MIDI Innovation Vault

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.

MIDI explores the current landscape of CAR T-cell therapy manufacturing and its impact on patient treatment. MIDI's CEO, Christopher Montalbano, sheds light on the challenges posed by the centralized manufacturing approach and delves into the promising alternative: Point-of-Care manufacturing. Chris breaks down the centralized manufacturing workflow for autologous CAR T-cell therapy, emphasizing the collection of T-cells from patients, their transportation to a centralized lab for genetic manipulation and cell expansion, and the subsequent infusion back into the patient. While highlighting the benefits of this therapy, he unveils the critical issues arising from the current centralized approach, such as limited access, manufacturing constraints, high costs, labor-intensive processes, and the need for specialized facilities. Tune into this episode and explore the paradigm shift toward Point-of-Care manufacturing, an approach that can revolutionize CAR T-cell therapy by bringing manufacturing and treatment to the patient's care site enabling commercial-scale production and economies of scale reducing costs, shortening manufacturing timelines, minimizing contamination risks, and preserving cell quality. Tune in to this episode and join the journey toward democratizing CAR T-cell therapy.

In this episode, MIDI's CEO, Christopher Montalbano, takes us on an enlightening journey into the world of CAR T-cell therapy, sharing invaluable insights into the effectiveness of CAR T-cell therapy against different types of cancer. CAR T-cell therapy exhibits greater efficacy in hematological malignancies like leukemia and lymphoma, while its impact on solid tumors is more limited. Christopher explains that the challenging nature of solid tumors, with their embedding in tissue and the presence of a hostile microenvironment, poses significant obstacles for CAR T-cells to penetrate and effectively combat the cancerous cells. Moreover, the heterogeneity of solid tumors, where different cancer cell types vary in their response to treatment, further hampers the therapy's effectiveness. Christopher highlights the ongoing efforts of researchers to overcome these obstacles and enhance the efficacy of CAR T-cell therapy against solid tumors. He discusses exciting approaches such as engineering CAR T-cells with multiple receptors to enhance recognition, modifying them to improve trafficking and infiltration into tumors, and even exploring alternative delivery methods for precise targeting. Don't miss this thought-provoking episode as we uncover the future of CAR T-cell therapy, bringing us one step closer to revolutionizing cancer treatment.

After our Episode 1 overview detailing various alternative types of cancer treatments, it appeared that CAR T-cell therapy is the treatment that looks most promising from multiple viewpoints. In Episode 2, How CAR T-cell Therapy is Produced & Achieve Efficacy, with Format Types Advantages/Disadvantages, we learn more about how CAR T-cell therapy works by targeting cancer cells while sparing healthy cells. Listen to Episode 2, "How CAR T-cell Therapy is Produced & Achieve Efficacy, with Format Types Advantages/Disadvantages".

In this podcast series on CAR T-cell Therapy, MIDI’s CEO and Co-Founder, Chris Montalbano, discusses his insight into this exciting and rapidly evolving field in cancer treatment.  The first FDA-approved CAR T-cell biopharmaceutical drug was introduced in 2017. Currently there are approximately 10 approved drugs, and the number in  development and FDA approval pipeline is growing exponentially.  This therapy is unique because it specifically targets cancer cells while sparing healthy cells, in contrast to other treatment methods that can kill both. The precision of this approach has generated much excitement within the medical community, as it has the potential to revolutionize cancer treatment. In this PodCast series, we will be discussing methods which can help mitigate the hurdles of time and cost by allowing the production process to scale in high volume, thus dropping cost per therapy, increasing production turn-around time and making the therapy accessible to a much larger population of patients.  It’s a POC (Point of Care) approach, where the biopharma product is produced at, or near, the patient treatment site. This will provide for true Democratization. Listen to Episode 1, "Why Democratization and how does CAR T-cell Therapy Compare to Alternative Methods of Cancer Treatment?"

Listen to this 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 MIDI's design control methods using our MATRIX-ALM tool. Now, in this episode, we cover RISK MANAGEMENT (ISO 14971) utilizing MATRIX to document RISK. Listen in as Andrew dives into everything from Risk analysis to production and post-production activities.  Complete the INNOVATION ROADMAP™ tour with us by listening to the final podcast in this series. We hope you have enjoyed the journey!

Throughout the series, we have been discussing the INNOVATION ROADMAP™ and its application in Medical Device Development. In previous episodes, we explored the first two stops on this journey, which did not require deployment under FDA-QSR and ISO-13485 Design Controls and Risk Management. These stops allowed us to investigate the market, identify opportunities, and refine them through exploratory technology investigations and interactive MVP breadboarding. In this episode, we are joined by Wolfgang Huber, Co-Founder of Matrix Requirements, who has created a unique and effective cloud-based tool to support companies in the process we discuss. Follow the INNOVATION ROADMAP™ to Stop 3 by listening to this episode.

