Post-Market Surveillance for a Medical Device: What You Need to KnowAriel
Post-Market Surveillance for a Medical Device: What You Need to Know
The journey of a medical device has a fair share of obstacles until it’s production is completed. While reaching the commercialization stage is, by all means, an important milestone, it is not, however, the end of the journey for the manufacturer. Regulators require post-market surveillance to ensure that a device remains both safe and effective.
It is important to differentiate between the post-market surveillance required of the medical device manufacturers by regulation and what the that which is conducted by the regulators themselves such as the FDA.
In addition to the regulatory requirement, post-market surveillance offers an opportunity for collecting market data that can provide valuable insight into the device improvement. The purpose of this article is to focus on the benefits of conducting post-market surveillance and what is needed to establish a system to do it correctly.
The immediate motivation for developing a post-market surveillance system simply comes down to regulation. Regulators require medical device manufacturers to have processes and procedures for monitoring and controlling product-related risks.
Data collection on the end-user experience can factor into future marketing and design changes, allowing you to improve your device for an updated version.
Another important role of post-market surveillance for medical devices is risk avoidance. By tracking long-term data, you can gain foresight in identifying potential malfunctions or weak points in your device design. Having access to this data earlier on, before a problem develops means you can take the necessary actions in a timely manner. This proactive approach can save significant costs on what would have been if timely action was not taken.
Creating an Efficient Post-Market Surveillance system
The most important part of the post-market surveillance system is tracking. You must designate channels to track the longevity and performance of your devices. Good starting points of reports for collecting are end-user and clinician surveys, customer complaint collection and to establish long-term clinical studies.
Manufacturers of class 3 devices will be familiar with the FDA’s unique device identification system whereby each medical device is given a code and the device information is required to be submitted to the Global Unique Device Identification Database (GUDID). Through a partnership with the National Library of Medicine (NLM), the FDA offers AccessGUDID, a separate, searchable database of device information.
Designing procedures and a documentation system with the end goal in mind is the foundation of creating a sound post-market surveillance system. The end goal should translate into clearly defined KPIs. Defining the criteria of what constitutes a potentially adverse trend that requires further analysis would be a good KPI.
Data needs to be collected in a way that allows for easy analysis. As mentioned above, the source of data collection must be defined as well so that there is consistency in the type of data collected and therefore will allow you to identify trends. It’s important to not get locked into one method of analysis and allow flexibility for different tools and approaches.
For software solutions to track post-market surveillance objectives and reports, manufacturers can leverage their existing DMR in their PLM system.
Post-market surveillance is a critical part of the life cycle of a medical device. This data tracking is required by regulators in the US and Europe. But it can also help your company minimize risk while maximizing the safety and effectiveness of your devices. Post-market surveillance takes a significant amount of work, but if done properly can provide an excellent return for the time and resources you put in.