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 QMS and agile development methodology. These strategies aim to reduce risk and ensure product availability in uncertain markets.
Key approaches covered include:
Shifting from traditional Just-in-Time (JIT) models to hybrid inventory strategies like the “sell-one-stock-one” approach.
Expanding supplier redundancy—moving from dual sourcing to tertiary and quaternary sourcing with geographic diversity.
Incorporating independent distributors to fill gaps in component availability, supported by procurement intelligence tools and rigorous quality screening.
The episode also features Pat Farrell of Advanced Assembly, who shares recommendations for managing printed circuit board (PCB) production within this new supply chain paradigm.
Together, Chris and Pat emphasize the importance of tight coordination between engineering, manufacturing, and supply chain teams from day one of development to proactively mitigate production risk and maintain project timelines in an unpredictable global landscape.
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, Assembly, Testability, Usability, Service, and Reliability. When DFX is applied early, it leads to smarter product decisions, faster development timelines, fewer late-stage issues, and better long-term business outcomes.
If you're developing a medical device, this episode offers practical insight into designing for success from the start and a way to derisk in this globally strained supply chain environment.
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 evolved to embed advanced Design for Excellence (DFX) strategies early in the development cycle. These methods, initially honed during the COVID-era supply chain crisis, are now proving indispensable as global tariffs and component shortages continue to challenge the industry.
Key takeaways from this episode include:
What DFX really means—and why it should never be an afterthought
The strategic advantage of Concurrent Engineering over traditional development models
How to align advanced development methodologies with ISO-13485 and FDA design control guidance
The role of MIDI’s Innovation Roadmap™ in mitigating risk and accelerating time to market
This episode lays the foundation for a series focused on strengthening medical device development pipelines, making them compliant and competitively agile.
Next, we’ll explore the supply chain conundrum further and share our Advanced DFX Strategy for design-for-supply-chain integration.
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 ICU stay and ventilation duration.
Currently conducting a pivotal clinical trial, the company has overcome challenges in development, funding, and regulatory pathways, building a strong team and strategic partnerships to move toward FDA clearance.
Join us as Guillermo shares how Liberate Medical is transforming pulmonary care.
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 tracks inhaler use with sensors to ensure proper technique and medication delivery.
Purcell is also creating an at-home diagnostics device to detect and classify up to 10 respiratory diseases. Despite navigating the challenges of the medical device industry, Nic has secured key academic partnerships and plans to raise funding in 2025 to scale the technology.
Join us to hear how Purcell is shaping the future of respiratory care.
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 one-handed drainage process, and a mobile app for remote monitoring.
Despite challenges during the COVID-19 pandemic, Symphysis Medical has made significant progress, leveraging strong clinical partnerships and a user-centered design approach.
Join us as Michelle and Tim discuss how they’re transforming pleural effusion care.
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.
Despite facing challenges in funding and regulatory hurdles, NeuEsse is poised to enter clinical trials and move toward commercialization. Joe shares how partnerships and strategic alliances will be key in bringing this innovative technology to the crowded wound care market.
Stay tuned as Joe discusses the future of regenerative medicine and his advice for aspiring MedTech entrepreneurs.
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 and Women’s Hospital, NaviSci tackles challenges like locating and measuring early-stage lung tumors for more accurate removal. Alan discusses the hurdles of medical device innovation, including funding, regulatory paths, and clinical refinement, and shares plans to expand NaviSci's applications to other cancers, aiming to partner with leaders in surgical robotics and medical imaging.
Join us to learn how Navigation Sciences is shaping the future of cancer surgery.
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.
With regulatory clearance in Europe and the U.S., and a commercial launch underway, Bill shares how Single Pass overcame challenges in funding, technical development, and hospital adoption to bring this innovative technology to market.
Join us to learn how Single Pass is transforming biopsy care and improving patient outcomes.
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 expertise in both medicine and engineering, Eyedaptic has rapidly developed user-focused solutions, despite facing challenges in funding and regulatory hurdles. Jay shares how strategic partnerships and a strong advocate investor base of eye care professionals have contributed to the company’s success. Eyedaptic’s latest innovation, which integrates a generative AI visual assistant, marks a new step in enhancing the quality of life for those with visual impairments. Join us as Jay discusses how Eyedaptic is shaping the future of visual health and pushing the boundaries of innovation.
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 core technology to better align with customer needs
Kenota Health’s unique approach starts with the problem and customer, designing tailored technical solutions. Despite challenges in regulatory processes, technology development, and funding, they’ve successfully leveraged strategic partnerships to navigate these hurdles. Looking ahead, Chris discusses the exciting potential of converging diagnostic technologies that could make testing more accessible, affordable, and effective at the point of care.
Join us to hear how Kenota Health is shaping the future of diagnostics and patient care.
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 and Cleveland Clinic Ventures balances financial growth with advancing patient care, shaping the future of healthcare.
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.
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.
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!
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.
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.
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.
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.
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".