<div data-id="1893" data-import-id="" data-scenario-id="" class="cht-ai col-sm-12 "><span class="ai-assist-link"><i class="ai-agent-icon" style=""></i></span><h1 id="executivesummarybiodegradablesurgicalmeshsupplychainscaleup">Executive Summary: Biodegradable Surgical Mesh Supply Chain Scale-Up</h1> <p>This comprehensive supply chain scale-up plan addresses the critical path for bringing a next-generation biodegradable surgical mesh from development to commercial manufacturing. The plan encompasses four key strategic pillars: raw material supply chain establishment, GMP manufacturing scale-up, comprehensive testing validation, and surgeon training deployment.</p> <p>The biodegradable surgical mesh represents a significant advancement in surgical materials, designed to reduce long-term complications through controlled degradation while maintaining structural integrity during tissue healing. Success requires meticulous coordination across regulatory compliance, manufacturing excellence, supply chain resilience, and clinical adoption strategies.</p> <p>Key strategic considerations include establishing qualified raw material suppliers for biodegradable polymers, implementing GMP manufacturing processes with specialized equipment for mesh fabrication, conducting comprehensive biocompatibility and sterilization validation, and developing surgeon training programs that demonstrate competitive advantages over traditional permanent meshes.</p> <p>The phased approach ensures regulatory submission readiness while building manufacturing capacity to meet market demand. Critical success factors include supply chain risk mitigation, regulatory compliance excellence, and clinical adoption through effective training deployment.</p> <h2 id="workbreakdownstructurebiodegradablesurgicalmeshsupplychainscaleup">Work Breakdown Structure: Biodegradable Surgical Mesh Supply Chain Scale-Up</h2> <div data-id="1893" class="table-wrap"><div class="top-row"><div class="pull-right"><a href="planner/csv/1893" data-rel="tooltip" data-original-title="Download CSV" class="js-csv"><i class="fa fa-fw fa-download"></i></a></div></div><div class="table-wrap-in"><table> <thead> <tr> <th id="wbs">WBS</th> <th id="activity_name">Activity Name</th> <th id="activity_type">Activity Type</th> <th id="duration">Duration</th> <th id="start_date">Start Date</th> <th id="end_date">End Date</th> </tr> </thead> <tbody> <tr> <td>BSM01</td> <td>Biodegradable Surgical Mesh Supply Chain Scale-Up Project</td> <td>Draft</td> <td></td> <td></td> <td></td> </tr> <tr> <td>1</td> <td>Raw Material Sourcing and Supply Chain Development</td> <td>Activity</td> <td></td> <td></td> <td></td> </tr> <tr> <td>1.1</td> <td>Biodegradable Polymer Supply Chain Establishment</td> <td>Activity</td> <td></td> <td></td> <td></td> </tr> <tr> <td>1.1.1</td> <td>Identify qualified biodegradable polymer suppliers (PLA, PGA, PLGA)</td> <td>Task</td> <td>14</td> <td>2025-01-01</td> <td>2025-01-15</td> </tr> <tr> <td>1.1.2</td> <td>Conduct supplier audits and qualification assessments</td> <td>Task</td> <td>21</td> <td>2025-01-16</td> <td>2025-02-06</td> </tr> <tr> <td>1.1.3</td> <td>Establish material specifications and acceptance criteria</td> <td>Task</td> <td>10</td> <td>2025-02-07</td> <td>2025-02-17</td> </tr> <tr> <td>1.1.4</td> <td>Negotiate supply agreements with qualified vendors</td> <td>Task</td> <td>14</td> <td>2025-02-18</td> <td>2025-03-04</td> </tr> <tr> <td>1.1.5</td> <td>Supplier qualification documentation milestone</td> <td>Milestone</td> <td>0</td> <td>2025-03-04</td> <td>2025-03-04</td> </tr> <tr> <td>1.2</td> <td>Secondary