Industrial / Product Design and Development Expert Witnesses: 16

Bransford Pickett, PE, DFE, BSc, MScBA, has over 25 years of experience as a Mechanical Engineer. SEFS expertise includes design and review of material handling equipment, material handling management, and ship board systems. SEFS offers litigation support services for Accident Investigation and Reconstruction covering failure analysis, process simulation, regulatory compliance, equipment reliability, and personal injury / safety. His materials handling and engineering services are offered to attorneys, insurance and end user companies nationally and internationally.

Mr. Pickett is a member on the American Society of Mechanical Engineers B30 committee on Safety Codes and Standards for cranes and rigging as well as a member of several subcommittees. He is also a member of American Society of Mechanical Engineers P30 Committee- Planning for the Use of Cranes, Derricks, Hoists, Cableways and Lifting Accessories. ASME BTH Standards Committee.

Mr. Pickett is a Professional Engineer, and holds a BSE from the University of Michigan, Ann Arbor, and a MScBA in Finance from San Diego State University, as well as a board certified Diplomate Forensic Engineer. He has qualified as an expert witness in the State of New York Supreme Court and the State of California Supreme Court.

Accident Investigation:

• Man baskets, Forklifts, Scissors Lifts, Aerial Lifts, Rigging Gear, Hydraulic Jacks, and Hydraulic / pneumatic Lift Systems, Automotive Lift Systems, Conveyors, Pallet and Packages Conveyors, Pneumatic Systems, Machine tools, Boats, Barges, and Elevators
• Tower, Mobile, Bridge, Truck, Portal, Container, Jib and Floating Barge Cranes, and Derricks
• Operator training compliance to National Commission for the Certification of Crane Operators, NCCCO, requirements for tower crane, mobile crane, overhead crane, articulating crane operator training and certification, signal person, and rigger certification
• Compliance covers applicable national and international standards that include the ABS, ASTM, ASM, ASME, ANSI, WSTDA, ALI, etc. and DIN, EN, FEM to list a few. National regulations include state and federal OSHA requirements as well as DOE, military specifications and standards

View Bransford Pickett's Consulting Profile.

Thomas W. Caldwell, PE, has over 40 years of experience in Materials Research and Development, Process and Product Development, and Manufacturing Operations in the Precision Cast and Machined Products industry.

Mr. Caldwell has designed and manufactured components for consumer and industrial products, including safety-critical applications such as aircraft landing gear brakes, seat belt lockup devices, windshield wiper, and window lift motor systems. He has experience creating and guiding technology development and manufacturing partnerships in Europe and Asia, licensing and selling intellectual property and creating supply chains in China.

Mr. Caldwell has lectured in the USA, Germany, Switzerland, and India on manufacturing premium quality metal products and manufacturing processes, and was a technical paper peer reviewer for 20 years for the Society of Automotive Engineers. A United States patent holder, he has published peer reviewed research in electrochemistry and materials processing, and has written and spoken numerous times on the subject of Materials Selection.

Litigation Support - Thomas W. Caldwell, PE, is a testifying and consulting expert for both plaintiff and defense counsel. His cases involve product failure for ferrous and non-ferrous alloy products such as hand tools, recreational and exercise equipment, fire fighting apparatus, rotating industrial machinery, construction hardware, piping, and lighting fixtures. Mr. Caldwell utilizes destructive and non-destructive methods for insuring product integrity.

Areas of Expertise:

Design Engineering Materials Failure Analysis Materials Engineering Mechanical Engineering Metallurgy Power Tools Products Liability Design Defects

Manufacturing Defects Fitness for Use Equipment Operation and Maintenance Accident Reconstruction Material Selection Manufacturing Process Design and Scale Up Safety Component Product Quality Control Safety Component Quality Systems Management

View Thomas A. Caldwell's Consulting Profile.

