I need to write a final written report for the device that I have been working on such as “SPECIAL BLOOD PRESSURE MACHINE PRODUCT THAT IS A WIRELESS, REMOTE MONITORING DEVICE THAT CONNECTS TO A SMARTPHONE APP WITH ACCURATE MEASUREMENTS”. The final report should not exceed 15 pages including drawings and references. The report should be organized as a written version of the marketing pitch that generally includes the following :
Elevator statement:
• What is the core problem the business is trying to solve ?
• What is the solution it has developed?
• What key benefits will the solution deliver to its target customers?
The clinical need:
• What is the need being addressed?
•Why is this need important?
• How is the need currenty deing addressed
(if at all) ?
• In what was are current solutions inadequate?
The solution:
What is the proposed solution to the need ?
• How will it be used (and by whom)?
• How does it better address the need thar
what is currently available?
What is the value proposition?
The market:
•Who is the target customer ?
•What is the market size ?
•How fast is it growing?
who are the primary competitors?
•How will the company differentiate itself
from the competition?
• What are me barriers to entry ?
Intellectual property:
• How will the company protect its IP ?
• How strong Is Its IP position?
R&D Strategy:
• How will the company prove (or has it
proven) that the solution is technically feasible?
• What are the risks that must be addressed
and how will they be mitigated?
• How will the product be manutactured and where?
Regulatory strategy:
• How will the company get its product cleared approved for the market?
• What will be required to demonstrate safety and efficacy?
Clinical Studies:
• How will the company collect safety and
efficacy data ?
• Where will the studies be performed and who will be the key investigators ?
• What other endpoints will be studied (and why)?
Reimbursement:
• What Is the reimbursement pathway?
• What codes will be used?
• How much resistance is anticipated?
Business Model:
• How will the company including its anticipated pricing and margins?
• What will be the timing and frequency of
revenue realization?
• What volume of business is needed to make
the model viable?
Sales and Marketing:
• Why will customers be compelled to use the product?
• How will the company close sales?
• How will the product reach customers?
Financial information:
• What are the company needs?
•What does it intend to do with the money raised (according to what timeline)?
• How and when will it generate a return for investors ?
Exit Scenarios:
• How are investors most likely achieve liquidity for their investment?
• When is an exit most likely to occur?
Management Team:
• Who are the key individuals that make up the
company ?
• What specific qualifications do they bring to bear?