Material and Component Sourcing</td> <td>Activity</td> <td></td> <td></td> <td></td> </tr> <tr> <td>1.2.1</td> <td>Source reinforcement fibers and additives suppliers</td> <td>Task</td> <td>14</td> <td>2025-03-05</td> <td>2025-03-19</td> </tr> <tr> <td>1.2.2</td> <td>Establish packaging material supplier qualifications</td> <td>Task</td> <td>10</td> <td>2025-03-20</td> <td>2025-03-30</td> </tr> <tr> <td>1.2.3</td> <td>Develop component traceability systems</td> <td>Task</td> <td>7</td> <td>2025-03-31</td> <td>2025-04-07</td> </tr> <tr> <td>1.2.4</td> <td>Complete supplier diversity and backup sourcing</td> <td>Task</td> <td>14</td> <td>2025-04-08</td> <td>2025-04-22</td> </tr> <tr> <td>1.3</td> <td>Supply Chain Risk Management and Resilience</td> <td>Activity</td> <td></td> <td></td> <td></td> </tr> <tr> <td>1.3.1</td> <td>Develop supply chain risk assessment protocols</td> <td>Task</td> <td>7</td> <td>2025-04-23</td> <td>2025-04-30</td> </tr> <tr> <td>1.3.2</td> <td>Establish inventory management and buffer stock strategies</td> <td>Task</td> <td>10</td> <td>2025-05-01</td> <td>2025-05-11</td> </tr> <tr> <td>1.3.3</td> <td>Create supplier performance monitoring systems</td> <td>Task</td> <td>7</td> <td>2025-05-12</td> <td>2025-05-19</td> </tr> <tr> <td>1.3.4</td> <td>Supply chain resilience framework completion</td> <td>Milestone</td> <td>0</td> <td>2025-05-19</td> <td>2025-05-19</td> </tr> <tr> <td>2</td> <td>GMP Manufacturing Scale-Up and Process Development</td> <td>Activity</td> <td></td> <td></td> <td></td> </tr> <tr> <td>2.1</td> <td>Manufacturing Process Development and Optimization</td> <td>Activity</td> <td></td> <td></td> <td></td> </tr> <tr> <td>2.1.1</td> <td>Design and optimize mesh fabrication processes</td> <td>Task</td> <td>28</td> <td>2025-05-20</td> <td>2025-06-17</td> </tr> <tr> <td>2.1.2</td> <td>Develop process control parameters and specifications</td> <td>Task</td> <td>14</td> <td>2025-06-18</td> <td>2025-07-02</td> </tr> <tr> <td>2.1.3</td> <td>Establish in-process monitoring and quality controls</td> <td>Task</td> <td>10</td> <td>2025-07-03</td> <td>2025-07-13</td> </tr> <tr> <td>2.1.4</td> <td>Process validation protocol development</td> <td>Task</td> <td>14</td> <td>2025-07-14</td> <td>2025-07-28</td> </tr> <tr> <td>2.1.5</td> <td>Manufacturing process optimization completion</td> <td>Milestone</td> <td>0</td> <td>2025-07-28</td> <td>2025-07-28</td> </tr> <tr> <td>2.2</td> <td>GMP Facility Design and Equipment Installation</td> <td>Activity</td> <td></td> <td></td> <td></td> </tr> <tr> <td>2.2.1</td> <td>Design cleanroom manufacturing facility layout</td> <td>Task</td> <td>21</td> <td>2025-07-29</td> <td>2025-08-19</td> </tr> <tr> <td>2.2.2</td> <td>Procure and install specialized mesh fabrication equipment</td> <td>Task</td> <td>42</td> <td>2025-08-20</td> <td>2025-10-01</td> </tr> <tr> <td>2.2.3</td> <td>Install environmental monitoring and control systems</td> <td>Task</td> <td>14</td> <td>2025-10-02</td> <td>2025-10-16</td> </tr> <tr> <td>2.2.4</td> <td>Conduct facility qualification (IQ/OQ/PQ)</td> <td>Task</td> <td>21</td> <td>2025-10-17</td> <td>2025-11-07</td> </tr> <tr> <td>2.2.5</td> <td>GMP facility readiness certification</td> <td>Milestone</td> <td>0</td> <td>2025-11-07</td> <td>2025-11-07</td> </tr> <tr> <td>2.3</td> <td>Manufacturing Scale-Up Validation</td> <td>Activity</td> <td></td> <td></td> <td></td> </tr> <tr> <td>2.3.1</td> <td>Execute process performance qualification (PPQ)</td> <td>Task</td> <td>28</td> <td>2025-11-08</td> <td>2025-12-06</td> </tr> <tr> <td>2.3.2</td> <td>Conduct