Updated book highlights significant changes medical device developers need to know

PHOENIXVILLE, Pa.: Facet Life Sciences, a regulatory affairs and product development strategy partner, is proud to announce the release of the second edition of FDA and Intellectual Property Strategies for Medical Device Technologies, an updated resource for medical device innovators featuring six Facet Life Sciences experts as contributing authors.

“The journey from medical device concept to commercialization has been significantly impacted by recent key shifts in the technological landscape, including artificial intelligence (AI), the current FDA and political climate, and the ever-evolving intellectual property and US commercial environment,” says Lisa Jenkins VanLuvanee, Ph.D., Facet Life Sciences Chief Operating Officer & VP of Research and Development. “We are proud to partner with the Volpe and Koenig intellectual property team again to provide clear, comprehensive, and updated guidance to help developers progress their medical devices efficiently through development, FDA review, and into the US market.”

The second edition of FDA and Intellectual Property Strategies for Medical Device Technologies:

• Updates the regulations and guidances that bear on FDA medical device approval, grant, clearance, and commercialization
• Provides detailed examples of major FDA hurdles commonly encountered by medical device innovators
• Further discusses the interplay between FDA regulatory review of medical device technology and intellectual property strategy

Facet authors include Michelle Byrne, William Hodnick, Joshua Eldridge, Randy Goodman, Lisa Jenkins VanLuvanee, and Dana Blue. FDA and Intellectual Property Strategies for Medical Device Technologies: Second Edition is available online from Springer International Publishing.

About Facet Life Sciences

Facet Life Sciences specializes in regulatory affairs and product development strategy for programs that challenge precedent. We help emerging biotech and life sciences teams understand what their therapies and devices must demonstrate, how FDA is likely to evaluate the evidence, and what constitutes a viable and, ultimately, approvable path forward. We bring integrated scientific, regulatory, and commercialization disciplines to guide you to and through early planning, review, and market readiness.

Fonte: Business Wire