Objectives/Goals:

One of the goals of the Small Business Innovation Research (SBIR) program is to increase private sector commercialization of innovations developed through Federal research and development. However, bringing a product to the marketplace can be a difficult and daunting task. For the past several years, the NIH has provided Technical Assistance Programs that target specific areas to assist our SBIR awardees with their commercialization efforts. The Manufacturing Assistance Program is a program within the NIH Technical Assistance Programs that is aimed at helping small companies identify, address, and develop a strategy to overcome some of the manufacturing issues related to the commercialization of SBIR-developed products.

Upon completion of the program, it is anticipated that participating companies will be able to make better manufacturing and operational decisions when converting their research into products by decreasing development costs and cycle time to market and/or minimizing anticipated operational expenses and increasing product quality.

Scope

The NIH is partnering with the National Institute of Standards and Technology’s (NIST) Manufacturing Extension Partnership (MEP) program (http://www.mep.nist.gov). The MEP’s nationwide network of non-profit centers will provide technical support to MAP participants as they move to a developmental stage that requires decisions in manufacturing transition strategies. 

NIH has contracted with Dawnbreaker®, a business consulting firm in Rochester, NY, to manage the program and coordinate the efforts with the MEP centers.

The technical support that MEP centers offer is quite broad in scope and has no real boundaries other than the manufacturing issues addressed must be related to an NIH SBIR-developed product. This could include, but is not limited to:

• method of scale up;
• cost estimation;
• quality control;
• prototyping;
• design for manufacturability;
• facility design;
• process development/ improvement;
• vendor identification and selection;
• plant layout;
• other similar issues. 

The program is free to participants; however it will require some dedication and time on the company’s part.  It is estimated that over a 2-3 month period between March and September 2008, approximately 100 person-hours of the company’s time will be needed for this project.  Of course the scope of the specific project will determine whether more time is needed. The size of the project is limited to available resources and will be scoped out with the assistance of the MEP Center representative.

Outcomes and participants’ next steps will vary depending on each participant’s needs; however each will receive a written report prepared by the MEP Centers which details the issues addressed, the suggested recommendations, any actions taken during the program, and suggestions for next steps.

Program Eligibility

Who MAY participate:

• Companies that have received an NIH SBIR (not STTR) Phase II award (grant, contract, cooperative agreement) in the last five fiscal years (FY 03-08).
• Companies must meet the current SBIR eligibility criteria as described in the NIH SBIR parent funding opportunity announcement (available from the NIH Small Business Funding Opportunities website http://grants.nih.gov/grants/funding/sbir.htm).
• Previous participants of any of NIH’s Technical Assistance Programs (i.e., Pilot Manufacturing Assistance Program, Commercialization Assistance Program, Niche Assessment Program); however, the same SBIR award may not be used.

Who SHOULD participate:

• Those needing to develop a manufacturing strategy
• Those seeking to manufacture themselves or need assistance identifying a subcontractor or partner company
• Those interested in Good Manufacturing Practices (GMP), International Organization for Standardization (ISO) certification
• Those interested in improving the quality of their product’s current manufacturing process/system
• Those willing to invest the time and effort

 
Application Process--APPLICATIONS DUE FEBRUARY 14, 2008 (Closed. Slots are full.)

• Complete the application available at http://grants.nih.gov/grants/funding/map_application.doc (MS Word - 36 KB)
• Email to Kay Etzler, etzlerk@od.nih.gov or fax to 301-480-0146

 
MEP Assessment

The first 30 applications received from a diverse geographical region will be visited by an MEP field staff member in their state. (Note: No more than 3 will be selected from a region served by the same MEP Center.) During these visits, the companies’ manufacturing needs will be assessed and a determination will be made if an MEP Center can help.  The number of hours a Center may work with any one company during the program is limited, so their assessments will include how effective they can be with the time and resources available.  Should an MEP Center not have the resource expertise available in-house, the Center will seek subcontractors to meet the participant’s needs.  The MEP Centers will recommend to NIH those most appropriate to participate.

Selection

NIH will select 25 companies to participate based on the following:

• MEP Center recommendations
• Fit with available resources and technical expertise
• Participant’s readiness level for developing a manufacturing strategy or implementing a manufacturing process
• Commitment of participants
• Geographical diversity (No more than 3 will be selected from a region served by the same MEP Center.)
• Project’s fit with the goals of the program

Notification will be approximately one week following completion of the MEP site visit.

Feedback

Each participant is required to provide two types of feedback. 

1. The first concerns experience with the program, benefits of the program, and level of satisfaction, and will be collected immediately upon the program’s completion. 
2. Twelve to 15 months later, NIST/MEP will forward for completion their standard NIST Survey and Project Tracking Process (an evaluation tool that will collect data on the participant company’s progress since its involvement in the program.)

Timeline

Points of Contact

NIH
Ms. Kay Etzler
NIH SBIR/STTR Program
Office of Extramural Programs
National Institutes of Health
Bethesda, MD 
Telephone: (301) 435-2713
FAX: (301) 480-0146
Email: sbir@od.nih.gov

NIST
Tab Wilkins
Account Manager & Sr. Technology Advisor
NIST MEP
Seattle, WA
Telephone:  (301) 646-4069
Email:  twilkins@nist.gov

Dawnbreaker
Terry McMahon
MAP Project Manager
Dawnbreaker, Inc.
Rochester, NY
Telephone:  757-651-8600
Email:  tmcmahon@dawnbreaker.com