George Is Keeping an Eye on You

Medical Obesity Devices Through a Patient’s Eyes

FDA is trying to look at medical obesity devices through a patient’s eyes as they work with the medical device industry and payers to foster innovative medical technology for the treatment of obesity. At a two-day meeting jointly sponsored by  the FDA and the American Gastroenterological Association, Telba Irony presented research conducted by FDA into the importance of attributes for new surgical obesity treatment.

Irony’s research provides a quantitative basis for estimating tradeoffs between safety and efficacy that patients are willing to make for different kinds of obesity treatments. As consumer research goes, it’s rudimentary stuff, but it’s a start. And it’s an infinite improvement over arbitrary, paternalistic judgments by experts detached from the real needs and values of patients.

The conference focused on both regulation and reimbursement for innovative surgical obesity treatments. The need for a new approach stems from the fact that innovative devices for obesity treatment have hit a choke point that is driving investment away. The time, money, and risk required to bring new medical obesity devices to market leaves investors looking for more attractive opportunities.

Compounding the problem, payers are reluctant to put a value on innovative technology for minimally invasive procedures because the benefits are seen almost exclusively by patients. Add this reluctance to a reluctance to pay for even well established obesity surgery techniques and we have a formidable barrier to innovation.

The innovative regulatory approach FDA is bringing to medical obesity devices is encouraging. The proof of its value will come if new treatment tools reach the market as a result.

Click here to read more in Modern Healthcare.

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