Expert Details
Physics, Mechanical Engineering, Medical Device Product Development, Blood Collection for Diagnostics & Therapeutics, Patent Litigation Expert Witness
ID: 737227
Pennsylvania, USA
He has particular expertise in mechanical engineering design and development of non-invasive and minimally invasive biomedical diagnostics systems, blood collection and stabilization, blood separation, and blood and cell preparation for diagnostic and therapeutic applications. He also has expertise in developing sample collection devices, including needles and lancets. He is co-inventor on thirteen issued US Patents and ten issued European patents for devices and methods in blood collection and processing, including lancing devices and blood separation for diagnostic testing.
Expert is also co-Founder and Chief Operating Officer of a startup biotech company, developing novel patented immunomagnetic blood cell separation technology with diagnostic and cell therapy manufacturing applications.
He received a Bachelor of Arts in Physics and Mathematics from DePauw University, Greencastle, Indiana, and a Masters and Doctor of Philosophy in Physics from Yale University. His doctoral research was in experimental atomic physics, where he gained experience in mechanical, electrical, and software engineering, optical physics, and vacuum engineering developing and maintaining the experimental research apparatus. He conducted postdoctoral research in experimental atomic and laser physics as a Postdoctoral Research Associate in Physics and Assistant Professor of Physics at the University of Virginia. At Lawrence Livermore National Laboratory, he expanded his mechanical and optical engineering expertise by developing x-ray spectroscopic and imaging instruments to measure x-rays emitted from laser-produced high-temperature plasmas.
Expert has 23 years of senior industrial executive experience building new products and new businesses in the healthcare, life sciences, material sciences, medical device, imaging, and diagnostics space. That experience includes leading R&D and product development engineering teams of mechanical, electrical, optical, and software engineers. His industry experience includes an engineering leadership role in 1996 in a company attempting to develop a non-invasive glucose measurement sensor. From 1996 to 2001, he led Engineering and Advanced Technology, including teams of optical, mechanical, electrical, software imaging, and clinical laboratory engineers, developing a noninvasive human complete blood count diagnostic device and diagnostic blood perfusion assessment tool for a medical diagnostic startup company. As a technical manager at Sarnoff Corporation from 2001 – 2004, he led a team developing and licensing a painless, minimally invasive blood glucose monitor. While at Becton Dickinson (“BD”), from 2004 to 2014, he developed and patented blood collection devices for point of care diagnostic testing.
Education
| Year | Degree | Subject | Institution |
|---|---|---|---|
| Year: 1983 | Degree: Ph.D. | Subject: Physics | Institution: Yale University |
| Year: 1976 | Degree: BA | Subject: Physics and Mathematics | Institution: DePauw University |
Work History
| Years | Employer | Title | Department |
|---|---|---|---|
| Years: 2015 to Present | Employer: Undisclosed | Title: Founder & Principal | Department: Consultancy |
Responsibilities:Expert Witness in Biomedical Patent LitigationMedical Devices and Diagnostics R&D, Business, and Product Development Consultant |
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| Years | Employer | Title | Department |
| Years: 2020 to Present | Employer: Undisclosed | Title: Founder & COO | Department: Operations |
Responsibilities:Founder & COO for biotech startup developing greatly improved cell separation / enrichment processes for cell therapy manufacturing, cell-based diagnostics, protein and vaccine manufacturing.• Conducted customer discovery, built business models and case, developed investor presentations, performed due diligence, set up laboratory and operations, conducted proof of feasibility experiments, developed patent strategy. |
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| Years | Employer | Title | Department |
| Years: 2004 to 2014 | Employer: Becton Dickinson | Title: Director, Core Technologies; Advanced Technology Leader; Technology Innovation Leader | Department: R&D |
Responsibilities:• Based on interest and experience in medical device product development, hired at Director level into Preanalytical [Vacutainer] business to bring innovative new product development leadership and vision to legacy business.• Moved into new innovation strategy role; charged with identifying and leading technology and product development of new-to-business concepts to reinvigorate core business. • Responsible for identifying adjacent business opportunities, building compelling business cases, and leading product development in new business spaces. Moved into this role to address critical need to identify higher growth business opportunities for low-single-digit growth business. |
