The Future of Lateral Flow Test Technology

Global Medical Device Podcast · 25 May 2022 · 43m · Episode 263

What this episode covers

Jeremy Stackawitz, CEO of Senzo Health, discusses his company's development of an amplified lateral flow test that is 10,000 times more sensitive than current COVID-19 offerings, aiming for a 7-minute result time. He explains the strategic pivot from general diagnostics to this specific technology, the challenges of navigating the FDA's Emergency Use Authorization (EUA) pathway, and the importance of data in building trust with regulators and investors. Stackawitz also addresses the legacy of Theranos, the future of point-of-care testing in retail settings, and the necessity of balancing laser focus with flexibility in a resource-constrained startup environment.

Other shows on the same ground, closest first.

  • Being an Engineer · 42m

    S7E15 Mustafa Poonawala | Diagnostic Clinical Trials, Prioritization, & Decision Latency in Engineering

    Mustafa Poonawala, CEO of DynaMill Research and Managing Partner at Steps Program Management, discusses accelerating diagnostic innovation through agile clinical trials and reducing decision latency in engineering. He explains how DynaMill uses AI and digital workflows to cut cycle times for medtech companies, contrasting this with traditional pharmaceutical CROs. Poonawala also shares leadership advice on prioritization, the value of R&D as optionality, and the importance of staying connected to engineering roots while mentoring teams.

  • Let's Combinate · 37m

    154 - IVD's, LDT's, Companion Diagnostics, Precision Medicine, Clinical Validation, Biomarkers, Test Methods, Detection Limits and CLIA with Devon C. Campbell

    Devon Campbell, Founder of Prodct LLC and CPO of myBiometry, explains the regulatory and engineering distinctions between In Vitro Diagnostics (IVDs), Lab Developed Tests (LDTs), and companion diagnostics. He details how IVD development mirrors medical device design control but adds critical layers of risk management regarding false positives and negatives, particularly for home-use devices like COVID tests. Campbell emphasizes that clinical validation requires proving statistical validity across diverse populations to establish Limit of Detection (LOD) and sensitivity, noting that clinical studies are often the most time-consuming and expensive part of the process for startups.

  • Let's Combinate · 45m

    245 - Reducing a 14-Step Emergency Injection to a Two-Step Auto-Injector

    Julia Anthony, founder and Chief Strategy Officer of Solution Medical, explains how her company is developing a drug-device combination product to simplify emergency hydrocortisone administration for patients with adrenal insufficiency. She details the transition from a 14-step manual reconstitution process to a proprietary dual-chamber primary container that enables a 4-step prefilled syringe and a 2-step auto-injector. Anthony discusses the regulatory strategy of a drug-led 505(b)(2) NDA, the challenges of aseptic manufacturing, and the human factors testing that validated the simplified user experience for both patients and injection-naive caregivers.

  • The Amp Hour · 1h 15m

    The Joulescope Upgrade with Matt Liberty

    Matt Liberty, founder of JetPerch LLC, discusses the launch of the Joulescope JS220, an upgraded high-dynamic-range current and voltage measurement device. He details the hardware evolution from the JS110, including the switch to a Lattice ECP5 FPGA, a Cortex-M7 microcontroller, and a 16-bit ADC, while explaining the custom firmware architecture and publish-subscribe protocol. Liberty also shares his experiences navigating the global chip shortage, managing supply chain risks with PartsBox, and the financial pressures of bootstrapping a hardware business.

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.