Regulatory activities,” he reveals.
Regardless of the desire to comply or implement PMS/real-world processes, he recommends using a common vocabulary and consolidating it into one shared term.
The FDA’s Real-World Evidence framework supports timely safety signal detection and potential labelling expansions.
2017, and then “echoed in the FDA’s RWE initiatives”. She suggests that it “marks a fundamental shift towards ensuring that medical devices remain safe, effective and trusted throughout their life cycle “by integrating technology that allows for ongoing analyses in real time”.
“Proactive, data-driven surveillance lets us detect safety-related signals early to monitor and fine-tune device performance in real time, a fundamental shift from simply reacting to problems,” she adds.
“By harnessing IoMT data, health records and patient registries, regulators can continuously safeguard patients while simultaneously unlocking new opportunities for device innovation.”
“By harnessing IoMT data, health records and patient registries, regulators can continuously safeguard patients while unlocking new opportunities.” Dr Brandi Niemeier, New Anglia University
Global differences
Also in the US, John Ziobro has worked in the medical devices field for 40 years. To name a few areas, this has seen him focus on engineering, document control, manufacturing and regulatory. A consultant for the past 16 years, he feels that the post-market surveillance (PMS, as defined in EU regulation) requirements that stem from Article 83 of the EU MDR have been “a burden without much benefit”. Ziobro’s global outlook has alerted him to varying attitudes between those in the EU and the rest of the world. “Most of my EU clients have added one to two people to manage the paperwork, while most of my non-EU clients have left the market. I’m unaware of a single design change that has occurred due to PMS
22
The future for the industry Botha predicts that consumer medical brands, such as Apple and Samsung, will “step up and become more valuable”. He also thinks there will be incumbent device manufacturers needing to change their approach to innovation, that “now span multiple device stakeholder communities without compromising quality and efficacy”. Meanwhile, according to Davidson, it’s unsurprising that more sophisticated analytics would make their way into actual investigations and analysis. “The use of enhanced analytics will likely identify potential outliers more quickly, allowing regulators to take action sooner,” he expects. “That can also help the providers, since the universe of claims at issue could be smaller, potentially making the claims easier to defend.”
“A system similar to the EU MDR Article 83 would be interesting. Post-market data could open up a whole new level of whistleblower, based on information collected by a device manufacturer,” continues Davidson.
Analytics and AI are also becoming increasingly prominent within healthcare, and Davidson personally thinks that these can act as beneficial tools to both healthcare providers and regulators. However, he warns all parties to be careful to not blindly rely solely on data and instead prioritise clinical judgment and human regulatory analysis.
Cross-borders
Some US-based medical technology manufacturers, such as Chicago’s Novian Health, are currently in their early stages of commercialisation in Europe. This entails aspects such as signing up distributors and scheduling demos. However, Novian Health’s VP of operations, Eugene Bajorinas, shared that the company does have post-market clinical follow-up and PMS plans. These include a registry to track longitudinal outcomes, and it is looking forward to collecting the real-world evidence.
All in all, it appears that whether they’re based in the US, EU or even elsewhere, regulators and manufacturers are attuned to such a shift in surveillance. Having a significant impact across the industry, it’s evident that a lot has changed in the past decade or so. And owing to a rapidly changing sector and new technologies in tow, it seems likely that more changes will soon follow suit. ●
www.medicaldevice-developments.com
Tada Images/
Shutterstock.com
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