The main theme running through FDA's guidance on ISO 10993-1 is that every medical device should be assessed for its specific risk to the end user. 

Audrey Turley and Thor Rollins

In June 1906, President Theodore Roosevelt signed into law the Food and Drug Act, which addressed "adulterated" products. Adulterated includes the addition of fillers of reduced "quality or strength;" coloring to conceal "damage or inferiority;" formulation with additives "injurious to health;" or the use of "filthy, decomposed, or putrid" substances in a product. It took until 1995 for FDA to release an official guidance specific to medical device regulation.

This document, known as the “blue book,” was the basis of biocompatibility regulation for decades. FDA published a draft...

December 20th, 2016
1

We asked industry experts to weigh in on what medical technologies will be big in 2017. Here's what to expect in the field of personalized medicine.

Tor Alden

From expanded indications for transcatheter aortic valve replacement systems to bioresorbable stents, medical technology took some big leaps forward in 2016. So what might 2017 have in store? We asked industry experts for some predictions. Here, in their own words, are the medical technologies they expect to see making headlines in 2017. 

Personalized Medicine

We are seeing a trend in personalization in every sector. One area that has seen a lot of progress is in the mapping of the human genome and the understanding of how individuals react to specific drug treatments. Increased technical power...

December 20th, 2016
0

We asked industry experts to weigh in on what medical technologies will be big in 2017. Here's what to expect in the field of closed-loop systems.

Herb Bresler

Medtronic's MiniMed 670G received FDA approval in September 2016.

From expanded indications for transcatheter aortic valve replacement systems to bioresorbable stents, medical technology took some big leaps forward in 2016. So what might 2017 have in store? We asked industry experts for some predictions. Here, in their own words, are the medical technologies they expect to see making headlines in 2017. 

Closed-Loop Systems

“Closed-loop” therapeutic systems are systems in which relevant biological conditions are continuously monitored in...

December 19th, 2016
0

Considering what FDA and medtech regulation may look like under the incoming administration.

Jim Dickinson

Emerging like the campaign that preceded it as the most unconventional in history, the incoming Trump Administration has many conservatives clambering aboard his train, expecting big changes—including relief for industries regulated by FDA.

For that to come about, much will depend on Trump’s choice for Secretary of HHS, six-term Atlanta-based congressman and orthopedic surgeon Tom Price, who has displayed little interest in the agency other than to unsuccessfully vote against it being given regulatory control over tobacco products.

His main focus is expected to be on repealing and replacing Obamacare, a mission more in keeping with his...

December 16th, 2016
0

In the second installment of this three-part article series, experts discuss federal initiatives regarding medical device postmarket surveillance and set out what device manufacturers should know.

Kevin Ong, PhD, PE, Michael Frohbergh, PhD, Jennifer Stevenson, Esq., and John Constance, Esq.

Editor's note: This is the second installment in a three-part series detailing the ins and outs of medical device postmarket surveillance. Read Part 1 and Part 3....

December 16th, 2016
0

Here's how to make health applications meaningful to patients and providers.

Dave Giles

Advances in sensors, smartphones, communications, and analytics give developers new tools to build creative and powerful applications that promise to improve health outcomes and reduce healthcare costs. According to the CDC, more than 75 percent of healthcare costs are due to chronic conditions, so applications that help manage blood pressure, diabetes, or weight loss can make a significant impact.

Technology has an important role to play, but to capture the most value for the patient and providers, the applications need to address three key elements: scalability, relevance, and stickiness.

Scalability

Applications need to scale...

December 15th, 2016
0

PwC’s annual report on top health industry issues predicts 2017 will be a year for partnerships, patient centricity, and value.

Marie Thibault

2017 can seem like a big question mark, but PwC believes at least one trend will stay the course—the shift toward value-based care.

In its annual report, “Top Health Industry Issues of 2017: A year of uncertainty and opportunity,” PwC highlights 10 issues that range from the future of the Affordable Care Act (ACA) to training medical students to practice in a value-based care environment. While there is a lack of clarity around exactly from the incoming Trump administration will mean for healthcare and the related government...

December 15th, 2016
0

A GE Healthcare executive offers practical advice on balancing patient safety, security, and usability for connected medical devices, including what to know about security in the cloud environment.

Marie Thibault

Blame it on the headlines, filled with news about ransomware attacks at hospitals, reports of hacking risks for various medical devices, and stories of hospital networks being breached via medical devices running old versions of operating systems. Perhaps because of increased awareness or a trend toward connected devices, the importance of connected medical device security has hit home for many manufacturers and health systems....

December 14th, 2016
2

In the first installment of this three-part article series, experts detail the requirements for complying with medical device postmarket surveillance regulations and describe potential sources for postmarket data.

Kevin Ong, PhD, PE, Michael Frohbergh, PhD, Jennifer Stevenson, Esq., and John Constance, Esq.

Editor's note: This is the first installment in a three-part series detailing the ins and outs of medical device postmarket surveillance. Read Part 2 and Part 3....

December 13th, 2016
0

The medical device industry’s biggest players spent billions in 2016 snapping up smaller companies and shuffling business units. These transactions are shifting the medtech landscape but, in some cases, haven’t proceeded as planned.

Marie Thibault

This was yet another year filled with mergers and acquisitions in the medical device industry, with several mega-deals valued well over $1 billion. Many of these transactions are rearranging the order of top players in various device sectors or entirely remaking a technology field. In addition to some of these evolutions, a couple of transactions haven’t moved forward as expected. All of this has added up to exciting and fast-paced changes in the medtech industry.

...

December 12th, 2016
0