3D Printing: A Transformational Journey Right Here in Connecticut

Severine ZygmontPresident, OPM Biomedical

May 14, 2015

Oxford Performance Materials, Inc.

3D Printing Is Everywhere…

But What Does It Mean?

According to Wiki: 3D printing is any of various processes used to make a three-

dimensional object. In 3D printing, additive processes are used, in which successive

layers of material are laid down under computer control. These objects can be of almost any shape or geometry, and are

produced from a 3D model or other electronic data source. A 3D printer is a type of industrial robot.

… In Reality It Means So Many Things!

Rapid Prototyping vs. Additive Manufacturing Filament Based Process vs. Powder Based Process Consumer Market vs. Industrial Market Printer Manufacturer vs. Part Manufacturer Model vs. Functional Structure Tooling vs. End-User Part Metal vs. Plastic vs. Cell Etc…

3D Printing…When Art meets FunctionEducation

Solar Energy

Ergonomic Design

Personalized Medicine

…Or When Function Becomes Enabled By 3D PrintingGive back mobility and hope at fraction of a price

Bring innovation to the surgeon with the patient in mind

Make structures lighter and saving energy

Reduce assembly with new design never manufacturable before

… And Sometimes Just Pure Art

3D Printing & Business3D Printing provides unique advantages for businesses: Affordable Customization Allows manufacture of more efficient designs – lighter, stronger, less assembly

required One machine, unlimited product lines Very small objects Efficient use of raw materials (less waste) Pay by weight – complexity is free Batches of one created on demand New supply chain and retail opportunities Prototyping allows for more affordable and quicker design testing

What can 3D Printing do for you?Source: 3D Printing and the Future of Manufacturinghttp://assets1.csc.com/innovation/downloads/LEF_20123DPrinting.pdf

It Can… Help educate students

o Visualizeo Create

Help with planningo Prototypeo Toolingo Surgery

Enable customizationo Ergonomic designso Patient specific devices

Help lower cost of ownershipo Reduce weighto Simplify assemblyo Reduce OR time

Innovate

Differentiate

Create Value

How 3D Printing and Innovative Technology Transformed a Small CT Business

How Did We Differentiate Ourselves And Create Value Using 3D Printing?

• Challenges: how do you all of this as a small business?

The right focus

The right environment

The right workforce

The right support

The right academic partners

Manufacturing legacyTechnology drivenTop universitiesQuality of lifeSmall business programsProximity to NYC and Boston

GrowthJob Creation

It’s Not That Simple…

High Performance Additive Manufacturing (HPAMTM)

12

Disruptive Solutions

Enabling System Technologies

MultidisciplinarySubject Area Experts

Ultra-high Performance Materials

World Class Additive Manufacturing

HPAM™ vs. Rapid Prototyping (RP)

HPAM™ allows for design and manufacture of fully functional end-use production products, driven by:

RP is an Efficient Approach to Producing Non-functional Models

HPAM™ is an Enterprise-based Approach to Manufacturing

• Material selection• Process development• Quality Management

System

• Application engineering expertise

• Product validation• Regulatory expertise

OPM Activity Timeline

F117 First Advanced Thermoplastic

Primary Structure1985

1979Dupont starts

PEKK development

2011OPM acquires first 3D printer

2000 OPM

Formed

2006 First Laser Sintered PEKK Tensile Bar

PEKK Extrusion

Developed2002

OXPEKK® on Boeing Spec

2007

FDA OXPEKK® Cranial

Clearance2013

Yale Partnership2014

2014 OPM A&IExpansion

FDA OXPEKK® Facial

Clearance2014

2013 America Makes Contract

2014 NG Testing Complete

OPM Expansion Relocation to South Windsor

2011

2005 First CE Mark forOXPEKK® Implant

2014Third LS

Machine

From material supplier to HPAM™ leader

MarketOpportunities

OsteoFab® Value Proposition

Proven Regulatory

Process

EnablingManufacturing

Process

Enabling Material

High Performance• Medical• Aerospace• Defense• High Temperature Industrial• Oil Field/Down Hole• High Performance Automotive

Engineering• Sporting Goods• Orthotic/Prosthetic• General Industrial• Lawn & Garden

Commodity• Infrastructure• Packaging

Increasing Temperature, Tolerance, &

Physical Performance

PEKK

PolyEtherKetoneKetone: PEKK

It All Started With The Right Material …..

Selective laser melting Multiple units processed in one build

“Debulking” of implant from powder bed

Dimensional Inspection Shipped within 5 days of receipt of STL file

Combined With The Right Manufacturing Technology …..

…and unique regulatory expertise along with the required facility certifications

Production Ready ISO 13485 Certification

cGMP Facility

All QC methods under QMS

Worldwide approvals on OXPEKK® devices

60,000+ implants utilizing OXPEKK® material since 2005

Two 510(k) clearances for OsteoFab® devices

3D Printed Patient Specific Cranial Devices

3D Printed Patient Specific Facial Devices

Creating An Accelerated Path To Market

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Cranial

Facial Shoulder Reconstruction

SpineRib Replacement

Spacer for KneeInfection

Osteotomy Wedge Small bonesFoot

Small bonesHand

Acetabular Cup

Ankle Reconstruction

All Of It… Right Here In CT!

How did I end up here?

This is when it all started for me…

OXFORD PERFORMANCE MATERIALS, INC. CONFIDENTIAL

F117 First Advanced Thermoplastic

Primary Structure1985

1979Dupont starts

PEKK development

2011OPM acquires first 3D printer

2000 OPM

Formed

2006 First Laser Sintered PEKK Tensile Bar

PEKK Extrusion

Developed2002

OXPEKK® on Boeing Spec

2007

FDA OXPEKK® Cranial

Clearance2013

Yale Partnership2014

2014 OPM A&IExpansion

FDA OXPEKK® Facial

Clearance2014

2013 America Makes Contract

2014 NG Testing Complete

OPM Expansion Relocation to South Windsor

2011

2005 First CE Mark forOXPEKK® Implant

2014Third LS

Machine

STEM

S.T.E.M: The Beginning of the Journey

STEM: the Keys to your future?

Valuable skillset applicable to a broad o Problem solvingo Project managemento Team work

Identifying and seizing opportunitieso Outside of the box thinkingo Making educated choices

Taking on challengeso Learning from successes and mistakeso Risk management

From a 8 y.o. kid who liked additions & subtractions to… Today!

K1-K8+ −× ÷

K9-K12STEM focus

Engineering School

ParentsTeachersMentors

Exchange Student

Intern First Job

Business

FinanceOperations

Marketing

Manufacturing

Management

Making a difference

Thank You

About OPM

Oxford Performance Materials (OPM) is a recognized leader in high performance additive manufacturing, delivering enterprise level, functional end-use products to the biomedical, aerospace and industrial markets. Since 1998, the founders of OPM have been developing advanced technology for a range of applications for the high performance polymer, poly-ether-ketone-ketone (PEKK). OPM has developed the proprietary processes necessary to build end-use products in PEKK using 3D printing/additive manufacturing (“AM”). OPM’s initial market focus areas are patient specific medical implants and the building of unique, complex parts in support of the aerospace industry. By concentrating on the most attractive sections of the AM value chain – the delivery of extremely high margin end-use products while establishing substantial barriers to entry in large addressable markets – OPM has established a unique position within the high-profile, high-growth 3D printing industry.

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