MIDI Innovation Vault

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 will be recognized by the FDA.

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 design and development.  More specifically, 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, 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 developers from the FDA

• Specific medical device Human Factors Engineering example relative to hazards, risks and the use related causes.

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.

This new series will cover the role of human factors engineering in medical device development and explore specific methods, techniques, and examples of implementation.

We begin with Episode 1 of the Series, Human Factors & User Interface Design for Medical Devices: The Overview. In this episode, Greg kicks-off the series with an executive-level discussion of the importance and benefits of MIDI's Human Factors & Usability Research quality process as related to medical device development programs.

Greg continues his deep dive into why HFE and Usability Research are critical elements and what is expected by the FDA. Additionally, we discuss HFE and Usability considerations' specifics involving the three major development components of a medical device: the Device Users, Device Use Environments, and Device User Interfaces.

In the remainder of this series, Greg affords the listeners full detailed access to his deep and diverse knowledge within specific verticals of Human Factors Engineering related to 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 RISK. Listen in as Andrew dives into everything from Risk analysis to production and post-production activities.

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 market, identify opportunities, and then perform exploratory technology investigations and interactive MVP breadboarding in support of and refinement of these opportunities.

In this episode, we're joined by our expert guest, Wolfgang Huber, Co-Founder of Matrix Requirements. Wolfgang and his team have created a very unique and effective cloud-based tool that supports companies doing exactly what we discuss in this episode.

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 and Chief Creative Officer, Gregory Montalbano discusses the INNOVATION ROADMAP™ 2nd Stop, which is Technology Innovation and the R&D Process.

As discussed in prior episodes, the FDA-QSR & ISO 13485 guidance recognizes both Stop 1 Market Exploration & Discovering Opportunities as well as Stop 2 Technology Innovation and the R&D Process are essential formative exercises for any business to implement while at the same time making it known that regulatory controls such as Design Controls & Risk Management do not have to be implemented at this point. The FDA recognizes the importance for an organization to explore development opportunities, methodologies and technologies first.

Learn more about how MIDI's INNOVATION ROADMAP™ yields innovation and competitive differentiation in the medical device market.

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 perform, yet they make it known that their regulatory controls such as Design Controls & Risk Management do not have to be performed at this point. They understand the importance of a company needing to explore opportunities first.

Learn more about the important methods MIDI deploys in regard to obtaining external needs to unlock innovation and competitive differentiation.

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 episode Chris outlines what's behind the MIDI expert DevelopmentDNA™ approach. He explains that the common perception in the industry is that the Medical Regulatory Design Controls and Risk management (meaning FDA-QSR & ISO-13485) are often viewed as a mandate, a process that will inhibit production innovation.

The perception shift lies in using the RECOMMENDATIONS (called FDA Guidance), REGULATIONS, Design Controls & Risk Management as a viable medical device development innovation platform given a properly outlined INNOVATION ROADMAP™, which MIDI calls its DevelopmentDNA™ approach.

Under this approach, MIDI's team of engineers and usability experts tied to their industrial designers have the ability to utilize DevelopmentDNA™’s 'INNOVATION ROADMAP' to address the functional, cost-to-manufacturer, safety and business requirements of what Chris calls 'the golden standard approach', which is paired with the follow-through to execute upon that approach in a rapid, AGILE product development fashion under MIDI's Quality-First umbrella.