# The Tools that Make Clinical Investigations

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2023-05-13
- Length: 37m
- Episode: 318
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-05-13-the-tools-that-make-clinical-investigations
- Listen: https://podcast.greenlight.guru/episode/the-tools-that-make-clinical-investigations

## Summary

Jon Bergsteinsson, founder of SMART-TRIAL by Greenlight Guru, discusses the critical role of Electronic Data Capture (EDC) systems in medical device clinical investigations. He argues that while ISO 14155 provides process standards, it does not guarantee data quality, which is instead determined by how data is formatted and collected using digital tools rather than paper or Excel. Bergsteinson highlights that purpose-built EDC platforms reduce the high costs of manual data entry, transcription errors, and audit preparation, ultimately providing a better return on investment than legacy methods. He emphasizes that leadership often lacks understanding of clinical operations and needs education on why digital-first approaches are essential for compliance and efficiency.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-05-13-the-tools-that-make-clinical-investigations#t=0) Introduction: Jon Bergsteinsson and SMART-TRIAL
- [4:49](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-05-13-the-tools-that-make-clinical-investigations#t=289) Challenges with Data Quality and ISO 14155
- [13:50](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-05-13-the-tools-that-make-clinical-investigations#t=830) The Cost Argument: Paper/Excel vs. EDC
- [18:27](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-05-13-the-tools-that-make-clinical-investigations#t=1107) Competitive Advantage of Digital Tools
- [21:43](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-05-13-the-tools-that-make-clinical-investigations#t=1303) Building the Business Case for Leadership
- [27:55](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-05-13-the-tools-that-make-clinical-investigations#t=1675) Case Study: Manual Data Entry from Japan
- [31:26](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-05-13-the-tools-that-make-clinical-investigations#t=1886) Why Digital-First Sets the Best Apart

## Topics

- [Connected products & IoT](https://hardwarepodcasts.com/topic/connected-products-and-iot)
- [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)

## Most relevant to

early-stage companies

## Mentioned

- SMART-TRIAL (product)
- Greenlight Guru (company)
- ISO 14155 (other)
- Excel (tool)
- SolidWorks (tool)

## Related episodes from other shows

- [S1E12 Simplifying Quality Management | Jon Speer](https://hardwarepodcasts.com/podcast/being-an-engineer/2020-06-05-s1e12-simplifying-quality-management-jon-speer) (Being an Engineer)
- [It’s Time for a Digital Transformation of Analog Data Entry](https://hardwarepodcasts.com/podcast/the-manufacturing-executive/2022-07-26-its-time-for-a-digital-transformation-of-analog-data-entry) (The Manufacturing Executive)
- [Quality Management in a Changing Manufacturing Environment w/ Naveen Poonian](https://hardwarepodcasts.com/podcast/the-manufacturing-executive/2024-08-27-quality-management-in-a-changing-manufacturing-environment-w-naveen-poonian) (The Manufacturing Executive)
- [205 - Why Less Than 20% of Companies Have Started Quality 4.0](https://hardwarepodcasts.com/podcast/lets-combinate/2025-09-11-205-why-less-than-20-of-companies-have-started-quality-4-0) (Let's Combinate)
- [123 - Uncovering HUGE Quality Issues, Inspection Readiness in 2024, Data Integrity, AlCOA+/PIC/S and Critical Thinking in Quality Management with Peter Baker](https://hardwarepodcasts.com/podcast/lets-combinate/2024-02-14-123-uncovering-huge-quality-issues-inspection-readiness-in-2024-data-integrity-a) (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/2023-05-13-the-tools-that-make-clinical-investigations. 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.