
Qualifying Your Suppliers Using a Risk-Based Approach
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…
Eliminating the Digital Divide in Life Sciences, Part 3: The Truth About Cloud Security
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…
Eight Things You Need to Know About the European Medical Device Regulation
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…
What to Make of FDA’s Secret Cache of Device Adverse Events
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…
Eliminating the Digital Divide in Life Sciences, Part 2
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…
Eliminating the Digital Divide in Life Sciences, Part 1: Compliance Concerns
Matthew M. Lowe
It’s human nature to resist change, and the life sciences industry is not exempt from a change-averse mindset. The proof: Life science organizations (LSOs) lag far behind counterparts in other sectors in implementing digital technologies that are designed to streamline business and manufacturing…
What to Expect During an FDA QSIT Inspection
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…
Big Data: Your Health vs. Your Privacy
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…
Ensuring Food Safety With Quality Management Software
Nicole Radziwill, Graham Freeman
In 2013, thousands of consumers in the United Kingdom (UK) and Ireland bought, prepared—and ate—beef lasagna, hamburgers, and frozen dinners. What they didn’t know is what they were actually putting in their mouths. Although a burger is only required by law in that region to contain 47-percent…
Improve Risk Management and Quality Across the Value Chain by Increasing Visibility
Kelly Kuchinski
Imagine building a brand over decades. Hundreds of millions of dollars invested in design and development. Sponsorships with celebrity athletes and professional and college teams. Leading-edge marketing making your company one of the top 20 brands in the world. It only takes one incident to unravel…
Power Moves: Turning Compliance Into True Quality
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?…
Life Science Regulations, Compliance, and the Move Toward QMS Software
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…
FDA Milestones
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…
Taking a Risk-Based Approach to Drug Inspections
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…
Proactive Processes in High-Reliability Organizations
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…
Inside Quality Digest Live for Jan. 25, 2019
Dirk Dusharme @ Quality Digest
We interview Stanley Chao, author of Selling to China: A Guide for Small and Medium-Sized Businesses (iUniverse, 2018), about the impact of the current U.S.-China trade war. Does China really care, and where do U.S. multinationals go from here? Also, a quick look at Conformance Manager, a web-based…
Inside Quality Digest Live for November 30, 2018
Mike Richman
One of our favorite things on our show is to welcome guests, either via Skype or live in the studio. And this week, we were joined by three of our great partners. Here’s a closer look: Interview: Nicole Radziwill of Intelex Radziwill is quality manager and data scientist along with the presenter of…
Inside Quality Digest Live for Nov. 16, 2018
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…
The Benefits of a Connected Quality Platform
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…
FDA: Innovation Spoken Here
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…
Canada's MDSAP Mandate Could Be Bad for Canadian Healthcare
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…
Quality’s Role in Biomedical Morals and Ethics
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…
Life Science Pioneer Takes Cues From 21 CFR and ISO 13485
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,…
Top Five Things Life Science Companies Need to Know about ISO and FDA Requirements
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…
Occupational Health and Safety: A Standard Approach
Andreas Engelhardt
An international standard that specifies requirements for an occupational health and safety (OH&S) management system, ISO 45001:2018—“Occupational health and safety management systems–requirements” replaces OHSAS 18001 as the primary OH&S standard used internationally. It follows other…
MDSAP: When Is a Certificate Not a Certificate?
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…
FDA Advances Efficient Approaches to Designing and Conducting Cancer Clinical Trials
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…
Inside Quality Digest Live for August 10, 2018
Mike Richman
‘Culture” is one of those business-speak words that’s used a lot, but for a good reason—having the right one is the key to unlocking your company’s quality potential. On the other hand, nothing will overcome a poor culture. Do you know which you have? We explored these issues during the Aug. 10,…
Investing in Advanced Domestic Drug Manufacturing
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…
The American Chamber of Horrors
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…
Three Things Medical Marijuana Startups Need to Thrive Despite Regulatory Uncertainty
Matthew M. Lowe
The medical marijuana industry is being heralded as the new frontier in the life sciences, thanks to the potential of cannabis-derived products in treating ailments that range from chemotherapy-induced nausea to epilepsy and neuropathic pain. If you’re a startup in the industry, what does this mean…
FDA Proposes Process Modernization to Support New Drug Development
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…
Why the FDA Presubmission Is an Underutilized Tool
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…
Benefits of FDA’s Breakthrough Device Program
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…
How to Leverage an EQMS for Managing Product Adulteration
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…
New Steps to Facilitate Medical Device Innovation
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…
How to Integrate Complaint Handling and Risk Management
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…
Some of the FDA’s Major Policy Goals for 2018
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…
FDA, International Regulators Look at Common Challenges to Innovation
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…
What a Risk-Based QMS Means
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…
MDSAP’s Final Pilot Report: A Glass 10% Full
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…
Inside Quality Digest Live for Nov. 10, 2017
Mike Richman
QDL co-host Dirk Dusharme was on vacation for our Nov. 10, 2017, episode, but we ably covered for his absence with some thought-provoking stories and great guests. Let’s take a look: “What Really Causes Workplace Stress” A multidisciplinary team of researchers at the University of Southern…
‘Gluten-Free Water’ Shows Absurdity of Trend in Labeling What’s Absent
Brandon McFadden
The food labeling craze coupled with banner headlines about the dangers of gluten, genetically modified organisms (GMOs), and hormones are leading to increasingly absurd results. For example, you can now buy “premium” water that’s not only free of GMOs and gluten but certified kosher and organic…
Three Stages of Quality Management System Implementation and Oversight
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…
Inside Quality Digest Live for Oct. 27, 2017
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…
FDA Eases Application Process for Compassionate Use
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…
Inside Quality Digest Live for October 20, 2017
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…
Design Validation vs. Clinical Evaluation
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…
Are Your Medical Devices Secure?
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…
FDA Seeks Public Input on Modernizing Regulatory Framework
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…
Leveraging FDA Resources to Encourage Students to Pursue STEM Careers
Richard Pazdur
When I was in high school, I spent summers working as a restaurant dishwasher, grocery store stock boy, and gardener in northwest Indiana. The idea of spending those weeks learning about science and medicine would not have been an option for me at that time. Yet, it is precisely those students…
Inside Quality Digest Live for August 11, 2017
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…
Medical Device Manufacturers Warned for CAPA Noncompliance
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…
Fostering Medical Innovation
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…
The Sugary Drink Tax
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…
How Will Real-World Evidence Affect 2017 FDA Guidances?
