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:

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 :

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

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

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.