Can the U.S. Maintain its Leadership Position in Medical Devices?

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According to a recent PwC study, the U.S. medical device industry is facing stiffer competition by rival countries – mainly Brazil, China and India. However, the U.S. innovation edge may face more threats from an inefficient American regulatory system, according to AdvaMed.

Unveiling its “Competitiveness Agenda” at device maker Stryker in Kalamazoo, MI, today, AdvaMed detailed six policy initiatives that would allow medical device companies to thrive.

AdvaMed’s Competitiveness Agenda proposes specific recommendations under six broad policy imperatives:

  1. Innovation in the life sciences must be a government priority, including requiring an innovation impact statement for significant new regulations that affect the health sector;
  2. The FDA review process must be reformed to reduce total review times. American patients should have as prompt access to new treatments as European patients do;
  3. Payment policies of Medicare, Medicaid and private insurers must support medical innovation and not penalize early adopters of new treatments and cures;
  4. A vigorous trade policy must support export growth and provide a level playing field for U.S.-based manufacturing;
  5. Strategic tax policies to level the playing field must be implemented, including improvements to the R&D tax credit to keep it competitive with other countries;
  6. The American research and development infrastructure must be sustained and improved. Special emphasis should be placed on creating research structures that support commercialization of the R&D.

“America is the acknowledged world leader in medical technology, but that leadership is being challenged,” said Stephen J. Ubl, president and CEO of AdvaMed. “We know medical technology has a bright future. The question is: will that future be made in America—or somewhere else? Without the right public policies in place to provide a level playing field between the U.S. and foreign competitors, America’s leadership will be lost.”

In addition to protecting jobs and helping patients, Stryker Chairman, President and CEO Stephen P. MacMillan stressed that device manufacturing is an important driver of current and future economic growth.

“Our industry plays such a great role in improving patients’ lives around the world, and we are a great source of producing good manufacturing jobs. As the markets for our products grow around the world, we want U.S. policies to be encouraging job creation here,” said MacMillan.

Read the entire release here.

Related post: ‘Crescendo of Complaint’ Calls for FDA to Improve Medical Device Regulation





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