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

1. Research & Development - Medical Device Innovation

2. Methodology Quality System Regulation User Research

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. 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. 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. 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. 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. 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. 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. 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. Methodology – Human Factors Anthropometry Biomechanics Ergonomics Psychographics Discovery

13. Anthropometry Biomechanics Ergonomics Psychographics Discovery Methodology – Human Factors

14. Methodology – Procedure Map Discovery

16. Industrial Design Process Methodology Quality System Regulation

19. Research & Development - Medical Device Innovation Thank you