Making Positive Contributions to Change
These are crucial times for the medical device industry. Some sort of healthcare reform is likely, as are major changes at FDA. Some of those in Washington who will have a major say in these changes are not friends of the medical device industry. (Google “John Dingell” and “Bart Stupak” if you want to get a sense of just how hostile they can be.) So it is up to industry’s representatives in Washington to make the case for the kind of reform that doesn’t punish the medical device and other life sciences industries.
Michael A. Mussallem, chairman and CEO of Edwards Lifesciences Corp. (Irvine, CA), became a major player in this debate in March when he was elected to a two-year term as chairman of AdvaMed’s board of directors. As the United States’ (and the world’s) largest medical device trade association, AdvaMed is chiefly responsible for making sure that the industry’s interests are understood and respected among lawmakers. Its actions are also essential to the industry being perceived as part of the solution, not part of the problem. Mussallem is now one of those responsible for making sure it goes about those tasks the right way.
These reasons are why he is the subject of the Q&A feature in the May issue of MD&DI. During our interview with him, he displayed a keen awareness of just how badly the medical device industry is misunderstood in Washington, and to some extent, among the public. He also seems to understand that it is vital that the message get out that the medical device industry, in contrast to what its critics in the government and media say, does not put profits ahead of patients.
At the same time, he understands the device industry has some work to do to repair its image. The highly publicized conflict-of-interest issues that have come to the forefront in recent years have hurt industry’s reputation. “Patients are far more aware of and skeptical about conflict-of-interest issues than they used to be,” he explains. “It’s very important that we increase our transparency to live up to and match the expectations of the public. We will try to be very consistent in terms of physician-payment disclosure.”
We hope you enjoy Mussallem’s insights, and the rest of our May issue.
Special Section: Testing
Factors for Implant Testing
By William Leventon
Several tools and processes can help OEMs check implant safety and performance.
Radial Tests for Endovascular Implants
By Melissa Lachowitzer
Device OEMs should familiarize themselves with radial strength and stiffness testing for endovascular implants.
Web Exclusive: See bonus footage of a segmental compression system measuring and recording the radial stiffness and strength of a self-expanding stent. Click here.
Discoveries in Adhesive Technology
By Aaron Smith
Adhesives can play a vital role in device design and ultimately help improve patient comfort.
Exploring Adhesive Tape
By Bill Hanna
OEMs may be able to speed up manufacturing with a thorough understanding of certain aspects of adhesive tape.
Sealing Seams with Laser Welding
By Sri Venkat and Andre McFayden
Laser welding has become a versatile tool for joining plastics in medical devices.
Harnessing Human Extracellular Matrix
By Gail Naughton and Robert Kellar
Extracellular materials could become a vital part of medical device production.
Mergers and Acquisitions
Establishing Value via Patenting
By Scott Lloyd
A patent portfolio can help a company show the potential of its technology and products.
Sterile Packaging: Measuring Microbial Barriers, Part 1
By Paul Herman and Curtis Larsen
An ASTM International standard aims to help ensure the integrity of sterile packaging.
More from this issue of MD&DI