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…
Quality Management Insights for Medical Device Manufacturers
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…
Solving Compliance and International Manufacturing Challenges
Ryan E. Day
Sponsored Content Founded in 1927 to produce aluminum splints—cutting edge at the time—Zimmer Biomet is a medical device company commanding second place in the entire world’s overall orthopedic market share. The organization’s stated purpose is to “Restore mobility, alleviate pain, and improve the…
Data-Driven Medicine
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…
PRISM Identifies Vaccine Safety Issues
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…
FDA: Helping Small Businesses Get Big Results
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…
Cybersecurity Management Expectations Clarified by the FDA
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-…
Five Tips for Medical Device Engineers on FDA Design Controls
Jon Speer
If you’re in the medical device industry, you may think that design controls are a confusing imposition on your processes. But they’re a necessary part of your requirements as a medical device developer, and I’ve noticed that this area tends to be rife with misconceptions, confusion, and generally…
Opening the FDA’s History Vault
Suzanne Junod, John Swann
The U.S. Food and Drug Administration’s (FDA) “History Vault” contains more than 10,000 artifacts that provide a journey through U.S. history and document the critical role played by one of the nation’s oldest public health agencies during its mission to promote and protect American health. These…
Tougher Quality Management Enforcement Possible by FDA
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…
New CDER Guidance Could Affect Quality Management Efforts
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…
Key Challenges for Risk Management in Medical Device Development
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…
Combination Products Review Program
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…
Inside Quality Digest Live: Jan. 13, 2017
Dirk Dusharme @ Quality Digest
I’m pinch-hitting for my co-host Mike Richman in the wrap-up of this past Friday’s episode of Quality Digest Live. Mike was off on vacation last week, so I presented the show myself. On Friday’s show, we covered: The FDA Mutual Reliance Initiative In order to lower their inspection costs, avoid…
The FDA Mutual Reliance Initiative
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…
Utility NERC Compliance Programs Challenged by New Risk-Based Approach
AssurX
If compliance with the North American Electric Reliability Corp. (NERC) Reliability Standards wasn’t complex enough, registered utilities must also factor in the regulatory nuances of the bulk power system’s (BPS) eight regional entities (RE), even as NERC emerges with new risk management…
Risk Management Programs: What the Latest Wave of HIPAA Fines Means
Michael Causey
The Department of Health and Human Services (HHS) hit hospitals and other healthcare delivery networks hard in the pocketbook with a wave of big fines zeroing in on security risk management issues between July and October. Is this the end of the fine tsunami? Don’t bet on it. In the most recent…
FDA Warning Letters Target Weak CAPA Programs Globally
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…
Creating a Safety Net for Medical Devices
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…
How Strong Is Your QMS Program?
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…
Manage Your Risk When Choosing Healthcare Payment Models
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…
RAPS Review: FDA CDRH Director Shuren Talks Priorities
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…
The Patient’s Voice Enhances FDA’s Approach to Drug Review and Development
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…
The Evolving Regulatory Landscape of 3D-Printed Medical Products
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…
The Real Reason the EpiPen and Other Off-Patents Are So Expensive
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…
FDA Introduces the Pre-RFD Process
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…
Six Tips to Make Sure Your 510(k) Submission Is Accepted
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…
Registration of Food Facilities
Erwin Miller
The Federal Drug Administration’s (FDA) mission to protect consumers from unsafe food follows different paths. The seven rules that have been finalized since the fall in 2015 to implement the 2011 FDA Food Safety Modernization Act (FSMA) will require food producers, importers, and transporters to…
Eight Reasons Why Your Design Controls and Risk Management Processes Fail
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”…
The FDA Forms New Partnerships to Ensure Product Safety
Howard Sklamberg
Globalization is posing challenges for public health. For the U.S. Food and Drug Administration (FDA), part of that challenge is the ever-increasing volume and complexity of FDA-regulated products coming to America’s shores. In fiscal year 2015, there were more than 34 million shipments of FDA-…
What We Mean When We Talk About EvGen, Part 2
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…
When Chemistry Meets Marketing
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.…
Passing an FDA Quality System Inspection
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…
Modernizing the Pharmaceutical Manufacturing Base
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…
The Rise and Fall of Theranos
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…
What We Mean When We Talk About EvGen, Part 1
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…
Why FMEA Is Not ISO 14971
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—…
Addressing Human Factors Relating to Combination Products
Jill Hartzler Warner, Thinh Nguyen
Combination products represent an important and growing category of therapeutic and diagnostic products under the U.S. Food and Drug Administration’s (FDA) regulatory authority. These products, which combine a drug, device, and/or biological product (referred to as “constituent parts”) with one…
Border Crossings
FDA
One of the vivid images that sticks with me from my tenure at the Food and Drug Administration (FDA) is of the port of entry at Nogales, Arizona. There, I saw large trucks from Mexico lined up as far as the eye could see, awaiting entry into the United States‎, many loaded full with fresh produce…
Amping Antimicrobial Discovery With Automation
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…
The Center for Biologics Evaluation Keeps Biological Product Standards High
Peter Marks
Part of the vision of the Center for Biologics Evaluation and Research (CBER) is to strengthen the center as the preeminent regulatory organization for biologics. One way CBER is achieving this is through the work of the Office of Compliance and Biologics Quality (OCBQ) and the Office of Vaccines…
FDA Proposes Cybersecurity Guidelines for Medical Devices
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 (…
Modernizing Pharmaceutical Manufacturing to Improve Drug Quality
The U.S. Food and Drug Administration (FDA) is working with drugmakers in a new way to help the industry adopt scientifically sound, novel technologies to produce quality medicines that are consistently safe and effective—with an eye toward avoiding drug shortages. When manufacturing problems…
How to Prepare for an FDA Inspection
Jon Speer
During the past several years, the FDA has been more aggressive and active in performing medical device company inspections. This has led to a far greater number of companies receiving Form 483 warning letters and citations. FDA Form 483s are a good way for your medical device company to flush $…
MDSAP Reaches for a 2019 Deadline in Canada
Grant Ramaley
The International Medical Device Regulators Forum (IMDRF) began a pilot phase for its new Medical Device Single Audit Program (MDSAP) in January 2014. This audit combines regulatory audits the manufacturer would typically face when they sell their products in certain IMDRF member countries: the…
Will You Be Ready for a FSMA Audit?
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…
FDA 2015: A Look Back (and Ahead), Part 3
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…
FDA 2015: A Look Back (and Ahead), Part 2
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…
FDA 2015: A Look Back (and Ahead), Part 1
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…
What We Mean When We Talk About ‘Data’
Robert M. Califf, Rachel E. Sherman
Medical care and biomedical research are in the midst of a data revolution. Put together, networked systems, electronic health records, electronic insurance claims databases, social media, patient registries, and personal devices comprise an immense new set of sources for data about health and…
Management Responsibility for GMP Oversight and Control
The QA Pharm
Historically, the Food and Drug Administration (FDA) has cited the Supreme Court decisions of United States v. Dotterweich (1943) and United States v. Park (1975) as Federal Food, Drug, and Cosmetic Act (FDCA) legal cases that establish that the manager of a corporation can be prosecuted under the…
When Inspections and Regulations Leave Quality Lacking, Try This
Howard Sklamberg, Jeffrey Shuren, Melinda Plaisier
Across the Food and Drug Administration (FDA), we are devoting tremendous effort, in collaboration with a variety of stakeholders, toward activities that drive—and increase–product and manufacturing quality. We believe quality can be quantified through close attention to data and consistent review…
Improving FDA Reviews of Combination Products
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…
FDA Eases Up a Bit on Enforcement Gas Pedal
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…
FDA Answers (Some) Medical Device Cybersecurity Concerns
Michael Causey
A new FDA guidance calls on the medical device community to be more proactive when it comes to developing a solid set of cybersecurity controls to ensure safety and efficacy for users. However, the agency isn’t putting the entire onus on medical device manufacturers. The FDA “recognizes that…
Ten Tips to Prepare for Electronic Health Records Audits
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…
Does Every Good Analytical Chemist Need to Be a Statistician?
Eston Martz
I read trade publications that cover everything from banking to biotech, looking for interesting perspectives on data analysis and statistics, especially where they pertain to quality improvement. Recently I read a great blog post by Tony Taylor, an analytical chemist with a background in…
FDA Touts Improved IDE Review Stats
Michael Causey
Ironically, the U.S. Food and Drug Administration (FDA) is sometimes wary of issuing guidances out of concern it will appear to be imposing new rules that will stifle innovation, according to Ken Skodacek, a policy analyst for the Clinical Trials Program at the Center for Devices and Radiological…
FDA’s 510(k) Guidance Emphasizes Software-as-Device Factor
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…
U.S. Drug Shortage Hits Patients, Pharmacies Hardest
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…
Cybersecurity—A Real Threat to Medical Devices
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…
Medical Device Makers Express Optimism About the Future...
