Medical Device Design: Shorten Prototype and Deployment Time with NI Tools. NI Technical Symposium 2008
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1 Medical Device Design: Shorten Prototype and Deployment Time with NI Tools NI Technical Symposium 2008
2 FDA Development Cycle From Total Product Life Cycle by David W. Fiegal, M.D., M.P.H. FDA CDRH
3 Amazon.com
4 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
5 Why? 85% Bugs originate in requirements 45% Project costs attributed to rework 49% Projects delivered 3+ months late
6 It s Tedious
7 The Truth It is impossible to get the requirements completely right the first time.
8 Algorithm Engineering
9 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
10 Requirements Gathering Focus Groups Strengths Provide useful feature ideas Relatively low investment and timely Weaknesses Feedback is often invalid Snap judgments Eager to please
11 Modeling Requirements Gathering
12 Requirements Gathering Virtual Prototype
13 Requirements Gathering Functional Prototype
14 Example Noninvasive blood pressure monitor
15 Blood Pressure
16 Measurement
17 System Diagram
18 Design and Implementation Steps Research Modeling Functional Prototype Specifications
19 Research System Diagram
20 NI CompactDAQ
21 Research Pressure Sensor Analog Input Data File Data File Algorithm Display
22 DEMO: DATA ACQUISITION
23 Algorithm Peak Valley Amplitude
24 Algorithm Mean Arterial Pressure (MAP) Diastolic = 70% Systolic = 45%
25 Software Modeling Develop state machine architecture Develop mock user interface Deliver user experience of end device with research debugging capabilities
26 State Machine
27 DEMO: SOFTWARE MODEL
28 Functional Prototype Move desktop code to real-time OS Port user interface elements Select components Estimate resources
29 Prototype System Diagram
30 NI CompactRIO
31 Prototype System Diagram
32 DEMO: FUNCTIONAL PROTOTYPE
33 System Flexibility and Price Deployment Curve PXI RIO PCI RIO CompactRIO CompactRIO Integrated NI Single-Board RIO Custom Number of Systems Deployed
34 Examples
35 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
36 What Is a Microprocessor? Microprocessor CPU RAM Digital Ports Memory/Data Bus RAM Memory RAM Devices Communications Buses Analog Components Communications
37 What Is a Microcontroller? Microcontroller CPU RAM ROM Counter Analog Components Serial Port Digital Ports
38 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
39 Technology Prototype System Architecture
40 Software Development Part III: Validation TOOLS FOR VALIDATION
41 Static Analysis LabVIEW VI Analyzer Toolkit Automate code analysis with 60+ configurable tests Performance Style Interactively inspect failures Generate custom reports
42 Requirements
43 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
44 NI Requirements Gateway
45 DEMO: REQUIREMENTS TRACEABILITY
46 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
47 FPGA Programmable Interconnects Logic Blocks I/O Blocks
48 Decision Making in Software Traditional System Crash Possible Patient Hardware Operating System Driver API Application Software Calculation Outputs
49 Decision Making in Hardware LabVIEW FPGA System Highest Reliability Patient Hardware Calculation Operating System Driver API Application Software Outputs
50 LabVIEW Statechart Module
51 Automatic Documentation LabVIEW VI documentation NI Report Generation Toolkit for Microsoft Office NI Requirements Gateway Reports
52 For more information: ni.com/medical
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