manufacturing scale-up validation studies</td> <td>Task</td> <td>21</td> <td>2025-12-07</td> <td>2025-12-28</td> </tr> <tr> <td>2.3.3</td> <td>Validate batch record procedures and documentation</td> <td>Task</td> <td>14</td> <td>2025-12-29</td> <td>2026-01-12</td> </tr> <tr> <td>2.3.4</td> <td>Manufacturing readiness decision gate</td> <td>Decision</td> <td>0</td> <td>2026-01-12</td> <td>2026-01-12</td> </tr> <tr> <td>3</td> <td>Sterilization and Biocompatibility Testing Validation</td> <td>Activity</td> <td></td> <td></td> <td></td> </tr> <tr> <td>3.1</td> <td>Sterilization Method Development and Validation</td> <td>Activity</td> <td></td> <td></td> <td></td> </tr> <tr> <td>3.1.1</td> <td>Evaluate sterilization methods (EtO, gamma, e-beam) compatibility</td> <td>Task</td> <td>21</td> <td>2026-01-13</td> <td>2026-02-03</td> </tr> <tr> <td>3.1.2</td> <td>Conduct sterilization dose mapping and validation studies</td> <td>Task</td> <td>28</td> <td>2026-02-04</td> <td>2026-03-04</td> </tr> <tr> <td>3.1.3</td> <td>Validate sterile packaging and shelf-life stability</td> <td>Task</td> <td>35</td> <td>2026-03-05</td> <td>2026-04-09</td> </tr> <tr> <td>3.1.4</td> <td>Complete sterilization validation documentation</td> <td>Task</td> <td>14</td> <td>2026-04-10</td> <td>2026-04-24</td> </tr> <tr> <td>3.1.5</td> <td>Sterilization validation milestone</td> <td>Milestone</td> <td>0</td> <td>2026-04-24</td> <td>2026-04-24</td> </tr> <tr> <td>3.2</td> <td>Comprehensive Biocompatibility Testing Program</td> <td>Activity</td> <td></td> <td></td> <td></td> </tr> <tr> <td>3.2.1</td> <td>Conduct cytotoxicity and sensitization testing (ISO 10993-5, 10993-10)</td> <td>Task</td> <td>42</td> <td>2026-04-25</td> <td>2026-06-06</td> </tr> <tr> <td>3.2.2</td> <td>Execute implantation and tissue response studies (ISO 10993-6)</td> <td>Task</td> <td>84</td> <td>2026-06-07</td> <td>2026-08-30</td> </tr> <tr> <td>3.2.3</td> <td>Perform degradation product safety evaluation</td> <td>Task</td> <td>56</td> <td>2026-08-31</td> <td>2026-10-26</td> </tr> <tr> <td>3.2.4</td> <td>Complete pyrogenicity and hemolysis testing</td> <td>Task</td> <td>28</td> <td>2026-10-27</td> <td>2026-11-24</td> </tr> <tr> <td>3.2.5</td> <td>Biocompatibility testing completion milestone</td> <td>Milestone</td> <td>0</td> <td>2026-11-24</td> <td>2026-11-24</td> </tr> <tr> <td>3.3</td> <td>Mechanical Performance and Degradation Validation</td> <td>Activity</td> <td></td> <td></td> <td></td> </tr> <tr> <td>3.3.1</td> <td>Conduct mechanical strength and fatigue testing</td> <td>Task</td> <td>35</td> <td>2026-11-25</td> <td>2026-12-30</td> </tr> <tr> <td>3.3.2</td> <td>Validate controlled degradation timeline studies</td> <td>Task</td> <td>56</td> <td>2026-12-31</td> <td>2027-02-25</td> </tr> <tr> <td>3.3.3</td> <td>Perform comparative analysis with predicate devices</td> <td>Task</td> <td>21</td> <td>2027-02-26</td> <td>2027-03-19</td> </tr> <tr> <td>3.3.4</td> <td>Complete performance validation report</td> <td>Task</td> <td>14</td> <td>2027-03-20</td> <td>2027-04-03</td> </tr> <tr> <td>4</td> <td>Surgeon Training Kit Development and Deployment</td> <td>Activity</td> <td></td> <td></td> <td></td> </tr> <tr> <td>4.1</td> <td>Training Content Development and Validation</td> <td>Activity</td> <td></td> <td></td> <td></td> </tr> <tr> <td>4.1.1</td> <td>Develop biodegradable mesh surgical technique protocols</td> <td>Task</td> <td>21</td> <td>2027-04-04</td> <td>2027-04-25</td> </tr> <tr> <td>4.1.2</td> <td>Create comparative efficacy and safety training