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 Expert  107726

Expert in Medical Device, Biotech, Pharma R&D, Tech Transfer, Mfg, Compliance, IP Valuation, Process Improvement


Available for your Consulting and Expert Witness Needs

New Jersey (NJ)
USA
Education Work History Career AccomplishmentsPublicationsConsulting Services Expert Witness Market Research

Summary of Expertise: Listed with other top experts in: 
Expert has an impressive and verifiable record of significant product, process and business improvements since 1980. These include: Time to market, new product development system improvement; Reengineering; Business unit performance and profitability improvement, Manufacturing process yield, quality, cost and performance improvement, Cost-of-Quality and profitability due diligence. Profitability due diligence is one of Expert' strongest areas. He knows how to streamline a manufacturing process without any major capital expenditures; identify the fundamental engineering principles that affect process and product performance by completing statistically valid experiments and process capability studies; establish optimal process parameters and complete process validation; complete "time and motion" productivity, efficiency and benchmarking studies. He has developed Cost of Quality, Performance and Productivity models for the identification, correction and prevention of related business inefficiencies that utilize 44 quantitative criteria, metrics. Expert knows how to transform poorly performing business units into profitable and fast growing entities by utilizing his rather simple but powerful methodologies. Since 1980, he has helped such companies as American Home Products, Johnson & Johnson, Alcoa, Minolta, B. F. Goodrich, Kimberly Clark, Abbott Laboratories, Medtronic, Cardinal and a number of start-up ventures realize millions of dollars in significant and quantifiable benefits. Expert uses his Cost of Quality, Performance and Productivity model for the identification, correction and prevention of related business inefficiencies. It utilizes 44 quantitative criteria and metrics.

Expert has expertise in resolving thorny manufacturing problems caused by material, process, and environmental conditions. Expert specifies the expected outcome, isolates the problem, uncovers the root cause and fixes it permanently. He has worked on projects involving fiber optics, blood and body fluid sensors/membranes, heart valves, pacemakers, blood collection and storage containers, kidney dialysis machines, oxygenator and heart/lung bypass devices, syringes, needles, blades and micro-surgical cutting instruments, sutures, PTCA-perfusion-fiber optic-central vascular-electrophysiology and suction catheters, guidewires, micro-catheters and coils, and stents. He has also worked with antithrombogenic-, biocompatible-, antimicrobial-, and infection-resistant technologies; dental and other surgical implants; bone graft plaster formulation; laparoscopic and incontinence devices; collagen homeostatic and drug transdermal delivery systems; sterile injectables; hospital waste disposal products; surgical drains and reservoirs; infection control devices; contact lenses; tortuous and capillary-pore microfiltration membrane and industrial filtration systems; gloves, towels, and surgical drapes. Expert has improved the performance, quality and cost of many poorly functioning products and processes through effective redesign, streamlining, statistical process control, optimization and defects elimination. He is thoroughly knowledgeable about extrusion, molding, thermoforming, cleaning, conditioning, coating, lubricating, biocompatibility/anticoagulation and anti-thrombogenicity, conventional and lyophilized drying, sterilization, packaging, liquid and powder dispensing, chemical compounding, mixing and handling technologies. He has successfully developed, installed, optimized and validated high-volume, in-line processes in manufacturing sites located throughout the US, UK, Puerto Rico, and Mexico.

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product improvement

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productivity improvement

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antithrombotic coating material

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biocompatible coating material

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biomedical device manufacturing

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cutting tool

 • 

heparin coating material

 • 

heparin coating process

 • 

medical device

 • 

medical device manufacturing

 • 

medical device manufacturing troubleshooting

 • 

medical device process validation

 • 

medical device product improvement

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slurry fluid flow

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slurry mixing

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surface modification

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surface modification engineering

