Episodi

  • 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 min
  • 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 min
  • 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 min
  • Ep 1 Series 11 | Navigating Human Factors & User Interface Design, The Overview

    Ep 1 Series 11 | Navigating Human Factors & User Interface Design, The Overview
    Feb 5 2024
    Dive into the realm of innovation with us in our inaugural episode. Our expert, Greg Montalbano, unfolds an insightful, executive-level narrative, spotlighting the pivotal role of Human Factors & Usability Research in medical device development. Discover why Human Factors Engineering (HFE) and Usability Research aren't just buzzwords, but essential pillars in medical device creation, especially under the meticulous eye of the FDA. We delve into the intricate dance of balancing the three major components of medical device development: the Device Users, their Use Environments, and the User Interfaces. But that's just the beginning! 🌐 Greg is set to guide you through the labyrinth of Human Factors Engineering specific to Medical Devices in each upcoming episode. Each session promises to enrich your understanding with his extensive expertise and unique insights. 🔍 Stay Curious, Stay Informed Don't miss out on this opportunity to gain unprecedented access to a wealth of knowledge in Medical Device development. Tune in, get inspired, and stay ahead in the ever-evolving field of medical innovation.
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    24 min
  • Ep 5 Series 10 | CAR T-cell Therapy Production; Regionalized Point-of-Care Approach

    Ep 5 Series 10 | CAR T-cell Therapy Production; Regionalized Point-of-Care Approach
    Aug 3 2023
    Step into the captivating world of cutting-edge cancer treatment in this episode unraveling the mysteries of CAR T-cell therapy, exploring its potential to transform the lives of cancer patients and the pivotal role that Point-of-Care (POC) manufacturing plays in making this groundbreaking therapy accessible and affordable to a larger population. In this technical and engineering-focused episode, Chris Montalbano, MIDI CEO, unveils MIDI's pioneering journey in developing an automated instrument with a contiguous disposable kit for the fabrication of autologous CAR T-cells. Departing from the conventional centralized manufacturing approach, this innovative automated system aims to condense the entire "vein-to-vein" workflow into a seamless and efficient process, eliminating the need for multiple instruments, cleanroom facilities, and large teams of technicians. Throughout the discussion, the challenges and regulatory aspects of POC manufacturing are tackled head-on. Chris sheds light on the need for a point of care regulatory framework that ensures the same level of safety and compliance as centralized manufacturing, highlighting the steps MIDI is taking to meet these requirements. This democratization approach to CAR T-cell therapy will significantly impact patient care. By cutting costs, shortening manufacturing timelines, reducing contamination risks, and improving treatment outcomes, the automated closed-system instrument with disposable set presents a revolutionary solution that aims to cater to a larger patient population. Tune into episode 5 and dive into the fascinating world of cancer treatment advancements and MIDI's pivotal role in shaping the future of CAR T-cell therapy. Learn how this breakthrough approach is set to transform the landscape of cancer care, bringing hope and healing to millions of lives.
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    11 min
  • Ep 4 Series 10 | CAR T-cell Therapy Production & Treatment, Instituting Democratization

    Ep 4 Series 10 | CAR T-cell Therapy Production & Treatment, Instituting Democratization
    Jul 24 2023
    MIDI explores the current landscape of CAR T-cell therapy manufacturing and its impact on patient treatment. MIDI's CEO, Christopher Montalbano, sheds light on the challenges posed by the centralized manufacturing approach and delves into the promising alternative: Point-of-Care manufacturing. Chris breaks down the centralized manufacturing workflow for autologous CAR T-cell therapy, emphasizing the collection of T-cells from patients, their transportation to a centralized lab for genetic manipulation and cell expansion, and the subsequent infusion back into the patient. While highlighting the benefits of this therapy, he unveils the critical issues arising from the current centralized approach, such as limited access, manufacturing constraints, high costs, labor-intensive processes, and the need for specialized facilities. Tune into this episode and explore the paradigm shift toward Point-of-Care manufacturing, an approach that can revolutionize CAR T-cell therapy by bringing manufacturing and treatment to the patient's care site enabling commercial-scale production and economies of scale reducing costs, shortening manufacturing timelines, minimizing contamination risks, and preserving cell quality. Tune in to this episode and join the journey toward democratizing CAR T-cell therapy.
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    13 min
  • Ep 3 Series 10 | Effectiveness of CAR T-cell Therapy

    Ep 3 Series 10 | Effectiveness of CAR T-cell Therapy
    Jul 10 2023
    In this episode, MIDI's CEO, Christopher Montalbano, takes us on an enlightening journey into the world of CAR T-cell therapy, sharing invaluable insights into the effectiveness of CAR T-cell therapy against different types of cancer. CAR T-cell therapy exhibits greater efficacy in hematological malignancies like leukemia and lymphoma, while its impact on solid tumors is more limited. Christopher explains that the challenging nature of solid tumors, with their embedding in tissue and the presence of a hostile microenvironment, poses significant obstacles for CAR T-cells to penetrate and effectively combat the cancerous cells. Moreover, the heterogeneity of solid tumors, where different cancer cell types vary in their response to treatment, further hampers the therapy's effectiveness. Christopher highlights the ongoing efforts of researchers to overcome these obstacles and enhance the efficacy of CAR T-cell therapy against solid tumors. He discusses exciting approaches such as engineering CAR T-cells with multiple receptors to enhance recognition, modifying them to improve trafficking and infiltration into tumors, and even exploring alternative delivery methods for precise targeting. Don't miss this thought-provoking episode as we uncover the future of CAR T-cell therapy, bringing us one step closer to revolutionizing cancer treatment.
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    6 min
  • Ep 2 Series 10 | How CAR T-cell Therapy is Produced

    Ep 2 Series 10 | How CAR T-cell Therapy is Produced
    Jun 20 2023
    After our Episode 1 overview detailing various alternative types of cancer treatments, it appeared that CAR T-cell therapy is the treatment that looks most promising from multiple viewpoints. In Episode 2, How CAR T-cell Therapy is Produced & Achieve Efficacy, with Format Types Advantages/Disadvantages, we learn more about how CAR T-cell therapy works by targeting cancer cells while sparing healthy cells. Listen to Episode 2, "How CAR T-cell Therapy is Produced & Achieve Efficacy, with Format Types Advantages/Disadvantages".
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    16 min