Taxonomy:  Biomedical Engineering Design



1)       The Generic Design Process

a.        Clarification and Specification

b.       Conceptual

c.        Detailed

d.       Embodiment/Synthesis

e.        Validation


2)       Design Tools

a.        Brainstorming and Idea Generation Techniques 

b.       Conventional Solution Searches

c.        Function Analysis

d.       Elementary Decision-Making Techniques

e.        Objective Trees

f.         Quality Function Deployment Diagrams

g.       TRIZ

h.       Concept mapping and related techniques

i.         Innovation Workbench

j.         other


3)       Design Management, Documentation, and Reporting

a.        Design Team Construction and Management

                                                               i.      Definition of a team

                                                              ii.      Team Characteristics

                                                            iii.      Team success factors

                                                            iv.      Team Leader

                                                             v.      Design Team

1.        Core Product Team

2.        Working Design Team

b.       Documentation Techniques and Requirements

c.        Databases, based on Access and Excel

d.       Reporting Techniques:  Presentations, Posters, and Reports 


4)       Product Definition

a.        Customer Surveys

b.       Company Needs

c.        Company Competencies

d.       Outside Competencies

e.        Product Fit

f.         Technology Match

g.       Product Differentiation

h.       Product Life Cycle

i.         Quality Function Deployment


5)       Product Documentation

a.        Documents

                                                               i.      The Business Proposal

1.        Project overview, objectives, milestones, schedule

2.        Market need and market potential

3.        Product Proposal

4.        Strategic fit

5.        Risk analysis and research plan

6.        Economic analysis

7.        Core project team

                                                              ii.      Product specification

1.        Accuracy requirements

2.        Reliability goal

3.        Safety issues

4.        Requirements to meet standards

5.        Anticipated environment

6.        Overall functional specification

7.        Human factors considerations

8.        other

                                                            iii.      Design specification

1.        Cost budgets

2.        Size and packaging

3.        Power budget

4.        Details of above product specification

                                                            iv.      Software quality assurance plan

1.        Purpose

2.        Reference documents

3.        Management

4.        Documentation

5.        Standards, practices, conventions, metrics

6.        Review and audits

7.        Test

8.        Problem reporting and corrective action

9.        Tools techniques, and methodologies

10.     Code control

11.     Media control

12.     Supplier control

13.     Records collection, maintenance, and retention

14.     Training activities

15.     Risk management

16.     Other

                                                             v.      Software requirements specification

1.        Purpose

2.        Scope of product

3.        Definitions

4.        References

5.        Overview

6.        Product perspective

7.        Product functions

8.        User characteristics

9.        General constraints

10.     Assumptions and dependencies

11.     Specific requirements

                                                            vi.      Software design description

1.        Decomposition description

2.        Interface description

3.        Detailed design description

4.        Detailed design description

b.       Records

                                                               i.      Design history file

1.        Design reviews

2.        Design verification

                                                              ii.      Design master record

1.        Design specifications

2.        Production process specifications

3.        Quality assurance procedures

4.        Packaging and labeling specifications

5.        Installation, maintenance and servicing procedures

                                                            iii.      Device history record

                                                            iv.      Technical documentation file

6)       Product development

a.        Hardware and software techniques

                                                               i.      Block diagram

                                                              ii.      Redundancy

1.        active

2.        standby

                                                            iii.      Component selection

1.        fitness for use

2.        reliability

3.        history

4.        safety

5.        mean time to failure

                                                            iv.      Component derating

                                                             v.      Safety margin

                                                            vi.      Load protection

                                                          vii.      Environmental protection

                                                         viii.      Product misuse

                                                             ix.      Design for variation

                                                              x.      Design of experiments

                                                             xi.      Software engineering management

1.        Planning

2.        Estimating

3.        Tracking progress

                                                           xii.      Choice of model

1.        High concern

a.        Waterfall

b.       Incremental delivery

c.        Spiral

d.       Cleanroom

2.        Low concern

a.        Design to schedule

b.       Evolutionary delivery

c.        Code and fix

                                                          xiii.      Choice of design method

1.        Top-down

2.        Data-driven

3.        Object-oriented

                                                         xiv.      Choice of programming language

1.        Data typing needs

2.        Exception handling

3.        Compilation

4.        Memory limitations

                                                           xv.      Software development activities

1.        Reviews

2.        Walkthroughs and inspections

3.        unit and system testing

                                                         xvi.      Software requirements analysis

                                                        xvii.      Software hazards analysis

