MIDI Innovation Vault ™

Greg Montalbano takes our listeners on a deep dive as related to the Human Factors Regulatory Standards and Guidance documents for US submission. 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 desig...

In this episode, Greg Montalbano, Co-Owner of MIDI takes us on a deep dive into the details as related to the FDA Perspectives on Human Factors and Device Development. We cover topics related to understanding Regulatory Requirements and Methods for Human Factors Usability Testing such as: • Why is FDA concerned about Human Factors Engineering and Usability • What is expected of medical device deve...

The much anticipated Series 3 podcast is now available!  Join MIDI's principal, Gregory Montalbano, in this series as he shares his deep understanding of the importance, requirements, and methods of Human Factors Engineering (HFE) and Usability Research during the design innovation process of medical devices.

The 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 our MATRIX-ALM design control tool. Now, in this episode, we cover RISK (ISO 14971) and utilizing MATRIX to document...

So far in the series, we have provided an overview of the INNOVATION ROADMAP™ as applied to Medical Device Development. We “opened up” the map and explained there are three key stops along this journey. We have already reviewed the first TWO stops which DID NOT need to be deployed under the FDA-QSR and ISO-13485 Design Controls and Risk Management. These first TWO stops allowed us to explore the m...

Listen to the newest episode in our podcast series, "PARADIGM PERCEPTION SHIFT in Medical Device Development: the INNOVATION ROADMAP™." 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 a...

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, we dive into the 1st Stop which is Market  Exploration & Discovering Opportunities. The FDA-QSR & ISO-13485 guidance recognizes this as a quintessential activity for any business to...

Episode 1 in our new series, "PARADIGM PERCEPTION SHIFT in Medical Device Development: the INNOVATION ROADMAP™ " is now available. Listen to this first episode as we prepare for an exploration "Explaining the INNOVATION ROADMAP™: Device Innovation as a Result of Embracing Regulatory Controls: FDA-QSR & ISO-13485" with Co-Owner of MIDI Medical Product Development, Chris Montalbano. In this epis...

This wrap up episode features special guest Christian Davis, VP of Product Development & Technology at Seal Shield. Chris Montalbano, MIDI Principal and Christian discuss Technological Approaches to infection prevention.  In the 4 previous episodes, we have detailed how current methods of HAI control in hospital environments can be applied to environments we encounter in our everyday live...

Part four of Paradigm Shift Required; Current and Future Industry and Technology Applications for Infection Prevention Technology & Development with host Matt Boutwell and Chief Creation Officer, Greg Montalbano of MIDI Product Development. 

Greg Montalbano, the Chief Creation Officer for MIDI Medical Product Development, joins host Matt Boutwell for Episode 3 in the Innovation Vault™. In episode 3 of this 5 part series, we'll hear Greg’s insight and experience on the subject of medical device market innovation and technology application for automation and semi-automation of infection prevention and detection procedures. Listen as Gre...

Part one of this series, Chris Montalbano, Principal of MIDI Product Development joined Host Matt Boutwell as they focused on the perceptions and approaches to infection prevention, then and now. In part two, we're diving into the environments. In the past, a central area of concern was in protecting hospital patients with a compromised immune system leaving them susceptible to hospital-acquired i...

Join Chris Montalbano, Principal MIDI Medical Product Development, and Host Matt Boutwell, as they discuss infection prevention within healthcare environments. Prior to the pandemic, one of MIDI's Medical Device Development areas of focus was on the creation of infection prevention solutions in the healthcare setting. Chris states that "We view the most recent events as a call to action at a more...