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

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2024-09-18
- Length: 37m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2024-09-18-154-ivds-ldts-companion-diagnostics-precision-medicine-clinical-validation-bioma
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/154---IVDs--LDTs--Companion-Diagnostics--Precision-Medicine--Clinical-Validation--Biomarkers--Test-Methods--Detection-Limits-and-CLIA-with-Devon-C--Campbell-e2oft89

## Summary

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.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2024-09-18-154-ivds-ldts-companion-diagnostics-precision-medicine-clinical-validation-bioma#t=0) Introduction: Devon Campbell and Prodct LLC
- [1:58](https://hardwarepodcasts.com/podcast/lets-combinate/2024-09-18-154-ivds-ldts-companion-diagnostics-precision-medicine-clinical-validation-bioma#t=118) Defining IVDs, Companion Diagnostics, and Precision Medicine
- [8:49](https://hardwarepodcasts.com/podcast/lets-combinate/2024-09-18-154-ivds-ldts-companion-diagnostics-precision-medicine-clinical-validation-bioma#t=529) Lab Developed Tests (LDTs) and Regulatory Pathways
- [12:32](https://hardwarepodcasts.com/podcast/lets-combinate/2024-09-18-154-ivds-ldts-companion-diagnostics-precision-medicine-clinical-validation-bioma#t=752) IVD Development Process and Risk Management
- [20:17](https://hardwarepodcasts.com/podcast/lets-combinate/2024-09-18-154-ivds-ldts-companion-diagnostics-precision-medicine-clinical-validation-bioma#t=1217) Clinical Validation, LOD, and Test Method Envelopes
- [29:12](https://hardwarepodcasts.com/podcast/lets-combinate/2024-09-18-154-ivds-ldts-companion-diagnostics-precision-medicine-clinical-validation-bioma#t=1752) Challenges in IVD Development and Clinical Studies

## Topics

- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)

## Most relevant to

early-stage companies, large enterprises

## Mentioned

- Prodct LLC (company)
- myBiometry (company)
- Roche (company)
- Novartis (company)
- FDA (other)
- CLIA (other)
- ISO 13485 (other)
- QMSR (other)
- 510(k) (other)
- PMA (other)

## Related episodes from other shows

- [#361: Speaking the Language of IVD](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-04-19-361-speaking-the-language-of-ivd) (Global Medical Device Podcast)
- [#348: Considerations for IVD](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-12-14-348-considerations-for-ivd) (Global Medical Device Podcast)
- [Similarities & Differences between In Vitro Diagnostic (IVD) Devices & Medical Devices](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-04-21-similarities-differences-between-in-vitro-diagnostic-ivd-devices-medical-devices) (Global Medical Device Podcast)
- [Part 1: The Theranos Loophole & Lab Developed Tests](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-02-10-part-1-the-theranos-loophole-lab-developed-tests) (Global Medical Device Podcast)
- [Quality Management for IVD Devices vs Medical Devices](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-04-05-quality-management-for-ivd-devices-vs-medical-devices) (Global Medical Device Podcast)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/lets-combinate/2024-09-18-154-ivds-ldts-companion-diagnostics-precision-medicine-clinical-validation-bioma. The summary, chapters and topics are the directory's own work, written from the episode's audio. The episode itself, its title and its audio belong to Let's Combinate.