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1 Challenges and opportuni1es of 3D prin1ng for orthopedic implant manufacturers Peter Mercelis, PhD director applied technologies healthcare Implants 2015, Paris NYSE:DDD

2 OVERVIEW Introduc1on to 3D Systems 3D systems: the digital thread Challenges and opportuni1es in Direct Metal Prin1ng Technology state of the art Technical considera1ons Real life illustra1ons

3 3D SYSTEMS INTRODUCTION Leading technology inventor: 1988: StereoLithography (SLA) invented by DDD founder and CTO Chuck Hull 1992: inventor of Selec1ve Laser Sintering (SLS) technology 1994: inventor of ColorJet Prin1ng (CJP) 1996: inventor of Mul1Jet Prin1ng (MJP) Largest 3D prin1ng company Market leader in industrial and medical 3D prin1ng

4 THE 3DS DIFFERENCE COMPLETE INTEGRATED SOLUTIONS DIGITAL THREAD 7 PRINT ENGINES PERCEPTUAL DESIGN 120 MATERIALS CLOUD PRINTING SERVICE

5 THE 3DS DIFFERENCE TOTAL SOLUTION PROVIDER FOR HEALTCARE INDUSTRY Produc1on hardware Materials Produc1on services Design and engineering tools Design and engineering services Training and educa1on tools

6 DIGITAL THREAD FROM END TO END Capture Create Print Provide

7 DIGITAL THREAD IN HEALTHCARE Digital Thread for Personalized Surgery, medical imaging through surgical outcomes. Our products and services meet the needs of customers ranging from medical device OEMs and teaching hospitals to individual healthcare professionals.

8 3D SYSTEMS HEALTHCARE On the forefront of surgical planning and personalized medical solu1ons for almost two decades.

9 3D SYSTEMS HEALTHCARE: SURGICAL SIMULATORS The most advanced and validated line of simulators Proven track record of rapid development of addi1onal modules and new simulators Best in market hands on procedural training Comprehensive skills assessment and progress tracking tools

10 DIRECT METAL PRINTING (DMP) 3DS produces revolu1onary orthopedic, maxillofacial, spinal and dental implants. Innova1ve metal prin1ng allows the most complicated implant designs with increased funclonality. Either serial- produced implants or unique palent- specific implants Implant prototype with variants in order to efficiently evaluate implant concepts and sizes

11 DIRECT METAL PRINTING: WHAT S IN A NAME? Ø 3D prin1ng technology Ø Using metal powder as raw material Ø Building fully dense pure metals and alloys Ø By using focused laser radia1on Ø In a controlled environment

12 DMP EVOLUTION: MATERIALS AND CHARACTERIZATION Stainless steel Tool steel Titanium Super alloy Aluminium Exotics Reference 316L SS 17-4 SS 15-5 Maraging X3NiCoMoTi Ti commercially pure grade 1 Ti commercially pure grade 2 Ti6Al4V ELI Ti6Al4V CoCrMo CoCrWMo Inconel 718 Inconel 600 AlSi10mg Tantalum Tungsten Dental Medical Industrial Aero Widest material pale-e available Addi1onal alloys under development

13 DMP ACCURACY AND RESOLUTION Extreme resolu1on allowing highly detailed scaffold produc1on High accuracy as built (+/- 50 µm for small parts) Hybrid manufacturing allows CNC precision and tolerances

14 HIGH PART ACCURACY AND RESOLUTION Tolerances Surface Roughness Repeatability Wall Thickness Feature Size Channel Diameter 50μm, % 4 7μm R a, μm R y 30μm 200μm 120μm 250μm

15 DMP: MATERIAL CHARACTERIZATION No compromise on material proper1es Compliance with relevant ISO and ASTM standards Extensive mechanical tes1ng: Tensile Strength Yield Strength Elonga1on at break Hardness Young s Modulus Impact Toughness Fa1gue tes1ng for dynamically loaded parts Cleanliness valida1on 100µm

16 DMP: MATERIAL CHARACTERIZATION Fully dense microstructures can be aoained Small grain sizes due to rapid cooling lead to high strength values Lamellar alpha- beta microstructures can be achieved for Ti6Al4V

17 DMP: MATERIAL CHARACTERIZATION Extensive mechanical tes1ng of scaffold structures: sta1c behavior 200 cube 6 cube diamond diamond Maximum strength σ max [MPa] rhombic dodecahedron truncated cube truncated cuboctahedron rhombic cuboctahedron Stiffness E [MPa] rhombic dodecahedron truncated cube truncated cuboctahedron rhombic cuboctahedron 0 0,0 0,1 0,2 0,3 0,4 Structure relative density ρ rel [-] 0 0,0 0,1 0,2 0,3 0,4 Structure relative density ρ rel [-]

