Hardware Podcasts

How RADx Tech II Program is Fast-Tracking COVID-19 Technologies to Market in 2021

Global Medical Device Podcast · 21 Jun 2021 · 27m · Episode 215

What this episode covers

Mark Marino, VP of Growth and Strategy Development at VentureWell, discusses the NIH RADx Tech I program's success in fast-tracking 150 COVID-19 diagnostic projects to market in under a year, resulting in 300 million tests. He outlines the upcoming RADx Tech II solicitation via the Point-of-Care Technology Research Network (POCTRN), which targets unmet needs in pediatric testing, multiplexing, and variant detection. Marino explains the phased 'shark tank' funding model, the critical role of QMS software like Greenlight Guru, and the regulatory pathway from Emergency Use Authorization (EUA) to traditional FDA clearance.

Most relevant to

companies scaling up

Topics

Mentioned

Companies
VentureWell, NIH, POCTRN, FDA, Broad Institute, Johns Hopkins, Emory, CIMIT, Aloom, Busby Medical
Products
RADx
Tools
Greenlight Guru

Related episodes from other shows

Other shows on the same ground, closest first.

  • Being an Engineer · 46m

    S5E8 Aaron Call | How to Find Money for MedTech Startups

    Aaron Call, founding principal of Jaunt, explains how his company helps MedTech startups navigate market intelligence and fundraising by focusing on customer discovery rather than just technical feasibility. He distinguishes between sustaining and disruptive innovation, detailing how Jaunt uses qualitative and quantitative research to validate product-market fit for Class I and II devices. Call also outlines the current venture capital landscape, noting the shift toward funding only exceptional companies, and discusses the integration of AI in healthcare administration and device development.

    Validation & product-market fitFundraising & investors
    9 chapters

  • Let's Combinate · 29m

    101 - Micro-Array Patches, Combination Products in Australia, Differences between TGA and RoW, Novel Delivery Systems, and Clinical Trials with Megan Polidano

    Megan Polidano, Head of Clinical and Regulatory Affairs at Vaxxas, explains the regulatory and technical challenges of developing micro-array patches, specifically Vaxxas' solid micro-needle technology for needle-free intradermal vaccine delivery. She details how the lack of specific guidelines for this novel combination product requires relying on EPARs and AusPARs, while highlighting Australia's CTN clinical trial scheme and Core A/B pathways as distinct from FDA or EMA processes. Polidano emphasizes that even using registered vaccines, formulation and administration changes necessitate full clinical development, including human factors testing and safety studies, to prove efficacy and usability.

    Medical & health devicesCertification & compliance
    10 chapters

  • Let's Combinate · 1h 07m

    017 - "Feet First" with Ahmed Zobi

    Ahmed Zobi, Founder and CEO of Syntr Health Technologies, explains how he bootstrapped his company from a university project to FDA 510(k) clearance for the SyntrFuge System, a device that automates the microsizing of adipose tissue for body contouring and wound care. Zobi details the strategic decision to target aesthetics and orthopedics first to generate revenue while pursuing diabetic foot ulcer indications, and describes the intense personal sacrifices made during the grant submission process and the COVID-19 pandemic. He emphasizes the importance of leveraging mentors, conducting customer discovery through the NSF iCorps program, and building a robust quality management system early to navigate regulatory requirements.

    Starting a product companyValidation & product-market fit
    9 chapters

  • The Pragmatic Embedded Podcast · 37m

    Rapid Prototyping for Medical Devices with Ross Dehmoobed

    Ross Dehmoobed, VP of software and platforms at Veranex, explains how his company applies agile methodologies to medical device development. He details the use of 'Fusion Core' libraries and custom hardware modules to enable rapid prototyping, allowing teams to demonstrate functional breadboards and software features within the first two weeks. Dehmoobed emphasizes that while planning and regulatory pathway definition (such as 510(k) or de novo) require upfront waterfall-style rigor, the execution phase benefits from short sprints, off-target unit testing, and continuous customer feedback to maintain quality and speed.

    Prototyping & iterationEmbedded firmware
    7 chapters

  • The Pragmatic Embedded Podcast · 33m

    How to Speed Up Safety Critical Processes

    Jeff Gable and Luca Njani discuss strategies to accelerate safety-critical development in medical devices, automotive, and aerospace without compromising quality. They argue that reducing scope for initial releases and automating documentation using modern tools like Jama and Matrix significantly shortens cycle times. The hosts emphasize that modern regulatory guidance, such as the FDA's Computer System Assurance, supports streamlined validation processes, allowing teams to iterate faster and uncover defects earlier.

    Medical & health devicesDesign for manufacturing & NPI
    7 chapters

The summary, chapters and topics are generated from the episode’s audio by this directory, not written by Global Medical Device Podcast. The episode itself belongs to its publisher.