Using AGILE in Medical Device Software Development

In school I was always taught that the medical device development process followed the waterfall model. However since entering the work force I have started to see other methods of development for different types of devices. I have recently been working with software medical devices. My client is constantly updating the software device by either adding new features or fixing defects. There is continuous development which means frequent pushes to market for this standalone software medical device. Because of this continuous improvement and continuous innovation....is the waterfall approach the best for development or will it hold up the innovation process?

AGILE software development is not a new process. However using AGILE in a heavily regulated environment such as within a medical device company is fairly new. I read a great paper by RBC Medical Innovations titled Is Agile Management a Medical Device Innovation Solution. I encourage everyone to take a look at this article.

It talks about the change in the FDA and how they have acknowledged using AGILE within a medical device company. The interesting thing about the FDA however is even though they acknowledge the use of AGILE in medical device companies they still require the use of IEC 62304 which means developers need to keep regulations in mind. One of AGILE's focus points is reducing the amount of documentation, however 62304 and 510(k) submissions require specific design control documentation. These two opposing forces need to be planned out carefully within companies in order to have successful submissions to the FDA. Once again the balance between innovation and regulation comes into play!

-- Jillian F. Walker