Cross-Practice Team Authors “Physician’s Guide to Commercializing a Medical Device Invention”

In The News
October 15, 2018
Thomas N. Bulleit
Megan R. Baca , Bradford Flint

Bringing together several different areas of the firm’s expertise, a team of Ropes & Gray lawyers authored a Practice Resource in the October issue of the American Health Lawyers Association’s Journal of Health & Life Sciences Law titled “Building a Better Mousetrap: A Physician’s Guide to Commercializing a Medical Device Invention.”

An AHLA Practice Resource is a how-to guide for lawyers. This one addresses the key steps a lawyer representing a physician inventor would take to bring a medical device to commercialization, including protecting and managing IP, forming a business and securing funds, FDA approval or clearance, FDA and anti-kickback restrictions on marketing, and third-party payer coverage and reimbursement.

The guide was written by health care partner Tom Bulleit (Washington, D.C.), IP transactions partner Megan Baca (Silicon Valley) and life sciences associate Brad Flint (Boston). Co-authors also include Abram Barth, now Senior Regulatory Counsel at GRAIL, Inc. (when the article was written, an associate in the firm’s life sciences practice) and Gelvina Rodriguez Stevenson, Associate General Counsel at the Children’s Hospital of Philadelphia.