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Snapshot: Proteus Digital Health

Proteus Digital Health
Name: Andrew Thompson
Title: Co-Founder and CEO
Company: Proteus Digital Health
Location: Redwood City, CA
Proteus Digital Health
Year Founded:
Number of Employees:
Description: Proteus Digital Health is the world’s leading digital medicines company

What impact will new technologies like yours have on the life science industry in the next five years?

Health care will be transformed by a new utility more available than electricity – the mobile internet. In the 20th century we all plugged in and transformed our homes, factories and hospitals. In the 21st century we all log on, and even greater benefits are emerging.

About the only thing spreading faster than chronic disease is mobile phones. Many owners of these devices are the people who manage chronic disease day to day: family careers. Today this is already by far the largest group of health care workers in the world. The most important tools they have now are medicines. In the future they will get help from their mobile devices as well. Proteus has developed a digital health feedback system that will integrate medicines with mobile devices – a solution that can help family careers as well as physicians and patients.

What impact will these technologies have on patients in the next five years?

Our goal at Proteus is to enable consumers to realize much more therapeutic value from the drugs that they are already using. What many studies show is that prescribing can be based on little evidence and patients often lack the information and motivation required to follow through on a doctor’s orders. These challenges result in hundreds of billions of dollars in excess costs and a lot more sickness than if medicines were prescribed and used accurately.

The Proteus digital health feedback system is designed to enable future physicians to make prescribing decisions based on more accurate information about actual use of a drug and patients individual physiologic responses. In addition these solutions are designed to enable patients to sustain positive health habits using specially designed tools that allow collaboration and communication with their caregivers. These software tools make use of social media and will enable companies like Proteus to personalize medicine just like Apple has personalized music and entertainment.

How did you ensure regulatory approval?

Proteus began pursuing FDA marketing clearance in October 2008 via the 510(k) process the FDA uses to clear low-to-moderate risk medical devices. While the FDA agreed with Proteus on the low risk nature of our ingestible sensor, the Agency had difficulty identifying a suitable, already marketed Predicate Device–hardly surprising given the innovative nature of our technology platform. In the end, the FDA agreed to use an accelerated “de novo” process accounted for in Section 513(f)(2) of the Federal Food, Drug and Cosmetic Act. This created an entirely new regulatory class (“Ingestible Event Marker,” 21 CFR 880.6305) based upon Proteus’s invention. Proteus gained FDA clearance in July 2012 to market the ingestible sensor as a medical device for co-ingestion applications.

What are the factors for success for health technologies like these?

The key is creating FDA approved digital health solutions that help consumers right away, and then deliver on longer-term clinical results. This kind of immediate value means doing jobs that consumers already struggle with – like ensuring grandmas with heart failure feel safe, sons with bipolar disease sense love, daughters with diabetes understand how to stay stable, and mothers are reassured they have the tools they need to keep their family healthy.

What are the hurdles?

Probably the biggest challenge is identifying the ways in which consumers find it easiest to engage with mobile tools that help them manage their own health or that of a loved one. It’s relatively easier to figure out what physicians need – but without patient engagement and use of the tool the data will not exist.

What could be changed to improve the success?

The most important part of a digital platform is that it creates data that can be used to deliver a much more focused and personal experience. That means you can change what you sell from a standardized product (like a pill) to a personalized solution (like an outcome). So the most important thing to change is the business model.

Why California?

Building our products required us to recruit a team with expertise in low power analog circuit design, semiconductors, MEMS, pharmaceutical formulation, medical devices, telecommunications, mobile software applications, data and analytics and to raise well over $100MM in equity capital. Is there anywhere else in the world this would be possible?

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