This Senior Associate specializes in drug delivery and FDA compliance issues for the medical device and biotechnology industries. Selected consulting projects include hypothermic organ transport devices, cell culture scale-up, disposable infusion devices and facility design and certification. Over the last 20 years he has held senior management positions with Becton Dickinson, American Hospital Supply Corporation and the IVAC Division of Eli Lilly and has been president of two start-up ventures in high technology medical products. He is experienced and knowledgeable in all aspects of electromechanical products, medical product development, GMP manufacturing and marketing.
He received his Ph.D. from the Department of Physiology and Pharmacology at Duke University and is currently an adjunct associate professor of cell biology there. He earned an undergraduate degree in chemical engineering from Georgia Tech. He has over 40 technical publications and is a contributor to the series Technology Management. Professional associations and listings include: American Men of Science, Who’s Who in Science and Engineering, Who’s Who of Emerging Leaders in America, Biophysical Society and the Society of General Physiologists.
This Associate contributes his various modeling, machining and computer skills to a wide array of engineering prototypes and manufacturing purposes. He has over eight years of professional CAD/CAM experience in the medical device, automotive and avionics industries. Technical expertise includes CAD sold modeling (SolidWorks, Pro/E, AutoCad), producing and verifying computer models and drawings according to engineering requirements. His CAM and manufacturing abilities provide a seamless transition from the computer screen to actual working hardware. He is extremely proficient in acrylic models and rapid prototyping. He received his AA degree in Drafting Technology - Technical, Phi Theta Kappa.
This Senior Associate has been engaged in the design and development of medical devices for more than 15 years. He is a hands-on product designer who has considerable knowledge of the techniques used to design, fabricate and evaluate high-tech catheters used in vascular, neurological, and urological applications. His industry experience has included manufacturing engineering positions for major catheter marketers as well as management positions in product development of cutting edge catheters for treating stroke and aneurysm patients.
He has considerable experience in working with medical investigators and clinicians, OEM suppliers, as well as engineering personnel of all disciplines. He is skilled in CAD and is also a proficient prototype machinist. He is very familiar with FDA requirements, and has experience with design control, documentation, as well as product and process validations. He received his BS in Chemical Engineering from U.C. Berkley and a Master of Science in Engineering, Mechanics and Materials from California State University, Long Beach. He has been awarded 18 US patents and has 14 patents pending.
This Senior Associate has over 20 years of experience in health care research, development and engineering. His industry experience includes director of engineering for the Hyland Division of Baxter Healthcare, as well as director of development, director of engineering and vice president of R&D for Baxter Pharmaseal Division. At Hyland he managed the process, facilities, and engineering support operations for the world’s largest fractionator of human plasma. He performed product and process development with polymeric materials and has extensive experience with injection and blow molding, as well as extrusion. As a consultant he was responsible for the design of new manufacturing space for a sterile gown manufacturer. He also performed validation studies for air and purified water systems for a major critical electronic implantable device manufacturer. As acting director of engineering for a firm which performs clinical trials on a new AIDS drug, he was responsible for design and construction management of a new drug manufacturing facility which includes WFI, clean steam, clean air, process suites, and aseptic filling.
He received his BS in chemical engineering from Rose Hulman Institute of Technology and an MBA from Loyola University of Chicago.
This Senior Associate is a seasoned management and technical professional with more than 20 years of hands-on experience in project management, manufacturing process development, process validation, and GMP compliance. He specializes in new product development, product and process validations for biotechnology, pharmaceutical and medical device manufacturers. He completed a wide variety of technology transfer, packaging, process improvement, failure analysis, production scale-up, and quality assurance projects. His product experience includes in-vitro diagnostic devices for diabetes and HIV, vascular access devices, liver assist devices, and a variety of ophthalmic devices. He has both domestic and international manufacturing experience.
He earned his BS in Chemistry from the California State University at Northridge and an MBA from Pepperdine University. He held increasingly responsible operations and management positions at Allergan Pharmaceuticals, Quidel Corporation and Lee Pharmaceutical. He has been awarded one US Patent. He is a member of the Parenteral Drug Association and the International Society of Pharmaceutical Engineers.
This Associate has been engaged in the design and development of medical devices for more than 15 years. He is a hands-on product designer who has considerable knowledge of the techniques used to design, fabricate and evaluate high-tech medical devices used in numerous applications. His industry experience includes manufacturing engineering positions for major corporations as well as management positions in product development of medical start-ups. This Associate has considerable experience in working with medical investigators and clinicians, OEM suppliers, as well as engineering personnel of all disciplines. He is skilled in CAD and is also a proficient prototype machinist. He is very familiar with FDA requirements, and has experience with design control, documentation, as well as product and process validations. He received his BS in chemical engineering from U.C. Berkley and a Master of Science in engineering, mechanics and materials from California State University, Long Beach. He has been awarded 11 US patents and has 9 patents pending.
