Medical Cutting Devices Expert for Surgical Edges and Medical Device Development

Expertise

• Medical device development and manufacturing implementation.
• Medical device and other product and process development including: Disposable and reusable medical device design, prototype and clinical supplies prototype fabrication and testing, manufacturing systems design and development, manufacturing tooling and fixture design, process piping, equipment installation and validation, sterilization and packaging validation.
• Product and manufacturing process improvement: Design of experiments for system modeling and optimization, multivariate and megavariate analysis for product testing and production data, product tolerance stack-up analysis for manufacturing, finite element analysis for computer-based product modeling.
• Design control systems and documentation: Design history files, design input, design output, design verification and validation, design reviews, design transfer, project planning and risk management.
• Product testing development: Synthetic and animal tissue models for testing, test fixture design, cutting edge sharpness test methods, trocar and needle test methods, needle and knife tip strength testing, in-direct sharpness testing, clinical testing of devices and surgical instruments.
• Product technology: Active motion electro-mechanical elements for surgical instruments, single and two phase (liquid-gas) fluid flows shape memory alloy components, fiber optic illumination and energy delivery.
• Manufacturing process technology: CNC Swiss turn machines, CNC milling machines, CNC grinding, rotary transfer machines, press and stamping operations, tumbling/ finishing operations, ultrasonic cleaning, aqueous wash systems, metal coining and blanking, tungsten inert gas welding, algorithm-based and neural and fuzzy logic system control, plastic component molding, electropolish systems and anodizing.
• Root cause analysis: Cause and effect diagrams, event and causal factor trees, fault tree analysis.
• Cutting and piercing of soft and hard tissue: Wound shape analysis, reduction of force/ trauma during incision creation, cutting edge configuration modifications that promote device performance and wound sealing.
• Alternative design generation: Create alternative designs relative to a target design using TRIZ (The Theory of Inventive Problem Solving) and value engineering, use of semantic language to create function model diagrams of patent claims and claim elements for re-design analysis.

Experience

Independent Consultant, Principal, 2005 - Present

• Provide medical device and engineering technology development consulting services for clients by
• Leveraging a consortium of scientists, engineers and business professionals to help manufacturers improve the client's technology return-on-investment.
• Designed and developed a disposable ophthalmic surgical kit for a client. Created and managed the design history file as well as created design documentation, conducted design reviews, created design verification and validation protocols and conducted testing, created quality plans, incoming inspection procedures, other production documentation and created the technical file.
• Developed multiple disposable medical instruments consisting of plastic molded and metal components for ophthalmic markets. Managed the development projects from concept to market release.
• Served as mechanical team leader for development of a novel automatic endoscopic reprocessor.
• Directed the work of engineers and designers, interfacing with the client.
• Designed the fluidics circuits and mechanical systems as well as generated medical device ISO documentation.
• Invented and developed novel guarded intra-vitreoretinal injection device.
• Fabricated prototypes and created documentation to qualify devices in conjunction with approval from an IRB for use in clinical evaluations.
• Gained valuable clinical feedback to facilitate short product development cycle times.
• Worked as a senior consultant with a multi-discipline team to develop a turn-key pilot production chemical deposition operation for large glass technology OEM.
• Carried out the thermal and fluidic designs of the system.
• Directed the work of engineers and designers during design and fabrication of these two large process modules.
• Apply TRIZ methodologies that help clients circumnavigate target patents and add to the strength of patent applications or find weaknesses in competitor's patents.
• Developed a novel in-line non-destructive test method for Alcon using partial least square-discriminate analysis models to infer blade knife sharpness.
• Devised state-of-the-art electropolish systems generations beyond those currently in use which features artificial intelligence control algorithms and new degrees of system freedom to create cutting edge geometry for surgical instruments unattainable with older technologies.
• Developed a test method to analyze musical instrument string performance using projection regression analysis reducing the need for testing by 'expert' listeners in production.

