Number of individual students required: Up to 5 students

Our team is looking for students to help develop the regulatory strategy for our virtual care and home diagnostic solution. We envision the strategy will include:

1. Probable regulatory classification based on predicate virtual care solutions and home based diagnostics
2. A comprehensive list of the predicate products/services and reason for inclusion
3. Likely clinical development requirements in terms of number of patients and endpoints
4. FDA/CDRH contacts, potential programs (Q-submission), and requirements
5. Next steps and a timeline for implementation

The final deliverable will be a presentation, references, and any supporting documents.

Students will need to:

• Review FDA website(s) for information
• Review applicable FDA guidance documents
• Summarize information in a clear and compelling way for use in later communications with partners, investors, etc. using documents, presentations, and/or spreadsheets

I have significant work experience in the life sciences and technology industries and will be the key point of contact. I will provide direction, answer questions, provide feedback on work products, and presentation coaching. I can also help point students in the right direction. I envision a weekly meeting to set goals, discuss progress and any issues, and make plans for the following week.