Regulations within digital health are a burden. Or are they?

Regulations within the medical device sector apply to both startups and large corporations. And while large corporations have a regulatory affairs department with sometimes dozens of highly experienced experts on hand, startups do not have those resources.

In particular within the EU, this challenge is currently exacerbated by the transition to the medical device regulation (MDR) and its increased number of requirements. Despite having more resources, even established companies struggle with unique device identification (UDI), the uncertainty around Eudamed, and an increased need for clinical data. In addition, organizations need to comply with applicable standards for their products and processes. Digital products add the topics of data privacy, information security, cybersecurity and data exchange. If your device includes an artificial intelligence algorithm, well…then there is not much guidance on how to properly include this in the regulatory process. This increased complexity and lack of guidance causes uncertainty in the entire MedTech space and especially for startups.

I recently heard someone say that regulatory affairs is “not rocket science”. And I completely agree. But, with that said, the requirements and their respective regulation and/or guidance documents can easily pile up to a few hundred or even a thousand pages. A startup cannot and should not navigate this complex regulatory landscape on its own. Startup teams need to find a good balance between in-house regulatory expertise and strategic partnerships to manage the complexities.

Timing is especially important. You should work alongside all internal and external stakeholders as early as possible to set up a concise regulatory strategy.

This includes input from medical professionals to ensure you develop a product that really benefits physicians and/or patients and blends in existing healthcare workflows. A robust, but manageable, process landscape should be set up. This should include risk management, software development, usability engineering, and clinical evaluation, just to name a few. You need to make sure that this landscape fits the individual needs of your company and is not a generic one-size-fits-all solution, as this might delay the time to market and company progress. The prevailing attitude is that these processes place an undue burden without providing any benefit. However, when done alongside the product development, following these processes can lead to a streamlined development process that:

  1. Incorporates all regulatory and stakeholder requirements right from the start
  2. Reduces the need for costly product changes at the end of the product development cycle due to missed user or regulatory requirements
  3. Reduces usability errors and improves risk mitigation

Regulatory experts need to make sure that all stakeholders understand that regulatory requirements are not a pain but add value to the entire product lifecycle and ensure patient safety.

I believe that a good regulatory strategy makes all the difference for a medical device startup. However, such a strategy requires regulatory experience which might not be available or expensive.

What I’ve seen lately especially among startups, is a new, increasing tendency to share regulatory knowledge and experiences openly, which I think is amazing. Hopefully, this allows more and more startups and small companies to navigate the regulatory landscape while focusing on innovation and driving change in the medical device sector for the benefit of patients and physicians.

I believe that companies with the best ideas and the best products that improve our healthcare system and the quality of life for patients should be successful. Success should not be limited to those with the most regulatory knowledge.



This post is presented by Orbit Health. Orbit Health is committed to enabling early intervention and personalized care of chronic disease through digital biomarkers and AI solutions.

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