By Brett Johnson and Lisa Sher
More than 1,700 medical device and diagnostics leaders from more than 360 companies, representing 24 countries and 33 states, attended the fourth annual industry gathering, AdvaMed 2010: The MedTech Conference from Oct 18-20 in Washington, D.C. The conference featured keynote speeches by Commissioner Margaret Hamburg, the new head of the FDA; and Donald Berwick M.D., Administrator of the Center for Medicaid and Medicare Services (CMS). AdvaMed 2010 provided one of the first opportunities for the device industry to hear from these recent appointees, who could have a big impact.
“We are pleased the conference has steadily grown, seeing a 17 percent increase in attendance from last year. This growth is a reflection of the diversity seen in the types of panels and speakers as well as the opportunities to connect with leaders in our industry, at companies large and small,” said James V. Mazzo, president of Abbott Medical Optics and board chairman of AdvaMed.
AdvaMed leadership comforted the audience of executives still reeling from the Obamacare medical device tax and the recent attack on the 510(k) approval process, saying that there has been a good dialog with these leaders, who have been accessible, engaged, receptive and understanding of the issues. Both Hamburg and Berwick emphasized their understanding of the importance of medical technology as a means to address the problems facing the industry. CMS head Berwick described his history as a physician with a true understanding of the family small-town doctor. He remembers, as a boy, his father making house calls in the middle of the night. Berwick’s father was a small-town doctor who truly took care of the residents in his Connecticut town.
Berwick discussed the critical need for greater integration of care. He noted that assembling the very best of every specialty is not an effective way of delivering quality care, no more than would be gathering the very best parts from a variety of different automobiles and then trying to assemble a car. It wouldn’t function. Carrying the automotive metaphor further, he described a U.S. healthcare system that isn’t designed to handle the burden we are placing on it. Just as you can’t expect a car to run faster than its top speed, you can’t expect this healthcare system to handle more than its design. He talked about the need to innovate and to accept change. He inferred that the status quo is unacceptable, that he would have no patience or time for those tied to the status quo and unwilling to change. Berwick described his aims as “better” care: better health outcomes and lower costs. He genuinely seems to understand the patient.
FDA Commissioner Margaret Hamburg also pointed out that we have an agency that was built in a time far simpler than the world we live in now, and that her mission is to upgrade the agency to handle this new complexity. There was recognition that FDA problems have forced a movement overseas. The agency needs to prepare for the 21st century and millions of products from hundreds of countries. For the FDA to keep up with this, it needs to be fully equipped.
The 510(k) review, which began in August, focuses on innovation, predictability and safety. The agency took a hard look at the Institute of Medicine’s preliminary report (the final report is due in the summer of 2011), and there was general support for the recommendations the FDA made. The process takes time, which Hamburg apologized for. It’s a real problem. Europe is where the innovation and the associated jobs are heading because it takes too long to get devices rolling in the U.S. Can the FDA get its act together?
Stephen Ubl, President and CEO of AdvaMed, pointed out that the amount of time to get approvals has about tripled in recent years, and these longer cycles have resulted in applications simply being withdrawn. There is a level of risk aversion at the FDA. We are now 17th in the world in R&D tax credits. Ubl indicated that the 510(k) worked pretty well, and that less than 1% of regulated products are problematic. The process had a very good record for many years, Ubl remarked, so why was this being changed?
Stephen Ubl, President and CEO of AdvaMed, pointed out that the amount of time to get approvals has about tripled in recent years, and these longer cycles have resulted in applications simply being withdrawn. There is a level of risk aversion at the FDA. We are now 17th in the world in R&D tax credits. Ubl indicated that the 510(k) worked pretty well, and that less than 1% of regulated products are problematic. The process had a very good record for many years, Ubl remarked. This begs the question as to why this is being changed in the first place.
During the conference, more than 782 one-on-one business partnering meetings took place–up 23 percent over 2009–and more than 60 company presentations were made. New this year were the widely attended sector meet-ups and funding forums, as well as an entrepreneur “boot camp” for emerging growth companies.
“Our industry is facing tremendous challenges in terms of the global economic climate, continuing uncertainties in the regulatory arena and new payment modalities that have yet to be fully developed. It is our goal to provide medical technology and diagnostic companies unparalleled insights and opportunities to advance their businesses and maintain U.S global leadership in this sector,” said Stephen J. Ubl, President and CEO of AdvaMed. “Access, Insight, Opportunity” was the tagline of AdvaMed 2010, and that is what the conference accomplished.