This Associate has over 20 years of experience in the design and program management of medical, industrial, and aerospace products. He holds a Bachelor's degree in electrical engineering form the California Institute of Technology specializing in solid state physics, and he has done graduate work in integrated circuit design at the University of California, Irvine. A member of numerous professional organizations, including the American Society for Quality Control and the Institute for Electrical and Electronic Engineers, he lectured on the validation of international medical products, the design of safe microprocessor systems, and contemporary techniques for temperature measurement. He founded and was director of Interface Instruments, Inc., which provided computer-based data-acquisition systems to several industries. He has first-hand experience with "expert systems" including work with automated optical PAP smear analyzers for Neopath and Amgenics. He designed numerous instrumentation products and developed unique methods for validating medical software safety.
He is a recognized expert in the area of risk and hazard analysis; including presenting seminars and teaching the use of fault tree analysis and FMEA generation and corrective action systems. He worked extensively with domestic and international regulatory agencies and established a group for the design and approval of international medical products. He developed validation protocols for products in medical, industrial, and aerospace markets which successfully led to the introduction of several multi-million dollar product lines.
This Senior Associate has developed new and innovative products for both domestic and international markets. He has over 20 years experience ranging from new product concept development, rapid prototyping techniques, product refinement, mechanism and part design, to production release. He has been awarded more than 15 design and utility US patents along with receiving an award of "Excellence in Design" by the editors of Design News for his I.V. infusion pump. His expertise in linking styling with engineering and form with function brings a unique set of skills to a project which creates products that sell.
In his career he has been associated with product development consulting firms along with several leading medical device manufactures. Products he designed utilized numerous polymers and materials. His knowledge of manufacturing technologies includes injection molding, die casting, CNC and screw machining, metal stamping, investment casting, powdered metal, and EMI/RFI coatings. He is very experienced in reducing production costs in new and re-engineered products by utilizing design methodologies such as design for manufacturing and assembly. Product lines have included multi-channel I.V. infusion instruments, class VI disposable I.V. sets, single outlet AC adapters, along with numerous other commercial products.
He earned his BS in product design from the Art Center College of Design in Pasadena, CA. He is a member of the Industrial Designers Society of America and Society of Plastics Engineers.
This Senior Associate has over 25 years of professional experience in the related fields of product development and technology realization, with special expertise in manufacturing processes and injection molding. His strengths include product analysis, marketing, and sourcing, as well as resource management, strategic planning, scheduling and technical writing. He held various model making positions at A&M Modelmakers company, Maywood, CA.; Precision Model Company, San Gabriel, CA.; and was a precision modelmaker in the Advanced Development Department of Hughes Aircraft Corporation.
In 1973 he founded his own company, a multi-faceted service oriented business specializing in product development and the translation of planar concepts into three-dimensional prototypes for engineering, market analysis and FDA 510(k) certification. The company’s primary focus is the medical device and consumer product industries, with special expertise in electro-optical and mechanical systems, inhalation devices and plastic injection technology. Clientele are nationwide including Bechtel Corporation, Avionics, Texas Instruments, IVAC, Mattel Toys, Spectra-Photo Research, CBS and the US Department of Transportation.
This Senior Associate has more than 25 years experience in the medical and plastics industry including 11 years experience as an officer of three companies where he played a key role in strategic planning, directed 7 plant start-ups and launched numerous new products. As engineering manager for McGaw Labs and vice president of operations for Delmed Inc., he designed medical products such as blood bags with anticoagulant solutions, blood sets, plastic I.V. containers, I.V. administration sets, peritoneal dialysis solution bags and associated sets, infusion systems, etc. In his role as vice president of engineering for Nypro, Inc. he directed major projects to develop injection molded components, tooling and associated assembly automation for companies such as Abbott Labs (VisionTM Blood Analyzer), Baxter (check valves for I.V. sets) and J&J (AcuvueTM contact lenses). As vice president of Operations for Advanced Tissue Science and director of engineering for Hybritech, he also gained experience in the biotech industry developing new products and associated instrumentation.
He attended Illinois Institute of Technology and earned a BS degree in mechanical engineering. In 1979 he was awarded a Masters degree in management from Claremont Graduate School, Claremont, California. He is the author of five US patents for various medical products.
This Associate has over 27 years experience in the healthcare industry in the management of sterilization methods, microbiology and chemistry laboratories, GMP compliance, in-house and contract sterilization methods (EtO, cobalt and aseptic filling). His experiences include in-house and contract laboratories for drugs, medical devices and in-vitro diagnostics products. He has been a microbiologist and manager of sterilization for Becton-Dickinson, an international supplier of drugs and medical devices; president and COO of China Biotech, a gamma contract sterilization service; and director of laboratory services and senior consultant for Pharmaceutical Systems, Inc. This Associate is a member of the AAMI/ISO committees for EtO and steam sterilization that drafted the International Guidelines for Sterilization. He published technical papers and spoke at various technical conferences. He is a member of several industry organizations including the American Society for Microbiologists, International Society of Pharmaceutical Engineers, American Society for Quality Control and the Association for the Advancement of Medical Instrumentation. He holds a BS in microbiology from South Dakota State.
