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Medical Device e-Manufacturing Targets
Martin BullemerKey Account Manager Medical
2008 April 16th
Medical e-Manufacturing IUM 2008 – MBU
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!
Medical e-Manufacturing IUM 2008 – MBU
The Medical Market for EOS
Dental MarketOrthopedic
Implant Market Medical Device
— Copings
— Bridges
— Implants
— Instruments
— Hip, Knee
— Shoulder
— Ankle
— Spine
— Trauma
— Machine devices
— Instruments
— Endoscope
— etc.
Medical e-Manufacturing IUM 2008 – MBU
The Dental Market
Medical e-Manufacturing IUM 2008 – MBU
Dental restorations in CoCr-SPx – todays mostsuccesful e-Manufacturing solution with EOSINT M
— 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
More then 10 systems sold for …
Source: EOS
Dental copings laser-sintered in dental CoCr-alloy on EOSINT M 270, before and after veneering… soon be more then 15 systems
Medical e-Manufacturing IUM 2008 – MBU
The Medical Device Market
Medical e-Manufacturing IUM 2008 – MBU
The World Medical Device Market
Source: 2005 Frost & Sullivan
Medical Device Industry - Estimated Value 2004: $ 148.28 billion with a growth rate in some segments of 10%/year
7% 6% 2%7%
1%1%
4%
4%
5%22%8%3%
7%
1%7%
2% 5% 7%
Cardiovascular Devices Wound Care ManagementNeurology Ophtalmic EquipmentRespiratory and Anaesthesia Disinfection & SterilizationDialysis Disposable Surgical SuppliesCosmetics & Aesthetics Orthopedic EquipmentSurgical Instuments Infusion SystemsHearing Aids EndoscopyDurable Medical Equipment Biomaterials and HemostatsFitness Equipment Robot Assisted and Image Guided Surgery
Main Targets
Medical e-Manufacturing IUM 2008 – MBU
Project summary
Source: Socinser, Prodintec
EOSINT M enables product optimization for surgical devices with new design concepts
— 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
Medical e-Manufacturing IUM 2008 – MBU
Design details
Complex surgical devices manufactured with optimized wall thickness
Source: Socinser, Prodintec
Design optimization for e-Manufacturing
— Variable wall thickness
Medical e-Manufacturing IUM 2008 – MBU
Design details
Source: Socinser, Prodintec
Design optimization for e-Manufacturing
— Complex shape as guidance for wire
— Draining hole
Complex surgical devices manufactured with optimized wall thickness
Guidance surface + wire or other surgical tools
Medical e-Manufacturing IUM 2008 – MBU
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
Medical e-Manufacturing IUM 2008 – MBU
— Evolution in the US!
•DePuy stated to bring laser sintering to manufacturing for medical instruments
Evolution in Medical Device Manufacturing
Source: EOS
Medical e-Manufacturing IUM 2008 – MBU
Project summary
Source: Deka Research, DARPA, EOS
EOSINT M is ideal for developing and producing innovative products
— 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
Medical e-Manufacturing IUM 2008 – MBU
Production details
Source: Produced by Deka Research for DARPA
Complex designs can be easily implemented using EOSINT M
— 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
Medical e-Manufacturing IUM 2008 – MBU
Orthopedic Implant MarketThe long way to become or to sell to a medical
device manufacturer.
Medical e-Manufacturing IUM 2008 – MBU
The Orthopedic Implant Market – TOP 10 - 2007
Source: EOS, www.odtmag.com 2007
Orthopedic Market 2007: $26 Billion
5,4
4,1
3,52,8
2,4
2,2
2 0,4130,4080,365
Stryker DePuy Zimmer S&N SynthesMedtronic Biomet DJO Kyphon Orthofix
Medical e-Manufacturing IUM 2008 – MBU
— 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
The Orthopedic Implant Market
Source: EOS, Frost & Sullivan
Medical e-Manufacturing IUM 2008 – MBU
— 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.
Orthopedic Implant Manufacturing
Source: EOS
Medical e-Manufacturing IUM 2008 – MBU
— A company who wants to start medical device manufacturing in theEU 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.
Orthopedic Implant Manufacturing
Source: EOS
Medical e-Manufacturing IUM 2008 – MBU
Thank You for your kind attention!
Medical e-Manufacturing IUM 2008 – MBU
www.eos.info