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.