General Session—Manufacturing
Atomic Oxygen Removal of Organic Contamination
from the Surfaces of Orthopaedic Implants
Wednesday, June 20th 11:00-11:55 AM
• Bruce Banks, NASA Glenn Research Center
• Michael Banks, M.D., Orthowest, Ltd.
• Eric Banks, Ph.D., NASA Glenn Research Center

• Generation of atomic oxygen in space and on Earth
• Atomic oxygen interactions with materials
• Atomic oxygen effects on cells, organic contamination and endotoxins
• Biological processes and patient implications of endotoxins contamination on orthopaedic implants
• Studies of endotoxins removal from orthopaedic surfaces
• Techniques for atomic oxygen generation
• Manufacturing processes for atomic oxygen removal of biologically active contaminants from surfaces of implants
• Techniques atomic oxygen cleaning validation
• FDA regulation

Bruce Banks is a senior scientist at the NASA Glenn Research Center. During his 40 years at NASA he has lead research activities in electric propulsion technology, thin film coatings, surface texturing processes, atomic oxygen interactions and space environmental effects. His efforts have resulted in 57 space flight experiments or functional applications of technology developed by his research team. He has authored 178 technical publications and 35 patents. He is the most patented researcher in the history of the NASA Glenn Research Center.

Michael Banks, M.D., is a Board-Certified orthopaedic surgeon practicing in Cleveland, OH. During his training at Case Western Reserve University, he was the Fred A. and Alice Lennon Research Fellow, studying the cellular mechanisms of orthopaedic implant loosening. He also participated as a fellow in Arthritis Surgery and Joint Reconstruction as Johns Hopkins University.

Dr. Eric Banks is a member of the Healthcare and Life Science executive team with specific focus in the area of information based medicine. Specifically, Dr. Banks leads a sales organization that delivers infrastructure solutions for healthcare with specific focus on wireless and mobility healthcare technology solutions to develop integrated communication systems that are critical to enabling connectivity for healthcare services and applications. Prior to joining the business world, Dr. Banks received a Ph.D. in physiology/biophysics from Case Western Reserve University where he studied human keratinocyte differentiation using both in vitro and in vivo model systems.

General Session—Manufacturing
Assessing the Cleanliness of Medical Devices
Wednesday, June 20th 11:00-11:55 AM
Stephen Spiegelberg, Ph.D., President, Cambridge Polymer Group, Inc.

The improvements in medical device design and surgical procedures in the past several years have resulted in a higher standard of clinical success for medical devices. As fewer complications arise from previous issues of material failure, product design, or surgical technique, emphasis is now being placed on the cleanliness of medical devices. Ideally, manufacturers would like to produce parts with no contaminants. Practically, this goal is not achievable, and manufacturing costs increase dramatically as manufacturers attempt to reduce the levels of contamination. Two key questions that most quality assurance engineers are asking these days are "how clean is clean enough?" and "how does one assess cleanliness?"

Recent product recalls relating to the device cleanliness have helped to spur activities within ASTM. Working with medical device manufacturers, analytical laboratories, NIST, the FDA, and medical device consultants, an ASTM task force has been working for the past 3 years to address issues of cleanliness in biomedical components. Work is being conducted to develop standards for assessing levels of cleanliness in metallic, ceramic, composite, and plastic components. The task force is also attempting to determine acceptable levels of cleanliness in the various biomedical devices.

Dr. Stephen Spiegelberg is the president and co-founder of Cambridge Polymer Group, Inc. He received his BS in Chemical Engineering from the University of Wisconsin-Madison, and his Ph.D. in Chemical Engineering from the Massachusetts Institute of Technology, where he studied toughening mechanisms in brittle plastics. He was a post-doctoral fellow at Harvard University, where he worked with NASA engineers to design and test an extensional rheometer for microgravity applications. He holds patents in analytical instrumentation and materials for biomedical application. At Cambridge Polymer Group, he directs a team of scientists performing contract research and testing on polymeric materials for the biomedical community and other fields. He chairs a task group in ASTM on the cleanliness of biomedical devices.

General Session—Manufacturing
Laser Marking and Engraving Using Integrated Through-the-Lens Vision
Wednesday, June 20th 3:30-4:25 PM
Faycal Benayad-Cherif, Ph.D., Virtek Laser Systems NA

Medical devices such as orthopedic components and screws are commonly serialized using laser-marking technology. Generally, parts are marked in the latter stage of production, where minor errors can turn into costly repairs or expensive waste.

