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FDA Compliance

Medical Device Industry Identifies Health Care Reform Among Top Challenges

New ASQ survey also shows neurological advancements offer most opportunity

Published: Friday, February 19, 2010 - 19:17

(ASQ: Milwaukee) -- A new survey from the American Society for Quality (ASQ) asking medical device manufacturers about industry trends and challenges shows a majority (64.7%) identify health care legislation as having a negative effect on the industry in the year ahead. Increased FDA oversight and compliance with regulations tops what manufacturers feel will be the biggest challenge in their industry in the coming year.

The ASQ medical device industry survey results also sites these 2010 challenges:

  • Impact of the health care reform
  • Cost reduction while maintaining quality
  • The effects of a proposed innovation tax


When it comes to innovation trends, manufacturers believe the hottest areas include:

  • Nanotechnology
  • IT/wireless capabilities for hospitals
  • Less invasive surgeries and devices used
  • Combination devices involving drugs and biologics


Hot trends

Respondents were also asked to identify the hottest medical device opportunity in the next three years:

  • 31.7 percent believe neurological advancements offer the hottest opportunity
  • 30 percent believe it is in cardiovascular
  • 25.2 percent said orthopedics


As for economic growth in 2010, more than half of respondents (56.9%) believe their organization will experience more economic growth than in 2009. A little more than 27percent believe they will experience about the same, and 10.3 percent believe there will be less growth than in 2009.

“Neurological, cardiovascular, and orthopedic opportunities are such industry hotbeds because of the growing senior population,” says ASQ medical device expert Dan Brown. “And while it’s clear that population will contribute to the economic growth of manufacturers, the pending health care legislation has most major equipment purchasing organizations on a wait-and-see approach.”

The survey was distributed to members of the medical device industry the week of Jan. 18–22. There were a total of 234 respondents.


About The Author

ASQ’s picture


The American Society for Quality (ASQ) is a global community of people dedicated to quality who share the ideas and tools that make our world work better. With millions of individual and organizational members of the community in 150 countries, ASQ has the reputation and reach to bring together the diverse quality champions who are transforming the world’s corporations, organizations, and communities to meet tomorrow’s critical challenges. ASQ is headquartered in Milwaukee with national service centers in China, India, and Mexico. Learn more about ASQ’s members, mission, technologies, and training at http://asq.org


Nice article. It will create

Nice article. It will create awareness among people regarding Health care Reform. In USA every company who is in medical device industry or in Health care market has to follow FDA Compliance. It is mandatory. For more information on compliance please check this website