medical device e-manufacturing targets...— implants (hip, knee, shoulder, ankle, fingers, trauma)...

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!


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.


The Dental Market


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


The Medical Device Market


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


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


Design details

Complex surgical devices manufactured with optimized wall thickness


Design optimization for e-Manufacturing

— Variable wall thickness


Design details


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


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



— Evolution in the US!

•DePuy stated to bring laser sintering to manufacturing for medical instruments

Evolution in Medical Device Manufacturing

Source: EOS


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


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


Orthopedic Implant MarketThe long way to become or to sell to a medical

device manufacturer.


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


— 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


— 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


— 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


Thank You for your kind attention!


www.eos.info

medical device e-manufacturing targets...— implants (hip, knee, shoulder, ankle, fingers, trauma)...

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