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Reliability & Robust Design
in the Medical Industry
for
"Meet the Experts" Design Forum Event
Mike Silverman // (408) 654-0499 // [email protected]
Ops A La Carte LLC // www.opsalacarte.com
© 2009 Ops A La Carte
1
Presenter’s Biographical Sketch – Mike Silverman
◈ Mike Silverman is founder and managing partner at Ops A La Carte, a Professional
Consulting Company that has in intense focus on helping customers with end-to-end
reliability. Through Ops A La Carte, Mike has had extensive experience as a consultant
to high-tech companies, and has consulted for over 100 different industries, including the
food industry.
◈ Mike has 28 years of reliability and quality experience. He is also an expert in
accelerated reliability techniques, including HALT&HASS (and recently purchased a HALT
Lab), testing over 500 products for 100 companies in 40 different industries.
◈ Mike just completed his first book on Reliability called “50 Ways to Improve Your Product
Reliability”. This course is largely based on the book material.
◈ Mike has authored and published 8 papers on reliability techniques and has presented
these around the world including China, Germany, Canada, Taiwan, India, Singapore,
and Korea. Ops has also developed and currently teaches 31 courses on reliability
techniques.
◈ Mike has a BS degree in Electrical and Computer Engineering from the University of
Colorado at Boulder, and is both a Certified Reliability Engineer and a course instructor
through the American Society for Quality (ASQ), IEEE, Effective Training Associates, and
Hobbs Engineering. Mike is a member of ASQ, IEEE, SME, ASME, PATCA, and IEEE
Consulting Society and is the current chapter president in the IEEE Reliability Society for
Silicon Valley.
2
Seminar Overview
Wed, Nov 14, 2012
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability
Overview
Developing an Effective Reliability Test Plan
3
COMPANY
OVERVIEW
Confidence in Reliability
Introduction
Ops A La Carte
– Founded in 2001
– Named top 10 fastest growing private companies
in the Silicon Valley in 2006 and 2009.
– Over 1500 projects completed in 11 years
– Over 500 Customers in over 30 countries
– Over 100 different industries, 7 main verticals
• CleanTech, Consumer Electronics, Defense,
• Industrial, MedTech, Oil/Gas, Telecom
– In 2012, we launched our new
Ounce of Prevention Strategy (OPS) Program
OPS in N.America
Our Consultants
OPS Around the World
LED Street Lighting
Singapore
PST
Our Consultants
• Ops Medical Projects
•
•
•
•
•
•
•
•
•
•
•
•
•
3M Health Care - Reliability Plan and data analysis for drug
delivery systems and devices
Abbott - ALT for glucose monitoring system
Accuray - Reliability Assessment and program plan for
stereotactic radiosurgery device for tumors
Applied Biosystems - HALT and RoHS services for DNA
sequencing products.
Boston Scientific - HALT, V&V, and CRE/CQE Training for
minimally invasive medical devices
Cardiac Assist - HALT for cardiac surgery device
Cardinal Health - ALT for neonatal CPAP device, root cause
analysis for nebulizer
Carestream - DfR Training for mammography solutions company
Cochlear - ALT Training for implantable hearing aids
Covidien - Reliability plan and predictions for drug delivery systems
Fisher and Paykel Healthcare - ALT for sleep apnea device
Flextronics Medical - Software reliability for medical systems
Hospira - Complete reliability program for infusion pumps
• Ops Medical Projects, continued
•
•
•
•
•
•
•
•
•
•
•
Intuitive Surgical - HALT, V&V, Reliability Improvement Plan, &
Vendor Quality for medical robotics
Lifescan/Johnson+Johnson - HALT for glucose monitoring
system
Luminetx - ALT for vein finding system
Mako Surgical - Reliability plan for robotic knee surgery system
Next Safety - Reliability prediction for pulmonary drug delivery
devices
OmniCell - HALT and ALT for medical dispensing systems
Ortho-Clinical/Johnson+Johnson - HALT for transfusion
medicine
Perfint Healthcare Devices - Reliability test plan for image
guided procedure system
Perkin-Elmer - HALT and HASS for medical illumination system
Philips Medical - Cable qualification testing for sonogram
system
Proteus Biomedical Inc. - HALT and environmental testing for
in-body computing (implantable)
• Ops Medical Projects, continued
•
•
•
•
•
•
•
•
•
•
•
Pulmonetic - HALT for ventilator system
Philips Medical (formerly Respironics) - Reliability plan, HALT,
ALT, and teardown analysis for sleep apnea device
Siemens Medical (formerly Acuson) - Reliability prediction for
nuclear medicine system
Solta Medical (formerly Thermage) - HALT for radiofrequency
cosmetic procedure systems
Stryker - HALT for medical illumination system
Suni Medical - Quality system review for dental medical imaging
systems
Tecan Systems - HALT and root cause analysis for laboratory
instrument
Terumo Medical (formerly Mission Medical) - Reliability plan,
FMEA, HALT, and ALT for blood collection system
Thoratec - HALT and ALT for heart pump devices
Ventana Medical – HALT and environmental testing for
automated immunohistochemistry (IHC) system
World Heart - HALT for pulsatile ventricular device
FREE Webinars for 2012
• Nov 7 – 40 Years of HALT (500 people)
• Dec 5 – Counterfeiting
• Jan 9 - Accelerated Life Testing
Details for all are on our site at www.opsalacarte.com
Upcoming Events
• Dec 4-5: BIOMEDevice Show - December 4-5, 2012
• Jan, 2013 – RAMS
• Feb, 2013 – MD&M West – Anaheim – Medical Testing
Details for all are on our site at www.opsalacarte.com
11
Ops’ New Reliability Book
How Reliable Is Your Product?
