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Surgical Implants Surgical Devices Expert Witness

Provides Opinion & Testimony In:

Patent Infringement, Implants, Medical Devices, Surgical Devices, Surgical Implants, FDA, Freedom Operate, 510K, PMA, Class 3 Medical Device, IDE PMA, HCTP, Products Liability, Cartilage, Orthopedics, Orthopedic Surgery, Sports Medicine, Material Science, Use Errors, Medical Device Testing, Human Factors, Engineering, Patient Safety, Biomedical Engineering, Clinical Engineering, Medical Device Service Management, Cervical Spine, Extremity Trauma, Workmens Compensation, Biological Implants, Xenotransplantation, Allografts, Autologous Grafts, Biological Devices, Xenotransplants, Osteomyelitis, Surgical Malpractice, Prosthetic Devices, Orthotics, Life Cost Planning, Fraud Determination, Artificial Leg Arm, Arm Brace, Leg Brace, Amputee, Plastic Hips Failure Analysis, Pvc Failure, Polymer Testing, Plastic Molding Polymers, Polyethylene,Defective Hip Implant, Rupture Process, Neck Injury Reconstruction, Fall Head Injury, Diving Accidents, Failure Accidents, Industrial Injuries, Slips, Trips Falls, Ergonomics Accident, Tissue Engineering, Regenerative Medicine, Biomechanics, Sports Injury, Tolerance Limits, Premises Liability, Device, Implant, Material, Bone, Muscle, Joint, Tendon, Patent, Spine, Medical Malpractice, Spinal Implants, Collagen, Hydrogels, Polyglycolic Acid, Polylactic Acid, Pluronic, Alginate, FTIR, Lyophilization, Plates, Screws, Due Diligence, Market Analysis, Market Research, Investment Analysis, Acl, Achilles, Foot, Knee, Fracture, Collagenase Resistance, Immunohistochemistry, IACUC, IRB, Research Plan, Stagegate, Product Development, Verification Validation, Scaffold, Growth Factors, BMP, Cages, Fusion, Varus, Valgus, Pain, Suffering, Meniscus,

Expert No. 3489

Skills

Medical Devices, Biomedical Engineering, Tissue Engineering, Regenerative Medicine, Medical Implants, Surgical Implants, Surgical Devices, Biomechanics, Biochemistry, Structural Biology, Analytic Chemistry, Laboratory Management,  Cell Biologics, Orthobiologics, Orthopedics, Biomaterials, Immunology, Biological Devices, Failure Analysis, FDA approval, Quality Control, Biological Assays.

Professional Experience

A Company

Portfolio Manager                                                
Texas
2011-Current

RTI Biologics                                                                                                         
Senior Tissue Engineer
Alachua, FL
2008- 2010

-Developed new tissue engineering products development for sports medicine application.
-Designed and tested new medical devices; developed new standard operating procedures (SOPs) and other protocols.
-Developed manufacturing process for biologics product suitable for GMP manufacturing.
-Worked on collagen-based allografts. Analyzed demineralized bone matrix osteoinductivity, biodegradation, biocompatibility.
-Studied various enzymatic assays such as: trypsin and collagenase resistance.
-Performed mechanical testing: Tensile and suture pull-out properties.
-Finalized process validation and verification.

Zimmer, Inc.
Senior Scientist II                                       
Austin, TX
2004-2008

