Taxonomy

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