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State of the Art in Design; 1974 These were my tools in 1971 when I entered Wentworth The drafting board lasted well into the 1980’s Calculators were not broadly available until 1973 A HP scientific calculator cost $400 in 1973, while a new VW cost $1600 COMPANY CONFIDENTIAL© COPYRIGHT 2010-2011 ConforMIS, Inc.1
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What is Knee Replacement? US Market +/- 700,000 Knee Replacements annually $3.2 Billion Worldwide $7 Billion Total Knee Replacement Where all 3 compartments are replaced 90% of all knee replacements are this Partial Knee Replacement Where 1 or 2 Compartments are replaced COMPANY CONFIDENTIAL© COPYRIGHT 2010-2011 ConforMIS, Inc.2
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Total Knee Replacement, TKR COMPANY CONFIDENTIAL© COPYRIGHT 2010-2011 ConforMIS, Inc.3 Modular Tibial Plateau, polyethylene and cobalt chrome, assembled at time of surgery Femoral Component Cobalt Chrome Patellar Component Polyethylene
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Unicompartmental Knee Replacement COMPANY CONFIDENTIAL© COPYRIGHT 2010-2011 ConforMIS, Inc.4 Indicated when there is disease in either the medial or lateral tibio-femoral compartment.
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Bicomparmental Knee Replacement COMPANY CONFIDENTIAL© COPYRIGHT 2010-2011 ConforMIS, Inc.5 Indicated when there is disease in the patello-femoral compartment and one of the tibio-femoral compartments.
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History of Knee Replacement COMPANY CONFIDENTIAL© COPYRIGHT 2010-2011 ConforMIS, Inc.6
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1885 DePuy is founded in Warsaw IN 1927 Justin Zimmer leaves DePuy to start Zimmer manufacturing 1934 Don Richards leaves DePuy to start Richards Manufacturing, now Smith & Nephew 1937 Venerable & Stuck develop Vitalium as a metal specifically for implant applications. 1968 Howmedica is founded in NYC 1974 Johnson & Johnson Orthopedics is founded in Randolph, MA 1977 Dane Miller leave Zimmer to found Biomet © COPYRIGHT 2012 ConforMIS, Inc. A Little Business History
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1978 Osteonics is founded in NJ 1979 Stryker acquires Osteonics 1985 Exactech is founded 1998 JnJ acquires DePuy 1998 Stryker acquires Howmedica 2003 Zimmer Acquires Centerpulse 2004 ConforMIS is founded COMPANY CONFIDENTIAL© COPYRIGHT 2010-2011 ConforMIS, Inc.8 A Little Business History
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Early Knee Surgery Relief of Pain Era 1800-1840 Resection Arthroplasty 1840-1890 Interpositional Arthroplasty 1891, Berlin Themistosicles Gluck, MD. First total knee replacement Fabricated from ivory 1938, Boston Smith-Peterson Mold Arthroplasty The first resurfacing knee implant © COPYRIGHT 2012 ConforMIS, Inc.
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Early Knee Surgery Relief of Pain Era 1958 Hinge prosthesis Hemiarthroplasty 1965 Proximal tibial replacement © COPYRIGHT 2012 ConforMIS, Inc.
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Lessons From Era 1 A knee is not a hinge; these implants suffered for fixation failure because the extreme constraint of the device transmitted torque to the stem, loosened the stems Metal on bone implants are more successful than hinges But pain persists in a high number of patients Fixation is unreliable COMPANY CONFIDENTIAL© COPYRIGHT 2010-2011 ConforMIS, Inc.11
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Meanwhile; 2 Major Innovations Take Place in Hip Surgery John Charnley 1958 John Charnley introduces the use of acrylic bone cement(PMMA) to fix teflon(PTFE) acetabular cups. 1962 Polyethylene(UHMWPE) demonstrates superior wear resistance in the laboratory and is applied to hip joints. © COPYRIGHT 2012 ConforMIS, Inc.
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Era #2 Restoration of Motion Cemented Metal and Polyethylene 1968; Polycentric First metal on plastic knee 1972; Geomedic High conformity Duo Condylar;1973 Low conformity COMPANY CONFIDENTIAL© COPYRIGHT 2010-2011 ConforMIS, Inc.13
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Duo Patella, 1975 First Tricompartmental Knee Replacement PCL retaining Total Condylar, 1975 PCL sacrificing Both Designed at HSS by; Insall Ranawat Walker COMPANY CONFIDENTIAL© COPYRIGHT 2010-2011 ConforMIS, Inc.14 Era #2 Restoration of Motion Cemented Metal and Polyethylene
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Lessons From Era #2 Tibial Fixation is inadequate w/out a central stem 1-Piece tibial plateaus with a central stem are superior Metal backed tibial plateaus emerge Highly constrained (at the tibial/femoral interface) implants have a higher tibial fixation failure rate But do not suffer from polyethylene wear to the same degree as low constraint designs Lower constraint implants have a higher failure rate due to polyethylene wear Replacing all 3 compartments results in better outcomes Range of motion rarely exceeds 100 degrees Implant sizes are inadequate Implant alignment matters © COPYRIGHT 2012 ConforMIS, Inc.