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surface preparation

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surface property

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surface treatment

Expert has thorough knowledge and expertise in the evaluation of plastic, metallic, glass, woven and non-woven fabric materials as well as various solutions and mixtures. He evaluates the stability, accelerated aging and actual failure of a material or product during normal use. He has completed product performance studies concerning the effect of radiation, e-beam, ethylene oxide and steam sterilization as well as temperature, humidity, pressure, vibration, and time. He has been involved in the successful transformation of numerous faulty product designs and sub-optimally operating manufacturing processes. He has developed statistically valid stress and other accelerated aging studies that simulated real time product aging. He has developed a sure-fire strategy for getting total FDA cooperation and fast product approval. He has developed and executed numerous laboratory test methods for completion of stability studies. In his work, he takes into account how the product will be used, what are the conditions of the product's storage before use, the underlying engineering. In the lab he knows how to simulate the "worst case scenario" conditions for a given product, and evaluate the product's performance. From his experience with medical devices, Expert has gained expertise with the development and execution of protocols for the evaluation, real life and accelerated aging, validation, and stability of both materials and overall products. He has applied his knowledge of reliability quantification, failure distributions, failure mode and effect analysis, maintainability, and statistical data analysis to a number of products. These include needle, syringe, blade, suture, blood collection tube, percutaneous transluminal coronary angioplasty catheter, transdermal drug delivery, suction catheter and canister, and collagen hemostat products. He has a thorough understanding of GMP and FDA regulations. In addition, Expert has expertise in writing specifications and other documentation for materials, processes, and products. He has written company policies and procedures, materials and process specifications, test methods, operating procedures, operator manuals, and finished goods specifications.

Expert has extensive, practical involvement in the prevention and/or resolution of human, material, process, and product problems through scientific experimentation. He knows how to draw valid conclusions from seemingly contradictory studies or limited data. These conditions include short production or laboratory runs, high cost of components or products, failure of product during actual use and/or too many experimental variables. He has knowledge of X-Bar and R control charts, cpK, process capability and measurement system analyses through reproducibility and repeatability, statistical process control, polynomial regression analysis and ANOVA/ANCOVA. He has completed projects that include: the elimination of manufacturing and service quality defects; solutions for improving a faulty product design; alternatives for streamlining a poor manufacturing process; strategies for gaining new or recovering lost market share; strategies for significantly improving an ineffective new product development process, among others.

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medical device reliability testing

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material degradation

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failure modes and effects analysis

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stability testing

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accelerated aging

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stress testing

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stress modeling

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design of experiments

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data analysis

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regression analysis

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analysis of covariance

In July 1999 Expert chaired the "Biotechnology and Pharmaceutical Patents, Licensing, Trademarks and Intellectual Property" conference in San Francisco, CA. His presentation was titled "Intellectual Property Valuation and Technology Transfer" and the main points included: How do I evaluate the value of the technologies I have? How do I find a prospective market? Should I find an "agent" to help me find buyers? How do I approach a prospective buyer? Should I "tailor" my technology for a potential buyer? How do I go about negotiating the terms of the contract? What are the pitfalls of technology transfer? What is the "right" Royalty Rate for my new technology, product? In December 1999 he presented a seminar on "Technology Transfer - Developing an Effective Documentation Management System" in Atlanta, GA. His main points included "How To: Develop technology transfer strategy and action plan; Utilize breakthrough methods for incorporating validation principles into technology transfer operations; Develop a link between customer and manufacturing lab; Ensure a cGMP compliant work-flow; Manage the life-cycle of your data; Document, manage and audit the technology transfer process; Assess the financial and economic advantages of successful technology transfer; Protect confidential, proprietary trade secrets and technology from inadvertent disclosure; Determine pitfalls and successes during the transfer/scale-up and manufacture of a bulk therapeutic." He has devised an analytical method for selecting, designing, developing, and manufacturing the "right" product. He has saved companies millions of dollars and precious time by terminating new product development projects that lacked business and/or technical merit. He has also accelerated the development and commercialization of numerous, worthy new products by re-focusing the limited resources of a company. This proprietary new product development tool interrelates quantitatively the needs of the user with product features/benefits, design criteria and specifications, and manufacturing conditions. In addition, he has developed a simple but powerful new product development project evaluation method that incorporates 154 market, technology, manufacturing, distribution, legal and other related criteria. He has worked with a wide range of products, ranging from portable blood gas analyzers to surgical and examination gloves. Expert aggressively defended a major American company's hypodermic syringe and needle market against a foreign competitor in a competitive benchmarking project. He has also prepared detailed business plans and completed competitive evaluations for most of these products. Expert has applied his knowledge of reliability quantification, failure distributions, failure mode and effect analyses, maintainability and statistical data analyses to a number of products. He has a thorough understanding of 510K, PMA, IDE, GMP and FDA/MHW regulations. In addition, he has interpreted patent claims and interacted with attorneys to determine if a given idea could be patented without the potential of its interference and or infringement with other patents.
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medical device design