This Senior Associate has been involved in the field of plastics manufacturing for over 20 years. He held positions with plastics industry leaders Caco Pacific, Dauntless Molds and the KippGroup in design, tooling and processing technology. Possessing an intimate knowledge in materials, part and mold design and processing, he imparts valuable insight to each project. He has extensive experience in the design and fabrication of high accuracy, high tolerance production molds utilizing standard and hot runner systems. He is highly experienced in the design of plastic components with a special emphasis on manufacturing. As senior design engineer for the KippGroup, he was involved with numerous projects for major medical device companies in both durable and disposable goods.
As plastics processing technology manager at U.S. Medical Instruments, Inc., he was responsible for specifying primary and auxiliary equipment required for integration of new molds into the manufacturing environment. He was involved in the establishment of a state of the art molding and fabrication facility from the ground up. He has served as an instructor in the indentured apprentice program, co-sponsored by the SPE and the state of California. He is also very skilled in the use of AutoCAD, SolidWorks, and other design software. He provides mold design and materials selection and processing consulting to industry.
This Senior Associate specializes in optical systems, from physical and geometrical optics design and testing, to specialized electronics and software for optoelectronic products. He has been involved in product development and metrology for over 25 years. Aside from medical devices and biotechnology, his experience spans a wide range from semiconductor processing to fiberoptic communications systems, biological, physical, and environmental sensors, avionics, and nuclear accelerators.
His recent projects have included the development of ophthalmic screening devices for diabetes, imaging fluorescence microscopes for genetic assays, robotic vision systems for nebulizers, embedded systems for dosimetry & flow measurement, polymer materials analysis & evaluation, optical design for in-vivo probes, optical blood glucose monitoring, monitoring of optical ablation of arterial plaque, inline colorimetric measurement of fluid concentration, computer-aided/image-guided orthopedic surgery systems, and a range of microscope- and laryngoscope-type devices. He has extensive experience in the optical characterization of materials including fluorescence, reflectance, UV/VIS, polarimetry, and laser-induced breakdown spectroscopy, among many others. Other recent work includes projects as diverse as solar power generation and biomass processing, microcurrent stimulation therapy, hybrid optical networking, and embedded controllers for sensory and robotic applications.
Before establishing his consulting business, he managed an optical sensors division for a small company which is now part of a large defense contractor, and held several industrial and research lab positions. He is familiar with product development and launch, as well as sales, marketing and business strategy, in areas such as medical devices, biotechnology, compound semiconductor devices, and OEM electronics.
He received his Ph.D. from the University of Colorado at Boulder, his M.S. degree from Brown University, and his B.A. from Whitman College, all in Physics.
This Associate has been designing and developing medical device, biotech, and solution packaging systems, including aseptic FFS systems, for over 20 years. He managed technology transfer and product feasibility studies for new and existing product applications and directed the worldwide implementation of multiple projects for Baxter Laboratories that encompassed international marketing and regulatory strategies. His broad product experience includes I.V. solutions, in-vitro diagnostics, laproscopic and electrosurgical instruments, a wide range of catheters, medical lasers, and numerous surgical specialty kits. He has first hand experience in qualification of all types of sterile packaging systems and conducted many process capability and package validation studies. He has been awarded nine US patents. His BS degree in packaging engineering is from Michigan State University.
This Associate is a consultant in health care technology. He has more than 20 years experience successfully designing, developing and bringing to market over 150 products and 477 catalog items. He spent the majority of his career with Baxter Healthcare, and next worked for small entrepreneurial companies and was a principal in two start-up ventures. He held positions as vice president of engineering with Stackhouse, Inc., president of Sarcos Medical Corporation, research scientist with Medtronic, Inc., and vice president of R&D, director of product R&D, and manager of advanced development with Baxter Healthcare Corporation. He has been awarded 9 US patents. This Associate holds a Ph.D. in polymer chemistry, Polytechnic University, New York and a BS in chemistry, Wagner College, New York. Expertise includes product design and development, regulatory affairs, patent strategy and assessments, and new technology /business opportunities.
This Senior Associate has over eighteen years management experience in biotech, drug delivery and medical device positions overseeing Research and Product Development, Engineering, Pharmaceutics, Regulatory, Quality and Operations departments. He is a proven leader in staffing and guiding multi-disciplined teams to timely and successful project completions. Mike has led "must have" product development efforts resulting in positive outcomes, from hitting market windows to successful IPO's. End products have been successfully sold into global markets. Product experience includes pulmonary drug delivery instruments, nebulizers, IV pumps and disposables, syringe pumps, vital signs monitoring equipment, large volume blood pumps and associated analytical instrumentation used during open-heart bypass procedures.
