medical device expert witness and consulting


Dr. John I. Izuchukwu, PhD, MBA, PE

Dr. Izuchukwu is CEO and founder. His industry career spans  over 20 years in the medical device and electronics industries, with contributions exemplified in the numerous products that were developed under his leadership, which today are improving the quality of healthcare, in hospitals, sub-acute and alternate care settings. His industry experience includes positions as senior director, global R&D and Engineering for Nellcor Puritan Bennett, a  Mallinckrodt/Tyco Company, now Covidien/Medtronic Company, and R&D team leader for Ethicon Endo-Surgery, a Johnson & Johnson (J&J) Company. 

At Nellcor, he led the development of many products for diagnosis and treatment of respiratory disorders, including spirometers for pulmonary function testing, oxygen delivery devices for patients suffering from chronic obstructive pulmonary disease (COPD),  and portable ventilators for treatment of sleep related disorders. They include Aeris590 oxygen concentrator, OxiClip (an oxygen conserving device), high-pressure gas tank regulators, High Efficiency Liquid Oxygen Systems (HELiOS) and telemonitoring devices for same, Continuous Positive Airway Pressure (CPAP) ventilators, Biphasic Positive Airway Pressure (BIPAP) ventilators for treatment of obstructive sleep apnea, aerosol devices for delivery of bronchodilators, spirometers and flow sensors for lung function testing.    

At J&J he led design and development of laparoscopic and endoscopic devices for general, gynecologic and thoracic surgery, including surgical staplers, graspers, dissectors, biopsy forceps, surgical knives and suction-irrigation devices. For medical inventions he has been awarded 19 utility patents.  

A registered professional engineer, he earned BS and MS degrees in industrial and mechanical engineering, from the University of Portland, a Ph.D. in Industrial and Mechanical Engineering from Northeastern University, a MBA from the Kellogg School of Management, Northwestern University, certificates in product development and European regulatory requirements for product safety and testing, respectively from Harvard Business School and TUV Rheinland NA.    

He served on the board of Ranken Jordan Pediatric Hospital in Saint Louis, and was an adjunct professor of engineering at Missouri University of Science and Technology. He is a recipient of the Albert Nelson Marquis Lifetime Achievement Award. Among his biographical citations, he is listed in Marquis Who’s Who in Science and Engineering, Who’s Who in the World, Who’s Who in America, and 2000 Outstanding Scientists of the 20th Century by International Biographical Center Cambridge, England.    

Product Liability Cases  

He has been an expert witness for attorneys representing plaintiffs as well as defendants on many cases that were successfully litigated or settled. In each occasion he was retained to evaluate the device alleged to be the cause of injury or death and give his professional opinion. His contributions to root cause analysis from an engineering point of view, experience, education and training helped the attorney to prosecute or defend the cases.

Patent Infringement Cases 

Drawing from training and decades of experience developing medical devices, insight into what is novel and non-obvious, he serves as an expert on patent infringement cases for attorneys representing plaintiffs as well as defendants. As one skilled in the art he assists with claim interpretation and construction (to establish the meaning of words for Markman Hearings) and writing of expert declarations in support of patent validity (infringement) or invalidity (non-infringement) contentions.       

Mark Comunale, MD

medical device consultants Dr. Mark Comunale is our Chief Scientific Officer.  He was formerly the chairman of the Department of Anesthesiology at Saint Louis University Medical School. He is currently chairman of the Anesthesiology Department and Assistant Medical Director at Arrowhead Regional Medical Center in Colton, California. He is President and CEO of Inland Empire Anesthesia Medical Group. His clinical experience includes fellowship in Anesthesia at Harvard Medical School; Associate Professor of Anesthesiology at Harvard Medical School, Professor of Anesthesiology, Saint Louis University Medical School, and hospital appointments at Beth Israel Hospital Boston, Beth Israel Deaconess Medical Center Boston and Saint Louis University Hospital (SLU Care). Past administrative positions include: Director, Cardiac Anesthesia Residency and Fellowship, and Associate Anesthetist-in-Chief, Department of Anesthesia and Critical Care, Beth Israel Deaconess Medical Center. Dr. Comunale has served on multiple boards, including Ischemia Research Institute, and Beth Israel Anesthesia Foundation. He has 15 years experience in the medical device industry, involving product development and product safety consulting for Hewlett-Packard Medical Systems Inc. and Agilent-Phillips Inc, for physiologic monitoring devices; Transfusion Technology Inc. and Belmont Instrument Inc. for rapid infusion and warming devices; Extant Systems Inc. for medical information software, Omincell Inc., for pharmaceutical devices and ITI Technology Inc. for minimally invasive surgery components. He earned an undergraduate degree in Biology at Boston University and Doctor of Medicine degree at Tufts University School of Medicine.

As one of the top consulting firms, our team is comprised of engineers and scientists, providing consulting and medical device expert witness services to clients, consisting of product development companies and law firms, on product liability and patent infringement cases. Comprised of top medical device experts and consultants, we provide consulting on a range of medical devices, including portable oxygen tanks, oxygen concentrators, and cpap ventilators.

