Special Counsel Meredith P. Vanderbilt Authors New Book on Additive Manufacturing for Orthopedic Implants

Meredith Vanderbilt, Special Counsel at Bartko Pavia LLP, alongside co-authors Dawn Abens Lissy and Brian McLaughlin, has published their new book, Additive Manufacturing for Orthopedic Implants: Material and Process Selection, Validation Activities, and Regulatory Submissions.

The book walks readers through the critical steps involved in developing spine, hip, knee, shoulder, and other orthopedic implants using additive manufacturing, covering the full product life-cycle from design and prototyping through process validation and FDA submission preparation.

It provides practical guidance on material selection across implant types and additive manufacturing technologies, examines the balance between design flexibility and regulatory expectations for patient-specific devices, and addresses common failure modes with strategies for risk mitigation. The book also outlines key facility, inspection, and documentation requirements for compliance, while offering decision-making tools, checklists, and validation frameworks to support implementation, along with clear direction on regulatory pathways for additively manufactured products.

As additive manufacturing continues to accelerate innovation in healthcare, the ability to align technical advancement with regulatory compliance will define success in the field. This publication provides practical guidance to help teams move from concept to commercialization with greater confidence and efficiency.

This work reflects the growing intersection of innovation and regulation. Meredith, leads Bartko Pavia’s life sciences and healthcare group where our firm advises clients on regulatory compliance, enforcement risk, litigation, and transactional matters. We work with medical device manufacturers, healthcare providers, and investors to navigate evolving regulatory frameworks and deliver practical, litigation-ready solutions. Learn more about our Life Sciences & Healthcare practice. 

To learn more or purchase a copy of the book, click here.