The year 2012 has been turbulent for the Medical Device Industry in Europe, with the  lagging economy, but also with the scandals over the breast and hip implants, and Notified Bodies showing malpractices. These scandals resulted in an enhanced speed with which the new proposal for the Medical Device Directive came out in September, but also in the French Breast Implant Company’s  bankruptcy and governments facing cost related to explantation and replacement, a continuing flood of lawsuits against hip implant manufacturers, and a negative image and lagging sales for Medical Device Industry.

With this in mind, I wonder why Medical Device Companies are not pro-actively investing in a clinical trial program as opposed to waiting until a revised MDD imposes a more strict clinical program?

Clinical Trial Scenario’s
To identify possible long(er) term safety effects, clinical trial scenario’s you can think of are a pre-market study or a post-market observational study in line with MEDDEV 2.12/2 rev2.
The first option will provide you the required safety information as well as clinical data for additional product claims at market release, but will also delay market release with several years and require substantial funding. Such scenario would therefore result in a substantial delay of the patients access to an innovative medical technology and an increased product price.
The second scenario, a post-market observational study or registry, will allow you to bring your product to the European market years sooner while also proactively monitoring for long-term safety issues and timely intervention when needed. When adding other health economic parameters besides safety, it will also help build your clinical evidence base for publications and additional product claims along the way and thereby support sales. Funds needed for such project will depend on many elements, but when kept simple to my opinion will be far less than 10% of the cost related to lawsuits, explantations and replacements, and reduced sales, and then I am not even reflecting on the harm done to the patients involved.

To me it seems there are cost-effective tools available to Medical Device Industry, that will be called upon by the European regulatory bodies in light of the recent scandals and the renewed MDD as Erik Vollebregt already stated in one of his early blogs on this topic. In fact the FDA already ordered for such postmarket surveillance studies for the metal-on-metal hip systems in 2011 and for surgical mesh implants in 2012. Therefore I wonder why you, being a medical device company, would not pro-actively start a post-market observational study and contribute to improving patient safety while also stimulate sales via better product claim support and image, and save money? Any concerns I did not address in the above? If none, why not initiating a post-market observational study as your New Year’s resolution?

If you want to know more about health economic parameters to ‘pimp’ your post-market observational study, or otherwise would like to exchange thoughts on the above please feel free to contact me. You can also stay tuned with my blog as I plan to post on this topic also.


About Annet Muetstege - Visscher

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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