50 Ways to Improve Product Reliability
A new book by Ops A La Carte LLC® Founder/Managing Partner Mike Silverman
The book focuses on Mike’s experiences
working with over 500 companies in his 25
year career as an engineer, manager, and
consultant. It is a practical guide to reliability
written for everyone in your organization. In
the book we give tips and case studies rather
than a textbook full of formulas.
Available January 2011 in hardback for
$44.95 or ebook for $19.95 @amazon.com or
http://www.happyabout.com/productreliability.php
For more info, go to www.opsalacarte.com
12
or
Ounce of
Prevention
Strategy
• Ops Solutions – Ops provides end-to-end solutions that target the corporate
product reliability objectives
• Ops Individual “A La Carte” Consulting – Ops identifies and solves the
missing key ingredients needed for a fully integrated reliable product
• Ops Training – Ops’ highly specialized leaders and experts in the industry
train others in both standard and customized training seminars
• Ops Testing – Ops’ state-of-the-art
provides comprehensive testing services
Ounce of Prevention Strategy (OPS)
What do Computer Laptop Battery fires, Toyota Prius crashes, BP Oil Rig explosion
have in common?
They all did not use our Ounce of Prevention Strategy (OPS). Our OPS methodology, if
used, will discover problems BEFORE your customers find them.
In today's world of product development, product cycles are shortening,
product complexity is accelerating, and companies are relying more on
outside resources.
Consulting Services
Goal
Setting
Gap
Analysis
Benchmark
Metrics
Block
Diagrams
Golden
Nuggets
Thermal
Analysis
Derating
Analysis
POF
PHASE
Assessment
Reliability
Plan
DOE
Tolerance
Analysis
Preventive
Mainten.
Test
Plan
HALT
RDT
Vendor
Assessmt
Outsourcing
Lessons
Learned
Warranty
Returns
Predictions
EOL
Analysis
Warranty
Analysis
FEA
ALT
HALT-AFR
Calculator
RCA
HASS
ORT
OOBA
Software
Reliability
CLCA
PHASE
Component
Selection
PE PHASE
FTA
PHASE
FMEA
Reliability
Reporting
Statistics
EDA for
Obsolesc
Seminar Overview
Wed, Nov 14, 2012
- DFR OVERVIEW -
Introduction
Design for Reliability Overview
17
Failure
Rate
Quality: Does
the product
work when the
customer first
receives it /
first turns it on?
Reliability: How
often does the
product fail after
the customer
receives it /
first turns it on?
Time
Reliability:
How long does
the product
work until it
wears out?
Seminar Overview
Wed, Nov 14, 2012
- DFR OVERVIEW -
Introduction
19
Similarities and Differences
Between Regulatory Programs
and Reliability Programs
Government Regulations
Food and Drug Administration FDA http://www.fda.gov/
21 CFR Parts 808, 812, and 820 Medical Devices; Current Good
Manufacturing Practice (CGMP) Final Rule; Page 2
SUPPLEMENTARY INFORMATION: I. Background (Design Controls)
“Specifically, in January 1990, FDA published the results of an
evaluation of device recalls that occurred from October 1983 through
September 1989, in a report entitled ‘‘Device Recalls: A Study of Quality
Problems’’.
