Defining Your Target Product Profile: Medical Device Products
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A target product profile (TPP) for a medical device is a key strategic document that summarizes the value proposition of the intended commercial product and assists in the development of a regulatory strategy. A well-designed TPP provides a structure to ensure that a company embarks on a product development program that is efficient and yet defines a listing of all relevant medical, technical and scientific information required to reach the desired commercial outcome.
Medical devices include instruments, apparatus or implants intended for use in the cure, mitigation, diagnosis, treatment or prevention of disease. (For medical devices related to in vitro diagnostic [IVD] products, see the TPP workbook and template designed for IVDs.)
Five key features have been selected for developing the TPP for medical devices:
- Intended use
- Device description
- Contraindications
- Non-clinical testing
- Clinical studies
Workbooks are comprised of two parts—the workbook guide, which contains instructions, examples and activities, and the workbook template, in which you can write your responses. You can personalize the workbook template by adding your company name and logo.
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| Workbook Guide Contains instructions, examples and activities. |
Workbook Template Write your responses and keep for your company’s records. |
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