Ph.D. Physics-Medical Product Development Problem Solving and Strategic Expert

Expertise

• Accomplished senior research and development leader, Ph.D. in physics, executing extensive experience in new product development, and focus in optical and medical devices and diagnostics.
• Targeting customer needs, assessing new technologies, and developing innovative business and technology opportunities. With both Fortune 500 and entrepreneurial, and startup company experience, bringing dynamic leadership and technical expertise to instrument business opportunity, technology assessment, and development.
• Expedite key technical leadership for preanalytical systems research and development, and strategic innovation efforts in adjacent market spaces, responsible for developing and executing business plans and technology strategies, generating $2 million internal investment for technology development in microfluidics applications. Identify and engage academic and commercial thought leaders and customers to provide product concept feedback, and manage external technology consultants.
• Spearheaded Preanalytical Systems “deep dive” technology assessment of blood fractionation technologies, providing an understanding of new separation technologies critical to next generation blood diagnostics.
• Managed invasive blood glucose monitor product development effort, spinning out a medical device startup company.
• Lead engineering and advanced technology functions for medical imaging startup, (Cytometrics), creating multiple generations of prototype miniature optical microscopes, and meeting milestones generating $51 million in angel investment for product development and commercialization.
• Develop and lead engineering efforts in, near- and mid-infrared spectroscopy instruments for medical diagnostics and process control; and in developing laser spectroscopy and x-ray spectroscopy methods.
• Develop IR absorption moisture sensor in the process control sensors and instrumentation for the pulp and paper, plastics industries, developing and commercializing new infrared and x-ray sensor technology.
• Focus on physical and life sciences technologies, deploy experts in these domains.

Services

• New product development (research): Panning, raising capital for, building, and leading internal and external research and product development programs to implement innovative product concepts-managing all activities.
• Assessments: In technology and strategic: Internal and external new, existing, and competing technologies to meet new product requirements, new business opportunities, and new concept development.
• Intellectual property: Development and valuation, defining intellectual property strategy, and implementing a major IP portfolio in start-up new technology company to increase company valuation.
• Strategic innovative efforts: Creating and building business and technology cases for new opportunities,

Expert Witness 

• Expert Witness for the respondent in a successfully concluded Section 337 investigation before the U.S. International Trade Commission, providing expert opinion for the respondent on the infringement, validity, and enforceability of the complainant's U.S. patent, in blood collection and preparation for therapy.
• Deposition testimony: In the Matter of Certain Blood Separation and Cell Separation Devices, U.S. International Trade Commission.
• 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.
• 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.
• Expert Witness for the defendant in a patent infringement case before USDC in Western District of Texas, involving two patents in the area of preparing blood samples for analysis of circulating nucleic acids using chemical agents that inhibit blood cell lysis.

Experience

RBL, Founder & Chief Operating Officer, 2020 - Present

• The creation of this company with its purpose to develop greatly improved cell separation, and enrichment materials for cell therapy manufacturing, cell-based diagnostics, protein, and vaccine manufacturing.

RSL, Proprietor, 2015 - Present

• Founder and Principal - Expert Witness in Patent Litigation, (Medical Device Business and Product Development Consultant).
• Expert Witness for a patent litigation case involving blood collection, blood separation, and blood sample preparation for clinical diagnostics, cell and platelet therapy.
• Medical device product development: Provide technical due diligence and develop solutions for blood collection platforms.
• Strategic Innovation: For Fortune 100 Healthcare Provider, delivered Point-of-Care-Testing Growth Opportunity Assessment and Emerging Technology Landscape, with actionable targets.
• Lean Startup Coach within program management office of Fortune 1000 data analytics company, developing repeatable lean startup process around customer discovery and validation, training materials for workshops.
• Mentored early-stage companies, building business models, plans, and funding presentations, leveraging lean startup, Business Model Canvas, and national NSF I-Corps business development methodologies.
• SphereVis CEO: Set up operations, built business models, developed investor presentations, performed due diligence, led licensing negotiations, for University of Pennsylvania life sciences startup developing super-resolution fluorescent optical microscopy for cell analysis.

Becton Dickinson, Franklin Lakes, NJ, 2004 - 2014

Leader, Technology Innovation, Research and Development, 2010 - 2014

• Responsible for identifying adjacent business opportunities, building compelling business cases, and leading product development in new business spaces for this global medical technology company with products in drug delivery, life sciences tools, and disease management in diabetes, women's health and cancer, and infection control.
• Addressed critical needs to identify higher growth business opportunities for low-single-digit growth businesses.
• Developed and executed two adjacent market business plans and technology strategies, achieving $2 million internal investment for medical device technology development, in (1) Tissue collection and preservation for improved cancer diagnostics; and (2) Point of care blood collection and diagnostic testing, managing consultants and partnerships in microfluidics technologies.
• Led product development of first tissue collection product to manufacturing release.

Technology Leader, Advanced Technology, Research, and Development, 2006 - 2010

• Moved into new innovation strategy role; charged with identifying and leading technology and product development of new-to-business concepts to reinvigorate the core business.
• Developed business unit technology and innovation strategy.
• Developed and streamlined technology scouting, due diligence, and innovation processes for new medical devices.
• Completed "deep dive" technology assessment and development of blood fractionation technologies.