-Designed and tested new medical devices; developed new standard operating procedures (SOPs) and other protocols.
-Implemented various new analytical and mechanical testing methodologies based on live advice of surgeons.
-Synthesized new three-dimensional, highly porous, biodegradable scaffold structures for implantation.
-Developed clinical protocols, participate in preparation of IDE/PMA, 510K, HCTP and MMTG for regulatory submission; performed pre-clinical research.
-Researched, developed, and investigated cartilage, soft tissue and other synthetic and natural biomaterials.
-Prepared manufacture procedures for technology transfer from bench testing to production.
-Evaluated external technologies not only in the US but also from Europe (Germany, Switzerland) and Asia.
-Complied and performed process verification and validation, failure-mode analysis, design control and input-output.
-Followed developments in journals and attended conferences/training -7 times per year; updated my team regarding the sales considerations and surgeons’ needs.
-Certified in Quality Assurance and Industry Practice.
-As Lab Manager, supervised the work of lab technicians, interns and post-doctoral fellows. Evaluated the IQ/OQ of the equipment that needed to be purchased; selected the best suppliers.
-Excellent annual evaluations; Worked closely with attorneys to obtain patents for team’s inventions.
-In 2005-2006, served as Co-Chair of the subcommittee F04-04-WK (ASTM International).
-Coordinated contract research with NAMSA, MDS Pharma, LifeNet, RTI, Allosource and other companies.

New World Laboratories, Inc.                          
Vice President
Worcester, MA
2003-2004

-Fully coordinated and commanded clinical studies and clinical trials in Europe.
-Managed an international team of scientists, veterinarians, medical doctors and businesspersons.
-Developed a research plan for medical device manufacture based on CDRH (FDA) regulations; Analyzed cell culture based on GMP and GLP conditions.
-Developed surgical techniques for spinal cord regeneration in a rat model (contusion type of injury in the spinal cord); Prepared samples for histological, electron microscopy, and other types of laboratory analyses.
-Prepared quarterly reports based on research data, performed data analysis and verification.
-Finalized contracts between a Moscow biotechnology company, a Swiss biotechnology company and New World Laboratories, formerly a Massachusetts corporation.
-Instituted scale up and scale down processes when the transfer of technology from one plant to another required manufacture at a new scale and with equipment configured differently.
-Undertook small and intermediate-scale manufacturing and packaging activities in pharmaceutical product development and the manufacture of approved products for clinical trial (CT) purposes.
-Ensured that operator, environment, process and product safety aspects are considered.
-Managed a team of scientists, veterinarians, medical doctors and business-persons; Collaborated internationally
-Coordinated contract research with NAMSA, Biomedical Research Models (BRM), UMass Medical School and other companies.

Harvard Medical School                                                                              
Post-Doctoral Research Fellow with Prof. Charles Vacanti
Boston, MA
2002-2004
Tissue Engineering and Regenerative Medicine Laboratory

-Performed cell culture of progenitor cells derived from CSF, human brain, rat spinal cord; studied cell expansion and passage.
-Characterized cells using immunocytochemical and immunohistochemical methods. Neuronal lineage specific markers like: NeuN, nestin, GFAP and other. [Chondrocyte isolation from a mouse femoral head; Mesenchymal cell implants for tissue generation; FISH (fluorescent in-situ hybridization) to identify Y chromosome in implanted tissue].
-Professor Charles Vacanti is the co-founder of the Tissue Engineering Society and co-editor of the Journal, Tissue Engineering.                  
  
Umass Worcester Medical School                                          
Post-Doctoral Research Fellow also with Prof. Charles Vacanti
Worcester, MA
1999-2002

-Isolated and characterized MSCs, chondrocytes, neurons, glial cells, intervertebral disc cells obtained from human, rat, pig and sheep tissue.
-Developed and characterized model systems involving MSCs seeded within the following biomaterials: calcium alginate, calcium phosphate, Pluronic F-127, fibrin glue, PGA/PLA, PLC.
-Analyzed cellular/mechanical microenvironment using time lapse photography, and immunocytochemistry methods. Investigated cell culture, passage, construction of 3D scaffolds and molds.
-Performed surgical procedures in rats, mice, pigs, and sheep that involved new tissue generation including spinal cord regeneration. 
-Performed the implantation of the cell/scaffold constructs subcutaneously and in situ for tissue regeneration.
-Performed biomechanical testing of engineered samples using Instron testing device. Different models were used: compression, displacement, and bending.  Calculations were based on biomechanical results: Ultimate tensile strength, equilibrium modulus, permeability, wound breaching strength, modulus, failure energy, and failure strain.
-Performed biomechanical testing in impaired-wound-healing model.
-Performed biochemical tests to quantify the extracellular matrix growth such as glucosaminoglycans, chondroitin sulfate, hydroxyproline and collagen amount.
-Quantified number of cells in the engineered tissue based on pico green and DMB (dye methylene blue dyes).
-Prepared samples for FACS (Fluorescent Activated Cell Sorter ) and analyzed possible carcinogenic potential of the cells e0nsuring their safety for the recipient organism. Skills included sterile technique, surgical dissection, handling of blood vessels, tissue culture, cell culture, immunohistochemistry, protein and molecular biology assays.