Expert has expertise in all facets of new medical product development, from idea generation and technical, business feasibility, to product manufacture and launch. These include: Idea generation; User needs establishment; Invention; Patenting; Technical and business feasibility; Modeling and prototyping; Design specification; Claims; Process pilot line; Manufacturing scale-up; Experimental design; Project management; Accelerated aging, failure analysis and stress testing; Clinical trials; FDA submissions; Product launch; On site project reviews; Training seminars and work shops.

Expert has thorough knowledge and expertise for identifying, entering and developing previously untapped, hidden or unreachable markets. He deals with the technical and business feasibility, business planning, due diligence, technology transfer considerations, and licensing/royalty rates. He performs several operations in his work, including: Intellectual Property assessment and management; Business opportunities assessment; Invention brokering; On site project reviews; Training seminars and workshops. In July 1999 he chaired the "Biotechnology and Pharmaceutical Patents, Licensing, Trademarks and Intellectual Property" conference in San Francisco, CA. His presentation titled "Intellectual Property Valuation and Technology Transfer" dealt with several of the main issues around the introduction of new products into a market. In December 1999 he presented another seminar titled "Technology Transfer - Developing an Effective Documentation Management System" in Atlanta, GA. There he discussed such things as developing a link between the customer and the manufacturing lab and managing the life cycle of data. He has developed and been using successfully several powerful, proprietary tools such as a new business acquisition and development template and a quantitative intellectual property due diligence technical and business feasibility template. Expert uses his simple but powerful Due Diligence Intellectual Property model for continuous screening and quantitative evaluation of new product ideas. It incorporates 154 market, technology, manufacturing, distribution, legal and other related criteria.

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medical device product development

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due-diligence investigation

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technology evaluation

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technology transfer

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technology licensing

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acquisition

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medical device patent


Show Secondary and Basic Areas of Expertise
Localities:
Expert may consult nationally and internationally, and is also local to the following cities: New York, New York;  Yonkers, New York;  Newark, New Jersey;  Jersey City, New Jersey;  Paterson, New Jersey;  Elizabeth, New Jersey;  Bridgeport, Connecticut;  Stamford, Connecticut;  Philadelphia, Pennsylvania;  and Allentown, Pennsylvania.

Often requested
with this expert:

Medical Device Product Development
Validation of Sterilization Processes and USP/ AAMI...
Pharmaceutical and Biomedical Business Development,...
Pharmaceutical Technology, Manufacturing, Quality Systems...

Education:
Year   Degree   Subject   Institution  
1985   MBA   Business Administration   Fairleigh Dickinson University  
1980   ME   Chemical Engineering   City College of New York  
1978   BE   Chemical Engineering   City College of New York  

Work History:
Years   Employer   Department   Title   Responsibilities

2006 to

 

(Undisclosed)

 

Medcial Device, Pharma, Biotech, R&D, Tech Transfer, Mfg, IP Valuation, Process

 

Improvement Consultant

 

He is responsible to help client companies exceed their business and technical objectives by resolving even complex problems that others had considered unsolvable. Methods and tools include Lean Manufacturing and Baldrige performance, LEAN Six Sigma, quality and productivity tools, and a number of self-developed, proprietary templates that have been yielding significant and quantifiable improvements since 1986 in intellectual property, technology transfer, product development, process development and validation, FDA regulatory compliance, PMA, 510K and IDE, remediation, design controls, risk assessment, manufacturing operations, quality assurance/control, business valuation and project management projects.

