As discussed in our last post, medical device manufacturers must recognize that the FDA leaves it up to the manufacturers to mandate their own software processes and regulatory expectations. Here are some important references that provide good information on this point.
First, in the AAMI TIR section on “The U.S. FDA Regulatory Perspective”, it explains that FDA Design Controls “do not define a development process or prescribe a specific development methodology or a specific software development lifecycle; rather, they specify controls that must be integrated into the manufacturer’s development processes, methodology, and lifecycle”.
Second, in the FDA’s “General Principles of Software Validation; Final Guidance for Industry and FDA Staff,” which provides guidance on the FDA’s expectations for software development processes, in the early section on “Scope” the guidance says: “Based on the intended use and the safety risk associated with the software to be developed, the software developer should determine the specific approach, the combination of techniques to be used, and the level of effort to be applied. While this guidance does not recommend any specific life cycle model or any specific technique or method, it does recommend that software validation and verification activities be conducted throughout the entire software life cycle.”
Finally, in the FDA’s “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices,” there is a description of the activities to be performed for software development and the deliverables that must come from those activities, but it does not prescribe how those activities must be performed or the exact format of the deliverables. This is left up to the manufacturer to define and describe – in fact, a description of the software development environment and processes is one of the required elements of a medical device software submission.
So, it is clear that it is not a question of whether Agile is suitable for medical device software, it is a question of how Agile can be applied in a way that satisfies regulatory expectations. “TIR45:2012 Guidance on the use of agile practices in the development of medical device software” provides recommendations to help you answer the how questions.
To order a copy of the Agile TIR from AAMI, visit their marketplace website and enter “TIR45” in the search box.
Don’t forget to join us for the PMI-MN Agile Local Interest Group on Monday, June17 at 5:30 pm to hear Kelly Weyrauch talk about these concepts and more. Admission is FREE of charge for the 5:30 – 6:30 session held at the Crown Plaza Minneapolis West, 3131 Campus Drive, Plymouth, MN 55441
Have you ever thought about using the Agile methodology in a highly regulated environment, such as the medical device industry? The effective Agile software development processes work across a variety of industries; sometimes they just need to be tailored a bit to fit regulations, such as those set by the FDA. Learn more about the topic on Monday, June 17th at 5:30 pm from Kelly Weyrauch when he talks about these concepts and more. Join us for the PMI-MN Agile Local Interest Group at the Crown Plaza Minneapolis West (3131 Campus Drive, Plymouth, MN 55441) for FREE at the 5:30-6:30 session. For now, here’s a sneak peek into the topic!
Agile in the Beginning
The early definition and applications of Agile software development methods did not seem to fit well with the needs of safety-critical software developers, such as medical device manufacturers. The initial creators and early adopters positioned Agile as an alternative to what was perceived to be the overly burdensome and ineffective development practices that were widely used by software developers in many industries. Initially, Agile was thought to be inappropriate for safety-critical applications where rigorous development processes were deemed a necessary evil, even if they were ineffective. As Agile was tailored to meet the needs of different contexts and as it was demonstrated that Agile could support as much rigor as is necessary for the context, applications of Agile became more common in the precautious medical device industry. Agile is now used by many medical device manufacturers including Medtronic, Boston Scientific, Cochlear, and St. Jude Medical.
The FDA and Agile
There are still concerns within the medical device industry about the suitability of Agile and the reaction that regulators such as the U.S. Food and Drug Administration (FDA) will have toward the use of Agile. To address the uneasiness, the Association for the Advancement of Medical Instrumentation (AAMI) (http://www.aami.org/) has published a Technical Information Report, “TIR45:2012 Guidance on the use of agile practices in the development of medical device software.” Written by industry and FDA representatives, this document provides recommendations for the proper application of Agile to satisfy the requirements and expectations of the medical device world.
The TIR provides many recommendations about specific Agile practices and principles, but there is one key concept that will help medical device manufacturers get past their initial concerns about what the FDA might think of Agile’s suitability for medical device software, and that is to recognize that the FDA does not mandate specific software practices, instead leaving it up the manufacturers to define their software practices and show how they satisfy regulatory expectations.
Check back later this week for more information and specific references on the topic!
Angela Johnson is a Certified Scrum Trainer for the Twin Cities area. Her ScrumMaster workshops and Agile training sessions teach small teams management skills for software and other product development projects. Angela’s Scrum training is commonly used for developing a framework for software development, but can also be a great workshop for team building in the Twin Cities. If you’re looking for a great product management workshop in Minneapolis or St. Paul, getting your ScrumMaster Certification and learning about Agile methods when you take a course from Angela Johnson is the best way to go! If you’d like to become a Certified Scrum Product Owner (CSPO) or Certified ScrumMaster (CSM) and are in Minneapolis, St. Paul or the Twin Cities area, sign up for one of Angela’s classes today – she offers the best ScrumMaster courses in the area!