# 049 - "What Does the Data Say?" with Shannon Hoste

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2022-09-07
- Length: 46m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2022-09-07-049-what-does-the-data-say-with-shannon-hoste
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/049---What-Does-the-Data-Say--with-Shannon-Hoste-e1maqs8

## Summary

Shannon Hoste, President of Agilis Consulting and former FDA reviewer, explains the regulatory framework for combination products, detailing the distinct roles of CDRH, CDER, and DMEPA in human factors reviews. She clarifies the critical distinction between design validation and human factors validation, emphasizing that the latter focuses specifically on safe and effective use rather than all user needs. Hoste also discusses the methodology for summative evaluations, including the rationale for the N=15 sample size per user group and strategies for recruiting representative participants to identify use errors.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2022-09-07-049-what-does-the-data-say-with-shannon-hoste#t=0) Introduction: Shannon Hoste and Agilis Consulting
- [1:50](https://hardwarepodcasts.com/podcast/lets-combinate/2022-09-07-049-what-does-the-data-say-with-shannon-hoste#t=110) Shannon Hoste's Career Path: From Steel to FDA
- [8:56](https://hardwarepodcasts.com/podcast/lets-combinate/2022-09-07-049-what-does-the-data-say-with-shannon-hoste#t=536) FDA Review Process: CDRH, CDER, and DMEPA Interactions
- [18:37](https://hardwarepodcasts.com/podcast/lets-combinate/2022-09-07-049-what-does-the-data-say-with-shannon-hoste#t=1117) Human Factors vs. Usability Engineering and Risk Management
- [21:46](https://hardwarepodcasts.com/podcast/lets-combinate/2022-09-07-049-what-does-the-data-say-with-shannon-hoste#t=1306) Design Validation vs. Human Factors Validation Definitions
- [25:41](https://hardwarepodcasts.com/podcast/lets-combinate/2022-09-07-049-what-does-the-data-say-with-shannon-hoste#t=1541) Summative Human Factors Evaluation Methodology
- [36:21](https://hardwarepodcasts.com/podcast/lets-combinate/2022-09-07-049-what-does-the-data-say-with-shannon-hoste#t=2181) Sampling Strategies: The N=15 Rule and Qualitative Testing
- [40:27](https://hardwarepodcasts.com/podcast/lets-combinate/2022-09-07-049-what-does-the-data-say-with-shannon-hoste#t=2427) Recruiting Representative Users and Screening Protocols

## Topics

- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Industrial & consumer product design](https://hardwarepodcasts.com/topic/industrial-design)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)

## Most relevant to

early-stage companies

## Mentioned

- Agilis Consulting (company)
- FDA (company)
- CDRH (other)
- CDER (other)
- DMEPA (other)
- Stryker (company)
- Intel (company)
- Enable Injections (company)
- Alumina (company)
- Patel (company)
- ISO 13485 (other)
- IEC 62366 (other)
- ISO 14971 (other)
- ISO 82030 (other)
- ASTM (other)

## Related episodes from other shows

- [Setting the Record Straight on Usability & Human Factors](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-11-03-setting-the-record-straight-on-usability-human-factors) (Global Medical Device Podcast)
- [Human Factors & Risk Management: What's Needed & Why?](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-03-02-human-factors-risk-management-whats-needed-why) (Global Medical Device Podcast)
- [#323 The Combination Products Handbook](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-06-16-323-the-combination-products-handbook) (Global Medical Device Podcast)
- [#450: Human Factors vs. Clinical Trials: Why Your MedTech Submission is Stalling](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-03-09-450-human-factors-vs-clinical-trials-why-your-medtech-submission-is-stalling) (Global Medical Device Podcast)
- [#347: Human-Centered Design in Medical Devices](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-12-07-347-human-centered-design-in-medical-devices) (Global Medical Device Podcast)

## Citing this page

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