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.

1. SE in Medical Device
Industry
Channy Laux
4/12/11
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2. Objective
• Compare and contrast product
development in Defense and Medical
Device Industries
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3. Agenda
• Different Types of Medical Devices
• BD Biosciences Products
• Compare & Contrast
• Challenges
• Conclusions
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4. Different Types of
Medical Devices
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5. Non-Invasive Medical Devices
Flow Cytometer Blood Pressure Monitor
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6. Invasive Medical Devices
Pacemaker
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7. Invasive Medical Devices
Injection Needle
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8. Invasive or Non-Invasive?
TRIMProb (Tissue Resonance InterferoMeter Probe)
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9. BD Biosciences Products
Flow Cytometer
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10. BD Biosciences Products
BD FACS Sample Prep Assistant III
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11. Compare & Contrast
Defense Medical Device
1962 - Publication of “A Methodology for 1978 - 21 CFR part 820 became
Maturity 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
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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
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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 user
Intended Use - User workflow SOP - For Invasive Device (i.e.
pacemaker) the intended use
is specific
- ConOps - Meetings with SME
Requirement - Formal analysis (UC, Causal - No abstraction control
analysis) - Ad-Hoc approach
- Interfaces - Requirement is complete
- Clear levels of abstraction when time is up
- ilities
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14. Compare & Contrast
Defense Medical Device
- System level - Functional organization at system
Architecture - Subsystem level level
- Architecture at a subsystem level is
more formal
- BIT (SBIT, PBIT, IBIT) - Manual Troubleshooting notes
Standard - Self diagnostics & Recovery - Manual Replaceable parts
functions - 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 & patient
Risk - Technical
- Schedule
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15. Compare & Contrast
Defense Medical Device
- Integration Plan/Strategy - Exploratory Testing
Integration - Independent integration platform - Manage system test configurations
- IRS, ICD, N2 diagram - Coordinate daily standup meeting
between subsystems
- Incremental integration leads to - System performance verification
Verification 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 Plan
Validation - Simulating customer scenarios -
Determine a go or no-go of the
product release
- Validation reports
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16. Challenges
Lab Technician
Flow Cytometer
Sample Prep
Robot
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17. Challenges
Intensive Care Unit
Bed Side Monitoring IV Pumps
Ventilator Brain Monitoring
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18. What To Do?
• Improve Systems Engineering process
(INCOSE Systems Engineering Handbook)
• System of Systems approach
• MBSE (Model Based Systems Engineering)
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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
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