Fighting the Obstacles

Attendees at the 2006 Neurotech Leaders Forum in San Francisco last month learned of a number of obstacles confronting new entrants to the neurotechnology industry [see conference report, p7]. Many of these obstacles were pointed out by keynote speaker Skip Cummins, CEO of Cyberonics Inc., who shared some of the more frustrating moments from his days in the neurotechnology industry.
One obvious barrier to commercialization familiar to most medical device executives is regulatory approval, and the FDA in particular.

Cummins pointed out that many of the standards the government uses in the approval process are put in place by regulators more accustomed to the pharmaceutical industry than neurotech interventions. In particular, the requirement for randomized control trials often puts neurotech device vendors at a disadvantage. Cummins also believes the FDA shortchanges quality of life issues and contends that long-term patient data that tracks results such as seizure counts and seizure severity, in the case of epilepsy, might reveal a more meaningful comparison between drug and device effectiveness.

Cummins then related some of the challenges Cyberonics confronted dealing with surgeons, hospitals, payers, and patients’ families, each of which was relatively unfamiliar with neuro device therapies. Building a demand creation model and assembling a sales force were also hurdles for the company, which could not rely on the pharmaceutical industry’s strategy of “smoking cigars with surgeons.” And dealing with Wall Street analysts and unscrupulous hedge fund managers often pushed the limits of Cummins’ patience.

But of all the obstacles confronting the neurotechnology industry, dealing with Medicare currently stands out as the most troubling, as Cyberonics has found with VNS therapy for depression. Several other presenters at the Neurotech Leaders Forum cited problems with CMS, including Evan Rosenfeld from Bioness. Perhaps the most appalling example cited was the agency’s explanation for denying coverage for Johnson & Johnson’s IBOT mobility device: paralyzed individuals could just scoot down the stairs on their behinds or slide down the bannisters. This type of reasoning makes Rush Limbaugh look truly sensitive and caring to individuals with disabilities.

Clearly, the neurotechnology industry has much work to do to overcome these obstacles. A good place to start is for firms to join together and form a united front to the media, the government, and the public. Organizations such as the Neurotech Network and the Neurotechnology Industry Organization may prove useful here. But it also helps for firms to share their experiences as Skip Cummins did so that we can be forewarned and forearmed to fight the battles that lie ahead.

James Cavuoto
Editor and Publisher