Products Engineering Expert Witnesses: 7

Gary D. Fletcher, PhD,  is the Founder and Principal Consultant at RnDDx Solutions LLC, a consulting firm founded in 2015, focused on Industrial Mechanical Engineering and Biomedical Engineering and Research and Product Development.  In his 30 years of experience, he has been co-inventor on 23 patents for devices and methods in blood collection and processing.

Litigation Support - Dr. Fletcher has subject matter expertise in Medical Device Mechanical Engineering and subject matter expertise in Medical Devices for Blood Collection and Blood Sample processing for diagnostics and therapeutics. He serves as an expert witness in patent infringement cases involving medical device and diagnostic biomedical engineering, blood collection, separation, fluidic preparation, and cell therapy preparation devices.

Dr. Fletcher offers patent litigation services to law firms and lawyers supporting medical device and diagnostic industry clients, who need physical science and mechanical and biomedical engineering expertise for District Court, PTAB, and International Trade Commision patent cases. As an industry consultant, his ideal clients are R&D, product development, and innovation leaders in startup, emerging, and established medical device and diagnostic companies, who face product development and competitive challenges.

Areas of Expertise:

Dr. Fletcher is an entrepreneurial executive with expanding R&D roles in business, technology, and new product development leadership and execution, building and guiding teams in both Fortune 500 and startup companies. With a PhD in physics from Yale, he has a proven record of leadership in creating innovative new businesses and products in healthcare, medical devices, diagnostics, life, materials, and optical sciences.

Randal Hill, PhD, has more than 40 years of experience practicing Materials Science and Chemistry. Dr. Hill is a distinguished product innovator credited with 59 patents. He is an involved member of multiple organizations, including American Chemical Society, Society of Petroleum Engineers, American Physical Society, and the American Oil Chemists Society.

Litigation Support - Dr. Hill is a well-respected chemical engineer who provides a scientist’s thorough understanding of diverse technology about chemistry, chemical engineering, and patenting. He offers services to attorneys representing plaintiff and defense. Dr. Hill breaks down complex, technical ideas into simple concepts, communicating industry-specific terminologies to judges, juries, and to those who belong to other fields of expertise. 

Areas of Expertise:

Background Experience - Dr. Hill began his career at a major detergent company followed by a company 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.

Timothy P. Harrigan, ScD, MBA, PE, is a Mechanics / Biomechanics and Modelling and Simulation Engineer with over 35 years of experience. He has spent 15 years in Orthopedic departments and the rest of his career in Biomedical Engineering. Dr. Harrigan has done accident reconstruction through analytical and computational models, and extensively used FEA, CFD and, Fluid-structure models.

Litigation Support - Dr. Harrigan has strong analytical skills and qualifications for both the biomechanical issues and the interacting mechanical and electrical environments. He works on both Design and Manufacturing Defects in Medical Devices, including total joint replacements, IV tubing, insulin pumps, IV fertilization, and heart valves. With 3 US Patents, and having passed the patent bar, Dr. Harrigan works effectively with IP professionals on expert reports Injury Biomechanics and Intellectual Property. 

Dr. Harrigan investigates injury and accident scenes to gather relevant data and develop quantitative models for impact injury, blast effects, vehicle collisions, industrial accidents, and premises injury. He develops situation models, accident scene models and device models, and evaluates the strengths and weaknesses of inferences from those working models. He's been Daubert/Robinson challenged but never excluded.

Selected Cases - August 2009 to Present:

• Investigated and testified on biomechanics in consumer product liability suit based on Chinese-made inflatable pool slide; won $20M verdict in Massachusetts. (Aleo v Toys-R-Us)
• Investigated and testified on biomechanics in consumer product liability suit based on Chinese-made inflatable pool slide; won $4M verdict in Missouri. (Grantham v Wal-mart)
• Investigated and testified on biomechanical factors in injury, including product, premises, and transportation litigation
• Provided expert testimony, developed finite element models, and made pressure measurements on bicycle seats in support of $3+M patent infringement claims in the U.S., Italy, and China
• Provided court testimony, deposition testimony, and reports in Patent infringement and validity actions including Inter-partes reviews. (IPR)

Certifications:

• Registered Professional Engineer, State of Texas #86769
• Registered Patent Agent, US Patent and Trademark Office, Registration #51,784

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:

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.

Rolf Biernath, PhD, 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 57 issued 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 a 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:

Background Experience - Dr. Biernath has 57 Issued US Patents on New Products, including:

• Industrial Adhesives and Tapes – 3D printing materials development, automation, and tape application processes
• Electronic Materials – epoxy thermoset adhesives & application process (elastomeric epoxy), high speed electronic connectors
• Electronic Displays – optical display films, outdoor digital displays
• Microreplication – textured adhesives and processes, microfluidics, e-Paper
• Signage – retroreflective signage, license plate recognition, ADAS, 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. Doctorate in Chemical Engineering focused on stresses in bonded planar layers, stress measurement, physical property modeling and stress modeling due to thermal, cure, solvent and other causes.

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 34 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. 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:

View Karl Leinsing's Consulting Profile.

David Smith is an experienced mechanical engineer (MS, PE) with seven issued patents. Award-winning inventor. Vice President of Alpine Engineering and Design, a mechanical engineering consulting company with clients around the United States ranging from individual inventors to Fortune 500 companies. Worked on the development of multiple successful products including among other things: aerial lifts, garbage trucks, thrill rides, ziplines, trailers, oil and gas equipment, exercise equipment, manufacturing equipment, and multiple consumer products. 

Graduated Cum Laude with a bachelor's degree in mechanical engineering. Completed a master's of science degree in mechanical engineering and an MBA with an emphasis in product development. Licensed professional engineer (PE) and certified safety professional in comprehensive practice (CSP). Certified trainer for boom lifts, scissor lifts, rough terrain, and counterbalanced forklifts. Over 10 years of experience in product development, patents, equipment safety, and risk assessments. 

Experienced expert witness having drafted over 200 reports/declarations in patent cases and catastrophic injury and death cases. Designed and built multiple custom testing devices to obtain data and evaluate opinions. Created multiple demonstratives to explain the mechanics and circumstances of accident sequences and patented devices. Testified in deposition 11 times and in trial once.