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

Area of Science:

• Biomedical Engineering
• Global Health
• Medical Diagnostics

Background:

• Point-of-care technologies (POCTs) are vital for rapid, on-site clinical decision-making.
• Effective POCT development requires understanding developer needs and challenges.
• POCTs are particularly important in cancer, nutrition, and infection diagnostics.

Purpose of the Study:

• To identify key needs, barriers, and challenges faced by POCT developers.
• To understand POCT development and implementation across diverse settings.
• To inform strategies for improving POCT effectiveness, especially in resource-limited areas.

Main Methods:

• Qualitative semi-structured focus group discussions (FGDs) were conducted.
• The study utilized a needs assessment process and the Phase Gate Framework.
• Data were collected from 24 technical developers and expert stakeholders in New York.

Main Results:

• Identified key themes: stakeholder engagement gaps, regulatory hurdles, market analysis deficits, manufacturing challenges, and LMIC adaptation needs.
• Participants stressed the importance of user-centered, context-responsive design.
• Emphasis was placed on strategic partnerships and early regulatory planning.

Conclusions:

• POCT developers and stakeholders encounter significant barriers to efficient development and implementation.
• Addressing developer needs is essential for adapting POCTs in low- and middle-income countries (LMICs) and diverse global settings.