In this episode, “Driving MedTech Innovation by Embracing Regulatory Controls,” join Chris Montalbano, CEO of MIDI, introduces the INNOVATION ROADMAP™ and explores how embracing regulatory controls can drive medical device innovation.
What You’ll Learn:
- The DevelopmentDNA™ Approach: Discover how MIDI leverages the DevelopmentDNA™ framework to seamlessly integrate FDA-QSR and ISO-13485 standards into the device development process, transforming perceived regulatory constraints into platforms for innovation.
- Changing Perceptions: Chris addresses a common industry misconception that regulatory controls and risk management stifle creativity and innovation. He reveals how these elements, when properly integrated, serve as catalysts for innovative medical device development.
- INNOVATION ROADMAP™: Gain insights into the MIDI’s INNOVATION ROADMAP, a strategic tool that aligns regulatory requirements with innovative design and development processes. Learn how this roadmap helps MIDI's engineers, usability experts, and industrial designers to meet functional, safety, and business needs efficiently.
- Quality-First™ and AGILE Development: Explore how MIDI’s Quality-First™ and AGILE product development methodologies ensure rapid execution of innovative ideas while maintaining compliance with regulatory standards.
Why Listen?
This episode provides a fresh perspective on how regulatory controls can be harnessed to fuel medical device innovation rather than hinder it. Whether you’re a developer, entrepreneur, or industry professional, Chris's insights offer practical strategies for transforming regulatory compliance into a competitive advantage.
Be at the Forefront of Medical Device Innovation.
Tune in to learn how regulatory controls can be a driving force for innovation and discover the best practices for integrating these controls into your development process. Get ready to embark on a journey that redefines the intersection of regulation and innovation in medical device development.
Listen Now and unlock the potential of regulatory frameworks to revolutionize your approach to medical device creation.