Agile Development for Medical Products

Agile Development for Medical Products examines how Agile product development can be reconciled with the regulatory requirements governing medical products. The paper draws on Kevin Thompson’s experience working with medical-product organizations and focuses specifically on the relationship between Agile development practices and FDA requirements for product requirements, testing, validation, documentation, and traceability.

The paper begins by examining what FDA-regulated development requires, including documented requirements, controlled records, defined and traceable test cases, validation of medical claims, and maintenance of a Design History File. It then considers how these requirements interact with Agile concepts such as Epics, Stories, deliverables, and Story-level testing.

A central challenge is the relationship between regulatory requirements and Agile product specifications. Medical product requirements may describe clinical or engineering outcomes that do not correspond directly to individual Agile deliverables. As a result, the relationship between regulatory requirements and Agile test cases can be many-to-many rather than the simpler hierarchical relationship commonly assumed by Agile work-management tools.

The paper examines three approaches to reconciling these two worlds: maintaining separate but parallel regulatory and Agile traceability systems, integrating regulatory requirements with Agile deliverables and test cases, and an ideal reconciliation in which regulatory requirements could be easily linked to the many Agile deliverables involved in developing the product while still accommodating validation information that cannot be derived from product testing alone.

The paper concludes that FDA compliance is not inherently more difficult under Agile than under traditional project management. The fundamental work of defining requirements, maintaining the Design History File, validating the product, and establishing traceability still has to be performed. The principal difference is that Agile approaches tend to perform this work incrementally rather than primarily up front, with tooling and the mechanisms for maintaining traceability becoming particularly important.