R. Kevin Smith PE, BSME, MMAE, has been a specialist in Engineering Forensic Safety and Design for 35 years. He has consulted on over a 1,000 matters nationwide. Mr. Smith is a registered professional engineer and holds a BSME and MMAE from the Illinois Institute of Technology in Chicago. He is board certified forensic engineer through the National Academy of Forensic Engineers. He specializes in Material Handling Equipment Safety, including lift trucks, dock safety, truck loading, conveyors, and aerial work platform safety. Mr. has been actively involved as a member of the committee that writes the Safety Standard for Low Lift and High Lift Trucks (ASME/ANSI B56.1) for over 30 years. He also serves on the B56.6 committee (rough terrain lift trucks) and the ANSI A92.5 and A92.6 subcommittees (self-propelled elevating work platforms). Litigation Support - Mr. Smith formerly worked for Triodyne, Inc. for over 15 years as a forensic engineer/principal engineer. As President of R. K. Smith Engineering Inc., for over 25 years, he currently has a laboratory for examination and testing, and owns or has access to varied testing equipment and tools. Kevin Smith has testified at depositions and trials on several hundred matters. He has performed hundreds of investigations into product failures involving injury and property damage, and has reconstructed numerous accidents. His expertise is available to counsel representing both Plaintiff and Defendant. Mr. Smith also was previously on the Adjunct Math faculty at Prairie State College for 13 years. Areas of Expertise:

Forklift Trucks Aerial Work Platform Lifts Product Testing Material Handling / Lifting / Rigging Equipment Accident Reconstruction Machine Guarding Safeguarding Warnings

Agricultural and Construction Equipment Skid Steer Loaders Stability Testing Loading Dock Safety Consumer Products / Testing OSHA Citations Codes & Standards Standard of Care in Design

View R. Kevin Smith's Consulting Profile.

ERIC P. ROSE, NPDP, MBA, Product Design and Manufacturing Expert Witness for Consumer, Medical, and Industrial products.

Product Liability, Commercial Dispute, Patent Infringement  services provided to plaintiff and defense attorneys.

BACKGROUND: 35+ years' experience in product design, product development, product testing, and manufacturing. Product innovation part-time academic since 2009. Certified New Product Development Professional (NPDP) since 2008. Member of: PDMA, SPE, ASQ. Public Speaker since 1985.

BS Product Design, ASU College of Engineering. MBA, Pepperdine University, Named inventor on numerous patents issued and pending worldwide, https://bit.ly/2UyCa4N

Deposed as a product design expert witness 4 times since Spring 2020 including twice in the 3M military earplug MDL. Daubert ruling at, https://bit.ly/EPR-3MEP-Daubert (Page 98).

Expert witness services at, https://bit.ly/PDEWS 

Expert witness testimonials at https://bit.ly/EPR-EWT

AREAS OF EXPERTISE:

Product Development Product Design ISO 9001 Manufacturing Design For Manufacturing (DFM) Plastic Product Design Personal Protective Equipment (PPE) Respiratory Protection N95 Masks

Hearing Protection / Earplugs Industrial Products Dental Devices Medical Devices Consumer Products Toys Durable Medical Equipment (DME) Furniture FMEA

View Pinnacle Product Innovation's Consulting Profile.

Mari S. Truman, PE, has more than 40 years of experience in Orthopedic Product Design and Development. As Principal Engineer with her company, Orthobiomech, LLC, she acts as an R&D design and development consultant to the orthopaedic industry and an injury biomechanics and medical device forensic expert. Ms. Truman's design experience includes implants and instrumentation systems used to repair fractured bones, torn ligaments and/or to reconstruct spine, knee, wrist, hip, ankle, elbow, thumb based cmc, and other finger and toe joints for many of the USA based orthopaedic conglomerates and a few Asian, Australian and European firms. Having designed and developed implants and instruments used for both human joint reconstruction and skeletal trauma repair, 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. Litigation Support - Ms. Truman has been providing Forensic Impact and Injury Biomechanics and Orthopedic Biomechanics to the legal industry for over 15 years. She draws on her strong knowledge of FDA and ISO EN13485 compliant design control processes, failure modes and effects analysis, clinically relevant tissue loading, and design safety assurance, including device performance requirements and warnings, during her medical device litigation reviews. Ms. Truman has a strong knowledge of the production and quality assurance processes used in the manufacture, cleaning, and sterilization of medical devices and the effects of such processes on product performance. Analysis of Traumatic Injuries Related To:

Falls and Fall Recovery Vehicular Collisions Assaults and Fights Projectile Impacts Occupation or Workplace

Failed Medical Implants Assistive Devices Orthotics Consumer Products Sports and Recreation, Occupational Overuse / Injury

View OrthoBioMech LLC's Consulting Profile.

