I am an inventor on 108 issued patents assigned to former employers; there are 68 published patent applications. I believe innovation is a team sport and facilitate collective genius.
I specialize in identifying potential hurdles: identifying the risks early. I apply First Principles thinking and identify root issues and means to mitigate risks.
I have served as a testifying expert in patent litigation specific to human interfaces and diabetes device technologies.
The FDA defines an “artificial pancreas” as composed of three elements: an interoperable continuous glucose monitor (iCGM), an alternate controller-enabled (ACE) pump, and an integrated automated glucose controller (iAGC). In the context of automated glucose control, each element is imperfect — there are opportunities to further evolve sensors, pumps and algorithms. The most mature component is the insulin pump. Sponsors of insulin pumps accept the role of realtime clinical support as patients encounter issues in delivering the potent drug: insulin. Sponsors of iCGMs require the patient to mitigate the risk of errors: the patients are to compare how they “feel” to the displayed glucose value. The cognitive load of managing an automated insulin delivery system can be overwhelming.
Insulet is the world-leader in disposable, tubeless insulin pumps and hybrid closed-loop systems.
We developed the first FDA-cleared (K162042), optical-based continuous glucose monitor for critical care. The technology is mid-infrared spectroscopy.
Services provided: testifying expert for Fish & Richardson in Baxter v. Fresenius; and as the testifying expert in a U.K. court: Insulet v. Roche.
Brought a new insulin pump project incubated in Denmark to Silicon Valley; staffed with local talent. Funding was initially Novo Ventures; raised $26M in a Series-A. The company was re-branded to Asante, sold to BigFoot Biomedical, and ultimately its IP assets were acquired by Insulet.
Warbug Pincus my first equity investor relationship: investigating glucose sensors and novel insulin pumps. Consulted for the Helmsley Trust in reviewing novel infusion pump technologies, including an example from Dean Kamen’s DEKA.
Led R&D in the development of a line of insulin pumps; kept promises to investors regarding submission timelines. Applying both evolutionary changes, and revolutionary innovation, brought a new pump platform that endured for a decade.