Medical Equipment Consultants: 11

Steven Burres has over 30 years of experience in the practice of Facial Plastic and Reconstructive Surgery. Dr. Burres provides all aspects of care including surgery, evaluation, treatment, and complications. He specializes in:

• Ear, Nose, and Throat
• Facial Plastic Surgery
• Liposuction
• Allergy

Dr. Burres has in-depth expertise in procedures such as cosmetic plastic surgery including hair, forehead, eyelids, nose, lip, facelift, neck lift, ear pinning and reshaping, cheek and chin implants, fillers, Botox, lasers, skin, scars, liposuction, and others except for breast implants and tummy tuck.

Dr. Burres' ear nose and throat experience includes broken noses and other facial fractures, hearing loss, vertigo, dizziness, smell, taste, nasal obstruction, sinusitis, tinnitus, hoarseness, GERD, sleep apnea, cancer, headaches, TMJ, skin disorders, facial nerve, and allergy.

Dr. Burres also has expertise in medical manufacturing having creative from concept-to-sales two medical businesses, one an injectable filler and the second a set of ear cleaning tools sold at major retailers.

Litigation Support - Dr. Burres has 20 years of experience serving as an expert witness and evaluator. He is a licensed QME/IME in California. His services are available to attorneys representing plaintiff and defendant for any medical legal matter including personal injury, workman's compensation, QME, IME, medical malpractice, or other medical manufacturing issues.

Education / Training:

• BA - University of Chicago, 1975
• MD -University of Chicago-Pritzker School of Medicine, 1979
• Residency Otolaryngology / Head and Neck Surgery, 1983
• Fellowship Facial Plastic surgery - Stanford University, 1985

Georgia J. Persky RN, MBA, PhD, CLNC, is a seasoned nurse with over 40 years of broad Clinical Nursing experience and 25 years of Senior Leadership in Healthcare Organizations. She has expertise in the micro issues in direct patient care and the broad Management, Quality, State, Federal, and Joint Commission regulatory issues in hospitals and long term care facilities. Dr. Persky provides private consulting for hospitals that want to improve patient care quality and satisfaction. A national speaker and author, her services are in demand for engagements on healthcare issues. 

Litigation Consulting Support - As a Certified Legal Nurse Consultant and Quality Reviewer, Dr. Persky has investigated hundreds of Malpractice and Injury cases as a quality reviewer and can assist in legal case review with chronologies, timelines, and evidence based reports. Dr. Persky's services are available to attorneys for plaintiff and defense seeking an expert in nursing and patient care with a strong understanding of how hospitals and nursing homes work. 

Facility Consulting Services:

• Provide hospital and nursing leadership and support in turnaround or acute regulatory situations
• Assess, plan, implement and evaluate Patient Care Services structure, processes and patient satisfaction initiatives
• Mentor nursing leadership team or screen and recruit new leadership
• Recommend strategies and tactics to improve efficiency or effectiveness in nursing and hospital operations
• Assess Perioperative Services and improve volume and patient flow
• Provide focused plan and implementation to address regulatory and accreditation issues and prepare leaders and staff for regulatory visits
• Develop Nursing, Operational and Strategic plan for handoff to new leadership team

Background Experience - Dr. Persky has served as Vice-President of Nursing and Patient Care Services for 25 years and most recently, New York Presbyterian Hospital at Columbia University Medical Center. For nine years, she was responsible for Risk and Quality Management and Patient Satisfaction for a 750 bed academic hospital. She directed a $200 million budget with 33 patient services units and Care Management, Respiratory Therapy, Social Work and Admitting Departments with 9 direct reports and 2,000 patient care employees. 

View Dr. Persky's Expert Witness Profile.

OrthoBioMech LLC provides Medical Device Development and Injury Biomechanics Analysis services to the orthopedic and legal fields. The founder, Mari S. Truman, PE, has more than 37 years of experience in Orthopedic Product Design and Development. As Principal Engineer, she acts as an R&D design and development consultant to the orthopaedic industry and an injury biomechanics and medical device forensic expert.

While working for and with the major US Orthopaedic companies, she designed numerous instruments and implants for repair of skeletal injury. Ms. Truman is named on 12 Orthopaedic Patents and frequently gives talks on implant design and injury biomechanics on topics such as: knee and thumb-based joint surfaces and kinematics, joint design, rapid prototyping, medical device design control, and injury biomechanics.

