1 EBM Inside Arcam provides a cost-efficient Additive Manufacturing solution for production of implants. Arcam s EBM technology is used for production of FDA-cleared and CE-certified orthopedic implants. Additive Manufacturing of orthopedic implants Since 2007 EBM-manufactured acetabular cups with Trabecular Structures for improved osseointegration have been implanted. EBM is also used for production of augments, femoral stems and spinal cages. Arcam is an innovative partner for manufacturing in the orthopedic implant industry, where we deliver customer value through our competence and solution orientation. Arcam AB Krokslätts Fabriker 27A SE Mölndal, Sweden Phone:
2 The future in implant manufacturing Arcam s Electron Beam Melting technology is the ultimate solution for additive manufacturing of orthopedic implants. The Arcam EBM process is particularly useful for cost-efficient production of high volume press-fit implants with advanced Trabecular Structures as well as one-off custom implants built with data derived from CT-scans of individual patients.
3 Inside the Arcam EBM process Something totally different Arcam has designed the EBM process specifically for cost-efficient production of orthopedic implants. The implants are built up layer-by-layer of metal powder, melted by a powerful electron beam. Each layer is melted to the exact geometry defined by the 3D CAD model. The Arcam EBM machines are equipped with a high power electron beam gun that generate the energy needed for high melting capacity and high productivity. The electron beam is controlled by electromagnetic coils which allows for an extremely fast and accurate beam control. The Arcam production platforms are capable of delivering a beam power of 3000 W and a scan speed that allows several melt pools to be maintained simultaneously - Arcam EBM MultiBeam. The vacuum system is designed to maintain a controlled vacuum level of 1x10-5 mbar, throughout the entire build cycle. The vacuum environment eliminates the risk of oxidation of the built material and secures state of the art material properties. In the medical field there are two obvious areas of special interest, cementless standard implants with advanced Trabecular Structures - Engineered Porous Materials and patient-specific (custom) implants based on CT-data. Today there are a large number of CE-certified and FDA cleared implants on the market produced by the Arcam EBM process. These products include primary and revision hip implants such as acetabular cups and augments as well as spinal implants.
4 EBM benefits Paradigm shifts The benefit with the Arcam EBM process should be seen from two perspectives. First, it is a cost-efficient production alternative to conventional casting and machining. Secondly, and more important, it opens up a world of opportunities for product differentiation. Due to the inherent freedom in design, the EBM process offers completely new opportunities for product differentiation and development of new trademarked trabecular structures. Further benefits with EBM production of press-fit implants: Single step production of solid and porous sections (Trabecular Structures) Structural continuity between solid and porous sections All-porous implants possible (augments, wedges, blocks, etc) Advanced Trabecular Structures achieved without grain growth in base material Trabecular Structures Engineered Porous Materials The EBM technology offers a unique opportunity to design and manufacture your own trademarked trabecular structure designs. When choosing the EBM technology for manufacturing you set yourself free from design constraints you normally have to consider due to limitations of traditional technologies for building porous materials. Through the freedom in design offered by the EBM process you may develop a trabecular structure design in a CAD environment with a minimum of capital investment and a virtually total freedom in design. To achieve the properties you look for in terms of osseointegration, primary fit etc you may optimize your design in terms of: Pore geometry Pore size Relative density Roughness Structure thickness Standard implants The EBM technology is a cost-efficient process for manufacturing both press-fit implants and cemented implants. For press-fit implants specifically, the EBM process lends itself for high volume production. Solid and porous sections of the implant are built in one process step, eliminating the need for expensive secondary processes for applying traditional porous materials. Custom implants CAD to Metal The EBM-technology offers a direct CAD to Metal process allowing production of patient-specific implants using data derived from Computer Tomography (CT). The CT data is used to create an exact CAD model of the desired implant. This CAD model is then used by the EBM machine to build the actual part.
