02Sep/14
Regulatory -Insight

What Changes Should Manufacturers Expect From FDA?

By Daniel R. Matlis

I recently had the privilege to moderate a panel entitled: “Outlook for the Medical Device Industry 2014 and Beyond: Advice from Proactive Leaders” at Camstar’s 2014 Global Conference. The panel included Vice Presidents of Operations from Advanced Bionics, ConforMIS and Terumo Cardiovascular Group.

In this, the third and final in our series of articles, we share insights and perspective from these executives addressing Regulatory issues impacting the future of the Med Tech industry. Continue reading

19Aug/14
Tech-Insight

Manufacturing Technology Insight from Proactive Leaders

By Daniel R. Matlis

I had the privilege to moderate a panel entitled: “Outlook for the Medical Device Industry 2014 and Beyond: Advice from Proactive Leaders” at Camstar’s 2014 Global Conference. The panel included Vice Presidents of Operations from Advanced Bionics, ConforMIS and Terumo Cardiovascular Group.

In this, the second in our series of articles, we share insights and perspective from these executives addressing Technology issues impacting the future of the Med Tech industry. Continue reading

11Aug/14
CFQ 2

FDA Forum Fosters Candid Discussion Between Industry and Agency

By Daniel R. Matlis

On June 26, the FDA hosted an Executive Forum on the “Case for Quality Initiative.” The forum brought together Industry Executives, FDA Officials and Industry Advisors in a series of roundtable discussions and presentations.

After the event, I had the opportunity to converse with two FDA Officials to gain their perspectives on the forum.

Continue reading

04Aug/14
Med-Tech-Question

Executives Offer Prospects for Med-Tech Business Model

By Daniel R. Matlis

I recently had the privilege to moderate a panel entitled: “Outlook for the Medical Device Industry 2014 and Beyond: Advice from Proactive Leaders” at Camstar’s 2014 Global Conference. The panel included Vice Presidents of Operations from Advanced Bionics, ConforMIS and Terumo Cardiovascular Group.

In this, the initial in our series of articles, we share insights and perspective from these executives addressing Business issues impacting future of the Med Tech industry. Continue reading

31Jul/14
Jeff-Shuren

FDA Signals Change in Health IT Compliance Direction

By: Ellyn McMullin, Research Associate

Jeffrey Shuren, M.D., J.D., Director, Center for Devices & Radiological Health spoke at the public workshop “Proposed Risk-Based Regulatory Framework and Strategy for Health Information Technology.”  Dr. Shuren provided an overview of the Health IT Report released in April jointly by the Food and Drug Administration (FDA), the Office of the National Coordinator for Health Information Technology (ONC) and the Federal Communications Commission (FCC). Continue reading