Alcon Manufacturing, Ltd., Reading, PA, 1989 - 2005

Principal Research and Development Engineer, 1992 - 2005

• Successfully planned and carried out applied manufacturing research and development activities resulting in a group portfolio of 70% to 90% internally generated projects.
• Worked closely with key individuals and organizations within Alcon as well as with the world's top ophthalmic surgeons and customers in pursuit of research and development goals yielding products that commanded 50% to 70% market share.
• Responsible for developing and controlling annual operations budgets for research and development successfully within MBO limits.
• Searched for and found new material, product and manufacturing technologies leading to new products or better manufacturing processes.
• Developed and adapted a TRIZ based methodology to defeat competitive patents.
• Successfully defeated four competitive patents and generated new patents to displace them.

Engineering Manager, 1992 - 2003

• Responsible to lead, manage, and mentor an engineering group of managers, engineers, designers, technicians, contract employees, consulting physicians and university research teams and a multi-million dollar portfolio of medical device applied research programs and development projects.
• Direct and joint responsibility for creating, staffing, and mentoring cross-functional teams using lean and six sigma principles to implement products which were released to market on schedule and outperformed competitive products as determined by benchmarking and reports from surgeons.
• Led a cross-functional team in the manufacturing implementation of an intraocular lens injector working with an outside vendor to turn, EDM, and shape several very complicated titanium components.
• Planned the project methodology and mentored engineers in the breakthrough improvement of a 15-year-old manufacturing electropolish process. Realized millions of dollars in yield improvement and created additional market share through producing more consistent products.
• Investigated and developed organic and inorganic knife coating technologies.
• Established systems for design control. Achieved certification under ISO and MDD standards.

Manufacturing Engineering Manager, 1991 - 1992

• Responsible for leading and managing a product and process oriented manufacturing engineering group of nine engineers, four designers and technicians, an assistant, and a fifteen person machine shop.
• Designed a unique proliferation strategy of computerized engineering tools for a large technical user base.

Senior Manufacturing Engineer, 1989 - 1991

• Responsible for the development of medical device line extensions and associated manufacturing processes.
• Developed a CNC Swiss Turning Center to make titanium phacoemulsification tips.
• The department expanded from 4 to 30 turning centers based on the savings realized by making the product in house vs. buying it from an outside source.
• Designed and implemented a system for automated on-line small precision parts gauging. Measured seven part variables simultaneously and automatically generated SPC information.

PrecisionForm, Inc., Lititz, PA, 1987 - 1989

Manufacturing Engineer

• Responsible for development of parts and their associated manufacturing processes for the automotive and aircraft industry.
• Planned and supervised large coolant drain system expansion. Led a team of 12 outside contractors and internal department members in an aggressive two-week effort to replace refurbish and expand the existing system without missing product deliveries to customers.
• Jointly organized the movement of a production facility.
• Redesigned press tooling to allow a major product to be run on a smaller press with a 30% increase in productivity and a safer operating environment and engineering consulting services for clients by leveraging a consortium of scientists and engineers to develop products and manufacturing processes.

RCA Corporation, Lancaster, PA, Mechanical Machine Designer, 1978 - 1987

• Initiated a joint effort between Villanova University and RCA Corp. to develop a "state of the art" phosphor-firing furnace. Served as project team leader to coordinate design.
• Developed process and supervised installation and testing of a 'state of the art' spray drying technique for zinc cadmium sulfide slurry. This process dried ceramic material instantaneously where the previous process took 24 hours.

Honors & Publications

Credentials

• Registered Professional Engineer, Pennsylvania.
• Certified Manufacturing Engineer, Society of Manufacturing Engineers
• Co-Investigator, Naval Research Laboratory - test equipment

Additional Research Support

• Researched and developed instruments for multifunctional small instrument design.
• Ben Franklin Phase 1 Award - Ben Franklin Technology Partners of Central and Northern Pennsylvania.
• Delivery of test equipment, Co-Investigator, Naval Research Laboratory.

Academic and Professional Affiliations

• National Society of Professional Engineers
• Society of Manufacturing Engineers

Grants

• Researched and developed instruments for multifunctional small instrument design.
• Ben Franklin Phase 1 Award - Ben Franklin Technology Partners of Central and Northern Pennsylvania.

Publications and Patents

• Author and Co-Author of numerous publications in reports, engineering, medical and technology journals.
• 13 Pending or Issued patents.

Education

• M.S., Engineering Science, Penn State University
• M.S., Business Administration, Penn State University
• B.S., Mechanical Engineering, Villanova University