Mike Barbella09.27.11
The nation’s largest medtech trade group kicked off its fifth annual conference on Sept. 26, bringing together industry leaders, investors and chief executives to discuss and strategize a plan for advancing the U.S. medical technology industry both domestically and internationally.
The three-day event, which runs through Sept. 28 at the Walter E. Washington Convention Center in downtown Washington, D.C., began with a sobering if not alarming assessment of the industry’s waning role in global medical innovation. Executives with the Advanced Medical Technology Association (AdvaMed) said the near four-year lag between product approvals in the United States and European Union is facilitating the erosion of America’s global leadership position in medtech expertise. A study released last fall by Josh Makower, M.D., CEO of ExploraMed Development LLC and consulting professor of medicine at Stanford University in Palo Alto, Calif., reached the same conclusion. Makower’s study found that high-risk medical devices took an average of 54 months to be approved by the U.S. Food and Drug Administration, while European regulators okayed those same devices in about 11 months.
“Our industry is a U.S. job creator, and in doing so, develops life-saving, life-enhancing technologies for patients around the world,” said Caroll Neubaer, AdvaMed 2011: The MedTech Conference Committee Chairman and Chairman/CEO of B. Braun of America. “This year, we are highlighting innovations by medtech companies and working to foster policy, finance and other industry discussions to advance our industry here at home and abroad.”
Policy makers, corporate chieftains and medtech movers and shakers discussed key health and compliance policies on the opening day of the conference, re-evaluating the controversial healthcare reform bill, analyzing opportunities in the Chinese medical technology sector, and determining the impact of the Sunshine Act on doctor-device company relationships. Conference organizers dedicated nearly four hours of special programming on the first day to global harmonization efforts, providing perspectives from industry representatives, regulatory officials and the academic world. Among the topics addressed was the Harmonization by Doing program, a joint effort between the FDA and Japan’s Ministry of Health, Labor and Welfare to promote regulatory harmonization between U.S. and Japanese regulatory policies.
Organizers also devoted a number of sessions to business development and finance, covering subjects ranging from partnership agreements and Indian healthcare market opportunities to the need for medtech business model development. One of the most anticipated sessions (judging by past events) is a state-of-the-industry report issued by global professional services firm Ernst & Young. The company’s “Pulse of the Industry 2011” is expected to include data on the financing and transaction activity of the U.S. and European medtech industry, as well as insights on emerging markets. Data from last year’s report found that venture financing in the United States and Europe plummeted 22 percent to $3.4 billion in 2009, with U.S. funding falling 24 percent to $2.7 billion and European financing slipping 6 percent to $701 million. By contrast, venture capital raised in both regions fell 7 percent in 2008 compared with the previous year.
New to AdvaMed 2011 conference lineup is a track on in-vitro diagnostics issues. “Last year, the association started ‘AdvaMeDx’ to focus solely on the regulatory, payment and legislative needs of its in-vitro diagnostics (IVD) members,” AdvaMed conference producer Ray Briscuso told Kenneth G. Walz, co-founder and partner of Popper and Company LLC a Sarasota, Fla.-based M&A advisory and specialty consulting firm to the life sciences industry. “The members asked us to make sure AdvaMed 2011 was the de facto meeting for AdvaMeDx…we added a dedicated track and a great deal of other programming specific to the diagnostics industry.”
That programming includes sessions on personalized medicine, the future of the IVD Directive, the future of advanced diagnostics, and molecular diagnostic reimbursement, coverage and coding matters.
In addition to specific subject tracks, AdvaMed 2011 features special programming that gives attendees access to CEOs, fosters deal-making, showcases life-altering innovations and teaches the necessities of new value creation. In the returning “CEOs Unplugged” series, top executives from Covidien plc, Biomet Inc., Cardinal Health, Zimmer Holdings Inc., Stryker Corporation, B. Braun Medical Inc., Baxter Healthcare, Abbott Laboratories and Edwards Lifesciences Corporation will discuss critical medical technology issues relating to the regulatory process, mergers and acquisitions, safety and quality, payment and healthcare delivery, and competitiveness. Startup firms interested in learning how to create new value attended the conference’s “Entrepreneurship Boot Camp” on Sept. 26, where they listened to panelists explain the importance of focusing on end users and discuss ways to create value without generating substantial overhead costs.
Attendees looking to network on a more personal level with medtech bigwigs will get the chance to do so on Sept. 27 and 28 at special “Sector Meet-Ups” covering the ophthalmic, orthopedic, cardiovascular, wound management and dental sectors.
Conference organizers have recruited an impressive list of guest speakers to address attendees during breakfast and lunch on Sept. 27 and 28. Indiana Gov. Mitchell E. “Mitch” Daniels, once a hopeful for the 2012 GOP presidential nomination and an outspoken opponent of the medical device excise tax, will speak during a plenary breakfast program on Sept. 27. His former boss, President George W. Bush, follows with a luncheon keynote that same day. On Sept. 28, the plenary breakfast program will consist of a panel comprised of John M. Taylor III, counselor to the FDA commissioner, and Jeffrey E. Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. Kathleen Sebelius, secretary of the Health and Human Services Department, and Maryland Gov. Martin O’Malley, are scheduled to address attendees during a closing luncheon on the final day of the conference.
