As a devices guy, I have an observation about the opposite: MD expertise that MP people may be lacking.
In the Devices Universe, Post-Market Surveillance has a different meaning than in the Pharma Universe. I see 'pharmacovigilance' often being mistaken for 'Medical Devices PMS'. This is not just a formal issue; this can cost patient's their life. It can also be very bad for share prices.
For all pharmacovigilance experts that are now wondering what I am talking about: vigilance reporting is just a small part in Medical Devices PMS. Well before reports start getting in, a PMS team must understand the risks, know where they made assumptions, be aware they have to look for unknown risks, have thresholds of accepted frequencies, develop strategies for collecting feedback, must have a justification for the level of under reporting they are expecting and many other things that enable them to collect and assess incoming user feedback. And that is just the part that is called the 'PMS Plan'. Handling incoming feedback, which may come in multiple shapes and sizes (reviews on Facebook, for example) also requires a detailed approach of which most must be developed by the medical device manufacturer, because only that manufacturer has the information and expertise to fully oversee the consequences. And then there is reporting and possibly the issuing of a Field Safety Corrective Action. Where in pharma the tool is quite blunt: take the product off the market. For medical devices there are many more options of performing an FSCA. The authorities expect that in any measure indicated in an FSCA the General Safety and Performance Requirements have been assessed for compliance against this new situation. I don't see something similar happening with medicinal products.
So there are huge differences in how to handle feedback from the market (and I haven't even started on Post-Market Clinical Follow-up...). I really hope that pharmacovigilance experts understand Medical Devices PMS is a totally different beast. Reach out if you want to know more, or if you want specific training.
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Ronald Boumans
MDR Expert
Super PRRC
Netherlands
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Original Message:
Sent: 18-Jun-2023 14:12
From: Ryan Connors
Subject: What's one thing pharma folks wish devices folks knew?
A question that's been rattling around in my mind: For our members who work in pharmaceuticals, is there anything about working in regulatory in pharma that you wish our colleagues who mainly work in devices knew a bit better?
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Ryan Connors
Social Media and Communications Specialist
RAPS
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