5 The EBM Roadmap From concept to production The Arcam application specialists are available for you to support your product idea, through the R&D process to product release, and in your ongoing production. 2. Setting up a production case While setting up your production case Arcam offers support to: Optimize build strategy, e.g. stacking of parts for optimal productivity Optimize build parameters for highest possible productivity Supporting the process validation with EBM-specific validation guidelines 1. Design Phase In the design phase of a new orthopedic implant Arcam offers support to: Optimize build parameters i.e. to achieve the desired trabecular structure properties and appearance Generate timely prototypes for design iterations Simulate production runs and develop ROI calculations Support your product certification process (CE and/or 510k approval under FDA regulations)
6 Cad environment Optimize your Trabecular Structure design for: Pore geometry Pore size Relative density Roughness Structure thickness Apply your trademark Trabecular Structure design to the actual implant design. 3. In Production Due to the high build speed, high repeatability and excellent material properties the EBM process is well suited for volume production. Arcam provide a number of tools to support volume production. Production-specific user interface fulfilling FDA requirements Layer verification capable of identifying any defect down to 100 μm EBM LogStudio for analyzing each build EBM Build Report to verify the success of each build Integration with Streamics software Prototyping and design verification Build prototypes for evaluation, testing and design iterations. Pre-production of implants for product certification and process validation. EBM production Volume EBM production
7 EBM materials Way beyond average Meeting established standards for material properties is important for any industrial application, for orthopedic implants it is crucial. Arcam is committed to ensure first-class material properties on all released materials. EBM-built materials have excellent material properties verified by static and dynamic testing of mechanical properties, chemical composition, detailed analysis of microstructures and biocompatibility studies. Arcam has developed the EBM technology for the following materials, each complying with applicable material standards for medical devices. Titanium Ti6Al4V Titanium Ti6Al4V ELI Titanium Grade 2 Cobalt-Chrome, ASTM F75
8 Production equipment Machines and more Arcam offers a complete portfolio of equipment, software, metal powders, service and training. The Arcam Q10 The Arcam Q10 is the 3rd generation EBM machine, optimized for cost-efficient production of orthopedic implants. It is a robust and reliable production equipment featuring many technical innovations that contribute to the state-of-the-art productivity, surface finish and user friendliness. Features include: Arcam EBM MultiBeam for high surface finish in combination with high build speed Active cooling and insulated powder bed for fast builds and high productivity Layer verification system ensuring build quality Auxiliaries In addition to the EBM machines Arcam offers explosion-protected vacuum cleaners, powder handling trolleys and powder recovery systems as part of our standard offer. The Arcam Powder Recovery System (PRS) is designed to minimize manual intervention and includes powder sieving for efficient powder recycling. Powders Arcam has a validated powder supply chain with full traceability of every powder batch delivered. All powders supplied by Arcam are extensively tested before release to customers which includes making sure the EBM parameter settings (Process Themes) are optimized to work well with the powders. Service and maintenance Arcam offers support agreements to ensure the performance of the machine throughout its lifetime. Arcam s service agreements include spare parts, updates, phone/mail support, emergency support and regular visits for preventive maintenance by our highly qualified field service engineers. Arcam s support organisation ensures that you get the best possible output from your EBM systems. Training Arcam offers basic training packages as well as advanced training packages for customers who require more in-depth EBM knowledge, or where the applications require special training.
