101
Medical Components Reliability Specifications Meeting – MLCC Phase I wrap up and Phase II introduction Anthony Primavera November 14, 2008

Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

  • Upload
    others

  • View
    6

  • Download
    0

Embed Size (px)

Citation preview

Page 1: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

Medical Components Reliability

Specifications Meeting – MLCC

Phase I wrap up and Phase II

introduction

Anthony PrimaveraNovember 14, 2008

Page 2: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

Background

Page 3: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

2

OverviewOverview

• Medical Electronics Trends• Growth Drivers• Technology Trends• Technology Integration Plans

– Key Technology Gaps– Initial Projects

• Component Reliability Specifications Project– Project Overview– Opportunities

• Medical Reliability for MLCC (multi-layer ceramic capacitor) Project Update

Page 4: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

3

Medical Electronics Trends Medical Electronics Trends -- GrowthGrowth• Impact to national economy on healthcare will

force the need for less expensive systems.– By 2010 there will be an expected 40 million persons in

the U.S. over 65 (U.S. Census Bureau)– 74 Million elders in US, 1.2 Billion world wide by 2025– US spending is currently 15-16% of federal budget on

health care. – By 2025, there will be 1 retiree for every 3 workers.– Higher spending will be required if current model is

continued to be followed. • long term impact is an international trend toward home

health technologies and preventive health care

Page 5: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

4

Medical Electronics Trends Medical Electronics Trends -- Growth Growth

Source: Bureau of Labor Statistics, pub in CNN/Money.com, “Where the jobs will be Greatest employment growth is likely to be in service industries, according to new labor study.” By Jeanne Sahadi, Feb 13, 2004.

• Medical related job demand fastest growing• Inadequate supply of labor

• Costs are critical• Rising hospital care costs, • Escalation in the number of un-

insured, • Shorter healthcare giver – patient

interaction time.

• Growing “Consumer Medical Electronics Market”• home diagnostic equipment,

wearable patient monitoring equipment, etc.

Page 6: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

$0

$20

$40

$60

$80

$100$Bn

GEOGRAPHIC DISTRIBUTION

Americas

$66Bn5% of

Electronics Industry

2007

5.1% CAAGR2007-2013

$89Bn

$60Bn

$66Bn

54%

Japan

8%

Europe

25%

Asia/ROW

13%

0%

10%

20%

30%

40%

50%

60%

70%

2006 2007 2008 2009 2010 2011 2012 2013

Kc78.273mw-med

5

Medical Electronics Trends Medical Electronics Trends -- Market GrowthMarket Growth

DISRUPTIVE TECHNOLOGIES / Consumer Medical

Products???

Page 7: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

6

Medical Technology DriversMedical Technology Drivers

Category DescriptionMedical TherapyTherapy managementPatient EligibilityAvailability

SOLUTION Hardware & Software

SUPPORT Technology Access

MARKET

Before Today (2006) Future (2012)Necessity Reactive ProphylacticCaregiver Caregiver/patient AutomatedCriticality driven Comfort driven Wellness/risk driven

Developed Nations Developing Nations

Local Global Global <--> g'local

DeviceTherapy specific

SystemLimited convergence

Multi-systemIntegrated / convergent

Newly formed markets, new technologies are in developmentNewly formed markets, new technologies are in developmentPREPRE--COMPETETIVE INDUSTRY COLLABORATION IS VITALCOMPETETIVE INDUSTRY COLLABORATION IS VITAL

Page 8: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

Implantable Defibrillators—US Annual–350,000 people newly indicated for this therapy –100,000 + defibrillator implants per year

Shock Shock

DeliveredDelivered

Tachy Arrhythmia Therapy Extending the lives of people whose

hearts beat too fast

Medical Market: Example Technology

Page 9: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

Heart Failure Therapy

– 5 year mortality rates as high as 50%

– Affects > 14M people (US, Europe & Japan)

TINESTINES

STEROIDSTEROID COLLARCOLLAR

GUIDE WIREGUIDE WIRE

ELECTRODEELECTRODE

Medical Market: Example Technology

Lead Technology

Pacemakers – Currently the largest medical device market

US Annual– 650,000 patients diagnosed with this condition annually– 300,000 implants annually

Page 10: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

Digital Health• In the past 10 years, growth, innovation and

miniaturization have lead to major advances in medical electronics manufacturing and the therapies they deliver.

