MIDI Innovation Vault ™

Listen to this first episode as we prepare to explain the INNOVATION ROADMAP™: Device Innovation as a Result of Embracing Regulatory Controls: FDA-QSR & ISO-13485, with the CEO of MIDI Medical Product Development, Chris Montalbano. In this episode, Chris outlines how to take control of the medical device development process utilizing a DevelopmentDNA™ approach. He begins by explaining a common...

In this podcast episode, MIDI Principal Greg Montalbano will discuss the various Point of Care and At Home Diagnostic testing technology applications covering the details of the science and value proposition for detection, market application, as well as global health. The technology platforms discussed in this episode include a host of Molecular Diagnostics, including: - CRISPR - RT-PCR - LAMP and...

In this podcast, MIDI’s Principal and Co-Founder, Gregory Montalbano, continues sharing insight into the current landscape as well as what is in store for the future related to Point of Care and at-home diagnostic devices. From evolving market trends and technology innovations to key challenges and unmet opportunities for global health, Greg covers it all. Episode 2 dives specifically into th...

In this podcast series on Point of Care and At Home Diagnostic Testing, MIDI’s Principal and Co-Founder, Gregory Montalbano, discusses his insight into the current landscape as well as what is in store for the future. Series topics will range from evolving market trends and technology innovations as well as key challenges and unmet opportunities for global health as related to the Point of Care an...

The discussion continues and series concludes with a deep understanding of the importance, and requirements of the world of Digital Therapeutics, also known as DTx as related to the healthcare device industry. This episode details DTx solutions go-to-market strategies, define DTx digital therapeutics ecosystem and stakeholders, as well as covering DTx solutions give-to-get value exchanges for Pati...

We continue the series topic, Digital Therapeutics known as medical treatments that can make medical claims, and receive regulatory authorization and reimbursement. In this episode, MIDI Principal, Greg Montalbano will dive into the details of Digital Therapeutics covering: • What is driving demand for Digital Therapeutics • Establishing Digital Therapeutic Regulatory Quality in today's crowded ma...

This series will review the evolution of digital health from isolated remote monitoring technologies ten years ago to an emerging subset of evidence-based, clinically evaluated software products and services. MIDI Principal, Greg Montalbano discusses current and future medical digital healthcare application development that is now moving faster than ever creating an increasingly crowded digital he...

In this special episode, MedDevice Supply Chain Paradigm Shift; Defining & Solving for Supply Chain Risk Utilizing MIDI’s De-Risk Method of DFSC, Chris and Pat will share unique and critical knowledge with the medical community. Chris and Pat step us through the “trials and tribulations” MIDI’s development teams have endured over the last 2 years and reveal unique strategic methods that MIDI h...

Chris Montalbano, CEO of MIDI walks us through the components of DFX (Design for Excellence). Listen in as Chris "unpacks" each of the DFX components in detail referencing MIDI's methodical yet prudent development approach. Both the functional engineering constraints and the essential business constraints as related to production and costing are considered simultaneously in this development approa...

The subject of addressing supply chain issues is quite an important and relevant topic for medical device manufacturers to integrate into their development strategies given the material and component shortages in today's economic environment. The first episode in the new MIDI series, Value of Concurrent Engineering with Inclusion of DFX in MedDevice, Operationalized under ISO-13485, addresses how...

In the last podcast episode of the series, MIDI Medical Product Developments CEO, Gregory Montalbano shares his personal insight as related to what an Accelerator or Incubator can and should be doing for its MedTech Startup entrepreneurial members. Greg also outlines the “Five Accelerator Model Types” and reveals each accelerator type's own motivations for establishing programs, investing resource...

In this episode, Gregory Montalbano speaks with Dr. Tom Luby who is the Director of Innovation at Texas Medical Center also known as TMC Innovation. In this role, Tom oversees all of the innovation efforts of TMC focused on research, education, and commercialization of novel healthcare solutions. Prior to Tom's role at TMC, he was the head of JLABS at TMC in Houston, Texas. In this episode, a deep...

MIDI Medical Product Development’s CEO, Gregory Montalbano speaks with Stephen Shapiro from eHealth Ventures. Steve is the co-founder of eHealth Ventures which is a consortium of world-class health care organizations and investors looking for disruptive digital health companies. After four years eHealth Ventures, located in Tel Aviv Israel, has become one of the world’s top leading global incubato...

