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FDA Workshop on Additive Manufacturing of Medical devices
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FDA Workshop on Additive Manufacturing of Medical …€¢ Stratasys to guarantee and control filament • Filament extrusion process • Serialization of prescribed filament • Controlled

May 18, 2018

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Page 1: FDA Workshop on Additive Manufacturing of Medical …€¢ Stratasys to guarantee and control filament • Filament extrusion process • Serialization of prescribed filament • Controlled

FDA Workshop on Additive Manufacturing of Medical devices

Page 2: FDA Workshop on Additive Manufacturing of Medical …€¢ Stratasys to guarantee and control filament • Filament extrusion process • Serialization of prescribed filament • Controlled

Jon Cobb Executive Vice President of Corporate Affairs

Page 3: FDA Workshop on Additive Manufacturing of Medical …€¢ Stratasys to guarantee and control filament • Filament extrusion process • Serialization of prescribed filament • Controlled

3D Printing Opportunities

• Personalization

• Design Flexibility

• Manufacturing Flexibility

• Promote New Manufacturing Techniques

• Opportunity for Product Cost Reductions

Page 4: FDA Workshop on Additive Manufacturing of Medical …€¢ Stratasys to guarantee and control filament • Filament extrusion process • Serialization of prescribed filament • Controlled

3D Printing Issues

• Personalization

• Manufacturing opportunities Availability

• Validating New Design and Manufacturing Processes

• Evaluating New Materials and Build Processes

Page 5: FDA Workshop on Additive Manufacturing of Medical …€¢ Stratasys to guarantee and control filament • Filament extrusion process • Serialization of prescribed filament • Controlled

Today’s Agenda

• Stratasys Technologies

• Stratasys Company Update

• Manufacturing with FDM

• Materials Development

Page 6: FDA Workshop on Additive Manufacturing of Medical …€¢ Stratasys to guarantee and control filament • Filament extrusion process • Serialization of prescribed filament • Controlled

FACTS

Page 7: FDA Workshop on Additive Manufacturing of Medical …€¢ Stratasys to guarantee and control filament • Filament extrusion process • Serialization of prescribed filament • Controlled

Diverse Printing Technologies

• Fused Deposition Modeling (FDM)

• Real thermoplastics with soluble supports

• Polyjet (resign jetting)

• Multi-material and multi-colored printing

• Smooth Curvature Printing (SCP)

• High precision lost wax printing

Page 8: FDA Workshop on Additive Manufacturing of Medical …€¢ Stratasys to guarantee and control filament • Filament extrusion process • Serialization of prescribed filament • Controlled

Factory of the Future

Page 9: FDA Workshop on Additive Manufacturing of Medical …€¢ Stratasys to guarantee and control filament • Filament extrusion process • Serialization of prescribed filament • Controlled

Represented Worldwide

Americas – Europe – Asia Pacific – Middle East

>560 patents >2,800 employees >21,000 customers >290 channel partners

Page 10: FDA Workshop on Additive Manufacturing of Medical …€¢ Stratasys to guarantee and control filament • Filament extrusion process • Serialization of prescribed filament • Controlled

3D Printing Industries

Industrial Consumer

Education

Dental

Medical

Jewelry

Automotive

Architecture

Aerospace

Military

Page 11: FDA Workshop on Additive Manufacturing of Medical …€¢ Stratasys to guarantee and control filament • Filament extrusion process • Serialization of prescribed filament • Controlled

Manufacturing with FDM

•InSight Software provides Flexibility (Fortus Systems) •Layer Thickness

• .007’ to .013” •Bead Width

• +/- 40% of layer thickness •Material Mix

• Variety of thermo plastics • Alternate build and support materials

•Raster Fill Patterns • Promotes new design and manufacturing process

Page 12: FDA Workshop on Additive Manufacturing of Medical …€¢ Stratasys to guarantee and control filament • Filament extrusion process • Serialization of prescribed filament • Controlled

Materials Development

•Key Company Focus – Opportunities Defined by Business Unit •Development Process

• Receive validation from material vendor • Establish FDM process validation • Final validation belongs to the user

•Example: Large Aerospace Manufacturer • Stratasys to guarantee and control filament • Filament extrusion process • Serialization of prescribed filament • Controlled distribution

Page 13: FDA Workshop on Additive Manufacturing of Medical …€¢ Stratasys to guarantee and control filament • Filament extrusion process • Serialization of prescribed filament • Controlled

Summery

•3D Printing Offers New Opportunities

• Design

• Manufacturing

•3D Printing Brings Affordable Customization

•3D Printing Means Change

•Stratasys 3DP Technologies is a Catalyst for Change

•Stratasys Partners with Companies, Government and

•Educators to Deliver Positive Change

Page 14: FDA Workshop on Additive Manufacturing of Medical …€¢ Stratasys to guarantee and control filament • Filament extrusion process • Serialization of prescribed filament • Controlled