# 012 - "Asking then Seeing" with Sara Waxberg Mcnew

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2021-12-22
- Length: 1h 16m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2021-12-22-012-asking-then-seeing-with-sara-waxberg-mcnew
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/012---Asking-then-Seeing-with-Sara-Waxberg-Mcnew-e1bums2

## Summary

Sara Waxberg McNew, Chief Scientific Officer at Design Science, explains the human factors process for medical devices, emphasizing the distinction between formative studies and summative validation. She details how to interpret ANSI/AAMI HE75 and IEC 62366-1 standards, manage risk for combination products, and handle regulatory submissions with the FDA. The discussion covers specific challenges like testing rare patient populations, using surrogates, and conducting threshold analyses for generics.

## Chapters

- [0:01](https://hardwarepodcasts.com/podcast/lets-combinate/2021-12-22-012-asking-then-seeing-with-sara-waxberg-mcnew#t=1) Introduction: Sara Waxberg McNew and Design Science
- [2:01](https://hardwarepodcasts.com/podcast/lets-combinate/2021-12-22-012-asking-then-seeing-with-sara-waxberg-mcnew#t=121) Career Transition: From Industry to Consulting
- [4:54](https://hardwarepodcasts.com/podcast/lets-combinate/2021-12-22-012-asking-then-seeing-with-sara-waxberg-mcnew#t=294) User Populations and Special Considerations
- [11:11](https://hardwarepodcasts.com/podcast/lets-combinate/2021-12-22-012-asking-then-seeing-with-sara-waxberg-mcnew#t=671) Formative Studies and User Needs vs. Requirements
- [16:47](https://hardwarepodcasts.com/podcast/lets-combinate/2021-12-22-012-asking-then-seeing-with-sara-waxberg-mcnew#t=1007) Workflow Issues and Service Design
- [26:03](https://hardwarepodcasts.com/podcast/lets-combinate/2021-12-22-012-asking-then-seeing-with-sara-waxberg-mcnew#t=1563) Human Factors Education and Anthropometrics
- [34:09](https://hardwarepodcasts.com/podcast/lets-combinate/2021-12-22-012-asking-then-seeing-with-sara-waxberg-mcnew#t=2049) Case Study: MR Interface Automation Assumptions
- [36:55](https://hardwarepodcasts.com/podcast/lets-combinate/2021-12-22-012-asking-then-seeing-with-sara-waxberg-mcnew#t=2215) Design Validation vs. Human Factors Validation
- [41:27](https://hardwarepodcasts.com/podcast/lets-combinate/2021-12-22-012-asking-then-seeing-with-sara-waxberg-mcnew#t=2487) The Human Factors Process: Formative to Summative
- [47:56](https://hardwarepodcasts.com/podcast/lets-combinate/2021-12-22-012-asking-then-seeing-with-sara-waxberg-mcnew#t=2876) Regulatory Submissions and FDA Expectations
- [56:41](https://hardwarepodcasts.com/podcast/lets-combinate/2021-12-22-012-asking-then-seeing-with-sara-waxberg-mcnew#t=3401) Combination Products and Threshold Analysis
- [1:04:21](https://hardwarepodcasts.com/podcast/lets-combinate/2021-12-22-012-asking-then-seeing-with-sara-waxberg-mcnew#t=3861) Reading HE75 and IEC 62366 Standards

## 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)
- [Careers & education](https://hardwarepodcasts.com/topic/engineering-careers-and-education)

## Most relevant to

early-stage companies

## Mentioned

- Design Science (company)
- Eli Lilly and Company (company)
- Philips Healthcare (company)
- Baxter Healthcare (company)
- Tufts University (other)
- ANSI/AAMI HE75:2009 (R2018) (other)
- IEC 62366-1:2015 (other)
- FDA (other)

## Related episodes from other shows

- [#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)
- [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)
- [#332: Regulatory Strategy and the Advantage of Diversity in MedTech](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-08-17-332-regulatory-strategy-and-the-advantage-of-diversity-in-medtech) (Global Medical Device Podcast)
- [Why Usability Matters](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-11-24-why-usability-matters) (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)

## 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/2021-12-22-012-asking-then-seeing-with-sara-waxberg-mcnew. 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.