The Shape of Things to Come Strategies for Success in the Age of 3D Printing. Husch Blackwell LLP

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1 The Shape of Things to Come Strategies for Success in the Age of 3D Printing Husch Blackwell LLP

2 What is 3D Printing and How Does it Work?

3 State of 3D Printing 1. As of 2014: 80,000 industrial printers worldwide since ,000 desktop printers sold in 2014 alone 38% of industrial printers are in U.S. Japan is 2 nd China is 3 rd 2. Total market as of 2014: $4.1B (includes prototyping + other non-commercial uses) $2B in products

4 State of 3D Printing 3. Standards being formulated by ASTM, ISO for industrial uses 4. Improvements: Speed, accuracy, materials

5 State of 3D Printing 5. 3D Printing Technologies Blown Powder: Metal powder blown coaxially to the laser beam which melts the particles on a base metal to form a metallurgical bond when cooled Thermal Extrusion: Thermoplastic filaments heated through a nozzle Stereolithography: UV-light

6 State of 3D Printing 5. 3D Printing Technologies (cont d) A laser or Selective Laser Melting (SLM); Selective Laser Sintering (SLS); Electron Beam Melting (EBM) Ink-jetting Photopolymer process: Tiny droplets of liquid photopolymer onto a tray & cured with UV-light electron beam melts or sinters powder (metal or plastic parts)

7 State of 3D Printing 6. Printer Capabilities 2014: Stratasys unveiled the first color multi-material 3D printer 2015: Voxel8 unveiled a printer capable of creating objects with both electrically conductive and insulating material: Thermoplastics Inks Pastes Photopolymers 2016: Hewlett Packard will release its Multijet Fusion range of 3D printers

8 State of 3D Printing New Technology HP s Entry Into Field: Current File Format - STL file format, first developed in 1989 Most 3D CAD software packages provide tools for STL file conversion STL Format Deficiencies (per HP): Processing time; and Object dimensional precision

9 State of 3D Printing New Technology Voxel driven design and printing.

10 State of 3D Printing Snapshot of the 3D Printer Players

11 State of 3D Printing 7. 3D Printing Applications Fashion: Jewelry Dresses Shoes Food Aerospace Homes Prototyping Pharmaceutical Medical Orthopedics/prosthetics Dental implants Prototyping surgical operations/surgical planning Skeletal reconstruction Tissue and organ replication (ear, nose, body parts) Hobby Much more

12 FDA Approves First 3D Printed Pill

13 Aerospace America, July-August 2015 edition State of 3D Printing

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16 State of 3D Printing 8. 3D Printer Materials

17 State of 3D Printing

18 State of 3D Printing 9. Service Providers Connect 3D manufacturers with customers Industrial based/commercial grade products Distinctive network of printers/all technologies Manufacturers execute agreement with service providers One service provider: 32 manufacturers using 266 different types of printers

19 State of 3D Printing 9. Service Providers (cont d) Service provider develops 3D blueprint Manufacturers bid on projects Customer selects Service provider issues license to selected manufacturer Send customer instructions

20 State of 3D Printing 10. Adobe Photoshop Upgraded to produce 3D blueprints

21 Impact on Manufacturing No entry barriers Digital scans/digital blueprints replace products Mass customization possible File sharing ramifications Reduced shipping and production costs Reduced logistic footprint Potential applications (limitless) Customers replace manufacturers Product demand drops

22 Legal Issues $ Regulatory Federal Drug Administration (FDA) Imports/Exports Commercial Contracts Tax Treatment & Accounting of Print-to-Order Revenue Product & Environmental Regulations Higher Education Licensing Agreements Healthcare Product Safety & Warranty Packaging & Transportation Intellectual Property

23 Intellectual Property Product Safety & Warranty

24 Patent Landscape USA 60% of 3D patents/patent applications: : 12,000 Pending: ~4,000 Issued: ~8,000 Expiring: : ~ : ~6

25 Who Are the Players? Intellectual Property Manufacturers of 3D printers Product manufacturers and designers Scanners/digital blueprint designers Customers Distributors

26 Manufacturers and Designers Intellectual Property Infringement Patents Trademarks Copyrights

27 Manufacturers and Designers Intellectual Property Infringement of Patented Product Who is the infringer? Third party fabricator? 3D printer manufacturer? Scanner/creator of digital blueprints? Someone who distributes the digital blueprint? Distributor of product?