FDA found that approximately 44 percent of the quality
problems that led to voluntary recall actions during this 6year period were attributed to errors or deficiencies that
were designed into particular devices and may have been
prevented by adequate design controls.
Reliability vs. Compliance
We have found that many medical companies confuse
reliability with compliance.
Just because you follow the compliance regulations does
not guarantee you have a reliable product.
In fact, the new IEC 60601-1 3rd Edition document requires
that your testing be based on risks you discover during your
risk management process.
In this presentation we will show you two different case
studies – one in which we met the basic reliability
requirements and a second in which we had a separate
reliability effort to address specific reliability risks.
CASE STUDY 1: FDA Class III
Medical Device Pacemaker
The following case study
illustrates how to use
regulatory and reliability
together in a program.
Case Study: FDA Class III Medical Device
Pacemaker interrogating device
Pre Market Approval
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Submitted and approved documents:
1) Corporate Quality System Handbook
2) Product Development Handbook
3) Product Development Management Plan and Report
4) Product development, review and approval record
5) Risk Analysis for both software and hardware
6) Failure Rate Prediction, parts count
7) Failure Mode Effects Analysis / Fault Tree Analysis
8) Product Validation test reports both hardware and software
9) Document change procedure
10) Document release procedure
11) Purchase procedure
12) Product serial number system
13) Material Review Board Procedure
14) Finish Goods Procedure
15) Internal Audit Procedure
16) Training Procedure
17) Standard Operations Procedure
CASE STUDY 2: Infusion Pump
The next example illustrates how
we worked with a company and
took them through an entire
reliability program to make sure
we addressed all major risks to
reliability.
CASE STUDY II:
MEDICAL INFUSION PUMP
The infusion pump was an n+1 design
We started with a reliability goal
statement
Then we wrote a comprehensive
reliability program plan
• RELIABILITY PROGRAM PLAN
 Which areas were the same
 Which areas were new
 Reliability allocations
 Gap analysis
 Reliability Tools Deployed, General for all assemblies
 Reliability Tools Deployed, Specific to certain assys
 How will tools be used
 Metrics to be used during program
 Reliability Reporting and Issues Management
 Roles and Responsibilities
 Reliability Deliverables
 Contingency Planning
 Ongoing Reliability Assurance
• NEW ASSEMBLIES
Two new motors - one for the cassette insertion
and removal, and one for the air sensor to pinch
the tubing in order to detect air bubbles in the
line.
A new power supply that was larger and also
had a battery charging circuit for the new
rechargeable battery.
A touch screen
An IEEE 802.11 wireless interface
A new rechargeable battery design
New software to handle all of these new features
• IDENTIFY RELIABILITY RISKS
Using the Risk Analysis process, we identified
as many new risks as possible
Then we set out to figure ways of mitigating
these risks
Design analysis techniques such as FEA, DOE,
and Thermal Analysis
Accelerated Testing techniques such as HALT,
ALT, and RDT
The important element here is that we always
had an eye on our goal.
• RELIABILITY TECHNIQUES USED
Motors – FEA, ALT
Power Supply – HALT then RDT
Touch Screen – ALT, Abuse Testing
Wireless Interface - HALT
Battery – Application Specific ALT
Software – Software FMEA, Software
Use Case Testing
• RESULTS
Using this process we saved time and money.
We found out issues during the design
analysis that would have required a redesign
had we found them later in the design, or
worse, out in the field
We found out issues during the testing that
would have set our program back months.
End result: We developed and delivered a
very reliable product and got it to market
faster.
Seminar Overview
Wed, Nov 14, 2012
- DFR OVERVIEW -
Introduction
Design for Reliability
Overview
33
DESIGN FOR
RELIABILITY (DFR)
OVERVIEW
34
Definition
• DfR is knowledge‐based engineering wherein, starting with capture of requirements and leading to assured reliability, a reliability plan is designed and executed using the full skills and knowledge of the project team.
• The goal of DfR is to work smarter through knowledge‐based tailoring of the reliability plan.
11/17/2012
Ops A La Carte ©
35
Is NOT
• Making a list of all possible reliability activities and then trying to cover as many as possible within the timeframe of the product development process.
• Assuming that product reliability is the sole responsibility of a reliability engineer (reliability engineer is the guide and mentor but not the owner – designer should be the owner).