                                                      xviii.      Requirements traceability

                                                          xix.      Software architectural design

                                                            xx.      Detail design

                                                          xxi.      Implementation

                                                         xxii.      Integration

b.       Structured and unstructured design techniques

                                                               i.      Innovation workbench – database and conflict map based

                                                              ii.      Axiomatic design

                                                            iii.      Structured design

                                                            iv.      Generic design

                                                             v.      Redesign

                                                            vi.      Reverse engineering

7)       Computer-aided design

a.        Definitions

                                                               i.      CAD: computer-aided design

                                                              ii.      CAM: computer-aided manufacturing

                                                            iii.      CAE: Computer aided engineering

                                                            iv.      FEM: Finite element method

b.       The computer-aided design process

c.        Components of CAD/CAM/CAE systems

                                                               i.      Hardware

                                                              ii.      Hardware configuration

                                                            iii.      Software components

d.       Windows-based CAD systems

e.        Rapid prototyping

8)       Human Factors Issues

a.        Human Factors definition

                                                               i.      The human element

                                                              ii.      The hardware element

                                                            iii.      The software element

b.       Human Factors Process

                                                               i.      Planning

                                                              ii.      Analysis

                                                            iii.      User studies

1.        Observations

2.        Interviews

3.        Focus groups

4.        Task analysis

5.        Benchmark usability testing

6.        User profile

7.        Advisory panels

c.        Safety

d.       Documentation

e.        Anthropometry

                                                               i.      Functional dimensions

                                                              ii.      Psychological elements

                                                            iii.      Workstation design considerations

f.         Labeling

g.       Software

h.       Feedback

i.         Prompts

j.         Defaults

k.        Error Management/Data Protection

9)       Industrial Design

a.        Usability Goals

b.       Design of User Interface Concepts

                                                               i.      Development of conceptual model

                                                              ii.      Development of interface structure

                                                            iii.      Development of interaction style

                                                            iv.      Development of screen templates

                                                             v.      Development of hardware layout

                                                            vi.      Development of screenplay

                                                          vii.      Refinement

                                                         viii.      Final design

c.        Model the User Interface

d.       Test the User Interface

e.        Specify the User Interface

                                                               i.      Style guide

                                                              ii.      Screen hierarchy map

                                                            iii.      Screenplay

                                                            iv.      Specification prototype

                                                             v.      Hardware layouts

f.         Additional Industrial Design Considerations

                                                               i.      Consistency and simplicity

                                                              ii.      Safety 

                                                            iii.      Environmental/organizational considerations

                                                            iv.      Documentation

                                                             v.      Alarms and signals

                                                            vi.      Displays

                                                          vii.      Interactive control

                                                         viii.      Feedback

                                                             ix.      Error management/data protection

10)    Biomaterials and Materials Selection

a.        Historical introduction

b.       The FDA and Biocompatibility

c.        International Regulatory Efforts, ISO standards

d.       Device Category and Choice of Test Program

e.        Preparation of Extracts

f.         Biological Control Tests

                                                               i.      Microbiological control tests

                                                              ii.      Tests for endotoxins

                                                            iii.      Tests for nonspecific toxicity

g.       Tests for Biological Evaluation

                                                               i.      Cytotoxicity

                                                              ii.      Sensitization

                                                            iii.      Skin irritation

                                                            iv.      Intracutaneous reactivity

                                                             v.      Acute systemic toxicity

                                                            vi.      Genotoxicity

                                                          vii.      Implantation

                                                         viii.      Hemocompatability

                                                             ix.      Subchronic and chronic toxicity

