# Best Practices for Clinical Evidence Management

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2022-09-22
- Length: 46m
- Episode: 281
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-09-22-best-practices-for-clinical-evidence-management
- Listen: https://podcast.greenlight.guru/episode/best-practices-for-clinical-evidence-management

## Summary

Keith and Kevin Kallmes, founders of Nested Knowledge, discuss the critical role of clinical evidence in medical device development, drawing on their experience building and selling a balloon catheter. They argue that entrepreneurs must validate unmet clinical needs through literature and clinician interviews before prototyping to avoid lack of product-market fit. The brothers detail their expensive early mistakes, including inadequate design history files and poor prioritization of navigability over robustness, which forced them to rebuild their device. They emphasize starting design controls at the concept stage and using pre-design validation to de-risk testing protocols before formal DV/DV.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-09-22-best-practices-for-clinical-evidence-management#t=0) Introduction: Keith and Kevin Kallmes of Nested Knowledge
- [3:54](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-09-22-best-practices-for-clinical-evidence-management#t=234) The centrality of clinical outcomes data in development
- [7:21](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-09-22-best-practices-for-clinical-evidence-management#t=441) Validating unmet need before prototyping and design controls
- [11:58](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-09-22-best-practices-for-clinical-evidence-management#t=718) Customer discovery: Talking to clinicians and strategics
- [15:14](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-09-22-best-practices-for-clinical-evidence-management#t=914) Systematic literature review and determining 'enough' evidence
- [18:08](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-09-22-best-practices-for-clinical-evidence-management#t=1088) Lessons from Nested Knowledge's first device failure
- [26:38](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-09-22-best-practices-for-clinical-evidence-management#t=1598) The importance of pre-design validation (pre-DV)
- [29:50](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-09-22-best-practices-for-clinical-evidence-management#t=1790) Managing clinical evidence and risk-based testing
- [31:21](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-09-22-best-practices-for-clinical-evidence-management#t=1881) Aging tests, sterilization, and entropy challenges
- [34:38](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-09-22-best-practices-for-clinical-evidence-management#t=2078) Prioritizing user needs and managing trade-offs
- [39:49](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-09-22-best-practices-for-clinical-evidence-management#t=2389) Clinical trial design, data harmonization, and CROs

## Topics

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

## Most relevant to

early-stage companies

## Mentioned

- Nested Knowledge (company)
- Marblehead Medical (company)
- Greenlight Guru (company)
- PubMed (tool)
- FDA (other)
- ISO 13485 (other)
- 510(k) (other)

## Related episodes from other shows

- [074: Medical Device Product Development Best Practices](https://hardwarepodcasts.com/podcast/product-startup/2021-05-05-074-medical-device-product-development-best-practices) (Product Startup)
- [Dakota Welker | User Needs, Design Inputs, Verification & Validation](https://hardwarepodcasts.com/podcast/being-an-engineer/2026-09-25-dakota-welker-user-needs-design-inputs-verification-validation) (Being an Engineer)
- [005 - “Compassionate Product Development” with Cameron Jones](https://hardwarepodcasts.com/podcast/lets-combinate/2021-11-03-005-compassionate-product-development-with-cameron-jones) (Let's Combinate)
- [176 - The Fastest Way to Ruin Drug/Device Development (And How to Avoid It!) with Eric Sugalski](https://hardwarepodcasts.com/podcast/lets-combinate/2025-02-19-176-the-fastest-way-to-ruin-drug-device-development-and-how-to-avoid-it-with-eri) (Let's Combinate)
- [104: Medical Device Certification vs Wellness Device](https://hardwarepodcasts.com/podcast/product-startup/2021-12-01-104-medical-device-certification-vs-wellness-device) (Product Startup)

## 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/2022-09-22-best-practices-for-clinical-evidence-management. 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.