1 11 TH EDITION I 2015 CONFERENCE PARIS I FRANCE Tuesday, June 16 th 2015 Étoile Saint-Honoré Conference Center Two tutorials on the orthopaedic market and contract manufacturing Keynote speakers from major
2 EDITORIAL MEET THE MAIN PLAYERS IN THE ORTHOPAEDIC MARKET T he I conference, which was held for the 10 th time in Lyon last year, now moves to Paris for its redesigned 2015 edition. On Tuesday, June 16 th, the Étoile Saint-Honoré Conference Center near the Arc de Triomphe will host the orthopaedic implant community (orthopaedic, contract manufacturers, public research laboratories, financial and private equity firms, etc.) for a full day of lectures and discussion on the changes underway in manufacturing technologies and purchasing strategies. The main theme of this day revolves around providing concrete answers to the following question: How can orthopaedic contract manufacturers position themselves in the face of a rapidly changing marketplace due to new technologies, materials, regulations and the emergence of BRIC countries? The day will start with two unique tutorials. The first will review extensive data on the European and worldwide orthopaedics market such as volume, price and market share of the various along with the impact of new bearings and high-growth products: dual mobility cups, mini-hip stems, universal shoulder stems, trabecular metal, etc. The second will focus on the contract manufacturing market along with technological and strategic changes; product-by-product contract manufacturing strategy for the major orthopaedic players (Zimmer, Stryker, DePuy Synthes, Smith & Nephew, Biomet, Medtronic, etc.) will be discussed including who subcontracts what (trends and ratios for each product) and the contribution of contract manufacturers during the various stages of manufacturing (forging, casting, machining, coating, packaging, etc.). More than a dozen speakers from leading will share their vision, analysis and goals, with a special focus on additive manufacturing. As in previous years, Avicenne, the host of the I conference, will be in Las Vegas in late March to take the pulse of the worldwide market by interacting with the main players in orthopaedics. Have a great conference! Ali MADANI, CEO of Avicenne consulting and Founder of the I event LOCATION: ÉTOILE SAINT-HONORÉ CONFERENCE CENTER 21/25, rue Balzac Paris (France) Subway: Charles-de-Gaulle-Etoile, George V, Ternes (lines 1, 2 & 6) PURCHASING MANAGERS FROM ORTHOPAEDIC COMPANIES AND CONTRACT MANUFACTURERS WILL ANSWER THE FOLLOWING QUESTIONS: What are the general trends and changes in orthopaedics contract manufacturing? Are the major EOMs relying more on contract manufacturing? What are the key growth factors and barriers to development for orthopaedics contract manufacturing? What roles will BRIC (especially China, India and Brazil) and Central European countries play in the future of contract manufacturing? Which products are the priorities? What are the risks for contract manufacturers in developed countries? What is the impact of regulations and certifications? Will this mean more inspections and audits, and stricter controls for contract manufacturers? What are the needs of orthopaedic OEMs? One-stop shopping, shared responsibilities, co-invention and co-development agreements, etc. What is the significance of provision of raw materials and associated services? What are the long-term trends affecting casting, forging, machining, coating and finishing processes? How will the availability of generic instrumentation affect spine and trauma surgery in low-cost countries? How has contract manufacturing of the coating process changed? How do the major EOMs work with product markings, packaging and sterilization? SPECIAL FOCUS ON ADDITIVE MANUFACTURING: STRATEGIES USED BY ORTHOPAEDIC COMPANIES Will additive manufacturing be a key technology for the orthopaedics industry in the years to come? What strategies are the major orthopaedic adopting relative to additive manufacturing? Buy or Build? Will the EOMs develop the capabilities internally to maintain a strategic advantage or do they prefer buying or subcontracting this technology? Technologies: Electron Beam Melting, Selective Laser Melting, Trabecular Titanium, Trabecular Tantalum, Trabecular Metal, Powder Technology, 3D printing. Applications: acetabular cups, knee replacement components, intervertebral cages, disc replacement, shoulder glenoid component, CMF implants, dental implants. Who will attend I? In 2014, the I conference celebrated its 10 th anniversary. Past conference attendees were from the following locations: France 45% Switzerland 15% USA 8% Europe and ROW 32% They represented these types of and institutions: contract manufacturer 45% up-and-coming orthopaedic manufacturer 23% major orthopaedic manufacturer 15% private equity and financial 9% public research laboratory 5% media 3% Rest of Europe & World USA Contract manufacturers 32% 8% 45% 15% Major orthopedic 15% 45% 23% 5% 9% France Switzerland Challenger orthopedic Public research laboratories Private equities, financial Medias 3%
