MRA – Member Companies Argenta Advisors, LLC Lighthouse Media, LLC The Bailey Group Medpace Baker Tilly Virchow Krause, LLP Oppenheimer Wolff & Donnelly LLP Boulder Creek Consulting/Green Gas QAD Inc. Canopy Medical, LLC Regulatory Strategies and Solutions, Inc. Creekridge Capital, LLC RJF, a Marsh & McLennan Agency LLC Co. DeviceAdvisors, LLP Silicon Valley Bank Devicix, LLC Square Feat, LLC DuVal & Associates, P.A. Swenson Gilliand & Associates Dymedex Consulting, LLC Talencio, LLC Healthcare Academy Technomics Research, LLC HGA Architects and Engineers ThreeWire, Inc. Introworks VTL Search KJ International Resources European Commercialization: Achieving Success as a Growing Medical Device Company J. Greg Davis Founder & CEO, MedCelerate, LLC My Device Background 4 ©2012 MedCelerate LLC, All Rights Reserved. Chasing Conflicting Commercialization Objectives Iterate Product Design Based on Clinical Experience Revenue and Reaching Cash Flow Positive Demonstrate Deep Penetration in Select Accounts Substantiate Market Potential What is Most Important to Achieve? Conduct Randomized Trial to Fine Tune U.S. Trial Parameters 5 Capture Competitive Market Share Create Buzz with KOLs & Potential Acquirers Collect Clinical Data & Experience ©2012 MedCelerate LLC, All Rights Reserved. Chasing Conflicting Objectives - Case Study Commercial Objectives • Exit Year 1 with revenues >$1M/month • Maintain premium pricing • Focus on deep penetration in accounts • “Go Big or Go Home!” Lessons Learned Implementation • Hired direct sales reps in UK & GER • Signed 18 distribution agreements • Engaged three GER sales agents Results • Maintained premium pricing • Objectives incompatible • Understand sales levers before expanding geographically • Strong adoption by some KOLs • KOL support only part of story • Focused on large accounts • Created strong buzz and awareness • Driving adoption best done directly • Launched in 22 countries in 7 months • Exited year at 25% of revenue plan • Adoption impacted by price, limited • Set premium price with strict controls • Product positioning: Easy-to-Use 6 clinical data and ease-of-use ©2012 MedCelerate LLC, All Rights Reserved. Blessing and Curse of CE Mark Approval EU Regulatory Class # of Patients Trial Region Cardiovascular III 30 Europe Peripheral Artery IIb 11 South America GERD III 24 South America Venous Disease IIb 11 Caribbean Cardiovascular III 25 Europe - Limited clinical experience, with small number of KOLs, does not guarantee product viability 7 ©2012 MedCelerate LLC, All Rights Reserved. Building Clinical Data Set Post-CE Mark - Case Study • CE Mark enrollment (30 patients) • One Employee • Adverse events • IDE enrollment • Product recalls • Redesign required • Registry initiated • Product line extensions • Registry data published (800) 2007 2008 2009 2010 2011 2012 (30)* (85) (500) (800) (3,500) (>5,000) * Cumulative # of implants • CE Mark approval • Contract manufacturer change • “Minor” design change • Limited product launch 8 • Contract manufacturer change • CE Mark approval, launch • IDE approval • Registry data published (253) • IDE enrollment complete • Registry data published (+1,000) ©2012 MedCelerate LLC, All Rights Reserved. Deciding Approach to Customer: Distributors versus Direct Employees? Product Profile Commercial Objectives • Changing clinical practice? • Alignment with objectives? • Physician learning curve? • Revenue ramp? • Market development? • Investor patience/dry powder? • Gross margin? • U.S. market strategy? • Niche product? Market Dynamics 9 Distributor Capabilities • Reimbursement? • Customer relationships? • Local tenders? • Technical expertise? • Hospital payment terms? • Financial stability? • Number of accounts? • Product portfolio? • Geographical spread? • Interest/desire? ©2012 MedCelerate LLC, All Rights Reserved. Distributor as Commercial Partner - Case Study Strategy • Involved early in commercial planning • Open and frequent communication to build trust • Collaboration on programs aimed at our commercial objectives • Open about company’s progress towards major milestones • Offered equity investment opportunity • Joint visibility with KOLs Results • Remained with us during 10-month redesign effort • Consistently achieved/exceeded quarterly sales targets • Produced strong product adoption in key accounts • Award for outstanding sales & clinical support performance, 2011 10 ©2012 MedCelerate LLC, All Rights Reserved. Delivering Robust Product Supply Requires Time & Teamwork In-house vs. Contract Mfg., New Packaging Design & Materials Evaluate Vendors, Technology Transfer, Vendor Management Product Branding, Multilanguage, International Symbols, Reg. Review Final Assembly /Pack Component Suppliers Financial Support Labeling, IFU Validations, Biological Indicators, Vendor Management Sterilization First Commercial Shipment! Logistics Bank Accounts, VAT, A/R & A/P, Inventory Reporting Order Entry & Fulfillment, Invoicing, Returns, Multi-lingual Support 11 Customer Service Authorized Rep Inbound/Outbound Transport, Warehousing, Traceability, Customs Appoint Safety Officer, Customer Complaints & Inquires ©2012 MedCelerate LLC, All Rights Reserved. Building Capable Supply Chain - Case Study 12 Pre-CE Mark (Q1 2011) Post-CE Mark (Today) Manufacturing • U.S. component mfgrs • Adhesive, kitting & pack in CA • Sterilization in CA • Product made in Ireland • Adhesive production in NC • Sterilization in Belgium • EU Operations Director (Irish) Labeling/IFU • English only • Generic labeling • 8 languages • New branding, Venaseal® Logistics • Non-existent • NL distribution center (outsourced) Authorized Rep • Non-existent • Emergo - NL Customer Service • Non-existent • Multi-language call center - NL Financial Support • U.S. bank account • 3 EU bank accounts • In-depth VAT analysis ©2012 MedCelerate LLC, All Rights Reserved. Product Transformation 13 ©2012 MedCelerate LLC, All Rights Reserved. Key Takeaways • Align commercial objectives, focus on few • CE Mark does not mean you have product • Validate sales levers before expanding “It’s all about what happens at the account level” • Product profile important for determining approach • Don’t underestimate supply chain complexities • How does technology save HC system money? Good Luck! 14 ©2012 MedCelerate LLC, All Rights Reserved. Panel Discussion Moderator Randy Ban Inspire Medical Systems Senior Vice President of External Operations Panelist J. Greg Davis MedCelerate, LLC Founder & CEO Panelist Ross Meisner Dymedex Consulting Managing Partner Thank You.