materials</td> <td>Task</td> <td>14</td> <td>2027-04-26</td> <td>2027-05-10</td> </tr> <tr> <td>4.1.3</td> <td>Develop hands-on training simulation models</td> <td>Task</td> <td>28</td> <td>2027-05-11</td> <td>2027-06-08</td> </tr> <tr> <td>4.1.4</td> <td>Validate training content with key opinion leaders</td> <td>Task</td> <td>14</td> <td>2027-06-09</td> <td>2027-06-23</td> </tr> <tr> <td>4.1.5</td> <td>Training content validation milestone</td> <td>Milestone</td> <td>0</td> <td>2027-06-23</td> <td>2027-06-23</td> </tr> <tr> <td>4.2</td> <td>Training Kit Manufacturing and Distribution</td> <td>Activity</td> <td></td> <td></td> <td></td> </tr> <tr> <td>4.2.1</td> <td>Manufacture training simulation kits and materials</td> <td>Task</td> <td>21</td> <td>2027-06-24</td> <td>2027-07-15</td> </tr> <tr> <td>4.2.2</td> <td>Develop digital training platform and e-learning modules</td> <td>Task</td> <td>28</td> <td>2027-07-16</td> <td>2027-08-13</td> </tr> <tr> <td>4.2.3</td> <td>Create training certification and competency programs</td> <td>Task</td> <td>14</td> <td>2027-08-14</td> <td>2027-08-28</td> </tr> <tr> <td>4.2.4</td> <td>Establish training distribution and logistics network</td> <td>Task</td> <td>10</td> <td>2027-08-29</td> <td>2027-09-08</td> </tr> <tr> <td>4.3</td> <td>Surgeon Training Deployment and Market Education</td> <td>Activity</td> <td></td> <td></td> <td></td> </tr> <tr> <td>4.3.1</td> <td>Launch pilot training programs with key medical centers</td> <td>Task</td> <td>21</td> <td>2027-09-09</td> <td>2027-09-30</td> </tr> <tr> <td>4.3.2</td> <td>Execute national training deployment sequence</td> <td>Task</td> <td>42</td> <td>2027-10-01</td> <td>2027-11-12</td> </tr> <tr> <td>4.3.3</td> <td>Implement surgeon certification and competency validation</td> <td>Task</td> <td>14</td> <td>2027-11-13</td> <td>2027-11-27</td> </tr> <tr> <td>4.3.4</td> <td>Training deployment completion milestone</td> <td>Milestone</td> <td>0</td> <td>2027-11-27</td> <td>2027-11-27</td> </tr> <tr> <td>5</td> <td>Regulatory Submission Documentation and Strategy</td> <td>Activity</td> <td></td> <td></td> <td></td> </tr> <tr> <td>5.1</td> <td>Regulatory Strategy Development</td> <td>Activity</td> <td></td> <td></td> <td></td> </tr> <tr> <td>5.1.1</td> <td>Define regulatory pathway and classification strategy</td> <td>Task</td> <td>14</td> <td>2027-11-28</td> <td>2027-12-12</td> </tr> <tr> <td>5.1.2</td> <td>Identify predicate devices and comparative analysis requirements</td> <td>Task</td> <td>10</td> <td>2027-12-13</td> <td>2027-12-23</td> </tr> <tr> <td>5.1.3</td> <td>Develop FDA pre-submission strategy and timeline</td> <td>Task</td> <td>7</td> <td>2027-12-24</td> <td>2027-12-31</td> </tr> <tr> <td>5.1.4</td> <td>Regulatory pathway confirmation decision</td> <td>Decision</td> <td>0</td> <td>2027-12-31</td> <td>2027-12-31</td> </tr> <tr> <td>5.2</td> <td>Manufacturing Documentation for Regulatory Submission</td> <td>Activity</td> <td></td> <td></td> <td></td> </tr> <tr> <td>5.2.1</td> <td>Compile comprehensive device master record (DMR)</td> <td>Task</td> <td>21</td> <td>2028-01-01</td> <td>2028-01-22</td> </tr> <tr> <td>5.2.2</td> <td>Prepare manufacturing process validation documentation</td> <td>Task</td> <td>14</td> <td>2028-01-23</td> <td>2028-02-06</td> </tr> <tr> <td>5.2.3</td> <td>Document quality management system compliance</td> <td>Task</td> <td>14</td> <td>2028-02-07</td> <td>2028-02-21</td> </tr> <tr> <td>5.2.4</td> <td>Complete design control documentation package</td> <td>Task</td> <td>10</td> <td>2028-02-22</td> <td>2028-03-04</td> </tr> <tr> <td>5.2.5</td> <td>Manufacturing