Imagine if all pharmaceutical companies had to re-apply for approval of all existing drugs. Crazy as it seems, this is what is happening in the medical devices space.
Ivanna and Sam speak to Jon I Bergsteinsson, founder of Smart-Trial by Greenlight Guru. We speak about the state of clinical trials in medical devices - and the increased diligence required by the med MDR regulation by EMA.
One of the ways medical devices differ from drugs is that it is mostly physicians and clinicians who have been interested in expanding their use for novel applications - and could do that though proving equivalence to existing devices in investigator-led trials.
With the new medical device regulation, that tendency is up for a revamping. Manufacturers of medical devices need to be able to have access to the data used to support a submission for regulatory approval. This means medical device companies are essentially being forced to conduct sponsor-led trials on their medical devices. Both the ones that are currently being developed - but also the ones that are already on the market.
“The clinical research in medical devices is now being transformed to focus more on submission-level research, which we have seen in the pharmaceutical space for decades.”
This radical change was sparked by a number of incidents in the medical devices space impacting patient safety - such as the PIP silicone breast implants scandal, where non-medical grade silicone was used.
The increase in requirements means that medical device companies will need to spend more on clinical research - and ultimately be funded better. But in some ways medical device companies have been ahead of its pharmaceutical cousins. For example patient reported outcomes have been a source of clinical data in medical devices since their inception - given the fact that often these are used by the patients themselves.
Guest:
Jon I Bergsteinsson: https://www.linkedin.com/in/joningib/
Smart Trial: https://www.smart-trial.com/overview
Greenlight Guru: https://www.greenlight.guru/
Notes:
The new EU MDR regulation: https://eumdr.com/
Medical device classification: https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device
PIP breast implants case: https://www.nhs.uk/conditions/pip-implants/
Medtech Europe: https://www.medtecheurope.org/
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