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Visit the website for AdvaMed, the Advanced Medical Technology Association which looks out for American interests, and you’ll read:
“The innovation ecosystem that supports medical technology is severely stressed. The U.S. has historically been the world leader in medical technology, but our leadership is eroding.”
AdvaMed proposes a five-step remedial plan.
(1) Improve FDA’s regulatory processes so the cost and time of development and approval of devices and diagnostrics is reduced and the CDRH mission statement that American patients will be the first in the world to have access to new devices is achieved, while maintaining the highest standards of safety and efficacy.
(2) Restructure CMS’s coverage and payment processes to support development of new technologies that improve treatment, diagnosis or prevention, and provide prompt patient access to these technologies.
(3) Reform the US tax system to create a level playing field, starting with repeal of the medical device excise tax – a tax that is draining resources from American manufacturing jobs and research.
(4) Improve access to international markets by insisting on free and fair trade in medical technology and working with foreign governments to achieve innovation-friendly regulatory and payment policies.
(5) Support the maintenance and growth of an R&D infrastructure second to none.
The Association concludes, “Failure to act will mean lost lives, unnecessary suffering, reduced job formation, and diminished economic growth.”
Do you agree?
Is US leadership in medical devices eroding? Do you agree with AdvaMed’s prescription?
Do you recommend other measures?
Meet me at Med Tech Monday (January 23, Irvine, California).
Device companies, venture capitalists, medical device designers, investment bankers, service providers, lawyers, startups, and biotech players are scheduled to attend.
At $295 it’s one of the smallest investments you can make for a full day of networking (meals and cocktail reception included) in the medical device space.
See http://medgroup.biz/MedTechMonday for details and I look forward to meeting you in person.
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SUPER BOWL TIME
Guess the correct Super Bowl teams and final score and win free admission to the next 10x Medical Device Conference at http://medgroup.biz/superbowl
Make it a great week.
P.S. I’m in San Francisco today and tomorrow at the Medtech Showcase and JP Morgan Healthcare events. Email me at JHage@MedicalDevicesGroup.net if you’re in town and want to meet in person.
Paul M. Stein
Paul M. Stein
New device companies are sprouting up across the U.S. & the industry has a shortage of quality talent in the US. Schools aren’t churning out engineers & technology experts at high enough rates, & millennials are less likely than previous generations to work for small companies that don’t show much potential for upward mobility. Talent scarcity is an issue U.S. device companies will have to address to protect their advantage at the top.
In 2015, when AdvaMed released their innovation agenda, the U.S. med device market value was 43% of the entire global market. The U.S. not only possesses the largest med device market, but it remains a major exporter of innovative products to the rest of the world: in 2015, exports of med devices from the U.S. over $44B in key product areas, and general medical/technical equipment exports over $83B. 2015 was a record year for investment in small innovative device companies, and the US continues gain device patents at a higher rate than the rest of the world markets combined.
The creation of Galvani Bioelectronics is one of many examples from the past two years of major global pharmaceutical companies relying on leadership from the U.S. device industry. They are recognizing that electronic & software development holds the key to the future of first-line medicine, & are partnering with American medical device companies to access the talent & resources required to engineer a future of personalized medicine.
That all being said, AdvaMed does still have one thing right. The innovation ecosystem for medical devices in America is still stressed.
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