In this episode, “Harnessing the Innovation Roadmap for Wearable IoMT Solutions – Part 2,” join Chris Montalbano, Co-Founder of MIDI, concludes the journey through the INNOVATION ROADMAP™ for Medical Device Development by focusing on Stop 3: Commercialization & Implementation. Previously, Chris provided a comprehensive overview of the roadmap and explored the first two stops, which do not require FDA-QSR and ISO-13485 compliance but set the stage for the critical third stop.
Episode Highlights:
- Recap of Innovation Roadmap Gate 1 & 2: Review the initial stages of the Innovation Roadmap, emphasizing activities that create a quality feedback loop and mitigate risks in preparation for commercialization.
- Commercialization & Implementation (Gate 3): Dive into the detailed steps of this phase, which requires compliance with FDA-QSR and ISO-13485 standards. Chris explains how MIDI's DevelopmentDNA™ process ensures each step aligns with these regulatory requirements.
- Step-by-Step Process: Explore the essential components for a successful commercialization and implementation strategy, including:
- Plans: Crafting strategic plans to guide the commercialization process.
- Requirements: Defining and managing product requirements to meet regulatory and market needs.
- Risk Control: Implementing robust risk management practices to ensure product safety and compliance.
- Design Inputs: Establishing comprehensive design inputs based on regulatory standards.
- Verification & Validation: Conducting thorough verification and validation to ensure product compliance and readiness for market.
- Engineering & Commercialization: Integrating engineering activities with commercialization efforts to effectively bring the product to market.
Why Listen?
This episode is essential for medical device developers, regulatory professionals, and industry leaders looking to understand the critical steps required for successful product commercialization. Chris Montalbano offers valuable insights into navigating FDA-QSR and ISO-13485 requirements, ensuring that your product is market-ready and compliant with regulatory standards.
Be at the Forefront of Medical Device Innovation
Stay ahead in the medical device industry by mastering the detailed steps for Commercialization & Implementation, aligning with FDA-QSR and ISO-13485 to achieve market success.
Listen Now
Tune in to explore the final phase of the Innovation Roadmap™, gain a deep understanding of the commercialization process under regulatory standards, and ensure your medical device is ready for market with expert guidance from Chris Montalbano.