18 DMP: MATERIAL CHARACTERIZATION Pure 1tanium, tantalum or Ti6Al4V as suitable scaffold materials Deforma1on mode determined by material selec1on Predictable dynamic fa1gue behavior

19 DMP: MATERIAL CHARACTERIZATION Excellent osseo- conduc1ve and osseo- induc1ve behavior of DMP scaffolds bone As built tantalum implant Almost full bridging of the critical size femur defect after 12 weeks Strong implantbone interface good quality of regenerated bone

20 DMP CHALLENGES Prin1ng the microstructure DMP users not only generate a 3D geometry, but produce the raw materials simultaneously Rigorous evalua1on and control of material proper1es needed: IQ/PQ/OQ process Full documenta1on of process parameters Online quality monitoring tools

21 DMP CHALLENGES

22 DMP CHALLENGES Online quality monitoring and feedback control as future aid for QC & QA On going development

23 DMP CHALLENGES How to ensure cleanliness? Loosely sintered/molten powder par1cles at outer surfaces inherent to powder manufacturing Proprietary methods for par1cle removal Validated cleaning protocols

24 DMP OPPORTUNITIES Unlimited design freedom Pa1ent specific designs Anatomical designs Complexity for free The World s First Titanium Complete Lower Jaw Zygoma1c Implant

25 DMP OPPORTUNITIES Scaffolds: designed porosity Superior rigidity/weight ra1o Arbitrary scaffold unit cell shape, size & orienta1on Full control over scaffold porosity degree and interconnec1vity Excellent osseointegra1on Standard acetabular implant Custom acetabular Implant (design by Ossis) Spinal fusion implant

26 DMP OPPORTUNITIES Flexible manufacturing Short lead 1mes Reduced inventory Digital manufacturing New business models Facilita1ng personalized medicine Cloud- based design and communica1on

27 REAL LIFE ILLUSTRATIONS VSP : Virtual Surgial Plan PaLent- specific InstrumentaLon & Surgical Planning U1lizing medical image data and 3D prinlng experlse to accurately plan surgery in a computer environment and then transferring to OR using customized instruments and models An online Web MeeLng with our engineers ensures surgeon has complete control of the surgical plan and instrument design. VSP RECONSTRUCTION VSP CRANIAL VSP ORTHOGNATHICS Recon Mandible model with plate bending template, fibula cukng guide, lel and right mandible guides and metal slot and drill tool, pre- op printed Mandible model

28 REAL LIFE ILLUSTRATIONS Collabora1on with Xilloc Medical BV and Prof. Jules Poukens

29 REAL LIFE ILLUSTRATIONS DentWise: mass customiza1on in dental prosthe1cs Cloud based client collabora1on Titanium and cobalt- chrome alloys Implant bars, bridges and removable prosthe1cs Hybrid manufacturing for excellent accuracy

30 REAL LIFE ILLUSTRATIONS CMF/orthodon1c implants Types; bone plates, bone anchors Annual quan11es Added value of DMP: Shape freedom Cost efficient manufacturing Image Courtesy Tita- Link

31 REAL LIFE ILLUSTRATIONS Veterinarian orthopedics: Tibial Tuberosity Advancement implants: TTA Rapid More than implants sold Veterinary Implants Image Courtesy Rita Leibinger Medical

32 REAL LIFE ILLUSTRATIONS Spinal industry Volume manufacturing of spinal fusion cages Spinal nails, screws, etc. First pa1ent- specific cervical spinal cage Annual quan11es up to ten thousands

33 REAL LIFE ILLUSTRATIONS Hybrid manufacturing: Combina1on of DMP technology with classical CNC machining Seamless integra1on with EDM, CNC milling, turning, etc. Surface finishing up to mirror polish Best of both worlds

34 CONCLUSIONS Direct Metal Prin1ng offers clear benefits for orthopedic, spinal, and CMF implant design and manufacturing DMP is a step in the manufacturing chain, compa1ble with other manufacturing techniques Learning curves may be dras1cally reduced by star1ng with outsourcing DMP is one of most important the enablers of digi1zed and personalized medicine

35 3D SYSTEMS HEALTHCARE Thank you for you aoen1on! Contact informa1on:

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