Jim Kuras has over 25 years of experience in the medical device industry, specializing in areas such as spinal orthopedics, craniomaxillofacial devices, cardiopulmonary products, and cardiovascular systems. He has a background in product development, regulatory affairs, clinical research, and corporate development. Notable achievements include pioneering total disc replacement technologies and expanding product offerings in areas such as spinal fusion, cranial fixation, and endotracheal tubes.

1. Jim Kuras
Medical Device Professional
Skills and Accomplishments
1James M. Kuras

2. Knowledge and Skills
James M. Kuras 2
• Manufacturing
o Chemical preparation of metal components
o Compression molding
o Injection molding
o Extrusion
o Adhesive application
o Thermoset compounding
o Machining
o Process specific equipment
• Regulatory Pathways
o EU Notified Bodies
• Class 2b
o USA FDA
• Class II & III
• Clinical Research
o Surgeon recruitment
o Site interactions
o Surgeon training
o Outcomes assessment
• Materials Research
o Biocompatibility
o Stability
o Process-ability
• Corporate and Organization
Development
o Fund raising
o Recruitment (internal and external)
o Corporate office and director
o Corporate governance
• Program Management
o Identified and qualified key markets/products
o Recruited technical, advisory and surgeon teams
o Developed teams and organizations based on
program requirements and needs
• Product Development
o Concept and market assessments & testing
o Project management & leadership
o Customer interactions
o Budget & timeline management
• Materials
o Polyurethane
o Polycarbonate
o PVC
o Silicone
o Polyolefin (Hexsyn)
o PEEK, PEKEKK
o Titanium & Titanium Alloy
o Stainless steel
o Urethane adhesives

3. Personal Background
• 25 Years of medical device market experience
o Class 2b, II and III
• B.S. in Applied Sciences and Technology
o 1986 Youngstown State University, Youngstown, Ohio
• Subsequent training:
o Completed several courses in developing and implementing self-directed
work groups (1993).
o Completed a MIT summer program in Cardiovascular Pathophysiology
(1989).
o Completed a Leadership and Organizational Development program
(1989).
James M. Kuras 3

4. Organizations
Product Development Focus
James M. Kuras 4
4.1 QP: QMS Key Process Interface Diagram
Management
Control
5.0 QP
Design
Control
7.3 QP
Supplier
Management
7.4 QP
Document
Control
4.2.3 QP
Complaint
Handling
8.2.1 QP
Distribution
7.5.5 QP
CAPA
8.5.2 QP
Production
and Process
Control
7.5 QP

5. Market Experience
Profile
James M. Kuras 5

6. Market Experience
• Spinal Orthopedics: (1994 – 2014)
o Global Marketing with a concentration in U.S. & EU
• Craniomaxillofacial: (1998 – 2001)
o U.S. Marketing
• Cardiopulmonary: (1992 – 1994)
o U.S. Marketing
• Cardiovascular: (1988 – 1992)
o U.S. Marketing
James M. Kuras 6

7. Spinal Orthopedics
Career Highlights
James M. Kuras 7

8. Spinal Orthopedic
Career Highlights
• AxioMed Spine Corp & AcroMed Corp: Opportunity
to work with key thought leaders in spine, product
development and research
o Global Market
o Regulatory Class 2b, II & III
o Teamed with key surgeons from the EU, U.S., U.K. and Australia
o Identified and characterized leading biomaterials in the spine orthopedic
industry
• Pioneered paradigm shifting technologies
• Fusion based systems (cages, rods, plates and screws)
• Total Disc Replacement (TDR)
• Anterior scoliosis system
• Trauma and tumor
James M. Kuras 8

9. Spinal Orthopedic
Career Highlights
• Freedom® Technology
Platform: Next
Generation TDR platform
featuring:
o Designs which mimic the function
of the human disc
o An exclusive proprietary
polymeric material
o Proprietary manufacturing
o Extensive biomechanical and
biocompatibility
characterizations
o Numerous clinical assessments
which validate the Freedom
Technology
o Reproducible surgical technique
James M. Kuras 9

10. Spinal Orthopedic
Career Highlights
• 3rd Generation of the
AcroFlex Lumbar Disc
• MIS cage and
instrument system
• Anterior and posterior
carbon fiber peek cages
• Redesign of the
AcroMed Pedicle Screw
system
• Open & closed pedicle
screws
• Kaneda Trauma System
James M. Kuras 10

11. Craniomaxillofacial
Career Highlights
James M. Kuras 11

12. Craniomaxillofacial
Career Highlights
• AxioMed, Inc.: Opportunity to partner with
Medtronic Sofamor Danek on the TiMesh Line.
o U.S. Market
o Regulatory Class II
• Created and founded AxioMed, Inc. s-corp based
company.
o Redeveloped the TiMesh Line of plates and screws
o Expanded product offering to include self-drilling cranial screws
o Optimized the TiMesh plate manufacturing
James M. Kuras 12

13. Craniomaxillofacial
Career Highlights
• TiMesh Plating and Screw
System
o Optimization of plate and screw
manufacturing
o Identified new source for custom
CP plates for cranial plating
o Developed line of cranial self
drilling screws
o Acquired cranial flap fixation
system
James M. Kuras 13

14. Cardiopulmonary
Career Highlights
James M. Kuras 14

15. Cardiopulmonary
Career Highlights
• Sheridan Catheter: Opportunity to work with and
for the pioneer in cardiopulmonary airway
catheters.
o U.S. Market
o Class II
• Senior Product Development Engineer responsible
for the development of
o Enhancing the existing line of endotracheal tubes
o Expanding the line with novel niche based products
James M. Kuras 15

16. Cardiopulmonary
Career Highlights
• Redesign of the
reinforced
endotracheal tubes
• Development of a laser
resistant endotracheal
tube
• Expansion of the line of
preformed
endotracheal tubes
James M. Kuras 16

17. Cardiovascular
Career Highlights
James M. Kuras 17

18. Cardiovascular
Career Highlights
• NAMIC: Opportunity to work with and for the
pioneer in disposable fluid management systems.
o U.S. Market
o Class II
• Clinical Application Specialist and Product
Development Engineer responsible for the
development of:
o Disposable Invasive blood pressure monitoring system
o Fluid management manifold, check valves and valve systems for
percutaneous catheterization
o Enhancement of NAMIC Disposable Syringe
James M. Kuras 18

19. Cardiovascular
Career Highlights
• DT Manifold Blood
Pressure System
• NAMIC Disposable
Syringe
• Check-valve Waste
System
James M. Kuras 19

20. Contact Information
James M. Kuras
(m) 440.479.1313
(in) www.linkedin/in/jmkuras
(e) jim.kuras@me.com
James M. Kuras 20