Four essentials for staying approved
1. Stay current with changes
Global regulatory requirements are frequently updated, so it is vital your company stays current. This can be difficult for smaller companies and start-ups, and those who want to remain focused on their core work of innovating, researching and developing new devices.
2. Understand what’s behind the changes
It is vital to understand the forces causing regulators to make updates. For example, has there been repeated device malfunctions, customer complaints, or problems with usage? Knowing this could impact various organisational operations, such as device design and clinician training.
3. Plan early
When regulations change, you have a small window of opportunity for ensuring you meet updated requirements, so early planning is key to maintaining compliance. Ideally, complete a gap analysis to determine what must be done to meet the new requirements, and then create a clear strategy for achieving that.
Regulators’ websites and notified bodies offer some guidance, although these can be difficult to comprehend unless you know regulatory jargon.
4. Seek support
Factors including frequent updates and global differences between regulatory requirements can make staying on top of PMS a resource-intensive activity for companies of all sizes. It can be a wise investment to outsource PMS to someone with experience and expertise in the global regulatory sector.
When speaking about the PIP disaster some years ago, Fazel Fatah, President of the British Association of Aesthetic Plastic Surgeons (BAAPS), noted that ‘…poor post-marketing surveillance of medical devices lies at the root of the PIP crisis. We feel there needs to be significantly more stringent monitoring of all medical devices […] via compulsory, regular reporting of adverse effects…’.
The importance of having a thorough Post Market Surveillance strategy cannot be overstated. Planning for the entire journey, including design and development, pre-market approval process, post-market reviews, recalls, and providing proactive response to regulators on potential issues, are all vital cogs in the life-cycle approach to the successful management of medical devices. By investing in a well-constructed post-marketing surveillance strategy, companies are better placed to detect and resolve issues early, mitigating the risk of patient harm and reputational damage.
Hydrix is a product innovation company developing FDA Class II and Class III medical devices for clients around the globe. Our unique team of designers, engineers, commercial and clinical & regulatory strategists combines to create market winning solutions that encompass financial, regulatory and clinical strategy.