Lessons from a mentor: achieving regulatory compliance retrospectively is more expensive

Meet Dr Marion Lepmets, our new mentor in the Connected Health cluster. She has worked with several medical device startups on their regulatory compliance projects. How could she benefit your company?

How did the idea to be a mentor for the cluster come up?

Many medical device companies do not think about regulatory compliance challenges when they start developing innovative medical devices. Unfortunately, without compliance with the MDR, medical devices cannot get CE marked and therefore cannot be marketed in the EU.

Achieving regulatory compliance retrospectively is more expensive and difficult than focusing on it at the start and following through with it in parallel to the development of the solution/device. My aim is to inform the members of the cluster of the importance of compliance early on and provide hands-on guidance and tools that help medical device developers on their regulatory compliance journeys.

Please share some examples of your experience in the healthcare sector which could be valuable for cluster companies?

I am co-founder and CEO of SoftComply with expertise in implementing compliant Quality Management Systems (based on ISO 13485, IEC 62304, ISO 14971 and FDA 21 CFR 820) and supporting companies in medical device risk management (based on ISO 14971).

As a mentor in EIT Health as well as Startup Creasphere – a Plug and Play, Roche and Sanofi-backed European Digital Healthcare Platform – I have worked with several medical device startups on their regulatory compliance projects.

In most cases, we start by determining the classification of the device under development and thereafter focusing on the specific regulatory requirements in the markets on which the device will be released, i.e. the MDR for the EU and the FDA in the US.

You can read more about the regulatory compliance journey of one of our customers here.

You have been involved in software development for a long time: what are the main lessons learned, mistakes to avoid, and dos and don’ts for newly created startups (in health tech)?

Besides making sure that there is clear demand for your product and having a good marketing/sales strategy, I would suggest working on regulatory compliance strategy in order to understand the work you will need to put into regulatory approval of the device and the costs associated with this.