MIDI Innovation Vault By cover art

MIDI Innovation Vault

By: Christopher Montalbano
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  • Summary

  • Welcome to the MIDI Innovation Vault(TM) Podcast! MIDI is an award winning strategic turnkey, FDA and ISO compliant product development consulting firm with over 45 years experience servicing domestic and international clientele representing medical, life sciences, and home healthcare markets. Our multi-disciplined, talented group achieves innovative results within rapid time lines under stringent regulatory constraints. MIDI's dedicated teams of research, design and engineering professionals offer a unique combination of talent and experience, consisting of key personnel working together with a record of outstanding achievement in developing Class I, II and III products. Our proprietary DevelopmentDNA™ approach to product development provides clients with a distinguished thoroughness in securing product results that answer market needs and increase sales as well as market share. From the first idea to the last detail, we balance technical information with strong orientation toward user-driven design solutions. Our disciplines blend all technical/IP and human requirements. This combination is maintained with a proper balance of research methods, design, engineering, cost-effective implementation, manufacturing knowledge, DFX, regulatory compliance, and the wherewithal to use the aforementioned disciplines in concert.
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Episodes
  • Ep. 4 Series 11 | Recommended Principals and Practices of Human Factors Engineering

    Ep. 4 Series 11 | Recommended Principals and Practices of Human Factors Engineering
    Mar 18 2024
    In this conclusive installment we explore the intricacies of AAMI HE75:2009 and its implications for medical device development. As you know, the FDA, AAMI, and the entire medical device development community are steadfast in their commitment to prioritizing usability research, human factors, and device ease-of-use. This commitment has led to the continuous evolution of standards and guidance documents, with AAMI HE75:2009 standing as a cornerstone in this landscape. During Episode 4, we meticulously dissect this guidance document, offering invaluable insights into its usability research and development methodologies. Our aim is to empower medical device developers with the knowledge they need to craft well-designed, safe, and effective medical devices that align with FDA regulations. This episode provides an opportunity to gain a deeper understanding of the principles and practices that underpin human factors engineering, ultimately driving innovation and enhancing patient outcomes.
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    27 mins
  • Ep 3 Series 11 | Human Factors Regulatory & Guidance Standards for US Submission

    Ep 3 Series 11 | Human Factors Regulatory & Guidance Standards for US Submission
    Mar 4 2024
    This episode specifically covers topics as related to the various organizations and regulatory bodies as well as standards and guidance documents to utilize for proper usability research and human factors engineering processes during medical device design and development. Learn more about: • What organizations have issued United States Regulatory and Guidance documents for Human Factors as related to medical device development. • The U.S. Standards and Guidelines that apply to certain medical devices types. • Organizations and their issued international regulatory standards of human factors for medical devices, of which are recognized by the FDA and the AAMI.
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    33 mins
  • Ep 2 Series 11 | Understanding FDA Perspectives on Medical Device Development

    Ep 2 Series 11 | Understanding FDA Perspectives on Medical Device Development
    Feb 12 2024
    In this episode, titled "Understanding FDA Perspectives on Medical Device Development" we embark on a comprehensive exploration of FDA perspectives alongside Greg Montalbano, Co-Founder of MIDI. Greg takes us on a comprehensive journey through FDA perspectives on Human Factors and Device Development, covering essential topics such as: - The FDA's concern regarding Human Factors Engineering and Usability - Expectations for medical device developers from the FDA - Real-world examples of medical device Human Factors Engineering relative to hazards, risks, and user-related causes This episode provides listeners with invaluable insights into the significance placed by both the FDA and MIDI on Usability Research and HFE quality processes. By understanding these crucial aspects, developers can ensure the creation of safe and effective medical devices that align with regulatory standards. Listen to MIDI’s HFE MedTech Podcast Episode 2! Don't miss out on this enlightening discussion—tune in now to gain a comprehensive understanding of FDA perspectives and the importance of Usability Research in medical device development!
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    12 mins
Economics
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