• Getting the product into test as fast as possible to test reliability into the product (a.k.a. Test‐Analyze‐and‐Fix)
• Only working on the in‐house design items and not worrying about vendor items
• Working in silos between EE, Mech E, Software, etc. (even if they apply some or most of the DfR tools) – all competencies must work together to reach common goals.
11/17/2012
Ops A La Carte ©
36
IS
• Identifying goals and requirements, consistent with customer and business objectives.
• Applying knowledge‐based management and engineering, to define, implement and improve plans to achieve goals and requirements.
• Providing clear metrics for review. Reviewing and taking timely corrective action.
• Reviewing and knowledge‐capture from all activities and outputs, with goal of continuous improvement.
• DfR is the process of building reliability into the design, with efficiency and assurance, using the best science‐based methods.
11/17/2012
Ops A La Carte ©
37
Flow
•
•
•
•
•
Initiate a Reliability Program
Determine next best steps
Reduce customer complaints Select right tools
Improve reliability
Program Plan
$ Profits
Goal
market
share
Gap Analysis
satisfaction
Benchmarking
Statistical
Data Analysis
Assessment Interviews
field
failures
complaints
11/17/2012
$ unreliability
Now
? Unknown Reliability ?
A detailed evaluation of an organization’s approach and processes involved in creating reliable products. The assessment captures the current state and leads to an actionable reliability program plan.
Ops A La Carte ©
38
Key Activities
6. Post‐Launch
5. Launch 4. Qualification
3. Development
2. Feasibility
1. Concept
11/17/2012
Ops A La Carte ©
39
DfR Key Activities
HASS, Control Charts, Re‐
validation, Audits, Look Across,
Lessons Learned, ORT 6. Post‐Launch
Design and Process Validation
Accelerated Test. Reliability HALT, 5. Launch Demonstration.
Evaluation Testing, DRBTR,
FEA, Warranty Data Reliability Growth modeling, Analysis, Change Point Analysis
DRBFM, Reliability 4. Qualification
3. Development prediction
Lessons Learned, Reliability Block Diagrams
DFMEA, Cost trade‐off analysis,
2. Feasibility Lessons Learned
Probabilistic design, Cost trade‐
offs, Tolerance Analysis
QFD, Requirements definitions, Benchmarking, Product usage analysis
1. Concept
Understanding of customer requirements and specifications
11/17/2012
Ops A La Carte ©
40
Key points for implementing DfR
activities
• Start DfR activities early in the process
• Reliability engineer’s job is to lead/coach the design team. Reliability achievement needs to be owned by design and manufacturing teams.
• Integration of Reliability and Quality Engineers with design teams. • Warranty/field data analysis (both statistical and root cause analysis) needs to be fed back to both design and reliability teams. • Reduce the number of tools in the toolbox, but use the remaining well. Neither all steps nor tools are necessary for all the programs.
11/17/2012
Ops A La Carte ©
41
Reliability Before Design
Traditional Reliability Model
Spending
Rate
Product Development
Spend Rate
6
5
4
Reliability Spend Rate
3
2
1
0
8
9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26
Time
Post-Launch
6 7
Launch
5
Qualification
4
Development
3
Concept
Feasibility
1 2
42
Reliability Before Design
Reliability Before Design /
Design for Reliability Method
Spending
Rate
Product Development
Spend Rate
6
5
4
New Reliability Spend Rate
3
$ Savings $
2
1
0
8
9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26
Time
Post-Launch
6 7
Launch
5
Qualification
4
Development
3
Concept
Feasibility
1 2
43
Seminar Overview
Wed, Nov 14, 2012
- DFR OVERVIEW -
Introduction
© Ops A La Carte LLC 2012
44
DEVELOPING AN
EFFECTIVE
RELIABILITY TEST
STRATEGY
45
Steps to a Good Design
In order to write better test plans:
1) Understand Requirements
2) Understand Use Environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform Design & Design Reviews
6) Write Design Verification Test plan
7) Write Reliability Test Plan
Understanding Requirements
Inputs include:
– Specifications
• MRD – Marketing Requirements Document
• PRD – Product Requirements Document
– Competitive Product Solutions
– Lessons Learned
– Constraints
Understanding Requirements
• Risks comes From Requirements That Are
– Incomplete
– Ambiguous
– Conflicting
– Not Testable
1) Understand requirements
2) Understand use environment
Understand Use Environment
•
•
•
•
What
What
What
What
are normal use conditions?
are typical abuse conditions?
are atypical (but real) abuse conditions?
is life of product?
