2024 Award Competition

Funding Opportunity

The Center for Advancing Point of Care Technologies (CAPCaT) in Heart, Lung, Blood, and Sleep Disorders (U54HL143541) announces the 2024 solicitation of grant applications focused on developing, adapting, or validating point of care technologies that can be rapidly applied to heart, lung, blood, or sleep disorders, with additional interest in projects that incorporate complementary and integrative health approaches. We plan, based on the receipt of meritorious applications, to fund up to four awards of up to $100,000 over 12 months, with one or more award(s) focused on complementary and integrative health.

Overview

CAPCaT was established with support from the National Heart, Lung, and Blood Institute (NHLBI) as well as the National Center for Complementary and Integrative Health (NCCIH). Our core mission is to support development and testing of promising point of care technologies that can be rapidly deployed to enhance the diagnosis, monitoring, management, and prevention of heart, lung, blood, or sleep disorders (NHLBI), with an additional interest in projects that incorporate complementary and integrative health approaches (NCCIH). We are a member of the Point of Care Technologies Research Network. For a listing of prior successful grant awardees, please see our website.

Areas of Focus

This national solicitation for CAPCaT’s pilot funding aims to attract research applications focused broadly on accelerating the development and clinical testing of point of care technologies for heart, lung, blood, and sleep (HLBS) disorders.

We conducted clinical needs assessments in 2019, 2020, and 2021 that identified chronic cardiovascular diseases, coagulopathies and other blood disorders, sleep disorders and lung diseases as the top conditions for which POC technologies could help diagnose, monitor, better manage, or prevent condition(s) (including complications of COVID-19) across the Heart, Lung, Blood, and Sleep spectrum. Additionally, accuracy, ease with which the technology could be incorporated into existing clinical workflows, availability, and cost were identified as the most important POC characteristics to healthcare providers. Applications that seek to address the conditions listed above, that have the desirable characteristics listed above, as well as those that address health disparities/social determinants of health will be given special consideration. We are particularly interested in the development of disease diagnostics and monitoring devices, wearable technologies, mobile applications, and other tools to improve heart, lung, blood, and sleep (HLBS) health in historically underserved, low-resource, and remote communities. We are also interested in the development of tools and technologies that will address barriers to uptake of the implementation and dissemination of evidence-based interventions for HLBS conditions and disorders in minority and low-income communities. Taken together, these areas of focus will be the basis for this funding round.

Areas of focus related to heart, lung, blood, and sleep disorders:

• POC technologies that aid in the home-based management of cardiometabolic disease by identifying acute decompensations (i.e., detection of an acute flare of chronic obstructive lung disease or decompensation after COVID-19 infection, thereby avoiding hospital admission) in specific populations (e.g., according to race, ethnicity, sex/gender, socioeconomic status).
• POC technologies that help better define patients at risk of bleeding or thrombosis, including key groups such as those treated with anticoagulants for pulmonary hypertension, venous thromboembolism, pulmonary embolism, or atrial fibrillation.
• POC technologies that help differentiate patients with atherosclerotic heart disease who will progress to myocardial infarction or sudden death from those with stable disease.
• Technologies that can monitor or enhance physiological responses to therapies (e.g., continuous positive airway pressure devices) at the point of care for the treatment of sleep disorders.
• POC devices that define physiologic, phenotypic, or molecular characteristics to predict HLBS outcomes and, when applied in clinical studies, predict differential responses to therapy in individuals and in different populations with HLBS disorders (e.g., sickle cell disease, heart failure).
• Mobile health (mHealth) and telehealth/telemedicine technologies and apps for improving communication among health care providers and between patients, families, and physicians and healthcare providers, medication adherence, diagnosis, monitoring, evaluation, medical management, screening, tracking, and treatment in underserved community settings and rural and remote locations.
• Leveraging robotic and autonomous systems for improving health, and preventing, reducing, and eliminating health disparities.
• “Smart” POC devices that both monitor physiology and use novel algorithms to assist, adjust, or intervene automatically to treat acute complications of cardiovascular disease (e.g., a heart failure monitor that can be used to adjust diuretic dosing to reduce acute heart failure worsening).
• POC technology that enables real-time, individual-level remote monitoring that would be used to detect and predict worsening respiratory status and reduce risk for intubation or hospitalization (i.e., in the context of pneumonia or recovery from COVID-19).
• POC technologies well-suited for use by healthcare providers in the ambulatory clinic or home setting that accurately measure critical determinants of health, including treatment adherence, integrate them into the electronic health record, and enhance quality of care. 

Areas of focus related to complementary and integrative health:
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.

