BML Health Managing Director Marc Saab was present at the OBIO Health Science Investment Summit that took place in Toronto from February 5th to 7th, 2025. It is Canada’s Premier Health Science Investment Event bringing together leading MedTech and BioTech companies with top investors in the field. More than $1.6B has been raised by OBIO Summit companies since 2018.
MedTech and digital health startups, and the investors backing them, understand that the ability to successfully navigate the industry’s complex regulatory landscape is often the deciding factor between success and failure.
If your company is facing challenges on your medical device development journey, or needs to better understand the impact of emerging technology – SaMD, AI/ML, VR/AR, Connected Devices, the Cloud – in MedTech get in touch with us.
For MedTech and digital health companies the runway is short and the cash burn is high. It’s high stakes with little room for error. We get it. Understanding regulatory risk and how to mitigate it, as well as identifying the most effective regulatory strategy and pathway for new innovations is important to both MedTech companies and investors.
Benefits to MedTech and Digital Health companies
The benefits for MedTech and digital health startups of engaging with Regulatory Affairs expert advisors early in their medical device development journey include:
- Communicates to investors that the firm understands its regulatory risk and certification pathway and is managing the process proactively.
- Helps the firm better navigate complex regulations, ensuring faster approvals, minimized delays, and a smoother path towards market entry.
- Helps avoid costly compliance mistakes, product redesigns and missed deadlines.
- Helps the firm align product design, clinical validation, and documentation with regulatory requirements.
- Helps the firm understand and address the impact emerging technologies (SaMD, AI/ML, VR/AR, the Cloud, Connected Devices) have on their medical device innovation.
- Capable Regulatory Affairs advisors will also provide insight into issues beyond regulatory compliance, such as clinical workflow integration and commercialization strategies.
Benefits to MedTech and Digital Health investors
Professional investors will also benefit from engaging Regulatory Affairs experts early as part of their investment process and due diligence, including:
- Obtaining a better understanding of regulatory risk and finding ways to mitigate it by identifying regulatory hurdles early, reducing investment risks and costly setbacks.
- Contributing to the startups meeting compliance requirements efficiently, accelerating commercialization and ROI.
- Allows investors to make better informed decisions to assess funding needs, project viability and market potential.
- An arm’s length expert opinion from an outside firm may identify issues that for whatever reason an internal process might not surface.
Whether you’re a MedTech firm seeking to create the next innovation that helps shape the future of healthcare, or a visionary MedTech investor seeking to fund the next HealthTech unicorn, it is important to understand the regulatory challenges and certification requirements the company will face in bringing the vision to reality.
As an investor, if you want to cut through the noise and help your investment portfolio companies design and execute regulatory strategy that works.
Contact BML Health today.
About BML Health
We support innovative MedTech companies that are shaping the future of healthcare. BML Health understands 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.
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