Point-of-Care Technology Research Network: An evolving model for collaborative translational research in biomedical engineering

Abstract

As the healthcare system evolves from a centralized, hospital- and office-based model to an emphasis on patient-centric care delivered in decentralized settings from the community and/or home to low resource settings domestically and internationally, some Point-of-Care Technologies (POCT) have become important and others may soon become important in facilitating care. These portable diagnostic and monitoring devices enable moving care closer to the patient. We review recent developments in a national model to accelerate the development of POCT, specifically the Point-of-Care Technology Research Network (POCTRN), comprising a multi-center scientific network supported by a coordinating center. We summarize the history of the Network, and then describe the primary objectives and key activities of the Network and highlight the role of a new coordinating center providing administrative and infrastructure support. POCTRN is committed to building evidence-based best practices for high-quality translation and commercialization in biomedical engineering to maximize clinical impact of Point-of-Care Technologies.

The healthcare system is evolving from the traditional, centralized, hospital- and office-based model to a model based on patient-centric care that is delivered in decentralized settings from the community and/or home to low resource settings domestically and internationally. In this context, some Point-of-Care Technologies (POCT) have become important and others may soon become important in facilitating care wherever the patient may be – the home, office, retail clinic, hospital bedside, or military field. These portable diagnostic, monitoring and treatment devices enable moving care to the patient rather than moving the patient to a site of care.

Early POCT for glucose levels and diagnosis of pregnancy and influenza are well-known. More sophisticated tests are now available or under development for a range of applications including acute and chronic disease management, clinical chemistry testing, imaging, and telehealth. This article reviews recent developments in a national model to accelerate the development of POCT, specifically the Point-of-Care Technology Research Network (POCTRN), created by the National Institutes of Health, and comprised of a multi-center scientific network supported by a coordinating center.

A new model for translational research in biomedical engineering

In 2006, the National Institute of Biomedical Imaging and Bioengineering (NIBIB), National Heart Lung and Blood Institute (NHLBI), and National Science Foundation (NSF) convened a workshop called “Improving Health Care Accessibility through Point-of-Care Technologies”‘ to address healthcare delivery challenges, particularly the fragmentation and inaccessibility of care [1]. The central workshop theme was that moving medical testing closer to the point at which care was delivered would reduce fragmentation of care and improve accessibility and clinical outcomes.

The workshop assessed clinical needs and opportunities for applications of POCT in a range of settings, including primary care, the home, emergency medical services, and global health. Sessions explored the state of development in sensors and microsystems, low-cost imaging, non-invasive monitoring, telehealth and informatics.

Based on recommendations emerging from the workshop, NIBIB created the Point-of-Care Technology Research Network (POCTRN) in 2007. POCTRN was designed to utilize a network model linking multiple Centers to create collaborations and leverage complementary strengths. Since its inception, the long-term goal of POCTRN has been to create a dynamic, sustainable national network that could identify key unmet medical needs as well as promising POCT technologies and then accelerate the translation of these technologies into solutions for broad impact in healthcare through de-risking and commercialization.

Since the inception of the network, there have been two completed five-year cycles of funding and a third five-year cycle currently underway. To date, POCTRN has supported ten academic Centers spanning diverse disciplines, institutions and geographic regions as listed in Table 1. NIH funding sponsors for the current Centers are listed in Table 2.

Table 1.

Point-of-Care Technology Research Network centers 2007–2023.

• Centers funded from 2007 to 2012 (Principal Investigators are in italics):

∘ Point-of-Care Center for Emerging Neurotechnologies, University of Cincinnati (Dr. Fred Beyette)

∘ Center for Point-of-Care Technologies Research for Sexually Transmitted Diseases, Johns Hopkins University (Dr. Charlotte Gaydos)

∘ Center for Point-of-Care Technologies for Disaster Readiness, University of California, Davis (Dr. Gerald Kost)

∘ Center to Advance Point-of-Care Diagnostics for Global Health, Program for Appropriate Technology in Health (PATH), (Dr. Bernhard Weigl)

• Centers funded from 2012 to 2017:

∘ Center for Point-of-Care Technologies Research for Sexually Transmitted Diseases, Johns Hopkins University (Dr. Charlotte Gaydos)

∘ Center for Future Technologies in Cancer Care, Boston University (Dr. Catherine Klapperich)

