Medical Device e-manufacturing Targets Martin Bullemer Key Account Manager Medical 2008 April 16th
The Medical Market for Laser Sintering Every human is different, which results in a wide variety of different parts and devices at a relatively small quantity. A highly flexible manufacturing solution is perfect for this!
The Medical Market for EOS Dental Market Copings Bridges Implants Instruments Orthopedic Implant Market Hip, Knee Shoulder Ankle Spine Trauma Medical Device Machine devices Instruments Endoscope etc.
The Dental Market
Dental restorations in CoCr-SPx todays most succesful e-manufacturing solution with EOSINT M More then 10 systems sold for Dental e-manufacturing single copings and small bridges The EOSINT M270 is able to produce 200 250 units within 11 hours two-shift production possible! complete process chain right partner in the dental market (scanner manufacturer) new CoCr material with less stress tendency CE certification and FDA listing soon be more then 15 systems Dental copings laser-sintered in dental CoCr-alloy on EOSINT M 270, before and after veneering Source: EOS
The Medical Device Market
The World Medical Device Market Main Targets 7% 2% 5% 7% 1% 7% 6% 2%7% 1% 7% 4% 3% 8% 22% 5% 4% Cardiovascular Devices Neurology Respiratory and Anaesthesia Dialysis Cosmetics & Aesthetics Surgical Instuments Hearing Aids Durable Medical Equipment Fitness Equipment Wound Care Management Ophtalmic Equipment Disinfection & Sterilization Disposable Surgical Supplies Orthopedic Equipment Infusion Systems Endoscopy Biomaterials and Hemostats Robot Assisted and Image Guided Surgery Medical Device Industry - Estimated Value 2004: $ 148.28 billion with a growth rate in some segments of 10%/year Source: 2005 Frost & Sullivan
EOSINT M enables product optimization for surgical devices with new design concepts Project summary Requirements: complex, sharp, hollow surgical devices ergonomic design customization (protection against product copy) Solution: DMLS with EOSINT M 270 EOS StainlessSteel GP1 (for ductile elements) EOS StainlessSteel PH1 (for hardened parts) Result: manufacturing of instruments for bone surgery customized and integrated parts hollow parts with lower weight lower cost per part compared to traditional solutions Top: thin-walled surgical devices built in GP1 on EOSINT M 270. Bottom: Complete set of instruments for bone surgery Source: Socinser, Prodintec
Design optimization for e-manufacturing Design details Variable wall thickness Complex surgical devices manufactured with optimized wall thickness Source: Socinser, Prodintec
Design optimization for e-manufacturing Design details Complex shape as guidance for wire Guidance surface + wire or other surgical tools Draining hole Complex surgical devices manufactured with optimized wall thickness Source: Socinser, Prodintec
EOSINT M offers rapid production of high-performance parts Production details Machine: EOSINT M 270 Layer thickness: 20 microns Build time: approx. 70 hours for one set (4 6 weeks conventional) Post-processing: support removal and shot-peening Source: Socinser, Prodintec
Evolution in Medical Device Manufacturing Evolution in the US! DePuy stated to bring laser sintering to manufacturing for medical instruments Source: EOS
EOSINT M is ideal for developing and producing innovative products Project summary Requirements: humeral mount for a fully integrated prosthetic arm developed by Deka Research for the Defence Advanced Research Projects Agency (DARPA) Revolutionizing Prosthetics Program Solution: EOSINT M 270 with Ti6Al4V material Result: complex part produced quickly and cost-effectively, with high quality single step, fully automatic build process part accuracy, surface quality and mechanical properties at least as good as with casting Humeral mount, produced in Ti6Al4V on EOSINT M 270 Source: Deka Research, DARPA, EOS
Complex designs can be easily implemented using EOSINT M Production details Machine: EOSINT M 270 Titanium version Material: EOS Titanium Ti64 Layer thickness: 30 microns Part dimensions: approx. 60 x 80 x 100 mm Build time: approx. 15 hours Source: Produced by Deka Research for DARPA
Orthopedic Implant Market The long way to become or to sell to a medical device manufacturer.
The Orthopedic Implant Market TOP 10-2007 Orthopedic Market 2007: $26 Billion 2,2 2 0,4130,4080,365 5,4 2,4 4,1 2,8 3,5 Stryker DePuy Zimmer S&N Synthes Medtronic Biomet DJO Kyphon Orthofix Source: EOS, www.odtmag.com 2007
The Orthopedic Implant Market Implants (hip, knee, shoulder, ankle, fingers, trauma) Huge market with some global players Potential (US) - Orthopedic Equipment 12,5 billion $ Trauma/Fixation 1,6 billion $ Estimation: 10-20 Mio procedures / a 150 pcs day, 24/7 production => 182 x EOSINT M (10 Mio units) This strategic market is asking mainly for CoCr, TiCp, Ti6Al4V, Ti6AlV4 ELI Source: EOS, Frost & Sullivan
Orthopedic Implant Manufacturing When we talk about implant manufacturing we have to fulfill several requirements, even our laser sintering machines are not a medical product but used for medical manufacturing. Mechanical properties must be according to the medical standards. Laser sintering machines must be validated / qualified for manufacturing, which will be a huge documentation task. Source: EOS
Orthopedic Implant Manufacturing A company who wants to start medical device manufacturing in the EU must work in compliance with EU-Directives: 93/42/EEC Medical Device Directive (MDD) 2007/47/EC Revision of the MDD Conformity assessment CE-marking Basement for this will be a QMS (quality management system) according to ISO 13485. Source: EOS
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