Hardware Podcasts

Part 1: The Theranos Loophole & Lab Developed Tests

Global Medical Device Podcast · 10 Feb 2023 · 37m · Episode 305

What this episode covers

Mike Drues, president of Vascular Sciences, explains the regulatory distinction between Lab Developed Tests (LDTs) and In Vitro Diagnostics (IVDs), noting that LDTs are currently exempt from FDA pre-market review under the guise of the 'practice of medicine.' He argues that this loophole, highlighted by the Theranos case, allows companies to bypass rigorous safety and efficacy testing, creating a double standard where hospitals face no oversight for modifying commercial devices while manufacturers do. Drues emphasizes that the VALID Act, which would bring LDTs under FDA jurisdiction, has been stalled in Congress despite bipartisan support, leaving a significant regulatory gap that risks patient safety.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Vascular Sciences, Theranos, Greenlight Guru
Also
FDA, CDRH, CLIA, VALID Act

Related episodes from other shows

Other shows on the same ground, closest first.

  • 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.

    Medical & health devicesValidation & product-market fit
    6 chapters

  • Let's Combinate · 1h 14m

    043 - “Half Knowledge Can Hurt” with Shadeed Salam

    Shadeed Salem, Founder and President of Synergy Bioscience, explains the critical differences between validating test methods for pharmaceutical products versus medical devices. He details how drug methods focus on specificity, linearity, and detecting toxic degradation products (LOD/LOQ), while device methods prioritize physical, mechanical, and visual inspections using Gage R&R. Salem shares a war story about remediating 4,600 OOS investigations by separating R&D and QC labs and validating 136 unverified methods to close an FDA warning letter. He emphasizes that 'half knowledge can hurt' when engineers assume drug and device validation protocols are interchangeable without understanding the underlying regulatory and scientific distinctions.

    Quality & yieldValidation & product-market fit
    9 chapters

  • Let's Combinate · 1h 00m

    047 - "Truthful Not Misleading" with Darshan Kulkarni

    Darshan Kulkarni, an FDA regulatory attorney and Adjunct Law Professor at Drexel University, explains the distinction between regulatory and legal compliance in the life sciences industry. He details how the First Amendment influences US promotional compliance, particularly regarding off-label speech and the 'truthful not misleading' standard established by recent court cases. Kulkarni also discusses the operational differences between FDA divisions for drugs (OPDP) and devices (CDRH), noting the latter's limited enforcement resources, and highlights the implications of the Sunshine Act on physician interactions.

    Certification & complianceIntellectual property
    9 chapters

  • Let's Combinate · 39m

    087 - From Crime Reporting to Regulatory Affairs and On/Off The Record with Ferdous Al-Faruque

    Ferdous Al-Faruque, known as Danny, Senior Editor at RAPS, discusses his transition from crime reporting to covering medical device and pharma regulations, including his work on FDA user fee negotiations and digital health. He explains the journalistic rules of engagement, detailing the distinctions between off-the-record, on-background, and on-deep-background conversations to protect sources while maintaining credibility. Al-Faruque also outlines his editorial process at RAPS, emphasizing the importance of independent reporting, ethical standards, and the operational challenges of covering complex regulatory trends like gene therapy and digital health with limited resources.

    Medical & health devicesIntellectual property
    7 chapters

  • Let's Combinate · 1h 19m

    031 - "The Five Stages Of Regulatory Grief" with Michelle Lott

    Michelle Lott, founder of Lean RAQA, discusses her journey from large manufacturer Baxter Healthcare to consulting for small-to-mid-size medical device companies, highlighting the gap in practical regulatory strategy. She details the 'five stages of regulatory grief' clients experience when facing FDA interactions, contrasting the US 510(k) process with the rigorous, ongoing costs of EU MDR compliance. Lott also explains the nuances of regulations versus guidance documents, the QMSR harmonization, and her unique perspective as an elected industry representative on the FDA Device GMP Advisory Committee.

    Certification & complianceQuality & yield
    11 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.