practiceThe report of the ENVI workshop on the Effectiveness of Medicines and Therapies is an interesting read from medical devices perspective: Typically the regulatory developments in medicinal products precede and therefore can predict upcoming trends for medical devices, and the report addresses the relevance of clinical effectiveness, i.e.  efficacy in real-world circumstances. The latter being particularly of interest as much of the clinical evidence for medical devices is collected in studies after marketing authorisation: Exactly the setting in which to gather effectiveness data.

Regulatory trends

Regulatory developments in medicine tend to be ahead of the ones in medical devices. Therefore trends in the medical device environment can be predicted by watching the ones in medicine. One only needs to check where the EU Medical Device Directive is heading: the current proposed version with its amendments is looking for clinical data on efficacy preferably obtained through randomised controlled trials (RCT) before marketing approval.  A situation which is standard for new medicines – where the product during development typically passes several clinical research phases before market authorisation, with a RCT in phase III – but is new for medical devices.

From the report it is clear that clinical product effectiveness will be more in the spotlight than before, and not just for medication. In fact in the discussion Boehm stressed that

“The European Committee is committed to ensure that all such evaluations – i.e. review of effectiveness of therapies – focus not only on drugs but also on medical devices and health interventions.”

Product effectiveness

The report describes how the understanding of clinical effectiveness of medicines has developed since 2005, and that there is an increasing need

“to identify the most valuable medicines, both in terms of clinical efficiency and cost-effectiveness”.

This to be able to meet the ever increasing demand due to a growing population, but also to guard patient safety after a product received market authorisation: Using a product in a real world setting typically leads to reduced safety and efficacy due to a greater variability.

When adding the need for long term clinical safety data for implantable medical devices, due to limited premarket data, it is clear why product effectiveness should be taken into account when developing clinical evidence plans.

Opportunity for Medical Devices

Clinical effectiveness data are collected in postmarket studies. This is challenging for the pharmaceutical industry as the premarket clinical investment in a drug is huge – fund as well as time wise – and the time left to benefit from it after market release is short due to expiring patents and competing generic medicines. In Europe, however, the premarket clinical efforts for medical devices are much less as they do not follow the premarket authorisation phases as described above, and much of the clinical evidence is collected in postmarket studies. In other words the setting and experience is already present and ‘only’ needs optimisation by ensuring that the right safety, effectiveness, and efficiency parameters taken are into account.

A serious threat in that respect may well be the call for comparative effectiveness: When the European Medical Devices Regulation is approved in its current form it would mean that for especially the higher class of devices RCTs are needed before as well as after market authorisation. In such case medical devices are facing the same dilemma as medicine, and one may start wondering who will pay the price in the end, but also whether proof of efficacy has priority over effectiveness as was also questioned in the ENVI report in the context of Complementary and Alternative Medicines (CAM).


Clinical evidence needs for new medication and therapies is developing in a direction that offers an interesting opportunity for medical devices in Europe: Effectiveness studies are more common in medical devices than in medicine, and one should seriously consider maximizing this effort by adding the right efficiency parameters as

“Efficiency, efficacy and effectiveness” are becoming the watchwords of the debate over healthcare systems”.

Please feel free to contact me if you want to exchange thoughts on the above.


About Annet Muetstege

My name is Annet Muetstege and I am a clinical research expert, based in The Netherlands, with over 25 years of experience in all aspects of clinical evidence planning and execution especially in medical devices. I am the co-founder of Applied Clinical Services.
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