Intellectual property and regulatory considerations are critical milestones in the development of a medical innovation. The following module focuses on utilizing the correct institutional resources (Technology Transfer Offices) and provides information on working with the FDA.
Inventions discovered in a university setting face unique resources and rules as compared to those founded in other contexts. Ownership and intellectual property protections are often left to the institution - specifically the Technology Transfer office - and the inventor may be directed on what resources, or opportunities to utilize, based on the judgement of this office.
Concurrently, success medical innovation is also predicated on the successful navigation of regulatory pathways. The FDA regulation pathways are dependent on the type of invention being proposed (e.g., “is it a medical device, drug, etc.?”), level of risk in using it, and whether similar, pre-existing technology exists.
This interactive will cover the disclosure, patent, and licensing processes, and how to navigate the network of industry regulation that shapes academic entrepreneurial work.
The sections are listed below:
Working with Technology Transfer Offices
Market Approval Pathways
See all topics in this section (and the full chapters) here.