Katie Weimer, MS

Vice President, Medical Devices 3D Systems - Healthcare

May 3, 2016

3D Printed Medical Devices: What’s Next?

additive manufacturing

digital manufacturing

rapid prototyping

additive fabrication

layer fabrication

3d printing

1970 1980 1990 2000 2010 2020

1971

The History of 3D Printing in Medicine

Sir Godfrey Hounsfield invents

the CT scan

1983 Chuck Hull invents

3D Printing via Stereolithography

1981 Drs. Jeffrey Marsh &

Michael Vannier create 3D models from 2D,

milled slices

1988 The first model of anatomy is

produced using 3D Printing by Dr. Mankovich @ UCLA

1985 3D milling of anatomy in

Germany and the US begins

1998 The first selectively

colored SLA model in the US, produced in Colorado

2003 Dr. Kenneth Salyer

successfully separates conjoined Egyptian twins

2003 3D Printing in

titanium gets its start for implants

2007 Virtual Surgical Planning (VSP) gets it start and moves toward

becoming the gold standard for surgical planning

2008 Personalized surgical instruments for total

knee surgery become commonplace

2014 Anatomical models for

surgical planning in hearts, kidneys and other organs

becomes common

2010 The US FDA clears

the first 3D printed metallic implant

Compliments of Andy Christensen, Littleton CO

February 5, 2015

Source: Wired Magazine Oct 13, 2014

How is 3D Printing being used in healthcare today?

3D printing is now a COMMON use for manufacturing of medical devices

anatomical models, personalized surgery, patient specific implants,

bracing and casting, mass customization, regenerative medicine and bioprinting.

Di Prima, Matthew. Presentation: “FDA Technical Perspective on Additive Manufacturing” Additive Manufacturing for Medical. Boston July 2015

• 70+ AM devices cleared through the 510(k) pathway

• Majority of 510(k) clearances for orthopedics applications

• Significant increase in 510(k) cleared devices 2011-2012

FDA Status of 3DP in Medical Devices

• Material Extrusion: “An AM process in which material is selectively dispensed through a nozzle or orifice”

• Binder Jetting: Powder is spread in equal layers and binder is applied through jet nozzles that “glue” the powder particles in the shape of a programmed 3D object

• Material Jetting: “An AM process in which droplets of build material are selectively deposited”

• Stereolithography: (vat photopolymerization) “An AM process in which liquid photopolymer is selectively cured by a light activated polymerization

• Powder Fusion: “An AM process in which thermal energy selectively fuses regions of a powder bed”

Types of 3D Printing 3D Printing, Additive Manufacturing, Rapid Prototyping

Add pics on basics of 3D Printing Material Extrusion: “An AM process in which material is selectively dispensed through a nozzle or orifice” FDM

Binder Jetting: Powder is spread in equal layers and binder is applied through jet nozzles that “glue” the powder particles in the shape of a programmed 3D object CJP

Material Jetting: “An AM process in which droplets of build material are selectively deposited” MJP

Stereolithography: (vat photopolymerization)

“An AM process in which liquid photopolymer is selectively cured by a light activated polymerization SLA

Powder Fusion: “An AM process in which thermal energy selectively fuses regions of a powder bed” SLS, DMP

Direct Metal Printing (DMP)

Selective Laser Sintering (SLS)

Stereolithography (SLA)

Fused Deposition Modeling (FDM)

ColorJet Printing (CJP) MultiJet Printing (MJP)

Anatomical Models

Anatomical Modeling Workflow

Diagnostic Imaging

Image Processing Model Design 3D Printing

From a CT scan / MRI / Ultrasound DICOM data, the two dimensional medical imaging data is converted into a three dimensional digital model using medical image processing techniques. Necessary features are then added to the digital model to prepare it for 3D printing.

Mohamed and Ahmed

Petero Pre-Op Post-Op

Grace Post-Op Pre-Op

Personalized Surgery

The Value Proposition

Stakeholders The Patient – “I want the best surgery possible, personalized to me”

The Surgeon – “I need to provide the best care possible to my

patients while optimizing how much I can do in a day” The Hospital – “To remain competitive we must cut cost while maintaining a high level of care” The Insurance Co. – “We will continue to fund a high level of care for our patients but at a decreasing rate and new treatments must demonstrate value” The Medical Device OEM – “To remain competitive we must innovate and provide better care at a diminishing selling price”

PERSONALIZED SURGERY IN HEALTHCARE

Medical Imaging Data

/ Image Processing

Virtual Planning Session

Guide Design Design

Review & Approval

Guides & Models

Printed and Shipped

Surgery

Virtual Surgical Planning (VSP®)

At its most basic level Virtual Surgical Planning (VSP) is about utilizing medical image data to accurately plan surgery in a computer environment and then transferring that virtual plan to the patient using customized 3d printed instruments.

Blessing

The Digital Thread

Pre-Op VSP® Post-Op

Haptic Guide Design

3D Printing

Final VSP Products Shipped to the Surgeon

Personalized Surgery

Amazing Result

Virtual Surgical Planning (VSP®) Patrick

Donor Recipient Recipient with Reconstruction

Personalized Surgery Postoperative Analysis

Comparison of Plan to Actual Outcome

3D Printed Metal Implants

Complexity is free

Bracing and Casting

It’s all about compliance

Stylish Breathable Lower Profile

Mass Customization

Future of Pharma & Bioprinting

Wake Forest Anthony Atala, MD Kidneys

Organovo San Diego, CA Human liver tissue

Tiny 3D-

Printed

Organs Aim

for 'Body on

a Chip

TeVido BioDevices Austin, TX Nipples, skin

Cornell University Larry Bonassur

Ears

University of Michigan Dr. Scott Hollister Tracheal stent

Localize technology

Reducing inventory

Increasing personalization

Making surgery more efficient

Thank You

katie.weimer@3dsystems.com