Ok! I am way behind...abut 5 months, I think?
Either way, if you're interested in my interpretation of the conference, part 1 is below:
Dave Prowten, president and CEO of JDRF, gave opening remarks. These included a touching tribute to Dr. Bob Goldstein,
Next up was Dr. Cathy Parker from Health Canada.
- Symposium focus on digital health interventions
- Discussed HC mandates for access and affordability of services and devices
- Use the regulatory system as a facilitatator, not a barrier, to treatments.
Dr. Aaron Kowalski
Chief Mission Officer, JDRF
One part of Dr Kowalski's speech that struck me: "Despite significant advances, there remains an unmet need in T1D". He discussed the JDRF Research pipeline, including technology, the diy/openaps community, glucose-responsive insulin, restorative & immune therapies, beta cell replacement, and other topics that would be covered throughout the day.
Dr. Joseph Cafazzo, Associate prof at U of T: Use of digital health interventions to improve management of T1D
- usability lab, where they test use and uptake of advanced features
- How do you enable closed-loop tech when there are technical and social barriers to their use?
- Advocating for open standards
- Nightscout, openaps LOOP, etc were featured in presentatioon.
- Industry needs to acknowledge that lack of interoperability hinders self-care
Dr. Courtney Lias, Director of of chemistry and toxicology devices, US FDA
Pathway to artificial pancreas:
Medtronic 670g is the only approved Automated Insulin Delivery device.
In the US, there are at least 7 companies developing new (mostly hybrid closed loop) algorithms.
Devices don't currently enable interchangeable use. Cgm developers need to look beyond individual MARD. Mismatch of data between services can lead to problems, including treatment errors. Interoperability is the ability of different components to communicate, exchange data, and use the data that has been exchanged. Intetoperability does not mandate the transmission of proprietary data.
Grant Kealey, Health Canada Scientific Evaluator, Medical Devices Bureau
The road to health Canada approval:
While informative, this segment of the presentation seemed very...govt.
Class 3 (pumps and sensors, BGMs) vs Class 4 medical devices (AEDs, closed-loop pump/cgms). Class 3 and 4 devices undergo rigorous scientific review to confirm device safety.
Artificial Pancreas history in Canada: Minimal 670g, now available in the states, has not applied for a Health Canada license application yet. Medtronic confirmed that they intend to submit in the near future.
Investigational testing in Canada:
Insulin pumps in Canada:
Licensing of pumps does not necessarily need a clinical study. Exceptions include new features, such as novel hypoglycemia reduction features or new cannula systems. Licensing of new sensors does require a clinical study.
Health Canada's talk was very careful to not discuss any openaps projects, even on the slide for innovation in devices:
How is HC positioned to review evolving diabetes devices?
Docs on new regulations for Software as a Medical device are expected to be posted for public consultation this summer.
Part 1 Panel:
*I didn't take notes on every question!
How do HC and FDA work together to approve devices (joint review process)? Short answer- they don't. Alignment of submissions is a
Pat Stewart, Director of medical device something. R2d2 reg approval of devices. Part of that is looking at relshp with foreign reviews. Each govt had their own regulatory framework. Indicated there is some fwd mkovement.
HC approvals for pediatrics: is it always a separate application?
HC would need a liceense amendment to add pediatric to their device usage. HC says it comes down to the availa polity of data to support review in pediatrics. Might lead to small delays in approval, but no significant delays.
Pushback from endos re: safety of data. Dr Joe C noted that most of these digital hjealth apps are fairly passive and are patient centred. Why should endos object to how a patient views their data?
Dr Kowalski took a different view. Looking at studies if the diy community, safety analyses, etc.
HC: Enhanced use of real-world elements. Freestyle libre was one example of a postmarket study. He cautioned that these postmarket coknsumer data studies aren't necessarily providing data that has been vetted (e.g., estimated sensor a1c in a study, vs actual lab a1cs).
What told do you see the regulator playing in Software as a Medical Device?
Most are Class 1, or not considered a Medical device at all. How to protect the public? Google Play and Apple are starting to police these types of apps.
Dr Kowalski : there are people with low IQs walking around dosing insulin daily, and they're not dying. They are not supported by data, but are dosing insulin. There is huge opportunity in data and decision support tools/apps. AK pointed out there is this fear of insulin, regulators are conservative in approvals bc of the danger, but people are using these drugs anyways. PWD seem to show we are being too conservative.
People still get hypos with the status quo. The Status quo is dangerous.