3 TUESDAY JUNE 16 TH, 2015 MORNING Ali Madani: Welcome - Overview CONFERENCE PROGRAM HIP 52 HIP SESSION I TUTORIAL: Orthopaedics Market (75 min) Ali Madani, CEO, Avicenne Orthopaedic Worldwide market: Hip, Knee, Shoulder, Trauma, Spine, Biologics, etc. Major Worldwide players: Position, market share, strengths & weaknesses: DePuy-Synthes, Medtronic, Zimmer, Stryker, Biomet, Smith & Nephew European players (> 100): market share in each country; position, strengths & weaknesses High-growth trends and segments, market dynamics, market shares: Dual mobility cups, Mini hip & shorter stem, Anterior surgical approach, Trabecular metal, Universal stems for shoulders, etc. Main countries (Germany, UK, France, Spain, Italy) and (Belgium, Denmark, Finland, Sweden, Ireland, Netherlands, Austria, Luxembourg, Greece, Portugal, Switzerland & Norway) Implant bearings segmentation: cemented, cementless, hybrid, Metal/PE, Ce/PE, Ce/Ce Reimbursement and regulatory trends Market forecasts up to 2018: data, main trends TUTORIAL: Contract Manufacturing (75 min) Ali Madani, CEO, Avicenne Orthopaedic Contract Manufacturing: By capability: Forging, casting, machining, coating, packaging and sterilization By 20 product: Hip, Knee, Shoulder, Trauma, Spine, Instruments, cases & trays, Contract Manufacturing and in-house rates and volumes for each product Contract Manufacturing Strategy for every Major Worldwide player: Forging, casting, machining, coating, packaging outsourcing vs. in-house process for DePuy-Synthes, Medtronic, Zimmer, Stryker, Biomet, Smith & Nephew OEM needs: Analysis of all Contract Manufacturing needs by OEM, volume, value Contract manufacturing market share by capability: Forging, casting, machining, coating, Instruments, cases & trays by player and by area COFFEE BREAK SESSION 2 20 Contract Manufacturing: Orthopaedic Company needs and strategies Bill Dow, CEO, Tecomet Trends in Medical Device Contract Manufacturing Tailwinds Headwinds Trends and Opportunities Bill Dow Bill has a broad background in general management focused in medical devices and services. He has served as Chief Executive Officer for firms with $1 million to over $0 million in revenue with products ranging from high-tech medical instruments involving electronics and software to commodity disposables. Start ups, turnarounds and growth maintenance have all been included in Bill s portfolio. Public, private and family owned business in disposables, capital equipment and services are also applicable descriptive terms. Griffith Micro Science (contract sterilization), Deknatel Snowden Pencer (chest drainage, sutures and surgical instruments), PLC (revascularization laser) and Aksys (home kidney dialysis machine) are among the he has managed. Bill earned his BS in Engineering from the United States Naval Academy and served in the United States Navy for seven years as a pilot and supply officer. SESSION 2 (CONTINUED) Daniel Delfosse, Innovation & Technology Director, Mathys Impact of regulations on the contract manufacturing of an European orthopaedic company What is the impact of regulations and certifications? Will this mean more inspections and audits, and stricter controls for contract manufacturers? What are the needs of orthopaedic OEMs? One-stop shopping, shared responsibilities, co-invention and co-development agreements, etc. Daniel Delfosse Daniel received the Diploma in Materials Engineering from ETH Zurich in 1985 and the Ph.D. from EPF Lausanne in During he was employed as research fellow at the University of British Columbia in Vancouver, Canada, working on fibrereinforced materials used for aircrafts. In 1996 he joined the Swiss Laboratories for Materials Testing and Research (EMPA) in Thun where his projects involved him with numerous SMEs, notably in the areas of watch making. In 2000 he joined Mathys Medical Ltd as head of product development for the orthopaedic division. In 2003 he became a member of the Executive Board of Mathys Ltd Bettlach. Since October 2007, he heads the Innovation & Technology department and is responsible for product risk assessment and the controlled introduction of innovative medical devices. Stefano Adami, Regulatory Affairs Senior Specialist, Zimmer GmbH Risk Management