                                                              x.      Carcinogenicity

h.       Alternative Test Methods

11)    Safety engineering: Devices and Processes

a.        FDA and other mandates

b.       Safety checklists

                                                               i.      Eliminate by design

                                                              ii.      Guard against

                                                            iii.      Warn the user

                                                            iv.      Train the user

                                                             v.      Mandate personal protective equipment

                                                            vi.      Other

c.        Accident investigation

d.       Process Improvement

e.        Tools and Techniques used in safety engineering

                                                               i.      Designsafe

                                                              ii.      Inherently safer design

                                                            iii.      Anticipatory failure determination

                                                            iv.      Failure modes and effects software

                                                             v.      Cause and effect diagrams

                                                            vi.      Accident reporting and investigation

1.        MAUDE

2.        VA system

12)    Prototyping and Testing

a.        Prototyping

                                                               i.      Types of prototypes

1.        Low-fidelity

2.        High-fidelity

3.        Exploratory

4.        Experimental

5.        Operational

6.        Horizontal

7.        Vertical

8.        Diagonal

9.        Global

10.     Local

                                                              ii.      The prototyping process

b.       Testing

                                                               i.      Definitions

                                                              ii.      Parsing test requirements

                                                            iii.      Test protocol

                                                            iv.      Sample size and test length

c.        Types of Testing

                                                               i.      Verification

                                                              ii.      Validation

                                                            iii.      Black box

                                                            iv.      White box

                                                             v.      Hardware

                                                            vi.      Software

                                                          vii.      Functional

                                                         viii.      Robustness

                                                             ix.      Stress

                                                              x.      Safety

                                                             xi.      Regression

13)    Quality Control and Improvement, Reliability, and Liability

a.        Reliability versus Unreliability

b.       Quality versus Reliability

c.        Definition of Reliability

d.       History of Reliability

e.        Types of Reliability

                                                               i.      Electronic

1.        Infant mortality

2.        Useful life

3.        Wearout

                                                              ii.      Mechanical

1.        Frictional

2.        Shrinkage

3.        Fatigue

4.        Surface erosion

5.        Corrosion

6.        Creep

7.        Material strength deterioration

                                                            iii.      Software

1.        Specification errors

2.        Design errors

3.        Typographical errors

4.        Omission of symbols

f.         Device Reliability

                                                               i.      Infant mortality

                                                              ii.      Useful life

                                                            iii.      Wearout

g.       Optimizing Reliability

h.       Reliability's Effect on Medical Devices

i.         Product Liability

                                                               i.      Negligence

                                                              ii.      Strict liability

                                                            iii.      Breach of warranty

1.        Implied warranty

2.        Exclusion of warranty

                                                            iv.      Defects

1.        Customer expectations

2.        Presumed seller knowledge

3.        Risk-benefit balancing

4.        State of the art

5.        Unavoidably unsafe products

6.        Manufacturing or production defects

7.        Design defects

8.        Defective warnings or instructions

                                                             v.      Failure to warn of dangers

                                                            vi.      Conduct of plaintiff

                                                          vii.      Conduct of defendant

                                                         viii.      Defendant-related issues

1.        Negligent misuse of product

2.        Negligent selection of product

3.        Failure to inspect

4.        Use of product with knowledge of defect

                                                             ix.      Manufacturer’s and physician’s responsibilities

14)    The Food and Drug Administration

a.        History of Device Regulation

b.       Device Classification

                                                               i.      Class I devices

                                                              ii.      Class II devices

                                                            iii.      Class III devices

c.        Registration and Listing

d.       The 510(k) Process

                                                               i.      Determining substantial equivalency

                                                              ii.      Preparation of a 510(k)

1.        Types of 510(k)s

a.        Identical devices

b.       Equivalent but not identical

c.        Complex devices or major differences in technological characteristics

d.       Software-controlled devices

2.        Format for 510(k)

e.        PMA Application

                                                               i.      The PMA process

                                                              ii.      Contents of a PMA

f.         Investigational Device Exemptions (IDE)

