Inventors, Investors, Regulators and Payors Struggle with New Technologies

December 20th, 2013 by MorganDowney Leave a reply »

A two day meeting on the regulatory and reimbursement factors affecting medical devices for the treatment of obesity is now wrapping up in Washington, D.C. The workshop is jointly sponsored by the FDA Center for Devices and Radiological Health (CDRH)  and the American Gastroenterological Association. The meeting is one in a sequence bringing together young companies trying to develop new devices, researchers, venture capital investors, regulators and reimbursement experts from governmental and private payors. The challenges of getting a new device approved through the regulatory process and then getting it paid for.

The sponsors were kind to invite me to provide two short talks. One was on the reimbursement environment and I re-capped the changes brought about by the Affordable Care Act which is covered elsewhere. The other part I was asked to address was “What do Patients Want?” I indicated that the millions of patients with obesity did not fit any one pattern of what they wanted, nor did I have any particular data. But I did feel confident to offer that patients wanted their physicians to be respectful, competent and helpful in their weight management issues. I offered patients wanted health professionals to understand obesity as a disease, not a personality type and to recognize that stereotyping and stigmatizing persons with obesity is a defining characteristic of this condition.

I also indicated that the reasons why some patients undertake weight loss efforts, while some do not and while some take extreme risks while other do not, reflects the diversity of the population and the risks they are willing to undergo. And while health professionals often focus on weight loss for the prevention of type 2 diabetes or cardiovascular disease, patients may be just as motivated by more daily concerns, such as back or joint pain, mobility problems, incontinence, dealing with the shame and embarrassment, harassment and discrimination they experience or perceive. Finally, while the field has tried to minimize the ‘cosmetic’ goals of weight loss, we cannot avoid living in a culture in which personal appearance is so important.

It appears the AGA-FDA collaboration will continue with the goal of making the approval process more predictable and efficient and thereby facilitating getting new technologies to persons with obesity.