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| Years | Employer | Title | Department |
| Years: 2001 to 2004 | Employer: Sarnoff Corporation | Title: Technical Manager | Department: Healthcare Products |
Responsibilities:Hired to expand commercial medical device and diagnostic product development contract business, and to create patentable internal product development capabilities which could be licensed or spun-out as startup companies. |
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| Years | Employer | Title | Department |
| Years: 1996 to 2001 | Employer: Cytometrics, Inc. | Title: VP | Department: Engineering, Advanced Technology |
Responsibilities:Hired as employee #6 to lead product development and build the product development team for the core noninvasive WBC [whole blood count] application.• Reporting to CEO, led optical, mechanical, electrical, software image analysis, and clinical team, and developed product prototypes. • Led research, development, and clinical testing of 4 generations of prototype video reflectance microscopes for noninvasive blood analysis, resulting in performance improvements and sensor miniaturization, which generated $10M in angel investment for continued development. Asked to lead innovative team developing additional clinical applications for the platform optical imaging instrument in circulation perfusion assessment. • Reporting to CEO, led team of five scientists evaluating technical feasibility of new product concepts, identified new applications of core technology, and assessed competitive technology. • Managed the development of a novel noninvasive technology platform, achieving product introduction 18 months after concept definition. •Led research, medical imaging analysis, and clinical groups, demonstrating clinical efficacy of noninvasive blood analysis and microcirculation imaging instrument, generating $41M in capital for continued development |
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| Years | Employer | Title | Department |
| Years: 1996 to 1996 | Employer: Biocontrol Technology Inc. | Title: Manager | Department: Engineering |
Responsibilities:Hired to lead product development.• Reporting to President, managed 25 electrical, mechanical, optical, and software engineers developing noninvasive glucose sensor utilizing diffuse reflectance near-infrared spectroscopy. • Led cross-functional teams to refocus technical effort, resulting in greater interaction between engineering, research, data analysis, clinical, and manufacturing departments and faster sensor performance improvements |
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| Years | Employer | Title | Department |
| Years: 1993 to 1996 | Employer: Andros, Inc. | Title: Sr. Physicist and Manager, Advanced R&D | Department: Engineering |
Responsibilities:Hired to expand development of new anesthetic and respiratory gas analyzers.• Reporting to VP Engineering, managed development of nondispersive infrared [NDIR] absorption anesthetic and respiratory gas analyzers, resulting in new OEM agreements with medical patient monitoring companies. • Assessed and tested biomedical and automotive sensor technologies, including low cost gas analyzer based on quenching of fluorescent radiation excited by blue LEDs, and portable gas analyzer based on solid-state IR sources and nonimaging IR optics. |
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| Years | Employer | Title | Department |
| Years: 1991 to 1993 | Employer: Measurex Corporation | Title: Staff Physicist | Department: Sensor Engineering |
Responsibilities:Hired to develop and commercialize new infrared and x-ray sensor technology.• Reporting to Manager of Sensor Engineering, developed, field tested, and released to manufacturing new infrared moisture sensor for paper industry use, requiring fewer calibrations and generating greater customer acceptance. • Researched and led customer acceptance tests of 10 and 30 keV x-ray sensors as thickness monitors, generating new sales in aluminum industry. |
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| Years | Employer | Title | Department |
| Years: 1986 to 1991 | Employer: Lawrence Livermore National Laboratory | Title: Physicist | Department: Physics |
Responsibilities:Hired into the Physics Department to understand and develop rapid laser and x-ray technologies.• Designed and fielded subnanosecond time-resolving crystal x-ray spectrometers to measure temperature and density of laser-produced plasmas, which provided data for modeling and development of x-ray lasers. • Formulated new nuclear test experiment, involving 2-dimensional x-ray imaging. |
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| Years | Employer | Title | Department |
| Years: 1983 to 1986 | Employer: University of Virginia | Title: Assistant Professor of Physics and Research Associate in Physics | Department: Physics |
