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Target Product Profiles

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 this guidance for industry 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 standard of care and competitive offerings.  The TPP can also be used to compare the advantages of different performance characteristics of potential product definitions.

With credit to the MaRS Discovery District Innovation Hub in Toronto, we provide the following links to target product profile information, workbooks and templates.  Each can be tailored for specific products being developed.

Medical Device Products TPP
Defining-Your-TPP-Medical-Device-Products-WorkbookTemplate (4).doc

Therapeutics TPP

In-vitro Diagnostic Products TPP


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