Heikki Pitkänen

Heikki Pitkänen has 16 years of experience in the medical device industry, with five of those as a team leader in notified bodies and accredited certification bodies. He is the founder of Lean Entries, Ltd., and a member of the Advisory Board for Healthcare Standards of CEN-CENELEC.    

  

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...