                                                               i.      Institutional  Review Boards

                                                              ii.      IDE format

                                                            iii.      HIPAA

g.       Good Laboratory Practices (GLP)

h.       Good Manufacturing Practices (GMP)

i.         Human Factors

j.         Design Control

k.        The FDA and Software

l.         Software Classification

m.      The FDA Inspection 

n.       Advice on Dealing with the FDA

o.       Manufacturer and User Facility Device Experience Database  (MAUDE)

15)    Licensing, Patents, Copyrights, and Trade Secrets 

a.        Patents

                                                               i.      Patent qualifications

1.        Subject matter

a.        Process or method

b.       Machine or apparatus

c.         Article of manufacture

d.       Composition of matter

e.        New and useful improvement

2.        Usefulness

3.        Novelty

4.        Nonobviousness

5.        Improvement of an existing invention

6.        A design

                                                              ii.      The patent process

                                                            iii.      Patent claims

                                                            iv.      Protection of inventor rights

                                                             v.      Patent infringement

                                                            vi.      Cautions

1.        Nondisclosure forms

2.        Disclosure forms

3.        Rights of the employer

4.        Rights of the institution

5.        Technology transfer offices

b.       Copyrights

                                                               i.      Requirements

1.        Fixation

2.        Originality

3.        Minimal Creativity

                                                              ii.      Coverage

1.        Literary works

2.        Motion pictures

3.        photographs, sculptures, graphic works

4.        Pantomimes, choreographic works

5.        Architectural works

                                                            iii.      Process

1.        Notice

2.        Registration

3.        Duration

4.        Protection

5.        Infringement

c.        Trademarks

                                                               i.      Selection of a trademark

                                                              ii.      The trademark process

                                                            iii.      Registration

                                                            iv.      Protection 

d.       Trade Secrets 

                                                               i.      Definition

                                                              ii.      Employer v employee ownership

                                                            iii.      Risks of trade secrets

                                                            iv.      Protecting trade secrets

1.        Non-disclosure documents

2.        Legal damages suit for economic injury

3.        Physical and computer security

                                                             v.      Use of trade secrets in conjunction with patents and copyrights

16)    Premarket Testing and Validation

a.        Standard Tests

                                                               i.      Cycle testing

                                                              ii.      Typical use testing

                                                            iii.      10x10 testing

b.       Allocation of Software Testing

c.        Verification and Validation Test Method Commonality

d.       Validation and Test Overview

                                                               i.      Techniques, methodologies and test approach

                                                              ii.      Software testing requirements

                                                            iii.      Verification and validation reporting

e.        The Essentials of Software Testing

f.         Drug Development

g.       Clinical Trials

                                                               i.      Animal studies

1.        FDA and IRB guidelines

2.        PETA

                                                              ii.      Human studies

1.        FDA and IRB guidelines

2.        Medical Ethics

17)    System Testing

a.        Purpose

b.       Failure Definition

c.        Types of Testing

                                                               i.      Event testing

                                                              ii.      Stress testing

                                                            iii.      Temperature/humidity testing

                                                            iv.      Environmental testing

1.        Operating temperature/humidity testing

2.        Storage temperature/humidity testing

3.        Altitude testing

4.        Threshold testing

5.        Vibration testing

6.        ISTA shipping test

                                                             v.      Electromagnetic interference testing

                                                            vi.      Life test/reliability demonstration

                                                          vii.      Customer misuse

1.        Fluid spillage

2.        Weight test

3.        Keyed connectors

                                                         viii.      Time related

                                                             ix.      Failure related

18)    Regulations Tracking

a.        Regulations

                                                               i.      US regulations

                                                              ii.      European regulations

b.       Standards

                                                               i.      US standards

1.        Software

2.        International

3.        Types

a.        De facto

b.       De jure

c.        Reference models

d.       Product or process

e.        Codes of practice

f.         Prospective and retrospective standards

c.        Coping with Increased Quality Assurance and Regulatory Issues

d.       Medical Device Directives

                                                               i.      Definition of a medical device

                                                              ii.      The medical device directives process

                                                            iii.      Directives

1.        Active implantable medical directive

2.        Medical device directive

