title: Bench to bedside: integrating advances in basic science into daily clinical practice.
abstract: This article focuses on the initial steps of commercial development of a patentable scientific discovery from an academic center through to marketing a clinical product. The basics of partnering with a technology transfer office (TTO) and the complex process of patenting are addressed, followed by a discussion on marketing and licensing the patent to a company in addition to starting a company. Finally, the authors address the basic principles of obtaining clearance from the Food and Drugs Administration, production in a good manufacturing practice (GMP) facility, and bringing the product to clinical trial.
authors: Section of Plastic Surgery, Division of Plastic and Reconstructive Surgery, Stanford University Medical Center, VA Palo Alto Health Care System, 770 Welch Road, Suite 400, Palo Alto, CA 94304, USA. Electronic address: rorymcg@stanford.edu.
authors: Rory B
authors: RB
authors: McGoldrick
authors: Section of Plastic Surgery, Division of Plastic and Reconstructive Surgery, Stanford University Medical Center, VA Palo Alto Health Care System, 770 Welch Road, Suite 400, Palo Alto, CA 94304, USA.
authors: Kenneth
authors: K
authors: Hui
authors: Section of Plastic Surgery, Division of Plastic and Reconstructive Surgery, Stanford University Medical Center, VA Palo Alto Health Care System, 770 Welch Road, Suite 400, Palo Alto, CA 94304, USA.
authors: James
authors: J
authors: Chang
mesh_terms: D018795:Device Approval; D006225:Hand / Q000601:surgery*; D006801:Humans; D008004:Licensure; D008389:Marketing of Health Services / Q000458:organization & administration*; D010330:Patents as Topic; D018581:Technology Transfer; D014481:United States
keywords: Clinical trials; Commercialization; Company startup; Food and Drugs Administration; Licensing; Marketing; Patenting; Technology transfer process