2010 to 2011

 

PENTAX Medical - Americas Hoya Corp.

 


 

Head, Quality (RA/QA/RC) & Continuous Improvement

 

Supervised directly the revalidation of a highly complex multi-layer co-extrusion manufacturing process inclusive of process flow/mapping/characterization, design of experiments, statistical analysis, identification of critical process parameters and critical quality attributes, commissioning/installation qualification and operational qualification protocols.

Reviewed/approved every new product development protocol/report/design change, engineering studies, various validation documentation, every change control, every CAPA, Nonconformance of the US and three facilities in Japan involving 500+ personnel.

Led a staff of three Quality Assurance (QA), Regulatory Affairs (RA), Quality System (QS) directors, two Quality Assurance (QA) managers and a Regulatory Affairs (RA) professional towards achievement of specific department and/or project goals.

2006 to 2006

 

CH2MHILL

 

Pharmaceutical, Biotech Consulting Division

 

Director, Regulatory Compliance & Operational Excellence

 

He was responsible to direct the company's resources to maximize profitability, revenue and growth as well as penetrate new market segments. Part of three senior executive staff team. Chair industrial conferences and/or present workshops in areas of expertise. Train internal resources to become proficient for completing consulting projects in the regulatory compliance & operational excellence business segments for clients in the pharmaceutical, biotechnology and medical device business sectors. Develop and implement rolling 5 year strategic plan. Expertise comprises six sigma, lean, kanban, 5S, quality risk management, process analytical technology, FDA inspection audits, high level strategic regulatory consulting, supply chain management, customer excellence, continuous profitability and quality improvements.

2003 to 2006

 

Schering Plough

 

Equipment Validation

 

Group Lead, Equipment Validation

 

He was responsible to lead the packaging validation group of medium size NJ pharmaceutical company comprising three equipment validation engineers for the validation of packaging processes for over 200 current and new liquid, ointment, cream, aerosol and tablet pharmaceutical products.

2002 to 2003

 

VTS Consultants

 


 

Lead Validation Consultant

 

He was responsible for GAP analysis, remediation plans implementation, IQ/OQ/PQ protocol generation, execution, data analysis, and final report preparation for facilities/utilities, equipment, and computer systems (GxP and 21 CFR Part 11 regulations).

1990 to 2001

 

Technobusiness Solutions

 


 

Consultant, Founder, President

 

He has helped companies exceed their business and technical objectives by resolving even complex problems that others had considered unsolvable. Methods and tools include Lean Manufacturing and Baldrige performance, Six Sigma, quality and productivity tools, and a number of self-developed, proprietary templates that have been yielding significant and quantifiable improvements since 1986 in intellectual property, technology transfer, product development, process development and validation, FDA regulatory compliance, PMA, 510K and IDE, remediation, design controls, risk assessment, manufacturing operations, quality assurance/control, business valuation and project management projects.

1984 to 1990

 

Becton Dickinson and Company

 

Bard Parker/AcuteCare Division

 

Research and Development/New Business Ventures Program Manager/Project Engineer, Acute Care Division

 

He was responsible for research, development and improvement of the performance of blood collection test tubes, needles, syringes, blades, lancets, catheters, drains, hemostats, wound healing and closure agents, sterile solutions, drapes, gloves, towels, bacterial filters and associated manufacturing processes; Transferring of technology, validation, troubleshooting and improvement of the performance of manufacturing processes in plants throughout the US, Mexico, Puerto Rico and England; Assisting in the marketing and sales of products by visiting customer accounts, conducting focus groups, exhibiting at trade shows and making presentations at purchasing groups.


1980 to 1984

 

Becton Dickinson and Company

 

Vacutainer Systems Division

 

Research and Development Senior Engineer/Junior Engineer, Vacutainer Systems Division

 

He was responsible for research, development and improvement of the performance of blood collection test tubes, needles, syringes, blades, lancets, catheters, drains, hemostats, wound healing and closure agents, sterile solutions, drapes, gloves, towels, bacterial filters and associated manufacturing processes; Transferring of technology, validation, troubleshooting and improvement of the performance of manufacturing processes in plants throughout the US, Mexico, Puerto Rico and England; Assisting in the marketing and sales of products by visiting customer accounts, conducting focus groups, exhibiting at trade shows and making presentations at purchasing groups.


