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.