As part of BML Health’s ongoing support for the Montreal MedTech ecosystem and evangelism of all things MedTech and Digital Health our Founder and Managing Director, Marc Saab regularly conducts informational clinics, seminars and talks addressing issues of deep strategic importance to MedTech and digital health startups.
For this purpose, Marc conducted a seminar on April 4, 2025 for the Propolys Incubator’s MedTech cohort on Critical QA/RA Considerations for MedTech and Digital Health Startups, introducing key concepts in Medical Device Regulatory Affairs (RA) and Quality Assurance (QA).
Propolys is the technology business incubator of Polytechnique Montréal, the Engineering School of the Université de Montréal. Their team offers value-added services and support to help technology startup projects progress along the road to success.
The objective of this introductory seminar is to better equip founders to design their medical device product development and clinical validation strategies while integrating the appropriate QA/RA considerations at the right stages before they become hurdles in the best case, and detrimental missteps in the worst.
Specific strategies for regulatory risk management, stepwise quality assurance development, and reaching incremental milestones with Health Canada and the FDA were presented.
The discussion prompted numerous questions and enriching exchanges. Understanding the rules of the game in the medical device regulatory environment is essential for any start-up, but in MedTech, the regulatory implications can be strategically decisive from the earliest stages.
A lack of focus on regulatory strategy for digital health startups from the start can lead to costly product redesigns and missed deadlines, ultimately placing the enterprise at risk, even MVPs should be compliant.
The session also included Sarah Lambert, a Propolys alumnus and strategic advisor to the MedTech cohort, she is also the Co-Founder of Ora Medical. Ora Medical is a Data-Driven physical rehabilitation firm developing innovative walking assistance tools and remote rehabilitation solutions.
Sarah shared her experience on how rigorous, well-integrated regulatory planning from the outset played a key role in shaping her company’s strategic roadmap. A key lesson shared is that reducing and simplifying scope is often the best Go-To-Market strategy to accelerate commercialization.
If you are experiencing challenges with your Medical Device Regulatory Strategy, or at any stage of your medical device development journey encompassing Medical Device Compliance, Clinical Workflow Integration or Market Readiness get in touch and let’s talk.
It’s never too early to consider issues of deep strategic importance to your firm.
About BML Health
BML Health supports innovative Medtech companies that are shaping the future of healthcare. We understand the impact of emerging technology in MedTech and Digital Health. Get in touch with us to learn how our iterative, lean and efficient approach to product development, clinical validation and regulatory affairs can help your organization get its MedTech solutions to market and gain adoption.
Stay Connected with BML Health.
Connect with BML Health on LinkedIn.
View BML Health MedTech insights on YouTube.
