Biomedical Device Design and Innovation: Capturing Customer Needs and Clinical Observations
Learn about the design process for biomedical devices, including capturing customer needs and identifying clinical observations. Discover how to find unmet clinical needs through scientific journals, newspapers, doctor and patient interviews, and field immersion. Understand the importance of documenting requirements and design specifications for regulatory approval, as well as the verification and validation process for compliance. Gain insights into developing successful medical devices by focusing on market pull versus technology push.
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Presentation Transcript
PD233: Design of Biomedical Devices and Systems (Lecture 4 ) Dr. Manish Arora CPDM, IISc Course Website: http://cpdm.iisc.ac.in/utsaah/courses/
Quick Review Definition & classification of Medical Devices Bioethics in Medical Device Innovation
New product definition process: Chapter 4, King et al., Design on Biomedical Devices & Systems
Capturing Customer Needs: Chance of success are much higher when there is Market Pull vs Technology Push Design is about solving an unmet need How to find unmet need?
How to find unmet clinical need? Look in scientific journal papers.. Look in newspapers.. Ask the doctor.. Ask the patient.. Immersion in field (PHC, Polyclinics, Hospitals) A lot of problems can be identified by careful observation in the real-life practice. Filter based on your competencies and interest
Clinical Observation Need Identification Requirements and Design Specification
Requirement and Design Specification Both requirements and design specification needs for be documented for regulatory approval Requirements deals with what needs to be done hard copy of strip chart is made available to clinician Design specification deals with how it is done hard copy of the strip chart is made available to clinician by pressing menu key
Verification and Validation Another big piece of regulatory approvals deals with documentation for Verification & Validations. Verification is process of ensuring all requirements are met at that stage of design. -Can be done at sub-system as well as system level. Validation is process of evaluating product to ensure compliance with specified and implied requirements -Validation is preformed at end of design cycle on actual device as manufactured according to manufacturing specifications and standards. Both need to be documented fully
Medical device design process as specified US- FDA requirements (source http://fda.gov)
