On December 4, 2017, the FDA offered new guidance to Medical device manufacturers on the usage of 3D Printing in healthcare, with a focus on patient-specific devices and treatments. Per the FDA’s statement:
“Once considered a futuristic technology on the distant horizon, 3D printing of medical devices, medications and human tissue is quickly becoming a promising reality. Patients have already benefitted from 3D printed medical products through access to personalized devices and innovative drugs that have led to significant health improvements. But the FDA is now preparing for a significant wave of new technologies that are nearly certain to transform medical practice. We’re working to provide a more comprehensive regulatory pathway that keeps pace with those advances, and helps facilitate efficient access to safe and effective innovations that are based on these technologies.”
The FDA went on to issue technical guidance to advise medical device manufacturers on recommendations on a range of issues that could be affected by 3D printing, including device design, testing, and quality control. This is a significant step towards the promise of truly personalized patient care, but we are still in the early stages of 3D printing’s ascent throughout the life sciences industry.
So what does this mean to device manufacturers? 3D printing (also known as Additive Manufacturing) is clearly becoming more adopted in the life sciences industries, and companies are looking to become more agile and offer more personalized manufacturing options. But any manufacturer or service provider can expect to deal with a dizzying array of new standards and regulations from the FDA.
To help make sense of this changing landscape, Dassault Systèmes hosted a panel discussion webinar with a select group of experts on the cutting-edge topic of 3D printing technology in the Healthcare and Life Sciences industries.
Our panelists include:
- Thomas Marchand, Co-Founder & CEO of BIOMODEX – a startup using 3D printed life-like organs that can be used for medical training and pre-operative preparation – to share the innovator’s perspective
- Jenny Chen, a trained neuro-radiologist and founder/CEO of 3DHEALS – a global community for the application of 3D printing in healthcare – to share the physician’s perspective
- Stavros Stefanis, leader in Deloitte’s Product Development practice, to share expert analysis on the use of 3D printing across the product development lifecycle
- The panel was hosted by Dan Matlis, President of Axendia, a leading analyst and advisory firm focused in the Life Sciences and Healthcare industries
This webinar discussing the current state and future applications of 3D Printing, Simulation and Digital Twin is free to view on-demand. Dassault Systèmes offers the only business experience platform that allows manufacturers to design, model, simulate, test, and manufacture a 3D printed device. For more information on our Industry Solution Experiences that help medical device manufacturers design for the future while navigating the regulatory landscape of today, visit our License to Cure, Made to Cure, and SIMULIA for Life Sciences landing pages.