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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