A new approach relies on image processing technology to laser-mark medical components. This concept differs from existing approaches as the laser automatically aligns itself to the part instead of the time-consuming approach of an operator aligning the part to the laser. The system uses a vision model that verifies the proper device is in place and computes the part position and orientation.

This presentation will address the concept, its medical applications, and the product’s ability to ameliorate common manufacturing concerns by: marking only the correct part; achieving mark placement accuracy <0.001”; reducing expensive waste; achieving higher throughput, improved production yield, and lower cost of operation.

Dr. Benayad-Cherif is product manager at Virtek Laser Systems NA. He has developed the IMP (Intelligent Mark Positioning) system, a machine vision based system that offers unique means of improving laser marking and engraving processes through mark verification and alignment. Prior to joining Virtek Laser Systems NA, Dr. Benayad-Cherif was Lead Engineer for 3D solutions at Genex Technologies. There, he managed the development of a new product, the 3D FaceCam, a state of the art 3D imaging device commonly used in medical, engineering and sculpting applications.

In 2000, Dr. Benayad-Cherif was Electro-Optics Manager at Nortek Networks where he developed vision based robotic instrumentation for handling, inspecting and testing MEMS based tunable lasers. Prior to Nortel Networks, Dr. Faycal Benayad-Cherif was Principal Software and Hardware manager at Intelligent Automation Inc. There, he developed the 4Dimensional Imager, a high-speed 3D imaging used in dental, aerospace and automotive applications.

Dr. Benayad-Cherif has received his PhD. in Engineering Design in the field of biomechanics, a M.S. in Electrical Engineering (3D imaging) from Tufts University and a bachelor in Physics from the university of Algiers. He is a member of the IEEE and SPIE societies and the author of several publications on robotics and 3D imaging. Dr. Benayad-Cherif is also the author of many US and international patents.

General Session—Manufacturing
Non-Contact Coating Measurement
Thursday, June 21st 11:00-11:55 AM
Jeff Pavelka, Development Manager, Sensory Analytics, LLC

This session will describe a new suite of laboratory and in-line measurement systems designed to provide real-time coating thickness and color results for orthopedic devices including titanium implants, screws and pins. These systems provide results totally independent of substrate thickness, weight or geometry; do not require any correction factors; and provide NIST-traceable results for measurements performed on abstract shapes, holes, curves, edges, and miniature components.

The technique incorporates nanometric precision and does not require direct contact with the specimen, broadening the applicability of this system over other currently available contact-based or destructive test and inspection methods.

Jeff Pavelka is the Director of Development of Sensory Analytics. With over ten years of new product development experience with metrology technologies and systems integration for high technology applications. his expertise has been responsible for development of the SpecMetrix™ portable measurement and robotically integrated systems and multiple software systems.

Jeff earned his MS degree in Technology from East Carolina University and a BS degree in Manufacturing Technology from Texas A&M University. Jeff holds one issued patent for metrology systems and is co-inventor on numerous active patent applications. He has presented papers at various technical conferences and is recognized as an emerging leader in novel coating measurement methodologies.

General Session—Materials
Titanium
Wednesday, June 20th 11:00-11:55 AM
Henry J. Rack, Sc.D., Professor
Clemson University, School of Materials Science and Engineering

Titanium alloys are finding ever increasing interest within the medical device industry. Originally this interest focused on alloys that had been developed for other purposes—for example, commercially pure titanium (Ti-6Al-4V) and Nitinol (TiNi). However, recent synthesis of newer alloys specifically designed for medical device application—for example TMZF and TiOsteum, has presented the biomedical community with both an opportunity and a problem.

The opportunity involves the application of multi-materials for device design and application, while the problem focuses on the general lack of interest within the commercial titanium industry for producing relatively small quantities of "boutique" alloys. This presentation will consider the opportunities and will describe various paths that might be taken for providing the necessary materials supply base.

Dr. Rack received his ScD from MIT in 1968. Since that time he has been employed at the Lockeed-Georgia Company, Sandia National Laboratories, and ARCO Advanced Materials.

Since 1985 he has been a Professor of Materials Science and Engineering at Clemson University. He is a Fellow ASM, a past member of the National Materials Advisory Board, a holder of the Humboldt Stiftung in Metal Physics, and is an Adjunct Professor at the Technical University of Clausthal, Germany.

His research activities have focused on phase transformations and mechanical response in light weight materials including Al, Mg and Ti alloys and their composites. During the past 10 years his research has lead to the development of a low modulus titanium alloy, a non-Ni containing shape memory alloy, TiC reinforced titanium and most recently the utility of severe plastic deformation in achieving nano and ultra-fine grained structures in titanium alloys intended for medical devices.

