# 059 - Literature Review, EU MDR CER’s, and Being Problem Driven with Ethan Drower

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2022-11-16
- Length: 41m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2022-11-16-059-literature-review-eu-mdr-cers-and-being-problem-driven-with-ethan-drower
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/059---Literature-Review--EU-MDR-CERs--and-Being-Problem-Driven-with-Ethan-Drower-e1qm5vs

## Summary

Ethan Drower, Co-Founder of CiteMed, explains how his company uses software to streamline the literature review process for EU MDR Clinical Evaluation Reports (CERs). He details the shift from ad-hoc searches to rigorous, reproducible protocols required by notified bodies, emphasizing the need to track search results and maintain continuous risk-benefit assessments. Drower discusses the operational challenges of managing large portfolios of devices and the importance of validating software tools to ensure compliance and efficiency in regulatory submissions.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2022-11-16-059-literature-review-eu-mdr-cers-and-being-problem-driven-with-ethan-drower#t=0) Introduction: Ethan Drower and CiteMed
- [2:19](https://hardwarepodcasts.com/podcast/lets-combinate/2022-11-16-059-literature-review-eu-mdr-cers-and-being-problem-driven-with-ethan-drower#t=139) Drower's Problem-Driven Career Path
- [11:56](https://hardwarepodcasts.com/podcast/lets-combinate/2022-11-16-059-literature-review-eu-mdr-cers-and-being-problem-driven-with-ethan-drower#t=716) The EU MDR Literature Review Problem
- [15:39](https://hardwarepodcasts.com/podcast/lets-combinate/2022-11-16-059-literature-review-eu-mdr-cers-and-being-problem-driven-with-ethan-drower#t=939) Reproducibility and Validation Requirements
- [21:14](https://hardwarepodcasts.com/podcast/lets-combinate/2022-11-16-059-literature-review-eu-mdr-cers-and-being-problem-driven-with-ethan-drower#t=1274) CiteMed's Software Solution for Organization
- [25:51](https://hardwarepodcasts.com/podcast/lets-combinate/2022-11-16-059-literature-review-eu-mdr-cers-and-being-problem-driven-with-ethan-drower#t=1551) Systematic Review Process and Classification
- [33:53](https://hardwarepodcasts.com/podcast/lets-combinate/2022-11-16-059-literature-review-eu-mdr-cers-and-being-problem-driven-with-ethan-drower#t=2033) Writer Qualifications and Notified Body Scrutiny
- [36:13](https://hardwarepodcasts.com/podcast/lets-combinate/2022-11-16-059-literature-review-eu-mdr-cers-and-being-problem-driven-with-ethan-drower#t=2173) Future of Regulatory Technology and AI

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)
- [Careers & education](https://hardwarepodcasts.com/topic/engineering-careers-and-education)
- [AI & machine learning](https://hardwarepodcasts.com/topic/ai-and-machine-learning)
- [Starting a product company](https://hardwarepodcasts.com/topic/starting-a-company)

## Most relevant to

early-stage companies

## Mentioned

- CiteMed (company)
- EU MDR (other)
- Clinical Evaluation Report (other)
- MDR (other)
- MedDev (other)
- PubMed (other)
- FDA (company)
- Eudamed (other)
- ISO 13485 (other)
- How to Get Rich (other)

## Related episodes from other shows

- [Systematic Literature Review for EU MDR](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-04-05-systematic-literature-review-for-eu-mdr) (Global Medical Device Podcast)
- [#362: Managing Risk in Clinical Investigations](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-04-25-362-managing-risk-in-clinical-investigations) (Global Medical Device Podcast)
- [Bridging the Gap between Medical Devices and Clinical Data](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-04-20-bridging-the-gap-between-medical-devices-and-clinical-data) (Global Medical Device Podcast)
- [Assessing the Global Regulatory Landscape](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-10-21-assessing-the-global-regulatory-landscape) (Global Medical Device Podcast)
- [Challenges for Regulatory Submission: EU vs. US](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-05-06-challenges-for-regulatory-submission-eu-vs-us) (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/2022-11-16-059-literature-review-eu-mdr-cers-and-being-problem-driven-with-ethan-drower. 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.