Needs Assessment Program for DHHS/NIH Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Awardees

Introduction 

This notice is issued by the NICHD Office of Acquisitions on behalf of the National Institutes of Health (NIH) Office of Extramural Research (OER).

This is a Small Business Sources Sought (SBSS) notice. It is not a Request for Proposal (RFP). No solicitation is available at this time. The purpose of this notice is to obtain information regarding:  (1) the availability and capability of all qualified small business sources; (2) whether they are small businesses; HubZone Small Businesses; Service-Disabled, Veteran owned Small Businesses; 8(a) Small Businesses; Veteran-owned Small Businesses; Woman-Owned Small Businesses; or Small Disadvantaged Businesses; and (3) their size classification according to the North American Industry Classification System (NAICS) code for the purposed acquisition. Your response to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible or if it is necessary to proceed through full and open competition. All size organizations are encouraged to respond. Small business organizations must have their size status certified by the Small Business Administration (SBA). The NAICS code is 541611 with a size standard of $15,000,000 in average annual receipts.

Description

National Defense Authorization Act for Fiscal Year 2019, passed by the 115th Congress and signed into law as Public Law 115-232, expanded the scope of support for the SBIR/STTR programs to improve the technical and business assistance (TABA) provided to Phase I and Phase II awardees.  The NIH Office of Extramural Research (OER) created Small Business Education and Entrepreneurial Development (SEED), a new business unit, to oversee, coordinate and strengthen efforts to accelerate commercialization of academic innovations across all member institutes and centers within the agency. The SEED office will administer the NIH TABA program in coordination with liaisons from NIH institutes and centers.

The scope of this potential resultant contract is to provide Needs Assessment Reports, as part of the larger NIH TABA program, that prioritize the technical and business needs of selected companies that are developing products/services with NIH/HHS SBIR/STTR funding.  Needs Assessment Reports provide summarized analyses of ten (10) commercialization areas from a life science industry perspective:

1. Target market attractiveness (need/size)
2. Technology/solution’s ability to address market need
3. Regulatory path
4. Business model profitability
5. Competition and Intellectual Property
6. Sales and marketing strategy
7. Management team
8. Strategic partners
9. Funding status/ Financial plan
10. Potential Exit Plan

The Needs Assessment Reports include analysis of the current state of the company and the life science product, identification of strengths and weaknesses for each of the commercialization areas (a-j) listed above, summary of the areas of highest priority that should be addressed by the company, and identification of appropriate resources and contacts for each of the commercialization areas (a-j) listed above that awardees can use to enhance the development of their life science product or service.

The contractor shall provide an experienced Project Manager for overall management, integration, and coordination of all contract activities, including the management and coordination of activities carried out under any subcontracts. The contractor shall also provide at least three (3) subject matter experts: A Medical Product Regulation subject matter expert, Life Science Industry Market Research subject matter expert, and Life Science Industry Business Development subject matter expert to manage and coordinate analysis of the commercialization areas listed above.