∘ Point-of-Care Technology Research Center in Primary Care, CIMIT (Drs. John Parrish and Steven Schachter)

• Centers funded from 2018 to 2023:

∘ Atlanta Center for Microsystems Engineered Point-of-Care Technologies (ACME), Emory University and Georgia Tech, (Drs. Oliver Brand, Wilbur Lam, and Greg Martin)

∘ Center for Point-of-Care Technologies Research for Sexually Transmitted Diseases, Johns Hopkins University (Drs. Charlotte Gaydos and Yukari Manabe)

∘ Center for Innovation in Point-of-Care Technologies for HIV/AIDS at Northwestern (C-THAN), Northwestern University (Drs. Sally McFall and Robert Murphy)

∘ Center for Advancing Point of Care in Heart, Lung, Blood, and Sleep Diseases (CAPCaT), University of Massachusetts (Drs. David McManus and Bryan Buchholz)

∘ Point-of-Care Technology Research Network Coordinating Center, CIMIT, (Drs. Steven Schachter and John Parrish)

Table 2.

NIH sponsors of the current Point-of-Care Technology Research Network.

• National Institute of Biomedical Imaging and Bioengineering

• National Heart, Lung, and Blood Institute

• National Institute of Allergy and Infectious Diseases

• National Center for Complementary and Integrative Health

• Fogarty International Center

• Office of Behavioral and Social Sciences Research

• Office of AIDS Research and Office of Disease Prevention

NIH POCTRN Program Directors: Tiffani Lash, Ph.D. (NIBIB) and Jue Chen, Ph.D. (NHLBI)

Current POCTRN centers

POCTRN’s purpose is to drive the development of appropriate POC diagnostic technologies through collaborative efforts that merge scientific and technological capabilities with clinical need.

The four current POCTRN Centers identify unmet medical needs and issue annual solicitations for proposals (www.poctrn.org), selecting promising proposals for funding through a rigorous peer review process. Centers typically fund three to five proposals per year for a period of six months to one year. Additional information can be found in other articles in this special issue.

Atlanta Center for Microsytems Engineered Point-of-Care Technologies (ACME-POCT)

ACME-POCT is focused on the development and translation of microsystems-engineered technologies including microchip-enabled devices that include microelectromechanical systems (MEMs)-based sensors, microfluidics, and smartphone-based systems. These microdevices are notable for their small size, batch manufacturability, and low power requirements, which are vital for point-of-care testing. The overall mission of the ACME-POCT is to assist and enable inventors and clinicians at a national level who have developed or are developing microsystems-based POCT to define their clinical needs, conduct clinical validation, and refine their technology with the objective of accelerating the path to translation and clinical adoption and directly addressing the barriers thereof.

Johns Hopkins University Center for Point-of-Care Technologies Research for Sexually Transmitted Diseases

The long-term goals of this Center include addressing the epidemics of STDs/HIV in the U.S. and in resource-poor settings by development and better use of point-of-care tests to address health inequity and improve the sexual health of individuals. Its mission is to develop and test the accuracy, acceptability, and optimal implementation of point-of-care tests for sexually transmitted diseases in diverse care delivery contexts both in the United States and in resource-limited settings. Rapid diagnosis and prompt treatment will improve sexual health in the world and prevent transmission of these infectious diseases. Definitive diagnoses of STDs may also change behavior, and, thereby, add to the sexual wellbeing of individuals. Considering resource-limited settings (RLS) early in the development process when defining the need and the design may allow for more frugal innovation; RLS often have diverse settings that may have more harsh environmental conditions (e.g., temperature and humidity) and require inexpensive products to ensure impact on patient-centered outcomes.

Center for Innovation in Point-of-Care Technologies for HIV/AIDS (C-THAN)

C-THAN supports the development of a pipeline of POCT designed to meet the clinical needs of people who live with HIV/AIDS in low- and middle-income countries. The core mission is to design products that aid in the diagnosis, management, monitoring and prevention of HIV and its complications. C-THAN has assembled a scientific consortium made up of Northwestern University, Universities of Lagos, Ibadan and Jos (Nigeria), Cape Town and Stellenbosch (South Africa), University of Sciences, Techniques and Technologies of Bamako (Mali) and Muhimbili University of Health and Allied Sciences (Tanzania).