Michael Causey
Crystal may be clear, but crystal balls, at least metaphorically, are certainly not. The late, great political columnist David Broder of The Washington Post used to run a column at the end of the year tallying up where he had guessed correctly—and where he’d missed the mark. Not many columnists…
Study: FDA 510(k) Approval Process Now Averages Six Months
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…
FDA’s Shuren Works to Ensure Medical Device Industry Innovators
Michael Causey
Calling it something of a “culture change” at the Center for Devices and Radiological Health (CDRH), Director Jeffrey Shuren said his team is working hard to find ways to speed approval of new medical devices by, in part, placing more stress on patient needs when looking at high-risk devices. If…
FDA Moves UDI Initiative Further Down the Production Line
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…
Four Reasons Companies Come Under a Consent Decree
The QA Pharm
When you peel back the layers of causes leading to serious FDA enforcement action, it comes down to a handful of fundamental reasons. 1. Management doesn’t know what is required Executive and senior management might not have regulatory experience. MBA programs may offer courses on quality, but…
Congress Crawls Out of 20th Century to Push Bipartisan ‘Cures’ Legislation
Michael Causey
Just when we’d all decided Washington lawmakers won’t accomplish much beyond enjoying their own excellent health insurance coverage, tasty bean soup in the Senate cafeteria, and the best parking on Capitol Hill, it turns out they might actually unite to accomplish something pretty big after all.…
Should the FDA Get Tougher on Investigational Review Boards?
Patrick Stone
The FDA says that investigational review boards (IRBs) aren’t required to collect a statement of investigator assurance from studies they preside over. This is troubling. My first question: How are IRBs going to assure that clinical investigators will abide by requisite 21 code of federal…
The FDA’s Action Plan Demands Some Industry Action, Too
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…
FDA Plays Catch-Up
Michael Causey
Informed consent (IC) is more than getting a quick signature from a clinical trial participant, the FDA gently reminds industry in a new guidance addressing increasingly complicated electronic IC (eIC) issues. Issued almost simultaneously with Apple’s new ResearchKit tool, which promises faster,…
Eight Questions That Define Your Medical Device User Needs
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…
Three FDA Initiatives That Affect Life Sciences
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…
Nestlé Takes a Bite Out of Unnecessary Additives
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…
FDA Gives the MDDS World a Big Break
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…
A CDRH Priority: Clinical Trials in the United States
Owen Faris, Jeffrey Shuren
At the Center for Devices and Radiological Health (CDRH), clinical trials are the foundation for our decisions to approve the most important medical devices—products that have the potential to save or sustain life, but also present the greatest risk to patients. During the past year, we saw…
Quality Takes Time, FDA’s CDER Reminds Drug Makers
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…
FDA’s CDER Has Ambitious ‘Front-Burner’ Priorities
Michael Causey
The folks at the Center for Drug Evaluation and Research (CDER) released their sometimes optimistic, but always enlightening guidance wish list and overall priorities for 2015. Let’s take a look. CDER director Janet Woodcock recently said these are her agencies “front burner” priorities: •…
How to Design-In Deming’s Philosophy
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…
Regulators Caught in the Act of Protecting Public Health
Melinda Plaisier, Michael Landa
  We were ready to head out to observe the inspection of a Miami seafood warehouse, but another team of investigators asked that we first look at evidence from their last job. They showed us a video of a huge quantity of rice contaminated with live insects. Their work, they knew, would prevent…
FDA’s Local Offices Flex Regulatory Muscle
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…
Are You Ready for 21st-Century eMDR Submissions?
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…
China Journal: Strengthening Relationships to Protect Public Health
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…
Common Cause: IMDRF and the Medical Device Single Audit Pilot Program
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…
Finessing an FDA 483, Part 2
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…
FDA Warning Letter Emphasis
Michael Causey
After a flurry of activity, it’s been relatively quiet lately on the FDA warning-letter front, though three device makers did get some bad news in recent weeks. FDA’s Philadelphia office hit Pittsburgh-based Zoll Manufacturing Corporation, a maker of  Class III medical device life vests, with a…
Responding to FDA 483 Observations, Part 1
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…
Medical Device Cybersecurity Risks
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…
FDA Proposals Take a Fresh Look at Some Stale Food Issues
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…
The FDA Is Reading Your Facebook Page...
Tamar June
In a previous column, Michael Causey looked at the FDA’s relatively ho-hum guidance on social media. Since then, the agency has issued an interesting warning letter to a Utah-based dietary supplement maker for, among other alleged infractions, “liking” off-label claims made about its product on…
It’s Time to Get IEC 62304 Before It Gets You
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…
Meet MAUDE
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…
FDA Guidance Advises Device Makers to Think About Home Use
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…
Essentials for Sustaining an Operational Pharmaceutical Quality System
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…
Time to Take a Closer Look at FDA MDDS Moves
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…
Protecting the Global Drug Supply
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,…
FDA Lets MDDS Off the Regulatory Hook
Michael Causey
The U.S. Food and Drug Administration (FDA) won’t enforce compliance with regulatory controls that apply to medical device data systems (MDDS) and medical image communications devices, recognizing the “low risk” they pose to patient safety and the importance they play in advancing digital health…
Validating for Success
Most of us, at one point or another, have been faced with making a decision to purchase a software application. Whether a simple application to manage your schedule or a more complex quality management software, the challenge is the same: How do you decide if a software application meets your…
Charles Darwin, Social Media, and the FDA’s New Guidance
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…
World Health Assembly 2014
Margaret A. Hamburg
The World Health Assembly is the decision-making body of the World Health Organization (WHO), attended every year by leading government health officials from its 194 member nations. Recently, I was pleased to participate as a member of the U.S. delegation in the 67th meeting of this important…
FDA Issues Final Guidance on Expedited Drug Approvals
Janet Woodcock
In recent years, there have been important advances to ensure that therapies for serious conditions are approved and available to patients as soon as sufficient data can show that the therapies’ benefits outweigh their risks. Despite the progress, there is much more work to be done. Many…
Is Your Medical Device ‘State of the Art?’
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…
Building Expertise and Crossing Boundaries to Improve Oversight
Howard Sklamberg
To keep the food supply safe, have safe, effective, and high quality medical products, and decrease the harms of tobacco product use, we have to work with the rest of the world. As the Food and Drug Administration’s Deputy Commissioner for Global Regulatory Operations and Policy (GO), I oversee…
Recipe for Success: Food Safety Regulations and the Role of Quality Management
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…
What Kind of Fish Is That?
