PD 233 Design of Biomedical Devices and Systems

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PD 233: Design of Biomedical Devices and Systems (Lecture 4 ) Dr. Manish Arora

PD 233: 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

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

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

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. . •

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

Clinical Observation Need Identification Requirements and Design Specification

Requirement and Design Specification Both requirements and design specification needs for be documented for

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

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)

Medical device design process as specified US- FDA requirements (source http: //fda. gov)

PD 233 Design of Biomedical Devices and SystemsPD 233 Design of Biomedical Devices and Systems
What is Biomedical Informatics Biomedical Informatics Biomedical informaticsWhat is Biomedical Informatics Biomedical Informatics Biomedical informatics
ADVANCED DB SYSTEMS BIOMEDICAL ENGINEERING Index INTRODUCTION BIOMEDICALADVANCED DB SYSTEMS BIOMEDICAL ENGINEERING Index INTRODUCTION BIOMEDICAL
Literary Devices WHAT ARE LITERARY DEVICES LITERARY DEVICESLiterary Devices WHAT ARE LITERARY DEVICES LITERARY DEVICES
POETRY REVIEW LITERARY DEVICES Sound Devices SOUND DEVICESPOETRY REVIEW LITERARY DEVICES Sound Devices SOUND DEVICES
Literary Devices WHAT ARE LITERARY DEVICES LITERARY DEVICESLiterary Devices WHAT ARE LITERARY DEVICES LITERARY DEVICES
Chapter 20 Product Issues Design of Biomedical DevicesChapter 20 Product Issues Design of Biomedical Devices
Keywords biomedical engineering medical devices design prototyping deliberateKeywords biomedical engineering medical devices design prototyping deliberate
last lecture Design Standards for biomedical devices Devicelast lecture Design Standards for biomedical devices Device
Principles of Biomedical Systems Devices 0909 504 04Principles of Biomedical Systems Devices 0909 504 04
Gizmoz and Gadgets Biomedical Gadgets Biomedical What isGizmoz and Gadgets Biomedical Gadgets Biomedical What is
Biomedical images processing and analysis Biomedical images processingBiomedical images processing and analysis Biomedical images processing
Future Personal Devices Design and Interactivity Future DevicesFuture Personal Devices Design and Interactivity Future Devices
The Biomedical Therapies Biomedical Therapy The previous sectionsThe Biomedical Therapies Biomedical Therapy The previous sections
Biomedical Journals Standards for Digital Images in BiomedicalBiomedical Journals Standards for Digital Images in Biomedical
Open Biomedical Ontologies Open Biomedical Ontologies OBO nOpen Biomedical Ontologies Open Biomedical Ontologies OBO n
Disorder Treatment Psychotherapies Talk Therapies Biomedical Therapies BiomedicalDisorder Treatment Psychotherapies Talk Therapies Biomedical Therapies Biomedical
Introduction to Biomedical Sensors BME 301 Biomedical SensorsIntroduction to Biomedical Sensors BME 301 Biomedical Sensors
BioMedical Waste Common BioMedical Waste Treatment Facility PresentedBioMedical Waste Common BioMedical Waste Treatment Facility Presented
Biomedical Signal processing matlab Zhongguo Liu Biomedical EngineeringBiomedical Signal processing matlab Zhongguo Liu Biomedical Engineering
LOUISIANA TECH UNIVERSITY BIOMEDICAL ENGINEERING INTRODUCTION QUESTIONS BIOMEDICALLOUISIANA TECH UNIVERSITY BIOMEDICAL ENGINEERING INTRODUCTION QUESTIONS BIOMEDICAL
Biomedical Instrumentation Chapter 6 in Introduction to BiomedicalBiomedical Instrumentation Chapter 6 in Introduction to Biomedical
Biomedical Lab Safety BME 70 AB Biomedical EngineeringBiomedical Lab Safety BME 70 AB Biomedical Engineering
Biomedical Research Biomedical Research Definition Study of theBiomedical Research Biomedical Research Definition Study of the
Biomedical Research Objective 1 Biomedical Research Definition ofBiomedical Research Objective 1 Biomedical Research Definition of
Biomedical Engineering Abby Heekin What is Biomedical EngineeringBiomedical Engineering Abby Heekin What is Biomedical Engineering
University of Pittsburgh Department of Biomedical Informatics BiomedicalUniversity of Pittsburgh Department of Biomedical Informatics Biomedical
Design of Biomedical Instruments and Systems Implantable DrugDesign of Biomedical Instruments and Systems Implantable Drug
MultiDisciplinary Senior Design Biomedical Systems and Technologies PMultiDisciplinary Senior Design Biomedical Systems and Technologies P
BIOMEDICAL DEVICES A MULTIINTERDISCIPLINARY SUBJECT Effective treatments ofBIOMEDICAL DEVICES A MULTIINTERDISCIPLINARY SUBJECT Effective treatments of
Power Semiconductor Devices Xi Liu Biomedical Engineering ECEPower Semiconductor Devices Xi Liu Biomedical Engineering ECE
Single Cycle Processor Design ICS 233 Computer ArchitectureSingle Cycle Processor Design ICS 233 Computer Architecture
An Overview of AP 233 STEPs Systems EngineeringAn Overview of AP 233 STEPs Systems Engineering
AP 233 Systems Engineering A NASAPDES Inc NeedsAP 233 Systems Engineering A NASAPDES Inc Needs
Chapter II Storage devices and interfacing Storage devicesChapter II Storage devices and interfacing Storage devices
OrthogonalTransfer ChargeCoupled Devices and LowNoise ChargeCoupled Devices ReadoutOrthogonalTransfer ChargeCoupled Devices and LowNoise ChargeCoupled Devices Readout
Hardware Devices Input methods and devices Mouse KeyboardHardware Devices Input methods and devices Mouse Keyboard
Selfrescue and respiratory devices 48 5b2 Selfrescue devicesSelfrescue and respiratory devices 48 5b2 Selfrescue devices
Literary and Poetic Devices Literary Devices A formLiterary and Poetic Devices Literary Devices A form
Metallization Contact to devices interconnections between devices andMetallization Contact to devices interconnections between devices and