How to stay approved: Why compliance with changing global post-market requirements matters
Joshan Joy is a Senior Regulatory Affairs Consultant at Hydrix specialising in pre-market and post-market processes and strategy. He has over 15 years’ experience with medical device design and development, regulatory affairs, device assessments, managing recall actions and more. Joshan Joy | LinkedIn
Global Post-Market Surveillance (PMS) requirements are changing. And thanks to public disasters involving implantable devices over recent years, it is more vital than ever that medical device companies stay current with changes and have rigorous PMS plans in place. Failure to do this could lead to patient harm and potentially irreparable damage to your company’s reputation and bottom line.
What is Post Market Surveillance?
PMS is a regulatory requirement designed to manage risk associated with medical devices across their lifecycle. It involves a set of processes and activities used to monitor a device and generate data that can accurately track its real-world behaviour and clinical outcomes. An effective PMS strategy ensures you can expediently identify any design, manufacturing and/or usage problems.
PMS requires both a reactive strategy (responding after an event has occurred, known as ‘vigilance’), and a proactive one (anticipating and endeavouring to prevent events before they happen). The need for PMS begins immediately upon device approval and commercialisation.
Benefits of an effective PMS strategy
An effective PMS strategy has obvious advantages for patients and clinicians, but it also benefits manufacturers. Regulations governing Quality Management Systems for medical devices require a proactive (as well as a reactive) PMS approach. This could include customer surveys, post-market clinical follow-up (PMCF) studies, and reviewing and analysing device registries (such as orthopaedic and cardiac registries for implantable devices) and adverse event databases by MHRA, FDA, TGA etc.
Regulators are quick to assess your PMS strategy, making it imperative to have one capable of monitoring post-market device performance, gathering and interpreting data, and implementing corrective action if necessary. Failure here could see your devices taken out of the market, or those already in the market being recalled.
For large companies, the reputational damage such actions cause could have implications for your other devices. As a start-up, it could potentially lead to company failure.
Another risk of inadequate PMS is financial loss, such as a fall in share price or the need to pay huge compensation claims. For example, in the widely publicised PIP (Poly Implant Prothese) case, the company was liquidated following revelations they were fraudulently manufacturing and selling breast implants filled with industrial-grade silicone.
In another case, Johnson and Johnson paid out around $2.8 billion in compensation as part of the fallout from their DePuy ASR metal-on-metal hip replacements. While these are extreme examples, they highlight potential problems companies face for failing to comply with regulations, either knowingly or unknowingly.
On the upside, an effective PMS strategy shows your commitment to the health and safety of patients. It allows you to identify and address any issues at an early stage before serious events occur. Quality data can also help you implement design changes to make the next generation of devices safer and more effective, and ensures you keep up with your competition.
Global changes in PMS requirements
Issues like those mentioned above, and more recent problems with urogynaecological mesh implants, have had a big impact on ensuring companies take a lifecycle approach to devices.
One of the biggest changes has been the up-classification of non-life-sustaining devices such as hip prostheses to the highest risk category. Along with implications for pre-market approval like increased clinical evidence scrutiny, this has led to increased PMS requirements, including the need to conduct PMCF studies and supply additional reports to regulatory bodies (such as competent authorities in Europe). This information will be included in publicly available medical device databases.
Other important issues that came to light included patients not knowing what device had been implanted, and in some cases, poor patient selection. Patients are now given more information choice together with a card identifying which device was implanted. In my observation, regulators who have traditionally remained removed from giving clinical advice or information are providing some indirect clinical guidance and oversight for managing patients affected by device issues.
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.