More than 1,700 industry stakeholders from 22 countries and 35 states registered to attend AdvaMed 2011.
The three-day event, which runs through Sept. 28 at the Walter E. Washington Convention Center in downtown Washington, D.C., began with a sobering if not alarming assessment of the industry’s waning role in global medical innovation. Executives with the Advanced Medical Technology Association (AdvaMed) said the near four-year lag between product approvals in the United States and European Union is facilitating the erosion of America’s global leadership position in medtech expertise. A study released last fall by Josh Makower, M.D., CEO of ExploraMed Development LLC and consulting professor of medicine at Stanford University in Palo Alto, Calif., reached the same conclusion. Makower’s study found that high-risk medical devices took an average of 54 months to be approved by the U.S. Food and Drug Administration, while European regulators okayed those same devices in about 11 months.
“Our industry is a U.S. job creator, and in doing so, develops life-saving, life-enhancing technologies for patients around the world,” said Caroll Neubaer, AdvaMed 2011: The MedTech Conference Committee Chairman and Chairman/CEO of B. Braun of America. “This year, we are highlighting innovations by medtech companies and working to foster policy, finance and other industry discussions to advance our industry here at home and abroad.”
Policy makers, corporate chieftains and medtech movers and shakers discussed key health and compliance policies on the opening day of the conference, re-evaluating the controversial healthcare reform bill, analyzing opportunities in the Chinese medical technology sector, and determining the impact of the Sunshine Act on doctor-device company relationships. Conference organizers dedicated nearly four hours of special programming on the first day to global harmonization efforts, providing perspectives from industry representatives, regulatory officials and the academic world. Among the topics addressed was the Harmonization by Doing program, a joint effort between the FDA and Japan’s Ministry of Health, Labor and Welfare to promote regulatory harmonization between U.S. and Japanese regulatory policies.
Organizers also devoted a number of sessions to business development and finance, covering subjects ranging from partnership agreements and Indian healthcare market opportunities to the need for medtech business model development. One of the most anticipated sessions (judging by past events) is a state-of-the-industry report issued by global professional services firm Ernst & Young. The company’s “Pulse of the Industry 2011” is expected to include data on the financing and transaction activity of the U.S. and European medtech industry, as well as insights on emerging markets. Data from last year’s report found that venture financing in the United States and Europe plummeted 22 percent to $3.4 billion in 2009, with U.S. funding falling 24 percent to $2.7 billion and European financing slipping 6 percent to $701 million. By contrast, venture capital raised in both regions fell 7 percent in 2008 compared with the previous year.
New to AdvaMed 2011 conference lineup is a track on in-vitro diagnostics issues. “Last year, the association started ‘AdvaMeDx’ to focus solely on the regulatory, payment and legislative needs of its in-vitro diagnostics (IVD) members,” AdvaMed conference producer Ray Briscuso told Kenneth G. Walz, co-founder and partner of Popper and Company LLC a Sarasota, Fla.-based M&A advisory and specialty consulting firm to the life sciences industry. “The members asked us to make sure AdvaMed 2011 was the de facto meeting for AdvaMeDx…we added a dedicated track and a great deal of other programming specific to the diagnostics industry.”
That programming includes sessions on personalized medicine, the future of the IVD Directive, the future of advanced diagnostics, and molecular diagnostic reimbursement, coverage and coding matters.
In addition to specific subject tracks, AdvaMed 2011 features special programming that gives attendees access to CEOs, fosters deal-making, showcases life-altering innovations and teaches the necessities of new value creation. In the returning “CEOs Unplugged” series, top executives from Covidien plc, Biomet Inc., Cardinal Health, Zimmer Holdings Inc., Stryker Corporation, B. Braun Medical Inc., Baxter Healthcare, Abbott Laboratories and Edwards Lifesciences Corporation will discuss critical medical technology issues relating to the regulatory process, mergers and acquisitions, safety and quality, payment and healthcare delivery, and competitiveness. Startup firms interested in learning how to create new value attended the conference’s “Entrepreneurship Boot Camp” on Sept. 26, where they listened to panelists explain the importance of focusing on end users and discuss ways to create value without generating substantial overhead costs.
Attendees looking to network on a more personal level with medtech bigwigs will get the chance to do so on Sept. 27 and 28 at special “Sector Meet-Ups” covering the ophthalmic, orthopedic, cardiovascular, wound management and dental sectors.
Conference organizers have recruited an impressive list of guest speakers to address attendees during breakfast and lunch on Sept. 27 and 28. Indiana Gov. Mitchell E. “Mitch” Daniels, once a hopeful for the 2012 GOP presidential nomination and an outspoken opponent of the medical device excise tax, will speak during a plenary breakfast program on Sept. 27. His former boss, President George W. Bush, follows with a luncheon keynote that same day. On Sept. 28, the plenary breakfast program will consist of a panel comprised of John M. Taylor III, counselor to the FDA commissioner, and Jeffrey E. Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. Kathleen Sebelius, secretary of the Health and Human Services Department, and Maryland Gov. Martin O’Malley, are scheduled to address attendees during a closing luncheon on the final day of the conference.
More than 1,700 industry stakeholders from 22 countries and 35 states registered to attend AdvaMed 2011.