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.