He has worked with small and large companies, from start-ups to industry leading corporations, embracing a wide range of product technologies and manufacturing systems. He has worked with Aerogen, Alaris, Ivac, Imed and Psicor. He is very familiar with regulatory requirements of the US FDA, EN and ISO. He received a BS in Electrical Engineering from Western Michigan University and has participated in various continuing education seminars and courses throughout his career. He has earned four patents and has another five applications pending. He has authored and presented technical papers during his career. He is a member of the California Healthcare Institute, Advamed, AAMI, and ASQ.
This Associate is a seasoned regulatory affairs and quality assurance officer, having held numerous executive positions in technology driven medical device companies. He was responsible for worldwide regulatory compliance for international manufacturers of software-based electromechanical drug infusion pumps, oximeter products, and cancer therapy products. He held senior level positions with Seimens, Nellcor, UltraMed, IMED, and American Hospital Supply Pharmaseal Division. He was involved in the formation of an entrepreneurial start-up that utilized electro-mechanical based instrumentation for ophthalmic applications. He is highly experienced with US FDA and international new product approval submissions. He was responsible for the successful launching of Regulatory Affairs Professional Society (RAPS), now a 6000+ international member organization dedicated to providing educational worldwide support of regulatory developments that impact the healthcare industry. He is active in ASQC, AAMI, HIMA, FDA co-sponsored committees dealing with new regulations and laws, as well as other professional societies. He earned a BS in pharmacy from Ohio State University and a Doctor of Clinical Pharmacy from USC. He is an Adjunct Professor for Medical Regulations, UC Medical Centers and a Certified Regulatory Affairs Professional.
This Associate is a very knowledgeable quality systems and regulatory specialist. He has over 20 years of experience in the medical device manufacturing industry working for industry leaders such as American Pharmaseal Respiratory Products, IVAC, Hybritech and Nellcor. He held management and technical positions in quality assurance, regulatory affairs, documentation control and configuration management, product development systems and manufacturing operations. He is a certified RAS quality systems auditor, trained as an environmental management systems (IS014001) auditor per ANS IIRAB accreditation standards, and is certified in document control/configuration management. He is conversant in and provided consulting services regarding ISO 9001/2, EN 46001, ISO 14001 and FDA GMP gap analyses, as well as education and training. He also provides ISO 9001/2 project guidance, coordination and registration. He is expert in quality systems procedure development. He is familiar with documentation control system assessments and development. He participated in FDA product submissions and regulatory research as well as EU CE product marking and approval. He holds a BA in biological sciences from the University of California, Santa Barbara. He is active in ASQ and Toastmasters International, and is a medical device industry advisor to the Institute of Configuration Management and Arizona State University of Engineering.
This Senior Associate is a medical instrumentation consultant to the healthcare industry. He held senior scientific, technical development, and vice president positions with IMED, Mini-Med, Siemens Infusion Systems, and Via Medical. He specializes in systems analysis, design, integration and testing, and has more than 15 years of successful hands-on medical product development experience. Much of this work focuses on closed loop feedback systems. He is involved with software, hardware, sensors, and modeling of fluid delivery systems for a wide variety of applications. He designs and implements software controls based on current FDA guidelines. He is well versed in the use of FMECA and fault tree analysis to generate risk assessments for medical devices. He also performs extensive clinical evaluation and report preparation for regulatory submissions.
He received his Ph.D. in electrical engineering from the University of Wisconsin, Madison. He also holds a BS with Honors and an MS in electrical engineering from Wisconsin. He has been awarded six patents. He published more than a dozen technical articles and presented at numerous scientific meetings.
This Senior Associate is a specialist in the development of real-time embedded software for safety-critical systems. He is an expert in software quality assurance including verification and validation, particularly as it applies to FDA, TUV and CE regulatory approvals for medical instrumentation. He is proficient in C/C++, various types of assembly language, FORTRAN, Pascal, Forth, Basic, LabView, Borland OWL, Microsoft MFC and Windows programming languages and environments. His product experience includes a variety of medical products and medical instrumentation systems, including pulmonary physiologic monitors, drug delivery systems, blood gas analysis interface systems, process control hardware and patient data management systems.
He received an AS in biomedical technology from Grossmont College, a BA in computer sciences from San Diego State University and has over 20 years of hands-on experience in the field of software development. He held positions ranging from programmer in the department of medicine at the University of California San Diego to vice president of R&D for Siemens Infusion Systems. His work earned seven patents. He served on the IEEE P1073 (Medical Information Bus) committee.