Gregory Montalbano speaks with Katie Reuther who is the Executive Director at Penn Health-Tech located at the University of Pennsylvania in Philadelphia. Together, Greg and Katie discuss in detail what the Center for Health, Devices, and Technology at the University of Pennsylvania, or Penn Health-Tech for short, and its associated Health-Tech Accelerator is all about. Greg and Katie discuss the h...

MIDI Medical Product Developments CEO, Gregory Montalbano is speaking with Diane Fabel who is the Director of Operations at The Center for Biotechnology located on the campus of Stony Brook University. On this podcast, Greg and Diane will discuss in detail what The Center for Biotechnology is all about. A deep dive is taken into the inner workings of the Center for Biotechnology ecosystem programs...

Gregory Montalbano speaks with Paul Grand who is the Founder and CEO of MedTech Innovator. Paul runs MedTech Innovator as a stand-alone non-profit which is also the largest accelerator of medical technology in the world. Together, Greg and Paul discuss the methods of mentoring and support offered to the entrepreneurial groups spanning medical device, digital health, and diagnostic applications. Pa...

MIDI Medical Product Development’s CEO, Gregory Montalbano speaks with Stephen Chambers, Managing Director, and Julie Wolf, Chief Science Officer of the Development Community IndieBio located in heart of New York City. In this podcast, Stephen and Julie will be discussing in detail what IndieBio NY is all about. Listen for a deep dive into the inner workings of the IndieBio ecosystem. Together, wi...

On Episode #2 of MIDI Innovation Vault™ Series; The Deep Dive into Medical & Scientific Accelerators, Incubator Labs and Development Communities, MIDI Medical Product Developments CEO, Gregory Montalbano speaks with Meghan Pinezich who is an Executive Team member of Columbia BioMedX, a biomedical engineering technology accelerator at Columbia University, formerly called the Columbia-Coulter Re...

In this release of MIDI’s Innovation Vault™ Podcast series principal, Gregory Montalbano hosts deep-dive one-on-one interviews with the Directors of seven top global MedTech and Biotech Accelerators, Incubator Labs, and Development Communities. Episode 1, introduces and outlines the upcoming series including introductions to each organization's Directors. Greg will then discuss with each organizat...

In the previous Podcast of this series, Chris Montalbano, CEO of MIDI, provided an overview of the INNOVATION ROADMAP™ as applied to Medical Device Development. He “opened up” the map with us and explained there are three key stops along this journey. We have already reviewed the first 2 stops which did not need to be deployed under the FDA-QSR and ISO-13485 Design Controls and Risk Management. Th...

In this episode, Christopher Montalbano, CEO of MIDI steps us through the medical device development Innovation Roadmap. Listen in as Chris helps us pinch-in, or zoom-out on the map, or for those of us who remember using paper maps, we're going to "open up the map" to see the entire scope first and discuss the three key stops along this innovation journey. Stop 1, Market Exploration, Discovering O...

In the previous episode, Chris Montalbano, CEO of MIDI, provided a detailed deep dive of Wearable IoMT Biosensory Devices. In this episode, Chris will elaborate on what Wearable IoMT Physiological Devices are all about by defining these devices, reviewing their application and then identifying challenges resulting in innovative design solutions.

In this episode, Chris Montalbano, CEO of MIDI, shares what biosensory devices are all about starting with defining these devices and then looking at the components which make up such devices. In a deeper dive, Chris also provides examples/ applications of these devices seen in everyday life and discusses the development and commercialization challenges tied to innovating solutions.

Chris Montalbano, CEO of MIDI, discusses what IoMT Wearables are, outlines some of the benefits they provide to the medical community, and then performs a deep dive on device sensor selection. Tune in to hear more about these devices embraced by users as lifestyle devices used in their daily environments. 

In Episode 4, titled Recommended Principals and Practices of Human Factors Engineering: The Deep Dive into AAMI HE75 and Methods for Human Factors Usability Research, we discuss and distill down this guidance documents usability research and development methods as related to what medical device developers need to know in order to generate well designed, safe and effective medical devices that...