Being a startup, time and optimal use of resources is of the essence. Health tech startups don’t have the luxury to do many trial rounds with their design. Therefore, a clear view of the regulatory requirements is critical for their success.
Causalus is a digital application developed to optimise the use of medication and minimise their potential adverse effects.
“In the big picture we aim to solve the severe societal and economic challenges caused by inappropriate polypharmacy, costing $100b’s annually in health expenditures. Since our target was to improve the safe use of medicines, it was clear that patient safety was the highest priority in designing the software. This meant we needed to have our software development, risk management and clinical evaluation processes in top shape upfront. Aside from setting up a proper Quality Management System according to the globally recognised ISO 13485 (QMS), ISO 14971 (Risk Management) and IEC 62304 (Software Life Cycle) standards, we needed to scan the European MDR and other global regulations for detailed requirements related to the safe and efficient application of medical device software in the clinical setting.” describes Panu Engelvuori, the COO and Quality Manager of Causalus.
Regulatory compliance is a typical struggle for a lot of startups. Causalus understood this and found it imperative for proper market entry that their team has a strong understanding of the requirements. They were trained to the regulatory essentials by Lean Entries and scanned the requirements relevant to their software from Entries, the digital regulatory tool, starting from the qualification and classification of medical device software.
“With the combination of services from Lean Entries, we were delighted to have a speedy start. Now, when our Causalus application is CE-marked, we appreciate even more how the seemingly complex regulations and standards were presented in the most simple and usable format. It was easy to dive into the details and focus on the pain points when the basics were clear and made sense. Without a doubt, gaining this knowledge efficiently, we were able to avoid the typical roadblocks and the savings in our time were counted in months.”
Causalus opted for regulatory coaching, whereby they create most of the needed documentation by themselves, always having an expert from Lean Entries to review and discuss the items. Panu concludes:
“We could’ve been faster by giving more responsibility to our consultants. But, in our case coaching has proven to be the most flexible and rewarding solution, making the foundation of our startup strong; now we have the essential quality management and regulatory know-how in-house, which also brings credibility, especially in the eyes of corporate customers.”
Ilona Santavaara, regulatory affairs and quality assurance expert from Lean Entries added:
“It has been rewarding to work together with the Causalus team because they are highly motivated, and the idea behind their product is great.”