MIDI Innovation Vault

Mar 18 2024
MIDI Innovation Vault Podcast artwork

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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Ep. 4 Series 11 | Recommended Principals and Practices of Human Factors Engineering

Mar 18 2024 27 mins  
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 a

Ep 3 Series 11 | Human Factors Regulatory & Guidance Standards for US Submission

Mar 04 2024 33 mins  
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

Ep 2 Series 11 | Understanding FDA Perspectives on Medical Device Development

Feb 12 2024 12 mins  
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 Eng

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

Feb 05 2024 24 mins  
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 creatio

Ep 5 Series 10 | CAR T-cell Therapy Production; Regionalized Point-of-Care Approach

Aug 03 2023 11 mins  
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-f

Ep 4 Series 10 | CAR T-cell Therapy Production & Treatment, Instituting Democratization

Jul 24 2023 12 mins  
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 therap

Ep 3 Series 10 | Effectiveness of CAR T-cell Therapy

Jul 10 2023 6 mins  
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 limit

Ep 2 Series 10 | How CAR T-cell Therapy is Produced

Jun 20 2023 15 mins  
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 whil

Ep 1 Series 10 | How does CAR T-cell Therapy Compare to Alternative Methods of Cancer Treatment?

Jun 05 2023 11 mins  
In this podcast series on CAR T-cell Therapy, MIDI’s CEO and Co-Founder, Chris Montalbano, discusses his insight into this exciting and rapidly evolving field in cancer treatment. The first FDA-approved CAR T-cell biopharmaceutical drug was introduced in 2017. Currently there are approximately 10 approved drugs, and the number in development and FDA approval pipeline is growing e

Ep 5 Series 9 | INNOVATION ROADMAP™: Stop-3, (conclusion) Commercialization & Implementation

May 09 2023 9 mins  
Listen to this FINAL episode in the series, "PARADIGM PERCEPTION SHIFT in Medical Device Development: the INNOVATION ROADMAP™." In this episode, we're joined by Andrew Martin, Vice President of MIDI. So far in this series, we have covered class identification, planning, requirements and MIDI's design control methods using our MATRIX-ALM tool. Now, in this episode, we cover RISK M