The Decade of the Product

As the decade comes to a close, it’s worth noting that some of the newest neurotechnology products to reach the market were probably in the incubation process 10 years ago, prior to the millennium. And that means that entrepreneurs who are just now developing new neurotech devices will not see their products hit the market until the end of the next decade.

In all likelihood, the 10-year (or more) product development cycle now confronting manufacturers will get even longer if current trends continue. NeuroPace CEO Frank Fischer, speaking at the 2010 North American Neuromodulation Society annual meeting [see conference report, p7], described some of the issues that affect device development in the neurotechnology industry.

Fischer discussed the three stages of device development: concept development, animal testing, and clinical evaluation in humans. Concept development stage is the time to test and refine the theory behind the invention. The animal testing stage is the time to learn about downsides, like side effects. The clinical stage is where you prove safety and efficacy. Fischer stressed that the cost of failure is minimal in the early phases and gets more significant as the development process matures. Accordingly, the first two stages require minimal resources and funding.

When it comes time for the clinical evaluation stage, device developers can take one of three approaches, and Fischer cited examples of all three. The easiest approach is to use devices that are already approved by the FDA and on the market. An alternative approach is to build semi-custom devices in partnership with an OEM supplier. The third, and most demanding approach is to build completely new devices. As an example of the first approach, Fischer cited Functional Neuromodulation Inc., a VC-backed startup seeking to use DBS for treatment of Alzheimer’s disease. The company is using off-the-shelf DBS systems from Medtronic. Leptos Biomedical, an example of the second approach, began its trials using Cyberonics devices and later partnered with an OEM to build semi-custom stimulators and leads. Fischer cited NeuroPace as an example of the third approach, and explained the reasons why a fully custom system was necessary.

While that approach required significantly more in-house engineering, device-development expertise, and financial resources than the other two strategies, the IP opportunity it presents the company will be much greater and Fischer believes it will more than justify the decade-long development cycle. We suspect that other entrepreneurs will look for other approaches to shorten that cycle, but we wish NeuroPace well and hope that their payoff comes soon.

James Cavuoto
Editor and Publisher



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