FDA
Have you sometimes wondered if that “wild caught” salmon actually came from an aqua farm? Or if the “U.S. catfish” in the display case might have been born and raised in Vietnam? Is that “red snapper” actually red snapper and worth the premium price? Scientists at the U.S. Food and Drug…
FDA’s Discouraging Third-Party MDSAP
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…
Medical Device Industry Endures Tough 2013
Michael Causey
It’s March 2014, but you could forgive medical device company leaders if they’re still smarting a bit from a generally tough 2013. Several new studies indicate a low level of mergers and financing occurred last year, which could slow product innovation down the line. Also there was a drop in 2013…
Why FDA Supports a Flexible Approach to Drug Development
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…
Medical Device Makers Urged to Play Nicer by Sharing Data
Michael Causey
You shouldn’t need Barney the giant purple dinosaur to remind you of the playground mantra “sharing is caring,” but maybe the medical device industry needs to do some quick Netflix streaming of back episodes. The Institute of Medicine (IOM), already working with more than a dozen drug makers, the…
Three Things You Should Never Say When Presenting
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…
Much Ado About SOTU
Michael Causey
Those of us in and around Washington D.C. like to tell folks in the days leading up to a president’s State of the Union (SOTU) address that the speeches rarely matter and are generally forgotten while the teleprompter’s still warm. Then we analyze them to death for a few days. I don’t mean to…
Medical Device Industry Identifies Problems with FDA’s UDI Initiative
Michael Causey
Let’s start with what most everyone agrees on: The Unique Device Identification (UDI) program is a swell idea. It gets a little trickier after that. In extensive comments, the Advanced Medical Technology Association (AdvaMed), Boston Scientific, and Merck, among more than a dozen other…
Interpreting the FDA View of Medical Device Design Controls
Dennis Payton
Some of the shortest descriptions in the Food and Drug Administration's (FDA) CFR 21 Part 820—“Quality System Regulation” are found in Section 820.30 and Section 820.40, totaling about a page of information about design and document controls. However short, these two sections outline some of the…
FDA’s Promises for 2014
Michael Causey
Given the fact that the FDA probably doesn’t know what it plans to do in 2014, predicting their actions is challenging, to put it mildly. With that slightly weasel-like caveat, it’s worth noting three events in 2013 that will almost certainly impact 2014. CDRH’s Office of Compliance…
FDA’s Voluntary Compliance Improvement Program Receives Tepid Response
Michael Causey
It’s a growing trend in these United States: paying extra for conveniences such as bypassing the riffraff in airport security lines, or whizzing past mere mortal motorists on pristine, pay-for express lanes. Where I live in the Washington, D.C. area, the new express road program in Northern…
FDA Accepting Comments on ‘Medical Device Development Tools’
Michael Causey
A new Food and Drug Administration (FDA) draft guidance, “Medical Device Development Tools—Draft Guidance for Industry, Tool Developers, and Food and Drug Administration Staff,” outlines a voluntary process for qualification of medical device development tools (MDDT). The guidance, issued Nov. 14…
FDA Sponsors e-Learning for Evaluating Drug Promotion
Thomas Abrams
You probably have seen many consumer advertisements for prescriptions drugs—on TV, in magazines, or online. Although those ads are expensive, did you know that in 2010, pharmaceutical companies actually spent more money advertising to healthcare professionals than they spent advertising to…
The Beginning of the End for Fake ISO 13485 Certificates
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,…
Former FDA Inspector’s Crystal Ball
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…
Improving Product Compliance With Quality Risk Management Data
Mike Roberts
My colleagues and I at LNS Research have spoken to numerous companies during the past several years that have done an admirable job of building compliance into production processes. However, there are still many companies, particularly in the manufacturing sector, that struggle to meet product and…
Thinking Globally to Strengthen Science and Public Health Locally
Margaret A. Hamburg
There are many good reasons to go to Arkansas in September: to visit Little Rock, America’s No. 1 most livable city; or attend the annual Eureka Springs Antique Automobile Festival, to name two. But neither of these reasons are why more than 100 scientists, researchers, government regulators, and…
Who Is the Customer of Your Document?
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,…
Why Product Life Cycle Is Critical in Medical Device Design Control
Dennis Payton
Given the Food and Drug Administration’s (FDA) increased findings for companies that must comply to CFR 21 Part 820—“Quality system,” it’s curious that the oversight body has not offered much guidance about product design control, particularly concerning sections 820.30 and 820.40 of the…
Medical Device Recalls Reach Five-Quarter High
Stericycle Inc.
According to the quarterly ExpertRECALL Index, 48 percent of all medical device recalls reported during the second quarter of 2013 had both U.S. and international components. In addition, the number of device recalls increased 30 percent from the last quarter, resulting in the highest number of…
FDA Publishes Guidance for Wireless Medical Devices
Bakul Patel
Many medical devices today perform at least one function by using wireless technology to support health care delivery. In telemedicine, for example, a wireless device can enable real-time monitoring of patients from a distance. Data from a patient-worn or implanted medical device goes directly to…
The Interoperability of Things
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…
Proposed Rules Will Strengthen Global Food Safety
Margaret A. Hamburg
It’s a small world. Every day, there’s a good chance that some of the food you’re eating came from another country. Fifteen percent of the food we eat, including nearly 50 percent of the fresh fruit and 20 percent of vegetables, is imported each year. That’s why it’s so important that we do…
Five Obstacles to Managing a Pharmaceutical Quality System, Part 1
The QA Pharm
Editor's note: This is the first 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. Compliance to current good manufacturing practice (cGMP)…
Resolving Disputes Concerning FDA and Medical Devices
David S. Buckles, Lawrence Romanell
Disagreements are inevitable in science, medicine—and even life. As part of a regulatory agency committed to public health, the Food and Drug Administration’s (FDA) medical devices center occasionally confronts scientific and policy disagreements among its staff and with the various stakeholders…
You Got Electronic Medical Device Reporting Questions?
Michael Causey
In a new 47-page guidance the Food and Drug Administration (FDA) appears to be doing its best to cover the waterfront for medical device manufacturers who need to better understand the complex medical device reporting (MDR) requirements. Topics range from the big picture (who is subject to this…
Eating GMOs Isn’t Kosher for Anyone
Kimberly Egan
What do China, Maine, Connecticut, Chipotle, and Whole Foods have in common? They all think you have a right to know whether the food you are eating contains any genetically modified organisms, known as GMOs. I like that. Why do I care? Because the genes in GMO plants have been altered in a…
FDA to Plug Holes in Medical Device Security Systems
Michael Causey
The Internet giveth and the Internet taketh away. For years, we’ve been hearing about the benefits online tools will bring to the medical industry, especially at hospitals and physicians’ offices. Many of those promises have come true, and it’s been a benefit for patients and industry. But that…
When Conduct Becomes a Crime
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…
Federal Regulators ‘Patent’ Another Bad Idea
Michael Causey
The shell game called the federal budget added another nut recently as media reports revealed that during the last 20 years, approximately $1 billion in fees paid by patent applicants has been diverted from its proper use at the United States Patent Office (USPTO). Critics argue that, as a self-…
Farm-to-Fork Traceability
James Andrews
T ake a moment to consider some of the foods we find at the supermarket: eggs, tomatoes, coffee — maybe even chocolate chip peppermint brownie ice cream. Now, try to imagine all the steps and processes that the food went through to get all the way to those shelves. Although the ice cream likely…
The FDA Is Taking Its Act Abroad
Michael Causey
The latest batch of Food and Drug Administration (FDA) inspection letters noting objectionable conditions, aka 483s, has a decidedly international flair: Italy, Japan, and Canada had the pleasure of hosting FDA inspectors in recent months. Three firms were found wanting by the agency in a number…
George E. P. Box Remembered
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…
Grow the Carrot, Chop the Tree
Michael Causey
The giant sequoia trees on the Pacific Coast are breathtaking. Majestic and seemingly indestructible, they stand tall as a reminder that slow and steady sometimes does win the race. But what’s great in a forest isn’t always so great elsewhere. Let’s push the metaphor a bit more, and say there’s…
A New Breed of Pharmacy Compounding Has Outgrown the Law
Margaret A. Hamburg
The deadly outbreak, in October 2012, of fungal meningitis associated with a compounded medication was a horrible tragedy. I’ve asked myself many times if and how it could have been prevented. I speak for everyone at the FDA when I say that our hearts go out to the many victims, including those…
Keeping Up With Mobile App Innovations
A smart phone that can perform an electrocardiogram (ECG)—measuring the electrical activity of a person’s heart to determine whether he is having a heart attack—is in my opinion an extremely smart phone. That is just one example of how mobile medical applications are transforming healthcare. As…
Raise a Glass to a Dumb Medical Device Tax Brewed in D.C.
