MPSS can help with strategies for bringing your medical product (pharmaceutical, medical device, or diagnostic) to the market. Through our close collaboration with the other teams at the Vanderbilt Center for Technology Transfer and Commercialization, we can guide you through the licensing pathway, as well as what steps to take to start a company based on your invention.
- Consultation on bringing your pharmaceutical, medical device, or diagnostic product to market
- Development of strategies for development, test data, FDA submissions, CMS reimbursement and other relevant topics
- Evaluating FDA marketing submissions and related needs
- Obtain early input on intended marketing submission through assisted informal FDA communication, such as selection of predicate device for 510(k) submission
- Guidance on FDA strategies for marketing pathways
- Submissions include 510(k), De Novo, PMA, HDE, ND
- Support for grant development
- Support investigators with review of planned grant submission
- Provide statement of regulatory support
- Take part in supporting grants as consultants or co-investigators
- Strengthen licensing agreements and new venture efforts through MPSS
- Review of contract and CTTC invention disclosures for potential regulatory needs
- Provision of FDA compliant documentation methods through use of the Vanderbilt Quality Management System to document product development needed for commercial distribution
- Project assistance and guidance for translation of the medical product from Vanderbilt to the marketplace
- Guidance on FDA strategies for marketing pathways
- Make connections for collaborative sites and investigators for your product or device
- Identify industry standards for product development, and for manufacturing and distribution for your product
- Provide assistance with external contract testing, prototyping, and manufacturing
- Support of new ventures based on Vanderbilt University medical product innovations