CURRICULUM VITAE FOR CARL R. McMILLIN, Ph.D.
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`EDUCATIONAL BACKGROUND
`MS & Ph.D. Case Western Reserve University (CWRU) - Macromolecular Science
`Bachelors
`General Motors Institute of Technology - Mechanical Engineering/Material Science
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`PROFESSIONAL AFFILIATIONS AND HONORS
`Recipient of 2015 C. William Hall Award from the Society for Biomaterials, 2015
`Delegate on first People-to-People program on Biomaterials, Peoples Republic of China, 2010 & attended World
`Biomaterials Congress, Changdu, China 2012
`University Hospitals of Cleveland, Cleveland, OH - Scientific/Community Member of the Human Institutional
`Review Board (IRB), 2005 to present – gratis. Certified in Human Research Protection.
`Edison Biotechnology Center and Omeris (State of Ohio) 1992–2002. Commercialization Cabinet 1997-2002;
`Scientific Advisory Council 1992-1994, Executive Advisory Committee 1992-1996
`External Advisory Board, Center for Cardiovascular Biomaterials, CWRU, Cleveland, OH, 1994-1998
`Executive Editor (USA) of the international journal, Bio-Medical Materials and Engineering, 1990-1996
`Editorial Advisory Board of Medical Plastics and Biomaterials, Canon Communications, 1994-1998
`Society for Biomaterials offices: Member Council 1999, 2000, 2001, Chair of the Biomaterials and Medical
`Device Commercialization Special Interest Group 1998, 1999 & 2005–2012 (former Biomaterials
`Availability and Policy SIG), and Vice Chair, 2000 – 2004 & 2012 - present.
`Reviewer for J. Biomedical Materials Res., J. Artificial Organs, Macromolecules, J. of Applied Biomaterials,
`Biomaterials Society annual meetings/Transactions, and Nanomedicine and Nanobiotechnology
`Member: Society for Biomaterials, American Society for Testing and Materials, and others when they existed -
`Cleveland Area Research Directors, NeoBio (Northeast Ohio interactive group on biomedical topics),
`One of thirty University of Akron faculty honored for "Significant Accomplishments in Teaching, Research, and
`Public Service," in 1984-1985
`One of ten USA scientists, 2nd Joint USA/USSR Symposium on Circulation and the Artificial Heart, Houston, l98l
`One of seven USA scientists, 3rd Joint USA/USSR Symposium on Artificial Heart R&D, Moscow, USSR, 1985
`Chair, Research (Faculty Grants) Committee of Univ. Akron (1987- 1989); Committee member 1984-87
`Adjunct Faculty, Cleveland State University, Applied Biomedical Engineering doctoral program, 2001-present
`Adjunct Staff, The Cleveland Clinic Foundation, Cleveland, OH, 1984-1993, 1995, 1996
`Member of several NIH Contract and Grant Peer Review Panels.
`Reviewed grants for Edison Biotechnology Center and for Summa Health System Foundation
`Member, Akron Campus Clinical Deans, 1984-88
`Topic Coordinator: Novel Biomaterials, 6th World Biomaterials Congress, 2000
`Invited speaker at Gordon Conference on Biomaterials, l980
`Grantsmanship Director, State of Ohio Jaycees, 1978 & 1979
`NIH (Heart, Lung & Blood Institute) Post-Doctoral Research Fellowships, l974 & l975
`Macromolecular Science Graduate Fellowships, l969-l974
`Girnell Scholarship, 1964
`DoD Secret Clearance, 1980-1983
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`SELECT RECENT MEETINGS ATTENDED
`2019 – Society for Biomaterials annual meeting, Seattle, WA
`2018 – Society for Biomaterials annual meeting, Atlanta, GA
`2017 – Society for Biomaterials annual meeting, Minneapolis, MN
`2016 – World Congress for Biomaterials, Montreal, Canada
`2012 – World Congress for Biomaterials, Chengdu, China
`2011 – North American Spine Society (NASS), Chicago, IL
`2010 – People to People Biomaterials Delegation to China (First “Biomaterials” delegation, organized by the
`President of the Society for Biomaterials)
`2008 – World Congress for Biomaterials, Amsterdam, Netherlands
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`NUVASIVE - EXHIBIT 2058
`Alphatec Holdings Inc. et al. v. NuVasive, Inc.
`IPR2019-00362
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`C.R. McMillin
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`WORK EXPERIENCE DETAIL
`1997 – present: Independent Consultant, Brecksville, Ohio, President Synthetic Body Parts, Inc.
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`Biomedical product development and biomaterials consulting conducted for start-up to multi-national
`companies. Occasional expert witness in patent and product liability lawsuits. Member of Univ. Hospitals
`of Cleveland Institutional Review Board (IRB) for human research protection (June 2005– present).
`Adjunct faculty at Cleveland State University (1999-~2009) teaching occasional courses.
`1989 - 1997: AcroMed Corporation, Cleveland, Ohio
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`Director of R&D, Director Polymer Laboratory, Senior Scientist. Conducted and directed research,
`development, evaluation, and commercialization of many metal, polymer, polymer/carbon fiber composite
`and elastomer-based orthopedics products, primarily for the spine.
`1983 - 1989: The University of Akron, Associate Professor, Dept. Biomedical Engineering, Director of the
`Cardiovascular Laboratory. Conducted research on accelerated rubber fatigue testing of rubber, blood-
`materials interactions, permeability of elastomers, and hemodynamics of artificial hearts, Taught graduate
`engineering courses in Biomaterials (& laboratory), Biocompatibility, and Artificial Organs.