• POC devices or applications that can monitor the dose, intensity, duration and/or frequency of complementary and integrative health approaches employed by the patients at the point of care.
• Solutions that integrate multiple signals into a signal output to measure the effectiveness of complementary and integrative health approaches, such as yoga and meditation, especially across HLBS metric (e.g., blood pressure, sleep). 
• POC devices or applications that use Artificial Intelligence/Machine Learning (AI/ML) to understand the effects of multicomponent interventions on multiple physiological and biological systems to monitor or quantify physical and/or emotional well-being, breathing, or sleep.
• POC technologies to improve biological and physiological outcome measures for use in clinical studies of complementary or integrative health approaches.
• POC technologies that can objectively measure pain or functional limitations due to pain, which would be treated by complementary and integrative health approaches, at home or in primary care facilities.
• Virtual reality (VR) systems that use therapy and other behavioral methods to help with pain reduction.
• Development and validation of gaming and virtual reality technologies for the accurate assessment of adherence and/or fidelity to the use of mind and body practices and interventions.
• POC technologies that can monitor symptoms, health related quality of life, or physiological responses to complementary and integrative health approaches at POC for the treatment of pain, mild to moderate depression, anxiety, or other symptomatic conditions, especially if they are applied across the heart, lung, blood, sleep disease spectrum.
• POC technologies that can objectively assess or monitor stress, pain, sleep dysfunction, depression, or anxiety, which would be treated or managed by complementary and integrative health approaches, at home or in clinical environments.

Point of Care Technologies Performance Criteria

We advise applicants to consider the following performance criteria for their POC technologies:

• Voice of the End User – Healthcare providers: Accuracy, availability, cost, and ease with which the technology could be incorporated into existing clinical workflows were identified as important POC characteristics by surveyed healthcare providers.
• Voice of the End User – Patients: Accuracy, immediate result availability, and out-of-pocket cost were identified as important POC characteristics by patients who participated in our needs assessment surveys. Applicants must understand the use case of the technology in the context of where the product will be used. Applicants must consider how the technology will be used to help eliminate health disparities (for example, is the product available in multiple languages, will it function in areas with low internet connectivity, etc.).
• Analytic Performance: As a rule, the performance of POC devices should be equivalent to central laboratory instruments regarding analytical accuracy, reportable range, and precision. Analytical time should be kept to a minimum (less than 5 minutes for common chemistry analytes and less than 15 minutes for immunoassays). Should a predicate device not exist, published preliminary data can be used to evaluate performance.
• Ease of Use: Ease of use is essential to successful implementation of POC test devices. In the case of instrumented devices, the user interface with the device should be designed to ensure regulatory compliance under the clinical laboratory improvement amendment (CLIA-88) with minimal requirements for intervention by the operator. Results readout must not be subjective but easy to read using color change readout, digital or graphic formats.
• Workflow: The POC technology should not require clinicians or staff to significantly alter the way they care for and treat patients in their practice setting and should ideally integrate into existing electronic systems.
• Result Availability: Results must be available in the home, at the hospital bedside or during an office visit (typically 10- to 20-minute result availability), so that decisions can be made in a timely fashion based on the test results.
• Reducing Operator Errors: The device should have built-in software safeguards to ensure proper operation and reduce common errors such as lock-out of untrained operators, lock-out for failed quality control (or failure to perform quality control) and lock-out of expired reagents.
• Sample Types: Samples that do not require a trained phlebotomist should be used, such as capillary finger-stick whole blood or saliva.
• Storage of Consumables: All consumables, including reagents, calibrators, and quality control materials, should be stored at room temperature. The minimal shelf life should be 6 months to 1 year.
• Device Footprint: POC devices should be designed to have as small a footprint as possible. Small benchtops or handheld devices are optimal.
• Information Connectivity: All instrumented POC devices should be capable of being interfaced to the electronic medical record system. The ability to transmit data using a bidirectional wireless interface is most optimal.
• Security of intellectual property: Clearly articulated security of intellectual property will be considered most strongly (may be issued or pending patents, or, for software, trademarks, or copyrights).
• Cost: Solutions that significantly reduce the cost of testing relative to the existing standard of care are encouraged.

Award Amount

• Direct Costs: Up to $100,000
• Indirect Costs: Reimbursement for indirect costs is covered at the federally negotiated indirect cost rate of the institution where the project study is performed, if applicable; otherwise, an indirect rate of 10% will be used.

Grant Term    

• 12 months. No-cost extensions may be awarded at discretion of NIH/CAPCaT.