Ms. Truman founded and ran ArthroMotion (1993-1997) and Seabrook International LLC's Midwest Design Center (1999-2002). Her project experience (non-inclusive):

• Total and Hemi Joint Resurfacing Systems: Hip, Knee, Wrist, Ankle, Hand/Toe, CMC, PIP, DIP, Shoulder
  
• Trauma Systems: Plates, specialty screws, intramedullary nails, wires, cables, external fixation systems, spinal fusion systems
  
• Soft Tissue Reattachment Systems

Speaking Venues: ASME Congress, North American Spine Society, Southern Biomedical Engineering Conference, International Society of Biomechanics, National Manufacturing Week Conference, American Society for Surgery of the Hand, International Hand and Wrist Biomechanics Symposium, International Federation of the of the Societies for Surgery of the Hand, Vth International Symposium on Computer Simulation in Biomechanics, Indiana Medical Device Manufacturer’s Council, Ohio Bar Association and the Ohio Trial Lawyer’s Association.

View Mari S. Truman's Expert Witness Profile.

Principal, John Lawrence Stevens, RAC, has over 20 years of FDA Regulatory Compliance experience encompassing virtually all FDA field positions. He also has 18 years of industry experience as a mid-level manager and senior executive in clinical, regulatory, and quality in the Medical Device Industry, including several large and small cardiovascular companies. 

Mr. Stevens has personally designed quality systems, prepared regulatory submissions (510(k), IDE and PMA) and managed 7 multi-center clinical trials for class 3 medical devices. From 1989-1993, he was the Industry Representative on the FDA Circulatory Systems panel which reviewed over 30 PMA clinical studies for cardiovascular devices. He regularly perform webinars regarding FDA and issues regarding Clinical Studies and Medical Devices.

View Mr. Stevens' Expert Witness Profile.

mdi Consultants, Inc - Experts in FDA regulatory affairs, quality assurance and ISO 9000 certification. With 6 years in the FDA and 26 years consulting to the industry, mdi Consultants, Inc. has been an invited Speaker worldwide on FDA regulations and policies and has obtained FDA expert status as third party auditors.

OUR APPROACH

We utilize the following three part approach to providing high quality services to our clients:

Unsurpassed consultant experience – we identify and recruit only top quality consultants with deep industry knowledge to provide the most complete and insightful advice to our clients

Up-to-date systems and processes – we have highly defined systems (e.g. manuals, training programs, technical files) and processes (e.g. audit methodologies, 510(k) submission, validations) that are constantly refined and kept current across the ever changing regulatory environment

Involvement in regulation development – we stay ahead of policies by participating in the development of regulation (e.g. HACCP, Scientific Advisor to U.S. Congressmen)

Envista Forensics is a global leader in Forensic Engineering & Recovery Solutions. They provide Cause & Origin, Failure Analysis, Fire and Explosion Investigations, Accident Reconstruction, Damage Evaluations and Equipment Restoration Services following disasters of all kinds. Envista has offered Consulting Services to the insurance, legal and risk management industries, as well as businesses, public entities, and universities for over 25 years. Their Experts travel globally from 30 offices located across the U.S., Canada, Mexico, the U.K., Australia and Singapore.

Insurance Industry / Claims Professionals - Envista understands the need to save money and expedite the claim, to serve the insured and reduce uncertainty. They offer a menu of services that address insurers’ needs for timely, reliable information, as well as their need to satisfy the policyholders. Envista's insurance clients include Property Adjusters, Casualty and Liability Adjusters and Examiners, Boiler & Machinery Specialists, Inland and Ocean Marine Surveyors, Subrogation and Recovery Professionals, SIU (Special Investigation Units), Forensic Accountants, and Lloyd's & London Market.

Businesses - Envista understands that buildings, equipment, data and other assets are critical to the profitable operation of any business. They are proud to offer a variety of services that help businesses protect themselves when they need it most. Envista offers specialized expertise with all types of business, especially Manufacturers, Technology Companies, Food Processing, Hospitals, Medical / Dental Care, Laboratories, R&D (Research & Design), Schools and Universities, Law, Accounting, and other Professional Service Firms, Banking, Securities, Financial, Energy, Transportation, Retail, and Broadcast and Entertainment.

