The medtech startup Terraplasma Medical was in Summer 2017 still at the very beginning of the approval of a medical deviceThe founders have now finally managed to obtain approval and all the necessary certificates for their medical device. The startup's learnings are now available in an interview with CEO Jens Kirsch.
The medical device called Plasma Care can treat wounds using cold atmospheric plasma. Thanks to approval, doctors and nurses are now allowed to use the handy, battery-operated device on patients. The process for obtaining approval for a medical device is highly regulated and has been more lengthy than expected.
Approval of a medical device: Lessons learned? Challenges?
Munich Startup asked founder Jens Kirsch how he dealt with the many challenges on the road to approval. In particular, the Medical Device Regulation, the then new, EU-wide medical device law introduced in 2017, caused Terraplasma Medical problems.
Jens, what were the biggest challenges for you during the approval process?
The impact of the Medical Device Regulation is now clearly felt throughout the medical technology industry. In particular, the slow accreditation of 'Notified Bodies' (state-authorized testing centers, editor's note) leads to drastic resource bottlenecks. As a result, even the German federal government is now pushing for longer transition periods and no longer ruling out supply bottlenecks for medical devices. We naturally felt these effects directly during the approval process for our new medical device, Plasma Care. We were unable to move forward as quickly as we had hoped.
Step by step: ISO certificate, safety testing and CE conformity
What were the most important steps for you to obtain approval?
The most important step besides the certification of our quality management system according to EN ISO 13485 (The standard that specifies the requirements for a quality management system for the design and manufacture of medical devices — Editor's note) was the creation and review of the technical documentation.
In addition to a comprehensive and in-depth clinical evaluation of the Plasma Care, several safety tests in accredited testing laboratories were also necessary. These tests include electrical safety, electromagnetic compatibility, and biocompatibility.
In June, however, our notified body issued us with all the necessary certificates, allowing us to successfully complete the CE conformity assessment procedure. Plasma Care can now be distributed in Europe and used by medical professionals in treatment.
Bottlenecks worse than expected in the worst case
Is there anything that you say today: I wish I had known that back then?
The resource constraints caused by the new Medical Device Regulation will be even more severe than already assumed in our worst-case scenario. Furthermore, the extremely lengthy administrative processes in the administrations of the participating study centers must be overcome before the clinical trial can begin, meaning that contract review there could easily take six months or more.
“Take more time”
What advice do you have for other founders who want to get a medical device approved?
Especially in the next years of the transition phase of MDD (= Medical Device Directive) to MDR (=Medical Device Regulation) to plan significantly more time for technical tests and review of technical documentation than in previous years.
A critical issue for startups is that most notified bodies are currently officially no longer accepting new clients. It's best to develop your approval strategy as early as possible with an experienced quality management or regulatory affairs consultant and contact a suitable notified body, ideally one with whom you already have a contact.
Thank you for sharing your experiences.