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, follow along in Episode 2 as we dive into the 1st Stop on the INNOVATION ROADMAP™, 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.

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 misperception in the industry that the Medical Regulatory Design Controls and Risk Management (under ISO-13485) are often viewed as a mandate, a process that will inhibit device innovation. The perception shift to be revealed will involve the utilization of FDA Guidance, Regulations as well as Design Control & Risk Management as a viable medical device development innovation platform given a properly outlined INNOVATION ROADMAP™. 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.

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 others Listen to Episode 3 to learn more about the rapid acceleration and application of Point of Care and At Home diagnostic platforms. The wide adoption of these testing platforms, coupled with other advances in care, and the participation of companies providing laboratory-like services available directly to the home or clinic, represents a significant advance in the delivery of medical care. It represents a cultural shift likely to persist long after COVID‐19 becomes an endemic illness—as it should—because it offers a profound opportunity to improve the affordability, access, and effectiveness of medical care for a range of common diseases.

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 the details of Point of Care & At Home Diagnostic Testing covering : • Decentralization of Diagnostic Testing & Regulatory Challenges: CLIA • POC and At Home Testing Data Privacy Challenges • And Multiplex Testing and Advancing Molecular Diagnostics

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 and at-home diagnostic devices. Greg will also showcase current and emerging methods of detection from qPCR to novel CRISPR diagnostic technology whose express purpose is to improve speed, accuracy, quality and access of diagnostic testing. Lastly, the listeners will have the unique opportunity to hear from Greg how technologists and device innovators like MIDI are addressing some of the most key challenges and opportunities within the Point of Care and Home Healthcare diagnostics markets.

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 Patients, Payers, Providers, Pharma & Medtech. In addition to the three common features for digital therapy adoption by consumers and healthcare providers.

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 market • The forms that Digital Therapeutics take on to serve the medical market

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 healthcare market. He discusses how the digital therapeutic revolution has generated new healthcare business model opportunities as well as global regulatory, market, and operating model challenges for healthcare and life science companies.

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 has deployed to mitigate our clients' risk in this uncertain world of supply. These approaches are not only critical to our clients' “financial viability” but of course critical to the “health of the general public” as related to being able to gain access to critical medical device technology.

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 approach.

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 is it related to an advanced DFX strategy. Chris Montalbano, CEO of MIDI, helps to define DFX. Additionally, Chris talks about how to operationalize DFX early in the development cycle under a Concurrent Engineering approach as well as what this approach entails and how it is different from alternative approaches.

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 resources and capital as well as the different metrics MedTech Accelerators use for measuring a start-ups success.

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-dive will be taken into the inner-workings of the Houston TMC Innovation and JLABS ecosystem. Greg and Tom discuss the methods of mentoring and support offered to the entrepreneurial groups spanning medical, scientific, and biotechnology applications. Tom also outlines the various TMC & JLABS corporate, university, industry as well as venture partner networks that support their members. Greg and Tom’s discussion also includes what TMC Innovation looks for in a startup and how they can apply to TMC’s programs.

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 incubators, currently supporting fourteen innovative digital health start-ups and emerging companies. Steve is a pioneer in the computer service, wireless, social media, and digital health sectors with a long history and experience ranging from start-up to successful exit. On this podcast, Greg and Steve will be discussing in detail what eHealth Ventures is all about.

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 history and inner workings of Penn-Tech Health and the University of Pennsylvania ecosystem partners. Together they discuss the methods of mentoring and support offered to the entrepreneurial groups spanning medical, scientific, and biotechnology applications. Katie also outlines the various Penn Health-Tech corporate, university, industry as well as venture partner networks that support their teams. Tune in to the Innovation Vault™ to continue the series and listen to Episodes 5 and 6 with our latest Medical Accelerator, Incubator Lab, and Development Community Podcast guests.

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. Together they discuss the methods of mentoring and support offered to the entrepreneurial groups spanning medical, scientific, and biotechnology applications. Diane also outlines the various Center for Biotechnology corporate, university, industry as well as venture partner networks that support their members. Greg and Diane’s discussions also include what the Center for Biotechnology groups looks for in a startup and how they can apply to the various programs offered. Lastly, today’s podcast discussion also highlights new biotech and MedTech innovative initiatives and exciting breakthroughs that are expected on the horizon from the Center for Biotechnology member network.

