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- Animal models can support and develop medical product development during the nonclinical phase.
- Well-designed animal models can address regulatory safety concerns and can provide further de-risking during product validation.
- Assessing minimum viable products and prototypes in animal models can improve quality assurance and compliance structure.
- Developing a roadmap for product innovation strategies (regulatory, reimbursement) is essential in order to avoid unnecessary preclinical testing.
- Involving end users in product development is critical for the success of the medical device in the market.
- Animal studies can provide insight and value in the preparation of the regulatory submission.
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Park, Sunghee E. and Schaer, Thomas P.
"Preclinical Animal Models,"
Academic Entrepreneurship for Medical and Health Scientists: Vol. 1
, Article 20.
Available at: https://repository.upenn.edu/ace/vol1/iss3/20