Systems Engineering and Point of Care Testing: Report from the NIBIB POCT/Systems Engineering Workshop

Area of Science:

• Biomedical Engineering
• Health Systems Science
• Clinical Informatics

Background:

• Systems engineering offers a framework for understanding and managing complex, interconnected systems.
• Point-of-care testing (POCT) technologies are emerging but their success depends on integration within broader healthcare ecosystems.
• The National Institute of Biomedical Imaging and Bioengineering (NIBIB) convened a workshop to explore the future of POCT.

Purpose of the Study:

• To introduce systems engineering concepts and their application to healthcare and POCT.
• To report on a workshop that identified future directions and challenges for POCT technologies.
• To develop a conceptual framework for POCT, considering its integration into various healthcare settings.

Main Methods:

• A modified deep dive workshop was conducted with diverse experts from clinical care, engineering, and regulatory affairs.
• Participants were divided into four thematic groups: Home, Outpatient, Public/shared space, and Rural/global.
• The workshop explored the current state of POCT, future directions, and long-term goals, identifying commonalities and specific challenges.

Main Results:

• A conceptual framework for POCT was developed, defining its functional space by four dimensions: Time, Location, Interpretation, and Tempo.
• Key challenges for POCT development and implementation were identified, categorized into eight areas: Design, Patient demand, Information presentation, Health Information Systems, Connectivity, Workflow, Maintenance/Cost, and Quality Control.
• Commonalities and specific challenges across different thematic areas (Home, Outpatient, Public/shared, Rural/global) were highlighted.

Conclusions:

• Systems engineering provides valuable tools for advancing POCT and integrating it effectively into healthcare.
• Addressing the identified challenges in technology development and implementation is crucial for the successful future of POCT.
• The proposed framework and identified challenges offer guidance for future research, development, and policy in point-of-care testing.