within the Product Lifecycle: an integrated approach Introduction on ISO 14971:2012: The standard requirements within the current Medical Device Directive Risk Policy as the base for a successful Risk Management Product Lifecycle: The use of different techniques for each phase Integration of the Risk Management within the Company: A Team approach Stefano Adami In 2003 he obtained his Degree in Mechanical Engineering at the University of Udine with a thesis on Finite Elements Analysis of a Wagner type femoral stem under development at Lima-Lto (Italy). After a period spent in England working for The Medical House an innovative medical device company, he joined Limacorporate (former Lima-Lto) where he developed his knowledge in orthopedics, focusing on regulatory affairs and quality. Stefano has leaded the Regulatory Affairs department from 2007 growing the team from 3 to 10 people worldwide and sustaining the growth of the company bringing the products to the main Markets, such as Japan, Australia, USA, Canada, China and Brazil. In 2012, thanks to a strong teamwork effort lead by Quality and Regulatory, Limacorporate successfully passed the first audit from FDA. In 2014, Stefano Adami has joined Zimmer Regulatory Affairs Department; currently he is leading a project for the deployment of a new Risk Management Global Procedure for the site of Winterthur. Conférence internationale pour l innovation des implants orthopédiques et des biomatériaux Mike Miller, CEO, Orchid Orthopaedic Solutions, LLC Challenges and Solutions in orthopaedic contract manufacturing Challenges: Price pressure - Complex regulations (FDA, Globally) - Consolidation Solutions: Culture Leader - Lean - Removing Costs - Technology Mike Miller Mr. Miller formed Stealth Technologies in 1990 and quickly established Stealth as a key supplier of high-performance auto parts. Groundwork was being laid to enter the business of supplying complex near-net forgings to the orthopaedic implant industry. Shortly after, Stealth became a major supplier in the implant forging business; Mr. Miller was instrumental in introducing these near-net forgings to the medical industry and has built Orchid into what it is today. In 2005, Mr. Miller was named CEO of Orchid. In 2008, Mr. Miller retired into the Chairman of the Board position. His love for the company brought him out of retirement in 2010 as he stepped once again into the role of CEO. Mr. Miller continues to serve on the Board of Directors for Orchid Orthopaedic Solutions.
4 LUNCH Conférence internationale pour l innovation des implants orthopédiques et des biomatériaux AFTERNOON SESSION 3 Additive manufacturing, Oxinium and Trabecular Metal Process for Orthopaedic implants & Instruments: from highly complex and customized manufacturing today to the mass market tomorrow Gordon Hunter, Group Manager, Materials Quality & Strategic Manufacturing - Advanced Surgical Devices, Smith & Nephew Implementing Oxidized Zirconium - Advanced Bearing Technology Combining the benefits of ceramic and metal Overcoming barriers for introducing a new technology Demonstrating safety and clinical efficacy Gordon Hunter For over 21 years, Gordon has worked on the commercial implementation of new materials and processes for making orthopaedic devices. He also manages quality assurance of the materials used in production. He led the development and implementation of OXINIUM TH oxidized zirconium knee and hip prostheses. He also works with polyethylene, bone ingrowth surfaces, and powder metal technologies. Before S&N, he worked for GE Aircraft Engines assisting with the development and commercial implementation of cold hearth melting for producing inclusion-free titanium alloys. Gordon graduated from the Massachusetts Institute of Technology with a PhD in Metallurgy in 1984, and has 18 US patents and over 50 technical publications. Claude Rieker, Director European Scientific Affairs, Zimmer Trabecular metal technology, an alternative to additive manufacturing Tantalum, one of the metals with the best biocompatibility The needs of a porous structure Example of the excellent clinical results (first implantation in 1997) Claude Rieker After having studied material sciences at the Swiss Institute of Technology in Lausanne (EPFL), Claude Rieker studied the rapid solidification of stainless steels at the University of Neuchâtel and obtained his PhD in 1990 from this university. He started to work in orthopaedics immediately after his PhD, designing hip implants and working closely with key European surgeons like M.E. Müller, H. Wagner, E. Morscher, and L. Spotorno. From 1995 to 2006, Claude Rieker had the global responsibility