General Principles of Software Validation; Final Guidance for Industry and FDA Staff Document issued on: January 11, 2002 This document supersedes the draft document, "General Principles of Software Validation,
Will Cloud Computing Work for the Life Sciences Industry? Even in a regulated industry there are many opportunities to start seeding the Clouds Cloud computing refers to the idea of delivering information
Connect yourself to MES MES pocket guide www.siemens.com/mes-simaticit s 2 Bringing excellence to your manufacturing enterprise with SIMATIC IT - your modular MES As a link between the technical production
WHITE PAPER Managed Services for Mission Critical Communications Introduction Much has been written about Managed Services in the communications industry, initially in the IT sector and more recently in
Guidance for Industry Q10 Pharmaceutical Quality System U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation
Guidance for Industry Process Validation: General Principles and Practices U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center
Solution, Success, Partnership Our solutions for your success. Masa your partner for the successful production of building materials. With intelligent and flexible solutions, Masa leads its customers to
FACTS AND FIGURES (JANUARY 2008) B R U S S E L S. D U B A I. F R A N K F U R T. G R E N O B L E. H O N G K O N G. N E W Y O R K. PA R I S. S Ã O PA U L O. S E O U L. S I N G A P O R E. S Y D N E Y. W A
FRAUNHOFER RESEARCH INSTITUTION AISEC CLOUD COMPUTING SECURITY PROTECTION GOALS.TAXONOMY.MARKET REVIEW. DR. WERNER STREITBERGER, ANGELIKA RUPPEL 02/2010 Parkring 4 D-85748 Garching b. München Tel.: +49
ITIL V3 Application Support Volume 1 Service Management For Application Support ITIL is a Registered Trade Mark and Community Trademark of the Office of Government and Commerce. This document may contain
DATA CENTER DESIGN White Paper JAN KREMER CONSULTING SERVICES Data Center Design White Paper Page 1 TABLE OF CONTENTS 1. INTRODUCTION... 4 1.1. DOCUMENT OUTLINE... 4 2. GENERAL DESIGN PRINCIPLES... 5 2.1.
Hurwitz ViCtOrY index Advanced Analytics: The Hurwitz Victory Index Report SAP Hurwitz Index d o u b l e v i c t o r Marcia Kaufman COO and Principal Analyst Daniel Kirsch Senior Analyst Table of Contents
White paper The future of Service Desks - vision Service Desks require strategic consideration and innovation to raise user productivity and to support business goals. Fujitsu has the experience and feedback
www.vce.com BEYOND CONVERGED INFRASTRUCTURE: DELIVERING A PRODUCTIVE CLOUD EXPERIENCE WITH INTEGRATED SOLUTIONS 1 Copyright VCE believes the information in this publication is accurate as of its publication
Executive report Increasing marketing campaign profitability with predictive analytics Table of contents Introduction..............................................................2 Focusing on the customer
QUANTIFYING THE RETURN ON INVESTMENT (ROI) The Business Case for Internet of Things Initiatives white paper EXECUTIVE SUMMARY ROI Redefined If someone asked you to create an ROI model for an investment
Project Management White Paper 141 Revision 1 by Neil Rasmussen and Suzanne Niles > Executive summary In data center design/build projects, flaws in project management and coordination are a common but
An introduction and guide to buying Cloud Services DEFINITION Cloud Computing definition Cloud Computing is a term that relates to the IT infrastructure and environment required to develop/ host/run IT
FNT EXPERT PAPER AUTHOR Eric Brabänder Chief Marketing Officer FNT GmbH // Run your Data Center as a Business DCaaB: From DCIM via DCSO to IT Factory. The ongoing digitization of the world around us driven
Outsourcing Workbook Page 1 Copyright 2008 Notice of rights All rights reserved. No part of this book may be reproduced or transmitted in any form by any means, electronic, mechanical, photocopying, recording,
Nokia Corporation Nokia Mobile Phones P.O. Box 100 FIN-00045 Nokia Group, Finland Tel. +358 7180 08000 Telefax +358 7180 34016 www.nokia.com/m2m Machine-to-Machine - Real Opportunity in Wireless Data Business
SANMINA-SCI CORP FORM 10-K (Annual Report) Filed 11/24/08 for the Period Ending 09/27/08 Address 2700 N FIRST ST SAN JOSE, CA 95134 Telephone 4089643500 CIK 0000897723 Symbol SANM SIC Code 3672 - Printed