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A Lean-Agile approach to achieving FDA compliance in medical device software

Our client is an industry pioneer in self-monitoring for diabetic patients, focusing on people using insulin therapy and managing type 2 diabetes. Their product makes testing for blood glucose and ketones far easier.

Consulting and rewriting to meet strict regulatory requirements

A compliance consultant introduced Bluefruit Software to the client, after growing concern that the product would not meet strict FDA standards.

The project started with a piece of consultative investigation. Our team investigated the client’s existing code and discovered that the software was non-compliant due to a lack of evidence and documentation, such as design reviews and code reviews. The software also had poor conceptual integrity, aside from the unit-tested core algorithm that calculated glucose and ketone levels. So, in this case, it was not possible to conduct reviews retrospectively. Code quality and a lack of reviews meant much of the product’s software needed to be rewritten from the ground up.

The client needed confidence that the work was going to be appropriately done the second time around. We proposed to work in a way that would enable the new software to meet the requirements for FDA approval; using the principles of AAMI TIR45 to apply IEC 62304 processes together with alignment to 21 CFR 820 for quality management.

Challenges Bluefruit Software faced

This was a successful project, but it wasn’t without its challenges:

  • Rewriting much of the code base from scratch.
  • Creating all necessary documentation and traceability right from the outset.
  • Ensuring documentation did not become a burden to the project.
  • Keeping to a tight timeline.

What our client gained

Bluefruit Software worked closely with the client to not only bring together a product which met compliance needs and requirements, but also improved the features delivered by the product and enhanced the benefits experienced by end-users managing their condition.

Outcomes achieved included:

  • Test-Driven Development (TDD) practices helped to meet many of the documentation requirements and restore confidence in the product.
  • Delivery of evidenced design reviews and code reviews, in a compliant way, which included acting (and evidencing this) on any issues identified—and doing this through Lean-Agile practices.
  • Access to a multi-skilled team, including compliance experts and programmers from both Bluefruit and the client.
  • Close collaboration with the client’s scientists to ensure rigorous and essential laboratory testing was carried out, recorded, adjusted, and evidenced as we went along, so there were short, rapid feedback loops.
  • The utilisation of emergent knowledge gained by Bluefruit which enabled the development of additional product features, like USB, and software for use in the client lab.
  • Project delivery at a rapid pace, with regular releases, to meet existing business timeline requirements.
  • Software for a self-monitoring device that had been developed with compliance in mind and was easy to use.
  • Access to a reliable Real-Time Operating System (RTOS) with Bluefruit’s in-house test-driven developed Satoru, paired with custom bare metal drivers

Approval ready

Bringing the project together by having transparent Lean-Agile processes in place that reflected the guidance on Agile in AAMI TIR45, we were able to help our client develop a product ready for FDA approval. Achieving necessary evidence and enabling innovation during development shows that following effective Lean-Agile practices and methodologies is not only suited to embedded software development generally but for embedded software and firmware in medical devices as well.

Find out if your medical device software is IEC 62304 ready

Are you wondering how well your device software holds up against IEC 62304? You can download your copy of The essential IEC 62304 checklist today.

The essential IEC 62304 checklist will help you:

  • Understand critical parts of the standard from a business perspective.
  • See the early signs of whether your medical device software is audit-ready or not.
  • Discover key opportunities working to IEC 62304 presents for your business.
Download your checklist

Insights: embedded software in medical devices