Student projects can range from clinical trial design, FDA or international submissions + reporting, drug classifications, to regulatory market research or adverse event profiling.

Example projects include:

FDA Regulatory Pathway Strategy

A Greek medical innovation company created a device where heart failure patients will be able to self-manage their condition and interact with their doctor, preventing any dangerous events. Students will research the FDA regulatory procedures required to enter the US market with this device and create a detailed regulatory pathway strategy.

Clinical Trial Design

The organization is an early-stage company engaged in the development of an eye blood flow circulation device. The device assesses and monitors sight-saving eye blood flow circulation during the aging process.

Students are challenged to write the protocol for a clinical trial. The protocol document will need to detail all aspects of the trial: its background, rationale, objectives, design, methodology, statistical analysis plan, and organization.

Communications Strategy for Medical Device- Pre-FDA Approval

The organization is an early-stage company engaged in the development of therapeutic device to reduce inflammation. The product is currently pending FDA approval. Organizational leaders seek student support to develop a communication strategy to promote the product effectively, but stay within FDA and legal guidelines as to not jeopardize the approval process. The desired outcome of the collaboration is an FDA compliant communication strategy for organizational leaders to implement on the website ahead of full FDA approval, including language and actions to be used and avoided.

We invite you to share your projects for consideration. Please include a brief summary of your organization, mission, and the regulatory affairs problem or topic you would like to address.