New Technologies and Materials

Transcription

1 New Technologies and Materials Daniel Delfosse BioTiNet, Topics 1. Introduction to orthopaedics (joint replacement) 2. Where are the problems to be solved? 3. What material or technology could solve the problem? 4. Integration of new technologies and materials into the current business 3 examples Page

2 Turnover (Mio CHF) Mathys Ltd Bettlach Locations: Headquarter CH, production CH & D, 12 subsidiaries 480 staff, Turnover 120 Mio CHF Average growth 10 % from 2003 to Page Focus on Joint Replacement Page

3 How (not) to drive innovations Evaluating the risks and opportunities Page 5 Innovation Management@ Mathys Input: 50 ideas/y (2-3 ideas selected) Customer needs, Clinical problems Own ideas New technologies (universities, companies) Innovation & Technology Marketing & Development Idea Scouting Idea Scoping Implant Research Development GATE I: Potential Success GATE II: Technical Feasibility GATE III: Potential Value & ROI Product Development Process Input/Output (M&D): 5 products/y (M & G-projects) Output: 1 product /y (50-70% of I-projects become a product) Page

4 Introduction to Orthopaedics (Joint Replacement) Osteoarthritis of the hip & knee Painful and disabling disease 4

5 Who are our end customers? «The patient» Age: average 65 years (18 to 100 years) 1. Earlier intervention (less suffering) 2. Higher life expectation 3. Higher activity level 4. Higher BMI increasing demands on implant Page The dilemma of an innovator (in orthopaedics/joint replacement) Different philosophies exist, but everything works : >90% survival rate at 10 years follow-up The killer demand: «Give me something new, innovative, but with 10-year clinical data!» Page

6 The dilemma of an investor (in orthopaedics/joint replacement) Joint replacement: Saturated market New products must work as well as existing ones Margins under pressure outcome-benefit prizing difficult to prove EBM, HTA Nobody pays (more) for incremental innovations Radical innovations need reimbursement Public swimming pool, Tokio Page Defining the Clinical Problem 6

7 What still goes wrong in hip replacement Anchorage Strength Articulation/wear Clinical problem = Potential for improvement 1. Anchorage 2. Articulation 3. Surgical technique 7

8 Incremental vs. radical innovation Incremental innovations: Optimisation at high performance level (>90% survival at 10y) mostly «marketing innovations»: good story no clinical improvement Lower production costs immediately visible for CFO Material improvements not visible within first 3 years Design improvements not visible within first 10 years Radical innovations: Self-healing or guaranteed implant survival for lifetime of patient (< 50 y) Pioneer: difficult registration and reimbursement Page Impact of New Materials & Technology (3 examples) 8

9 Step costs (CHF) 1. Improvement of knee prosthesis Clinical/economical problem: TKA too expensive for emerging markets (and DE). Potential improvement (manufacturing technology): Change design/tolerances Change material Decrease manufacturing steps Page Improvement of knee prosthesis 70 Femoral Knee manufacturing costs Costs Seite

10 Improvement of knee prosthesis Potential improvement (manufacturing technology): Decrease manufacturing steps 1. (Near-)Net-shape blanks 2. Eliminate mechanical grinding 3. Reduce manual labour casting or additive manuf. vibratory finishing cost reduction 40% Page Improvement of hip joint replacement Revison cause #1: wear Wear particles lead to bone loss and implant loosening Every step you take: > PE-particles 10

11 Improvement of hip joint replacement Clinical problem: Wear leads to osteolysis and implant loosening. Potential improvement (material technology): Increase wear resistance better materials 1. Harder metals Failed 2. Tougher ceramics ceramys ( 5 Mio TO in 5y) 3. Cross-linked polymers vitamys ( 5 Mio TO in 2y) Materials technology offers more improvements than design Page A radical innovation: ACL-healing ACL ruptures: 2 to 4 mio/year worldwide 11

12 A radical innovation: ACL-healing Radical re-thinking of clinical problem: ACL have self-healing capability! Page A radical innovation: ACL-healing Male patient, 25 y, with torn ACL DIS 1-year post-op, ACL healed 12

13 A radical innovation: ACL-healing Female patient, 25 y, 6mth post-op Female patient, 48 y, 9mth post-op Integrating new technologies and materials into the current business 13

14 Improvement of knee prosthesis Lessons learned (manufacturing technology): New manufacturing technology offers big potential for cost reduction BUT: Needs close relationship to subcontractor Needs willingness for external partner to innovate Needs mutual agreement re. IPR/(co-)exclusivity Needs investment in new machines Needs support from RA & QM Page Mission 2004: Development & production of own HXLPE Project schedule: Evaluation of IPR, purchase patent: 2005 Materials development: Biocompatibility testing: Biomechanical in-vitro testing: Manufacturing technology: CE-mark for RM-Pressfit vitamys First implantation Clinical proof in-vivo: Nov

15 Development & production of own HXLPE Lessons learned (materials development): New materials offer big potential for wear reduction BUT: Needs close relationship to subcontractors Needs time to develop/optimise/test and get CE-approval & registration in JP/CN/BR/FR etc. Needs even more time to prove the clinical benefit Needs investment in new machines Needs support from top management Page A radical innovation: ACL-healing A flop, a hype or a revolution? Project start: 2007, animal studies 2007& 2008 IPR: 3 different patent applications 2008, 2009 & 2011 First implantation: 2009 (pilot study Univ. Hosp. Berne, 10 cases) Optimisation of surgical technique: (200 cases) Start of multicenter study: June 2013 (5 clinics, CH/DE/BE) Problem no. 1: no official reimbursement Problem no. 2: no acceptance (newcomer) Investment: 4 mio CHF vs. turnover: 0.5 mio CHF Page

16 A radical innovation: ACL-healing Lessons learned (new therapy): Radical innovations offer big potential to revolutionise medicine BUT: Needs willingness to innovate (leave the beaten track) Needs time to develop/optimise/test and get CE-approval Needs more time to prove the clinical benefit (HTA) Needs even more time to get reimbursement Needs investment in new marketing approach Needs support (& patience) from top management Page Conclusions 16

17 Conclusions 1. Innovation management: Define and understand the basic underlying clinical problem. improve care, reduce cost 2. Materials development & technology Be well connected with your subcontractors and universities. select best external partners 3. Integration of new technology: Ensure support from the top management, because the project time* will be longer than they think. t* = 2t + B Page Thank you for your attention! If you're not failing every now and again, it's a sign you're not doing anything very innovative. Woody Allen Page