“Don’t depend on documents to manage your documentation!” Product teams developing a new medical device need to produce a lot of documentation but that doesn’t mean they should use the documents to manage all the product data, especially for software-intensive medical devices.
“Are these the latest software requirements? Who has the latest draft test protocol?” If you’ve ever been in this situation of trying to track down the latest product data for the medical device you’re developing, you know how frustrating it can be. This is typical of a document-based approach, where product data are managed in a set of documents. It may work for simple, hardware-only products but it can’t keep up with the complexity and rapid changes needed for software-enabled medical devices.
Fortunately, there’s a better way. Using a platform approach to managing development, where requirements and other product data are managed in a single platform (The Hub), everyone on the team can always have access to the latest information–a single source of truth. And documents exported from The Hub are automatically kept in sync. So, for example, you won’t discover later in an audit that one of your risk documents doesn’t agree with a requirements document.
As a consultant I’ve helped many companies transition from a document-based approach to a platform-based approach. It can be challenging to adopt the new way of working at first but I’ve never seen a product team want to go back to the old way once they’ve transitioned. Because they can see how much more efficient and flexible it is working from The Hub.
In a series of articles I co-authored with Monik Sheth, founder of Ultralight Labs (now part of Greenlight Guru), we explain what it means to adopt a platform-based approach to managing product data and documentation. We show how The Hub enables product teams to rapidly respond to product changes while enhancing product quality and generating rigorously controlled documentation. See below for links to the four articles as well as a single downloadable eBook, which combines the articles for ease of reading.
As software becomes a bigger and bigger part of many medical devices, it’s important to adopt development approaches and tools that can keep up with the complexity and rapid changes needed for these products.
Links to More Information
Article 1 – Two Approaches to Developing Software-Enabled Devices
Article 2 – Never Ending Documentation – Building the Hub
Article 3 – How to Dramatically Improve V&V Efficiency
Article 4 – Dynamic Risk Management for Software-Enabled Devices
eBook (Articles 1-4): Two Approaches to Developing Software-Enabled Devices