Exploring the needs of technical developers and stakeholders in point-of-care technology development: a qualitative study.

INTRODUCTION

Point-of-care technologies (POCTs) are essential to providing clinical care for patients, with their potential for rapid and accurate results on site supporting efficient clinical decision-making.

OBJECTIVES

To understand the current key needs, barriers and challenges of POCT developers for effective development and implementation of POCTs across diverse settings particularly in the domain of cancer, nutrition and infections.

DESIGN

A qualitative semi-structured focus group discussion (FGDs) was employed. The FGDs were guided by the needs assessment process and the Phase Gate Framework. The qualitative data were coded and analysed in NVivo and refined into various themes.

SETTING

The study was conducted in person at Cornell Tech Campus in May 2024, New York, USA.

PARTICIPANTS

24 participants were purposively sampled from the PORTENT (Point-of-Care Technologies for Nutrition, Infection and Cancer) network. Participants included technical developers (eg, engineers, scientists, startup leads) and expert stakeholders (eg, funders, policy advisors, clinicians and academic partners) involved in POCT development, evaluation and implementation.

RESULTS

A total of 24 participants participated in the in-person FGDs in New York (n=24). Key themes identified included gaps in stakeholder engagement, limited regulatory preparedness, insufficient market analysis, challenges in scaling and manufacturing and the need for context-specific adaptation in low- and middle-income country (LMIC) settings. Participants emphasised the importance of user-centred and context-responsive design, strategic partnerships and early planning for regulatory and implementation pathways.

CONCLUSIONS

Technical developers and expert stakeholders in the POCT landscape face various barriers to efficient and effective development and implementation of POCTs. It is important to consider their needs when adapting POCTs in LMICs and diverse settings.