© 2009 Ops A La Carte 1

Mike Silverman // (408) 654-0499 // mikes@opsalacarte.com

Ops A La Carte LLC // www.opsalacarte.com

Reliability & Robust Design in the Medical Industry

for

"Meet the Experts" Design Forum Event

© 2009 Ops A La Carte 2

Presenter’s Biographical Sketch – Mike Silverman

◈Mike Silverman is founder and managing partner at Ops A La Carte, a ProfessionalConsulting Company that has in intense focus on helping customers with end-to-endreliability. Through Ops A La Carte, Mike has had extensive experience as a consultantto high-tech companies, and has consulted for over 100 different industries, including thefood industry.

◈Mike has 28 years of reliability and quality experience. He is also an expert inaccelerated reliability techniques, including HALT&HASS (and recently purchased a HALTLab), 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 ProductReliability”. This course is largely based on the book material.

◈Mike has authored and published 8 papers on reliability techniques and has presentedthese around the world including China, Germany, Canada, Taiwan, India, Singapore,and Korea. Ops has also developed and currently teaches 31 courses on reliabilitytechniques.

◈Mike has a BS degree in Electrical and Computer Engineering from the University ofColorado at Boulder, and is both a Certified Reliability Engineer and a course instructorthrough the American Society for Quality (ASQ), IEEE, Effective Training Associates, andHobbs Engineering. Mike is a member of ASQ, IEEE, SME, ASME, PATCA, and IEEEConsulting Society and is the current chapter president in the IEEE Reliability Society forSilicon Valley.

© 2009 Ops A La Carte3

Seminar OverviewWed, 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

COMPANY OVERVIEW

Confidence in Reliability

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

Introduction

OPS in N.America

Our Consultants

OPS Around the World

Singapore

Our Consultants

PST

LED Street Lighting

• 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

11© 2009 Ops A La Carte

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

12© 2009 Ops A La Carte

Ops’ New Reliability BookHow 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

• 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-artprovides comprehensive testing services

orOunce of

Prevention Strategy

In today's world of product development, product cycles are shortening, product complexity is accelerating, and companies are relying more on outside resources.

Ounce of Prevention Strategy (OPS)

What do Computer Laptop Battery fires, Toyota Prius crashes, BP Oil Rig explosionhave 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.

Consulting Services

GoalSetting

Assess-ment

Bench-mark

FTAFMEA

GoldenNuggets

Component Selection

Predict-ions

ThermalAnalysis

DeratingAnalysis

POF

DOE Tolerance Analysis

Preventive Mainten.

EOL Analysis

WarrantyAnalysis

TestPlan

HALT RDT ALT HALT-AFR Calculator

FEA SoftwareReliability

RCA CLCA

VendorAssessmt

HASS ORT OOBA

LessonsLearned

WarrantyReturns

ReliabilityReporting

Statistics EDA forObsolesc

Out-sourcing

Metrics

ReliabilityPlan

PHA

SEPH

ASE

PHA

SEPE

PHA

SE

Gap Analysis

Block Diagrams

© 2009 Ops A La Carte

17

Seminar OverviewWed, 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

Failure Rate

Time

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?

Reliability: How long does the product work until it wears out?

© 2009 Ops A La Carte

19

Seminar OverviewWed, 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

Similarities and Differences Between Regulatory Programs

and Reliability Programs

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 6-year period were attributed to errors or deficiencies that were designed into particular devices and may have been prevented by adequate design controls.

Government Regulations

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.

Reliability vs. Compliance

The following case study illustrates how to use

regulatory and reliability together in a program.

CASE STUDY 1: FDA Class III Medical Device Pacemaker

• 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: FDA Class III Medical DevicePacemaker interrogating device

Pre Market Approval

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 2: Infusion Pump

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

MEDICAL INFUSION PUMP

• RELIABILITY PROGRAM PLANWhich areas were the sameWhich areas were newReliability allocationsGap analysisReliability Tools Deployed, General for all assembliesReliability Tools Deployed, Specific to certain assysHow will tools be usedMetrics to be used during programReliability Reporting and Issues ManagementRoles and ResponsibilitiesReliability DeliverablesContingency PlanningOngoing Reliability Assurance

MEDICAL INFUSION PUMP

• NEW ASSEMBLIESTwo 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

MEDICAL INFUSION PUMP

• IDENTIFY RELIABILITY RISKSUsing 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 AnalysisAccelerated Testing techniques such as HALT,

ALT, and RDT

The important element here is that we always had an eye on our goal.

MEDICAL INFUSION PUMP

• RELIABILITY TECHNIQUES USEDMotors – 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

MEDICAL INFUSION PUMP

• RESULTSUsing 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.

