While legal considerations play a role in determining if or how soon use of a medical device is adopted, other factors are now just as important and in some cases more important in influencing a provider's product selection process.
Changing Times Raise Barriers to Device Innovation
Article preview from Medtech Insight- August, 2010
Health care is a heavily regulated industry with guidelines, rules, and laws designed to protect patients. For medical device manufacturers, these regulations include a specific process for approval that can mean years to get a product from the drawing board to the market. However, once a device is approved for sale, deterrents can still prevent a product from being adopted by providers, and the changing health care environment is intensifying those types of barriers.
A good example of some of the current post-approval hurdles comes in a recent report by health care staffing and management company Jackson Healthcare, which found 53% of physicians surveyed had delayed adopting new medical technology, procedures, or treatments due to the fear of a lawsuit. The survey was designed to take the pulse of defensive medical practices and perhaps have some effect on the push for tort reform. (Forty-nine percent of physicians answering the survey said defensive medicine has a negative impact on medical innovation.)
However, focusing too heavily on the tort reform issue can detract from the overall evaluation process that ultimately determines whether a new technology will be adopted by a provider. To be sure, legal considerations play a role in determining if or how soon a product is utilized, and for a number of years, groups of providers, manufacturers, and others have been engaged in battles to enact legislation that addresses those concerns. But while those legislative quests have taken place, the industry itself has been evolving. Other issues now are just as important—and in some cases more important—in influencing a provider's product selection process.
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