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Executive Summary
One-two pages maximum that summarizes all of the important product features, competitive advantages and marketing highlights of the project, briefly touching on all of sections that follow.

Begin by telling us which of the four categories your BFS fits into: Freshman Design, Senior Design, Graduate Thesis or the Open Category.

Product or Service Description
Fully describe the technology or product you have developed in as much specific detail as possible. Fully describe all of the qualitative and quantitative features, differentiating characteristics, competitive advantages and other important aspects of the proposed new biomedical technology business venture in as much detail as possible. What aspects of the proposed business will differentiate it from the competition?

Describe the business model to be used, ie- to license the technology to a third party for commercialization or to become the OEM yourself. Define how revenues and profits will be generated. Describe proposed methods of production and key strategic alliances or approvals needed. Describe any proprietary technologies or intellectual property to be obtained and/or used in the business.

Market Analysis
Begin this discussion by defining the overall market and size of the industry a new business created around your biomedical technology product will be operating in. For all of your projects, your chosen overall industry is Health Care.

Define the target market sub-category of the Health Care industry your proposed product would be existing in. Your project most likely falls under one of these sub-categories

• Biomechanics
• Prosthetic Devices/Artificial organs
• Medical Imaging
• Biomaterials
• Biotechnology
• Tissue Engineering
• Neural Engineering
• Biomedical Instrumentation
• Bionanotechnology
• Physiological Modeling
• Rehabilitation Engineering
• Medical & Bioinformatics
• Clinical Engineering
• Biosensors
• Medical & Biological Analysis
• Nanomedicine
• Drug Delivery

Report the important financial and operating metrics for your chosen target market in terms of current sales or expenditures, volume of transactions, patients serviced, etc.

Use the Internet and WWW for as much research as possible. Direct interviews with industry representatives is also a good source for this type of information. All industry statistics cited and sources used must be properly acknowledged.

Competitive Environment
What is the current industry approach or method used to address the problem your project involves? What are the strengths and weaknesses of the current approaches?

Identify and discuss the current known competitive products and potential future competitive products currently under research for your technology.

What organizations or companies are currently operating or conducting research in this space? What are their relative strengths and weaknesses? Is the competitive landscape highly fragmented or consolidated among a handful of well-established known competitors?

How is your proposed product superior in terms of quality, quantity, features or pricing?

Prepare a Competitive Matrix (use one of the sample formats on this website [Sample 1 , Sample 2 ]). This is a profile of how your proposed new biomedical product will compare to four or five known competitive products or alternative methods. Choose up to four different methods or companies you surfaced from your market analysis to prepare this matrix.

Financial Requirements
This section of your BFS should be divided into two subsections as follows:

• Prototype Creation Costs: Prepare a detailed schedule and estimate the total cost requirement for building, synthesizing, coding or creating a single working prototype of your proposed biomedical project. This should start by preparing list of the anticipated capital equipment expenditures(CAPEX) needed, followed by the anticipated operational and overhead costs for the build. CAPEX costs are things such as specialized laboratory equipment (e.g. centrifuges, incubators, oscilloscopes, etc) and office equipment (computers, etc). Operational and overhead costs are things like laboratory materials, supplies and space specifically needed to create the prototype. Provide specific vendors, quantities and prices, wherever available.
• Prototype Testing Costs:Prepare a detailed schedule and estimate the costs required for laboratory performance testing of your proposed new product. This may include costs for further in-vitro studies, animal studies, if needed, additional laboratory space, equipment, materials, supplies, personnel, etc. It is not necessary at this stage to try to estimate the costs associated with clinical performance testing of your new product, if that will be needed.

Recommendations and Conclusions
This section of your BFS should include a narrative summary and conclusion of your prototyping and initial performance testing experiences and final recommendations for proceeding with the technology. If your initial research results have been positive offer a possible strategy for further research, testing and business product launch. If your research results have been inconclusive or negative, and you feel the idea should be discarded, explain your rationale in detail and provide a possible alternative approach to the problem you originally identified.

Assuming your research has produced positive results and should be continued into the future for possible launch into the health care marketplace include a strategy and discussion covering the following:

• Intellectual Property Issues:Whatever you have originally developed as part of your research is IP. The question becomes is it necessary to protect it and how to best accomplish that?
• Future Research and Development Requirements:This would include a discussion of, as needed, continued in-vitro lab research, animal studies, clinical performance testing (for devices), clinical trails testing (for drugs) along with a projected timeline and cost estimate to complete these tasks. Discuss possible sources for financing this phase of the products development: government grants, direct investments, loans, technology licensing agreements, etc.
• Regulatory and Product Liability Issues: If your product will require governmental approval prior to commercial business launch or will have special product liability issues to contend with discuss them here. Not all biomedical products require governmental approval. The basic rule is that if your product will have any direct contact with a future patient then itÕs use will have to be approved by the appropriate government agency, such as the FDA, prior to use.
• Recommended Product Launch Business Strategy:The choices here are straightforward: Either planning to launch the business with your own resources, Òde novoÓ or find an industrial partner to license the technology to complete whatever research and governmental approvals are needed and actually manufacture and launch the product into the health care marketplace. Chose one approach or the other and provide a financial projection of the future revenues and potential profits your product could generate over itÕs anticipated useful lifetime. For patented biomedical technologies, it is best to use the duration of patent protection as the ÒusefulÓ lifetime of the technology.

Appendices
Attach your resume and the resume of all of your team members.

Attach any important documents you have used or referenced throughout the BFS, especially industry or market analysis information you have obtained