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.

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.