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. Paul will also outline the various MedTech Innovator industry as well as venture partner networks that support their members. Greg and Paul’s discussions will also include what MedTech Innovator looks for in a startup and how they can apply to the MedTech Innovator programs. Lastly, this podcast will also cover new MedTech innovative initiatives and exciting breakthroughs that are expected on the horizon from the MedTech Innovator member network.

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 the 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, with Greg, they will discuss the methods of mentoring and support offered to the IndieBio entrepreneurial groups spanning medical, scientific, and biotechnology applications. Stephen and Julie will also discuss the various IndieBio partner networks that support their entrepreneurs and what IndieBio looks for in a startup as well as how they can apply. This discussion also covers new innovative biotech and medtech initiatives and exciting breakthroughs that are expected on the horizon from the IndieBio entrepreneurial companies.

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 Research Partnership. Meghan completed her Bachelors in Chemical Engineering at the University of Virginia and Masters in Biomedical Engineering at Columbia University. Currently, Meghan is also a PhD candidate in the laboratory disciplines of Stem Cell and Tissue Engineering. On today’s podcast, Greg and Meghan will be discussing in detail what Columbia BioMedX’s Accelerator program is all about. They will discuss the inner workings of the BioMedX as well as touch on Columbia’s larger Lab-to-Market Accelerator network. Discussions will cover the BioMedX methods of mentoring and support for their entrepreneurial groups which include medical, scientific, and biotechnology applications. Mehgan will also review the various BioMedX corporate, university, industry as well as venture partner networks that support their members. Meghan will also reveal what BioMedX looks for in a startup member and how they can apply to their programs. Lastly, in today’s podcast discussion, Meghan will talk about new initiatives and breakthroughs that are expected on the horizon from the BioMedX member network. Real-world examples will be discussed on what she has personally experienced and saw as a BioMedX Participant and now as an Executive Program Manager.

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 organization's Director, various topics involving mentoring and support methods offered to their members, whose technology applications span from medical devices, digital health, diagnostic applications, Biotech, and more. Additionally, Greg will ask the Directors to share their industry knowledge, experience, insight, and best advice for MedTech start-ups covering topics such as: - Their organizations' individual value proposition, methods, and approach when selecting, mentoring, and supporting an entrepreneurial group member. - How their group offers entrepreneurs a development community that scales through industry and venture partner networks. - The specifics of what attributes their accelerator and incubator organizations look for in a start-up member. - Recommendations on how a start-up can begin on their path to be part of an accelerator or incubator program….and how to differentiate your application. - As well as descriptions of MedTech and Biotech innovation initiatives and breakthroughs that are expected from their entrepreneurial members. In this episode, Greg gives his expert advice and golden nuggets of wisdom before diving in with each of the global Accelerator and Incubator lab's Directors in the coming episodes.

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. These activities support a programmatic quality feedback loop as well as mitigate risk for Stop #3 of the Innovation Roadmap (Commercialization & Implementation) which does need to be deployed under FD-QSR & ISO 13485, and is greatly detailed in this episode. In this methodical process, MIDI's DevelopmentDNA™, ISO-13485 compliant process details each step in Commercialization & Implementation (Stop 3)  under Design Controls and Risk Management. The steps include instituting: Plans Requirements Risk Control Design Inputs Verification Validation  Engineering & Commercialization activities keyed to the items noted above

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 Opportunities. Stop 2, Technology Innovations and the R&D Process. Stop 3, Commercialization and Implementation, which is getting ready for market. Chris then takes us through a deep dive on Stop 1 and 2 with Stop 3 being discussed during the next podcast.  Additionally, during this podcast episode, Ryan Kraudel, VP of Valencell joins us as an expert in the area of biometric sensor technology. Valencell makes the biometric sensor technology and sensor systems that get integrated into consumer and medical wearable devices, and have a key focus on what are known as PPG sensors

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 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.

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 lives which would help in the fight against COVID-19. We then explored what areas in both these environments would require protection and how the technologies might manifest themselves in the way of semi-automated or automated devices, providing for a passive user ceremony. Episode 5 dives into the next level of detail as Chris and Christian explore some of the latest in various infection prevention technologies found within devices.

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 Greg goes into great detail to give you insight on what is happening today in the world of infection prevention.

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 infections. Today, COVID-19 has changed how we work, travel, and shop for the foreseeable future. These densely populated spaces need to be protected and addressed. Additionally, this virus has revealed multiple flaws in the supply chain structure, one of which is at the online retail level, with potentially contaminated packages being shipped from warehouses to the customer's home. Listen as Matt & Chris dive deeper into the environments of infection prevention.

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 rapid and broader scale." Listen as Matt & Chris talk about the changes in risks, the perceptions, and what is really going to help mitigate loss of life related to infections.