Medtech Throughput Labs

Patch Throughput

Medical device patches in a tenth of the time.

There is an opportunity to dramatically accelerate medical device software updates: twelve months to one month, a hundred days to ten. Safer patches. A pipeline FDA has cleared in advance. A targeted 100× return on the R&D investment. We need medical device manufacturers to help shape it.

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The problem

Patching is bottlenecked by testing

It is increasingly easy to create a verified fix for a software bug. What takes the time is verification and validation (V&V) testing and system integration testing: proving that the patched device still behaves correctly in every configuration it ships in, and still works with everything it connects to. Today, there is no approach, technology, or regulatory environment that resolves this bottleneck.

A recall of more than one million pacemakers took eight months to produce a software fix. The fix introduced unintended behaviors of its own, and the corrected correction arrived fifteen months in, on an issue associated with four deaths and 2,557 serious injuries.

FDA, 2026

The opportunity

What we are targeting

10×Faster patch throughput
Twelve months to one month. One hundred days to ten. An order-of-magnitude reduction in the time from available fix to deployed patch.
100×Targeted return on investment
A $100K investment returning $10M in value.
SaferConfidence in every patch
Catch regression and availability errors before they happen, not after the patch is in the field.
FDAAligned from the start
Literal pre-clearance of the tooling pipeline by FDA, through a Predetermined Change Control Plan (PCCP) or the Medical Device Development Tools (MDDT) program.

The goals

Four goals, each a dramatic improvement over the status quo

  1. Accelerate software throughput in regulated healthcare

    Simultaneously increase the quality, speed, and reliability of the software testing pipeline, so the investment not only secures critical infrastructure but dramatically improves the status quo of medical device software engineering practice.

  2. Increase patch safety and patch acceptance

    For medical device software in every operational environment — in clinics, in or on bodies, and in homes — so that cybersecurity updates can be applied continuously across healthcare.

  3. Make healthcare innovation faster, better, and cheaper

    Deliver healthcare-ready technologies that increase software throughput, so innovators can focus on clinical challenges rather than validation overhead.

  4. Make an industry-wide impact

    Demonstrate generalizability and commercial adoption across device types and manufacturers, rather than one-off case studies or a single technology transfer.

The next steps

A Stage 2 government proposal that needs medtech behind it

MTL and our technology partners are seeking funding from ARPA-H to focus on these goals. In other words, we’re working to spend the government’s money on medtech’s needs.

We are asking for your support. We can’t do this in a vacuum.

  1. Register your interest in the form below.

  2. Get involved. We’ll be at industry events and will send invitations for webinars to learn more.

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