# Early Feasibility Studies in Latin America

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2022-06-08
- Length: 42m
- Episode: 266
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-06-08-early-feasibility-studies-in-latin-america
- Listen: https://podcast.greenlight.guru/episode/early-feasibility-studies-in-latin-america

## Summary

Julio Martinez-Clark, CEO and co-founder of BioAccess, explains why Colombia is an ideal destination for early feasibility studies (EFS) and first-in-human clinical trials for US medtech companies. He details how Colombia offers cost-effective, ethical, and high-quality sites, addressing the immense struggle US companies face with patient recruitment and expensive, slow FDA processes. Martinez-Clark highlights Colombia's regulatory predictability, cultural similarities, and unique GCP certification process, while noting challenges like language barriers and the need for Spanish translation of regulatory documents.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-06-08-early-feasibility-studies-in-latin-america#t=0) Introduction: Julio Martinez-Clark and BioAccess
- [3:51](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-06-08-early-feasibility-studies-in-latin-america#t=231) Why Colombia for Early Feasibility Studies
- [8:31](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-06-08-early-feasibility-studies-in-latin-america#t=511) Colombia's Business and Regulatory Advantages
- [11:59](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-06-08-early-feasibility-studies-in-latin-america#t=719) Challenges: Language and Translation Barriers
- [15:10](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-06-08-early-feasibility-studies-in-latin-america#t=910) Colombia's Unique GCP Hospital Certification
- [19:46](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-06-08-early-feasibility-studies-in-latin-america#t=1186) Sponsor Tours and Site Selection Process
- [24:29](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-06-08-early-feasibility-studies-in-latin-america#t=1469) BioAccess Services and Market Access
- [28:25](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-06-08-early-feasibility-studies-in-latin-america#t=1705) Patient Recruitment and Social Media Strategies
- [32:54](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-06-08-early-feasibility-studies-in-latin-america#t=1974) Commercialization and Latin American Regulatory Landscape

## 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)
- [Manufacturing partners & offshoring](https://hardwarepodcasts.com/topic/manufacturing-partners)

## Most relevant to

early-stage companies

## Mentioned

- BioAccess (company)
- Greenlight Guru (company)
- FDA (other)
- Colombia (other)
- Latin America (other)
- OECD (other)
- Pacific Alliance (other)
- UMDR (other)
- MDSAP (other)
- ISO 13485 (other)

## Related episodes from other shows

- [Electronica 24: Innovation, Economic Transformation, Democracy and Sustainability in Costa Rica](https://hardwarepodcasts.com/podcast/ems-c-level/2025-01-31-electronica-24-innovation-economic-transformation-democracy-and-sustainability-i) (EMS@C-LEVEL)

## 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/2022-06-08-early-feasibility-studies-in-latin-america. 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.