Randal Hill, PhD, Thought leader in chemistry, materials science and intellectual property.  Award winning PhD scientist with 30+ years in applied chemistry.  Visiting Scientist at MIT for 5 years to foster silicone-based nanotechnology projects.  Holder of 69 issued patents.  Author of Silicone Surfactants book and 60 articles.  Served as Patent Science Advisor to grow patent portfolio by 1500%.  Deveoped display for Amazon Kindle.  Readily adapts expertise to new problems.  Served as adunct faculty at Stanford and University of Minnesota.  Organized two international symposia.  Invited speaker at Gordon Conference and four international colloid meetings.  Associate Editor of Journal of Surfactants and Detergents.  Involved member of American Chemical Society, Society of Petroleum Engineers, American Physical Society, and American Oil Chemists Society. Awards  include 3 Dow Corning Technical Achievement Awards, as well as the AOCS Samuel Rosen Award for Surfactant Chemistry.  

Experience includes fire-fighting foams, well fluids, adhesives, silicone defoamers, formulation of household and personal care products, applications of silicone surfactants, silicone-based nanotechnology for soldier protection, development of pigments for electronic displays.

Chemistry / Chemical Engineering Materials Science Intellectual Property / Patents Silicones Surfactants Emulsions Microemulsions Chemical Product Development

Colloid and Surface Science Agricultural Adjuvants Chemicals Detergents Formulation Liquid Crystals Personal Care Products Household Care Products Electrophoretic Displays

Background Experience - Dr. Hill began his career at a major detergent company followed by developing sugar-based surfactants. He went on to spend 20 years with Dow Corning developing personal care applications for silicones, leading the pigment science group at E Ink developing the next generation of color electrophoretic ink displays, and leading the Formulation Development group at Flotek to expand the product line by 300% and grow the patent portfolio by 1400%.

Dr. Hill is now known for his work on silicone surfactants, especially for his work on super wetting. During his time as MIT Visiting Scientist with Dow, he also initiated work on silicone-based superhydrophobic surfaces, which led to a publication that has since been cited nearly 1,500 times.

Dr. Hill is the author of 60 publications, including an authoritative book entitled, Silicone Surfactants. He is a highly awarded inventor with accolades that include 3 Dow Corning Technical Achievement Awards, as well as the 2017 AOCS Samuel Rosen Award for Surfactant Chemistry.

Karl L. Linck, PE, is an expert in Food Industry Production and Packaging with over 45 years of experience. A Professional Engineer in WI, IL, AZ, CA, FL, and ID, his main area of experience is with Sanitary Systems and their Design in Hygienic Food Processing. 

Litigation Support -  Along with design of many food processing / packaging systems and engineering department development and leadership, Mr. Linck has provided expert witness testimony for cases involving IP and Contract issues. His services are available to attorneys representing plaintiff and defendant and include site inspection, thorough reporting, depositions, and trial testimony as needed. 

Areas of Expertise:

Sanitary Food Systems Food Processing Systems Food Processing Equipment Facility Sanitary / Hygienic Design Facility Automation Site Selection

Equipment and Engineering Contracting Packaging Material Engineering Packaging / Production Line Efficiency MAP - Modified Atmosphere Packaging Food Packaging Systems / Equipment Food Production Operations

 Background Experience - Much of Mr. Linck's career has focused around dry, oils, refrigerated and frozen products in the pasta, natural cheese, processed cheese, appetizer, and entrée areas. He has led strategic growth of engineering functions, including procurement and customization of production equipment, production line layouts and facilities design, automation, packaging material engineering, site selection, and support engineering functions for all production operations and distribution/office needs.  

From 1992 to 2019, Mr. Linck served as Vice President of Engineering for Sargento Foods, Inc., where he provided key technical direction and management critical to growth and assembled the engineering department to support innovation, improvements, and production support with proper engineering/technician skill sets, among other duties.

Mr. Linck is currently the sole proprietor and engineer for Karl Linck, Technical Consulting, where he specializes in engineering educational material development, manufacturing consulting, expert witness work, and expert advice for the food industry.

Harvey C. Voris’ entire engineering career has been devoted to the Fitness Industry. He has over 35 years of Fitness Equipment Design experience and has been issued 7 U.S. utility patents. Mr. Voris has a Bachelors of Science in Engineering from UCLA with a specialization in Bio Structural Mechanics. 

Mr. Voris' Masters in Engineering is from Cal State Long Beach where he specialized in Fatigue and Failure Analysis. He has spent 21 years devoted to the development and promotion of safety standards for the fitness industry. Mr. Voris has authored numerous standards and has chaired the ASTM committee devoted to fitness standards development since 1995. 

