Design Process
for Medical
Instrumentatio
n
Design Criteria
Many factors affect the design of
biomedical instruments
Different factors for different types of
instruments
Categorized as
Signal
Environment
Medical
Economical
Next figure shows how these factors are
incorporated into the initial design and
development of an instrument
Design Process for Medical Instruments
• Sensitivity
• Range
• Differential or Absolute
Input
Signal • Input Impedance
Initial
Factors • Transient and Frequency
Response Instrume
• Accuracy nt Design
• Linearity
• Reliability
• Specificity
• Signal to Noise Ratio Prototype
• Stability: Temperature,
Environment Tests
Humidity,
al Factors Pressure, Acceleration,
Shock, Vibration,
Radiation Final
Measura • Power Requirements Instrume
• Mounting Size, Shape
nd • Invasive or Noninvasive
nt Design
• Tissue-Sensor Interface
Requirements
Medical • Material Toxicity
• Electric Safety FDA BMD
Factors
• Radiation and Heat Approval
Dissipation
• Patient Discomfort
• Cost
• Availability Productio
Economic • Warranty n
Factors • Consumable
Requirements
• Compatibility with
Existing Equipment
Some Design Consideration
Sensor type determines signal-processing
equipment
Some compromises in specifications are
required to obtain final design
Actual tests on a prototype are always
needed before making final design
Design modifications may be needed
Changes in performance
Interaction of elements in a complex instrument
Good designs are a result of many
compromises throughout development
process
Commercial Medical
Instrumentation Development
Team project Process
Has many phases
New ideas
Introduced at health care facilities
Industry personnel involvement
Evaluating new ideas at Companies
Competent person responsibility
Authorized
Communicates with proposing persons
Signing a preliminary disclosure
Discussing detailed ideas
Preliminary feasibility analysis
Medical feasibility
Technical feasibility
Compliant with companies interest and capabilities
Medical Feasibility Analysis
Should involve
Examining clinical needs
Patient indications
Number of patients
Clinical specialty
Operation condition
Evolutionary products vs. revolutionary
products
Technical Feasibility
Analysis
Should include
Description of the core technologies
Suitability of available components
Breakthroughs or inventions
System analysis
Preliminary cost estimates
Resulting in building a functional
prototype
To be tested on animals and humans
Manufacturing Feasibility Analysis
Should be done early
Alternative technologies can be selected
Brief business plan
Financial aspects
Personnel requirements
Competitions
Patents
Standards
Manufacturing requirements
Sales and service requirements
Time schedule for the project
Detailed feasibility review at the end of this
phase
Development Process …
continue
Writing product specifications and
features
Numerical values for performance
Operating requirements
Size, weight, and color
Say every thing about “what” is required
but nothing about “how” it is to be achieved
Used by design and development engineers
throughout the product life cycle
Confidential document
Used to make a manufacturable prototype
Development Process …
continue
Prototype production
Functions are partitioned into hardware and
software
Using CAD (computer-aided design) to prepare
Circuit diagrams
Software requirements
Mechanical designs
Used for design reviews
Should be developed as early as possible
Tested on animals or human subjects
To verify expected operation and performance
Make correction according to clinical
feasibility data