The medical device field has several unique aspects important to address when writing a business plan; for example, clinical & regulatory paths, (including clinical trials, FDA & CE approval) and medical insurance refunds.
Below is a table of contents, for example:
1. Overview of the business concept
2. Brief description about the industry / market
3. Brief description about the products, strategies, & competition
4. A summary of what is needed to do in order to reach the target (e.g regulatory approvals)
5. Business Model: How are you going to make money?
6. Financial plan – How much capital has been drafted and how much capital is required in the current round?
7. Management’s CV
* This should not be more than three or four pages. You may wish to send the executive summary before sending the full business plan to generate more interest.
1. Background on the problem/illness; What are the current possibilities for diagnostics/ therapy; characterization of the target audience
Market size and opportunity
1. Describe the market
2. Market size in numbers & geographic description (US / world)
3. Competitors, their market share (if applicable), strengths & weaknesses, prices
4. Distribution channels & the sale process
5. Current reimbursement for expenses
Product and Production Processes of the Company
1. A detailed description of the product and a brief description on future development
2. How “far along” product development is and does the company have proof of the feasibility
4. A clear description of why the product is special, which problem it solves, who will buy it & why, and what prevents others from developing the same product
5. If possible, specific economic report that shows value (e.g customer manufacturing efficiency)
6. What changes will the customer/distributor/health provider have to make in order to adopt the product, and how are you going to ease this behavioral transition
Clinical and Regulatory
1. Which regulatory approvals are needed (IDE, 510K, NDA, CE, etc.)
3. The nature of the clinical trial, an estimated number of participants, the time window followed by the experimenters, and the necessary end points in order to get a regulatory approval
1. Patents filed & their status etc.
2. Licensing agreements & royalties, etc.
3. Is there a similar patent? If so, how are we different?
1. The management team & their CVs, relevant past experience, and past success (include names of companies)
2. Which key positions are still unmanned and are there any possible candidates?
3. Scientific Advisory Committee, Board of Directors, and other key partners (e.g lawyers, accountants, etc.)
Current Status of the Project and Investment needs
1. The company’s achievements to date (including product development & trials, etc.)
2. The amount of investment required and use of funds
3. The financial history and current investors (capitalization table showing how much each investor holds %, including options for employees)
4. Key milestones that will be achieved until the next fund raising
5. How much money will be required in order to reach a stage where the company is self-sustaining?
1. Projected revenues as a % of the market
2. Projected income and expenses of the Company with the investment required
3. The expected pricing of products
Footnotes and references
1. Relevant clinical articles
2. Renderings or photos of the product
3. References to relevant information used for various forecast