3.        In vitro diagnostic medical device directive

                                                            iv.       General and particular Essential requirements

                                                             v.      Identification of harmonized standards

                                                            vi.      Identification of a notified body

                                                          vii.      Declaration of conformity

                                                         viii.      Application of CE mark

e.        ISO 9000 standards

                                                               i.      Fundamental safety and effectiveness principles

                                                              ii.      Device classification

                                                            iii.      Standards and the design process

f.         Canadian Regulations

g.       Pacific Rim

19)    Manufacturing and Quality Control

a.        A History of Good Manufacturing Practice (GMP)

b.       The GMP Regulation

                                                               i.      Design controls

                                                              ii.      Purchasing controls

                                                            iii.      Servicing controls

                                                            iv.      Changes in critical device requirements

                                                             v.      Harmonization

c.        Design for Manufacturability (DFM)

d.       Design for Assembly  (DFA)

e.        The Manufacturing Process

                                                               i.      Preproduction activity

                                                              ii.      Pilot run build

                                                            iii.      Production run

                                                            iv.      Delivery to the customer

20)    Product Issues  

a.        Product Safety and Legal Issues

                                                               i.      Definition of safety

                                                              ii.      Safety and reliability

                                                            iii.      The legal aspects of safety

                                                            iv.      System safety

                                                             v.      Hardware safety

1.        Component derating

2.        Safety margin

3.        Load protection

                                                            vi.      Software safety

                                                          vii.      Verification and validation of safety

                                                         viii.      Effective safety programs

b.       Accident Reconstruction and Forensics

                                                               i.      Medical device accidents

                                                              ii.      Biomechanics and traffic accident investigations

1.        Data collection

2.        Injury estimation

a.        Abbreviated injury scale (AIS)

b.       Injury severity scale (ISS)

3.        Impact analysis

4.        National Highway Transportation Safety Association

5.        Stapp conference data

21)    Professional Issues 

a.        BME Related Professional Societies

                                                               i.      AAMI

                                                              ii.      ACM

                                                            iii.      AMIA

                                                            iv.      BMES

                                                             v.      IBE

                                                            vi.      IEEE-EMBS

                                                          vii.      RESNA

b.       Standards Setting Groups

                                                               i.      AHA

                                                              ii.      ADA

                                                            iii.      ASQC

                                                            iv.      ASTM

                                                             v.      AAMI

                                                            vi.      ASME

                                                          vii.      IEEE

                                                         viii.      JCAHO

                                                             ix.      MDMA

                                                              x.      NFPA

                                                             xi.      OSHA

                                                           xii.      UL

c.        Professional Engineering Licensure

                                                               i.      Engineering internship

                                                              ii.      Registration as a professional engineer

                                                            iii.      Rules of professional conduct

d.       Codes of Ethics

                                                               i.      IEEE

                                                              ii.      NSPE

                                                            iii.      BMES

e.        Forensics and Counseling

f.         Continuing Education

22)    Miscellaneous Issues

a.        Learning from Failure

b.       Design for Failure

                                                               i.      Safety considerations

                                                              ii.      Convenience considerations

c.        Product Life Issues

                                                               i.      Analysis of field service reports

1.        Uses of databases

2.        Data analysis

                                                              ii.      Failure analysis of field units

                                                            iii.      Warranty analysis

                                                            iv.      Product Testing Issues

23)    Future Design Issues 

a.        NSF DMII

b.       National Institute of Biomedical Imaging and Bioengineering 

c.        The National Institute of Science and Technology

d.       DARPA - Defense Advanced Research Project Agency

e.        Miscellaneous and Other Areas of Future Design Activity

24)    Related topics

a.        Institutional safety

b.       Entrepreneurship

c.        Medical ethics

d.       Bio and agricultural engineering