MIDI Innovation Vault ™

In this episode, MIDI CEO Christopher Montalbano outlines how MIDI adapted to the rapidly shifting supply chain environment during the COVID Era and how these same methods assist in derisking during the Tariff Era. Chris introduces MIDI’s Advanced Design for Supply Chain (DFSC) Strategies, developed under their broader DFX (Design for Excellence) framework and implemented through their ISO 13485 Q...

In Episode 2, Chris Montalbano, CEO of MIDI Product Development, takes a closer look at DFX, Design for Excellence, and what it really means when applied to medical device development, especially when derisking is required in the face of global uncertainty (tariffs). Chris breaks down how DFX goes beyond just cost and manufacturing. It’s about designing for every critical factor: Manufacture, Asse...

In this kickoff episode of Designing Through Disruption, Christopher Montalbano, CEO of MIDI Medical Product Development, explores how medical device teams can integrate a resilient, forward-thinking approach into their product development strategies, especially in the face of global uncertainty (tariffs). Chris introduces listeners to MIDI’s DevelopmentDNA™ process and explains how their firm has...

Welcome to MIDI’s Innovation Vault Podcast. In this episode of MedTech's Next Wave: Innovators from LSI, we’re joined by Guillermo Cohen, Vice President of Liberate Medical. Liberate is advancing pulmonary care with its vent-free respiratory muscle stimulator, which uses noninvasive electrical stimulation to prevent expiratory muscle weakness in patients on mechanical ventilation, aiming to reduce...

Welcome to MIDI’s Innovation Vault Podcast. In this episode of MedTech's Next Wave: Innovators from LSI, we’re joined by Nic Purcell, founder of Purcell, a London-based life science startup. Purcell is developing smart, reusable inhalers and an AI platform to improve the quality of life for patients with respiratory diseases. Inspired by his own health challenges, Nic’s innovative device track...

Welcome to MIDI’s Innovation Vault Podcast. In this episode of MedTech's Next Wave: Innovators from LSI, we’re joined by Michelle Teirney, CSO, and Tim Jones, CEO of SymPhysis Medical. Symphysis is developing a smart drainage device for patients with pleural effusion, allowing them to manage their condition independently at home. Their innovation features a simplified insertion procedure, a on...

Welcome to MIDI’s Innovation Vault Podcast. In this episode of MedTech's Next Wave: Innovators from LSI, we’re joined by Joe Connell, founder and CEO of NeuEsse, a company revolutionizing wound care with their plant-based skin substitute, Omega Skin. Made from soy protein, Omega Skin regenerates skin with minimal scarring while retaining natural pigmentation, hair follicles, and sweat glands....

Welcome to MIDI’s Innovation Vault Podcast. In this episode of MedTech's Next Wave: Innovators from LSI, we’re joined by Alan Lucas, co-founder and CEO of Navigation Sciences. Alan shares how his company is advancing precision cancer surgery with the NaviSci System, an innovative platform designed to identify and track soft tissue tumors during surgery. Born from a collaboration with Brigham a...

Welcome to MIDI’s Innovation Vault Podcast. In this episode of MedTech's Next Wave: Innovators from LSI, we’re joined by Bill Colone, CEO of Single Pass, a company redefining minimally invasive surgical solutions. Single Pass has developed an electrocautery device that prevents bleeding during biopsy procedures, enabling patients to go home immediately without extended hospital monitoring. Wit...

Welcome to MIDI’s Innovation Vault Podcast. In this episode of MedTech's Next Wave: Innovators from LSI, we’re joined by Jay Cormier, CEO and founder of Eyedaptic. Eyedaptic is transforming visual health with its groundbreaking augmented reality technology, designed to enhance the peripheral vision of those suffering from macular degeneration, helping them regain functional sight. By combining exp...

Welcome to MIDI’s Innovation Vault Podcast. In this episode of MedTech's Next Wave: Innovators from LSI, we’re joined by Chris Harder, CTO of Kenota Health. Kenota Health is revolutionizing diagnostics and patient care, focusing on solving critical healthcare challenges. Founded by two entrepreneurs passionate about improving allergy management, Kenota recruited Chris to help re-engineer their...

Dive into our latest episode of MIDI’s Innovation Vault Podcast, where our COO, Greg Montalbano, sits down with  JD Friedland , General Manager of  Cleveland Clinic Ventures . JD shares his journey from investment banking to leading healthcare innovation and provides insights into how Cleveland Clinic is driving advancements in digital health, medical devices, and life sciences. Discover how JD an...

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 docu...

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...

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 Engin...

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, espec...

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,...

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, emphasizi...

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. Christop...

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 he...

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 exponentially.  Th...

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...

Throughout the series, we have been discussing the INNOVATION ROADMAP™ and its application in Medical Device Development. In previous episodes, we explored the first two stops on this journey, which did not require deployment under FDA-QSR and ISO-13485 Design Controls and Risk Management. These stops allowed us to investigate the market, identify opportunities, and refine them through exploratory...

In our previous episode, Chris Montalbano provided an overview of the INNOVATION ROADMAP™ as applied to medical device development in addition to describing the 1st Stop, which was Market Exploration & Discovering Opportunities. In this new episode, Principal and Chief Creative Officer, Gregory Montalbano discusses the INNOVATION ROADMAP™ 2nd Stop, which is Technology Innovation and the R&...

The first episode of this series provided an overview of the INNOVATION ROADMAP™ as applied to Medical Device Development. We “opened up” the map and explained the three key stops along this journey. Now, follow along in Episode 2 as we dive into the 1st Stop on the INNOVATION ROADMAP™, which is: Market Exploration & Discovering Opportunities. The FDA-QSR & ISO-13485 guidance recognizes th...