Review Criteria

 

Award Information

Review Criteria

FAQs

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 (see https://www.fda.gov/medical-devices/digital-health-center-excellence/guidances-digital-health-content). 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:  

1. Significance: Does the project address a significant medical need?  
   
   
2. Scientific Basis: Is there a sound scientific basis presented (including preliminary data) that supports the technology and the proposed research?  
   
   
3. 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?  
   
   
4. 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.  
   
   
5. 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?  
   
   
6. Expertise: Do one or more members of the applicant team have expertise in population/public health and implementation science?  
   
   
7. 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?  
   
   
8. 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?  
   
   
9. 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?)  
   
   
10. 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 (see https://www.fda.gov/medical-devices/digital-health-center-excellence/guidances-digital-health-content). 
    
    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?  

11. 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? 

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

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