• Patient care enhancement• New and Unique Medical Products• Monitor Systems• Sensor Technology• Improved Diagnostics

• Wireless technology for data transfer • Instant and remote monitoring• Power can be transmitted via RF signals• Can off-load computing and data storage to remote host system

outside the device.

Page 11: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

Digital Health

• Miniaturization / Nano• MEMS• Self or bio powered systems• Localized measurement – ex lab on a chip

• And many more….

• All these advancements lead to complex problems involving materials management, energy constraints, data security, reliability and above all patient safety.

Page 12: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

Stents

PTCA Systems

IntravascularBrachytherapy

Atherectomy

Stents

PTCA Systems

IntravascularBrachytherapy

Atherectomy

Areas of Opportunity in Medical Market

Pacemakers

AICDs

Leads

AblationCatheters

Pacemakers

AICDs

Leads

AblationCatheters

Pacemakers

AICDsLeads

AAA Systems

PeripheralStents

Neurovascular

AAA Systems

PeripheralStents

Neurovascular

AAA Systems

PeripheralStents

Neurovascular

ENDO--VASCULARSOLUTIONS

Beating Heart BypassSurgery

Minimally-Invasive

Vein Harvesting

Beating Heart BypassSurgery

Minimally -Invasive

Vein Harvesting

Beating Heart BypassSurgery

Minimally -Invasive

Vein Harvesting

CARDIACCARDIACSURGERYSURGERY

EQUIPMENT

FOR

SURGERY

DATA TRANSFER AND ANALYSIS DATA TRANSFER AND ANALYSIS DATA TRANSFER AND ANALYSIS

IMPLANTABLEPRODUCTS

Coclear devices

Pin and drug

VASCULARINTERVENTION

Beating Heart BypassSurgery

Minimally-Invasive

Vein Harvesting

Beating Heart BypassSurgery

Minimally -Invasive

Vein Harvesting

MRI

SONOGRAM

BLOOD

ANALYZER

-

DIAGNOSTIC

AND

MONITORING

Page 13: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

Challenges to Implanted Device Assembly

•What make us so different?

•Small, smaller, smallest….•Severe constraints on space, weight, shape, power consumption, bodily fluids etc.

•Sealed device, must be right the first time, and last for years and years.

•Volumes can’t drive supply chain.

Server & telecom Driving ThisLarge I/O BGAs

Implantable devices need that!

Page 14: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

Challenges: 1 – Design Limits

Space is our Enemy!No, not that space

This Space

Free space inside a device is, wasted on air

Page 15: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

14

Medical Technology Trends Medical Technology Trends -- SectorsSectors

• Global trends defined within three medical sectors– Diagnostic imaging devices and large scale equipment, e.g.,

Ultrasound, MRI, etc. – Portable products (those devices that are easily transported) – Implanted products (those devices implanted in a human body)

Some product solutions will necessarily consist of combinations of all three categories of devices.

• Main differences– Product size, features and form factor– Energy type, source and usage– Reliability requirements– Regulatory issues– Supply chain

MEDICAL APPLICATIONS ARE VARIEDSIZE/FUNCTIONALITY DRIVES DIFFERENCES IN TECHNOLOGY GAPS

Page 16: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

15

Gap Identification Gap Identification -- DiagnosticsDiagnostics

Gaps 2006 2008 2010 2012

DesignHigh density sensor arraysIntegrated detection-processing architecturesLow power image detection and processingHigh speed image acquisition

MaterialsMagnetic susceptibility <100 ppmLow temperature assemblyThermal managementConnector-less assembly

Data Processing and TransferHigh signal fidelity (low loss, high integrity)High bandwidthUltra-low data/bit error rates

Diagnostic Imaging Systems

Green = No Gap Issues or Resolved Yellow = Known Gap Mitigation Techniques Red = No Known Solution – Development Required

