Mod6_pt3_MedicalDevices_ProductDevelopment

Mod6_pt3_MedicalDevices_ProductDevelopment - 12/2/2009 1...

Info iconThis preview shows pages 1–6. Sign up to view the full content.

View Full Document Right Arrow Icon

Info iconThis preview has intentionally blurred sections. Sign up to view the full version.

View Full DocumentRight Arrow Icon

Info iconThis preview has intentionally blurred sections. Sign up to view the full version.

View Full DocumentRight Arrow Icon

Info iconThis preview has intentionally blurred sections. Sign up to view the full version.

View Full DocumentRight Arrow Icon
This is the end of the preview. Sign up to access the rest of the document.

Unformatted text preview: 12/2/2009 1 Medical Devices Product Development Design Control David W. Mullis, Jr., Ph.D. RAC PHAR 6010 New Product Development Methodologies Concept Feasibility Definition Implementation Deployment Beta Testing End of Life M i l e s t o n e R e v i e w s 12/2/2009 2 Engineering Development Life Cycle System C oncept Software System Requirements Detailed Design Code & Unit Test Software System Design System Requirements Integration & Test Review Preliminary Design Review Critical Design Review Test Readiness Review Device Development Continuum 4 12/2/2009 3 Medical Devices Preclinical Evaluation Focus on device concept and potential uses Identify testing requirements to characterize device and its performance Nonclinical testing Bench/Engineering test Animal Testing GLPs GLPs Consider performing formal hazard analysis Consider needs for human clinical data to determine safety and effectiveness 5 Medical Devices Preclinical Test Plan Biological Testing for Materials or Components Biocompatibility Biocompatibility ISO, FDA Guidance Bench/Engineering Test Component Testing Design Verification Design Validation System Testing In vivo Testing Animal Testing for Safety Animal Testing for Functionality 6 12/2/2009 4 Medical Devices Human Testing Questions on Safety Questions on Effectiveness Determination of Risk Significant Risk Device Nonsignificant Risk Device Nonsignificant Risk Device 7 Medical Device Requirements for Human Testing Determine Risk to Patients/Users Significant Risk Device Study Nonsignificant Risk Device Study Investigational Device Exemption (IDE) 21CFR812 Types of Studies Types of Studies Feasibility or Pilot Studies (small scale) Confirmatory Studies (typically for SE determination) Pivotal Study 8 12/2/2009 5 Develop Clinical Plan Medical Device Requirements for Human Testing Summarize report of prior investigations Conduct extensive literature review Focus on research questions Determine population and valid sample size Define clinical endpoints Define clinical endpoints Develop clinical study protocol Define statistical analysis plan Develop Case Report Forms (CRFs) 9 Determine FDA requirements to conduct Medical Device Requirements for Human Testing Study...
View Full Document

Page1 / 15

Mod6_pt3_MedicalDevices_ProductDevelopment - 12/2/2009 1...

This preview shows document pages 1 - 6. Sign up to view the full document.

View Full Document Right Arrow Icon
Ask a homework question - tutors are online