Litigation Support - Mr. Voris provides engineering analysis and accident reconstruction related to consumer and fitness products and facilities. His services are available to attorneys representing both plaintiff and defense. With 35 years of experience, a biomechanics background, and extensive experience in design and product testing, Mr. Voris speaks with authority on the following critical issues:

Product Liability - Patent Development - Patent Infringement - Facility Risk Management - Standards Compliance

View Harvey Voris' Consulting Profile.

Khalid Sorensen, PhD, is a highly accomplished technology leader in Automation, Mechatronics, Motion Control, Manufacturing, Machine Vision, and Human-Machine Interaction. He has over 20 years of experience developing and deploying world-class mechatronic, motion control, and automation solutions.

Dr. Sorensen has directed the development and implementation of 100s of complex, multi-disciplinary mechatronic systems for high-profile industry leaders including Toyota, Ford, Alcoa, Caterpillar, Boeing, NuScale, and many others, and high-profile facilities including Fukushima and Chernobyl.

Litigation Support - Dr. Sorensen has testified in numerous Product Liability and IP disputes – both at the Federal and District court levels, as well as the ITC, USPTO, and US Customs and Border Protection.

Areas of Expertise:

Automation Dynamics and Control Systems Kinematics Machine Vision Manufacturing Mechatronics Photogrammetry Robotics

Segways Sensors Tire Mechanics Traction Control Wheel Slip Vibrations Warnings See Full List

Career Highlights:

• Founded a technology company where he invented and was the Chief Architect of Expertoperator^TM, Safemove^TM, Automove^TM, and Cranevision^TM – technology known within the primary metals, automotive, and heavy-equipment sectors for enhancing crane safety, productivity, and ease-of-use; Developed state-of-the-art, on-line, time-optimal trajectory synthesis software for Cartesian machines - key drivers in the acquisition of his company 5 years after inception by a global leader in automation.
• Served as CTO at PaR Systems, a world-class supplier of large-scale robotic automation, control, advanced manufacturing, and nuclear-handling solutions.
• Founded Finity Engineering, which provides design, analysis, consulting, and litigation support services in the areas of robotics, automation, and mechatronics.
• Adjunct Associate Professor of Mechanical Engineering at Georgia Tech. Teaches various engineering topics including Dynamics, Controls, Vibrations, Mechatronics, the Design Process, Product Development, Engineering IP, Product Liability, and others.
• Invited talks at premiere institutions globally including MIT, Kumoh National Univ. of Tech, Korea Atomic Energy Research Inst., Hyung Hee Univ., Huazhong Univ. of Science & Tech.

View Finity Engineering's Business Consulting Profile.

James Parker has over 35 years of relevant industry experience specializing in Electronic Security Systems & Sensors, Electronics R&D, and New Product Development. He has in-depth knowledge of electronic product design in both Wired and Wireless Technologies and outstanding knowledge of Environmental and False Alarm Immunity. Products, such as alarm systems, that Mr. Parker led the design of, have an installed base in the millions. 

Litigation Support - Mr. Parker provides Patent Litigation support to counsel representing both Plaintiff and Defense and is experienced with civil liability, criminal and patent litigation, including Inter Partes Reviews (IPRs). He has the ability to explain complex technical material in a straight forward manner. Mr. Parker's past clients include Cravath, Swaine & Moore LLP, Weil, Gotshal & Manges LLP, Fish & Richardson PC, Alarm.com, 2GIG Technologies, and Nest Labs. His services are available nationally and internationally. 

Areas of Expertise:

Electronic Security Security Systems Burglar Alarm Systems Intrusion Detection Motion Detection Wireless Alarm Systems Wired Alarm Systems Occupancy Detection Systems Premises Security Residential and Commercial Security Inter Partes Reviews (IPRs)

Research and Development Engineering Management New Product Development Electronic Engineering Embedded Systems Alarm Control Panels PIR (Passive Infra-Red) Motion Detection uW (Microwave) Doppler Motion Detection Solar LED Flood Lights (Patio to Street Level) Patent Litigation Intellectual Property

Background - Mr. Parker is the Past Vice President of Engineering for Digital Security Controls Ltd. (DSC), a leading global manufacturer of electronic security systems and components with sales exceeding $400 million annually. He is currently the President at EE-Systems Group Inc. Canada (R&D) where he is responsible for overseeing new product and business development. A prolific inventor, Mr. Parker has been granted over 25 unique patents with approximately 100 patent documents published worldwide. 

View James Parker's Consulting Profile.

Randy Phares is an expert in Packaging, specializing in Corrugated, Crating, Baling, Shipping, Warehousing, Manufacturing Safety and Load Securement. He has over 30 years of progressive leadership experience in Packaging, Procurement, Shipping, Lean Manufacturing, Quality, Safety, Productivity, and Business Improvement.

