Our Urisens project at Aalto University is developing a diaper embedded biosensor platform that screens abnormal clinical conditions. We are a Business Finland funded research-to-business project, one among the acclaimed SPARK Finland program. In my career, I’ve been a university researcher and professor with a doctor of science degree and in industry I’ve held project and business development responsibilities in some of the largest health tech companies globally. In my academic and industry roles I didn’t need to understand the details of regulatory compliance, although I noticed the importance.
Now that I am working on transforming research innovation into business I have come to realize that in depth knowledge on regulatory compliance becomes key. As a SPARK Finland project we’ve enjoyed the access to Entries and the Regulatory Essentials in Health Tech series of webinars.
These tools are a fast track to understand what regulations mean to health tech business and how they entangle with every phase of product realization.
We’ve learned, for example, that the foundation of clinical evaluation and risk management shall be laid at the earliest stage of the process to cut significant amounts of time in reaching the market and to optimize the outcomes of these processes in supporting our goals in healthcare.
Before exploiting these regulatory tools I was daunted by the complexity of regulatory compliance. Now I feel relief and understand how our project can harness regulations and standards to our benefit and avoid the regulatory pitfalls.
The Entries tool is very effective in transmitting knowledge. I have experienced nothing comparable to it as an educational hands-on application. I’ve certainly saved weeks worth of my time in reaching this new level of regulatory knowledge and find confidence in moving forward.