Career Accomplishments:
Awards/Recognition

In 1983 Expert received a Research and Development Achievement Award from Becton Dickinson for resolving a thorny manufacturing, product quality problem.


Publications:
Publications and Patents Summary

Expert has 2 patents


Consulting Services:
Selected Consulting Examples:
  • · Identified consulting trends, unmet client needs and directed the development of a new brochure for penetrating the regulatory compliance, operational excellence, LEAN Six Sigma, continuous process improvement market segments. · Devised and implemented a plan to improve website content, navigation and search hit rate.· Identified and develop strategy for a collaborative relationship with a strategic partner having complementary consulting products and services. · Developed and presented a proposal to a large pharmaceutical company with two manufacturing plants in Puerto Rico with deliverables to help launch and then implement an Operational Excellence program.· Lead the packaging validation group of a NJ pharmaceutical company comprising three equipment validation engineers for the validation of packaging processes for over 200 pharmaceutical products. · Ensured all consent decree, cGMP Workplan commitments and regulatory compliance initiatives were completed ahead of time and in full compliance with company standards. · Completed commitments on time for compliance audit responses and preventative actions on protocol variances.· Supervised group towards the completion of over 150 equipment qualifications and packaging validations in support of the Validation Certification Program (VCP), New and Base Business Product Presentations.· Drove Continuous Quality Improvement as a mindset. Reduced equipment qualification protocol variance occurrence rate to 13%. Achieved 75% first pass regulatory compliance approval rate for protocol variance reports. · Continued building a new company-wide culture for ultimately achieving transformational change. Participated in team building sessions for the department, created a follow-up list of areas for improvements identified during team building and monitored progress against list on an ongoing basis. Completed development plans as part of Performance Evaluation process on time and monitored progress. Promoted the new company values and facilitated their assimilation into every-day activities on an ongoing basis. Kept Packaging group informed of business goals and priorities through weekly staff meetings. · Participated as a team member towards building stronger relationships with Marketing, Quality Assurance, Manufacturing, Engineering and Project Planning groups.
  • · Extensive experience in GAP analysis, remediation plans implementation, IQ/OQ/PQ protocol generation, execution, data analysis, and final report preparation for facilities/utilities, equipment, and computer systems (GxP and 21 CFR Part 11 regulations). · Audited existing validation reports and developed Periodic Quality Evaluation documents for lyophilization, autoclaving, washing, depyrogenating, aseptic liquid filling and packaging, air handling/conditioning (including environmental monitoring), laminar hood, tank, clean-in-place (CIP), sterilize-in-place (SIP) and sterile water treatment processes of a Fortune 50 pharmaceutical company.· Developed and executed IQ, OQ, PQ and PV protocols/reports for the validation of analytical laboratory instruments, liquid, cream and tablet packaging equipment for contract packaging and drug manufacturing companies.· Completed documentation and product quality audits about the state of control of about 100 manufacturing equipment and processes for over 3,000 products at 1,000 employee healthcare manufacturing facility. · Assembled documented evidence that supported the continued use of manufacturing equipment and processes until validation activities were completed. Documentation audit comprised the assessment and remediation of over 2,000 SOPs. Product quality audit comprised the assessment of quality control, nonconformance, process yield and product incident report (complaint) data for the last 12 months. · Established template for and completed 40 calibration SOPs. · Established template for correctly determining the criticality of over 3,000 medical products and reclassified their performance characteristics. · Established template for and completed the development of 35 analytical, material and product test methods. · Brought medical device manufacturer into FDA compliance, reduced by 35% all required documents for manufacture, management and control of the related products and, significantly improved the quality of collected data.
  • · Researched, developed and improved the performance of blood collection test tubes, drug delivery systems, needles, syringes, blades, lancets, catheters, drains, hemostats, wound healing and closure agents, sterile solutions, drapes, gloves, towels, bacterial filters, membranes and associated manufacturing processes; Transferred technology, validated, troubleshot and improved the performance of manufacturing processes in plants throughout the US, Mexico, Puerto Rico and England; Assisted in the marketing and sales of products by visiting customer accounts, conducting focus groups, exhibiting at trade shows and making presentations at purchasing groups. · Improved by 32% sharpness of needle for blood gas syringe at manufacturing plant of a sister division. Validated process resulted in timely launch of "Precision Glide" worldwide advertising campaign and turned around politically explosive situation. Improved by 35% dissolution of lyophilized heparin powder for blood gas syringe. Optimized granule particle size, binders, concentration and freeze-drying parameters. Validated process resulted in timely launch of new product, a $10 million market opportunity. · Improved by 50% quality of blood collection tubes with computer model predicting performance. Established and controlled silica powder's particle size distribution and agglomeration, the most important process parameter. Validated process resulted in $2 million annual savings. · Identified and satisfied unmet needs of customer by inventing and completing quantitative competitive evaluation of suction catheters and suction canister membranes. Solved airflow restriction (related to a membrane) and sealing problems, which reversed $500 thousand product back orders. New advertising campaign resulted in $5 million sales gain. · Reduced tubing and adapter costs of molded suction catheter by $175 thousand annually. Validated processes eliminated seventeen-year-old extrusion and molding problems. · Led efforts of two venture groups developing biosensor technology for portable blood gas analyzer. Resulted in small company acquisition with $20 million market opportunity. · Designed and proved feasibility of blood plasma separation tube. Product was developed and marketed with $5 million first year sales. · Invented and developed suction catheter for airway management of critically ill patient. Received design patent. Coordinated market testing of new product. · Developed new package and product performance profile for haemostatic implant agent. Projected annual savings, $1.5 million with FDA efficacy test costs reduced by $225 thousand. · Qualified and validated PVC suction catheter kits for radiation sterilization with Bodolay Packaging equipment. Evaluation schedule compressed from twelve months to six. Resulted in $125 thousand annual savings. · Qualified and validated new bottom web for sterile solution tray with high volume form/fill/seal packaging equipment. Help redesign and build packaging dies in three months.
Recent Client Requests:
  • Expert in Class room training 1 day - bandages and wound dressing products.
  • Expert in PFMEA applied to chemical processes.
  • 21 cfr part 11 expert for consulting on Tissue Bankink.
  • FDA analytical expert needed for consulting on HPLC methods for FDA review.
  • Expert in Silicone bonding.
  • GMP & FDA expert for consulting on GMP / 510K.
  • Materials science or surface science expert for consulting on plasma surface treatment.
  • Expert in medical devises for consulting on adding a voltage stress test to one of the ICs in current development.
Click the green button above to contact Expert for a free initial screening call regarding your expert consulting needs.  Expert is available for consulting to corporate, legal and government clients.  Remember, your initial screening call to speak with Expert is free.