Grant Requirements

• The Awardee must provide CAPCaT a monthly progress report
• The awardee must submit progress report data into the CIMIT's Guidance and Impact Tracking System (GAITS) on a quarterly basis
• The awardee (or a team designee) must participate in the CAPCaT Kickoff and Showcase events

Grant Recommendations

• The awardee is strongly encouraged to participate in the Biotech East program 
• The awardee is strongly encouraged to participate in the abbreviated I-Corps program sponsored by the UMass Center for Clinical and Translational Science 

CAPCaT Resources Leveraged by Awardees

CAPCaT makes adjunct resources available to awardees and other interested point of care technology researchers. These include:

• NIH resources, such as the I-Corps program and the CAPCaT independent Data Safety Monitoring Board
• Access to the Point-of-Care Technology Resource Network (POCTRN)
• The rich technology and business development resources of our Massachusetts Medical Device Development Center (M2D2) 
• Clinical translation and validation expertise
• A technology development core
• Statistical expertise through the UMass Quantitative Methods Core 
• CAPCaT’s annual Showcase event featuring
  • opportunities for awardees to receive 1:1 pitch coaching from NIH experts
  • exposure to large strategic investors, other entrepreneurs, and students
  • expert panelists presenting best practices for seeking large strategic investment
  • presentations by representatives from the NIH’s small business programs about funding opportunities and tips and best practices for small businesses

Review Criteria

To be considered for an award, applicants must possess secure intellectual property rights. This includes regulatory plans for the hardware and software used in the technology. Applicants must be familiar with the relevant FDA guidance regarding digital health products.

Beyond that, the scientific merits of each application will be reviewed by a panel comprised of experts in clinical care, engineering, and business/technology commercialization. Applicants will be invited to submit full proposals based on their scientific merit, programmatic balance, geographic balance, and technology maturity level. An independent panel will score all applications for scientific merit and the CAPCaT team will make further programmatic decisions regarding selection of awardees based upon the application’s scientific merits, the alignment of the project with the focus of the Center, the potential impact of the technology being developed, the feasibility of the approach, and the adequacy of the plan that is articulated for the protections of human subjects and data safety monitoring.

The evaluation criteria used to review applications include:

Significance:

• Does the project address a significant medical need?

Scientific Basis:

• Is there a sound scientific basis presented (including preliminary data) that supports the technology and the proposed research?

Responsiveness to the CAPCaT/NIH Areas of Interest:

• Is the project designed to accelerate the refinement and clinical testing of point of care technologies for heart, lung, blood, and sleep disorders?
• Is the project designed to improve the diagnosis, monitoring, prevention and management of heart, lung, blood, and sleep disorders or other related symptoms that may incorporate complementary and integrative health approaches?
• Does the project address one of the areas of special focus identified above?
• Does the technology under development include one or more of the desirable characteristics mentioned above that will accelerate rapid adoption into clinical practice?

Technology Performance:

• Reviewers will be asked to review the Technology Performance Criteria above. Is the project at a “late stage” of development (defined as ready for clinical validation or prototype refinement)?
• Projects proposing prototype development or preclinical studies are not in scope. Later-stage technologies that are closer to deployment will be given priority.

Feasibility:

• Does the scientific team have the transdisciplinary expertise to move the project forward (i.e., engineering, usability testing, behavioral aspects of health, clinician engagement, statistical expertise)?
• Are all human subject regulatory procedures (approved IRB protocol, current human subjects training certification, project registered as a clinical trial) complete so that the project can start in a timely way?
• Is it highly likely that the proposed science can be accomplished with the funding and time allotted?

Expertise:

• Do one or more members of the applicant team have expertise in population/public health and implementation science?

Implementation science:

• In the application, has the applicant team considered / addressed implementation science metrics and outcomes such as acceptability, adoption, appropriateness, fidelity, penetration, and sustainability?

Equity:

• Does the applicant address social determinants of health (diverse and inclusive study populations), and does it appear they strive for health equity through interventions and outcomes?

Innovation:

• Does the proposed technology transform patient outcomes or how patient care is delivered? (i.e., a new POC that enables diagnosis/treatment in the home of a patient who would otherwise have had to go to the clinic or hospital for the diagnosis/treatment?)

Intellectual Property and Development Plan:

• Secure intellectual property rights are required for funding and should be clearly outlined in the application. This includes regulatory plans for the hardware and software used in the technology. Applicants must be familiar with the relevant FDA guidance regarding digital health products.
• Has the team developing the technology met with the appropriate bodies to secure intellectual property and designation as an investigational device?
• Has the team acquired a 510k exemption?
• Has a path to FDA approval or clearance been identified and is it clearly articulated?
• Is there a patent or license that has been submitted or secured in the US or overseas?

Consumer Costs and Commercialization Strategy:

• What is the commercialization strategy?
• Does the strategy have the potential to reduce healthcare costs for patients and/or payors?

Environment:

• Do the study team and/or company have an environment that is conducive for success?
• Has there been outside investment in the company?