One commonly used tool to help define and position potential new biomedical products/solutions is to complete a Target Product Profile (TPP). Industry uses TPPs in strategic planning and product development to help decide which projects to undertake, and how they will deliver competitive and differentiated value to customers. The U.S. FDA has endorsed the process and has issued guidance for industry and review staff on use of TPPs for evaluating potential products. Thus, investigators translating research into commercial development opportunities can align their approach with downstream regulatory and industry expectations by use of Target Product Profiles from the very beginning of the process.
Each Target Product Profile identifies key product and market properties that need to be addressed, and how the product compares to current stand of care and competitive offerings. The TPP can also be used to compare the advantages of different potential product definitions performance characteristics.
The following templates provide examples for therapeutic and device products. Each can be tailored for specific products being developed.
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