Constant Global regulatory changes and more recently EU MDR and In Vitro Diagnostic Regulations are compounding “content” requirements. Structuring content can help medical device manufacturers immensely. Five key challenges and some solutions:
1. Time to Market
Medical device manufacturers are always under pressure to get their projects to the market as soon as possible. There are many content requirements for these devices. Medical device manufacturers need to speed up the time it takes to create, translate, review, and approve the content.
2. Similar yet Different Requirements
Health authorities & Notified Bodies around the world often have similar requirements. However, the order, format, and templates used can vary widely. Using standardized, structured content sets medical device manufacturers up for maximum reuse.
3. Reuse without Content Changes
Medical device content has a lot of reuse potential. In order to keep a single source of truth and avoid content drift, manufacturers need to reference small, format-free, reusable pieces, rather than copy / paste / tweak over and over.
4. Start with Approved Content by HA/NB
It is always best to start off with previously approved content. Chances are high that Regulators more likely to accept language that they approved in a previous submission.
5. Med Devices are Getting Smarter
Medical devices are getting smarter. Industry must move to standardized, structured content to accommodate the advances that are coming.