Michael Causey
A prominent politician goes before his constituents during a tough reelection campaign. He’s introduced by the local mayor, and strides to the stage, waving and smiling to enthusiastic applause. “It’s great to be here with you tonight. I love this great state of [fill in the blank]. Erica and I…
Simple Nutrition Facts for Complicated People
Kimberly Egan
Nutrition labels have been much in the news lately, presumably because we have once again won the fattest nation contest. The Food and Drug Administration (FDA) and various nutrition researchers have all put out some thought-provoking information for us to ponder. The problems First, people don’t…
Study: FDA Enforcement Growing for Medical Device Companies
Michael Causey
Turns out that some paranoid people have a reason to, well, be paranoid. Researchers from the London Business School issued a report last year finding that many people at work who thought they were being talked about were probably right. Maybe some in the medical device industry can be forgiven…
Speeding Time to Market at Motorola
IntraStage
The first production Model T auto in 1908 ushered in a new era of transportation by shrinking dramatically the time it took for people to move from place to place. Like the Model T, communication technologies such as email, mobile phones, and the Internet are dramatically shrinking the time for…
Save Us from Sprouts and Cilantro
Kimberly Egan
On Jan. 4, 2013, the Food and Drug Administration (FDA) took the first step in its history to regulate produce farmers. The agency issued a 547-page proposed rule that spends a lot of time reducing everything humanity has learned about plants since agriculture emerged in the Fertile Crescent 10,…
How Effective Are Flu Shots?
Jim Frost
This flu season has been worse than normal. The Centers for Disease Control and Prevention (CDC) data show that the flu has struck early and hard. Influenza cases shot up during December rather than the more usual January or February, and 47 states report widespread influenza cases. I get a flu…
FDA Warns WebTrader Users: Remove Your Files or Lose Them
Tamar June
A Jan. 11, 2013, email sent by Michael Fauntleroy, program manager for the Food and Drug Administration (FDA) Electronic Submissions Gateway (ESG), the agencywide solution for accepting electronic regulatory submissions, warns those using the WebTrader for electronic submissions to delete their…
A New Era in Food Safety Oversight
FDA
Last December, Sunland Inc. entered into a court-ordered agreement imposing requirements that must be complied with if the company is to operate. This consent decree follows the Food and Drug Administration’s (FDA) suspension of Sunland’s food facility registration in November 2012. The suspension…
It’s Time for the FDA and States to Step Forward for Public Health
Patrick Stone
It’s clear that the Food and Drug Administration (FDA) should have more compounding pharmacy oversight, but how long will it take them to make other important decisions on public health? The recent news is troubling. For example, a shipment of tainted steroid from a Massachusetts-based compounding…
Global Cooperation Helps Expand Safety Net
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…
Regulatory Science Is Not Boring
Susan Kelly
I’m a relative newcomer to government work, having joined the Food and Drug Administration (FDA) about 18 months ago after decades of being a journalist. My job is to assign, write, and edit FDA consumer updates, which are news stories posted on www.fda.gov designed to give consumers important…
Give the FDA More Authority Over Compounding Pharmacies
Patrick Stone
Compounding pharmacies, where the creation of a particular pharmaceutical product to fit the unique needs of a patient is done, have enjoyed the protection of their state pharmacy board, or they don’t distribute outside their home state (no interstate sales). This means that compounding pharmacies…
Is the FDA Better Off Than It Was Five Years Ago?
Patrick Stone
During a debate with then-President Jimmy Carter, Ronald Reagan famously asked Americans if they were better off than they were four years previously. It worked for Reagan, so we’re going to try a variation of it here. Is the Food and Drug administration (FDA) better off than it was four or five…
What the Heck’s Going On at the FDA?
Michael Causey
The Cold War may be over, but apparently spying is still a growth industry. The latest spy-craft news comes from the seemingly staid Food and Drug Administration (FDA), which appears to have more George Smiley and John le Carré types than we’d ever imagined. According to reports in The New York…
FDA and EU Spar on Medical Device Regulation
Michael Causey
Sure, the Italians have better food, the English richer royal culture and accents, and French women don’t get fat, but we in America regulate medical devices better, don’t we? Not so fast, says the European Union. They apparently aren’t happy that the Food and Drug Administration (FDA) is writing…
FDA Introduces Triage Pilot Program
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…
Medical Device CEO Laments ‘Anti-Industry’ FDA Culture
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…
Going Long in Medical Device Manufacturing
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…
Lawmakers’ Silly Season No Laughing Matter for Device Industry
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…
FDA Budget Could Hike User Fees, Overseas Inspections
Michael Causey
Budget-conscious firms that do business in China and elsewhere outside the United States may not like what they find in the Food and Drug Administration’s (FDA) request in the Budget of the United States Government, Fiscal Year 2013. While it is one of the few agencies that could see its overall…
Misguided FDA Food Regulations Will Hike Costs, Not Safety
Julie Gunlock
This year will mark another push for aggressive food regulation at the Food and Drug Administration (FDA). On tap, salt regulations and industrywide regulations dictating which foods can be advertised on television. In October 2011, the FDA announced in the Federal Register that it would begin…
FDA Offers Salty Recipe for Increased Food Regulation
Michael Causey
It’s actually bigger than a battle over a popular condiment, according to some folks who oppose what they say is the Food and Drug Administration (FDA) overplaying its regulatory hand. We’re not going to settle this controversy here, but some experts suggest you may be able to sprinkle a little…
Quality Pro Salaries Keep Pace with Inflation
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…
FDA Reorganization Signals More Inspections for Drug, Device Firms
Michael Causey
Under pressure from all sides, the beleaguered Food and Drug Administration (FDA) keeps announcing new reorganization initiatives, name changes, and all sorts of stuff that would be funny if it was scripted by the same team handling Steve Carell’s departure from The Office and the ushering in…
Foreign Exporters Study U.S. Food Safety Law
FDA
The Food and Drug Administration’s (FDA) international program has logged nearly 75,000 hits to its web pages on the new food safety law, as foreign companies that export food to the United States scramble to learn how the law affects them. “A lot of our foreign offices are being deluged with…
Quality by Design Pilot Presents Industry with New Challenges
Patrick Stone
What products will be affected by the Food and Drug Administration’s (FDA) quality by design (QbD) stipulation, as outlined in its report, “Pharmaceutical Quality for the 21st Century: A Risk-Based Approach”? It will apply to new marketing authorization applications, new drug applications, Type…
The Food Safety Modernization Act: A Public Health Imperative
Les Schnoll
According to recent data from the Centers for Disease Control and Prevention, every year about 48 million people get sick, 128,000 are hospitalized, and 3,000 die from food-borne diseases. Hardly a day goes by where there isn’t another recall of food contaminated with a variety of microorganisms…
When ‘Reason to Believe’ Halts Food Production
Cathy Crawford
As of July 3, 2011, the Food and Drug Administration (FDA) has increased authority to use administrative detention as an enforcement tool. For this reason, companies that manufacture, prepare, pack, or hold food should ensure strong record-keeping practices. Under the current criteria of the…
FDA Protects Us from Terror of Unpasteurized Milk
Patrick Stone
I don’t know about you, but I sleep easier now knowing that our Food and Drug Administration (FDA) has declared war on unpasteurized milk in the United States [Editors note: also see Fox News, NaturalNews.com]. It’s not enough that the U.S. government is fighting the war on terror (an oxymoron)…
Should Commitments Made to the FDA Be Taken Seriously?
