Karl West discusses how 3D printing has helped fuel the start-up of two medical device companies - Centerline Biomedical and Custom Orthopedic Solutions. 3D printing allowed for the creation of prototypes, patient-specific models for surgical planning and training, and customized tools that helped the companies demonstrate their technologies and progress to investors. The models were crucial for visualizing and refining complex anatomical devices and surgical plans in a time-efficient manner. Without 3D printing, the start-up process would have taken significantly longer and incurred greater costs.

1. Fueling Start-Up MedicalFueling Start-Up Medical
Companies through 3DCompanies through 3D
ModelingModeling
Karl West, MSKarl West, MS
Lerner Research / BMELerner Research / BME
September 9, 2016 1

2. September 9, 2016 2
Background?
• Mechanical Engineer / Physics
• Started at the Cleveland Clinic within BME working on Aortic
Replacement Devices in 2002.
• Patented 12 Endovascular Aortic Devices
• These devices are placed Minimally Invasively using
Fluoroscopy (x-Rays)
• Started 3D printing patient specific anatomical models to better
understand the complex aortic geometries
• Roy Greenberg MD, battle with cancer.
• Invented an new imaging technology without ionizing radiation
• Presented Idea / Prototype to Physician and Innovations Group
• In 2014, the Start-Up called Centerline Biomedical was created

3. September 9, 2016 3
The Problem…
Placing a device within the aorta using x-ray imaging system

4. September 9, 2016 4
The Whole Problem!
Radiation Dose to the Patient and Caregivers in the Room

5. Radiation Exposure…Radiation Exposure…
• Average fluoro time (N=369) is 86 minutesAverage fluoro time (N=369) is 86 minutes
• Effective dose of 106 mSvEffective dose of 106 mSv
• How does that relate to other modalities,How does that relate to other modalities,
like CT scans?like CT scans?
73715 DAP  86 mins * 60000 DAP / 70 mins
106 mSv = 73715 * 0.145 mSv / (total DAP) avg. conv. Factor from Panuccio et.

6. Frequency of Peak Skin Dose During Fenestrated Stent Graft
Implantation
What Prolonged Radiation Exposure CanWhat Prolonged Radiation Exposure Can
Look LikeLook Like
Redness
Hair Loss
Ulceration
Skin Loss
300 min
~21 gray

7. Solution…Solution…
September 9, 2016 7
Intra-Operative
Positioning
System or
IOPS
Vascular
Algorithm
Electro-Magnetic
Tracking
Innovation

8. Intra Operative Positioning System (IOPS)
Fluoroscopy
Similar to GPS (Global Positioning System)
technology, electromagnetic navigation creates a
three-dimensional virtual “roadmap” from the
patient’s CT-Scan that enables the physician to
steer a unique set of catheters through the
vasculature to reach the targeted areas in a
minimally invasive manner.
Same patient
Same moment
IOPS

9. Patient-Specific, Pre-operative ModelsPatient-Specific, Pre-operative Models
Arterial
Pre-operative
Axial Images
from MDCT
Bone
Patient-specific arterial and bone models are
used to intra-procedurally track the catheter
position in the IOPS display.

10. IOPS Components & Set-up
IOPS Cart
Sensor Enabled Catheter
Dual Modality
Registration Markers
Window Field Generator

11. September 9, 2016 11
How 3D Models Made it Possible!!

12. September 9, 2016 12
Patient Tracking Pad
3D Printed EM
Tracking Markers

13. September 9, 2016 13
Generator Mounts for OR Table
3D Printed EM
Generator Table
Mount

14. IOPS in OR 76IOPS in OR 76

15. 3D Printed Patient Specific Training System3D Printed Patient Specific Training System
September 9, 2016 15
CAD Model
3D Printed Model

16. Another Start-Up with Close Ties to 3D PrintingAnother Start-Up with Close Ties to 3D Printing
Custom Orthopedic Solutions or
COS

17. Custom Orthopedic Solution (COS) ProductCustom Orthopedic Solution (COS) Product
SummarySummary
• Surgical plan based on patient CT scanSurgical plan based on patient CT scan
• Surgical plan information captured in patientSurgical plan information captured in patient
specific SmartBonespecific SmartBone
• Instrumentation to transfer from SmartBone toInstrumentation to transfer from SmartBone to
patient (Intelligent Reusable Instrument = IRI)patient (Intelligent Reusable Instrument = IRI)
• Advantages:Advantages:
- Improved procedure visualizationImproved procedure visualization
- Able to accommodate real-time adjustmentsAble to accommodate real-time adjustments
17

18. 18
Smartbone DefinedSmartbone Defined

19. 19
Smartbone PrintedSmartbone Printed

20. 20
COS in the Clinical SettingCOS in the Clinical Setting

21. 3D Educational3D Educational
Case No. 2015-117
Anatomy Identification Mode (User selects locations)
3D Printed Model
Tracking System
Virtual Practical Exam ModeTask Augmentation Mode
Coord
(x,y,z)
Display
3D
Coordinate
(x,y,z)
Left Anterior
Descending
Artery
Left Anterior
Descending
Artery
XX Image Correlation HistologyXX
Cardiac Module
Pathophysiology Contemporary Topic

22. September 9, 2016 22
In Conclusion
• Extremely difficult to prototype for a show-and-
tell session without the 3D models
• Modifications to design in a short period of time
allowing the company to show investors “Quick
Forward Progress”.
• Patient specific models for training prior to
surgery.
• We would be 2+ years behind without the 3D
printer along with increased development costs