The FDA Agile Practices In Medical Device Development Under IEC 62304
Agile methods are state-of-the-art for software developers and they can be adapted to IEC62304 in the highly regulated medical device field. The Association for the Advancement of Medical Instrumentation (AAMI) has issued a Technical Information Report, TIR45 Guidance on the use of AGILE practices in the development of medical device software This report maps IEC 62304 activities into the agile development process.
With documented regulatory compliance required at every development stage of a medical device, proven traditional processes like Waterfall deliver effectively, however, not necessarily efficiently, in terms of development speed. In a traditional Waterfall model, the linearly executed process is meticulously checked for errors. While this approach reduces errors and facilitates the documentation of each stage of the life cycle, it lacks in efficiency.
While the Waterfall development model is the most straightforward way to apply IEC 62304, Agile, with its incremental iterative approach delivers efficiency through parallel processes and flexibly operating self-governing teams. Despite the initial impression that Agile may be more difficult to track and document for medical device regulatory compliance requirements, regulatory compliance with IEC 62304 is achievable.
The key to using Agile in medical device development is to gradually internalize the cultural changes it entails, and replace the old tool set with an integrated Agile ALM solution that allows enforcement of compliant processes, ensures traceability and transparency throughout the lifecycle, and automates documentation to facilitate compliance audits.
Critical to using Agile under IEC 62304 is organizing the content of iterations as well as staffing the software development team. Since an iteration of medical software development involves additional activities related to mandatory documentation of software development, these additional tasks either extend the duration of an iteration or may reduce the number of other tasks completed.
The team should be comprised of appropriate personnel to effectively and efficiently handle the additional development tasks. Such personnel would include: a project manager experienced in medical devices who would oversee the software development team, and a quality manager who would oversee the reviews critical to the success of using Agile with IEC 62304.
Documentation has to be initialized and updated according to the content of iterations. Reviews should be planned before, during and after iterations, according to the content and evolution of the backlog. A consolidation phase is necessary to verify correct implementation.
Agile development practices are compatible with IEC 62304 and can be implemented to provide strong support for compliance with regulations. Agile development, in conjunction with IEC 62304 specifications, offers medical device software developers added benefits that result in more efficient development processes while ensuring regulatory compliance.
