Medical Device Consultant: Endoscopic and Surgical Stapling Devices; Oxygen Delivery Systems, Sleep Apnea and CPAP Devices

Expertise

Medical Devices

• Medical device product and process development.
• Design and development of respiratory devices.
• Medical device injury analysis.
• Medical device product failure analysis.
• Diagnostic, monitoring, sedative and therapeutic drug delivery devices.
• Laparoscopic and endoscopic surgical devices.
• Surgical stapling devices and skin stapling devices.
• Oxygen concentrators.
• Oxygen conserving devices.
• Sleep Apnea therapy devices, (CPAP, BPAP devices).
• Spirometry, spirometers and flow sensors.
• Compressed medical gas storage and delivery.
• Design and development of respiratory devices.
• Manufacturing and assembly of medical devices.
• Portable ventilators for respiratory therapy.
• Anesthesia machines.
• Spirometry, spirometers and flow sensors.
• Compressed medical gas storage and delivery.

Regulatory

• Medical device design verification and validation.
• 510k medical device registration.
• ISO 9000 / ISO 9001 / ISO 13485.
• Regulatory approval process for Class I and Class II medical devices.
• ISO 1345 and FDA Medical Device Quality System Regulations (QSR) - 21 CFR Part 820.
• Medical device quality system review and Gap analysis.
• Medical Device Risk Management - ISO 14971.
• ISO 9000 and ISO 9001 Quality Management System (QMS) Requirements.

Functional Expertise and Services

• Patent infringement and invalidity analysis.
• Failure mode effect and criticality analysis.
• Incident investigation and root cause analysis.
• Forensic engineering; forensics investigation support.
• Quality function deployment.
• Reliability engineering.
• Statistical quality control.
• Design for manufacturing and assembly.
• Manufacturing process planning.
• New product and process development.

Legal Services

• Intellectual Property Expert (Patent Infringement and Invalidity Contentions)
• Legal Forensics
• Product Liability Expert
• Medical Device Expert (Medical device defect and failure analysis).

Experience

Undisclosed Company, President and CEO, 2001 - Present

• Founder of this biomedical research and development company with primary focus on surgical procedures and products.
• Establish vision and direction, lead funding efforts, appointed board members, recruited management team, developed business, strategic and operational plans, conducted market research, defined target markets and competitive strategies.
• Lead research and development activities, providing technical direction for new product development and process.
• Develop research and development strategy that leverages academia for basic research and design firms and original equipment manufacturers for system and component level design in a way that reduces product development cycle time and cost.
• Invent and secure patents for an oxygen conserving device, a conformal oxygen system for persons with respiratory disability, and a backpack-able field anesthesia machine for surgical care on battlefields, disaster locations and rural hospital settings.
• Validate market needs through target customers, scientific presentations and independent research.
• Awarded grants by the National Institutes of Health (NIH) for proof of concept and prototype development of an ambulatory oxygen device and a portable anesthesia machine.
• Provide design services to attorneys on patent litigation, medical device failure analysis liability and product liability investigations.

Nellcor Puritan Bennett, Saint Louis, MO, Sr., Director Global R&D, 1998 - 2001

• Led global engineering, research and development for the Alternate Care business segment in the respiratory business group.
• Managed product development, sustaining engineering and regulatory activities across sites in the United States, France and Canada with a $20 million R&D budget.
• Built research and development from scratch to over 100 engineers and scientists, equipped with standardized design tools, laboratories and test engineering facilities.
• Established a common product development process to accelerate screening, adoption, development and commercialization of inventions.
• Development and career plans for managerial and individual contributors.
• Unified cross-functional teams with a common product development process, performance metric and reward system.
• Developed diagnostic and therapeutic devices for respiratory care, including chronic obstructive pulmonary disease (COPD) and sleep apnea disorder.
• Brought to market more than a dozen new products, contributing over $200 million in revenue and average of 50% gross margin. This includes the Renaissance II spirometer for diagnosis of respiratory disorder, Puritan Bennett OxiClip (an oxygen conserving device), Aeris 590 oxygen concentrator, HeLIOS (high efficiency liquid oxygen system), GK418, GK420CPAP devices for treatment of sleep apnea, KS330 and KS325 bi-level ventilator for respiratory support. These products are helping to advance patient care in acute, sub-acute and alternate care settings.
• Established a global advisory board of thought leaders in medicine, to provide clinical guidance to research and development advances into emerging market areas.