`1975 - 1983: Monsanto Research Corporation, Dayton Laboratory, Dayton, Ohio
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`1978 - 1983: Contract Manager, Senior Research Chemist.
`1974 - 1975: Case Western Reserve University, Cleveland, Ohio, NIH Postdoctoral Research Fellow. Studied
`blood platelet/surface interactions.
`1974 - 1975: Cleveland Clinic Foundation, Cleveland, Ohio, Visiting Scientist, Artificial Internal Organs Dept.
`1972 - 1974: Case Western Reserve University, Cleveland, Ohio, Doctoral Research. Elucidated the conformation
`of blood clotting proteins and changes in structure with surface interaction.
`1971 - 1972: Queen Mary College, University of London, England, Research Associate. Studied solvent effects
`on craze and crack growth in amorphous and semicrystalline polymers (with the world renowned fracture
`mechanics expert, Professor Andrews).
`1969 - 1971: Case Western Reserve University, Masters Research. Evaluated vacuum ultraviolet spectroscopy
`for characterizing the conformation of biopolymers.
`1964 - 1969: Packard Electric Division, General Motors Corporation, Warren, Ohio, Jr. Engineer, Engineer.
`Bachelor’s Thesis on flammability of polymers for use in electrical wiring systems.
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`• Over 100 journal, symposia & contract research publications, book chapters, patents, and theses
`• Over 75 national or international meeting presentations as author or co-author
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`Worked with surgeons to develop implants for custom implantation & some for wider commercialization
`➢ Designed and oversaw over $1M in research to achieve successful FDA approval for the use of
`PEEK, PEKEKK and carbon fiber reinforced versions of these polymers for orthopedic use (esp.
`PLIF & ALIFs) including biocompatibility, long-term rat carcinogenicity, & Spanish goat
`implants.
`➢ Materials and design optimization of the worlds first carbon fiber composite posterior lumbar
`interbody fusion (PLIF) cages (Brantigan Cage, now sold by J&J), including material selection,
`cadaver spine measurements, strength vs size optimization, and production quality control issues.
`➢ Developed with Dr. Brantigan, the world’s first carbon fiber composite anterior lumbar interbody
`fusion (ALIF) cages (e.g. measured about 100 cadaver spines to determine size and shape of
`system of cages to optimize strength vs footprint, material specification, oversight of cage
`production and quality control, in charge of instrument development and acquisition and
`engineering changes of instrument and cage drawings
`➢ Extended this technology to thoracic and cervical ALIFs and PLIFs including many additional
`cadaver vertebral body measurements
`➢ Developed and patented a novel process and fiber orientation to achieve 3D structure for the first
`carbon fiber composite spine fusion cages (solo patent)
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`C.R. McMillin
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`➢ Developed first functional artificial spinal discs implanted in patients in the USA with Dr. Steffee.
`Was listed as lead inventor on one disc patent using polyolefin rubber with Ti end plates and listed
`as an inventor on other artificial disc patents.
`➢ Developed first functional artificial spinal discs with Dr. Steffee constructed using silicone rubber
`and titanium and implanted in patients
`➢ Developed first functional cervical artificial spinal discs with Dr. Steffee. These were clinically
`implanted in both polyhexene and silicone rubber-based versions
`➢ Developed world’s first custom carbon fiber composite artificial vertebral bodies as well as
`UHMWPE/Titanium artificial vertebral bodies designing and have manufactured devices based on
`individual patient x-ray, CT and MRI information
`➢ Developed the Brantigan stackable system for variable heights of artificial vertebral bodies,
`determined cage sizes, spline composition, had CAD drawings & prototypes made, evaluated
`dimensions and fit of prototypes.
`➢ Developed world's first carbon fiber composite skull plate (presented at the Sidney World
`Congress of Biomaterials with clinical x-ray)
`➢ Invented a new fiber structure to make a composite structure that would not split when used for
`long bone fixation plates. The PEEK carbon fiber composite long bone plate was clinically
`implanted and I was granted a solo patent on the fiber structure making it possible
`➢ Developed first PEEK carbon fiber composite ankle stabilization spool implant with Dr. Steffee
`for a custom implant
`➢ Developed first PEEK carbon fiber composite wrist stabilization wedge implants for Dr. Steffee
`and scrubbed in for implantation
`➢ Developed world’s first PEEK carbon fiber composite spine stabilization plates using custom TiN
`coated titanium washers and screws to interface with composite plates. About a dozen were
`clinically implanted and explanted after a year after fusion was achieved.
`➢ Worked with Dr. Steffee to develop and implant the world’s first (custom) artificial sacrum
`➢ Worked with Dr. Keppler to develop and implant world’s first (custom) carbon fiber composite
`intramedullary nail
`➢ Developed world’s first PEEK and also PEEK/Carbon fiber injection molded screws (with custom
`screw thread design to match material properties) - used clinically for spine implant stabilizations
`➢ Developed world’s first PEEK cable ties for orthopedic stabilization (after a surgeon had used a
`common nylon cable tie in a spine surgery)
`➢ Helped develop and had manufactured linear polyethylene “Graf loops” and associated Ti screws
`for spine stabilization
`➢ Translated stainless steel screw design to first AcroMed titanium posterior cervical screws
`➢ Evaluated commercial potential of new materials and designs for AcroMed spine products
`➢ As consultant, worked with over 50 small to multi-national companies helping to solve
`biocompatibility and commercialization problems. Also, expert on patent and device failure
`litigation issues. Expert & testified on Bianco v Globus theft of trade secrets re expandable spine
`fusion cage. Expert & testified on Gore v Bard patent case on basic patents relating to the
`structure of PTFE vascular grafts.
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`9/27/2019
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