Health tech startups may often run into problems when it comes to understanding the complex world of regulation when they are trying to bring a new product to the market. The Regulatory Essentials in Health Tech (REHT) training series is an excellent introduction to health tech regulation, and it helps health tech startups and university innovation teams avoid the typical pitfalls of the health tech sector.
The REHT series consists of 14 webinar sessions, 2,5h each. The sessions cover all stages from the birth of a medical device or in vitro diagnostic innovation to market access and post-market surveillance.
We asked regulatory experts and trainers Heikki Pitkänen and Karri Airola to tell us more about the training series. Read what they had to say below!
Q: Can you tell me something about the background of the training series? When was it started and why?
A: The training series of Regulatory Essentials for Health Tech was first designed for startup and researcher communities in 2019 to provide a horizontal overlook of the regulatory basics throughout the life cycle of a medical device. The aim is to provide this information as early as possible to enable months’ worth of time savings for startups on their way to the market. The training series has been connected to the digital Entries services from the start, together enabling a steep learning curve regarding compliance which is a typical burden for newcomers and requires substantial resources to tackle.
Q: How has the series developed over the years?
A: The very basics, the first four sessions, have remained quite the same. The first task is always to familiarize the startups or researcher teams with the basic terminology and jurisdiction and to give an overlook of how regulatory compliance connects with developing a business. Over the years we have added several special sessions to overarch the entire lifecycle of a medical device all the way to post-market activities. The last additions have been specific sessions for in vitro diagnostics, US FDA and the Person Responsible for Regulatory Compliance (PRRC). At the same time, the contents of the digital Entries services have evolved to cover more early advice and a personalized draft of a Regulatory Strategy for the startup.
Q: Have there been any specific changes? Has the training always been online, for example?
A: When we started the training in 2019 it was first a live two-day event. When the Covid-19 pandemic forced us to make it an online event, we decided to transform it into a series of webinars that would be easy to digest for startups and give them the freedom to focus on sessions that serve their needs. With an online series, we’ve been able to reach startup communities in various locations internationally. The biannual cycle of the training series and the on-demand option through recordings now makes it accessible to anyone at any time with the latest knowledge on regulatory essentials.
Q: Who would you recommend the training for?
A: At a minimum, the key personnel of startups: the founders, designers, regulatory & quality managers and supply managers. In universities, the entire research-to-business team. When they plan to bring a new device to the market, they should make themselves aware of how regulations affect their business from the early days of innovation to market access and beyond. And even further, how to make regulatory compliance their competitive advantage. The training series also offers an excellent package for the more mature health tech companies who’d like to upgrade the basic regulatory knowledge of their employees. Business advisors and tech transfer officers are frequent attendees.
Read more about the training series >>
Or get in touch with us!
Heikki Pitkänen
CEO & Founder, Lean Entries - Senior Expert, Regulations & Quality
heikki.pitkanen@labquality.fi
Karri Airola
Senior Expert, Regulations, Quality & Training
karri.airola@labquality.fi
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