Systems Engineering in Medical Devices

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With new technologies come many innovative medical devices and tools to help treat patients and to improve their quality of life thru diagnosis, monitoring and therapy. New fields of study within Engineering are emerging throughout the academic community to better understand and improve these devices and tools. As a Systems Engineer what are we doing in this application that’s different from others? What are the challenges? What do we need to improve on? And Why?

This presentation provides an overview of the different types of Medical Devices and addresses the associated implications that affect the system under design. An example of a specific Medical Device will be presented along with a description of how the system integrates with Biological component. Systems Engineering Process comparison between Medical Device industry and Defense industry where Systems Engineering was conceived has been integrated throughout this presentation. You will learn more about some of the challenges that Medical Devices industry is facing and potential Systems Engineering solutions with specific approach and methodology.

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Systems Engineering in Medical Devices

  1. 1. SE in Medical Device Industry Channy Laux 4/12/11 1
  2. 2. Objective• Compare and contrast product development in Defense and Medical Device Industries 2
  3. 3. Agenda• Different Types of Medical Devices• BD Biosciences Products• Compare & Contrast• Challenges• Conclusions 3
  4. 4. Different Types ofMedical Devices 4
  5. 5. Non-Invasive Medical Devices Flow Cytometer Blood Pressure Monitor 5
  6. 6. Invasive Medical Devices Pacemaker 6
  7. 7. Invasive Medical Devices Injection Needle 7
  8. 8. Invasive or Non-Invasive?TRIMProb (Tissue Resonance InterferoMeter Probe) 8
  9. 9. BD Biosciences Products Flow Cytometer 9
  10. 10. BD Biosciences Products BD FACS Sample Prep Assistant III 10
  11. 11. Compare & Contrast Defense Medical Device 1962 - Publication of “A Methodology for 1978 - 21 CFR part 820 becameMaturity Systems Engineering” effective; required Current Good 1969 - MIL-STD-499; began to mandate SE Manufacturing Practices (CGMP) practices 1996 - 21 CFR part 820 added 1990 - NCOSE Design Control and ISO 9001 1995 - INCOSE concepts; including requirements and verification/validation but not 1998 - EIA 632 released (based on MIL- a complete SE process STD-499B which was never released) 1996 - ISO 13485 Quality 1999 - IEEE-1220 Management Systems for 2002 - ISO/IEC 15288 Designing and Manufacturing SE viewed as Medical Devices * The architect * The requirements engineer SE viewed as * Interface engineer * Requirements engineer * System Integrator * Ad-hoc troubleshooting * The system verification & qualification * Verification & Validation planner and tester … * Facilitator 11 11
  12. 12. Compare & Contrast Defense Medical Device SoS with capabilities based on Systems focus on the intra-Complexity interoperability between operability Satellites, Aircrafts, Land Vehicles, Ships, C4ISR - DoD - Regulatory Affairs (worldwide)Stakeholders - External systems - Medical Core Team member - User with formal training - User (IVD, RUO, Expert, Novices) with preferences (Lab Workflow, Individual, Local) - Biologists 12
  13. 13. Compare & Contrast Defense Medical Device - Normal Operation - Research Use Only (RUO)Operation - Training - In-Vitro Diagnostics (IVD)Modes - Diagnostics - Training - Diagnostics - System to System I/F (ICD) - Limited control of end userIntended Use - User workflow SOP - For Invasive Device (i.e. pacemaker) the intended use is specific - ConOps - Meetings with SMERequirement - Formal analysis (UC, Causal - No abstraction control analysis) - Ad-Hoc approach - Interfaces - Requirement is complete - Clear levels of abstraction when time is up - ilities 13
  14. 14. Compare & Contrast Defense Medical Device - System level - Functional organization at systemArchitecture - Subsystem level level - Architecture at a subsystem level is more formal - BIT (SBIT, PBIT, IBIT) - Manual Troubleshooting notesStandard - Self diagnostics & Recovery - Manual Replaceable partsfunctions - Redundancy capabilities - Component shelf life tracking - Field Service Engineering - Status log - For invasive devices such as pacemaker there would be more built-in capabilities such as redundancy, PBIT, … - Budget - Hazard to user & patientRisk - Technical - Schedule 14
  15. 15. Compare & Contrast Defense Medical Device - Integration Plan/Strategy - Exploratory TestingIntegration - Independent integration platform - Manage system test configurations - IRS, ICD, N2 diagram - Coordinate daily standup meeting between subsystems - Incremental integration leads to - System performance verificationVerification final test and verification focuses more on application - Design for verification protocols - Verification Platform (test set) - Device level of verification is - First Article Inspection mostly done by subsystem test - System qualification/validation - Validation PlanValidation - Simulating customer scenarios - Determine a go or no-go of the product release - Validation reports 15
  16. 16. Challenges Lab Technician Flow CytometerSample Prep Robot 16
  17. 17. Challenges Intensive Care UnitBed Side Monitoring IV Pumps Ventilator Brain Monitoring 17
  18. 18. What To Do?• Improve Systems Engineering process (INCOSE Systems Engineering Handbook)• System of Systems approach• MBSE (Model Based Systems Engineering) 18
  19. 19. Conclusions• SE in Medical Device Industry is not as elaborate as in Defense Industry, however, focus is on product safety• Different types of Medical Devices demand different levels of SE practices• Improving SE process in the Medical Device industry will optimize the following – Efficiency of product development – Usability – Flexibility 19

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