December 15, 2014

Agile and Medical Device Development: Is It a Good Fit?

Agile
As part of the 2014 State of Medical Device Survey, we asked respondents if their product development team was considering or already using Agile. The results were surprising; almost half are either successfully using Agile or are planning to adopt Agile practices within the next 12 months. Another third said they are working to understand how or if Agile can help their development efforts. using-agile 600

Why Agile?

Why are so many medical device companies becoming more agile? Agile development methodologies improve the economics of product development by reducing costly and unnecessary project overhead. A major advantage that Agile has is the reduction in wasted time and effort Waterfall developers spend designing or documenting functionality that is never implemented or that changes before implementation. Agile has been widely adopted by software development teams to improve the quality of software, rapidly develop and deliver working software, and minimize risk by incrementally developing requirements as they evolve. In an Agile process, verification and validation is performed after each sprint, rather than at the end of the development cycle. agile vs waterfall

Why Now?

Although Agile has been popular for years, it only recently caught fire in the medical device industry. Part of the reason for this may be that the FDA embraced Agile in January 2013, adding AAMI TIR45:2012, “Guidance on the use of Agile practices in the development of medical device software,” to its list of approved standards. Another reason could be that it took this long for Agile buy-in to trickle up from the developer level to management. There is always a resistance to trying new things when "we've always done it this way," and this is especially true in compliance-heavy industries like medical device development.

Agile Doesn't Mean Purely Agile

Pure Agile teams are the unicorns of the software development world; rumored to be beautiful, but they probably don't exist. Among Seapine's medical device customers, most who have adopted Agile are using a hybrid approach. In other words, the software teams use agile practices to iterate quickly and respond to change, but they're also maintaining all the traceability and documentation that’s required to get the product through regulatory approvals. It's a little bit Agile, a little bit Waterfall. Because of its emphasis on working software and incremental development cycles, which reduce requirements and software changes, Agile can be an excellent way for medical device companies to reduce risk while bringing high-quality products to market faster than their competitors. While the reduced amount of documentation may seem problematic from a traceability standpoint, integrated software tools can make up for this by automatically tracking changes, linking artifacts, and generating the reports needed to meet the requirements of the FDA and other regulators. We explore this topic in depth in our free white paper, Agile in FDA-Regulated Environments. And to learn more about this year's survey results, download the 2014 State of Medical Device Development 2014 report.