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With medical devices ranging from simple needles to life-saving high-tech implants, ensuring the highest possible level of safety is one of the industry’s greatest priorities. Here, as the chair of the ISO technical committee for quality management and related general aspects for medical devices,…
Bundled payments. Volume-to-value. Cost accounting. Process improvement. Patient engagement. Population health. Organizational leadership. These are more than just the newest industry buzzwords: They’re the trends that will compel the healthcare industry to transform its business model. They will…
The other day, I visited a retail outlet of a wireless services provider to get information about its international roaming packages. The company has a few thousand outlets nationwide; they’re called “relationship centers” staffed with half a dozen employees who try to up-sell products and…
Today, design has a seat at the table. With the success of products like the iPod and the iPhone, businesses have realized that a good user experience is key for improving the bottom line. Yet even with this determined focus on design, most digital experiences fall short of user expectations.
Of…
When I go to customer experience conferences, B2B companies are underrepresented, both in attendees and speakers. When clients look for benchmark data, B2B reports are few and far between.
These are just two examples of why I want to revisit a question I posed in a post I wrote two years ago: If…
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…
Two years removed from its all-time high, customer satisfaction with the retail trade sector fell for a second consecutive year, sliding 2.6 percent to an ACSI score of 74.8. Despite the decline for 2015, the overall score for retail stands almost exactly at its long-term average (74.6).
A closer…
The perils of focusing on customer acquisition and sales over customer experience and retention can be summed up nicely with this: “As fast as you’re bringing customers in the front door, they’re running out the back door.” Some refer to it as the leaky bucket syndrome.
If only companies knew…
I’ve noticed that many companies are using the trendy term “digital transformation” without fully understanding what it means. Leveraging digital technology to make organizational processes and offerings more efficient may increase profit margins in the short term. But a true digital…
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 (…
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…
The healthcare industry is under pressure to improve performance across strategic measures of performance, including delivery cost, operating revenue, employee engagement, patient safety, patient experience, and patient outcomes. A growing number of organizations turn to innovation as a way to…
A s the market gradually moves toward value-based reimbursement, hospital payments to physicians have also been in transition from purely productivity-based pay to incentives based in part on quality, patient experience, and efficiency of care. This shift has taken place in employment,…
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 $…
Ask how you can help, always keep a smile, respond to requests promptly... the list goes on. You’ve probably been exposed to an abundance of tips and tricks about how to become more customer-friendly.
That kind of advice can definitely be valuable, but what you likely don’t hear—unless you’re a…
Technology is a useful tool in quality. That said, there are limits to what technology can do. Here’s my summary of its advantages and disadvantages for quality professionals.
1. Data and measurements. Technology can help you automate measurements and analysis of data (Minitab statistical software…
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…
What happens when we really understand our customers’ desired outcomes or the jobs they are trying to do? Something pretty incredible.
A few weeks ago I wrote about “Faster Horses... and Customer Outcomes” and the importance of asking the right questions to understand desired outcomes in order to…
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…
This month Quality Digest Daily welcomes Michael Webb, a noted author and consultant who writes about how the quality and productivity sciences improve sales and marketing departments.
How well does your company benefit from quality improvement and productivity? For instance, how well do you…
It amazes me how seemingly disparate ideas, when considered together, can create new ways of seeing the world. Bear with me for a minute, and I’ll share an insight I’ve received lately based on two seemingly unrelated ideas.
Here’s the first idea: New York Times bestselling author Bruce Feiler…
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…
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…
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…
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…