The QA Pharm
Responses to the Food and Drug Administration’s (FDA) Warning Letters and the FD483—a written notice of deficiencies found during inspections—are usually full of commitments. They involve what will be done to correct compliance problems, and when it will be done. The FDA has even started to ask…
FDA to Set Production Standards for Safer Fruit and Vegetables
FDA
As headlines from Europe implicate tainted vegetable sprouts in more than 4,000 illnesses and dozens of deaths, American consumers may wonder, “Could that happen here?” The United States has had its own headline-grabbing outbreaks from contaminated vegetables—such as lettuce in 2010, peppers in…
Independent Study Finds FDA 510(k) Review Process Has Slowed
Michael Causey
Well, this is getting interesting. For the past several months, we’ve had relatively partisan folks on each side of the medical device industry vs. the Food and Drug Administration (FDA) debate saying either the 510(k) premarket notification  process wasn’t doing so badly (the FDA), or that it was…
FDA, Industry Grapple with Similar Quality, Technology Challenges
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…
FDA Demands Corporate Commitment at PolyCarbon Industries
The QA Pharm
Just when you think that the Food and Drug Administration (FDA) has to stick to the script by quoting chapter and verse of current Good Manufacturing Practices (CGMPs), it gets very progressive and offers straight talk about corporate commitment and leadership. I have reported before that the FDA…
ACLASS’s Greenaway Speaks on Food Safety Modernization Act
ACLASS
Keith Greenaway, vice president of ACLASS, a brand of ANSI-ASQ National Accreditation Board that provides accreditation, gave a brief talk titled “Focus on Inspections and Compliance” at the FDA Food Safety Modernization Act public meeting held on June 6, 2011. His prepared remarks follow: The…
Much Ado About Bean Sprouts
Kimberly Egan
I don’t know how I missed this gem, but on March 24, 2011, the Food and Drug Administration (FDA) sent a Warning Letter to Jonathan’s Sprouts Inc. informing the company that it was (among other things) marketing its organic mung bean, alfalfa, and broccoli sprouts as drugs. The FDA said it has…
Quality Digest Interprets the Voice of the Customer
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…
For Corrective Action Plans, Where Are the Resources?
The QA Pharm
Can you imagine the stream of firms that venture into their respective FDA district offices to give presentations on their warning letter response and to offer their assurance that they truly “get it?” You can be sure these firms had several dry runs and dress rehearsals to hone their material…
Turning Point for Food Safety
Cor Groenveld
How safe is our food? It is a question asked all over the world on a daily basis as food-scare stories fill the media and governments act to calm consumer fears. There is a real and tangible concern among the public; an IBM consumer confidence survey in 2009 found that 80 percent of those…
Being Comfortable in a World of Never-Ending Change
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…
Under-Promise, Over-Deliver
Quality Transformation With David Schwinn
“Under-promise, over-deliver” is a phrase taught to me many years ago by my friend and colleague, PQ Systems’ owner Michael J. Cleary. It may have always been true. It may always be true. It is certainly true today. I am in the middle of a sabbatical that requires me to buy and learn to use new…
FDA Questions Data Integrity at Ningbo Smart
The QA Pharm
A March 30, 2011, Food and Drug Administration (FDA) Warning Letter to Ningbo Smart Pharmaceutical Co. revealed that it had reported conformance to specifications on certificates of analysis, when in fact no testing was done—among other issues. The FDA rather understatedly informed Ningbo Smart, “…
Food Safety Auditors’ Red Flag: No Documented Issues
Lisa Lupo
Companies aren’t perfect, and neither are the people who work for them. Since this is a fact rather than a judgment, it’s reasonable to expect errors in manufacturing and process management. When an audited company continues to show a flawless record for, say, a food-safety audit, chances are it…
Killing Time: How to Manage Interruptions
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.…
Are You Prepared for Foreign Food-Supplier Verification Laws?
TraceGains
Under the Food Safety Modernization Act (FSMA), food manufacturers and processors who import food ingredients and raw materials will be required to implement a Foreign Supplier Verification Program, essentially mandating that foreign suppliers undergo the same rigor and scrutiny as domestic ones.…
Are You Prepared for Foreign Food-Supplier Verification Laws?
TraceGains
Under the Food Safety Modernization Act (FSMA), food manufacturers and processors who import food ingredients and raw materials will be required to implement a Foreign Supplier Verification Program, essentially mandating that foreign suppliers undergo the same rigor and scrutiny as domestic ones.…
Consent Decrees—When the FDA Gets Tired of Talking
The QA Pharm
By the time a consent decree comes along—which happens when a firm repeatedly violates current good manufacturing practice (cGMP) requirements and the Food and Drug Administration (FDA) forces it, through legal channels, to make specific changes—it’s no longer a discussion about responses to…
Consent Decrees—When the FDA Gets Tired of Talking
The QA Pharm
By the time a consent decree comes along—which happens when a firm repeatedly violates current good manufacturing practice (cGMP) requirements and the Food and Drug Administration (FDA) forces it, through legal channels, to make specific changes—it’s no longer a discussion about responses to…
Tips on Preparing for an FDA Inspection
Bruce McDuffee
If you’re in the business of manufacturing drugs, medical devices, nutraceuticals, or manufacturing or importing any product in the United States that falls under current Good Manufacturing Processes (cGMP) regulations, your facility will be inspected by the U.S. Food and Drug Administration (…
Congressional Committee to Reduce Waste, Eliminates Self
Kimberly Egan
It turns out that I am not the only one who has noticed that food regulation is sometimes a little, well, silly. The federal government recently “identified a mother lode of government waste and duplication” and decided that getting rid of it “could potentially save billions of tax dollars annually…
QC, QA, Sensationalism, and “Seasoned Ground Beef”
Ryan E. Day
The recent brouhaha involving a class-action suit against Taco Bell alleging that their beef filling is more filling than beef really got me thinking, but not about what’s in the tacos. Instead, it got me thinking about quality control, quality assurance, and particularly about customer…
Speed Up Your Medical Device Time to Market
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…
Is It Quality Assurance or Quality Control?
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…
Internal Quality Audits: Valuable or False Security?
The QA Pharm
Most pharmaceutical companies have an internal current good manufacturing practices’ (CGMP) auditing program administered at the site and corporate levels of the organization. Auditors are typically part of the quality assurance or regulatory compliance function, and the usual approach is to…
Should Food Safety Laws Apply to All Growers?
Dirk Dusharme @ Quality Digest
For most of us, food safety is a topic that, at best, only lurks at the edges of our brains. It rarely becomes something we really think about until we open up our refrigerator and try to figure out what’s growing in the back corner of the bottom shelf, or until we hear stories about people being…
FDA Inspections: When You Know You Have Problems
The QA Pharm
People often ask me how best to prepare for a Food and Drug Administration (FDA) inspection when you know that you have problems. My first response is that they have already taken the first step: acknowledging that there are problems. Believe me; that is a huge first step. Just like Alcoholics…
Snake Oil, Anyone?
