If you aim to bring a medical device or drug to market, you are likely aware of the term post-market surveillance. Also known as PMS, post-market surveillance refers to the process of collecting, analyzing, and interpreting data on the performance, usage, and adverse effects of a medical device or drug. While that may sound complicated, PMS is a vital part of ensuring that your products are safe and effective. In this article, we’ll cover the basic FAQs around post-market surveillance for medical devices.
What is post-market surveillance?
PMS is a data science process that medical device manufacturers must follow in order to ensure the quality and efficacy of their products. By gathering real-world data, medical companies are able to better tailor their devices and drugs to the patients who are actually using them. While clinical studies provide valuable understanding and insight, data taken from the general public can vary. So PMS is valuable for this reason.
It’s worth noting, however, that PMS is more than just a potential business strategy that medical manufacturers can employ. As a matter of fact, Post Market Surveillance is a legal requirement in the US and around the world. The Food and Drug Administration (FDA) requires postmarket surveillance be conducted in the following situations:
Any class II or class III device that…
- Could cause serious adverse health consequences in case of device failure.
- Has widespread use in pediatric medicine.
- Is intended to be implanted in humans for over a year.
- Provides life-saving (or life-sustaining) functions outside of medical facilities.
Why is post-market surveillance important for medical devices?
As the FDA requirements above hint, one reason why post-market surveillance medical device procedures matter is because they can save lives. By doing your due diligence as a medical device manufacturer, you can rest assured that your work is serving the greater good and improving the lives of patients. If anything does go wrong, the problem can be caught early and rectified.
PMS can also help identify new opportunities for medical companies, too. For example, data collection could help medical providers and insurance companies recognize a drug’s potential for off-label use. Last but not least, PMS is important for medical device manufacturers because it helps them stay compliant and audit-ready.
What happens during post-market surveillance?
Post-market surveillance is comprised of four main activities:
- Collect Data. This requires gathering data from healthcare providers, patients, insurance claims, and public health records.
- Compliant handling. This includes addressing any reported complaints, incidents, or adverse events related to the medical device, and taking appropriate actions to rectify them
- Analyze Data. This requires synthesizing the data points you’ve gathered and uncovering a cohesive picture of what’s actually happening.
- Interpret Data. This requires building a thoughtful ongoing action plan based on the data that has been collected and analyzed.
How is post-market surveillance conducted?
A few key data sources for PMS include:
- EHRs. Electronic health records from healthcare providers.
- eCRFs. Electronic Case Report Forms from clinical settings
- PRO data from patient-reported outcome surveys.
- Public datasets from government organizations.
- Insurance claims data on cost and utilization.
Collaborating with healthcare providers and payers to gather this data comprises an important part of PMS. In order to be fully compliant with FDA regulations and other government rules, it is important that this data be carefully analyzed and implemented, as well.
What are the benefits of post-market surveillance?
One of the key benefits of PMS is being able to answer important questions about your medical device or drug. For example:
- Is this device resulting in better outcomes for patients?
- Is the device being used by the patients you expected?
- Does the population using this device have important comorbidities to consider?
- Are off label uses of this drug or device common?
- Are patients experiencing any adverse reactions?
- Are there any important changes that need to be made or corrective action that must be taken?
Knowledge is certainly power for medical device manufacturers. Knowing how your products perform can help you make smarter decisions that lead to better patient outcomes in the future. And this can help your organization gain recognition and trust, empowering even more advances down the road.
Identifying potential safety problems with a device
One important reason why the FDA and other regulatory agencies require PMS compliance is because the process offers potential insight into safety problems with medical devices. Identifying safety issues can empower you to take decisive action that saves lives and preserves your organization’s reputation in the medical community. A few options at the disposal of medical device and drug manufacturers include:
- Changing recommendations for physicians and healthcare providers.
- Issuing a warning against off label uses that conflict with patient safety.
- Identifying specific populations who should not use your drug or device.
- Removing a dangerous product from the marketplace entirely.
While none of these options are easy decisions, careful consideration and proper PMS compliance can help organizations make the right choice even in critical circumstances.
Helping to improve the design of future devices
Post-Market Surveillance is more than just a legal requirement or even an ethical obligation. It also offers organizations a chance to improve their product design and bring better devices to market. The insights that PMS offer medical device manufacturers is sometimes invaluable. By keeping the importance of research and data analysis front and center, your company can help push the entire medical industry forward and improve patients’ lives at the same time.
Providing valuable feedback to device manufacturers
The designs and use cases that look great on paper don’t always translate to real life patient experience and outcomes. PMS provides useful feedback that device managers can use to improve decision making and product development in the future.
By now, you should have a deeper understanding of post-market surveillance and why it matters. If you are hoping to bring a medical device to market and don’t know where to start when it comes to PMS compliance, Innovenn can help. We are a Wisconsin-based consultancy that specializes in helping organizations navigate the healthcare industry. With over a hundred years of combined experience and a passion for improving the lives of patients, we are the perfect partner for PMS and other medical industry needs.