The Road Map to the Finish Line

The pending sale of Satiety's Intellectual Property is another example of the problem in the United States with regards to new technology introduction into the United States. Satiety was one of a number of transoral GI devices that is meant to treat obesity; a problem that was in pandemic form the last time I checked. Venture capital was the economic push to get it to market. As usual, the finish line... FDA approval and insurance reimbursement remained elusive, as the goals of what needed to be obtained in clinical and safety results were either never clearly defined or set at a level that no therapy, other those achieved short-term with a major operation for weight loss, could achieve. I have to believe there is some concession given to the fact that we cannot treat all obesity with surgery given the costs and risks of the procedures.

This is a prime example of the disconnect currently between the inventor, capital, the FDA and reimbursement. There are 4 pots of money for an inventor or start-up:

1. Grants (good luck)  
2. Angel investment (limited in amount)
3. Venture capital
4. Friends, families and fools (Bill Gates is not my dad or cousin)

If you look at that, it is quite clear that there has to be a roadmap to get to the finish line (FDA clearance/reimbursement) that is known and achievable, if we hope to bring anything new to the GI physician and GI patients that is not a "me to" product. People funding projects want to know they have a reasonable chance for success or, they could as effectively burn $20 dollar bills in the backyard on their grill. That's where the DeLegge Medical Technology Accelerator can be so helpful; as a broker and director. Taking technology and having a clear pathway to success has to be established before the first prototype is conceived. I have to think that everyone involved (FDA, payors, inventors) actually wants patients to get better with the help of new technology at some point. If not, then we are in real trouble. It might take a coordinated patient "uprising" to change the playing field with the FDA and payors if those goals cannot be predetermined and achievable through "reasonable" means.