documentation completion milestone</td> <td>Milestone</td> <td>0</td> <td>2028-03-04</td> <td>2028-03-04</td> </tr> <tr> <td>5.3</td> <td>Regulatory Submission Preparation and Filing</td> <td>Activity</td> <td></td> <td></td> <td></td> </tr> <tr> <td>5.3.1</td> <td>Prepare 510(k) or PMA submission package</td> <td>Task</td> <td>28</td> <td>2028-03-05</td> <td>2028-04-02</td> </tr> <tr> <td>5.3.2</td> <td>Conduct internal regulatory submission review</td> <td>Task</td> <td>7</td> <td>2028-04-03</td> <td>2028-04-10</td> </tr> <tr> <td>5.3.3</td> <td>Submit regulatory application to FDA</td> <td>Task</td> <td>3</td> <td>2028-04-11</td> <td>2028-04-14</td> </tr> <tr> <td>5.3.4</td> <td>Regulatory submission milestone</td> <td>Milestone</td> <td>0</td> <td>2028-04-14</td> <td>2028-04-14</td> </tr> <tr> <td>6</td> <td>Competitive Positioning and Market Strategy</td> <td>Activity</td> <td></td> <td></td> <td></td> </tr> <tr> <td>6.1</td> <td>Market Analysis and Competitive Intelligence</td> <td>Activity</td> <td></td> <td></td> <td></td> </tr> <tr> <td>6.1.1</td> <td>Conduct comprehensive competitive landscape analysis</td> <td>Task</td> <td>14</td> <td>2028-04-15</td> <td>2028-04-29</td> </tr> <tr> <td>6.1.2</td> <td>Analyze market size and growth opportunity assessment</td> <td>Task</td> <td>10</td> <td>2028-04-30</td> <td>2028-05-10</td> </tr> <tr> <td>6.1.3</td> <td>Evaluate pricing strategy and value proposition</td> <td>Task</td> <td>7</td> <td>2028-05-11</td> <td>2028-05-18</td> </tr> <tr> <td>6.1.4</td> <td>Complete market positioning analysis</td> <td>Task</td> <td>7</td> <td>2028-05-19</td> <td>2028-05-26</td> </tr> <tr> <td>6.2</td> <td>Value Proposition Development and Messaging</td> <td>Activity</td> <td></td> <td></td> <td></td> </tr> <tr> <td>6.2.1</td> <td>Develop clinical differentiation messaging strategy</td> <td>Task</td> <td>14</td> <td>2028-05-27</td> <td>2028-06-10</td> </tr> <tr> <td>6.2.2</td> <td>Create economic value and cost-effectiveness analysis</td> <td>Task</td> <td>10</td> <td>2028-06-11</td> <td>2028-06-21</td> </tr> <tr> <td>6.2.3</td> <td>Develop surgeon adoption and training value messaging</td> <td>Task</td> <td>7</td> <td>2028-06-22</td> <td>2028-06-29</td> </tr> <tr> <td>6.2.4</td> <td>Complete competitive positioning strategy</td> <td>Task</td> <td>7</td> <td>2028-06-30</td> <td>2028-07-07</td> </tr> <tr> <td>6.3</td> <td>Market Launch Preparation and Go-to-Market Strategy</td> <td>Activity</td> <td></td> <td></td> <td></td> </tr> <tr> <td>6.3.1</td> <td>Develop commercial launch timeline and milestones</td> <td>Task</td> <td>10</td> <td>2028-07-08</td> <td>2028-07-18</td> </tr> <tr> <td>6.3.2</td> <td>Create sales force training and market education programs</td> <td>Task</td> <td>14</td> <td>2028-07-19</td> <td>2028-08-02</td> </tr> <tr> <td>6.3.3</td> <td>Establish key opinion leader engagement strategy</td> <td>Task</td> <td>10</td> <td>2028-08-03</td> <td>2028-08-13</td> </tr> <tr> <td>6.3.4</td> <td>Competitive positioning roadmap completion</td> <td>Milestone</td> <td>0</td> <td>2028-08-13</td> <td>2028-08-13</td> </tr> </tbody> </table></div><div class="bottom-row"><div class="pull-right"><a href="planner/csv/1893" data-placement="bottom" data-rel="tooltip" data-original-title="Download CSV" class="js-csv"><i class="fa fa-fw fa-download"></i></a></div></div></div> <h2 id="comprehensiveprojectnotes">Comprehensive Project Notes</h2> <h3 id="criticalsuccessfactors"><strong>Critical Success Factors</strong></h3> <ul> <li><strong>Supply Chain Resilience</strong>: Establish multiple qualified suppliers for