Expert Witness:
Expert Witness Experience Summary:
He has the following expertise: · Twenty-six years of pharmaceutical, medical device, biotechnology and other industrial sector experience with an impressive and verifiable list of accomplishments in: * Operational excellence, LEAN, Six Sigma, kanban, 5S, Baldrige business transformation, supply chain management, customer excellence, continuous process, quality and profitability improvements, * Validation, regulatory compliance, process analytical technology, quality risk assessment/management and remediation, ES/COMM./IQ/OQ/PQ/PkV protocols, SOPs and Validation Master Plans for facilities/utilities, equipment, and computer systems (GxP and 21 CFR Part 11 regulations), * Research and development, technology transfer, intellectual property valuation/management and business due diligence. · Proprietary methods, templates & tools: Lean Manufacturing and Baldrige performance, LEAN Six Sigma, quality and productivity tools, and a number of self-developed templates that have been yielding significant and quantifiable improvements since 1986 for intellectual property, technology transfer, product development, process development and validation, FDA regulatory compliance, PMA, 510K and IDE, remediation, design controls, risk assessment/management, manufacturing operations, cost of quality, quality assurance/control, business valuation and project management projects. · Technical Know-how: Biomaterials, material surface treatment, tribology, colloids, cutting tools, membranes, powders, gels, fluid pumping and processing, aseptic filling, drug delivery systems, lyophilization, sterilization and packaging, process analytical technology, quality by design, quality function deployment, design controls, system/component impact assessment, critical process parameters, critical quality attributes, test method development, deviation investigation, CAPAs, quality risk assessment/management, PMA, 510K and IDE, modeling, statistics, Six Sigma and Baldrige performance, LEAN manufacturing quality and productivity tools.
Recent Litigation Client Requests:
  • Expert in surgical drains for consulting on insufflation of air into wound.
  • Pharmaceutical litigation expert for consulting on heparin litigation case.
  • Biomedical engineer expert witness for consulting on Use of pre-filled diluent syringes in the Autoject device by an MS patient. The syringe broke when using the Autoject and caused injuries to our client.
  • Pacemaker bio engineering expert for consulting on heart device litigation.
  • Expert in intota for consulting on regulatory status of sterile syringes used for enteral feeding.
  • Medical packaging expert for consulting on bottle design and sterility.
Click the green button above to contact Expert for a free initial screening call regarding expert testimony, litigation consulting and support, forensic services, or any related expert witness services.  A few litigation needs include product liability, personal injury, economic loss, intellectual property (patent, trademark, trade secret, copyright), and insurance matters.  Remember, your initial screening call to speak with Expert is free.

