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

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

What is 3D Printing and How Does it Work?

State of 3D Printing 1. As of 2014: 80,000 industrial printers worldwide since 1988 140,000 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

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

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

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)

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

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

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

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

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

FDA Approves First 3D Printed Pill

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

State of 3D Printing 8. 3D Printer Materials

State of 3D Printing

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

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

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

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

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

Intellectual Property Product Safety & Warranty

Patent Landscape USA 60% of 3D patents/patent applications: 2002-2014: 12,000 Pending: ~4,000 Issued: ~8,000 Expiring: 2003-2014: ~225 2013-2014: ~6

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

Manufacturers and Designers Intellectual Property Infringement Patents Trademarks Copyrights

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?

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

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

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

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

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

Risk Analysis: Indemnification Distributors Intellectual Property

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

The Shape of Things to Come Product Safety & Warranty

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

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 - $22,000,000. 2013: Products liability cases ranked 7 th in total verdict amounts: $769,000,000

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.

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

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.

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

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

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

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

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.

Yesterday: Star Trek Today: Reality

Questions? Who Are You? Sam Digirolamo Partner samuel.digirolamo@huschblackwell.com 314.345.6225 Brandan Mueller Partner brandan.mueller@huschblackwell.com 314.480.1825 Sam Digirolamo Brandan Mueller