General Session—Materials
PEEK Update—Advances in Implantable Biomaterials
Wednesday, June 20th 1:30-2:25 PM
Dr. Stuart Green, Senior Project Manager
Invibio Ltd. UK
Craig Valentine, Technical Manager
Invibio Inc.

Modern imaging technologies, in combination with new biomaterials, now enable medical practitioners to visualise internal healing as never before. This is most important in spinal fusion, where often the surgeon wishes to observe that fusion has been successful post operatively and over a period of weeks. Traditional metallic biomaterials either obscure observation such as by blocking x-rays, or produce distorting image artefacts as with MRI.

Polyetheretherketone (PEEK) polymer has been engineered to meet the needs in these and other implant applications requiring non-metallic, non-resorbing materials. Biocompatbile and lightweight, PEEK polymer is easily processed into medical artefacts by moulding or machining. It is highly chemically resistant, stable, and is compatible with all common methods of sterilisation. These factors, together with excellent mechanical properties—including low creep and high fatigue resistance—have contributed to the success of this high quality, cGMP manufactured product.

This presentation will compare and contrast polymeric resorbable and non-resorbable biomaterials, and metallic and ceramic biomaterials, in the context of PEEK and PEEK-based composites and compounds.

Dr. Stuart Green is a Chartered Engineer and a Fellow of the Institute of Materials in the UK. He graduated from the University of Liverpool in 1984 with a degree in Chemistry with Materials Science and completed his PhD on short-fibre reinforced polymer composite materials in 1988. He later joined Victrex Manufacturing Ltd in 1999 after a varied career as an aerospace materials engineer and polymer scientist involved with advanced materials development.

Invibio was formed as a wholly owned subsidiary of Victrex Plc in 2000 and at that time Dr Green became the Technical Manager with responsibilities for the development and safety testing of biomedical materials based on PEEK-OPTIMA including composites, compounds and stock shapes. Dr Green also provided technical and regulatory support to Invibio customers worldwide and has aided customers with their submissions to the United States Food and Drug Administration and European notified bodies.

Recently Dr Green became Senior Project Manager for Invibio with responsibilities for technical support to the Americas and Asia Pacific.

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Craig Valentine joined Scapa Porritt, an industrial textiles company, as development chemist following graduation from the University of Wales at Cardiff in 1991 with an honours degree in Polymer Chemistry and Technology.

After completing a year of post graduate study in Technical Textiles, he transferred to Syn Strand, Scapa's monofilament division based in South Carolina, initially as Technical Service Manager and then as the Research Scientist responsible for formulation development. He is the co-inventor of eight patents.

After twelve years in the US, Craig decided to return to his native England, joining Invibio as Technical Manager in January of this year. Craig is a member of the American Chemical Society and the Society of Plastics Engineers.

General Session—Materials
Steel Update—Trends and Innovations for Orthopaedic Applications
Wednesday, June 20th 3:30-4:25 PM
Anthony Guitterez, Market Manager, Medical Products
Carpenter Technology Corporation

This presentation will summarize current trends and innovations relative to stainless steels and cobalt-based alloys used in the orthopaedic industry. Topics include:

• raw material supply and demand challenges (nickel & cobalt)
• orthopaedic application trends
• material innovations (evolutionary vs. revolutionary)
• suppliers vs. business partners

Anthony Guitterez is the Market Manager for Medical Products at Carpenter Technology Corporation. With more than ten years' experience in the specialty metals industry, his responsibilities include global management and support of Carpenter's specialty metals for the medical industry. During his career he has served in various business development and technical service roles.

Anthony holds a B.S. in Metallurgy from the Colorado School of Mines and an MBA from Boston University. He is an active member of ASM International.

General Session—R&D
Smart Implants—In Pursuit of Eradicating Joint Replacement Infections
Wednesday, June 20th 11:00-11:55 AM
Javad Parvizi, M.D.
Orthopaedic Surgeon, The Rothman Institute

Biological modifications of conventional devices to counteract current implant-associated problems are underway. Self-protective 'smart' implants are examples of such accomplishments. The modification of the implant surface with a permanent covalent bond and tethering of antibiotics or other biofactors, if proven to be effective, is likely to transform the practice of orthopedic surgery and other medical specialties.

