Application Criteria - POCTRN
The POCTRN Center at CIMIT is seeking proposals from academic and industry applicants who desire to commercialize a neurotechnology, provided that a compelling proof-of-concept has been demonstrated. While all stages of maturity will be considered, preference will be given to efforts at an earlier stage.
Applicants must collaborate closely with active clinical specialists, as well as product development experts, in the development of the proposal and while conducting the work. Input from these collaborators must be clearly reflected throughout the application. CIMIT can assist in connecting potential applicants with clinical collaborators, if requested.
- Detail the limitations of the currently available solutions and describe how the proposed approach will advance upon current neurotechnology.
- Clearly define the current state of the art and highlight how their proposed technology will advance patient care.
- Include data showing that the diagnostic or therapeutic intervention has already been demonstrated to address the targeted indication in silico or in vivo with enough confidence that the remaining challenges are primarily related to building a commercializable prototype and demonstrating its safety and effectiveness.
- Address at least one area of interest of the Blueprint MedTech participating Institutes, Centers, and Offices. Applicants are encouraged to discuss their concept with the points of contact to ensure mission fit.
- Propose medical devices with first-of-its-kind technologies, unique and novel intended use, new safety aspects for FDA to consider, and/or new regulatory aspects for FDA to consider.
- Responsive applications may also pivot and refine existing technologies toward new intended use or use in novel settings (e.g., innovating and translating a neuromodulation device approved for healthcare-setting only to home-use).
Applications will NOT be considered for:
- Device technologies that do not significantly advance upon the state of the art (e.g., device technology that proposes minor modifications to FDA-approved/cleared medical device technology).
- Animal model development: all in vivo models must be well established and characterized, and available to the applicant.
- Efforts to develop neurotechnology for fundamental study of the nervous system.
- Fundamental basic/applied research projects that employ existing market approved devices for their labeled uses.
- Projects focused on technologies for augmentation of healthy individuals.
- Device technologies not regulated by the FDA.