Less than 5% of health technology innovations are successfully integrated and adopted in a true clinical setting. This is the hard truth about the Medical Technology field. How can medical device companies better manage their regulatory risk and improve their probability of success?

In this live on site seminar presented as an adjunct to the Advamed Medtech Conference 2024, on October 15th 2024 in Toronto, Canada, Marc Saab – Founder and Managing Partner of BML Health – provided an introduction to key concepts in Medical Device Regulatory Affairs (RA) and Quality Assurance (QA), as well as Clinical Workflow Integration as part of go-to-market strategy and planning to give MedTech startups and established companies the best chance at true clinical adoption.

Seminar Objectives:

• To better equip founders to establish medical device product development and validation strategies with appropriate QA/RA considerations incrementally and at the right stages, before they become hurdles in the best case, and detrimental missteps in the worst.
• To alert founders to real go-to-market challenges early on, so that expectations can be managed and appropriate strategies can be in place to mitigate risks at every stage of development.

In support of these goals, three real world case studies were presented and discussed with the group.
To view the complete presentation please click here.

This seminar was designed specifically for early and mid-stage MedTech startups, to clarify key concepts and to help founders develop preliminary strategies that can evolve as their businesses do.  Specific strategies for regulatory risk management, stepwise quality assurance development, and reaching incremental milestones with the FDA were presented.  

Beyond regulatory approval, the integration of health technology innovations into the infrastructure of an existing clinical environment is complex, requires the collaboration of several key stakeholder groups, involves change management and risk management, and differs significantly between clinical organizations. Overlooking or misunderstanding these factors has led companies – startups and established companies alike – to fail in market adoption and add significant costs and delays to their go-to-market strategies, long after clinical validation, regulatory clearance and reimbursement have been achieved.

Marc Saab is a passionate business leader with over 25 years’ experience in Medical Device and Digital Health. His expertise is in all aspects of medical device product development from conception R&D to launch, clinical validation, and commercialization, including regulatory compliance and strategic business development. 

BML Health understands the challenges faced by MedTech companies in product development, clinical validation, regulatory approval and clearance, reimbursement and market readiness and uses a lean, iterative and collaborative approach to help them successfully navigate their unique medical device development journey.

If you are facing challenges on your medical device development journey get in touch and let’s talk about it.

About BML Health
Supporting innovative Medtech companies that are shaping the future of healthcare. BML Health understands the impact of emeging 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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