A well-written procedure documenting the complaint management process, including the creation of a complaint form, is required by the QSR. 

By Bob Mehta

I have always experienced great difficulty in trying to fathom why medical device manufacturers fail to invest in developing effective approaches for complaint management. After all, when a customer calls to complain, the information garnered as part of the complaint process can be used to strengthen the organization as a whole, improving the product performance and the quality management system (QMS).

In the U.S. medical device industry, not only is the effective handling of complaints warranted, it is mandated by FDA, with the requirements delineated within the agency’s quality system regulation (QSR). For those of you...

August 11th, 2014

As autonomous, intelligent medical devices that effectively manage chronic conditions without constantly reminding patients of their disease become reality, will human factors engineers still be needed?

As patients and caregivers become key stakeholders, human factors engineering and user-focused methods are becoming increasingly important in medical device design. But will these practices soon be rendered obsolete?

During a panel at the MD&M East conference in June, Steve Wilcox, principal and founder of Design Science, made a quip in response to being asked about the future that had a room full of human factors engineers nervously laughing.

“Where things are going is for all of us human factors types to be out of...

August 8th, 2014

The Center for Drug Evaluation and Research regulates advertising and promotion of drugs more strenuously than CDRH regulates devices. Maybe it's time for a change.

By Jim Dickinson

Historically, U.S. law has given the Federal Trade Commission (FTC) primary authority to regulate the advertising and other promotion of prescription medical devices not otherwise restricted by FDA. 

Keep up to date on all the goings-on at FDA by attending the MD&M Minneapolis conference October 29 & 30, 2014.

Restriction most commonly occurs in the conditions of...

August 5th, 2014

Having already conquered social media, original Star Trek star George Takei has boldly gone where innovators hope many physicians and patients will be going in the near future – the world of mHealth. Takei visited the AAPR's Innovation@50+ Health Expo in Boston and got a crash course in digital health from Quantified Care, a company working to launch the first curated mobile health marketplace for physicians and patients, when he underwent a “smartphone physical” featuring devices like the AliveCor EEG, CellScope, and the Mobisante iPhone-based ultrasound.

 Watch as Takei takes his physical and explores Boston's booming biomedical industry.

August 5th, 2014

By Noreen King

Noreen King

Like many U.S.-based contract manufacturers, I have been a big proponent of onshoring manufacturing for over a decade.

And it’s easy to see why. When you consider the quality and communication challenges, increased time to market, rising wages in China, the increased cost of shipping, and political and environmental factors, one thing becomes clear: Onshoring is smart business.

Meet U.S.-based contract manufacturers at the MD&M Minneapolis...
August 4th, 2014

Offshoring can help manufacturers cut costs and get their products to patients in emerging economies around the world. But it's not the right move in every instance.

Get more advice on best practices for medtechoutsourcing at MD&M Minneapolis, October 29 & 30, 2014.

In general, says Julia Wall, an analyst with Decision Research Group, medical devices of moderate complexity are best suited for outsourcing to offshore entities.

“If you look at FDA’s classification of devices, Class I, II, and III, the devices...

August 1st, 2014

In a recent conversation with a device industry professional, it became clear how the reality on the ground for device vendors has shifted in the last few years.

The gentleman enlightened me that the nonprofit Fairview Health Services, a large health system in Minnesota, had dramatically reduced the number of orthopedic vendors.

“I would love to know why they did that,” said Shaye Mandle, President & CEO of Lifescience Alley, in a recent interview.

Mandle knows the answer of course - every hospital and health system in the country is scrutinizing costs, and in many cases either pressuring vendors to lower their cost or share in some operational risk.

Nonetheless, it’s still an interesting exercise to know how hospitals are making these...

July 31st, 2014

By Stephen B. Wilcox, PhD, FIDSA

There have always been human factors issues associated with medical packaging, particularly packaging designed for use by patients, as opposed to medical professionals. For example, packaging designers have struggled for years with making packaging easy to use for target users while still making it childproof. The catch, of course, is that target users may suffer from disabilities like compromised dexterity or vision problems, or even cognitive deficits, by virtue of the very conditions—such as diabetes, glaucoma, and heart failure—that their medical devices or drugs are designed to address.

Stephen B. Wilcox, Ph.D., FIDSA

Thus, the...

July 30th, 2014

Today terms such as EMRs and EHRs are ubiquiitous, but the discipline of health informatics, which includes these systems, is not even 100 years old.

The infographic below created by Adelphi University draws on several sources to show that the history of health informatics dates back to 1949 when Dr. Gustav Wagner in Germany established the German Society for Medical Documentation, Computer Science and Statistics, the world's first professional association for informatics.

This led to the spread of health informatics as a formal discipline in Europe and elsewhere. And now, a whole new world has opened up in informatics with the rapid adoption of tablets to maintain and use EMRs.

See below for more milestones...

July 25th, 2014

Earlier this month the Centers for Medicare and Medicaid Services released four new proposals to amend portions of the Sunshine Act.

There are four proposed changes:

a) Eliminate the continuing medical education (CME) exclusion from reporting requirements.
b) Require companies to specify the marketed name of a drug, device, biologic or medical supply associated with a certain payment whereas previously companies could simply identify the therapeutic area or product category.
c) Require companies to report  to report stock, stock options or any other ownership interest as distinct categories.
d) Eliminate the definition of "covered device."

As many experts responded, the ink is barely dry...

July 23rd, 2014