28 Manufacturers and Designers Intellectual Property Infringement of Trademark ( ) Molding vs. Sticker/Ink-printing Molding (advantages/disadvantages) Sticker/Ink-printing (advantages/disadvantages) Infringer can remove trademark Need well-rounded IP strategy

29 Manufacturers and Designers Intellectual Property Infringement of Copyright ( ) Sculptured works - easier to copy CAD program (engineering drawings) Electronic instructions to 3D printer/digital blueprint Digital blueprint - easy to transmit to anyone 3D printing repositories/databases

30 Intellectual Property Alternate Ways to Protect Products Copyright for 3D product configuration and software for design? Who owns software, if contract with someone to write code? Trade Dress How we structure patent claims: Scanners Method Claims manufacturing by 3D printing Product by process claims Claims for computer readable storage medium (i.e. digital blueprint) Scanning Method Claims Design patents

31 Manufacturers & Designers Intellectual Property Risk Analysis: Patent, trademark, trade dress, copyright clearance Use of third party vendors Commissioned works Protection Patent claims Copyright Trade dress Customization New business models Licensing/Partnering agreements Fan of your product

32 Scanners/Digital Blueprint Designers Intellectual Property Risk analysis: Patent Trademark/trade dress Copyright Protection Indemnification Ownership rights

33 Risk Analysis: Indemnification Distributors Intellectual Property

34 Customers/Users of Product Intellectual Property Risk analysis: Patent Trademark/trade dress Copyright Customization: Ownership rights Protection

35 The Shape of Things to Come Product Safety & Warranty

36 Who Are the Players? Product Safety & Warranty Government regulators Product safety organizations Trial lawyers Consumers Commercial Customers

37 Product Safety & Warranty Landscape Products liability lawsuits: In 2013, 10 of the top verdicts in the U.S. were products liability claims ranging from $63,000,000 - $22,000, : Products liability cases ranked 7 th in total verdict amounts: $769,000,000

38 Product Safety & Warranty Landscape Increased enforcement of government regulations: U.S. and International sales & regulations are possible with a click of the mouse. Regulators examine products and company processes. U.S. state enforcement up Fines are up in the U.S.

39 Product Safety & Warranty Landscape U.S. Consumer Product Safety Commission Record-high penalties in 2014: Baja Inc. and One World Technologies Inc.: $4.3 million - failure to report defects and an unreasonable risk of serious injury Cinmar: $3.1 million - failure to report defective wooden step ladders Meijer: $2 million - distributing recalled products Electrolux: $750,000 - delay in reporting a safety hazard associated with wall ovens

40 Manufacturers & Designers Product Safety Dodge Government Fines By Training 3D Printing Personnel on Government Compliance: Children s testing Materials Size Proper age Proper labeling FHSA CA Prop 65 Compliance program to monitor federal, state and international regulatory issues must include 3D printing.

41 Manufacturers & Designers Product Safety Expediency of 3D Printing can't trump cornerstones of product development: Risk analysis FMEA Materials testing Misuse analysis

42 Manufacturers & Designers Product Safety Pre-Fight Training - Products liability lawsuits: Documenting development and safety processes Warnings drafting Warranty drafting Insurance Contractual protections

43 Scanners/Digital Blueprint Designers Product Safety & Warranty Negligent design claims: Documentation of development program Documentation of testing program Contractual issues & warranties: Indemnification by purchaser Warranty for a particular purpose Warranty for merchantibility

44 Scanners/Digital Blueprint Designers Product Safety & Warranty Proper warnings & instructions: ANSI Z535 ISO Warnings against potential misuse Regulatory compliance: Monitoring claims and complaints Identifying the proper agency of jurisdiction

45 Summary Product Safety & Warranty Regulatory and Products Liability Threats Continue but.. Strong product stewardship and compliance program allows companies to take advantage of this technology.

46 Yesterday: Star Trek Today: Reality

47 Questions? Who Are You? Sam Digirolamo Partner Brandan Mueller Partner Sam Digirolamo Brandan Mueller