Director, Core Technologies, Research and Development, 2004 - 2006

• Medical device product development, based on interest and experience, hired at Director level into preanalytical (Vacutainer) business at BD, to bring innovative new product development leadership and vision to legacy business.
• Built team key technical capabilities to support innovation of current and next-generation products.
• Led research and development teams resolving manufacturing problems in core plastic blood collection products, solving plastic materials changes, material coatings changes, manufacturing process changes.
• Led business unit research and development-rollout of technology development stage-gate process, reducing technology risk and saving money in new product development.

Sarnoff Corporation, Princeton, NJ, Principal Investigator, 2001 - 2004

• Sarnoff, (previously RCA Laboratories, now part of SRI) was a contract research laboratory executing both government and commercial research and new product development contracts in hardware, software, image analysis, and market analysis.
• Deployed to expand Sarnoff's 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.

Technical Manager, Healthcare Products, 2001 - 2004

• Product development program manager, directed 12-member multidisciplinary group, creating patented painless minimally invasive blood glucose monitor; achieved successful spinout as medical device startup. Managed an 8-month, $2 million budget.
• As Co-Principal Investigator, prepared successful Department of Homeland Security research grant funding instrumentation development for rapid detection of airborne biological weapons, based on electrostatic particle collection and Raman spectroscopy detection.

Cytometrics, Inc., Philadelphia, PA, 1996 - 2001

• Medical imaging and diagnostic startup commercializing a platform miniature optical reflectance microscope for human in vivo assessment of circulation perfusion and noninvasive measurement of whole blood count parameters, using hemoglobin optical absorption spectroscopy.

Vice President, Advanced Technology, 1998 - 2001

• Invited to oversee an innovative team, developing additional clinical applications for the platform optical imaging instrument in circulation perfusion assessment.
• Led research, medical imaging analysis, and clinical groups, demonstrating the efficacy of miniature noninvasive blood analysis and microcirculation reflectance imaging microscope, using hemoglobin optical absorption spectroscopy, generating $41 million of capital.
• Managed the development of technology platform, achieving product introduction 18 months after concept definition; honored with Cytometrics Founders' Award.

Vice President, Engineering, 1996 - 1998

• Hired to lead product development and build the product development team for the core noninvasive WBC (whole blood count) application.
• Led Research and Development departments: optical, mechanical, electrical, software image analysis, and clinical team - developing 4 generations of instrument prototypes for blood analysis, resulting in $10 million investment.

Biocontrol Technology Inc., Indiana, PA Product Development Lead & Engineering Manager, 1996

• Biocontrol Technology was an established medical device company developing noninvasive glucose measurements based on near-infrared skin reflectance spectroscopy.
• Hired to lead product development and Manager, Engineering.
• Reporting to President, managed 25 electrical, mechanical, optical, and software engineers developing noninvasive glucose sensors utilizing diffuse reflectance near-infrared spectroscopy.

Andros, Inc., Berkeley, CA 1993-1996

• Expanded development of new anesthetic and respiratory gas analyzers of this OEM supplier of gas analysis instruments based on infrared absorption spectroscopy to the automotive and medical device markets.

Senior Physicist and Manager, Advanced Research and Development, 1993 - 1996

• Managed development of non-dispersive infrared [NDIR] absorption gas instrumentation.
• Assessed biomedical sensor technologies, oxygen gas analyzer using quenching of fluorescence.

Measurex Corporation, Cupertino, CA, 1991 - 1993

• Fulfilled the Staff Physicist role for this company that provided process control sensors and instrumentation for the pulp and paper, and plastics industries.
• Responsible for developing and commercializing new infrared and x-ray sensor technology.
• Developed, field-tested, and released to manufacturing new IR absorption 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 the aluminum industry.

Lawrence Livermore National Laboratory, Livermore, CA, 1986 - 1991

• As Physicist for the Department of Energy national lab dedicated to research and development of energy, weapons, laser, defense, and biological technologies, and tasked by 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.
• Formulated a new nuclear test experiment, involving 2-dimensional x-ray imaging.

University of Virginia, Charlottesville, VA, 1983 - 1986

Assistant Professor of Physics and Research Associate in Physics

• 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-excited atoms and laser photodetachment studies of atomic negative ions, discovering new effects.

Honors & Publications

Academic and Professional Affiliations

• Member, American Association for Clinical Chemistry (AACC)
• Member, American Chemical Society (ACS)

Awards

• Outstanding contributions to the furtherance of Cytometrics’ mission
• Elected to Phi Beta Kappa, with 4.0 GPA

Publications 

Author and Co-Author of over a dozen articles, peer-reviewed journals, and educational text in the subjects

• Spin-Exchange Effects- Elastic and ionizing collisions
• Elastic and ionizing collisions
• Scattering electron polarimetry
• Resolved Zeeman Thresholds in Photodetachment
• Strong Laser Field - Threshold Shift

Workshops and Speaker

• NIST Cross-Industry Issues in Nanomanufacturing. Workshop Organizer, Plenary Speaker, and Report Co-author; Organized and chaired session - "Surfaces, Interfaces, and Non-bonded Interactions of Nanomaterials." Plenary Speaker - "Pharmaceuticals and Medical Devices”

Patents

Inventor-Co-Inventor of 15 patents in the areas of:

• Biological Fluid Collection Device-Testing
• Blood sampling transfer device
• Biological fluid sampling system
• Lancet Device with First-Drop

Education

• Ph.D. Physics, Yale University, New Haven, CT
• M. Phil. Physics, Yale University, New Haven, CT
• B.A. Physics and Mathematics, DePauw University, Greencastle, IN