biodegradable polymers to ensure material availability and cost control throughout commercial scale-up</li> <li><strong>GMP Manufacturing Excellence</strong>: Implement robust manufacturing processes with appropriate environmental controls for biodegradable material handling and processing</li> <li><strong>Regulatory Compliance Strategy</strong>: Align manufacturing documentation with FDA device classification requirements and predicate device comparative analysis</li> </ul> <h3 id="riskmitigationstrategies"><strong>Risk Mitigation Strategies</strong></h3> <ul> <li><strong>Material Degradation Risk</strong>: Implement controlled storage environments and shelf-life validation studies to ensure product integrity throughout supply chain</li> <li><strong>Manufacturing Scale-Up Risk</strong>: Conduct thorough process validation and technology transfer protocols to ensure consistent product quality at commercial volumes</li> <li><strong>Regulatory Approval Risk</strong>: Engage FDA early through pre-submission meetings to confirm regulatory pathway and evidence requirements</li> </ul> <h3 id="keydependenciesandintegrationpoints"><strong>Key Dependencies and Integration Points</strong></h3> <ul> <li><strong>Manufacturing-Testing Integration</strong>: Coordinate sterilization validation with manufacturing scale-up to ensure process compatibility and product integrity</li> <li><strong>Training-Launch Coordination</strong>: Align surgeon training deployment with commercial launch timeline to ensure market readiness and adoption</li> <li><strong>Supply Chain-Manufacturing Alignment</strong>: Synchronize raw material supply contracts with manufacturing capacity ramp-up requirements</li> </ul> <h3 id="qualityassuranceandvalidationframework"><strong>Quality Assurance and Validation Framework</strong></h3> <ul> <li><strong>Process Control Strategy</strong>: Implement statistical process control and real-time monitoring for critical quality attributes throughout manufacturing</li> <li><strong>Biocompatibility Excellence</strong>: Execute comprehensive ISO 10993 testing program with particular focus on degradation product safety evaluation</li> <li><strong>Documentation Standards</strong>: Maintain FDA-compliant documentation systems throughout development and manufacturing scale-up phases</li> </ul> <h3 id="marketaccessandcommercialconsiderations"><strong>Market Access and Commercial Considerations</strong></h3> <ul> <li><strong>Surgeon Education Priority</strong>: Focus training programs on demonstrating clinical advantages over permanent mesh solutions and proper handling techniques for biodegradable materials</li> <li><strong>Competitive Differentiation</strong>: Emphasize reduced long-term complications and improved patient outcomes as primary value propositions over traditional mesh products</li> <li><strong>Pricing Strategy</strong>: Develop evidence-based economic value propositions that justify premium pricing through improved patient outcomes and reduced revision procedures</li> </ul> <p>Would you like to expand the plan with additional columns such as Predecessor, Importance, Complexity, External Budget, FTEs Needed, or Functions, Roles, and Skills for complete resource and priority planning?</p> <p>How else can I help refine your biodegradable surgical mesh supply chain scale-up plan?</p> <div class="clearfix"></div> <p><span class="badge resp-time" style="background: none; border: solid 1px #ccc; color: #333;text-shadow: none; font-weight: normal; font-size: 14px; line-height:1.1;"> <i class="fa fa-clock-o" style=""></i> 1:31 </span></p></div>