Wright Medical Group, Inc.

Transcription

1 Wright Medical Group, Inc. A Global Orthopaedic Medical Device Company We are a global orthopaedic medical device company specializing in the design, manufacture, and marketing of reconstructive joint devices and biologics. Wright's product offerings include large joint implants for the hip and knee; extremity implants for the hand, elbow, shoulder, foot and ankle; and both synthetic and tissue-based bone graft substitute materials. 1

2 Wright Medical Group, Inc. Two Fundamentally Solid Platforms EXTREMITIES and BIOLOGICS ORTHO-RECON 40% 60% 2

3 Foot & Ankle Product Portfolio - Most comprehensive & innovative SIDEKICK Fixation GRAFTJACKET Ulcer Repair Matrix VALOR NAIL Fixation CHARLOTTE Jones Fracture Screw DARCO Screws CHARLOTTE CLAW CHARLOTTE CLAW 3.5mm Implant 2.7mm Implant CHARLOTTE Compression SIDEKICK Stealth Fixation INBONE Total Ankle AM Surgical Endoscopic Blade CHARLOTTE 7.0 MUC Screw BIOFOAM Wedge ORTHOLOC Plate LIS FRANC Plate CHARLOTTE 3.0 MUC Screw DART-FIRE Screws ORTHOSPHERE Implant CHARLOTTE Snap-Off Screw DARCO DPS Plate BIO-ARCH Implant ORTHOLOC Plate SWANSON Hammer Toe Implant ENDO-FUSE Rods and Beams DARCO PIA Plate DARCO LPS Plate DARCO BOW Plate DARCO MPJ Plate LPT Toe Implant SWANSON Great Toe CORETRAK Tube Fixator MTP Plate DARCO RPS Plate 3

4 Upper Extremity Product Portfolio - Legacy Leadership In Niche Segments GRAFTJACKET Graft SWANSON Finger Implant EVOLVE Plate MICRONAIL Implant RAYHACK Ulnar Shortening RAYHACK Radial Malunion EVOLVE Implant 4

5 Ortho Recon Innovative Knee Portfolio ADVANCE Medial Pivot 10+ Years of clinical success Medial-Pivot Kinematics MIS Instrumentation Cementless Fixation Patient-Specific Instruments 5

6 Ortho Recon Innovative Hip Portfolio Modular Hip Systems Innovative & Comprehensive Acetabular Systems Resurfacing & BFH Modularity Bearing Options CONSERVE PLUS Total Hip Resurfacing CONSERVE Total with BFH Technology Hip System Confidence with Stability. DYNASTY Acetabular with BIOFOAM CANCELLOUS TITANIUM 6

7 BACKUP SLIDES 7

8 Quality System Global Quality System Certifications Ø ISO 13485:2003 Ø ISO 9001:2008 AATB Accredited Tissue Bank FDA Establishment Registration #

9 Quality System Overview Quality Policy We will meet or exceed the expectations of our customers by complying with requirements, by maintaining the effectiveness of the quality management system, by training employees, and by designing and building quality into our products.

10 Quality Manual

11 FDA Initiatives Fostering Device Innovation DeNovo reforms to the regulatory pathway for lower-risk novel devices with no 510k option, but which do not warrant the PMA requirement for higher-risk devices 510(k) program reform: CDRH plan to incorporate new scientific information into regulatory decision making Draft guidance on Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device Refuse to Accept Guidance E-Copy Draft FDA Guidance Implementation of UDI in labeling

12 Recent Trends Approval Challenges 510(k) Standard of care in question Slower reviews- Spending total review time allowed before generating additional questions Increase in 510(k) conversion (Specialà Traditional) based on supportive data (eg. Test data, adverse event reports) Additional scrutiny of pre-clinical data Device intended for use in Class II and Class III applications must be split into 2 separate 510k filings. Ex. Hip 510ks now require duplicate filings (MoM vs MoP, CoP) Reviewers recent enforcement related to E- Copy and Refuse to Accept Draft Guidance Historical performance (Corrective Fixes)

13 Corrective Fixes Fixes made and intent to launch Device launched Adverse events w/ root cause Not eligible as Special 510k since data review req d How to address corrective fix in the filing? Typically want sponsor to be able to replicate the failure mode observed clinically Demonstrate that comparatively the modified device should not fail in similar capacity Demonstrate that subject device is equivalent to nondefective device Original device recalled, obsoleted, or continued to be sold

14 Pre- Clinical Data Bench testing not demonstrating equiv. to predicate. Subject not performing as well. New patient population within scope of intended use/ indications for use (possibly a specific indication for use) New technological characteristics that may have clinical impact (e.g. device affects surrounding bones) Device performs below level of predicate device on the bench and clinical ramifications are not known/ cannot be predicted in an animal model

15 Recent Trends Approval Challenges 510(k) Letter to the File Device modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device 1997 Guidance vague and requires interpretation 2011 draft guidance was closed for comments, but later dropped by FDA Fewer changes qualify - Ex. Sizes outside of cleared range require 510k regardless of worst case determination FDA scrutiny of LTF process expected during Quality audits

16 Recent Trends Approval Challenges 510(k) LTF Instruments Enforcement of inclusion in PMA /510k filing Unique instruments take on classification of device:

17 Recent Trends Approval Challenges 510(k) LTF Instruments Customs Strict FDA interpretation of current guidance One-of-a-kind device limited to physician or dentist If another company makes device, it is generally available / not custom Device that could be used for >1 patient is not custom Modification to an existing device (shorter, fatter, left-handed, etc) is customized, not custom, and requires a pre-market submission Burden of proof lies with manufacturer Increase of Compassionate Use requests to due to strict interpretation of policy. New guidance delayed by FDA

18 Recent Trends Approval Challenges 510(k) LTF Instruments Customs Labeling Lack of FDA guidance for new communication methods (eg. Social Media guidance delayed) General vs Specific claims Text Requirement in Device Labeling All symbols on outer package label must be accompanied by text on the outer package label. Fair & balanced promo Final guidance on the implementation of UDI

19 International Trends Country of Origin identification Limited Global government resources (reviewers) Re-registration of devices licensed before early 2000 s causing approval delays (Latin America) Increased requests for additional data to support new product registrations and license renewals Strict adherence to test standards (mechanical, biocompatibility of final implants) EU: New regulations to impact CE Marking Canada: Uncertainty from Health Canada regarding licensing of instruments (regulations vague on grouping ) 19

20 Wright Initiatives Review of company-wide policies and procedures to ensure continued compliance to evolving regulations (domestic and global) Delays in review have required the adjust of internal timelines for new product launches, as well as global renewals Review and streamline of product portfolio. Product redeployment initiated for R.O.W. markets. Communication with FDA to enlist least burdensome approach for UDI implementation Active involvement with industry groups (eg. AdvaMed, OSMA)