Request for Project Information: "Military Dental Research - Seeking New Technologies and Development Partners

The Medical Technology Enterprise Consortium (MTEC) is excited to post the MTEC-24-03-Dental Request for Project Information (RPI) focused on surveying the current state of engineering and medical prototypes, knowledge products, and manufacturing capacity related to military dental research. PURPOSE OF THE PROJECT INFORMATION PAPER: This Request for Project Information (RPI) contains background material and guidance for the preparation of project information papers to the MTEC. Project information papers will be reviewed by the Sponsor and used in a manner that shapes NAMD efforts in this technology space. The results of the project information paper submission will serve as a means to assess the development landscape and potentially focus efforts that will follow. As a note: This RPI is issued solely for information and planning purposes and does not constitute a solicitation. Neither unsolicited proposals nor any other kind of offers will be considered in response to this RPI. Responses to this notice are not offers and will not be accepted by the government to form a binding contract or agreement. Responders are solely responsible for all expenses associated with responding to this RPI. FOCUS AREAS OF INTEREST: Due to the Navy and Marine Corps diverse warfighting capabilities, Sailors and Marines (and Joint Service members) operate in a vast array of challenging and austere environments. Their missions often require the suspension of regular oral hygiene and routine dental care which can result in the development of dental diseases and emergencies. Routine clinical dental care is necessary to maintain the resilience and readiness of the warfighter, and next generation biomedical products and solutions are required to maintain proper dental health and to treat, predict, and prevent dental diseases in challenging environments. Furthermore, combat injuries frequently result in significant damage to the oral maxillofacial region, leading to distinct consequences such as cosmetic alterations, functional impairments, and chronic orofacial pain. There is a pressing need for novel biomedical, engineering, and clinical devices and products that can effectively address these multifaceted consequences, while prioritizing long-term comprehensive care, to restore both physical and cosmetic aspects of the face and maxillofacial region. The specific focus areas of interest are as follows (not listed in order of importance): Focus Area 1 - Evaluation of Technologies for Dental Care, Diseases, and Emergencies: The government is interested in technologies, devices, and methods for the prevention and treatment of dental and maxillofacial injuries and infections and orofacial pain occurring in a military population that often operates for extended periods of time in austere/extreme environments. This includes methods to provide routine clinical dental care, predict and prevent dental diseases (though molecular and computational methods), and treat dental diseases and emergencies in operational environments. This focus area also includes products or devices to treat injuries to the oral cavity, face, and facial bones sustained during combat (e.g., mandibular fractures, stabilizing facial burns, restoring functional aspects of the face and mouth, long-term post-trauma care, etc.). Proposed technologies should be at least at a Technology Readiness Level (TRL) of 5. Interested parties are encouraged to submit information papers using the template included in the RPI. Focus Area 2 - Capabilities Areas of Expertise: The government is interested in building relationships with partners to accomplish strategizing, planning, and prototype development activities for technologies that address dental care, diseases, and emergencies. These relationships would aim to translate new biomedical prototypes out of the laboratory (military or academic) setting and through the regulatory approval process, with ultimate applications for use by military dental clinicians and maxillofacial surgeons (especially the Navy and Marine Corps). Specific capabilities of interest include (but are not limited to): Customization of dental care and maxillofacial surgical devices or adaptations for military use; Ruggedization of maxillofacial surgical and dental care devices; o Manufacturing of dental care devices or materials (scale-up, initial production runs, etc.) that may include novel components such as micro- or nanoparticles and micro- or nanocapsules; Investigational Device Exemption/Investigational New Drug (IDE/IND)-enabling studies required by the U.S. Food and Drug Administration (FDA) with specific indications for dental care and oral or maxillofacial surgery; Conduct of clinical studies using prototypes in the areas of dental, oral, or maxillofacial restoration; or Activities related to securing regulatory approval by the FDA with indications for dental care and/or maxillofacial surgery. Project Information Papers should clearly describe expertise in each of the aforementioned areas as it relates to the dental research and combat injuries involving the maxillofacial region. Interested parties are encouraged to submit project information papers using the template included in the RPI. REQUIREMENTS OF THE PROJECT INFORMATION PAPER: The intent of this RPI is to understand respondents interest and technology capabilities within the abovementioned focus area. MTEC is seeking input from both MTEC members and nonmembers via a project information paper to be considered by the government. Project information papers will be shared with the reviewers under non-disclosure agreements. More information on how to submit Project Information Papers is included in the RPI. MTEC: The MTEC mission is to assist the U.S. Army Medical Research and Development Command (USAMRDC) by providing cutting edge technologies and supporting life cycle management to transition medical solutions to industry that protect, treat, and optimize Warfighters health and performance across the full spectrum of military operations. MTEC is a biomedical technology consortium collaborating with multiple government agencies under a 10-year renewable Other Transaction Agreement (OTA), Agreement No. W81XWH-15-9-0001, with the U.S. Army Medical Research Acquisition Activity (USAMRAA). MTEC is currently recruiting a broad and diverse membership that includes representatives from large businesses, small businesses, - nontraditional defense contractors, academic research institutions and not-for-profit organizations. POINTS OF CONTACT: For inquiries, please direct your correspondence to the following contacts: - Technical and membership questions should be directed to the MTEC Chief Science Officer, Dr. Lauren Palestrini, Ph.D., contact@example.gov - All other questions should be directed to the MTEC Program Manager, Mr. Evan Kellinger, contact@example.gov To view this solicitation, visit www.mtec-sc.org/solicitations/.