1. ROBERT P. STATHOPULOS “Moving a ‘first product’ out of the engineering laboratory and onto
the production floor is an obstacle course that requires expertise in
434 Liberty Street, Boonton, NJ 07005-1542 good product and process development that satisfies customer needs,
Cell: 973.214.7009 E-Mail: rstat@optonline.net manufacturer profitability and regulatory compliance”
R&D/OPERATIONS CONSULTANT/CONTRACT MANAGER – MEDICAL DEVICE/COMBINATION PRODUCTS
Product Development Expert focused in two business arenas –
 Assist CEO of early-stage medical technology  Assist President of established medical device
venture to move ‘first product’ from development manufacturer to improve return-on-investment for
to production product development
Skills set includes design, development and manufacture of medical devices and combination products. Provides
practical application of design controls and design validation, process controls and process validation, and purchasing
controls and supplier validation.
On-site consulting to early-stage ventures for over 15 years. Clients have included SNS Venture (Johnson & Johnson
Development Corporation), NuPathe, Vyteris, Vasomedical, Inviro Medical, Retractable Technologies, FiberOptic
Sensor Technologies, and Ryan Medical. Held corporate positions at Johnson & Johnson, Davis & Geck, Bard-Parker
and Becton Dickinson as Director of Product Development, Manufacturing Development and Business Development.
Assumed technical responsibility for Becton-Dickinson hypodermic needles, Bard-Parker surgical blades, and Johnson
& Johnson neurosurgery products.
CAREER HIGHLIGHTS
Director, Research & Development / Director, Business Development for $50M division of Becton Dickinson
Director, Manufacturing Development for $250M division of American Cyanamid Company (Davis & Geck)
Director, Product Development for $125M subsidiary of Johnson & Johnson (Codman & Shurtleff)
Director, Strategic Manufacturing, Vyteris, Inc.
Start-Up Executive / Management Consultant, Product Development Technology, Inc.
NOTABLE SUCCESSES
 Developed comprehensive cost reduction strategy for neurostimulation patch to reduce manufacturing cost by 90%
with product design optimization and assembly process automation. (SNS Venture)
 Redesigned feasibility drug-device patch, developed prototyping process and produced hundreds of engineering
and clinical prototypes. (NuPathe)
 Selected contract manufacturer for drug-device patch, conducted design transfer and designed unique package for
point-of-use assembly. (NuPathe)
 Developed cost reduction program for drug-device patch to reduce manufacturing cost by 35% across supply chain
of two-dozen suppliers with internal final assembly operation. (Vyteris)
 Redesigned manual assembly operation for second generation capital equipment, with optimized receiving,
inventory and shipping workflow, across three separate buildings. (Vasomedical)
 Recruited and led design and development team to redesign product molds and modify automated assembly
machine to build safety syringe products. (Inviro Medical)
 Wrote over 200 product design, manufacturing and quality specifications for safety syringe product line and
assisted in production equipment selection and production facility design. (Retractable Technologies)
 Headed R&D to complete product development, and headed Operations to startup production, of fiber optic
catheter and monitor marketed by C.R. Bard. (FiberOptic Sensor Technologies)
EDUCATION AND BOARD AFFILIATIONS
M.S. Bio-Engineering, Polytechnic Institute of New York; B.E. in Mechanical Engineering, City College of CUNY
Founding Board Member, Retractable Technologies, Inc.; Advisor, New Jersey Angels Network