Course Overview
Needs and Markets
Intellectual Property
Regulatory and Reimbursement
Company Formation
Video
Slides
Questions
Example
Worksheet
Financials
Summary
Provide FEEDBACK |
This worksheet is meant to help you organize and complete
a business plan that may help you to obtain outside funding for
your idea. The analysis that you have completed in each of the preceding
sections will be critical in completing this plan.
Make sure to look at the example
materials in this section of the CD for a sample business plan.
Before completing your business plan, take a moment
to assess the type of funding that is appropriate for your concept.
If necessary, review Leslie Bottorff's slides on potential funding
sources. When writing your business plan, keep this target audience
in mind, and tailor your plan to their interests and strengths.
A simple business plan summary is as follows; your
business plan may differ from this format depending upon the specifics
of the opportunity you are pursuing. In total, a well-formed business
plan should contain between 15 and 20 pages.
- Executive Summary
- One to three pages summarizing the key points of your business
plan
- Include clinical need, market, solution, and unique contribution
- Clinical Background
- Describe the disease or clinical area
- Describe shortcomings of current solutions
- Product Details
- Describe your solution and how it addresses the need
- Describe the technical challenges that remain before your
product is proven
- Summarize your patents and their status (pending, issued,
licensed)
- Describe other solutions and demonstrate the uniqueness of
your product
- Market Analysis
- Describe the customer base for your product, including the
annual number of people affected
- State a fair price for your product, taking into account potential
reimbursement, the cost of similar devices, and the value to
the customer and to the healthcare system
- Indicate whether reimbursement currently exists, and strategies
for obtaining sufficient reimbursement for your product
- Indicate the total addressable market size, in dollars
- Describe the market growth history and potential
- Clearly state all assumptions used in arriving at these figures
- Regulatory Strategy
- Indicate the FDA requirements that will likely be imposed
upon your device
- Provide a timeline for regulatory approval, taking into account
all necessary trials
- Business Strategy
- Summarize the relevant experience of each founder
- Indicate key hires that will be necessary to bring the product
to market
- Summarize any marketing strategies, distribution plans, or
support requirements that would be unusual for your company
- Indicate facilities, equipment, and other fixed assets that
will be required
- Financial Model
- Can be left blank for now; will be completed in the final
section of this course
- Summary
- Analysis of risks
- Summary of compelling opportunities
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