GLOBAL 3D PRINTED MEDICAL DEVICES MARKET ANALYSIS

3D Printed Medical Devices Market, By Application Type (Orthopedic Implants, Dental Implants, Cranio-maxillofacial Implants, Internal and External Prostheses), By Technology (Stereo Lithography (SLA) – Liquid Based 3D Printing, Selective Layer Sintering (SLS) – Powder Based 3D Printing, Digital Light Processing(DLP), Fused Deposition Modeling (FDM): Plastic Filament Extrusion Based, PolyJet / InkJet 3D Printing, Electronic Beam Melting (EBM)), By Material (Plastics (Thermoplastics, Photopolymers), Biomaterial Inks(Polymers, Ceramics, Hydrogels), Metals and Alloys), and By Region (North America, Canada Latin America, Europe, Asia Pacific, Middle East and Africa) - Size, Share, Outlook, and Opportunity Analysis, 2019 - 2027

Published In : Jan 2020
Code : CMI29
Pages :180
Formats :
Excel and PDF
Industry : Medical Devices

Regional Analysis

North America region held dominant position in the global 3D printed medical devices market in 2019, accounting for 46.0% share in terms of volume, followed by Europe.

Regulations

North America

Under U.S. FDA,

Center for Devices and Radiological Health (CDRH) regulates 3D printed medical devices
Center for Biologics Evaluation and Research regulates 3D printing in biologic applications
Center for Drug Evaluation and Research regulates 3D printing in drug development applications

In May 2016, the U.S. FDA noted Design and Manufacturing Considerations and Device Testing Considerations as two broad areas for addressing quality-related issues, verification and validation of pre-marketing approvals for 3D devices

The U.S. FDA has emphasized the importance of assessment of material control, 3D printer, and post-printing processes for successfully evaluating device performance
According to the U.S. FDA, mechanical testing for 3D printed devices should take into account a device's build orientation relative to the 3D printer
The U.S. FDA approves majority of devices in 3D printing technology as Class II