Responsibilities:• Reporting to Prof. Daniel Larson, mentored seven graduate students, resulting in 6 peer-reviewed publications.• Designed and executed precision measurements in high field nuclear magnetic resonance spectroscopy of laser optically pumped atomic rubidium and laser photodetachment studies of atomic negative ions confined in Penning trap, discovering new effects. • Taught undergraduate introductory physics laboratory course. |
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Career Accomplishments
| Associations / Societies |
|---|
| Member, American Association for Clinical Chemistry (AACC) Member, American Chemical Society (ACS) |
| Awards / Recognition |
|---|
| Cytometrics Founders’ Award, “for outstanding contributions to the furtherance of Cytometrics’ mission.” Elected to Phi Beta Kappa, with 4.0 GPA |
| Publications and Patents Summary |
|---|
| Expert is co-inventor on 13 issued US Patents and ten issued European patents for devices and methods in the area of blood collection and processing including lancing devices and blood separation for diagnostic testing. Publications: 10 Conference Organizer: 2 Conference Proceedings: 2 |
Additional Experience
| Expert Witness Experience |
|---|
| Expert has testified as an expert in the following case(s) during the previous four years: • Deposition testimony: In the Matter of Certain Blood Separation and Cell Separation Devices, • Deposition testimony: Patent infringement complaint, re: declaration supporting defendant’s responsive claim construction brief More detail on previous and current cases: • Served (2019) as Expert Witness for the respondent in a successfully concluded Section 337 investigation before the US International Trade Commission. Provided expert opinion for the respondent on the infringement, validity, and enforceability of the complainant’s US patent in blood collection and preparation for therapy. Prepared and submitted two declarations for the Markman hearing, including my declaration supporting claims construction, and a rebuttal declaration. Prepared and submitted Expert Witness Report and a rebuttal expert report. Was deposed for 8 hours by the complainant’s counsel and 1 hour by the Investigative Attorney for the Office of Unfair Import Investigations. Prepared and submitted Expert Witness Statement and rebuttal witness statement. One week before the scheduled ITC Hearing, in part because of the strength of his declarations and statements, the complainant withdrew the complaint and filed a motion to stay the hearing. • Was retained (2020) as Expert Witness for the defendant in a patent dispute before the USDC in Delaware, involving four patents in the area of blood collection and processing. Reviewed drafts of the Petition for IPR, involving two of the four patents, informing the defendant’s counsel that Expert believed the arguments presented in the draft IPR Petition were not strong. Was not asked to prepare an IPR Expert Declaration, nor did he review the final IPR Petition. Expert has not been asked to prepare other expert witness documents. • Was retained (2020) as Expert Witness for the defendant in a patent infringement case before USDC in Delaware, involving two patents in the area of medical diagnostic testing fluidic systems and methods of sample processing, and point-of-care diagnostic fluidic systems and uses. Reviewed prior art, and on June 29, 2020, the plaintiff dismissed their suit. • Currently (2021) retained as Expert Witness for the defendant in a patent infringement case involving two patents in the area of preparing blood samples for analysis of circulating nucleic acids using chemical agents that inhibit blood cell lysis. Prepared a declaration supporting defendant’s responsive claim construction brief, and was deposed by plaintiff regarding the declaration. • Currently (2021) retained as Expert Consultant for counsel developing patent litigation strategy for a client in glucose monitoring space, assisting in the preparation of five (5) IPR Petitions. In summary: Number of IP matters supported – 5 Number of IPR matters supported – 6 Number of depositions in IP matters – 2 Number of testimonies in IP matters – 0 Expert confirms that he has never had a Daubert motion filed against him. |
Fields of Expertise
biomedical product development, medical device product development, medical device market research, biomedical device engineering, medical diagnostics, biomedical diagnostic instrumentation, blood assay diagnostic instrumentation, in vitro diagnostics, blood collection tube, blood analysis, blood fractionation, blood separation, laboratory blood analyzer, blood sampling, blood testing, biomechanical engineering, biomedical device, biomedical engineering, biological cell separation, blood cell, cell lysis, technology scouting, optical device, biomedical imaging, microscopy, noninvasive diagnosis, noninvasive glucose sensor, blood capillary