# Similarities & Differences between In Vitro Diagnostic (IVD) Devices & Medical Devices

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2021-04-21
- Length: 34m
- Episode: 198
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-04-21-similarities-differences-between-in-vitro-diagnostic-ivd-devices-medical-devices
- Listen: https://podcast.greenlight.guru/episode/similarities-differences-between-in-vitro-diagnostic-ivd-devices-medical-devices

## Summary

Milton Yarberry, Director of Medical Programs at Integrated Computer Solutions (ICS), joins host John Spear to discuss the regulatory and engineering distinctions between In Vitro Diagnostic (IVD) devices and traditional medical devices. They clarify that while IVDs are a subset of medical devices subject to similar quality systems (21 CFR Part 820, ISO 13485), their risk classification is based on the assay's impact rather than direct patient harm. The conversation highlights how IVD manufacturers often struggle with design controls because their background is in clinical science rather than commercial engineering, leading to a focus on analytical fidelity over user interface. They also address the evolving regulatory landscape, including CLIA Waiver requirements, the status of Lab Developed Tests (LDTs), and the impact of the EU MDR/IVDR and FDA Emergency Use Authorizations (EUA).

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-04-21-similarities-differences-between-in-vitro-diagnostic-ivd-devices-medical-devices#t=0) Introduction: Milton Yarberry and Integrated Computer Solutions
- [2:32](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-04-21-similarities-differences-between-in-vitro-diagnostic-ivd-devices-medical-devices#t=152) Defining IVDs: Samples, not Patients
- [5:08](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-04-21-similarities-differences-between-in-vitro-diagnostic-ivd-devices-medical-devices#t=308) Risk Classification and User Safety in IVDs
- [8:01](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-04-21-similarities-differences-between-in-vitro-diagnostic-ivd-devices-medical-devices#t=481) CLIA Waiver and Human Factors Design
- [12:57](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-04-21-similarities-differences-between-in-vitro-diagnostic-ivd-devices-medical-devices#t=777) Similarities: Quality Systems and Regulatory Controls
- [14:40](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-04-21-similarities-differences-between-in-vitro-diagnostic-ivd-devices-medical-devices#t=880) The Mindset Gap: Science vs. Commercialization
- [18:53](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-04-21-similarities-differences-between-in-vitro-diagnostic-ivd-devices-medical-devices#t=1133) Design Controls and Verification in IVDs
- [24:04](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-04-21-similarities-differences-between-in-vitro-diagnostic-ivd-devices-medical-devices#t=1444) LDTs, EU MDR, and the EUA Landscape

## Topics

- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Industrial & consumer product design](https://hardwarepodcasts.com/topic/industrial-design)

## Most relevant to

early-stage companies

## Mentioned

- Integrated Computer Solutions (company)
- Greenlight Guru (company)
- ICS (company)
- CLIA (other)
- FDA (other)
- EU MDR (other)
- IVDR (other)
- EUA (other)
- 510(k) (other)
- ISO 13485 (other)
- IEC 62366 (other)

## Related episodes from other shows

- [244 - 5 Critical Quality Differences Between Drugs and Devices](https://hardwarepodcasts.com/podcast/lets-combinate/2026-07-01-244-5-critical-quality-differences-between-drugs-and-devices) (Let's Combinate)
- [154 - IVD's, LDT's, Companion Diagnostics, Precision Medicine, Clinical Validation, Biomarkers, Test Methods, Detection Limits and CLIA with Devon C. Campbell](https://hardwarepodcasts.com/podcast/lets-combinate/2024-09-18-154-ivds-ldts-companion-diagnostics-precision-medicine-clinical-validation-bioma) (Let's Combinate)
- [187 - Why Drug and Device Development Use Different Playbooks (QbD vs. Design Controls Explained)](https://hardwarepodcasts.com/podcast/lets-combinate/2025-05-07-187-why-drug-and-device-development-use-different-playbooks-qbd-vs-design-contro) (Let's Combinate)
- [258 - Combination Product Quality: Human Factors, CDMO Scorecards, ISO 14971 vs. ICH Q9, with Ben Locwin](https://hardwarepodcasts.com/podcast/lets-combinate/2026-10-12-258-combination-product-quality-human-factors-cdmo-scorecards-iso-14971-vs-ich-q) (Let's Combinate)
- [015 - "Would You Use it on a Family Member?" with Monir El Azzouzi](https://hardwarepodcasts.com/podcast/lets-combinate/2022-01-19-015-would-you-use-it-on-a-family-member-with-monir-el-azzouzi) (Let's Combinate)

## Citing this page

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