The “Orthopaedic Clinic”
Medical Doctor of Orthopaedic Surgery and Researcher (part-time research, part-time clinical)            Chisinau, Moldova and German cities
1996-1999

-Received stipends for research and design of Spinal Fusion Devices and other medical and engineering technologies.
-Collaborated with the Midas Rex Institute, New York on spinal fusion devices and engineering technologies.
-Collaborated with various corporations in Germany including “New Technology in Advanced Spine Surgery” (translation) as well as corporations interested in craniocervical surgery.
-Collaborated with the “St. Elizabeth” Clinic in Straubing, Bavaria in biomedical and engineering research.

Education

1990 – 1996
M.D. with highest commendations, focus of residency on Spine Surgery & Orthopaedics                                                                                  
Testemitanu Medical School, Chisinau, Republic of Moldova

1996-1999
Orthopedic Surgery Residency, Board Certified in Moldova & Licensed to practice also in Germany

Laboratory Skills

Mammalian cell and tissue culture, Live-dead staining, Pico green, CMFDA assay, MTT assay, Centrifuge, DNA/RNA isolation/extraction, Electrophoresis – (DNA and Protein), Homogenizer, Lyophilizer, GAG assay, Microscope, PCR, Spectrophotometer, Sonicator, Amplification, Detection and Quantification, Protein Expression, Purification, DSC, computer tomography, product molding, use of materials such as: collagen, hydroxyproline, cartilage, graft, allograft, Analysis in prokaryotic and eukaryotic systems, Gene targeting, Construction, Screening and analysis of transgenic and knockout pigs, In Vitro analysis, Northern blot analysis, Southern blot analysis, Western blot analysis, Dot blot analysis, Histological and histochemical analysis, ELISA analysis, Flow cytomerty analysis, Immunoassay, Apoptosis analysis, Cell cycle analysis, Gel mobility shift assay (GMSA), Flourescence microscope analysis, Tissue Culture, Tissue Processing, Biomaterials synthesis, immunoprecipitation, con-focal microscopy and CHIP assays, screening of small molecules by in-vitro assays, histological staining, histological analysis, pathological evaluation, in-situ hybridization, immunohistochemistry, purifying proteins by using ion exchange, gel filtrate, hydrophobic and affinity chromatography, polymer synthesis and modification, polymer blends and composites preparation, material characterization, biocompatibility test, degradation of implants material, synthesis of porous polymeric scaffold, immunofluorescent staining, microCT, bone histology, various mathematical and statistical softwares.

Professional Affiliations

Member of Orthopedic Research Society
Member of the American Society for Testing of Materials (ASTM)

Patents and Disclosures

Available Upon Request

Honors and Awards

Albert Villar Award; American-Austrian Foundation Award;  Fellowship Grant in Salzburg Orthopedic Clinic; DAAD Award and Stipend; WISE Foundation Stipend, Worcester, USA; German Ministry of Health, Berlin, Germany; “Soros” Foundation Scholarship, NY, USA; Sch. N19, Silver Medal, Chisinau, Moldova; Dusseldorf Medica 1997; Spine Fellowship Grant at “St. Elizabeth” Clinic, Straubing, Bavaria.
                       
Publication Activities & Proceedings Of Meetings

Available Upon Request

Personal

-Title: International Chess-Master
-Languages: English, German, Moldovan, Romanian, Russian, some French.
-Excellent references and recommendations available from every single one of my past employers.
– Traveled to 32 countries (tourism).

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