Taran March @ Quality Digest
Pharmaceutical manufacturer Johnson & Johnson, which for decades has enjoyed a trusted reputation for soothing babies and overcoming head colds, is currently facing criminal investigation by the U.S. Food and Drug Administration (FDA). The company’s McNeil Consumer Healthcare unit closed a…
Digital Pen Speeds Data Management, Helps FDA Compliance
Digital pen technology is an efficient data management solution that offers better operational visibility, enabling manufacturers to react quickly to the production process and respond to issues via immediate data access. Hyla Soft’s FactoryScribe is a lightweight web application built around…
This Year in Quality, Part One
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…
Comparing Pharmaceutical Continuous Monitoring Systems: Part 2
Environmental Quality Corner with Ken Appel
Ken Appel is the manager of regulated industries for Veriteq. In part 1 of this article, we discussed the pros and cons of various systems for stand-alone monitoring instruments (e.g., chart recorders and data loggers) and wired networks, with and without power over Ethernet (POE). In the…
Comparing Pharmaceutical Continuous Monitoring Systems: Part 1
Environmental Quality Corner with Ken Appel
Ken Appel is the manager of regulated industries for Veriteq. T he U.S. Food and Drug Administration (FDA) and its European Union counterparts recently agreed to cooperate on pharmaceutical plant inspections to enable stepped-up enforcement of safety guidelines. These agreements will help…
Food Safety: Challenge or Opportunity?
Thomas R. Cutler
Food safety standards are becoming increasingly stringent. Although government legislation has long been implemented, your customers may be driving an even higher standard of food safety through the Global Food Safety Initiative (GFSI) or Safe Quality Food (SQF) Institute, which require third-…
When All Else Fails, Lower Your Standards
The QA Pharm
My definition of “specification” is rather simple: It’s a promise. Just like any other promise, you’d better be sincere when you make it and be able to keep it. Failure to keep a promise brings disappointment. Frequent failure leads to distrust. And consciously breaking a promise is nothing less…
A Cure for Customer-Activated Tone Deafness
The QA Pharm
We hear much about the importance of listening to customers and meeting their needs. Lean Six Sigma devotees say that metrics from the customer’s vantage point are at the center of their philosophy. Many pharmaceutical companies embed their high view of the professional community and patients…
Savvy Compliance Strategy, Part IV
Sal Lucido
Figure 1: Closed-loop process for managing regulatory compliance In Part I, Part II, and Part III of this compliance series, I have described the benefits of using a closed-loop process for managing regulatory compliance (illustrated in figure 1). Readers of this series…
Quality Assurance: To Count the Cost—or Not?
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…
21 CFR Part 11: Auditors Are at Your Door
Environmental Quality Corner with Ken Appel
On July 8, the Food and Drug Administration (FDA) announced an initiative “… to evaluate industry’s compliance and understanding of Part 11 in light of the enforcement discretion described in the August 2003 Guidance for Industry Part 11, Electronic Records; Electronic Signatures—Scope and…
Savvy Compliance Strategy, Part III
Sal Lucido
In Part I and Part II of this series we discussed the benefits of using a closed-loop process for managing regulatory compliance called the “circle of compliance,” pictured in figure 1. I also showed how setting up key performance indicators (KPIs) that monitor performance to goals is a good way…
One-Year Exemption from FDA Inspections Possible
Oriel STAT A MATRIX
Medical device manufacturers may gain a one-year exemption from Food and Drug Administration (FDA) inspections if their establishment has been audited under one of the regulatory systems implemented by the Global Harmonization Task Force (GHTF) founding members using ISO 13485. Manufacturers must…
Congress Can Wait… But the FDA Won’t
Environmental Quality Corner with Ken Appel
For quite some time, polls have indicated that public approval for Congress remains at an all-time low. Congressional gridlock is difficult to watch for U.S. citizens who care about any issue and how our legislative process resolves the problems of our time—no matter what their party affiliation…
Consumer Product Testing Rule Should Include Design Analysis
Gene Rider
Approximately three-fourths of product safety recalls in the United States are the result of some design flaw in the product rather than a manufacturing or other defect. Most violations of the U.S. Consumer Product Safety Commission (CPSC) “small parts” standard, for example, are the result of…
Savvy Compliance Strategy Can Improve GMP
Sal Lucido
The compliance department’s primary function is to ensure that the company complies with all applicable regulations, rules, and laws. Regardless of the industry—life science, energy and utilities, or financial services—this is a universal mandate. As someone who serves customers across many…
Achieving the LIMS Promise
In the classic Aesop fable, “The Fox and the Grapes,” a fox desires some grapes hanging high overhead. When he is unable to come up with a way to reach them, he convinces himself that the grapes are probably sour and therefore not desirable anyway. “Sour grapes” has become an idiomatic expression…
What the Gulf Oil Spill Has to Do With Drug Safety
Environmental Quality Corner with Ken Appel
At the time of this writing, inspectors from the Food and Drug Administration (FDA) are at work monitoring seafood safety in areas affected by the oil spill in the Gulf of Mexico. Finger-pointing continues and there is now talk on the news of criminal prosecutions. The full economic effect of the…
On My Honor
The Un-Comfort Zone With Robert Wilson
With the morning mist still on the Hudson River and the sun just kissing the cliff tops of the New Jersey Palisade, Aaron Burr, vice president of the United States, shot and killed former Secretary of the Treasury Alexander Hamilton. Political opponents for years, the duelists faced each other…
FDA Inspectional Observations Increase Focus on Qualifications, Personnel Training
Oriel STAT A MATRIX
In recent years, there have been published reports of an increase in Food and Drug Administration (FDA) inspectional observations associated with training deficiencies. Specifically, these inspectional observations have focused on training related to the quality system requirement that…
The New Mind-Set of the Pharmaceutical Industry
Environmental Quality Corner with Ken Appel
Having exhibited at INTERPHEX for many years, Veriteq, a provider of environmental monitoring and validation solutions, has made many connections with leading pharmaceutical and biotech companies. The Veriteq team attending INTERPHEX 2010, on April 20–22, was struck by two trends in the…
Defining Quality: The FDA’s Position on Good Manufacturing Practices
Where does the U.S. Food and Drug Administration (FDA) stand on good manufacturing practices (GMP), the set of regulations that govern manufacture and testing of medical devices and other medical products like pharmaceuticals, diagnostics, and food? And what of the universal device identification…
Event: Training Within Industry Summit
(TWI Institute: Liverpool, NY) -- Training within industry is needed more now, in this down economy, than ever before. It was in a time of crisis that the Training Within Industry (TWI) Service proved its worth more than 60 years ago. Today, leading organizations are turning to training within…
More Stringent FDA Review Processes for Medical Devices on the Horizon
Oriel STAT A MATRIX
After years of focusing on the pharmaceutical industry and establishing better controls for reviewing the safety and efficacy of pharmaceutical products prior to approval, the Food and Drug Administration (FDA) is now directing its attention to the medical device industry. On Feb. 18, the FDA…
Precise Pipetting Helps Set Standards for Molecular Diagnostics
Jennifer Sprance
The molecular diagnostics industry is a relatively new territory that offers much promise for early disease detection and personalized patient care. When analyzing samples at the molecular level, there are serious consequences for errors, and tests must be highly accurate and precise. For example…
On-Demand Compliance Software Helps Small Medical Device Makers Compete
Benny Shaviv
The rapid pace of technological advancement in the last decade has introduced both significant benefits as well as significant challenges to medical device makers. Companies these days are faced with demands of bringing products to market faster and faster, not only to meet sales and market…
Shewhart, Deming, and Data
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…
It’s All Your Fault!
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…
Electronic Medical Device Reporting Best Practices
Joby George
The FDA’s Center for Devices and Radiological Health (CDRH) posted a notice of draft guidance that will require all medical device adverse-event reports to be submitted electronically. While the process of electronic submission of data is a more efficient and traceable means for reporting, it…
Quality Management Systems Are Not for Renegades
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…
Good night and sweet dreams!
