Software as a Medical Device: From Regulatory Strategy to Market Readiness

Join MIDI in this webinar discussion about how bringing Software as a Medical Device (SaMD) to market requires more than developing innovative technology. Regulatory strategy, software development, risk management, and commercialization planning need to work together from the beginning. In this webinar, Gregory Montalbano, Founder of MIDI Medical Product Development, will provide a practical framework for developing SaMD products with regulatory requirements built into the development process rather than addressed after the software has been created.

Attendees will learn how to:

• Integrate regulatory requirements into software development using FDA expectations, IEC 62304, risk management, cybersecurity, and design controls as part of the development lifecycle.
• Determine the most appropriate FDA pathway by understanding intended use, device classification, predicates, 510(k), Third Party 510(k) Review, De Novo, and when FDA interaction may be valuable.
• Create submission-ready documentation as the product evolves, reducing the risk of costly DHF gaps, redevelopment, and delays later in the program. • Connect regulatory strategy with product and business strategy so development, clinical evidence, FDA milestones, funding, and commercialization objectives remain aligned.
• Reduce regulatory uncertainty early by identifying the decisions that can have the greatest impact on development cost, schedule, and market entry.
• Rather than treating regulatory compliance as a final hurdle before submission, this session will demonstrate how a well-planned regulatory strategy can become an integral part of product development and a powerful tool for reducing risk. Whether you are developing your first SaMD product, preparing for an FDA submission, or refining the strategy for an existing digital health platform, this webinar will provide practical insights for moving from innovation toward commercialization with greater clarity and confidence

Date: Wednesday, September 16, 2026
Time: 12:00 PM – 1:00 PM ET
Location: Online

Meet the Speakers

Gregory Montalbano, COO & Co-Founder, MIDI Product Developmemt

Greg has more than 30 years of experience developing medical and life science products, with a multidisciplinary background spanning digital and industrial design, software-driven product development, UI/UX, usability, human factors, ergonomics, regulatory design controls, and commercialization. His experience provides a unique perspective on the growing convergence of software, connected technologies, and traditional medical device development.

Greg co-pioneered MIDI’s integrated DevelopmentDNA™ process, the firm’s innovation engine for advancing medical technologies from early concept and user needs through design controls, development, verification and validation, regulatory readiness, and commercialization.

As a hands-on director, Greg works with MIDI’s multidisciplinary teams and clients to translate innovative technologies into commercially viable medical products and Software as a Medical Device (SaMD) solutions. He has authored or co-authored more than 50 design and utility patents and is an Associate Member of AdvaMed and the Industrial Designers Society of America.

Greg also serves as an advisor to several domestic and international medical technology accelerators and incubators. He has lectured at universities and industry events on medical product development, design for manufacturing, UI/UX, human factors, digital health, and the application of AI in medical technology.