Medical Device Design: Shorten Prototype and Deployment Time with NI Tools NI Technical Symposium 2008
FDA Development Cycle From Total Product Life Cycle by David W. Fiegal, M.D., M.P.H. FDA CDRH
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Cost of Getting It Wrong Development Phase Cost Ratio Requirements 1 Design 3 to 6X Implementation 10X Development Testing 15 to 40X Acceptance Testing 30 to 70X Post Release 40 to 1,000X
Why? 85% Bugs originate in requirements 45% Project costs attributed to rework 49% Projects delivered 3+ months late
It s Tedious
The Truth It is impossible to get the requirements completely right the first time.
Algorithm Engineering
Requirements Gathering Interviews Very useful if you ask the right questions of the right people Important first step in communication Often stakeholders do not know what they want
Requirements Gathering Focus Groups Strengths Provide useful feature ideas Relatively low investment and timely Weaknesses Feedback is often invalid Snap judgments Eager to please
Modeling Requirements Gathering
Requirements Gathering Virtual Prototype
Requirements Gathering Functional Prototype
Example Noninvasive blood pressure monitor
Blood Pressure
Measurement
System Diagram
Design and Implementation Steps Research Modeling Functional Prototype Specifications
Research System Diagram
NI CompactDAQ
Research Pressure Sensor Analog Input Data File Data File Algorithm Display
DEMO: DATA ACQUISITION
Algorithm Peak Valley Amplitude
Algorithm Mean Arterial Pressure (MAP) Diastolic = 70% Systolic = 45%
Software Modeling Develop state machine architecture Develop mock user interface Deliver user experience of end device with research debugging capabilities
State Machine
DEMO: SOFTWARE MODEL
Functional Prototype Move desktop code to real-time OS Port user interface elements Select components Estimate resources
Prototype System Diagram
NI CompactRIO
Prototype System Diagram
DEMO: FUNCTIONAL PROTOTYPE
System Flexibility and Price Deployment Curve PXI RIO PCI RIO CompactRIO CompactRIO Integrated NI Single-Board RIO Custom Number of Systems Deployed
Examples
NI Medical Device Grant Program $25,000 in software and services For those evaluating NI hardware as a component in their medical device Visit ni.com/medical to apply
What Is a Microprocessor? Microprocessor CPU RAM Digital Ports Memory/Data Bus RAM Memory RAM Devices Communications Buses Analog Components Communications
What Is a Microcontroller? Microcontroller CPU RAM ROM Counter Analog Components Serial Port Digital Ports
LabVIEW Real-Time LabVIEW FPGA LabVIEW Touch Panel LabVIEW for ADI Blackfin LabVIEW for ARM LabVIEW Embedded Technology Real-Time Processor FPGA Industrial HMI Microprocessor Microcontroller
Technology Prototype System Architecture
Software Development Part III: Validation TOOLS FOR VALIDATION
Static Analysis LabVIEW VI Analyzer Toolkit Automate code analysis with 60+ configurable tests Performance Style Interactively inspect failures Generate custom reports
Requirements
Traceability Ability to chronologically interrelate the uniquely identifiable entities in a way that matters. Documenting the lifetime of a requirement including its changes Understanding the impact of those changes upstream and downstream
NI Requirements Gateway
DEMO: REQUIREMENTS TRACEABILITY
Source Code Control (SCC) SCC software tracks changes to files Direct access to SCC packages For purchase such as Microsoft SourceSafe Open source such as Subversion
FPGA Programmable Interconnects Logic Blocks I/O Blocks
Decision Making in Software Traditional System Crash Possible Patient Hardware Operating System Driver API Application Software Calculation Outputs
Decision Making in Hardware LabVIEW FPGA System Highest Reliability Patient Hardware Calculation Operating System Driver API Application Software Outputs
LabVIEW Statechart Module
Automatic Documentation LabVIEW VI documentation NI Report Generation Toolkit for Microsoft Office NI Requirements Gateway Reports
For more information: ni.com/medical