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…
New Protocols Will Test Effects of RFID Systems on Medical Devices
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…
Achieve the Effective Corrective Action That ISO 9001:2008 Requires
John Stiller
 Story update 9/23/09: Reference to 9.5.2.f was changed to 8.5.2.f in second paragraph. As more suppliers are required by their regulators and customers to achieve ISO 9001 certification, and because certification symbolizes a point of competitive differentiation in a tight economy, emphasis on…
“The More You Learn, the More You Earn”
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,…
New Food Safety Policy Adds to Confusion
Resistance to the National Animal Identification Scheme (NAIS) has been strong. This six-year-old USDA policy initiative to reduce the catastrophic effects to the livestock and meat industry from a major animal disease outbreak has received so much negative reaction from so many and now seems…
Does Anybody Really Know What Time It Is?
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…
What Should The Quality Manager Do?
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…
ISO 13485: Creating a Globally Harmonized Quality System
Richard A. Vincins
Through the 1990s, the application of a quality system relied primarily upon the Food and Drug Administrations’ (FDA) good manufacturing practice requirements or the FDA 21 CFR Part 820 Quality System Regulation. At that time, the international standards for quality management systems (QMS) were…
The Devil’s Advocate Problem-Solving Approach
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…
Attitude is Everything
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…
Analyzing Data Saves Millions for County Tax Payers
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,…
Can You Twitter Your Way to Performance Excellence?
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…
Verifying the Effectiveness of Corrective Action
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…
Part Tracking Keeps Suppliers/Customers Happy
Mark Symonds
It’s no secret to anyone, anywhere, that we’re experiencing a global business challenge, especially in manufacturing. One could argue that for too long, manufacturers in the United States have been complacent and indifferent to signs of market change, steadily losing market share to offshore…
How Accreditation Could Have Prevented an Outbreak of SARS
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…
The Power of Observation, Part 1
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…
Value Adds to ISO 9001 Compliance
Sandford Liebesman
I've been auditing to ISO 9001 since 1992. A part of my auditing philosophy has been to add value to the audited organizations by suggesting opportunities for improvement. Following, I will describe the most effective “value adds.” Continual improvement Look at ISO 9001:2000 subclause 8.5.1--"…
FDA Importer Guidance For Devices
Tamar June
The Food and Drug Administration (FDA) has had many challenges and setbacks in the past few years. From budget cuts, to high-level departures, the agency has also faced fury from lawmakers on Capitol Hill over high-profile device, drug, and food recalls. Off the record, current, and former…
Ultra Low Pressure Calibrators Help Pharmaceutical Operation
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…
Improving the Effectiveness of Internal Auditing
Richard Strouse
Internal auditing, when effectively implemented, can arguably be considered the most important tool in the quality system tool box. It’s the primary method for continuously monitoring a company's quality management system (QMS). In fact, the feedback from internal auditing is critical to the growth…
Defining Accuracy and Precision
George Rodrigues
Liquid delivery is a common laboratory process and this critical function is often overlooked. As a result, routine research and test results can be in error based on a simple misunderstanding or misapplication of liquid delivery instruments. This article focuses on defining and exploring accuracy…
Risky Business
Rory Granros
When regulatory compliance and risk management come to mind, they usually evoke feelings of fear, uncertainty, and doubt as to how well an organization is prepared for government scrutiny or any worst-case business scenario. Questions arise, such as: Have we developed the proper procedures to…
Vidalia Hospital Goes Lean
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…
The Advancement of Controlled Clinical Trials
From an antacid to a new cancer treatment, every drug must be proven safe and effective in controlled clinical trials before the U.S. Food and Drug Administration (FDA) allows it to be sold in the United States. When federal law first required controlled clinical trials in 1962, most people…
The Effect of One Microliter
George Rodrigues
Pharmaceutical processes typically take place on the scale of gallons or liters, even tens of thousands of liters. So why would anyone worry about one little microliter? Because in some situations, deviations as small as one microliter can mean the difference between success and failure. Modern…
Preparing for ISO 13485 Certification
James Jardine
The International Organization for Standardization has developed more than 17,000 international standards on numerous subjects. For medical device companies, the most important of these standards is ISO 13485, which provides internationally recognized guidelines pertaining to quality management…
Top Four Activities to Prepare for ISO 13485 Certification
James Jardine
The International Organization for Standardization has developed more than 17,000 international standards on numerous subjects. For medical device companies, the most important of these standards is ISO 13485, which provides internationally recognized guidelines pertaining to quality management…
Final FDA Rule on Dietary Supplements
In June 2007, the U.S. Food and Drug Administration issued the dietary supplement current good manufacturing practice (CGMP) final rule (21 CFR Part 111). In essence, the final rule requires that the proper controls be in place for dietary supplements during manufacturing, packaging, labeling, and…
Final FDA Rule on Dietary Supplements
Sharon Phillips
In June 2007, the U.S. Food and Drug Administration issued the dietary supplement current good manufacturing practice (CGMP) final rule (21 CFR Part 111). In essence, the final rule requires that the proper controls be in place for dietary supplements during manufacturing, packaging, labeling…
Final FDA Rule on Dietary Supplements
Sharon Phillips
In June 2007, the U.S. Food and Drug Administration issued the dietary supplement current good manufacturing practice (cGMP) final rule (21 CFR Part 111). In essence, the final rule requires that the proper controls be in place for dietary supplements during manufacturing, packaging, labeling…
Advantages to Risk-Based Validation
David Ade
For companies doing business in regulated environments, the benefits of implementing software systems are abundant. Improved product safety, higher quality, enhanced efficiency, and increased probability of maintaining regulatory compliance are just a sample of the numerous benefits…
Essential Elements of Effective CAPA Systems
Ken Peterson
From the perspective of the U.S. Food and Drug Administration and other regulatory agencies, corrective and preventive action (CAPA) is viewed as the central component that affects all control points including design controls, production and process controls, records and documents change controls,…
Pharma’s Transition from Paper to Pixels
MasterControl Inc.
The advantages to pharmaceutical companies of using electronic solutions to modernize their paper-based or partially electronic processes are enormous. Automation speeds up and connects all interrelated processes (corrective and preventive actions, customer complaints, audits, deviation…
Managing Risk Has Its Rewards
Tim Lozier
In today’s quality management systems, the ability to control and correct processes is key to maintaining a high level of compliance within an organization. Whether it’s tracking incoming customer complaints, identifying nonconforming materials from production, or using corrective and preventive…
Regenerating Nerves
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…
Detecting Disease
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…
Skin Deep
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’…
Numerical Optimization
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…
Measuring Up
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…
High-Resolution Imaging
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…
Overcoming the Global Challenges
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…
Opening a Cellular Door
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…
The Right Thing to Do
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…
Molecular Imaging of a Virus
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…
Self-Powered Nanoscale Devices
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…
Close Encounters of an Electromagnetic Kind
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…
New Tools
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…
Fake Pharmaceuticals
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…
High-Tech Drug Delivery
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…
Managing Diabetes
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…
High-Shear Fluid Processing
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…
Successful Enterprise Resource Planning
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…
The Prescription for Health Care Excellence
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…
Laser Scanning Helps Validate Design of New Venous Filter
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…
Consumers Must Drive Quality Health Care
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…
Quality Assessment: Process or Outcome?
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…
RFID in Health Care: a Four-Dimensional Supply Chain
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…
How Experimental Design Optimizes Assay Automation
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…
New Biopharmaceutical Coalition Aims to Support SAFE Initiative
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…
A Blueprint for Electronic Record Retention
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…
The Business Case for FDA CFR 21 Part 11 Compliance
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…
Medical Matters
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.…
The Business Case for FDA CFR 21 Part 11 Compliance
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…
Coming Soon
Quality Digest
Our BioMed Community is under Construction. Check back soon. Our launch date will be Jan. 26, 2005
      

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