Universities & Public Entities - Risk Managers and Business Officers responsible for the operations of colleges, universities, local government and other entities have the challenging role of working to prevent financial exposure following disasters involving business-critical equipment, buildings/structures, data/networks, as well as safety. Envista engineers and technicians have over a quarter century’s worth of experience providing forensic consulting for college risk professionals, as well as the insurance carriers and legal professionals who serve them.

Consulting Services:

• Equipment Damage Assessments
• Forensic Engineering / Causation Analysis
• Building & Structure Damage Assessments
• Equipment Restoration & Preservation
• Evaluation of Repair and Replacement
• Project Management of Repair and Recovery Efforts Options
• Data Recovery
• Computer Forensics
• Forensic Video Services
• Cyber Incident Analysis

View Envista's Expert Witness Profile.

Elite Medical Experts works with attorneys to provide 100% Board-Certified physicians and surgeons practicing at the professorial level at the nation's leading universities. From Stanford to Yale, and from every medical and surgical specialty, Elite secures full-time practicing high-level experts from the nation’s most respected medical institutions. Each specialist is truly unique – a Board Certified professor with a dedicated clinical practice, extensive publications, and top-tier credentials from a major U.S. medical center. 

Complex Consulting at the Intersection of Medicine & Business
Elite Medical Experts also consults on complex strategic and tactical issues for enterprises of any size, and has extensive experience securing top-tier Professors of Medicine and Surgery for a range of complex consulting engagements. Elite Medical Experts is mission-critical to:

Corporate Consulting Occupational Health Special Projects Product Development Legislative Issues FDA Navigation Television, Film, Print News, and Other Media

FTC Rules and Regulations Lobbying Intellectual Property Focus Groups and Due Diligence Keynote Addresses, Endorsements Executive Search for Strategic Advisors, Directors, and Board Members Device & Drug Insight for Hedge Funds and Private Equity

To learn how you can align with nationally recognized thought leaders from myriad areas of expertise, call Elite today and ask for our Director of Complex Consulting:

Dr. Burton Bentley II, M.D., FAAEM
CEO, Elite Medical Experts, LLC.

View Elite Medical Experts' Expert Witness Profile.

Dr. David Schaafsma, PhD has over 25 years of experience in Optical Systems, Optical Physics, Microscopy & Spectroscopy, Optical Materials, Lasers, Optoelectronics, Sensors, Data Acquisition, Product Development. sales, marketing, business development, operations, and management at small businesses, at government laboratories, and as an independent consultant. Before founding Applied Optical Engineering, Dr. Schaafsma was the director of Sensor Technology at Tetra Tech Data Systems (later Ipitek) and was responsible for all R&D, product development, and commercial activity in fiber optic sensors, and also worked on numerous projects involving fiber communications and embedded systems. As a Senior Scientist at the Naval Research Laboratory, he made the first chalcogenide fused fiber coupler and achieved the first results with single-mode IR-transmitting fiber in mid-IR scanning near-field microscopy. At the National Institute of Standards and Technology in Boulder, Dr. Schaafsma's research focused on Quantum Optics and Fundamental Metrology of Vertical-Cavity Surface-Emitting Lasers, and included the construction of a confocal fluorescence system with a noise floor of 4 photons. As a Senior Characterization Engineer at Bandgap Technology Corp., he oversaw the production of compound semiconductor devices such as surface acoustic wave (SAW) modulators, vertical-cavity surface-emitting lasers (VCSELs), high electron mobility transistors (HEMTs), solar cells, and laser diodes for an industry which was then in its infancy. Dr. Schaafsma holds two patents, a near-field optical microscope with infrared fiber probe and an infrared optical fiber coupler. He has spoken about many topics at professional venues such as conferences, to potential clients and corporate officers of multi-billion dollar companies, as well as to classes of students. Dr. Schaafsma is also a noted authored having written numerous publications in his areas of expertise. Areas of Expertise

Medical Product Design / Development Optics – Geometric, Diffractive, Waveguide, Optical Technology, Optical Materials Networks, Data Links, Protocols Fiber Optics Lasers & Light Systems Embedded Computer Systems, Microcontrollers Infrared Materials, Technology, Products Imaging & Microscopy (SEM & Optical), Spectroscopy

Software & Programming, Embedded & High Level Languages Electronics, Embedded Design Sensors, Data Acquisition Semiconductor Metrology, Photovoltaics, Renewables Project Planning / Management ISO 9000, SPC Tooling / Process Development Market / Patent Research Grant Writing

View Dr. Schaafsma's Expert Witness Profile.

