NIH SBIR Consultant / Project Lead — Dental Medical Device

I am seeking an experienced NIH SBIR/STTR consultant to lead the grant application process for an early-stage dental medical device. This is not simply a grant-writing position. I am looking for someone who can quarterback the process from initial program-fit assessment through preparation and submission of an NIH SBIR application. About the Product The product is a novel dental device designed to improve the workflow for adjacent Class II composite restorations. The product is well beyond the idea stage. Development to date includes: Functional prototypes CAD and engineering development Manufacturing/tooling development Patent Issued Clinical-user evaluation with dentists Preliminary performance and usability data Ongoing regulatory and manufacturing planning I am the inventor and a practicing dentist and can provide the clinical, technical, product-development, and commercial information needed for the application. What I Need I would like the consultant to take the lead on the SBIR process, including: Assessing NIH/NIDCR SBIR program fit and funding opportunities Recommending the appropriate Phase I funding strategy Helping define the research question and Specific Aims Developing the research plan with my technical input Identifying any outside researchers, laboratories, consultants, or academic collaborators needed for the proposed work Advising on communication with the NIH/NIDCR program officer Developing the proposal narrative Assisting with budget development and justification Developing required commercialization content Managing application requirements, documents, and deadlines Guiding me through NIH/SBIR registrations and administrative requirements Performing compliance review of the complete application Coordinating the application through submission My preference is for a low-lift process on my side: I will provide the subject-matter expertise and requested information, while you manage the grant-development process and keep the project moving. Ideal Background Strong preference for someone with: Demonstrated NIH SBIR/STTR experience Successful/funded NIH SBIR applications Phase I medical-device, biomedical, dental, or healthcare experience Experience developing Specific Aims and research strategies Familiarity with NIH/NIDCR Experience managing an SBIR application from concept through submission Ability to advise strategically rather than simply edit or write provided material Dental-device experience is a plus but is not required if you have substantial NIH medical-device experience. When Applying Please provide: Number of NIH SBIR/STTR applications you have worked on. Number that received funding, if available. Examples of medical-device/biomedical projects you have supported. Your experience with NIDCR, if any. Your role in previous applications — writer only vs. full project/application lead. How you would approach determining whether this project is a strong NIH SBIR candidate. What parts of the process you would handle versus what you would require from me. Your estimated fee structure and approximate total cost for a Phase I application. Please begin your response with “NIH SBIR” so I know you have read the full posting. I am looking for someone who can function as the SBIR project lead, not simply a general grant writer.