Memorandum

FDA announces nine participants in digital health Pre-Cert pilot program: Apple, Fitbit, J&J, Roche, Samsung, Tidepool, and Verily – September 26, 2017

Today, FDA Commissioner Dr. Scott Gottlieb announced the nine organizations selected to participate in the Agency’s exciting digital health software precertification pilot program (FDA Pre-Cert): Apple, Fitbit, J&J, Pear Therapeutics, Phosphorous, Roche, Samsung, Tidepool, and Verily. The reveal came in Dr. Gottlieb’s keynote address to the 2017 AdvaMed (MedTech) Conference in San Jose (read his full remarks here) and via FDA press release earlier today. We’re thrilled to see such excellent diabetes representation – evidence that diabetes is a poster child for digital health and there is high interest in moving things more rapidly through the regulatory process. We are also impressed with the FDA’s commitment to diversity, with selected organizations ranging widely in size, structure, and category. Having non-profit Tidepool alongside juggernauts Apple and Verily and Samsung is quite cool to see and we are very moved by how many companies are working on diabetes. We’re also glad to see Fitbit in the mix, showing continued interest in moving beyond wellness and into the medical device world. The FDA has pushed this program forward rapidly, reviewing 103 applications since the pilot was announced in July. PreCert will allow the agency to first look at the company, rather than primarily at the product being submitted. This “firm-based approach,” sort of like a ‘TSA Pre-Check’ for digital health submissions, is intended to expedite product reviews from vetted companies – either minimizing the burden of submissions or eliminating them in some cases (see our detailed report here). Public updates on the program will be available here, and a stakeholder meeting is already on the docket for January. We have high hopes for this program, and look forward to seeing how it improves FDA’s agility, allowing it to better match the rapid pace of digital health innovation. We wonder who else applied from the diabetes world, and assuming this program is successful, how quickly it will be available more broadly.

  • Reminders of selected organizations’ diabetes involvement:
    • Apple has had a longstanding relationship with Dexcom and more recently promoted One Drop. The just-launched iOS11 added insulin delivery tracking to Apple Health. Meanwhile, the Apple Watch continues to move into the medical device world, including the announcement two weeks ago that it would begin a Heart study to detect atrial fibrillation. The upcoming WatchOS4 will launch with a feature called Native Core Bluetooth, capable of talking directly to third-party accessories without the phone nearby – Dexcom’s CGM transmitter was shown back in June, though there is no official timing on when direct CGM-to-Watch communication will launch.
    • Fitbit recently partnered with Dexcom to develop products for diabetes, starting with CGM data on the Fitbit Ionic smartwatch in 2018. The company also established a professional CGM partnership with Medtronic in December. It has also indicated recent interest in sleep apnea, given Ionic’s new Sp02 sensor.
    • J&J overall has a lot of digital health efforts (e.g., 7 Minute Workout, IBM Watson, robotic surgery with Verily), though not much has happened in the diabetes division with the ongoing strategic evaluation and potential for a sale (see 2Q17). We wonder if J&J’s own Bluetooth-enabled BGM, WellDoc partnership, not-yet-launched OneTouch Vibe Plus with Dexcom G5 integration, or other diabetes efforts will be impacted by this pilot.
    • Roche has been talking more recently about diabetes and digital health – see our EASD coverage – with a focus on building an open diabetes management ecosystem with its own Bluetooth-enabled BGM, Senseonics’ Eversense implantable CGM, recently-acquired mySugr, and even a reusable smart pen available in cooperation with Pendiq in Germany in 2H17 (per an under-the-radar German press release). Could these efforts be accelerated in the US with this pilot?
    • Samsung signed a commercial agreement with WellDoc in April, integrating the BlueStar C consumer diabetes app with Samsung Health. Samsung has also been partnered with Medtronic Diabetes on sending CGM data to Android phones.
    • Tidepool recently launched a second version of its device uploader and a redesigned mobile app. We hope it moves faster on diabetes data with this pilot!
    • Verily has diabetes-related partnerships with Dexcom (next-gen CGM), Sanofi (Onduo), Novartis (glucose-sensing contact lens), and GSK (Galvani Bioelectronics). It also has the ongoing Baseline study to collect a comprehensive set of health information from ~10,000 participants – some healthy, some at-risk of disease, and some with overt disease.
    • Not involved in diabetes: Pear Therapeutics makes clinically-validated digital therapeutics for drug-abuse disorders, Schizophrenia, and PTSD. Phosphorous makes diagnostic tests and software to facilitate next-generation sequencing).
  • In his keynote remarks, Dr. Gottlieb was excited by progress on FDA’s device side (“some of the most creative, and forward-leaning advances in regulatory policy”). The “iterative process for innovation,” he said, “lends itself to modern constructs for collecting and making use of data, including the use of real-world evidence, prospective registries, or statistical frameworks that improve the reliability of practical data.” He also implied that the precertification construct could form part of the framework for other legislative areas, such as lab-developed tests. The whole speech is worth reading.

Close Concerns’ Questions

Q: How much faster will this PreCert pilot program allow selected organizations to move? For the larger companies selected, will this impact diabetes at all?

Q: How long will it take for the pilot to be expanded, assuming outcomes are positive? What other companies were not selected but could benefit from this effort?

Q: Where could faster regulatory reviews and less burden makes the biggest difference in diabetes tech and digital health – insulin dose titration? CGM? Mobile apps?

 

-- by Maeve Serino, Brian Levine, Adam Brown, and Kelly Close