MIDI Innovation Vault

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.

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.