The current strong interest in translational products has brought experts from both the basic sciences and clinical practice to exploit the advances in biotechnology in hope of further improving the practice of medicine. Periprosthetic infection is one of the challenging and dreaded complications associated with joint arthroplasty.

This presentation will describe the in vivo performance of an innovative implant in an animal model. The implant has been engineered to be bactericidal by covalently binding vancomycin to the alloy surface. In comparison with unmodified titanium surfaces, the antibiotic-derivatized surface minimized clinical signs of infection, reduced bacterial proliferation, and prevented bone destruction. Preliminary findings are encouraging and hold great promise for the management of periprosthetic infection.

Javad Parvizi, M.D. is a board certified academic orthopedic surgeon currently an Associate Professor at Thomas Jefferson University, Philadelphia. His clinical area of interest includes pelvic, hip, and knee reconstruction. He is the Director of the Clinical research at the Rothman Institute and actively involved in conducting clinical trials and outcome studies on joint replacement patients. In addition he is actively involved in basic science research in tissue engineering and has received numerous grants from the National Institute of Health, Department of Defense, and other funding bodies for his work on development of self-protective smart orthopedic implants. He serves in numerous committees at institutional and national levels, and is a member of various editorial boards for orthopedic journals. He has received wide recognition for his clinical and basics science research. He is the author of numerous papers, book chapters, and books.

General Session—R&D
Smart Implants—"Systems on Chip" Products Through Integration of Microelectronics and Micromachining
Wednesday, June 20th 1:30-2:55 PM

The introduction of Micro Electro Mechanical Systems (MEMS) opens a new world of implantable and non-implantable medical devices through the use of sensors, actuators, and "smart systems." Wireless communication between small MEMS devices and an external power system is expected to dramatically change the way clinicians and surgeons interact with the body and musculoskeletal environment, including the completion of activities that were previously thought impossible.

The presenters will discuss MEMS technology for medicine, its application to spine and general orthopedics, and the formation of a new company called OrthoMEMS.

• Edward Benzel, M.D., Chairman
Cleveland Clinic Spine Institute

Edward C. Benzel, MD, is Chairman of the Cleveland Clinic Spine Institute, the Director of the Neurological Surgery Residency Program, Co-Director of the Spine Surgery Fellowship Program, at the Cleveland Clinic.

Dr. Benzel's major clinical interests embrace many aspects of neurosurgery, but are focused on spinal disorders including cervical spondylosis, syringomyelia and Chiari malformation, complex spine instrumentation, and spine tumors. Clinical research has encompassed such issues as hydrocephalus, neonatal hemorrhage, cerebrovascular disorders, cranial trauma, critical care, brain death, microelectromechanical systems (MEMS), and of course, spinal disorders.

He has been actively involved in the Congress of Neurological Surgeons, American Association of Neurological Surgery, North American Spine Society, and Cervical Spine Research Society. In addition to serving on numerous committees, and in different positions on the Board of Directors of the various societies, Dr. Benzel is Chairman of the World Spine Society (WSS), a division of the North American Spine Society, whose mission is to "improve spine health worldwide."

Dr. Benzel rigorously reviews clinical and research content for numerous professional neurosurgical and spine publications. He was Co-Chairman of the Editorial Review Board of the Journal of Neurosurgery (2003-2004), and is currently Chairman of the Review Board for the Journal of Neurosurgery: Spine. He has served as a reviewer for Neurosurgery, Spine, and The Spine Journal, and is an ad hoc reviewer for a variety of additional journals.

He has authored multiple textbooks (6), and over 178 book chapters. His seminal texts, Biomechanics of Spine Stabilization (1st & 2nd Editions) and Spine Surgery: Techniques, Complications, Avoidance and Management are conceivably the highlights of his publication endeavors.

Dr. Benzel holds several patents and has participated in many medical advances. He is perhaps best known as an educator; he has directed the Neurosurgery Residency Training Programs, and the Spine Fellowship Programs at both the University of New Mexico and at the Cleveland Clinic. His innovation in Neurosurgery Resident Education has won accolades and numerous awards.

