Drug & Device Development Service
The MCHRI Drug & Device Development Service offers support to investigators on the scientific information required to support an Investigational New Drug (IND) or Device (IDE) application to the FDA. This includes the design of an effective regulatory strategy, consultation on appropriate pathway(s), and coordination and submission of necessary documents.
Typical IND/IDE application services include:
- Format, organization and leading of FDA meetings (INTERACT, Pre-IND, Pre-Sub, etc.)
- Designation and status requests and meetings (Orphan, Rare Pediatric, Fast Track, Breakthrough, RMAT, etc.)
- Outline and format of IND/IDE application and interaction
- Maintenance of the IND/IDE (annual reports, safety reports, final reports, etc.)
Identifying and securing (enough) funding for a medical products development is a challenge. However, due to the recent priorities shifting within the NIH and the FDA, award programs have been implemented to support the translational of drugs and devices to meet health challenges faced by the maternal child health population.
Typical funding support services include:
- Identification of potential funding sources (Internal/External, Philanthropic, Federal, etc.)
- Budgeting and resource allocation
- Identification of campus & shared resources (3D Printers, Specialized Testing Equipment, Clinical Care Support, etc.)
Selecting the right time to commercialize a medical product is challenging. Factors such as the size of the market, competition, intellectual property and clinical need may each alter the approach to commercialization. The Drug & Device Development Service provides a unique method to answering this dilemma proposing solutions to expedite the translation of the medical product into the clinical setting.
Typical support services for innovation include:
- Initial prior art & intellectual property search
- Opportunity analysis (Identification of Market Leaders, Cost of Competing Products, etc.)
- Business modeling & long-range planning
- Coordination with venture capital & creation of pitch materials