Additive Manufacturing 101: Changing Medical Product Development and Manufacturing. Fred Fischer Stratasys Incorporated

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1 Additive Manufacturing 101: Changing Medical Product Development and Manufacturing Fred Fischer Stratasys Incorporated

2 Terminology Known by many names:! 3D Printing! Rapid Prototyping! Rapid Tooling! Rapid Technologies! Rapid Manufacturing! Advanced Manufacturing! Additive Fabrication! Additive Layer Manufacturing! Direct Digital Manufacturing! Direct Manufacturing

3 Terminology! Additive Manufacturing!! Term covering all technologies!! Term covering all applications!! Replacement for RP! Definition:!! Collection of technologies, directly driven by CAD data, to produce 3-Dimensional physical models and parts through an additive process.

4 Typical Build Process 1- Pre-Process 2- Produce Part 3- Post Process ` `

5 Solution Classification Additive Manufacturing On-Demand Services (Service Bureaus) LOWEST BARRIER TO PARTS 3D Printers MOST AFFORDABLE SOLUTIONS 3D Production Systems HIGHEST PERFORMANCE SYSTEMS! Distributed globally! 3 10 day turn around avg.! Almost all technologies! $10 -$50K USD! Simple and easy to use! Optimized for form, fit some function! $50-$500K & up USD! Optimized for performance! Broad application solution

6 Primary Applications for Additive Manufacturing Technology Additive Manufacturing Concept Models Functional Prototypes Manufacturing Tools End-Use Parts Established / Traditional (Design) Direct Digital Manufacturing (Manufacturing)

7 Technology Assessment 3D PRINTERS 3D Printers 3D PRODUCTION SYSTEMS 3D Production Systems Performance Requirements Increase Conceptual Models Functional Prototypes Manufacturing Tools End-Use Parts

8 Optimal Design Cycle Design Change Design Change Design Change

9 Prototype Early and Often to Minimize The Cost of Change 80% of Product cost finalized 10,000 Relative Costs 1 $ $ Concept 10 1,000 $ $ 100 $ Engineering Detail Tooling Production Source: Rosenberg, Boston University

10 Conceptual Models & Functional Prototypes! Direct benefits!! Reduce time to market! Solidify design earlier! Reduce late design changes!! Lower product development cost! Design changes earlier in process! Make mistakes early and often! Indirect benefits!! Facilitate communication!! Improve product design

11 !"#$%&'()*$#%!+,-$.'%/+)$0*,1% 2(,-'*+,"0%34+'+'5.*,1%

12 Altimate Medical Stands Up to Lowering Costs Time-to-market reduced 90%!! Device designed and built in 6 months!! Prototyping costs also substantially reduced FDM for in-house prototypes!! 2 alternative prototype devices built!! All from ABS-M30i Process Development Time Cost More holistic view of device design!! Found 29 design errors/changes!! Saved estimated $185,000 changes Outsourcing to Service Bureau Fortus system in-house 3 weeks $1,000 2 days $100 Savings 19 days (90%) $900 (90%)

13 Medtronic Tests Surgical Instrument Surgeons unhappy with implant fastening tools!! 2 tools required to fasten set-screws!! Results was often a violent impulse Fortus used to produce functional prototype!! Combined 2 existing tools!! Strong enough to fasten stainless screws Prototype enabled design improvements!! Surgeons used prototype in hospital!! Found tool could be improved by rotating handle Benefits of in-house prototyping!! Speed and communications lead to better products!! Substantial cost savings! " #$% &' To Slide: Materials Back To Functional Prototypes Back to Primary Applications

14 Case Studies Manufacturing Tools End-Use Parts

15 Primary Applications for Additive Manufacturing Technology Additive Manufacturing Concept Models Functional Prototypes Manufacturing Tools End-Use Parts Established / Traditional (Design) Direct Digital Manufacturing (Manufacturing)

16 Manufacturing Applications (DDM)! Direct benefits!! Financial gain! Lowering costs! Increasing profits!! Time advantages! Decreasing time-to-market! Decreasing cycle time! Indirect benefits!! Design freedom!! Product redesign frequency!! Rapid response

17 Manufacturing Applications (DDM) Best fit when:! Relatively low volumes!! Short run production!! Bridge to tooling! High part complexity!! Eliminate expensive tooling!! Reduce long lead times! Part acceptable!! Aesthetics not critical!! Finishing processes feasible!! Physical properties acceptable

18 ACIST Medical Medical devices automate contrast injection "! Numerous different models & systems "! Relatively low production volumes New product development challenges "! Deliver multiple concepts to physicians in days "! Receive and integrate field feedback FDM 3D Printers primarily for design applications "! Quick concept models in days not weeks "! Improved product design & reduced part count Fortus 3D Production System "! Higher requirement functional prototypes "! Increased manufacturing tools on floor "! Enables low-volume manufacturing! " #$% In their own words &'

19 ScriptPro: 79% Drop in Low-Volume Part Cost Custom machines require many bezel sizes "! Difficult to forecast which bezels are needed "! Cost of tooling would be very high ScriptPro invested in Fortus system "! Builds bezels as needed to customer orders "! Meets precise tolerance requirements Elimination of tooling saves money "! Injection molding would cost $31,650/year "! FDM manufacturing costs $6,750/year New or modified bezels don t require re-tooling "! ScriptPro can add new bezels at very low cost "! Engineers can continually improve the product /$'6+)%!+#'% 7*8$%!"#$%&'(") *(+,'"-)./01234) 24),567) 89:),';$%&),'-'&5+)*<-=).21>34) 0),56)?5@'"-7).AB1C44) D>CEF) 3C),567) DCGEF)! " #$% &'

20 Virtumed: MRI Components MRI coils for high-strength fields!! Small quantities; typically 1 to 5!! Complex multi-component assemblies Conventional manufacturing!! Small, simple parts were machined!! Large, complex parts were RTV molded!! Total lead time of 4 months FDM for prototype and production coils!! Materials compatible with magnetic field!! 78% cost & 94% lead time reductions Other advantages!! Simplified design process; less engineering time!! Parts optimized for function, not manufacturing!! Fewer parts due to consolidation /$'6+)%!+#'% 7*8$% HIJ)*(+,) K)*5%L'"$).A41C44) 02)M$$N7) 89:)).B12GG) 0)M$$N)?5@'"-7).021A0A) >GE) 03)M$$N7) CBE)! " #$% &'

21 Summary! Additive Manufacturing Technologies!! Proven!! Integrated in medical markets and more!! Poised as a disruptive technology!! Never more appropriate time evaluate benefits! Check out major manufacturers here today!!! Build your part on a system

22 Additive Manufacturing 101: Changing Medical Product Development and Manufacturing Fred Fischer Stratasys Incorporated

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