MEDICAL INFUSION PUMP

© 2009 Ops A La Carte

33

Seminar OverviewWed, 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

© 2008 Ops A La Carte

34

DESIGN FOR RELIABILITY (DFR)

OVERVIEW

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

• 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.

Is NOT

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

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.

• Initiate a Reliability Program• Determine next best steps• Reduce customer complaints • Select right tools• Improve reliability

Now

Goal

$ unreliability

$ Profits

Assessment Interviews

StatisticalData Analysis

Benchmarking

Gap Analysis

Program Plan

complaints

fieldfailures

satisfaction

marketshare

? Unknown Reliability ?

11/17/2012 Ops A La Carte © 38

Key Activities

1. Concept

2. Feasibility

3. Development4. Qualification

5. Launch 

6. Post‐Launch

11/17/2012 Ops A La Carte © 39

DfR Key Activities

QFD, Requirements definitions, Benchmarking, Product usage analysisUnderstanding of customer requirements and specifications

DFMEA, Cost trade‐off analysis,Lessons LearnedProbabilistic design, Cost trade‐offs, Tolerance Analysis

FEA, Warranty Data Analysis, DRBFM, Reliability predictionLessons Learned, Reliability Block Diagrams

HASS, Control Charts, Re‐validation, Audits, Look Across,Lessons Learned, ORT 

HALT, Evaluation Testing, DRBTR,Reliability Growth modeling, Change Point Analysis

Design and  Process ValidationAccelerated Test.  Reliability Demonstration.

1. Concept

2. Feasibility

3. Development4. Qualification

5. Launch 

6. Post‐Launch

11/17/2012 Ops A La Carte © 40

Key points for implementing DfRactivities

• 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.

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42

Reliability Before Design

SpendingRate

Qualification Time

0

1

2

3

4

5

6

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26

Development

Feasibility

Concept

Launch

Post-Launch

Product Development Spend Rate

Reliability Spend Rate

Traditional Reliability Model

43

Reliability Before Design

SpendingRate

Time

0

1

2

3

4

5

6

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26

Qualification

Development

Feasibility

Concept

Launch

Post-Launch

Product Development Spend Rate

New Reliability Spend Rate$ Savings $

Reliability Before Design / Design for Reliability Method

© Ops A La Carte LLC 2012© 2009 Ops A La Carte

44

Seminar OverviewWed, 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

© 2008 Ops A La Carte 45

DEVELOPING AN EFFECTIVE

RELIABILITY TEST STRATEGY

Steps to a Good DesignIn order to write better test plans:1) Understand Requirements2) Understand Use Environment3) Perform FMEA4) Use Robust Design techniques5) Perform Design & Design Reviews6) Write Design Verification Test plan7) 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

Steps to a Good Design

In order to write better test plans:1) Understand requirements2) Understand use environment

Understand Use Environment

• What are normal use conditions?• What are typical abuse conditions?• What are atypical (but real) abuse conditions?• What is life of product?

Steps to a Good Design

In order to write better test plans:1) Understand requirements2) Understand use environment3) Perform FMEA

Perform FMEAFailure 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)

Steps to a Good Design

In order to write better test plans:1) Understand requirements2) Understand use environment3) Perform FMEA4) Use Robust Design techniques

Use Robust Design TechniquesDesign 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 variationwhile 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)

MDfR-Mechanical Design for Reliability

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!).

Steps to a Good Design

In order to write better test plans:1) Understand requirements2) Understand use environment3) Perform FMEA4) Use Robust Design techniques5) Perform design and design reviews

Designing to RequirementsMechanical

• Common Hardware• Minimize Part Count• Feature Integration• Design For Assembly• Design For Test• Design for Service

Designing to RequirementsElectrical

• Select Parts With Long Lifetimes• Design For Assembly• Design For Test

– In-Circuit Test–Functional Test

• Design for Service

Designing to RequirementsSoftware

• 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?

Steps to a Good Design

In order to write better test plans:1) Understand requirements2) Understand use environment3) Perform FMEA4) Use Robust Design techniques5) Perform design & design reviews6) 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 matrixUse FMEA to record how each failure

mode is covered by which requirement.

Steps to a Good DesignIn order to write better test plans:1) Understand requirements2) Understand use environment3) Perform FMEA4) Use Robust Design techniques5) Perform design & design reviews6) Write design verification test plan7) Write Reliability Test Plan

Write Reliability Test Plan

Write Reliability Test PlanStart 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 - InhalerFeatures 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 InhalerFEATURE Operator Design Maintenance ManufacturingDose DialCleaningChange vialChargebatteryOn/OffUse

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 InhalerFEATURE Opera

torDesign Maintenance Manufacturing

Implant- Stimulation- Safe SealLead

- Connectivity- Safe Seal

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 SilvermanManaging Partner

Ops A La Carte, LLC(408) 654-0499

mikes@opsalacarte.comwww.opsalacarte.com