International Experience:
Years   Country / Region   Summary
1982 to 1982   England/Plymouth   Transferred technology and processing equipment for manufacture and assembly of blood collection tube products comprising tube washing/treating, silicone coating/drying, micro-volume liquid dispensing into glass tube, rubber stopper cleaning/lubrication and assembly to glass tube, tube labeling, tube evacuation, case carton and master packaging operations.
1985 to 1985   USA/Puerto Rico   Transferred technology and manufacturing equipment for the manufacture and assemply of microcollection plastic tubes containing either various liquid or powder blood coagulation or anti-coagulation materials.
1990 to 1990   Mexico/Juarez   Transferred technology and manufacturing equipment for the manufacture and packaging of a water or saline pack, surgical gloves, gloves into a form/fill/seal package.

Language Skills:
Foreign Language   Description
Greek   Expert is fluent in Greek.

Market Research:
He has cutting edge expertise in industry trends, growth, key players, customers, attitudes, technologies, cost technologies, etc. for the medical device, pharmaceutical, biotechnology and life science market segments.

Completed Projects:

· Researched, developed and improved the performance of blood collection test tubes, drug delivery systems, needles, syringes, blades, lancets, catheters, drains, hemostats, wound healing and closure agents, sterile solutions, drapes, gloves, towels, bacterial filters, membranes and associated manufacturing processes; Transferred technology, validated, troubleshot and improved the performance of manufacturing processes in plants throughout the US, Mexico, Puerto Rico and England; Assisted in the marketing and sales of products by visiting customer accounts, conducting focus groups, exhibiting at trade shows and making presentations at purchasing groups. · Improved by 32% sharpness of needle for blood gas syringe at manufacturing plant of a sister division. Validated process resulted in timely launch of "Precision Glide" worldwide advertising campaign and turned around politically explosive situation. Improved by 35% dissolution of lyophilized heparin powder for blood gas syringe. Optimized granule particle size, binders, concentration and freeze-drying parameters. Validated process resulted in timely launch of new product, a $10 million market opportunity. · Improved by 50% quality of blood collection tubes with computer model predicting performance. Established and controlled silica powder's particle size distribution and agglomeration, the most important process parameter. Validated process resulted in $2 million annual savings. · Identified and satisfied unmet needs of customer by inventing and completing quantitative competitive evaluation of suction catheters and suction canister membranes. Solved airflow restriction (related to a membrane) and sealing problems, which reversed $500 thousand product back orders. New advertising campaign resulted in $5 million sales gain. · Reduced tubing and adapter costs of molded suction catheter by $175 thousand annually. Validated processes eliminated seventeen-year-old extrusion and molding problems. · Led efforts of two venture groups developing biosensor technology for portable blood gas analyzer. Resulted in small company acquisition with $20 million market opportunity. · Designed and proved feasibility of blood plasma separation tube. Product was developed and marketed with $5 million first year sales. · Invented and developed suction catheter for airway management of critically ill patient. Received design patent. Coordinated market testing of new product. · Developed new package and product performance profile for haemostatic implant agent. Projected annual savings, $1.5 million with FDA efficacy test costs reduced by $225 thousand. · Qualified and validated PVC suction catheter kits for radiation sterilization with Bodolay Packaging equipment. Evaluation schedule compressed from twelve months to six. Resulted in $125 thousand annual savings. · Qualified and validated new bottom web for sterile solution tray with high volume form/fill/seal packaging equipment. Helped redesign and build packaging dies in three months.

