# #361: Speaking the Language of IVD

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2024-04-19
- Length: 44m
- Episode: 361
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-04-19-361-speaking-the-language-of-ivd
- Listen: https://podcast.greenlight.guru/episode/361-speaking-the-language-of-ivd

## Summary

Christie Hughes, a principal consultant and IVD expert at Qserve Group, explains the distinct regulatory, design, and risk management requirements for in vitro diagnostics (IVDs) compared to general medical devices. She details how IVDs are classified by complexity, the critical importance of user needs for diverse operators ranging from lab technicians to laypeople, and the specific hazards of false positives and negatives. Hughes also highlights the current industry upheaval caused by the FDA's proposed rule on Laboratory Developed Tests (LDTs) and the ongoing transition to the European IVDR, noting the significant compliance burden for labs and manufacturers alike.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-04-19-361-speaking-the-language-of-ivd#t=0) Introduction: Christie Hughes and Qserve Group
- [3:27](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-04-19-361-speaking-the-language-of-ivd#t=207) Regulatory Landscape: LDTs, IVDR, and Enforcement Discretion
- [11:24](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-04-19-361-speaking-the-language-of-ivd#t=684) IVD Subspecialties and Classification Systems
- [19:06](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-04-19-361-speaking-the-language-of-ivd#t=1146) Risk Management: False Positives, Negatives, and Patient Harm
- [29:38](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-04-19-361-speaking-the-language-of-ivd#t=1778) Design Controls and User Needs in IVD Development
- [39:04](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-04-19-361-speaking-the-language-of-ivd#t=2344) Resources for Learning IVD Regulatory Language

## Topics

- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Design for manufacturing & NPI](https://hardwarepodcasts.com/topic/design-for-manufacturing)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)

## Most relevant to

early-stage companies

## Mentioned

- Qserve Group (company)
- FDA (other)
- IVDR (other)
- CDRH (other)
- ISO 13485 (other)
- ISO 14971 (other)
- CLIA (other)

## Related episodes from other shows

- [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)
- [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)
- [055 - "Critical Tasks and Knowledge Tasks" with Alexandra Benbadis](https://hardwarepodcasts.com/podcast/lets-combinate/2022-10-19-055-critical-tasks-and-knowledge-tasks-with-alexandra-benbadis) (Let's Combinate)
- [099 - Medical Device vs. Medicinal Product Reviews in the EU, Working at MHRA, Notified Bodies, EU MDR, ICH Q6 and Writing All About It with Janine Jamieson](https://hardwarepodcasts.com/podcast/lets-combinate/2023-08-23-099-medical-device-vs-medicinal-product-reviews-in-the-eu-working-at-mhra-notifi) (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)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-04-19-361-speaking-the-language-of-ivd. 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 Global Medical Device Podcast.