3D Printing Image

In the medical device industry, the ultimate objective is to improve and accelerate innovation without sacrificing safety or efficacy. Additive manufacturing is a superpower to support that by enabling rapid iterations, design freedom, tailored solutions, and on-demand manufacturing. In this session, “Leveraging Additive Manufacturing for Medical Devices from Concept Through Production,” Carl Douglas, P.E., looks at 3D printing, which was long an early development tool for proof of concept and validation testing, but that traditional subtractive or molding manufacturing has been primarily used for later stages of development and launch. Douglas is a co-founder of DI Labs, Willmar, MN.

The session will explore the limitations that prevent 3D printing for production, including limited materials, tolerances, process controls, traceability, and biocompatibility. Douglas will discuss the role of 3D printing: As a prototyping tool, 3D printing is ideal but the demands for production are significantly more rigorous. Through the past decade, additive manufacturing has evolved from 3D printing to become a manufacturing resource offering greater impact to medical device innovation.

Doulgass will focus on factors such as available materials, production technologies, process controls, repeatability, surface finishes, and quality have and how such advancements have opened the door for additive manufacturing to become a full-scale production resource. Further, he will address the nuances between 3D printing and additive manufacturing: They may be cut from the same cloth but must be managed very differently in order to deliver for the demands of medical device manufacturing. Like any other manufacturing method, there are special considerations required to achieve successful results through late-stage development and into market launch.

Additive manufacturing must be tightly controlled; from materials to operating environment, processes, and the quality steps. He will share success stories leveraging additive manufacturing as a superpower for medical device component production from the special considerations to the dramatic advantages.