Interconnect Density

Page 17: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

16

Gap Identification Gap Identification -- PortablesPortables

GapsReliability

User Interoperability and Wireless

RF Traffic

Standards for Components Used in Portable Medical Devices

Materials & Processing

Targeted Nanoparticles

Design

Technical convergence at the device/component level

Ubiquitous remote programming

Novel energy sources

Point-of-care clinical biomarkers

Portable Medical Devices

2012201020082006 2012201020082006

Green = No Gap Issues or Resolved Yellow = Known Gap Mitigation Techniques Red = No Known Solution – Development Required

RF Traffic ReliabilityComponent Reliability

Nanomaterials

Remote programmingEnergy SourcesClinical Biomarkers

Page 18: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

17

Gap Identification Gap Identification -- ImplantablesImplantables

GapsReliability

Standard implantable device use conditions

Medical component test methods

Medical component reliability standards

Materials & Processing

RoHS compliant components

RoHS compatible implantable device processes

Nano materials for implantables

Advanced materials for implantables

Reaching physical limitations of interconnect technology

MEMS packaging for implantables

Design

MEMS sensors

Higher capacity/alternative energy sources

Higher energy density, higher voltage charge delivery capacitors

Smaller volume (size) components

Active Implantable Medical Devices

2012201020082006 2012201020082006

Analytical Tools & Methods

Advanced integrated modeling tools (electrical, thermal, mechanical, optical, chemical)

Advanced micro measurement tools

Business

Optimized supply chain

Long development cycle

Product life cycle management

Green = No Gap Issues or Resolved Yellow = Known Gap Mitigation Techniques Red = No Known Solution – Development Required

Component Reliability

RoHS

Nanomaterials

Interconnect densityMEMs packaging

Advanced design

Optimized Supply ChainProduct Life cycle

Page 19: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

18

Potential ProjectsPotential Projects

Common between multiple medical product sectors:• Component reliability: Medical Electronics

Components Reliability Specifications Project• RoHS compliance for medical electronics• Interconnect density: Advanced Printed Wiring

boards• RF Reliability: Impact of increasing RF traffic in

increasing clinical and home environments

ONGOING FOCUS ON COMPONENT RELIABILITY PROJECT

Page 20: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

Medical Component

Reliability Specifications

Project

Page 21: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

20

Medical Component Reliability Specifications ProjectMedical Component Reliability Specifications Project

Object: • To leverage industry knowledge to create a minimum set of

requirements for electronics components for application in life critical applications

• This will allow component suppliers access to the entire industry by providing commonly accepted accelerated testing, extrapolation analysis, materials and processes

• Medical device manufacturers will achieve proven quality, reliability and consistency from these components

Page 22: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

21

Medical Component Reliability Specifications ProjectMedical Component Reliability Specifications Project

Specific Deliverables:• Test and Extrapolation Methodologies

– Sampling Population Assessment– Range and Conditions of Applicability– Test Methodologies and Criteria– Medical Grade Guidelines

• FMEA of MLCC (Multi-Layer Ceramic Capacitors) failures• Use Conditions for Life Critical Medical Components• Review of existing and related Standards and Test Methods• Preliminary Test Results for MLCC devices at NIST• Creation for Test DOE matrix for use in Medical Reliability for

MLCC Project

Page 23: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

22

Medical Components Reliability Specifications Project

Project Members (SOW)

Page 24: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

23

Medical Components Reliability Specifications Project

Project Suppliers

Page 25: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

24

Medical Component Reliability Project ProcessMedical Component Reliability Project Process

Supplier Methods, Processes, Risks

• Raw Materials (e.g. for capacitors Ceramic, Tantalum, Terminations)

Existing Standards• Supplier Plan• Component Reliability and

Assessment

Use Conditions• Manufacturing Process & Testing• Storage (before / after assembly)• RoHS Compliant Requirements • Operating (In Use)

Accelerated Testing and Extrapolation Methodology• Sampling/population assessment• Conditions of Applicability• Test Methodology and Criteria