Click the green button above to contact Expert for a free initial screening call regarding your marketing research, industry research, and company research needs.  For research needs involving multiple experts or secondary research, a Research Director can be assigned to coordinate the work into a custom report for you as a potentially quicker and more cost effective alternative to doing this work yourself or hiring a boutique consultancy.  Remember, your initial screening call to speak with Expert is free.


Additional Skills and Services:
Training/Seminars

· Chairman of 3.5 hours Regulatory Compliance and Business Excellence Workshop: Regulatory Compliance and Business Excellence Lessons Learned (Seminar Speaker); Case Studies on How-To Troubleshoot Quickly and Correctly Your Material and/or Process Problems With Analytical Laboratory Expertise/Know-How; Data-Driven Methods for Regulatory Compliance and Business Excellence; Case Study - Improving Manufacturing Performance & Cycle Time at DuPont Pharmaceuticals, Interphex 2007 - April 26, 2007, New York, NY · Seminar Speaker: Developed and presented 3 hour workshop with subject “Lean Six Sigma for Pharma Manufacturing: Benefits of Compliance” with only 4 hours prior notice and was congratulated by the seminar attendees and International Quality & Productivity Center (IQPC) Conference Director, July 24 - 26, 2006, Philadelphia, PA · Conference Chairman: GMP Requirements, Outsourcing and Manufacturing of Active Pharmaceutical Ingredients. Presented seminar on Technology Transfer Strategies, 26-27 March 2001, New Orleans, LA · Conference Chairman: R&D Alliances for Pharmaceutical/Biotechnology: Build Collaborations and Consortiums to Achieve Maximum Commercialization. Presented seminar on Valuation, Contracting and Licensing Agreements, Strategies for Newly Developed Technologies, 23-24 October 2000, Boston, MA · Seminar Speaker: Manufacturing Active Pharmaceutical Ingredients (APIs): Effective sourcing and supply chain management of APIs. Cleaning validation for API manufacturing facilities. Critical strategies for API regulatory requirements, validation, outsourcing and technology transfer. Presented seminar on technology transfer strategies, 6-7 December 1999, Atlanta, GA · Conference Chairman: Biotechnology and Pharmaceutical Conference: Patents, Licensing, Trademarks and Intellectual Property '99: Strategies to maximize protection and financial profits. Presented seminar on Intellectual Property Valuation, 28-30 July 1999, San Francisco, CA · Seminar Speaker: Business Transformation Through Re-engineering and Continuous Improvement - powerful models and practical strategies for an ever rapidly changing global business environment, 19 May 1999, Princeton, NJ

Supplier and Vendor Location and Selection

Expert has experience locating vendors of detergents, wetting agents, coatings, lubricants, and surfactants, liquid dispensing systems, liquid micro-volume measuring instruments and equipment, chemical formulation and mixing systems, powder handling and processing systems, packaging equipment and testing apparatus, freeze drying/lyophilized equipment, biocompatible, anticoagulant, silicone, polyurethane, rubber, stainless steel, alloy, filtration and membrane materials surface properties measuring equipment (surface tension, film thickness, adhesion), surface analysis and characterization instruments, OEM manufacturers, and viscosity measurement instruments.

Other Skills and Services

He has innate talents, skills and expertise in solving complex technical and business problems that others previously had considered unsolvable.


 

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