BMEidea: Narrative Description Guidelines
(Not to exceed 10 pages)

1. Describing the problem to be solved (no more than 1/2 page)
   What are the market and/or industry needs that you intend to solve?
2. Project objective statement (no more than 1/2 page)
   How does your team intend to address the problem?
3. Documentation of the final design, including applicable standards and risk analysis (1 page)
   Upload graphical representations and photographs separately as appendices.
4. Prototype of the final design (1 page)
   Upload graphical representations and photographs separately as appendices.
5. Proof that the design is functional and will solve the problem (1 page)
   Include test data, market research or pre-clinical/clinical trials.
6. Results of a patent search and/or search for prior art, assessment and patentability (1 page)
   Two excellent resources for this search are www.uspto.gov, and your institution's technology transfer office.
7. Anticipated regulatory pathway (510(k) vs. PMA, etc.) (1 page)
   Consider researching how the FDA has treated analogous devices.
8. Estimated manufacturing costs (1 page)
   Provide detailed per unit cost breakdown, including volume discount, for components, final assembly, quality assurance, etc.
9. Market analysis and sales strategy (1 page)
   Define the market need, competitive landscape, potential market size, selling price, distribution channels, reimbursement strategy, etc.
10. Executive summary, outlining strategy for commercialization and opportunity statement (2 pages)
    Two pages that summarize all of the above and serve as a stand-alone justification for why this idea should be pursued. Be sure to address the essentials including:
    Problem: What is the problem you aim to solve?
    Solution: How do you solve it?
    Competition: What are alternate methods of solving the problem; or anticipated methods that could be in competition with you in the future?
    Differentiation:  Why will people choose your solution over others?
    Technical Feasibility:  Have you done it and can it be done?
    Regulatory and Reimbursement:  What FDA approvals will be required?  What Medicare/Medicaid strategy is needed?
    Sales and Marketing: What is the estimated size of the market (with rationale)? Who is the buyer/customer/user? Who will they buy it from? At what pricing?

Please Note: the narrative may not exceed 10 pages in length, double spaced, 12 pt type. If you have any questions, please call the NCIIA at 413-587-2172.

Limitations: the limit is one entry per department within an academic institution. Inter-institution collaborations are encouraged; a faculty advisor is required from both institutions.