Author: Erin McDermott, Account Manager Life Sciences, Reed Tech
Last week, I had the pleasure of attending the 6th Annual Medical Device Postmarket: Surveillance and Clinical Follow-Up Conference presented by Q1 Productions. This conference, or more of a workshop, provided a great opportunity to network with and learn from the unsung heroes of safety and quality, Postmarket Surveillance (PMS) Professionals. Over the course of two days, a lot of topics were explored—EUDAMED, notified bodies, artificial intelligence, social media, cyber security, audits, VMSRs, PSURs—but nothing seemed to resonate quite like the evolution of postmarket surveillance.
We discussed that, of course, quality assurance and safety monitoring after the device has gone to market is a huge part of the responsibility that comes along with a Postmarket Surveillance role. Not only are you under a legal and ethical responsibility to protect the public health, but PMS is the safety net of your company.
However, companies are realizing that looking at safety events more holistically, and involving their postmarket team as early as device design, is a huge asset to themselves, users, and patients. With a single complaint costing thousands of dollars, your surveillance data can provide actions and insights that translate to significant monetary savings. So while you are well aware your data and expertise can create implied insights, what can you do to help your company jump on board with this trend?
- Create a device profile that highlights benefit/risk ratio and safety information. Rather than spending your time processing complaints or figuring out how to better process complaints, your focus can shift on how to ensure there are fewer complaints. It’s possible some products would have a negative benefit/risk cost ratio.
- Learn to speak their language. Not everyone speaks risk, but if you can translate your data to have a financial or analytical impact that is meaningful to other roles.
- Focus on Human Factors Engineering. Make sure the product is doing what you intended it to do when you designed it. And also that the product has intuitiveness for knowledgeable users.
- Utilize competitive data to anticipate possible safety events with your device.
Additionally, work to create a standard approach to handling product issues if they do arise. Create a Risk Management Plan then adjust it, along with your product expectations or device design, accordingly. Big data has allowed us to shift our postmarket surveillance from passive to active.
In accordance with these trends, Reed Tech has developed Navigator™ for Medical Devices. Troves of safety and quality data exist at your fingertips and can be manipulated to help at any point in the device lifecycle. You have access to PMAs, 510(k)s, and safety events. You can view your own data, competitors’ data, and industry averages. We are even working on predictive recalls (currently greater than an 80% success rate) to support the next wave of AI and the next evolution of the Postmarket Surveillance Role.
How are you helping show the worth of surveillance data earlier in the lifecycle process? We would love to hear more about your approach! To continue the conversation, or learn more about Navigator for Medical Devices (and get a free two-day trial!), reach out to me at 267.961.0232 or firstname.lastname@example.org.