Agile can be used to support medical device development, but careful adoption is key. Read this post for Agile insights, strategies, and best practices!
Join the DZone community and get the full member experience. Over time, traditional development approaches for medical devices have proven inefficient and hard to scale, making it difficult to keep up with increasing market demands. Leveraging Agile in medical technology development offers significant benefits and the promise of an edge in an increasingly competitive market. However, many MedTech developers still feel that this approach is not compatible with meeting requirements for product development in highly regulated industries. Nonetheless, many organizations are already reaping the benefits of Agile, with the right planning and processes in place to tailor the methodology to MedTech device development. Read on to find out our top insights and best practices for using Agile in medical device development, and how your organization can start enjoying its benefits! With the lives of patients and healthcare professionals at stake, MedTech developers often see new development approaches as an unnecessary risk. In addition, Agile as an approach seems unsuitable for regulated medical device delivery to developers who are married to traditional methods, mainly because they believe that constantly changing requirements and decentralized development are not compatible with achieving the compliance needed to bring MedTech products to the market safely. Since Agile was originally developed with software in mind, many also maintain that it is not an appropriate methodology for combined hardware and software development, since incremental or iterative development when it comes to hardware becomes much more complicated than just changing lines of code when needed. While Agile may not have always been ready in the past to deal with the regulatory requirements of MedTech development or the needs of combined hardware/software systems development, this can be solved by adapting Agile strategies to the specific needs of regulated medical device development. And many organizations are already doing so — and reaping the benefits. In response to the growing interest and use of Agile methodologies in medical device development, the Association for the Advancement of Medical Instrumentation (AAMI) published a guideline called the AAMI TIR45:2012 “Guidance on the use of Agile practices in the development of medical device software” in 2012.
