Dates
Join Megalabs for expert insights on taking a medical device from concept to market, co-hosted by BioNext, Western & Western Research Parks.
Bringing a medical device from concept to market is a complex journey requiring strategic planning, rigorous testing, and regulatory compliance. This event will provide entrepreneurs, researchers, and innovators with a roadmap to navigate product development, certification, and commercialization. Industry experts will cover key topics, including Technology Readiness Levels (TRLs), product prototyping, early market fit assessment, and essential testing and certification processes such as IEC 60601 compliance.
Participants will gain practical insights from experienced professionals and have opportunities for networking and 1:1 mentorship. Priority booking for 1:1 meetings is available to businesses within Western Research Parks and BioNext. Please register for a meeting time by clicking here.
Event Agenda
Morning Session: Presentation & Discussion - 10:00 AM – 12:00 PM
Welcome & Opening Remarks
Introduction to Medical Device Development
- Understanding the pathway from concept to commercialization
- Overview of key challenges in product development
Technology Readiness Levels (TRLs) & Their Impact on Product Development
- Understanding TRLs and their role in prototyping and scaling
- Case studies of successful transitions from TRL stages
Early Market Fit & Business Strategy
- Assessing market demand and refining your value proposition
- Identifying target customers and regulatory considerations
Medical Device Testing & Certification: When & Why It Matters
- Basics of IEC 60601 electrical safety & EMC compliance
- Common certification pitfalls and how to avoid them
- Steps to prepare for regulatory approval
Midday Session: Networking Lunch - 12:00 PM – 1:00 PM
- Informal networking and discussions
Afternoon Session: 1:1 Meetings (Pre-Booked) - 1:00 PM – 3:00 PM
- Private consultations with industry experts
- Individual guidance on specific projects or challenges
Priority booking is available for businesses within Western Research Parks and BioNext. Please register for a session by clicking here.
Keynote Speakers:
Kirusha Srimohanarajah, P.Eng – Vice President, MegaStudio, Megalab Group Inc.
Kirusha Srimohanarajah is a product development expert with a strong track record of leading multidisciplinary teams and bringing complex medical technologies to market. As Vice President of MegaStudio at Megalab, she works closely with physicians and clinical teams to transform ideas into innovative, commercially viable products. Her experience includes neurosurgical tools, life support systems, and medical imaging technologies. Earlier in her career, she was part of the founding team at Synaptive Medical, where she helped develop key technologies such as Modus V and Brightmatter Guide.
With over 16 granted patent families and extensive international experience across North America, Asia, and the Middle East, Kirusha combines deep technical knowledge with global business strategy. She is also a dedicated educator, frequently guest lecturing at institutions including the University of Waterloo and University of Victoria, where she was recently named Employer of the Year. Currently, she is completing her MBA at Johns Hopkins University, specializing in Healthcare Management, Innovation, and Technology.
Vince Hamilton – Quality Engineering Director, Megalab Group Inc.
Vince Hamilton has over 30 years of experience in business development, product management, and quality engineering within the medical, biotech, and scientific instrumentation sectors. His expertise spans quality management systems (QMS), regulatory compliance, and product lifecycle management. He has worked extensively with mass spectrometers, biosensors, and diagnostic equipment, bringing invaluable knowledge in testing, compliance, and product strategy. Currently, Vince is focused on supporting startups and established companies in meeting stringent regulatory requirements and achieving market success.
David Bell – Partner & Sales Manager, Megalab Group Inc.
David Bell is a regulatory compliance expert specializing in EMC, electrical safety, and environmental testing. As a Partner and Sales Manager at Megalab Group Inc., he has helped numerous companies navigate complex international certification processes to launch their medical and laboratory products successfully. David’s experience in medical device testing and market access strategies makes him a key resource for innovators seeking to commercialize their technologies.
About Megalab
Megalab provides accredited testing and compliance solutions for medical, biotech, and scientific instrumentation companies. Their services ensure products meet international regulatory standards, facilitating a smoother path to market entry.
About BioNext
BioNext is a MedTech incubator focused on accelerating the translation of early-stage ideas into commercial innovations. BioNext offers access to infrastructure, prototype manufacturing, testing, and preclinical services, supporting entrepreneurs as they bring groundbreaking MedTech solutions to market.
Western Technology Transfer Office, Western Innovation and Strategic Partnerships
Western's Technology Transfer Office (WTTO) is your gateway to turning groundbreaking research into real-world solutions. The office works closely with researchers and inventors to navigate the commercialization journey. WTTO's mission is to amplify Western's research and foster innovation that addresses local, national, and global challenges by ensuring that ideas leave the lab and create tangible societal and economic impact.
About Western Research Parks
Western Research Parks is a dynamic innovation hub bridging the gap between research and industry, offering cutting-edge labs, coworking spaces, and flexible office rentals. Businesses benefit from access to Western University’s research expertise, a diverse talent pool, and a thriving ecosystem of entrepreneurs and established companies.
Photography:
Please be advised that photographs and video may be taken at Western Research Parks events for use on Western Research Parks' web, print and social properties. We won’t sell your photo, but we may share it with media and/or partner organizations. By attending this and any Western Research Parks event, you consent to being photographed and/or filmed, and to your image or likeness being used at Western Research Parks' discretion.