Since he began his career in 1990, Mr. Phares has held almost every job in packaging operations. These include manufacturing, distribution, sales, design, safety, transportation, and running entire multinational business units for a Fortune 1000 Corporation. He has worked on projects in Asia, Jamaica, Afghanistan, Latin America, Eastern and Western Europe, USA, and Canada.

Mr. Phares has run packaging testing labs, design centers managed fleets of trucks, manufacturing machinery, and managed world class packaging manufacturing operations. He is a published international author, and speaker who was the President of the South Texas Manufacturers Association. He is a Packaging and Procurement Subject Matter Expert since 2019 saving over $10 million for SGS-Maine Pointe the #1 Supply Chain Consulting Firm according to Consulting.us and one of America’s Best Management Consulting Firms of 2022 according for Forbes Magazine.

Honors and Awards - Best Achievement of Organizational Business Improvement in Manufacturing Award presented by the Global Six-Sigma and Business Improvement Awards for an extensive plant turnaround for Temple-Inland (now International Paper). Best Performing Plant Award for 4 consecutive years out of 26 plants for Gaylord Container (now International Paper).

Litigation Support - Randy Phares is a leading Packaging and Load Securement Subject Matter Expert relied upon for his experience, knowledge, and in-depth understanding of packaging, logistics, manufacturing, distribution, freight, and intellectual property. He performs forensic analysis and testing of packaging failures, loading, unloading and distribution failures that caused damage or injury. His services include thorough reporting, depositions, consulting, and trial testimony as needed.  

Cases involve crated, palletized, banded or boxed products, or boxed products loaded in railcars, trucks, vans or parcel trucks, warehoused, transported (loaded, or unloaded), or injury using a pallet jack, forklift, or by hand.

 Areas of Expertise: 

Corrugated Packaging Folding Carton Packaging Boxes Crates Pallets Pallet Jacks Warehousing   Packaging Logistics

Packaging Distribution Manufacturing Load Securement Freight - Rail, Trucking, Air Packaging Workplace Safety Packaging Product Liability Packaging Intellectual Property Packaging Design

View Randy Phares' Consulting Profile.

Howard J. Cohen, PhD, has over 30 years of experience in Software Engineering, Architecture and Implementation. He possesses particular expertise in Algorithms, Relational Databases, Graphical User Interfaces (GUIs) and Software Applications in general. His experience has been in a broad spectrum of technology, in several languages, in a wide variety of applications, and on multiple platforms. Dr. Cohen's background includes Electronic Design Automation, Bioinformatics, Digital Cartography, Banking Systems for Foreign Exchange Traders, and many more. He is the co-inventor on approximately 120 patents.

Dr. Cohen has over 15 years of experience as an Expert Witness. He possesses excellent written and verbal communications skills, including the ability to express himself well in interpersonal contacts, make presentations to large audiences, explain complex concepts clearly, and write well on levels ranging from the scientific to end user documentation. He is available to analyze complex systems, to write clearly about technical issues, and communicate face-to-face in a manner appropriate for any audience to understand the issues, the technology and the point of view. Dr. Cohen has been deposed and testified at arbitration hearings and in Federal Court.

Expert Witness Projects Include:

• Trade Secrets
• Copyright
• DMCA - Digital Millennium Copyright Act
• Patent Infringement
• Source Code Analysis
• Business Practices
• Damages Analysis
• Computer Software Security / Forensics

View Consulting Profile.

James Caylor, PE, is an independent consulting Mechanical Engineer specializing in NH₃ and CO₂ Refrigeration Systems used in process and cold storage applications. Clients have included Leprino  Foods, Safeway, Dreyer’s, Tyson, ConAgra, Unilever, Nestlé, Imperial Irrigation District, Lineage Logistics, and Grupo Kuo (Kekén).

Background Information - Mr. Caylor's first 15 years in the refrigeration business were spent as a service and startup technician, including a UA steamfitter apprenticeship, 11 years in the industrial field and the final 8 years self-employed as Caylor Refrigeration. He then returned to college and graduated from Arizona State University in 2000 with a BSME. 

Mr. Caylor worked as a project engineer for two design/build contractors and became a PE before moving to Tyson Foods’ corporate design group in 2005. He joined Jacobs Engineering’s Food and Beverage Group in Fort Worth in 2007, finished in 2013 as Deputy Director in charge of all refrigeration projects and opened his own consulting firm in 2014.

