The big idea

Today’s medical device software updates often take months, while cyber threats move in hours. The T1 Moonshot focuses on type 1 diabetes (T1D) automated insulin delivery (AID) systems as a proving ground to compress safe, compliant update cycles from months to days—without sacrificing safety, performance, or regulatory alignment.

Why start with T1D?

AID systems (CGM + pump + control algorithm) are mature, widely used, and operate within clear regulatory frameworks—ideal conditions to demonstrate what rapid, trustworthy updates can look like in a life-critical setting. What we prove here can extend to other medical devices and cyber-physical systems.

What we’re building

A composable suite of market-ready tools for automated testing and assurance - a pipeline - that  t1d tech manufacturers can adopt and regulators can trust, featuring:

• Validation models to test updates across thousands of simulated clinical conditions in hours.

• Qualified Medical Device Development Tools to make regulatory acceptance automatic.

• AI-assisted verification that generates, runs, and learns from targeted test suites.

• Research roadmap for any unsolved gaps in the pipeline.

 

Together, these enable continuous verification & validation and day-scale security patches with maintained or improved user trust.

What success looks like

• For people with T1D: less disease burden and more trust.

• For manufacturers: lower cost per feature/update, and faster time-to-market.

• For regulators: higher review quality, consistency, and lower burden.

• For the ecosystem: a replicable model for other life-critical systems.

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We’re aiming to turn today’s months-long test pipelines into weeks or days through automation and qualified tools.

Who this is for (and how you fit)

• People with T1D & caregivers: help define what “trustworthy” and “freedom” mean in everyday life.

• Regulators & reviewers: advise on predictable pathways (e.g., MDDTs, PCCPs).

• Manufacturers & startups (and loopers/open-source): adopt and shape the assurance pipeline; accelerate feature velocity safely.

• Security, testing, and DevOps experts: contribute methods, metrics, and tooling that translate to FDA-ready evidence.

• Unicorns, researchers, and innovators: unique knowledge, experience, and skills.

 

We will need it all!

 

How we’ll get there

We’re convening cross-stakeholder workshops to characterize the moonshot, scope the toolsuit, align on success metrics, and seed pilots with industry and philanthropy partners.

 

(While we need regulatory collaboration, we believe there's no new policy required; we’ll work within existing pathways.)​​​​​

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P.S. Our north star is simple: ship safer improvements faster—and prove it with evidence that everyone can trust.