Brian Seppa, CPA

Mr. Brian Seppa serves as Chief Financial Officer. He brings to the team more than fifteen years of broad experience in finance and accounting, administration and management. This includes six years experience with Securities and Exchange Commission (SEC) reporting for a $700 million publicly funded consumer products corporation; recapitalizations of privately held corporations through public bond offering, debt offering and new credit facility. He has worked for small to mid-sized privately held corporations.  Mr. Seppa was a CPA with KPMG Peat Marwick, “a Big Four” accounting company. His most recent experience is Chief Financial Officer for Euro-Pro Operating LLC, a $240 million consumer products distributor; with full responsibility for strategic planning, development and leadership of the corporate finance organization. He directed financial planning and analysis, accounting, tax, treasury, budgeting and administrative functions. Prior to this he was Corporate Controller for the Holmes Group. Mr. Seppa is a Certified Public Accountant, and is a member of the Massachusetts Certified Public Accountants, and AICPA. He received a Bachelor of Science in Accounting from New Hampshire College.

Ron Lasser, PhD

Dr. Ron Lasser is Director of Engineering. He is also a Professor of the Practice in the School of Engineering at TuftsUniversity, where he combines teaching with on-going engineering practice, to bring practical knowledge to the classroom, on how to solve real life engineering problems. As a practicing engineer, he continues to work with companies to bring innovative products to market, to develop strategic business and technology portfolios, and solve technology management problems. Most recently, Dr. Lasser was a Principal at Product Development Consulting, Inc. where he worked with U.S. and international clients on product realization, innovation and technology, product definition, and product portfolio management. He started his career in telecommunications and computers developing Unix and MS DOS-based systems and networks for AT&T Bell Laboratories. He worked at Dupont in their Electronic Prepress business developing scanners, document processing, and color imaging products, and was director of engineering at General Scanning responsible for medical imaging, printing technologies, expanding product lines, and involved with taking the company public. Ron holds Ph.D., MS and BS degrees in mechanical engineering, from Carnegie-MellonUniversity, and has completed executive education in Strategic Marketing Management at the Harvard Business School. He is a member of Sigma Xi, a research society for learning and science, The American Society of Mechanical Engineers (ASME), and The Institute of Electrical and Electronics Engineers (IEEE), and a member of the advisory boards for Hematotypes. 

Douglas Kern, PhD

 Dr. Douglas Kerns is consulting R&D engineer in the areas of micro-electromechanical systems (MEMS), microelectronics, and bioinstrumentation. Dr. Kerns is co-founder of Signetics, a design company specializing in microelectronic design for biomedical applications, and has been an independent contractor on projects involving analog and mix-signal designs for sensor interface and signal processing. He was a senior scientist at Tanner Labs, a division of Tanner Research, a senior analog designer at Analog Devices, and a member of the technical staff at Jet Propulsion Laboratory. He has been a principal investigator on many federally funded SBIR projects. He was a visiting associate in Engineering at California Institute of Technology. He earned a Bachelor of Science in electrical engineering from Northwestern University, and the Master of Science and Ph.D. degrees in electrical engineering from California Institute of Technology. 

Product Development

Inov8Design, a Boston based design services firm provides design services to Core Devices, in the areas of ergonomic, structural, and mechanical developments.  Inov8 is headed by Joel Lieblein, a veteran of 32 years of technology product development and manufacturing with a portfolio including more than 200 technology products brought to market.  They include spirometry devices designed for Puritan Bennett and Mallinckrodt, sensors and transmitters designed for Mettler Toledo, an Intra-aortic balloon pump (IABP) for Arrow International, lens manufacturing equipment for Gerber Scientific, a family of materials testing systems for Instron, power connectors for American Power Conversion, structural housings for Reveal Imaging, sterile device packaging for St. Jude, and vacuum test devices for Varian. Inov8 Design is a collaboration of two partners, Joel Lieblein and Daniel Jones.  Collectively, they bring more than seven decades of creative product development to each program.  

Inov8 specializes in chassis and enclosure development, ergonomics, and manufacturability.  Capabilities include mechanical engineering, electronic design, and embedded systems software.Joel has a diverse technical background well suited to the world of medical device development, emphasizing efficient use of materials, shielding, cooling, and fabrication processes.  His initial work was with Bally Design in Pittsburgh.  In 1977 he became VP of Industrial Design at Gunn Associates in Boston.  In 2002 he co-founded Inov8 Design where he continues to provide vision and strategic guidance.  Joel received a BFA in Industrial Design from Carnegie Mellon University in 1977.  Joel holds five US patents. Daniel is a co-founder of Inov8 Design and serves as Business Development Manager.  His initial work was with Electric Boat on the Trident Program.  Following stints with Emhart and Thornton he established the Industrial Design group at Prime Computer in 1986, overseeing all aspects of appearance and ergonomics of Prime’s family of proprietary products.  He joined Gunn Associates in 1990 and co-founded Inov8 Design in 2002.  Daniel received an MFA from Smith College in 1977 and was a professor at Dartmouth College before returning to product development.  Daniel holds two US patents