The experienced health care team at Kegler Brown works hand-in-hand with the intellectual property and corporate practice groups to advise clients on the best practices for bringing their health care technology ideas to market. Although we comprehensively address all of the applicable state and federal health care regulations that can affect new health care innovations, our attorneys keep an intense focus on the client’s business model and the overriding importance of introducing new technologies to the mass market as quickly and cost-effectively as possible.
- FDA analysis: reviewing new products (e.g. any new medical device, nutritional product or pharmaceutical) to determine necessary steps to comply with FDA regulations; determining whether new products must be approved by the FDA before marketing them
- Clinical trials: advising on the clinical trial process, including determining what prior notice must be given to the FDA; working with the government review board to develop an acceptable trial protocol
- Licensing: obtaining necessary licenses for distribution once approval has been given
Our health care commercialization practice works with clients across the entire health care industry. Our most recent work is highlighted by our representation of a group of emergency room physicians who developed a revolutionary new medical device and by our partnership with a business that has recently created a device to monitor and record exercise and physical activity levels.