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Research & Development - Medical Device Innovation

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Research & Development - Medical Device Innovation by Sean Hägen, IDSA Principal
Director of Research & Synthesis - presentation to ASQ Tampa May 2010

Published in: Business

Research & Development - Medical Device Innovation

  1. 1. Research & Development - Medical Device Innovation
  2. 2. Methodology Quality System Regulation User Research
  3. 3. <ul><li>Identify Use Error Modes </li></ul><ul><li>Determine Error Mitigation Solutions through: </li></ul><ul><ul><li>Product Design & Human Factors </li></ul></ul><ul><ul><li>User Interface Design </li></ul></ul><ul><ul><li>Instructions for Use (IFU) & Training </li></ul></ul><ul><ul><li>Restriction of User Groups </li></ul></ul>Usability User Research FDA Guidelines Design Inputs “ Each manufacturer shall establish and maintain procedures to ensure that the design requirements relating to a device are appropriate and address the intended use of the device, including the needs of the user(s) and patient.” 21CFR820.30
  4. 4. Quantitative Qualitative Conjoint Formative Summative Medical industry leaders such as Philips, Ethicon Endo-Surgery, Baxter, and GE Healthcare use qualitative methodologies that augment conventional quantitative research processes to collect and characterize optimal device requirements. Discovery Methodology – Immersive User Research
  5. 5. Methodology – Ethnography Generative Pre-Interview Journals Passive/Interactive Observation Workflow Analysis Discovery Generate new opportunities for innovation by identifying latent needs and potential use error modalities – “show me, don’t tell me”.
  6. 6. Methodology – Projective Use-case Mapping Generative Interview/Experience Mapping Focus Groups Enable users to visually describe their definitive moments, needs and aspirations in the context of their day-to-day work experiences – the why behind the what. Discovery
  7. 7. Pre-Interview Kits Interactive Study Models ( iProps) Focus Groups Methodology – Participatory Design Generative Discovery The user participates in the design process, especially decisions regarding component configuration and user interface layout.
  8. 8. Methodology – Generative Ethnography Contextual Observation Workflow Analysis User Preference Studies Identify procedure efficiencies by characterizing the context of use and the interaction of users. Discovery
  9. 9. Methodology – Generative Ethnography Contextual Observation Workflow Analysis User Preference Studies Discovery Observe the user testing concepts they configure in context of the environment of use (or simulated) with study models (iProps) that can be adjusted to their needs.
  10. 10. Methodology – Usability Studies Evaluative Pre-Interview Journals Interview/Experience Mapping Passive/Interactive Observation Focus Groups Usability Studies Evaluate subsystem and feature level design and work flow for optimal human factor engineering, preferably in context of use (environment). Discovery
  11. 11. Methodology – Usability Studies Evaluative Pre-Interview Journals Interview/Experience Mapping Passive/Interactive Observation Focus Groups Usability Studies Evaluate user preferences and the usability of concepts prior to formal development through observing behavior rather than eliciting opinion. Discovery
  12. 12. Methodology – Human Factors Anthropometry Biomechanics Ergonomics Psychographics Discovery
  13. 13. Anthropometry Biomechanics Ergonomics Psychographics Discovery Methodology – Human Factors
  14. 14. Methodology – Procedure Map Discovery
  15. 15. Procedure Map Metrics <ul><li>Steps from User’s Perspective </li></ul><ul><li>Tasks within each Step </li></ul><ul><li>Task Time </li></ul><ul><li>Step Time </li></ul><ul><li>Stage Time </li></ul><ul><li>Emotional Association with each Step </li></ul><ul><li>Instrument/Device used in each Step </li></ul><ul><li>People Involved during each Step </li></ul><ul><li>Challenges for each Step </li></ul><ul><li>Mitigations for each Step </li></ul><ul><li>Implications for each Step </li></ul>Discovery Methodology – Procedure Map
  16. 16. Industrial Design Process Methodology Quality System Regulation
  17. 17. Device Development <ul><li>Discovery </li></ul><ul><li>Conceptual Design </li></ul><ul><li>Design Development </li></ul><ul><li>Engineering/Implementation </li></ul><ul><li>Production Liaison </li></ul>User Research
  18. 18. Post Market Surveillance & Use Error User Research <ul><li>What is your definition of a use error complaint? </li></ul><ul><li>What is your method of collecting field complaints? (listening systems), i.e., software used? </li></ul><ul><li>Would you share a blank collection form with us? </li></ul><ul><li>Do you trend complaints for use error? </li></ul><ul><li>How does this information get to the new product team? </li></ul><ul><li>How does the new product team use this information? </li></ul><ul><li>How many times do complaints result in use error risk management item </li></ul><ul><li>What help would you want in the area of post market surveillance for use errors? </li></ul><ul><li>Would you be willing for us to contact you again as we progress in this project? </li></ul>
  19. 19. Research & Development - Medical Device Innovation Thank you

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