Healthcare Features

Rob Matheson's picture
Rob Matheson
Liquid-liquid separation and chemical extraction are key processes in drug manufacturing and many other industries, including oil and gas, fragrances, food, wastewater filtration, and...
Jon Speer's picture
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...
Eric Cooper's picture
Eric Cooper
You’re in the market to build a new house. Would you tell the builder what you’re looking for, or would you just tell him to build “something?” If the latter, what’s the likelihood that the house...
Mike Richman's picture
Mike Richman
During last Friday’s episode of Quality Digest Live, we looked at the far-reaching implications of a prospective merger, previewed our latest webinar with DNV, considered the importance of fun at...
Sharona Hoffman's picture
Sharona Hoffman
CVS operates 9,700 pharmacies and 1,000 MinuteClinics. A decade ago, it also purchased Caremark and now operates CVS/Caremark, a pharmacy benefits manager (PBM), a type of business that administers...
Scott Gottlieb's picture
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...
Jenna Gallegos's picture
Jenna Gallegos
Biology is becoming increasingly digitized. Researchers use computers to analyze DNA, operate lab equipment and store genetic information. But new capabilities also mean new risks, and biologists...
Quality Transformation With David Schwinn's picture
Quality Transformation With David Schwinn
I was recently reminded of a fundamental statement about continual improvement. In Out of the Crisis (Massachusetts Institute Center for Advanced Engineering, 1986), W. Edwards Deming stated, “I...
Lou Valdez's picture
Lou Valdez
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...
Patrick Horine's picture
Patrick Horine
Readmission of patients within 30 days of discharge is one of the most serious issues plaguing healthcare delivery in the United States. No one wants to go to the hospital, let alone return shortly...
Mike Richman's picture
Mike Richman
During last Friday’s episode of QDL, we examined the potential of quality thinking to improve outcomes for people’s health, manufacturing, and workplace efficiency. Let’s take a look: “World...
Jay Desai's picture
Jay Desai
The presidential symposium at this year’s annual meeting of the Child Neurology Society of America in early October in Kansas City raised many eyebrows: The first presentation focused on burnout...
Jon Speer's picture
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...
Grant Ramaley's picture
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...
Davis Balestracci's picture
Davis Balestracci
During the early 1990s, I was president of the Twin Cities Deming Forum. I had a wonderful board to work with, one of whom was Doug Augustine, our self-appointed provocateur. Doug was a 71-...
The QA Pharm's picture
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...
Dirk Dusharme @ Quality Digest's picture
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...
Scott Gottlieb's picture
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...
Mike Richman's picture
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...
Ken Kingery's picture
Ken Kingery
The first in-car measurements of exposure to pollutants that cause oxidative stress during rush-hour commutes has turned up potentially alarming results. The levels of some forms of harmful...