• Shuvo Roy, Ph.D., Co-Director
BioMEMS Laboratory, Lerner Research Institute, Cleveland Clinic

Dr. Shuvo Roy received a B.S. degree, magna cum laude, with general honors for triple majors in physics, mathematics (special honors), and computer science from Mount Union College, Alliance, Ohio, in 1992. He received a M.S. degree in electrical engineering and applied physics and a Ph.D. degree in electrical engineering and computer science from Case Western Reserve University in 1995 and 2001, respectively. Dr. Roy was recruited to the Cleveland Clinic in late 1998 to develop MEMS technology for biomedical applications. The resulting BioMEMS Laboratory has developed a focus on MEMS in vivo for high impact applications in biomedical imaging, tissue engineering, surgical instruments, implantable sensors, and portable diagnostics. New intellectual property has resulted in the formation of startup companies resulting from clinical collaborations. Media coverage of the BioMEMS Laboratory work includes reports in the New York Times, PBS Newshour with Jim Lehrer, NBC Wall Street Journal Report, Science, and Small Times.

Dr. Roy is on the editorial board of peer-reviewed journals: Biomedical Microdevices and Sensors and Materials. In 2004, he established The Cleveland Clinic NanoMedicine Summit, which brought together over 300 scientists, engineers, and clinicians to focus on nanotechology solutions for unmet medical needs. This meeting evolved into the successful Materials, Medicine, and Nanotechnology Summit in 2006. He has more than 80 technical publications, has coauthored 2 book chapters, been granted 11 U.S. patents, and given more than 35 invited presentations. He is the recipient of a Top 40 under 40 award by Crain’s Cleveland Business in 1999 and the Clinical Translation Award at the 2nd Annual BioMEMS and Biomedical Nanotechnology World 2001 meeting. In 2003, Dr. Roy was selected as a recipient of the TR100, which features the world’s 100 Top Young Innovators as selected by Technology Review, the Massachusetts Institute of Technology’s Magazine of Innovation. In 2004, he was presented with a NASA Group Achievement Award for his work on harsh environment MEMS. In 2005, Dr. Roy was named as a Who's Who in Biotechnology by Crain's Cleveland Business and selected as a Cleveland Clinic Innovator.

• Doug Lee, President & CEO
OrthoMEMS

Douglas Lee has been President and CEO of OrthoMEMS, a wireless medical device company spun-out and incubated at the Cleveland Clinic, since its inception in 2004. Mr. Lee was also Chairman, President and CEO of The Dr. Spock Company, a venture-backed company in children’s health from 2000 to 2003.

Prior to that, Mr. Lee was Managing Director of Premier Medical Partner Fund LP, a healthcare venture capital fund from 1997 to 2002. Before Premier, he was a Vice President in the new ventures and corporate business development group at Guidant Corporation, a Fortune 500 medical device company divested from Eli Lilly, from 1995 to 1997.

Earlier in his career, he was an investment banker. He has served as a board member or observer of several venture-backed and start-up companies including Atrionix (acquired by J&J), Durect Corporation (NASDAQ: DRRX), and Endotex (acquired by Boston Scientific). Mr. Lee earned a B.S. in business administration from the University of California at Berkeley in 1987 and an MBA from the University of Chicago in 1991.

General Session—R&D
Using Analysis to Design Better Orthopaedic Products
Thursday, June 21st 9:00-9:55 AM
Vince Adams, Product Manager/Analysis
SolidWorks Corporation

Stringent regulatory controls, the use of expensive materials and the need for performance-to-weight ratio improvement makes the use of design analysis technologies such as finite element analysis (FEA) increasingly more important in today’s orthopaedic design industry. Participants in this session will learn about the state of the art in design analysis tools and techniques. The relevance of common design analysis practices will be discussed in the context of orthopaedic products and, where possible, will be illustrated with case studies and examples. This session will provide a solid introduction to the fundamentals of this important technology for building better products faster, as well as offer participants an opportunity to ask questions related to their particular needs to an industry expert.

Vince Adams has enjoyed multiple successes as a Product Design Engineer and Project Manager, accumulating several US & international patents. He learned the power of finite element analysis (FEA) as a design tool early in his career and has helped shorten the learning curve for many designers based on his experiences.

Vince is co-Author of "Building Better Products with Finite Element Analysis" from OnWord Press and other books on using & managing analysis in the desing process, has authored numerous articles on FEA, and has been an invited speaker at conferences on FEA and product design around the world. As a Product Manager on the SolidWorks analysis products team, Vince is committed to helping design engineers worldwide achieve greater success with simulated product validation.

General Session—Supply Chain
Lean Supply Chain Win/Win Culture Change—
Optimizing OEM-Supplier Cash Flow
Wednesday, June 20th 1:30-2:25 PM
Andy Novotny, Managing Partner
InterPro Group, LLC

Speed = Supply Chain Competitiveness. Learn how to speed up the flow of information, materials, and cash between operations and businesses in the supply chain. Enable stakeholders in your supply chain to see information in a unified manner and collaborate in the decision making process and make this information globally accessible while lowering costs.

