Medical Device Development – MIT Enterprise Forum

MindFlow Design attended the MIT Enterprise Forum yesterday which explored “Navigating the FDA Challenges of Marketing Wireless Health”.

Matthew Banet the CTO of Perminova explained their N4 Monitoring System to a panel of seasoned executives and the audience. Their goal is to make their monitoring system as simple as a consumer heart rate monitor and as accurate a medical monitor found in hospitals… all for $300, sold direct to consumers.

Some very interesting questions arose like, “What if the at-home medical product market was more like the consumer market?” The speed at which medical products could evolve would be tremendous. The health and financial advantages to patients and the healthcare system would be equally as great. For example, from 2001-2011 Apple’s iPod essentially evolved through 26 iterations of the product. In the same period, a Glucometer by a major manufacturer evolved and took on two different form factors only twice! Technological advancement that Apple enjoyed over that decade is unprecedented and couldn’t have been possible without constant feedback from millions of people on how to make it better.

Mitchell Goldman pointed out that liability is one of the key factors that drives the FDA regulatory process. A product like Perminova’s would most likely need a prescription similar to CPAP machines in the sleep apnea market. However, it might not if it monitored vital signs, sent them to the cloud where they were reviewed by a doctor who called the patient with a diagnosis. Clearly not Perminova’s business model. It’s the presence of an algorithm that alters the data and displays it to the patient which is the challenge. Mitch recommended a two prong strategy which would involve developing two products. One that was FDA cleared and the other a self-monitoring system that did not need FDA clearance and could be sold as a consumer product.

I think we’re on the verge of a big change in the at-home medical product market. Perminova is one of the innovative companies working to pave the way for mass adoption of a more consumer product based medical market model. Qualcomm Life and its 2net wireless connectivity product is another. More and more startups are approaching MindFlow Design for development help with similar types of at-home medical products so we’re hoping now is the time.

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