Duane M. Bryant MD, MS, is a seasoned Ophthalmologist certified by the American Board of Ophthalmology. Dr. Bryant has over 30 years of clinical and surgical experience with Cataracts, Glaucoma, Laser Surgery For Glaucoma, Laser Surgery for Diabetic Retinopathy, Laser Surgery for Central Vein Occlusion and Branch Retinal Vein Occlusion, and Intravitreal Avastin Injections.

Regularly participating in Continuing Medical Education courses, Dr. Bryant's expertise is cutting edge. In 2014 alone, he attended the Retinal Physician Symposium, the Kiawah Eye Meeting, the Diabetic Retinopathy and Vein Occlusion, and Current Concepts in Ophthalmology. 

Litigation Support - Dr. Bryant has been involved in expert witness, peer chart review, and IME work for over 10 years. His services are available to counsel representing both Plaintiff and Defense.

Consultative / Forensic Experience:

Cataract Surgery Glaucoma Laser Surgery Ocular Trauma

Diabetic Retinopathy (Medical and Laser Treatment) Vein Occlusion (Medical and Laser Treatment) Life Care Planning for cases of Visual Impairment See Case Descriptions

Peter Crosby has over 45 years experience in the medical device industry. He has served as CEO of six medical device companies in four countries (public and private), and brought many products to the world market through clinical trials and regulatory approval.

Through Biomedical Business Resources LLC, he provides many services including:

• Advisory - helping clients with strategy, operations, execution, and business building\
• Mentoring, especially first time CEOs
• Expert Witness - assisting attorneys with multiple expert reports, depositions, and testimony at trial and arbitration. Cases include disputes about intellectual property , product liability, and commercial contracts
• Board Services - offering Independent Board Member services for companies, public or private, with experience in building companies, and helping management teams in times of high growth and rapid change

Mr. Crosby's product experience includes implantable devices (cochlear implants, cardiac pacemakers, implantable defibrillators, artificial heart, neurostimulation), in vitro diagnostics, imaging (ultrasound and X-ray), software, AEDs, and patient monitoring. His clinical domain experience includes ophthalmology, otolaryngology, cardiac surgery, cardiology, orthopedics, pain management, anesthesia and intensive care.

View Peter Crosby's Expert Witness Profile.

ATech Designs, Inc. is a five-time award winning Product Development, Design and Consulting company. They have worked with clients in many different fields of work including the Medical Product Device Design and Development industry. The types of medical products ATech Designs, Inc. has developed include medical disposables, medical devices, laparoscopic devices, anastomotic connectors, catheters, intravenous (IV) devices, mitral valve repair devices, non-invasive surgical instruments, and knitted multi-pole pockets for RF endometrial ablation. Services Include:

Product Design and Development Machine Design Polymer Selection Detail Drafting Finite Element Analysis (FEA) Manufacturing FACTTM Molding

Product Assembly Product Testing Root Cause Analysis / Dynamic Mechanical Analysis Animal Studies Clinical Studies Expert Court Witness Design Prototyping

Karl R. Leinsing, MSME, PE, President of Atech Designs, Inc., is a Professional Mechanical Engineer who specializes in Medical Device Product Development from concept to production. Mr. Leinsing has been granted over 20 patents (needle free IV valves, laparoscopic devices, needlescopic devices, suture lockers, catheters, mitral valve repair devices, knitting machines) and excels in solving the most complicated problems and design challenges. The winner of five design awards, Mr. Leinsing is recognized as one of the top 100 medical device professionals in the nation by MD&DI. For dedication to his industry, he was made the 2014 Chairman of the Medical Device and Manufacturing Conference in Anaheim, CA. Mr. Leinsing has also been acknowledged for his work in a publication by Life Magazine.

View Karl Leinsing's Expert Witness Profile.