OEMS will learn how to: Improve material availability, productivity of procurement and AP management, cash flow, vendor's customer service cost, and vendor commitments; and to reduce vendor lead-times, AP and vendor AR, reduce vendor inventory and risk of obsolescence.

Suppliers will learn how to: increase revenues, improve customer service, productivity of sales/customer service and AR management, AR and cash flow; and to reduce lead time, OEM inventory and purchasing cost, risk of obsolescence.

Manufacturing and/or distribution operations will learn how to: improve material availability, inventory turns and productivity; reduce inventory space, work in process, and setup-time; and increase production throughput, planning and productivity, and reduce production space.

Andy Novotny is Founder and Principal of InterPro Consulting. Mr. Novotny has over two decades of experience, both as a practitioner and consultant. His core competencies include industrial product development and manufacturing. In addition, he has extensive knowledge about Business Process Changes, IT Systems, Team Building, Management Vitalization, and Strategies for Improved Market Position. Born in Austria, he speaks fluent English and German. He has lived in the United States since 1993 and he is American citizen. His background includes Industrial Manufacturing and Electronics Engineering, a total of 6 years secondary education at a European technical institute.

Mr. Novotny's assignments included strategic, tactical and implementation responsibilities on management, interim management, and consulting levels. He has established new plant operations, integrated plants after mergers and acquisitions, and improved operational performance through product deployment planning, plant layouts, vitalizing of organizational hierarchies, developing lean information flow, implementing information systems, and integrating suppliers. In 2000, Mr. Novotny has started to help companies to identify opportunities, develop strategies, and implement programs to collaborate with suppliers and customers by aligning lean enterprise principles and information systems including Internet technology. In today’s globally competitive markets, the Lean Supply Chain Methods developed by Mr. Novotny yield significant advantages and results for manufacturing and distribution businesses.

Mr. Novotny has had practitioner product development and operations management experience in both Europe and North America. He established a new US plant producing industrial equipment, owned by a European company. This assignment included design and execution of plant layout, establishing engineering and manufacturing resources, material sourcing, business process development, and information systems selection and implementation including financials. The result was a 450% increase in shipments over a three-year period while significantly improving profit margins.

In Europe, his role was to help propel a new manufacturer of robots and automation systems into MARKET LEADER status, a goal achieved in 5 years. As head of Manufacturing & Materials, he led 120 employees and successfully managed to manufacture over 5000 robots and automation systems.

Prior to his management career, Mr. Novotny has had extensive experience working with industrial organizations in many western and eastern European countries and the middle-east. Through his travel experiences in the far-east he is also familiar with the cultural differences in this region.

Mr. Novotny is active in a variety of industry associations and he serves on the Board of Directors of the Association for Manufacturing Excellence (AME) and the Turnaround Management Association (TMA). Mr. Novotny can be reached at 860-229-9445, or via e-mail at andyn@interproconsult.com.

General Session—Supply Chain
Outsourced Processes and Regulatory Compliance—
How it Works, Where it Fails
Wednesday, June 20th 3:30-4:25 PM
Marc-Henri Winter, President
G-MED North America, Inc

Although it is common in the medical device industry—and especially in the orthopaedic sector—to appeal to subcontractors for the design and full or partial realization of a product, experience shows that in some cases this externalization may be at the origin of issues. In the most critical case, it will impact the safety of the product; in other cases, the consequences concern the inspection or regulatory audit results.

Based on ISO 13485 standard and the US QSR, this session will clarify the requirements applicable to medical device manufacturers when they outsource critical activities and will focus on the selection of vendors and the control of outsourced processes.

Covered topics include selection criteria; Quality Management System and certification; monitoring of outsourced processes; validation of processes; change control; vendor-customer communication; contracts/agreements.

Actual cases experienced by LNE/G-MED in the orthopaedic industry will be used to illustrate and will review situations where the lack of control of outsourced activities had direct consequences for the legal manufacturer.

Marc-Henri Winter is currently the G-MED North America, Inc. President/Executive Manager. For over seven years, he has been working for LNE/G-MED, initially as a project manager and then as the G-MED regional office manager. He is a senior lead auditor of quality management systems with reference to the European CE marking and the Canadian regulations, as well as the ISO 9001 and ISO 13485 standards. Mr. Winter is also in the process of qualifying as an FDA third party accredited inspector.

As a technical reviewer, his expertise covers non active implantable devices and surgical instruments, with a specific focus on the