systems engineering in medical devices
DESCRIPTION
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.TRANSCRIPT
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SE in Medical Device Industry
Channy Laux4/12/11
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Objective
• Compare and contrast product development in Defense and Medical Device Industries
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Agenda
• Different Types of Medical Devices• BD Biosciences Products• Compare & Contrast• Challenges• Conclusions
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Different Types of Medical Devices
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Non-Invasive Medical Devices
Flow Cytometer Blood Pressure Monitor
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Invasive Medical Devices
Pacemaker
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Injection Needle
Invasive Medical Devices
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Invasive or Non-Invasive?
TRIMProb (Tissue Resonance InterferoMeter Probe)
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BD Biosciences Products
Flow Cytometer
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BD Biosciences Products
BD FACS Sample Prep Assistant III
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Compare & ContrastDefense Medical Device
Maturity 1962 - Publication of “A Methodology for Systems Engineering”
1969 - MIL-STD-499; began to mandate SE practices
1990 - NCOSE1995 - INCOSE1998 - EIA 632 released (based on MIL-
STD-499B which was never released)1999 - IEEE-12202002 - ISO/IEC 15288SE viewed as
* The architect* The requirements engineer* Interface engineer* System Integrator* The system verification & qualification planner and tester …
1978 - 21 CFR part 820 became effective; required Current Good Manufacturing Practices (CGMP)
1996 - 21 CFR part 820 added Design Control and ISO 9001 concepts; including requirements and verification/validation but not a complete SE process
1996 - ISO 13485 Quality Management Systems for Designing and Manufacturing Medical Devices
SE viewed as* Requirements engineer* Ad-hoc troubleshooting* Verification & Validation* Facilitator
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Compare & Contrast
Defense Medical DeviceComplexity SoS with capabilities based on
interoperability between Satellites, Aircrafts, Land Vehicles, Ships, C4ISR
Systems focus on the intra-operability
Stakeholders - DoD - External systems- User with formal training
- Regulatory Affairs (worldwide)- Medical Core Team member- User (IVD, RUO, Expert, Novices) with preferences (Lab Workflow, Individual, Local)- Biologists
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Compare & Contrast
Defense Medical DeviceOperation Modes
- Normal Operation- Training- Diagnostics
- Research Use Only (RUO)- In-Vitro Diagnostics (IVD)- Training- Diagnostics
Intended Use - System to System I/F (ICD)- User workflow SOP
- Limited control of end user- For Invasive Device (i.e. pacemaker) the intended use is specific
Requirement - ConOps- Formal analysis (UC, Causal analysis)- Interfaces- Clear levels of abstraction- ilities
- Meetings with SME- No abstraction control- Ad-Hoc approach- Requirement is complete when time is up
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Compare & Contrast
Defense Medical DeviceArchitecture - System level
- Subsystem level- Functional organization at system level- Architecture at a subsystem level is more formal
Standard functions
- BIT (SBIT, PBIT, IBIT)- Self diagnostics & Recovery- Redundancy capabilities- Component shelf life tracking- Status log
- Manual Troubleshooting notes- Manual Replaceable parts- Field Service Engineering
- For invasive devices such as pacemaker there would be more built-in capabilities such as redundancy, PBIT, …
Risk - Budget- Technical- Schedule
- Hazard to user & patient
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Compare & Contrast
Defense Medical DeviceIntegration - Integration Plan/Strategy
- Independent integration platform- IRS, ICD, N2 diagram
- Exploratory Testing- Manage system test configurations- Coordinate daily standup meeting between subsystems
Verification - Incremental integration leads to final test and verification- Design for verification- Verification Platform (test set)- First Article Inspection
- System performance verification focuses more on application protocols- Device level of verification is mostly done by subsystem test
Validation - System qualification/validation - Validation Plan- Simulating customer scenarios -Determine a go or no-go of the product release- Validation reports
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Challenges
Sample Prep
Lab Technician
Flow Cytometer
Robot
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Challenges
Ventilator Brain Monitoring
Bed Side Monitoring IV Pumps
Intensive Care Unit
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What To Do?
• Improve Systems Engineering process (INCOSE Systems Engineering Handbook)
• System of Systems approach
• MBSE (Model Based Systems Engineering)
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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