"Medical device manufacturers need to engage in the political process," says JC Scott, Senior Executive Vice President, Government Affairs, The Advanced Medical Technology Association (AdvaMed). "It is a critical time for the industry and the policies that are put in place now - in terms of payment reforms, the new user fee agreement with the US Food and Drug Administration, and the device tax - have the potential to significantly alter the innovation ecosystem," he notes.
What challenges and changes is the medical device manufacturing industry facing today?
The industry is facing a number of headwinds created by federal regulatory and tax policy. The number one priority is repealing the medical device tax. The tax has already caused the loss of thousands of jobs and studies indicate it could cost upwards of 43,000. Other studies show that the tax could cut R&D investment by USD 2 billion per year, meaning patients will have to wait longer for the next generation of treatments and cures. Fortunately, bipartisan majorities in both the US House and Senate are on record supporting repeal, so there is momentum to get rid of this dangerous tax.
Repealing the medical device excise tax is essential for competitiveness. The device tax will cost the industry about USD 30 billion over the next ten years and makes the already uncompetitive US tax system even more uncompetitive.
Companies and their employees need to update their policymakers at all levels and let them know how policies translate into medical progress, job creation, economic growth or the lack thereof.
How should the industry adapt to the new healthcare landscape?
Demonstrating value is going to be key for medical technology companies going forward. The Affordable Care Act puts in place new mechanisms - such as Accountable Care Organizations and bundling - that are intended to change the US health care system to better reward quality and efficiency. But these programs present the danger of incentivizing a "cheapest is best" approach to health care. If you have a device or diagnostic, you have to be able to show that it is going to help a patient recover more quickly at less cost.
What opportunities could medical device manufacturers capitalize on?
The key driver of health care costs is the crushing burden of chronic disease. Diabetes costs the US USD 174 billion annually, cancer USD 264 billion and heart disease USD 273 billion, just to cite three examples.
Finding solutions to better manage or even cure these and other high-cost chronic conditions represent an incredible opportunity for medical technology companies.
How can manufacturers better demonstrate the value of medical technology?
Governments are looking for ways to provide high-quality health care to their citizens but are facing budget pressures. Medical technology companies are in an optimal position to provide the solutions to these challenges. The devices and diagnostics our industry produces detect disease earlier, make health systems more efficient and help patients recover more quickly. That translates into real savings as patients are able to recover faster and get back to their lives. Companies need to provide the evidence that whatever the cost of a given medical technology intervention, that cost will be made up from the gains of a healthy, more productive citizenry.
Written by: Sarin Kouyoumdjian-Gurunlian, Press Manager
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