Center for Advancing Point of Care in Heart, Lung, Blood and Sleep Diseases (CAPCaT)

CAPCaT’s core mission is to support development, deployment, and testing of promising “late-stage” POCT that can be rapidly deployed to enhance the diagnosis, monitoring, management, and/or treatment of heart, lung, blood or sleep disorders, with an additional interest in projects that incorporate complementary and integrative health approaches. These approaches include natural products, such as herbs, prebiotic, probiotics, and selective medical diets, and mind and body practices including acupuncture, meditation, manual therapies (e.g., spinal manipulation/mobilization), hypnosis, meditative movements (e.g. tai chi, yoga, etc.), and music/art therapies.

Key activities of each center

• Assessment of clinical and user needs to inform device design and further define publicly available clinical needs information

• Evaluation of promising POC prototype or working devices from the perspective of device performance and potential for clinical impact

• Completion of clinical testing appropriate for the stage of development of the chosen POC technology and the target clinical application, to facilitate translation and commercialization

• Training and education of relevant stakeholders in the development and utilization of POC technologies, including technology developers, industry partners, practitioners and the lay community (as potential users)

• Development of partnerships with industry and other stakeholders to facilitate commercialization

• Utilization of network collaboration as needed to achieve goals and increase visibility of POC testing

POCTRN Coordinating Center

A POCTRN Coordinating Center was established by NIH in 2018 to provide administrative and infrastructure support to the component Centers and the Network overall. The Coordinating Center is based at CIMIT (www.cimit.org) in Boston. By building upon its experience as a POCTRN Center in Primary Care in prior years, the Coordinating Center has developed a robust infrastructure to support Center leadership, investigators and the POC community.

The objectives of the Coordinating Center are to streamline administrative processes, thereby minimizing the administrative burden on individual Centers; share experiences and learnings from prior POCTRN cycles with the Centers to accelerate start-up and sustain momentum; enable network cohesion and collaboration by assisting Centers to leverage complementary strengths and avoid duplicative efforts; and collaborate with the Centers to build an evidence base on best practices for high-quality translation and commercialization to maximize clinical impact of POC technologies.

To achieve these objectives, the Coordinating Center provides the following resources, some of which are further described elsewhere in this special issue: 1) CIMIT CoLab®, the virtual collaboration platform, for proposal management, 2) Guidance and Impact Tracking System (GAITS) for project milestone and impact tracking and reporting, 3) CRAASH (Commercialization Results Accelerator to Advance Solutions in Healthcare) course for selected teams, 4) POCTRN website (www.poctrn.org), and 5) Webinars (recorded and archived on the website [https://www.poctrn.org/meetings]) and co-authored publications [2,3] for educating the community of interested clinicians and biomedical engineers.

POCTRN – an evolving model that works

POCTRN is committed to building evidence-based best practices for high-quality translation and commercialization to maximize clinical impact of POC technologies.

From 2012 to 2017, POCTRN supported over 90 projects and provided consultation and engagement with ~2500 other researchers. Comprehensive metrics for the entire network will be reported in a separate publication. As an example of the impact that an individual Center can have, the Point-of-Care Technology Research Center in Primary Care achieved the following metrics from 2012 to 2017:

• Created a portfolio of 31 awards at different levels of maturity across the development pipeline with >65% still active in Year 5

• Established a national award network (e.g., 66% of projects funded in Year 4 and 5 were from outside the regional base of the Center)

• Increasing emphasis towards the end of the 5-year period on funding companies to support later stage development with increased likelihood of near-term impact (e.g., 50% of awards in Year 5)

• Enabled funding: $48.5 million (approximately 20X the NIBIB investment)

• Publications: 43 (37 scientific, 6 Center leadership)

• Patents: 8 (2 issued, 4 full applications; 2 provisional applications)

• Presentations: 57 conference proceedings and presentations.

Conclusion

As healthcare system models evolve with increasing emphasis on patient-centric care delivered in distributed settings in the community and home, the need for POCT to enable this model of care has intensified. To accelerate POCT development, NIH created POCTRN, a model that supports and facilitates collaborations across disciplines, institutions, and geographic regions. This dynamic multi-center network accelerates the translation of POCTs into solutions for broad impact in healthcare through de-risking and commercialization. As the network grows, POCTRN continues to build an evidence base on best practices for high-quality translation and commercialization to maximize clinical impact of Point-of-Care Technologies.