As with any process, the time and administration involved in post-market surveillance is often significantly underestimated. Couple this with medical device manufacturers that are not taking their post-market surveillance seriously enough and you get the perfect recipe for failing to meet compliance requirements. If this is the case, manufacturers can face large monetary fines, seizure of products, imposition of special compliance contracts and even possible hefty jail terms for the executives deemed responsible.
Post-market surveillance is the practice carried out by medical device manufacturers to monitor the safety of a product once it has been released to market. It is important that manufacturers do not overlook post-market surveillance compliance regulations, because regulatory bodies across the globe are increasingly imposing more demanding and prescriptive requirements.
When a medical device manufacturer adopts a more proactive approach to post-market surveillance there are substantial benefits that come with it. Not only does the company develop a strong name in the market for producing reliable and safer devices, but it also can reduce complaint handling costs due to fewer incidents and increased customer loyalty.
Follow these eight key steps to stay on top of post-market surveillance and navigate the changing regulatory climate requirements.
1. Stay Ahead of the Game
Manufacturers should not rely solely on waiting to be informed that significant regulatory changes have been made. Manufacturers should take a proactive approach when it comes to post-market surveillance. Awareness of future changes can be obtained from a range of other activities, such as attending trade association meetings (or joining these groups), and regularly monitoring industry websites and other healthcare forums. Having proactive processes in place to keep up with the regulatory changes of post-market surveillance not only means manufacturers will produce safer devices, but also that they will be well positioned to identify product, design and process improvements early during the manufacturing process.
2. Keep Observing
Continually monitor internal processes to ensure that the organization is prepared. As part of this crucial step, manufacturers need to establish suitable systems for the proactive scrutiny of trends in complaints and incidents that occur with their devices. It is also important to monitor ad hoc events. For example, if there was a change to the scope of an originally planned change, it needs to be monitored so see if it will have an effect on the organization.
3. Post-Market Clinical Follow-up Studies
Manufacturers need to identify and investigate any residual risks that are associated with a specific device that has been placed on the market, and often post-market clinical follow-up (PMCF) studies are required. Factors that can impact the PMCF include innovation; significant changes to a device or its usage; risk factors; type of procedure; population; safety; post-market surveillance findings; emergence of new information; and CE Marking.
4. Tap into All Feedback
Manufacturers need to be in a position to adequately identify the root cause of any issues with their devices in order to put the appropriate corrective actions in place, thereby preserving company reputation and avoiding expensive reparatory measures. It is important to keep all lines of communication open between customers who have already filed a complaint and the business in order to garner all necessary information about relevant complaints and understand if there is any scope for possible future complaints.
5. Keep Training
A big problem area for manufacturers is producing correct vigilance reporting decisions. There is plenty of ambiguity when it comes to defining a serious injury, when there is potential for serious injury and understanding what exactly constitutes a serious public health threat for example. However, in order for manufacturers to be prepared to deal with these issues head on, training of company personnel is crucial. Personnel need to be properly trained on performing investigations and vigilance reporting while simultaneously keeping track of vigilance reports that are filed, as well as feedback from regulatory bodies. This process should not be rushed, and sufficient time must be allocated to train personnel and evaluate its effectiveness.
6. Realistic Expectations
Manufacturers must be realistic about the time and resources required to implement determined changes. Manufacturers need to preempt possible issues or challenges and account for the extra time and resources that might be needed to provide support. If manufacturers do not have the available resources in-house, they should consider bringing in external support.
7. Know Your Limits
Don’t be scared to admit that something is out of your company’s area of expertise; it is perfectly acceptable to ask for outside help. The global complex regulatory framework is challenging and not many organizations have the full level of expertise required to manage regulatory changes across numerous countries.
8. Support Personnel
Any changes that are occurring can significantly impact personnel. The adoption and effectiveness of these changes can be significantly influenced by ensuring that personnel are aware of any incoming changes.
Post-market surveillance is an area that is being neglected by some device manufacturers. Now that it is under the global regulatory spotlight, adopting a more proactive approach (instead of simply meeting regulatory compliance requirements) will help businesses generate additional substantial benefits such as building reputation and expanding their customer base.