According to the preliminary results of a study* aimed at the Finnish medical device industry, regulatory compliance pops up as the second biggest challenge burdening the industry. This, according to the study, comes in the wake of challenges for establishing effective international distributor channels. To me, this only verifies what I have experienced working in the industry and in notified bodies. Looking more closely at medical device startups around the world, more often than not, in my experience, they have taken substantial steps to design a device or software before properly taking regulations into account. Some have determined that their product is not a medical device when in fact, it is (or vice versa). Sending those startups back to the drawing table to modify their device and procedures accordingly is tragic, especially when one can see the benefits the technology would bring for patients. Those startups face the costly and time-consuming endeavor of redesigning the device, and with it, a high potential of failure. However, diligence with regulations would have helped inform right choices from the start.
To me, the issue goes back to the time before seed funding of a startup, to the level of regulatory knowledge among its founders and investors. They may have great prospects with future clients, but as long as regulatory issues are not properly considered, a major risk for the business looms. An encouraging example from Finland suggests that venture capitalists have a growing interest in learning the regulatory basics. They have become a notable group of consumers for the regulatory digest (see website in Finnish). This digest has been produced by the Finnish Funding Agency for Innovation (Tekes) with Tom Ståhlberg of Healthtech Finland providing the contents. It is specifically designed to raise awareness concerning regulatory compliance and help medical device stakeholders take compliance issues into account from day one. Similar global digests are published, for instance, by the Regulatory Affairs Professionals Society (RAPS), based in the USA.
Such sources of condensed information are invaluable in a field where regulations, standards, and guidelines are diverse and winding. One of the issues I have found most problematic is the amount and scattered nature of regulatory information and services available. For startups, this realm of information appears as tangled as a jungle. Starting from scratch, even the basics are awkward. For example:
- Which regulations and standards are relevant to us and which are not? When are they enforced?
- What’s the deal with harmonized standards or accredited certification and what is the perception of Notified Bodies and Competent Authorities on both?
- What is the difference between design verification and validation and how do they revolve with the essential requirements, clinical evaluation, risk management, or post-market surveillance?
- If I can manage all this, and in view of other issues on the horizon, which new requirements demand compliance next year?
Consider the new requirements stipulated in the medical device regulations for a ‘person responsible for regulatory compliance’ (Article 15 in the MDR and the IVDR). These new requirements make a lot of sense. But to me, they also highlight the contrast between the amount of work and responsibility related to regulations, and the resources and knowledge available in most startups. Moreover, in practice, it is the entire organization at every level of engagement, in-house or outsourced, that should be sufficiently acquainted with the requirements and share the responsibility for their completion.
The work of the International Medical Devices Regulators Forum (IMDRF) and the Medical Device Single Audit Program (MDSAP) are great examples of a need, a vision, and active cooperation for the global harmonization of requirements. Looking further, by harnessing modern digital means, it is possible to create sophisticated regulatory services that increase harmonization and allow swift access to regulatory know-how and best practices. As a consequence, many more medical device startups will be able to break through to the market with compliant devices and services. This will bring growth for the global medical device industry and faster access to innovative healthcare.
The solution our company is developing for regulatory compliance focuses on convenience, speed, and contextual learning. It is a platform where those with years of experience concerning regulations can translate the requirements into digital paths, where those unacquainted with regulations learn the basics hands-on, and where the global regulations and compliance services make up a library to reduce the scattered nature of information.
*Health technology industry in Finland (in Finnish), University of Turku and Turku University of Applied Sciences, sponsored by the Finnish Funding Agency for Innovation (Tekes), 2017.