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Newsletter V. 2024 Issue 1 – Embracing Change for Medical Device Excellence

March 2024 – What are “re-entrant design controls” and why would a medical device company need them?

Re-entrant design controls provide a systematic and efficient way to manage upgrades to a medical device over the lifetime of the product, which is especially important for software-intensive, connected medical devices or capital equipment.

Security Patches to Software

Predetermined change pathways are an important part of re-entrant design controls and are also key to expediting software security patches. Procedures for rapid deployment of security patches have become an area of FDA focus with their latest cybersecurity guidance.

Want re-entrant design controls but don’t want to spend months revising SOPs? 

The Adaptive Design Controls package incorporates re-entrant design controls, support for agile software development, and adapts to the software tools your product teams use.

How Do We Manage Design Iterations During Development?

Modern development methods involve frequent iterations of hardware and software. If your company’s design control procedures assume a once-through, linear approach (with no unknowns) then your quality system is likely undermining product teams instead of supporting them. Here are three recommendations for improving quality system support for design iterations during development (without compromising compliance):

1 – Staged change control: don’t use a one-size-fits-all change management process; instead make the change controls appropriate to the stage of development: use a lightweight process for early in development then increase controls as the project progresses, eventually to full production controls at the time of launch.

2 – Emergent requirements: don’t mandate completed product requirements at the beginning of development; instead allow the initial release of a product requirements document to include multiple TBDs that identify uncertainties and gaps which the product team will then resolve during development as they gain more knowledge from prototyping and testing.

3 – ALM system: implement an Application Lifecycle Management system (software tool) for managing risk, requirements, design, and test data and traceability amongst these elements. An ALM system provides a single source of truth for key design control content throughout development and can keep up with frequent product design iterations (the DHF documents are then generated automatically out of the ALM system database).

Avoid Big Surprises with Big Projects

The challenges that product development teams and leadership face have to do with more than just technology. Complex medical devices take longer to develop, have bigger teams, and require a wider variety of expertise than developing simpler products.

The panel of medical device experts share how to address these problems, about the successes and failures that they’ve experienced, and about how to give every product team the best chance for success.

Watch full video at


April 3 – Cybersecurity Live Q&A with FDA on Cybersecurity Premarket Guidance – Greenlight Guru online webinar

April 3 Cybersecurity and SBOMs I Have an SBOM Now What? – Medcrypt online webinar 

April 23-25 INCOSE Healthcare – Minnesota

May 1&2 DeviceTalks – Boston

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