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Practice
How to implement new diagnostic products in low-resource settings: an end-to-end framework
  1. Melissa Latigo Mugambi1,
  2. Trevor Peter2,
  3. Samuel F Martins3,
  4. Cristina Giachetti4
  1. 1 Department of Global Health, University of Washington, Seattle, Washington, USA
  2. 2 Clinton Health Access Initiative, Boston, Massachusetts, USA
  3. 3 Bill and Melinda Gates Foundation, Seattle, Washington, USA
  4. 4 AdvantDx, San Diego, California, USA
  1. Correspondence to Dr Melissa Latigo Mugambi; mugambi{at}uw.edu

Abstract

Diagnostics developers often face challenges introducing in-vitro diagnostic (IVD) products to low- and middle-income countries (LMICs) because of difficulty in accessing robust market data, navigating policy and regulatory requirements and implementing and supporting products in healthcare systems with limited infrastructure. Best practices recommend the use of a phase-gate model with defined activities and milestones by phase to successfully move a product from concept to commercialisation. While activities for commercialisation of products in high-income countries (HICs) are well understood, the activities required for introduction of IVDs in LMICs are not. In this paper, we identify the key activities needed for IVD product development and implementation and map them to the various phases of the model, paying particular attention to those activities that might be conducted differently in LMICs.

  • in-vitro diagnostics
  • product development
  • implementation
  • phase-gate model
  • low-and middle-income countries

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/bmjgh-2018-000914

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    Footnotes

    • Handling editor Seye Abimbola

    • Contributors MLM wrote the first draft of this paper with substantial input from CG. All authors (MLM, TP, SDFM, CG) provided critical input on subsequent drafts.

    • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

    • Competing interests None declared.

    • Patient consent Not required.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data sharing statement No additional data are available.