The National Institutes of Health NIH is piloting a manufacturing assistance program for its Small Business Innovation Research (SBIR) Phase II awardees.  The goal of the program is to provide individual technical assistance in manufacturing to SBIR Phase II awardees as they prepare to commercialize their SBIR-developed products. Through an effort with the National Institute of Standards and Technology’s (NIST) Manufacturing Extension Partnership (MEP) program and their national network of non-profit centers, technical support will be provided to companies as they move to a developmental stage that requires decisions in manufacturing transition strategies.  This includes 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 and other similar issues. 

As a result of this pilot, it is anticipated that participating companies will be able to make better manufacturing and operational decisions converting their research into products by:

• decreasing development costs and cycle time to market
• minimizing anticipated operational expenses and increasing product quality

This program will target a diverse group of research projects supported by NIH which could include, but are not limited to, drugs, biologics, vaccines, and devices, as well as software (including healthcare-related, educational tools, and multimedia programs).

The role of the selected contractor in this project will be to coordinate and facilitate the program based on the following program specifics.

Program Specifics

Selection of Participants:  Approximately 30 NIH SBIR Phase II awardees will be identified by NIH as potential participants in the program. 

MEP Centers’ staff will visit and screen potential participants and in coordination with the selected support contractor, will recommend to NIH those most appropriate to participate in the pilot.  The targeted number of selections is 25.    

MEPCenter Mentoring:  The MEP Centers will work one-on-one with participants and provide expertise and services tailored to the participants’ most critical manufacturing needs.  Issues will be identified and solutions offered through a combination of direct assistance from the MEP centers and their consultants.

The average number of staff hours spent by each center for each participant is estimated to be about 50 – 100 and all projects will be completed by August 31, 2007.  Projects requiring a larger time period for completion will not be considered for this pilot. 

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

Feedback Collection: Upon completion of the program, two types of feedback will be collected from all participants.  (1) Immediate feedback will be collected by the support contractor concerning participants satisfaction with the program.  (2) Twelve to fifteen months following the completion of the program, the NIST MEP Program Manager will facilitate the implementation of the standard NIST Survey and Project Tracking Process (an evaluation tool that will collect data on each participant’s progress since their involvement in the program). He/she will analyze it and provide a full report to NIH that summarizes the data. 

Estimated Timeline 

• Mid-December – MEP Centers begin site visits
• Mid-February – Sites visits, assessments, and participant selections completed.
• January – August 2007 – One-on-one mentoring performed by MEP Centers.  All mentoring must be completed by the end of August 2007. NOTE:  Companies will begin work as they are accepted into the program; therefore, start dates will be staggered. 
• October 2007 – Summary of satisfaction feedback completed and provided to NIH by contractor.