of all research activities in tribology for Sulzer / Zimmer and developed / optimized all the bearings within the portfolio of Sulzer / Zimmer. During these 11 years of research, Claude Rieker gained extensive knowledge on hard-on-hard bearings, on highly cross-linked polyethylene technologies, and also on all tribologic aspects of total joint arthroplasties. The key results of these activities have been published in peer-reviewed journals. For the last 8 years, Claude Rieker has the responsibility of the European Scientific Affairs for Zimmer. Stephanie Kochbeck, Business Development Manager Medical, EOS GmbH Electro Optical Systems Evolution of Additive Manufacturing in the Medical Market Is AM becoming a mass market technology or will it stay a niche one? For which orthopaedic applications? Which challenges and opportunities exist for AM as a production technology for medical devices? What can we learn from other industries using AM? Stephanie Kochbeck Business Development Manager Medical, EOS GmbH Electro Optical Systems Stephanie Kochbeck, a Mechanical Engineering graduate from ETH Zurich and MBA graduate from Collège des Ingénieurs, is Business Development Manager Medical at EOS GmbH since EOS is the technology and market leader for design-driven, integrated e-manufacturing solutions for Additive Manufacturing, an industrial 3D printing process. EOS offers a modular solution portfolio including systems, software, materials and material development as well as services. Stephanie is responsible for establishing Additive Manufacturing solutions in the orthopedic market as well as discovering and exploring new business opportunities in this field. COFFEE BREAK
5 SESSION 4 Implants, Instruments & Raw Materials Procurement sourcing Orthopaedic Supply Chain Management Mario Powierski, Supplier Quality Specialist, Biomet Deutschland GmbH Integrated Supplier Approval - from compliance to IT Integrated supplier approval: implementing a process covering all internal stakeholders from compliance to IT Knowing your supply chain: issues with identifying and approving the different parts of a supply chain Legal, regulatory, ISO and other requirements: bringing it all together Mario Powierski As part of the Biomet Deutschlands QA team, Mario is responsible for all activities related to supplier approval and assessment. He leads the supplier assessment team and coordinates assessment activities such as documentation reviews, onsite audits, continuous monitoring of supplier performance etc. One key activity was the introduction of an auditing process which led to numerous audits of implantable raw material manufacturers within Europe and Russia. All in all Mario conducted over 50 audits during the last 5 years covering for example raw material, packaging, print product manufacturers, as well as special service providers and contract manufacturers. He also leads the team of internal auditors of Biomet Deutschland and coordinates and conducts internal audits as per ISO requirements. Last but not least Mario is also managing the complete QM system of our Biomet Switzerland location. Steve Smith, President, Edge International The role of the distributor in medical grade raw materials Who are the customers for medical grade materials? Current volumes and trend for 2016 and beyond Role of the Distributor compared to the Manufacturer Value added services from the Distributor Steve Smith Steve Smith is president and owner of Edge International, based in Dayton, Ohio, USA. Edge is a stocking distributor of Cobalt-alloys, Titanium and Stainless Steel used in the manufacturing of orthopaedic implants, spine and trauma products for the medical device industry. Smith has extensive experience in specialty steels and metals, gaining initial knowledge of manufacturing at a major UK specialty steel mill, before moving into distribution. He saw a need for less than mill quantities of medical alloys from stock, especially for the contract manufacturers and has concentrated in this field for the last 20 years. Edge conducts business on a worldwide basis. SAVE THE DATE! The I 2016 Conference & Exhibition will be held in the spring of 2016 in Paris. This 2-day meeting will bring together orthopedic specialists from all over the world. If you are interested in presenting a talk, having a booth or being a sponsor for I 2016, contact: Marketing beginning now! CONTACTS: For any questions related to the organization of the I 2015 conference, you can contact the organizers by Ali Madani, Chairman: Monica Visinoni, Conference Manager & Sponsorship: Claude Foubert, Event Director: MEDIA PARTNERS: Photo: Pixel & Création - Fotolia.com