Prelude

The core focus of the EU MDRs is Postmarket surveillance [PMS], with the recent guidance document, TIR 20416:2020 reinforces this quite clearly[1]. The goals of PMS are:

1. Monitoring medical device safety and performance
2. Meeting regulatory requirements
3. Contributing to lifecycle management

To achieve these goals the guidance document wants manufacturers to:

1. Actively and systematically gather data
2. Record and analyze relevant data
3. Focus on quality, safety, and performance
4. Engage in PMS data gathering and, more importantly, analysis as a lifecycle activity
5. Use this data to draw conclusions regarding quality, safety, and performance
6. Modulate rigor of PMS activities based on the risk class

Further, the guidance states what is to be done with the collected data:

1. To update the benefit-risk determination and to improve the risk management as referred to in Chapter 1 Annex I;
2. To update the design and manufacturing information, the instructions for use. and the labeling;
3. To update the clinical evaluation;
4. To update the summary of safety and clinical performance referred to in Article 32;
5. For the identification of needs for preventive, corrective, or field safety corrective action;
6. For the identification of options to improve the usability, performance, and safety of the device;
7. When relevant, to contribute to the PMS of other devices; and
8. To detect and report trends in accordance with Article 88.

Set-up 

So, does Marketing or Product management play a role in PMS? Well look at it this way, if you don’t, then you are in for some surprises.   Just look at the concepts in the lists above [bolded], do you currently play a role with regards to these concepts? 

What role should we play?

At the very least, you as a marketer need to be aware of, and involved with, any PMS findings that might impact your product line or device.

I got involved with the design of the PMS process and reviewed every Incident Investigation. Communication to the field was only a small part of the role I always played. 

The only thing worst than not having a formal PMS process is not knowing that you need one.  

The PMS process should not be feared or viewed as a necessary evil but as an opportunity to better satisfy your customer and provide a safer product to the field.

Two types of data collection are required, proactive and reactive. As a marketer you need to support quality or customer service in writing and interrupting: 

Proactive data from-

1. Surveys
2. Questionnaires
3. Clinician user interviews
4. The use or membership in registries
5. PM clinical follow-up studies (if you have to do them make them worthwhile as a promotional opportunity
6. Monitor the market environment for activity by competitors

Reactive data from-

1. Complaints
2. Service reports
3. Maintenance reports
4. Unsolicited observations from all stakeholder (good and bad)

All this data should be feedback to your new product development teams regularly.

Conclusion:

You must, as a marketer, be involved with the PMS process!

Lessons:

1. Make the regulatory processes work for you.
2. If you are acting as a customer advocate get involved with every aspect of your product line.
3. You are responsible for protecting the brand, PMS is a great early warning system when the brand is in jeopardy.

“Experience is what you get, right after you need it most.”

Make it a great day!

Tim Walker

Tim Walker is the Principal Consultant for The Experia® Group, a consulting firm specializing in providing experience and expertise during critical device commercialization phases to increase the probability of success. 

One-on-One, or, team coaching is available.

www.theexperiagroup.com. Contact, The Experia® Group for a free 30-minute consultation to determine if 30+ years of experience can contribute to your success. [email protected]

© 2021,  The Experia® Group, LLC

  [1] Risk-based Postmarket Surveillance In The Age Of EU MDR: Incident Investigation, Jayet Moon, December 11, 2020.  Med Device Online.