All Features
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…
Annette Franz
When you think of the phrase “inside-out” relative to the customer experience, you probably cringe. This is not a phrase that customer experience professionals take lightly.
“Inside-out” means companies focus on processes that are designed and implemented based on internal thinking and intuition…
Dirk Dusharme
Our Nov. 17, 2017, episode of QDL looked at factories controlled by large-volume 3D metrology, the value (or not) of four-year degrees, and creepy Christmas.
“Developing the Light-Controlled Factory”
A UK development project directed by the University of Bath and supported by University College…
Davis Balestracci
During the early 1990s, I was president of the Twin Cities Deming Forum. I had a wonderful board to work with, one of whom was Doug Augustine, our self-appointed provocateur. Doug was a 71-year-old retired Lutheran minister, and we all loved him because he always pulled us right back to earth with…
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…
Chip Bell
Variation and defects. They are the bane of all manufacturing companies. They signal an absence of efficiency, a neglect of productivity, and a total disregard for cost effectiveness. Who is seen as the rescuing knight in shining armor? Sir Six Sigma!
Fundamentally, Six Sigma (always capitalized,…
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…
The QA Pharm
If I could summarize in one page the most important lessons I have learned in pharmaceutical quality assurance over the last 40 years, this is it.
When it comes to putting a procedure into written words, it doesn’t mean the words will be effective in getting people to follow the procedure.
The…
Dirk Dusharme
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…
Christopher Martin
Nearly two decades ago, rising from the ashes of the once-giant video game hardware manufacturer Sega, Microsoft debuted the Xbox and entered into the video game market with the intent of competing directly with Sony’s PlayStation brand. By 2006, Microsoft’s launch of the second-generation of Xbox…
Scott Gottlieb
The FDA has a long history of supporting patient access to investigational new treatments. This includes working with drug and device companies through the clinical trial process that may lead to FDA approval of the treatment. We also offer expanded access programs that provide investigational…
Mike Richman
We cover a wide range of topics on QDL most weeks, but our latest episode, from Friday, Oct. 20, 2017, provided a steady drumbeat of technological detail. Here’s what we chatted about:
“Energy Harvested from Evaporation Could Power Much of U.S., Says Study” Renewal sources of energy like solar…
Ken Kingery
The first in-car measurements of exposure to pollutants that cause oxidative stress during rush-hour commutes has turned up potentially alarming results. The levels of some forms of harmful particulate matter inside car cabins was found to be twice as high as previously believed.
Most traffic…
Jon Speer
How confident are you when it comes to design validation? Does this always involve clinical evaluation, or not? We’ve found that, like many other terms in medical device development, the two can end up getting confused. When do you use one or the other?
There tends to be a lack of clarity out…
Dirk Dusharme
Our Oct. 13, 2017, episode of Quality Digest Live looked at edge computing for natural disasters, medical records, and zero defects.
“New Research May Improve Communications During Natural Disasters”
Could edge computing help communications during disasters?
“How Health Care Leaders Should…
Kristine Bammert
On July 5, 2017, I was on a canal boat in Amsterdam cruising to a dinner meeting when I received a call saying, “We need immediate access to your condo; water is rushing into the street from beneath your front door.” And my heart stopped beating for a moment.
Floods are serious. Even as water…
Bill Kalmar
If you were born prior to the 1950s, you may remember a sitcom filmed in black and white about two New York cops and their exploits in the city. As they pursued criminals and responded to various neighborhood incidents, there was always the prescribed call on their radio: “Car 54, where are you?”…
Ann Cleland
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 Emergency Response Team (ICS-CERT…
Annette Franz
There’s a problem with journey maps? Well, not with the maps themselves but with how people talk about them.
I love attending webinars and reading articles about journey mapping because I’m always curious about how others talk about them, what their approaches are, and what outcomes they’ve…
Mike Richman
Our most recent episode of QDL from Friday, Sept. 29, 2017. featured news, technology, and two great interviews. Let’s have a closer look:
“Domestic Cars Fail to Keep Up With International Competition”
The most recent American Customer Satisfaction Index (ASCI) survey took a look at people’s…
Anna Abram
We’re at a moment of extraordinary opportunity to improve public health. New innovations are giving us fundamentally better ways to address disease. Some of the same technology is providing consumers with a broader selection of foods that can improve peoples’ diets and products that can expand…
Patricia Morrill
Do all employees in healthcare understand how their jobs link to patients in some way? If they do, then they are more likely to know the importance of service excellence.
Does every leader, physician, and employee know the statistic that preventable medical errors are the third leading cause of…
American Customer Satisfaction Index ACSI
Customer satisfaction with automobiles and light vehicles slips 1.2 percent to a score of 81 on the American Customer Satisfaction Index’s (ACSI) scale of 0 to 100. A year ago, the industry improved driver satisfaction, and sales were at record highs. This year, demand seems somewhat saturated,…
Dirk Dusharme
Our Sept. 22, 2017, episode of QDL was decidely techie, covering artifical intelligence, the internet of things, Manufacturing Day, and a cool color-matching tool that uses your smart phone.
Manufacturing Day preview
There is a lot happening on Manufacturing Day, which falls on Oct. 6 this year,…
Joshua Fairfield
Internet-enabled devices are so common, and so vulnerable, that hackers recently broke into a casino through its fish tank. The tank had internet-connected sensors measuring its temperature and cleanliness. The hackers got into the fish tank’s sensors and then to the computer used to control them…