Team Members to Share Medical Device Research and Regulatory Experience
Wayne, PA, November 8, 2018 – Facet Life Sciences, a leading provider of development software and services for small and growing life sciences teams, today announced that two team members are contributing to a new book, “FDA and Intellectual Property Strategies for Medical Device Technologies”.
Lisa Jenkins VanLuvanee, Ph.D., Vice President of Research and Development at Facet Life Sciences, and Dana Blue, M.S., Product Development Champion at Facet were tapped for their experience interacting with the U.S. FDA and their proficiency and practical knowledge in clinical and nonclinical research of medical devices. Dr. Jenkins VanLuvanee and Ms. Blue collaborated with Gerald B. Halt, John C. Donch, Amber R. Stiles and Brandon R. Theiss to develop the content for the book.
Dr. Jenkins VanLuvanee commented, “We really enjoyed being part of this effort. The book is full of practical guidance for medical device innovators and will be a great resource for early stage teams who need to understand potential intellectual property issues and regulatory concerns.”
Ken VanLuvanee, President and CEO, Facet Life Sciences, commented, “This book is yet another example of the caliber of talent that Facet has been able to retain. Our experts are routinely meeting with the FDA while developing and executing regulatory strategies that help our clients navigate the complex regulatory development process. We are proud to share that expertise in the upcoming book.”
The publisher is promoting the book as offering “comprehensive, easy to understand guidance for medical device technology innovators on how to work through the United States FDA regulatory review process, while also providing insight on the various intellectual property concerns that many medical device innovators face.” The book is slated for publication by Springer International Publishing in January 2019.
About Facet Life Sciences
Facet Life Sciences is the leading provider of innovative development solutions (software and services) designed to help small teams get to and through the FDA©. Our Product Development Champions deliver expert nonclinical, CMC, and clinical regulatory services using cutting-edge technologies that speed product R&D efforts. Facet teams create and manage critical development documentation for some of the industry’s fastest growing, most innovative life sciences companies.