NAVIGATE is the annual Cognition User Conference in Boston MA, USA for Cockpit users. These are organizations that develop medical devices or combination products (a combination of a drug and a device) and use Cockpit to support the product development process and gather evidence that the device is safe and reliable. For more information about Cockpit see www.guidedcompliance.eu.
Agile Medical Device Development: Do or Don’t?
That was the title of the presentation of Synergio delivered by Esmée Bertens and Edwin Schumacher.
Today, software development mainly applies Agile methods and practices, such as Scrum. The challenge for most software departments is to scale up Scrum, a team-oriented Agile process to hundreds or even thousands of people where software development can take place in different locations worldwide. The Scaled Agile Framework (SAFe®) is often used for this purpose.
However, medical devices are not just software. Hardware is also an important element to develop and that also applies to regulatory compliance. Compliancy in the form of a Design History File (DHF) and a Quality Management System (QMS) are “must-haves” to bring a medical device on the market. An important question is whether Agile can also be used to develop hardware and compliancy files.
The presentation discussed six typical aspects of Agile, sometimes at odds with what people in a traditional project organizations are accustomed to. Based on this, the audience was involved with the presentation by asking a number of questions about Agile in their own organization, now and in the future.
Are you curious about the outcome of our research? The articles will be published shortly.