For latest version: please go to https://academicentrepreneurship.pubpub.org/pub/tzu9lgys/release/4 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.