3) Perform FMEA
Perform FMEA
Failure Modes and Effects Analysis
(FMEA) is the process by which we
explore potential failure modes and
then prioritize by key risks
Perform FMEA
• Use good brainstorming techniques,
breaking sessions out by different
disciplines/areas
–User (UFMEA)
–Wearout (WFMEA)
–Design (DFMEA)
–Software (SFMEA)
–Process (PFMEA)
–Interface (IFMEA)
3) Perform FMEA
Use Robust Design Techniques
 Design for Robustness (RD) is a
systematic engineering based
methodology that develops and
manufactures high reliability
products at low cost with reduced
delivery cycle.
 The goal of RD is to improve R&D
productivity and reduce variation
while maintaining low cost before
shipment and minimal loss to
society after shipment.
Example of Robust Design: MIR
Space Station
• Robustness = survivability in the face of unexpected
changes in environment (exo) or within the system (endo)
Example of Optimal Design
• M. Alboreto dies (Le Mans, April 2001) due to slight loss
of pressure in left rear tire. The system was extremely
sensitive to boundary conditions (was optimal, and
therefore very very fragile!).
MDfR-Mechanical Design for
Reliability
3) Perform FMEA
5) Perform design and design reviews
Designing to Requirements
Mechanical
•
•
•
•
•
•
Common Hardware
Minimize Part Count
Feature Integration
Design For Assembly
Design For Test
Design for Service
Electrical
• Select Parts With Long Lifetimes
• Design For Assembly
• Design For Test
– In-Circuit Test
– Functional Test
• Design for Service
Software
• Understand reqts before coding
• Phase containment approach
• Growth through defect tracking
Design Reviews
• Compare plan with reality
• How to determine actual
status?
– Engineer says he’s 90%
done, but how do you know?
– Short schedule milestones
should have broken the
project into short
measurable pieces
• Do your reviews ever
uncover anything?
3) Perform FMEA
5) Perform design & design reviews
6) Write design verification test plan
Develop Design Verification Test
 Create tests that match each
requirement and can be traced back
to ensure you have covered the
requirements.
 Use trace matrix
 Use FMEA to record how each failure
mode is covered by which
requirement.
3) Perform FMEA
5) Perform design & design reviews
6) Write design verification test plan
7) Write Reliability Test Plan
Write Reliability Test Plan
Write Reliability Test Plan
Start with DVT plan and then review
FMEA to determine what areas
standard tests will not guarantee
reliability.
1) For Environmental tests, do you
test outside specs/to failure ?
2) For Electrical/Mechanical
stresses, do you test outside
specs for margin ?
What You Need to Write a
Good Test Plan
•
•
•
•
•
Goal
Sample Size
Time
Acceleration
Confidence
What Is Confidence ?
Case Study 1 - Inhaler
Features of
Inhaler
•
•
•
•
•
•
Dose Dial
Cleaning
Change vial
Charge battery
On/Off
Use
Developing a Test Plan
with FMEA
• What types of tests can you think of for
this device?
Run Exercise
Features of Inhaler
FEATURE
Dose Dial
Cleaning
Change vial
Charge
battery
On/Off
Use
Operator
Design
Maintenance Manufacturing
Case Study 2 - Implantable
Features of Implantable
• Implant Section
– Provide stimulation to brain
– Provides safe seal
• Lead
– Makes connection to implant
– Provides safe seal
Slide courtesy of Intrapace
Developing a Test Plan
with FMEA
• What types of tests can you think of for
this device?
Run Exercise
Features of Inhaler
FEATURE
Implant
- Stimulation
- Safe Seal
Lead
- Connectivity
- Safe Seal
Opera
tor
Design
Maintenance Manufacturing
FMEA Summary
• FMEA helps improve product by mitigating
major risks.
• FMEA also prompts design consideration
and improvement, to make the design
more robust before testing
DFR Summary
• Design for Reliability (DFR) is integrating
reliability into each portion of product life
cycle.
• Reliability is not just about testing.
– You can’t test reliability into a product.
• You Must Design it In!
• Using DFR, you will design reliability and
availability into your product to make these
more predictable.
Results
Q&A
CONTACT INFO
Mike Silverman
Managing Partner
Ops A La Carte, LLC
(408) 654-0499
[email protected]
www.opsalacarte.com

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Transcription

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