# Managing Business Risk as a Medical Device Company

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2021-05-03
- Length: 34m
- Episode: 201
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-05-03-managing-business-risk-as-a-medical-device-company
- Listen: https://podcast.greenlight.guru/episode/managing-business-risk-as-a-medical-device-company

## Summary

Michael Cremeans, Life Sciences Industry Practice Leader at Hylant, joins host Jon Speer to discuss how medical device companies can manage enterprise business risk beyond just product safety. They cover the importance of engaging insurance experts early to navigate complex contractual liabilities, such as those found in term sheets and group purchasing organization agreements, and how robust quality systems like those in Greenlight Guru can improve insurance outcomes. Cremeans emphasizes that companies should not treat insurance as an afterthought but rather integrate risk management into their overall business strategy to protect against financial and legal damages.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-05-03-managing-business-risk-as-a-medical-device-company#t=0) Introduction and the Case for Business Risk
- [3:17](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-05-03-managing-business-risk-as-a-medical-device-company#t=197) Timing Risk Management Engagement
- [7:33](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-05-03-managing-business-risk-as-a-medical-device-company#t=453) Contractual Liability and Distribution Risks
- [11:34](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-05-03-managing-business-risk-as-a-medical-device-company#t=694) Insurance Requirements in Term Sheets and Contracts
- [19:33](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-05-03-managing-business-risk-as-a-medical-device-company#t=1173) Greenlight Guru's Role in Risk Mitigation
- [24:42](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-05-03-managing-business-risk-as-a-medical-device-company#t=1482) Building a World-Class Risk Profile
- [31:44](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-05-03-managing-business-risk-as-a-medical-device-company#t=1904) Conclusion and Contact Information

## Topics

- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Pricing, margins & unit economics](https://hardwarepodcasts.com/topic/pricing-and-unit-economics)
- [Leadership, teams & culture](https://hardwarepodcasts.com/topic/leadership-and-culture)
- [Policy, trade & tariffs](https://hardwarepodcasts.com/topic/policy-trade-and-tariffs)

## Most relevant to

early-stage companies

## Mentioned

- Hylant (company)
- Greenlight Guru (company)
- ISO 14971 (other)
- ISO 13485 (other)
- FDA (other)

## Related episodes from other shows

- [025 - “The Frying Pan to the Fire” with Edwin Bills](https://hardwarepodcasts.com/podcast/lets-combinate/2022-03-23-025-the-frying-pan-to-the-fire-with-edwin-bills) (Let's Combinate)
- [S5E29 Steve Gompertz | Medical Device Quality Control & Regulatory Requirements](https://hardwarepodcasts.com/podcast/being-an-engineer/2024-07-19-s5e29-steve-gompertz-medical-device-quality-control-regulatory-requirements) (Being an Engineer)
- [Not By Accident: Risk Management for Manufacturing Executives w/ Van Carlson](https://hardwarepodcasts.com/podcast/the-manufacturing-executive/2021-03-02-not-by-accident-risk-management-for-manufacturing-executives-w-van-carlson) (The Manufacturing Executive)
- [068 - Benefit/Risk Ratios, PRRC, and Mythical Medical with David Rutledge](https://hardwarepodcasts.com/podcast/lets-combinate/2023-01-18-068-benefit-risk-ratios-prrc-and-mythical-medical-with-david-rutledge) (Let's Combinate)
- [202 - Becoming an Expert in the Work Nobody Wants to Do/Design, Risk, and the Messy Middle of Combination Products w/Joey Frechin](https://hardwarepodcasts.com/podcast/lets-combinate/2025-08-20-202-becoming-an-expert-in-the-work-nobody-wants-to-do-design-risk-and-the-messy) (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/2021-05-03-managing-business-risk-as-a-medical-device-company. 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.