Litigation Support - Mr. Caylor has been retained in seven expert witness cases, including one completed and two more scheduled  depositions. Two of these are currently preparing for trial and one for arbitration. Disputes tend to fall into one of three categories:  

Component Function - System Design / Installation/ Operation - Regulatory Compliance

Mr. Caylor has also consulted for lawyers representing a food processing firm facing EPA citations at multiple plants. His forensic analysis services are available to attorneys representing plaintiff and defendant and include site review, thorough reporting, depositions, and trial testimony as needed.

Areas of Expertise:

System Design and Design Review (owner’s agent) Mechanical Code Review (IIAR, IFC/IMC, ASME B31.5, ASHRAE Std 15) Operational analysis Industrial Process Refrigeration Cold Storage

Ammonia Carbon Dioxide Piping Insulation OSHA / EPA

View James Caylor's Consulting Profile.

Dr. Rolf Biernath, PhD, Chemical Engineering, University of California, Berkeley, and BChE, Georgia Institute of Technology) has over 35 years of experience in the Chemical Industry with a concentration on Polymer Science and Engineering and Material Science Fracture Mechanics. He worked in Materials and Processes at 3M for 31 years in senior technical roles developing materials, processes, and systems. His 58 US patents span a broad range of scientific and engineering disciplines.

Litigation Support - Dr. Biernath is a Patent & Civil Liability Expert Witness having worked with in-house and outside attorneys in prior art searches. He's drafted claims and strategized claims in a variety of fields. He has written Expert Reports for Civil Liability, including material failure analysis, computer simulation, and manufacturing assessment. He is known for his ability to explain complex technical problems simply.

Areas of Expertise:

Adhesives and Tapes Polymer Engineering Failure Analysis and Prediction Electronic Displays (LCD, ePaper) Light Sources (LEDs, LASERS) Short-Wave InfraRed (SWIR) imaging

Applied Physics Metrology Optical Sensors Optical Films Mid-IR Sensors and Emitters Physics-based Digital Twins, Computer Modeling

Background Experience - Dr. Biernath has 58 Issued US Patents on new products and processes, including:

• Industrial Adhesives and Tapes – 3D printing materials selection, development, automation, and tape application processes
• Electronic Materials – epoxy thermoset adhesives & application process, high speed electronic connectors
• Electronic Displays and optical display films, outdoor digital displays
• Microreplication and textured adhesives and processes, microfluidics, e-Paper
• Signage – retroreflective signage, license plate recognition, ADAS,and Human Invisible, Machine-Readable Coding System
• IoT and IIoT / Automatic and predictive selection and replacement

Dr. Biernath has expertise in stresses in planar systems due to a range of causes including, thermal expansion mismatch, humidity and solvent uptake or loss, and cure shrinkage. He understands assembly processes for tapes and adhesives including interpreting Technical Data Sheets, Application Data Sheets, developing test methods, and selecting materials.

View Biernath Consulting, Inc.'s Business Consultant Profile.

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 40 patents (needle free IV valves, laparoscopic devices, needlescopic devices, suture lockers, catheters, mitral valve repair devices, sleep apnea, CPAP, catheter dressing, stapler, knitting machines) and excels in solving the most complicated problems and design challenges. Mr. Leinsing also has experience with e-cigarettes, vaping devices, bedside glucose monitors, pumps of all types, continuous glucose monitors (CGM), auto-syringe, pen injectors, peritoneal dialysis, wound dressings and pumps, IV systems, bone anchors/plates/screws, suture devices, urinary incontinence devices, urinary catheters, AAA stent graphs, fixation devices, and many other medical devices.  His company has a fully equipped medical lab with calibrated measurement and test equipment and all is fully documented with high quality reports with pictures and video to provide credible results and easy to understand compelling data.

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. Mr. Leinsing offers litigation support services to the legal community. He has extensive experience with Patent and Product Liability cases including report writing, depositions, and testimony.

Areas of Expertise:

Intravenous (IV) Systems & Disposables Hernia Repair Endometrial Ablation Laparoscopic Instruments Injection Ports Catheters Heart Valve Repair / Replacement Subcutaneous Ports

Bed Rails Cervical Screws Syringes, pen injectors, auto-injectors IV / Insulin Pumps Glucose Monitors Peritoneal Dialysis Pumps Abdominal Aortic Aneurysm (AAA) Repair Sleep Apnea Devices (CPAP)

View Karl Leinsing's Consulting Profile.