Best Practices in Fostering Innovation

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Best Practices in Fostering Innovation

  1. 1. 9/9/2013 Best Practices in Fostering Innovation while Retaining Quality and Compliance Geoff Hutchins Chief Operating Officer
  2. 2. 2 W E L L N E S S F O R B U S I N E S S ® Understand the business value and objective Keep the business objective at the forefront to define priorities • Define and communicate the business value – Why are we undertaking this project and what is the business goal • Product development type – New to market product or platform – Next generation or enhancement of existing product or platform • Market entry strategy – Staged approach to understand user perception and value – First to market or fast follower – Geographic market entry – Maximize initial sales due to imminent competitive threat
  3. 3. 3 W E L L N E S S F O R B U S I N E S S ® What Design Quality Management System? Document Control Roles and Responsibility Change Control Inspection Measurement and test Purchasing Controls (Suppliers) Training Design Controls •Define the supporting QMS elements •Plan Design QMS activities •Partition responsibility •Document in Quality Plan •Monitor QMS performance • Plan Manufacturing transfer QMS When did I start to design? •Be very clear when you start the design •Try not to do technology development and product design at the same time Concept Design Design Controls Begin Kimberly A. Trautman
  4. 4. 4 W E L L N E S S F O R B U S I N E S S ® Analysis of Premarket Review The real review time Average Time To 510(k) Decision Percent with AI Request on First Cycle
  5. 5. 5 W E L L N E S S F O R B U S I N E S S ® Medical Mobile Applications (MMA) Regulated MMA Mobile Apps subject to Enforcement Discretion Unregulated Mobile Apps
  6. 6. rcainc.com | 262.842.1250

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