jim kuras professional accomplishments 2015
TRANSCRIPT
Jim KurasMedical Device Professional
Skills and Accomplishments
1James M. Kuras
Knowledge and Skills
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• Manufacturingo Chemical preparation of metal componentso Compression moldingo Injection moldingo Extrusiono Adhesive applicationo Thermoset compoundingo Machiningo Process specific equipment
• Regulatory Pathwayso EU Notified Bodies
• Class 2bo USA FDA
• Class II & III
• Clinical Researcho Surgeon recruitmento Site interactionso Surgeon trainingo Outcomes assessment
• Materials Researcho Biocompatibilityo Stabilityo Process-ability
• Corporate and Organization Developmento Fund raising
o Recruitment (internal and external)
o Corporate office and director
o Corporate governance
• Program Managemento 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 Developmento Concept and market assessments & testing
o Project management & leadership
o Customer interactions
o Budget & timeline management
• Materialso Polyurethane
o Polycarbonate
o PVC
o Silicone
o Polyolefin (Hexsyn)
o PEEK, PEKEKK
o Titanium & Titanium Alloy
o Stainless steel
o Urethane adhesives
Personal Background• 25 Years of medical device market experience
o Class 2b, II and III
• B.S. in Applied Sciences and Technologyo 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).
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Pre-revenue to Small Capital
Organizations
Product Development Focus
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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
Market ExperienceProfile
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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
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Spinal Orthopedics Career Highlights
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Spinal OrthopedicCareer Highlights
• AxioMed Spine Corp & AcroMed Corp: Opportunity
to work with key thought leaders in spine, product
development and researcho 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
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Spinal OrthopedicCareer 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
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Spinal OrthopedicCareer 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
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CraniomaxillofacialCareer Highlights
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CraniomaxillofacialCareer 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
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CraniomaxillofacialCareer Highlights
• TiMesh Plating and Screw
Systemo 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
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Cardiopulmonary Career Highlights
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CardiopulmonaryCareer 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 ofo Enhancing the existing line of endotracheal tubes
o Expanding the line with novel niche based products
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CardiopulmonaryCareer Highlights
• Redesign of the
reinforced
endotracheal tubes
• Development of a laser
resistant endotracheal
tube
• Expansion of the line of
preformed
endotracheal tubes
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Cardiovascular Career Highlights
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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
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Cardiovascular Career Highlights
• DT Manifold Blood
Pressure System
• NAMIC Disposable
Syringe
• Check-valve Waste
System
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Contact Information
James M. Kuras
(m) 440.479.1313
(in) www.linkedin/in/jmkuras
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