The results of a recent ASQ (Milwaukee, WI) survey were released, showing how device manufacturers feel about industry trends and challenges. Survey takers (234 device professionals) cited increased FDA regulations as the biggest challenge in the industry for the coming year. Additionally, the majority of respondents (64.7%) predict that healthcare legislation will have a negative effect on the industry in 2010.

Dan Brown, ASQ medical device expert, says that it’s not necessarily healthcare reform that is causing the problem, but rather the uncertainty of the legislation that has put pressure on firms. “It stems from hospitals,” he says. “Clinical sites are holding off on ordering equipment, but not necessarily canceling orders. The pending healthcare legislation has most major equipment purchasing organizations on a wait-and-see approach.”

On the positive side, the survey also asked participants to identify the hottest innovation areas. These include the following:

• Nanotechnology.
• IT and wireless capabilities for hospitals.
• Less-invasive procedures and devices.
• Combination devices involving drugs and biologics.

For trends happening in the next three years, respondents said they expected significant advances in three categories, as follows:

• Neurological (31.7%).
• Cardiovascular (30%).
• Orthopedics (25.2%).

“Neurological, cardiovascular, and orthopedic opportunites are such industry hotbeds because of the growing senior population,” says Brown. The survey was conducted January 18–22, 2010.