Honorable Mention: Tidepool

Tidepool
Tidepool has its sights set on providing a straightforward, central smartphone app that can communicate with and control different insulin pumps, glucose monitors and dosing. (Tidepool)

Bringing nonprofit approaches to the particularly for-profit diabetes enterprise

CEO: Howard Look
Founded: 2013
Based: 100% remote, work-from-home employees, plus a Palo Alto, California, mailing address

The scoop: A nonprofit software developer among a field of private firms and startups, Tidepool is an atypical addition to our Fierce 15. But its work is no less promising.

Committed to open-source projects, data liberation and radical transparency, the company has worked to make life with diabetes easier—with its sights set on providing a straightforward, central smartphone app that can communicate with and control different insulin pumps, glucose monitors and dosing.

And along the way, Tidepool has begun to convince the largest medtechs in the diabetes space to start playing by their rules.

For just over a year, this 501(c)3 has been working toward its own 510(k) for an app it calls Loop. Born from the homegrown, community-led software project of the same name, Tidepool hopes to shepherd the program through the FDA and return it with all the benefits of the agency’s stamp of approval—while updating the public every step of the way. 

Because not only is the underlying code for Loop published online as a resource for others, but so are all of Tidepool’s interactions with the FDA and its review process.

“As a nonprofit, we can do that,” says Howard Look, founder, president and CEO. “We can be totally open and transparent about everything we're doing, and say, ‘Hey, does this work well for you?’ And we get great feedback.”

This includes meeting agendas and minutes, the company’s statistical analysis plans, and its quality assurance strategies—as well as the agency’s written feedback, including responses from as recently as last month on Tidepool’s proposed labeling and observational study data, which has shown gains of more than an hour per day in healthy glucose ranges. 

“We do all of that because we feel it’s better for the industry and for the community,” Look says. “And once it’s approved, our postmarket surveillance will be out in the open. We’ll want people to know what they can expect from Tidepool Loop and how it’s operating out in the world.”

Compared to the do-it-yourself version of the automated dosing app, which the company estimates has been installed by about 9,000 people, the future, FDA-regulated program will be functionally equivalent—with the addition of safety guardrails to keep insulin levels from getting too high or too low, as well as a more polished interface and the features users have come to expect from other downloads on the iPhone App Store.

RELATED: Medtronic steps toward diabetes interoperability with Tidepool collaboration

“At the time my daughter was diagnosed with Type 1 diabetes, I was actually working in the consumer electronics division at Amazon,” says Look, who has also held roles at Pixar and TiVo. “And one of my first reactions was, why is all this software so bad?”

Going forward, the upcoming version of Loop also aims to overcome many of the impediments faced by its DIY predecessor. “It initially only worked with older, aftermarket Medtronic pumps,” he says, though its reach has grown to other systems over the years.

“Another issue is that a whole bunch of people aren’t comfortable with building it themselves,” he adds. “And a lot of people just aren’t comfortable using an unregulated piece of software when the stakes are as high as they are with insulin delivery.”

Now, Tidepool maintains development partnerships with Medtronic, Insulet and Dexcom to make sure the Loop app can talk with their myriad diabetes devices. 

This also includes an agreement with Medtronic that will financially support its push to the FDA—in return for helping the medtech giant develop a new, interoperable version of its MiniMed insulin pump—as well as future marketing team-ups with Insulet and Dexcom. Once complete, Tidepool sees Loop consolidating and replacing the individual apps shipped alongside companies’ respective devices. 

The company largely describes its work as a stone placed on the boulders built by people who came before, and it hopes other startups and researchers will be able to add to the height.

“Our mission is to give back everything that we’re doing to the community,” says Look. “We consider it a wonderful thing if people take our intellectual property and go do amazing things with it.”

What makes Tidepool fierce: The company hasn’t just been working to change conversations in the diabetes industry, but among regulators as well. 

Over the past few years, the FDA has moved to incentivize the development of new, interoperable devices—by creating new pathways to market for plug-and-play ACE insulin pumps and other systems, for example—and Tidepool has been a part of those discussions from the beginning. 

“The FDA has helped make it a reality by declassifying—saying that if you follow the special controls, they will change your class III device to a class II device and dramatically reduce the regulatory filing period,” says Look. “It’s a huge incentive. It allows companies to move faster and deliver more innovative solutions more quickly. That’s not just better for the community, it’s better for their business. If they can get a product out under a 510(k) clearance in 90 days, that’s way better than getting a product out in a year-and-a-half or two years under a [full premarket approval].”

“I think that is going to turn out to be one of the greatest regulatory innovations that has transpired, in the way that it helps the diabetes community,” he adds.

Tidepool was also selected in 2017 as one of the few tech-focused companies to participate in the agency’s exclusive digital health precertification pilot program, tasked with helping to shape the FDA’s future software oversight activities.

“It’s Apple, Google’s Verily, Johnson & Johnson, Roche, Samsung, Fitbit, and then tiny little Tidepool,” Look says. “I think we had 10 employees at the time, … and it’s been an incredible experience. I think we have genuinely helped influence how the program is taking shape.”

Now, with about 50 decentralized employees, working remotely with each other across the country, Tidepool has been pushing for more open data sharing and patient ownership, along with the dissolution of concentrated company silos of diabetes information.

“We would go to each company and say, ‘Look, it is not your data,’” he says. “Imagine a thermometer company, and you took your temperature, and the company asserted that that information is their intellectual property. We would never stand for that.”

That mission has dovetailed with the company’s efforts to compile donated, anonymized data from insulin pump and CGM users for use in scientific research. 

Last month, Tidepool passed 10,000 donations and agreed to award a number of those real-world, longitudinal data sets to Type 1 diabetes research teams spanning 12 institutions selected by the Juvenile Diabetes Research Foundation.

“I don't think we could have done that as a for-profit company,” says Look, describing the credibility and trust needed within the community to collect and distribute that information—including basal insulin levels, bolus amounts and blood sugar readings that industry and academic partners can use to help build machine learning tools and prediction algorithms, among other projects.

“No one entity has all the great ideas,” says Look. “And so by making anonymized data available and letting researchers try new things, I feel that we're helping to expand the boundaries of what's possible for diabetes therapy.”

Honorable Mention: Tidepool

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