Ethicon Endo-Surgery, Inc., (A Johnson & Johnson, Co.), Blue Ash, OH, 1994 - 1998

• Team Leader of research and development in endo-mechanical devices.
• Led research and development for a $200 million business unit focused on endoscopic surgical devices.
• Led parallel projects and cross-functional teams of design, manufacturing, reliability and quality engineers, marketing, regulatory and clinical personnel, to develop, test, validate and bring to market a family of hand held instruments for general, gynecologic and thoracic surgery, including skin staplers, graspers, dissectors, and scissors in accordance with FDA/GMP guidelines.
• Translated customer needs into key product attributes and technical specifications using QFD and conjoint techniques, resulting in positive customer ratings and 100% new product success rate. Introduced a platform strategy that emphasizes interchangeable parts, to consolidate suppliers, reduce material cost by $1.6 million and cycle time by 12 months.
• Prosecuted and received three surgical skin stapler patents.
• Relocated assembly from Peterboro, Canada to Juarez Mexico - reducing labor cost by $1.2 million.
• Earned Johnson & Johnson Achievement Award for design quality assurance on the Proximate-Plus-MD family of skin stapler projects.
• Received Ethicon-Endo Surgery Innovation Award for contributions to patent estate.

Digital Equipment Corporation, Engineering Systems Group, Marlboro, MA, 1983 - 1994

Worldwide Strategy Manager and Product Development Manager

• Led worldwide product development strategy for a $400 million business unit.
• Managed strategic joint ventures for engineering and manufacturing automation technologies targeted at Digital's VAX/VMS and ULTRIX platforms.
• Negotiated technology licensing and strategic agreements to close portfolio gaps, reduce product development cycle-time and cost of goods.
• Established the simultaneous product development process; a unique approach to product development, which establishes operational guidelines for managing products throughout their life cycles.

Manager Aerospace Strategy and Data Integration Products

• Responsible for worldwide Aerospace business strategy and development of industry specific design and manufacturing automation solutions.
• Developed strategy to grow revenue from $500 million to $1.0 billion in five years.
• Developed products for concurrent engineering and legacy CAD/CAM data integration based on IGES and Standard for The Exchange of Product Data (STEP) translators.
• Harmonized strategy with CALS (Computer-Aided Acquisition and Logistics Support) - initiative for digital interchange of technical information among computer systems.
• Represented DEC on the External Research Board investigating and proposing joint ventures.

Manager Manufacturing and Application Center for Technology

• Managed a $20 million consulting practice targeted at Fortune 100 Aerospace and Defense Electronics manufactures.
• Developed and delivered consulting modules on engineering and manufacturing process automation, concurrent engineering, product data management, Computer-Aided Design and Manufacturing (CAD/CAM), Computer-Aided Engineering (CAE), Deming, Juran, Ishikawa, Taguchi, Quality Function Deployment (QFD), Design-for-Manufacturing (DFM), Total Quality Management (TQM) and operations management principles.
• Managed delivery of multi-million dollars process re-engineering projects at Raytheon, Lockheed, GE, Grumman, Allied Signal, Sikorsky, Ford and General Motors.
• Grew revenue by 50% to $30 million during a two year window.

Manager Mechanical Design Automation

• Managed application engineering responsible for mechanical design automation tools, which were optimized to run on Digital's computers, operating systems, and database management systems, including competitive migrations.

Strategic Alliance Mgr, Computer-Aided Software Engineering

• Managed strategic alliances for computer-aided software engineering solutions
• Developed strategic plans, performed portfolio gap analysis and negotiated joint ventures for a family of software design automation tools that fulfilled global customer needs.
• Recruited and migrated Cadre and IDE's SA/SD tools to Digital's platforms.

Tektronix, Test & Measurements Group, Beaverton, OR, Mechanical Design Engineer, 1980 - 1983

• Responsible for mechanical design, simulation, testing and manufacturing process planning.
• Designed adjustable work dispensers and automated assembly systems. Led project on numerical control and distributed intelligence.

Honors & Publications

Academic and Professional Affiliations

Adjunct Professor for the following Universities:

• Missouri University of Science & Technology
• Saint Louis University
• University of Maryland University College
• Fontbonne University
• Babson College
• Framingham State College

Grants

• Oxygen Device for Persons With Respiratory Disability, NIH Grant
• Portable Field Anesthesia Machine, NIH Grant

Credentials

• Registered Professional Engineer
• Certificate New Product Development, Harvard Business School
• Certificate European Medical Device Directives for Product Safety and Testing
• Johnson & Johnson Achievement Award for Design Quality Assurance
• Ethicon Endo-Surgery Innovation Award for Inventions and Invention Disclosures
• UMR Faculty Recognition for contribution to Engineering Education Center
• DEC 100 and DECathalon Awards for impact on revenue growth Memberships

Publications

• Author and co-author of books, chapters to books, journal articles, proceedings, researchers and Inventors citing.
• 19 patents.

Education

• MBA Kellogg School of Management, Northwestern University, Evanston, IL
• Ph.D. Industrial & Mechanical Engineering, Northeastern University, Boston, MA
• M.S. Mechanical Engineering, University of Portland, OR
• B.S. Industrial & Mechanical Engineering, University of Portland, OR