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Era #3 Solving Fixation, Wear and ROM 1980; LCS Meniscal bearing provides high conformity with low constraint Oxford Uni does the same Insall/Burstein Posterior Stabilized Increased ROM over Total Condylar PCA Porous Coated Anatomic First uncemented knee Introduced the first modern instrument set © COPYRIGHT 2012 ConforMIS, Inc.
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1986; PFC Left and right femurs Oval patella Keel tray Cemented and Porous coated components Solves the problems that PCA did not COMPANY CONFIDENTIAL© COPYRIGHT 2010-2011 ConforMIS, Inc.17 Era #3 Solving Fixation, Wear and RoM
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Lessons from Era #3 Metal backed patellas do not work fail from poly that is too thin Uncemented tibial plateaus are unreliable Uncemented femoral components work well PS knees are easier to install and work for all possible patients CR knees are more bone preserving The market is divided about 50/50 CR to PS Polyethylene wear persist Modular tibial inserts work well Mobile bearing knees perform well, but remain a ‘cult’ implant COMPANY CONFIDENTIAL© COPYRIGHT 2010-2011 ConforMIS, Inc.18
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Era #4; the 1990-2000 Modular Systems Emerge 1989; PFC Modular Established the first single brand system Modular components CR Primary PS Revision PS Shared tibial plateau Shared bone cuts 1 instrumentation system © COPYRIGHT 2012 ConforMIS, Inc.
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Era #4; the 1990-2000 A better Understanding of Polyethylene Tibial contact areas are increased to reduce contact stress Polyethylene failure mechanisms become understood Oxidation, the effects of gamma irradiation crosslinking Sterilization systems are modified for the polyethylene components to eliminate oxidation ETO re-emerges Vacuum and insert gas system Barrier packaging COMPANY CONFIDENTIAL© COPYRIGHT 2010-2011 ConforMIS, Inc.20
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Lessons from Era #4 Complete system approach to knee brands are the standard of care Tibial insert backside wear emerges as a problem Tray finish is indicated Micromotion between insert and tray become important Titanium tibial trays are black balled (incorrectly) Maybe the mobile bearing advocates were correct COMPANY CONFIDENTIAL21© COPYRIGHT 2012 ConforMIS, Inc.
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The Present Era, #5 Improving Patient Satisfaction Small incision and less traumatic surgery emerges Computer navigation becomes the rage Zimmer introduces the ‘Gender Solution’ Mobile bearing knees take 15% of the US market(DePuy) But decline substantially by 2010 The first Highly Crosslinked Polyethylene’s emerge into general use Robotic surgery emerges Patient Specific Implants and Instrumentation emerge COMPANY CONFIDENTIAL© COPYRIGHT 2012 ConforMIS, Inc.22
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COMPANY CONFIDENTIAL© COPYRIGHT 2010-2011 ConforMIS, Inc.23© COPYRIGHT 2010-2011 ConforMIS, Inc.23 Career Considerations
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Biomechanical Engineering Jobs Research & Development Product Development: Entails either product design or project management or both in the design and introduction of new products to the commercial marketplace. Biomechanical Testing: Is more research orientated in you provide the biomechanical validations to prove that new products meet design expectations. Material Engineering: Is more specialized in a degree in a specific materials field is usually required. These jobs either are focused on the development of new materials and material processing methods, or support the above 2 disciplines. They can also support ongoing manufacturing and be involved with failure analysis. COMPANY CONFIDENTIAL© COPYRIGHT 2010-2011 ConforMIS, Inc.24
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Biomechanical Engineering Jobs Academics Applied Research: Utilizes your biomechanical knowledge to solve existing problems, or to develop new treatments. Is typically a hybrid of research and early product development activities, but does not bring a product to marketplace. These types of projects are typically licensed to industry. Teaching Pure Research: Conducts original research into solving various problems in medicine. COMPANY CONFIDENTIAL© COPYRIGHT 2010-2011 ConforMIS, Inc.25
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Manufacturing Manufacturing Engineering: Develop manufacturing methods for medical devices. These can involve machining, molding, casting and assembly processes. This is not typically associated with advanced degrees in the biomedical field, yet I know several very successful people in this area who started with biomedical degrees. COMPANY CONFIDENTIAL© COPYRIGHT 2010-2011 ConforMIS, Inc.26
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Where Will Your Generation Take The Art of Product Design? My career has seen the advancement from the slide rule and drafting board to fully automated design software. In 1995 it took about 4 weeks to design a knee component, once the design parameters were established. Today we can do it in 30 minutes. In 1978 it could take 20 weeks to have tooling designed and manufactured to make orthopedic implants. Today we can rapid prototype a knee femoral component literally over night, and have it ready to implant in 7 days. Where will your generation take the technology? COMPANY CONFIDENTIAL© COPYRIGHT 2010-2011 ConforMIS, Inc.27
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Slamin’s Words of Wisdom on Career Find your passion and pursue it with all of your energy Focus on producing quality results; career growth will follow naturally Be honest with yourself and all of your colleagues Learn to work well in a team; No one does it alone Be patient You are expendable, in any organization Know when to say good night Find a non-work passion and nurture it. Don’t forget to live COMPANY CONFIDENTIAL© COPYRIGHT 2010-2011 ConforMIS, Inc.28
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Thanks; COMPANY CONFIDENTIAL© COPYRIGHT 2010-2011 ConforMIS, Inc.29
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