CO

MPO

NEN

T R

ELIA

BIL

ITY

PRO

JEC

T TE

AMInputs OUTPUTS

Medical Grade Specifications

Page 26: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

25

SubgroupsSubgroupsUse Condition

Objective: – Establish use conditions of life critical implantable medical devices using published literature

Output:– Extensive literature based definition of post-implant and pre-implant operating conditions - C

thermal, mechanical, electrical, environmental and biocompatibility conditionsLifetime Prediction

Objective: – Assess the contribution of each Use Condition, and combinations thereof, to enable

measurement of realistic mechanisms Accurate prediction, Consistent reportingOutput:

– Define what constitutes failure - Identify key parameter(s) controlling life times– Determine acceleration/extrapolation mechanisms - Develop methodology for experimental tests

LOT HOMOGENEITYObjective:

– Develop sampling and testing methodologies to minimize, and essentially eliminate, the introduction of defective Multi-Layer Ceramic Chip (MLCC)

Output: – Failure Mode and Effects Analysis requirements

– Statistical methods to establish quality (initial) performance– Statistical methods to establish reliability (time dependent) performance– Process capability assessment tools / process control– Acceptance criteria (within lot and lot-to-lot)

Page 27: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

Project Deliverables

Page 28: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

Test and Extrapolation

Methodologies

Page 29: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

28

Test and Extrapolation MethodologiesTest and Extrapolation Methodologies

Main goal is to determine guidelines and methods to assess component reliability as related to implantable medical or other life critical applications.

Proposed solution was to develop an understanding of the expected failure modes and mechanisms, use conditions, and comparative rate of each type of failure.

Once established, test methods could be developed to hopefully accelerate the failures and be used to improve reliability of those component types that a correlation between failures and acceleration methods could be established.

Phase 1 of the MLCC component project established the data used to create the working test DOE matrix.

Phase 2 of the project will result in execution of the test DOE and establishment of the correlation between accelerated tests and failure modes. The test results will be used to generate the guidelines and recommended test methods determined to be suitable for implantable or life critical MLCC’s and subsequently other device.

Page 30: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

Medical Failure Modes

and Effects Analysis

(FMEA) of MLCC

Failures

Page 31: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

30

Failure Modes and Effects Analysis (FMEA)Failure Modes and Effects Analysis (FMEA)• FMEA

Procedure by which each potential failure mode for a given component within the system is analysed to determine the effects on the system, potential risk to the patient or user, failure causes, and associated prevention controls

– Failure Mode• The Failure Mode is the manner by which component failure is

observed or characterized

– Potential Effect(s)• A Potential Effect is the consequence a Failure Mode has on the

safety or functionality of the device

Page 32: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

31

FMEA ExampleFMEA ExampleComponent Function Failure Mode Potential Effects(s) S F D Risk

IndexPotential Cause(s)

Preventio n/Control

sMedical Grade MLCC

Metal Layers – Terminations

Unsolderable plating material

Open circuit 3 2 1 6

Cold solder joint 2 2 3 12Defects in plating material

Delamination 3 2 3 18

Open circuit 3 2 1 6Defects in barrier layer Increased ESR 1 1 4 4

Voiding 1 2 2 4Poor Cohesion/Adhesion of the underlying material Ag or Cu

Open circuit 3 2 1 6

Poor shear strength

2 2 2 8

Delamination 3 2 3 18Oxidation of terminations

Poor solderability 3 2 1 6

Mechanical Dimensions out of spec Lack of mechanical fit

2 1 1 2

Open circuit 3 2 1 6Short circuit 3 1 1 3Potential arcing path

3 1 2 6

Termination bandwidth out of spec

Open circuit 3 2 1 6

Short circuit 3 1 1 3

Page 33: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

Use Conditions for Life Critical

Medical Components

Page 34: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

33

Use Conditions TableUse Conditions Table

Defined By:

• Mechanical• Thermal• Electrical• Environmental• Biocompatibility• Physical

Page 35: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

34

Use Conditions Mechanical Table ExampleUse Conditions Mechanical Table Example

Page 36: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

Review of existing and

related Standards and Test Methods

Page 37: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

36

Examples of Standards and Test Methods ReviewedExamples of Standards and Test Methods ReviewedAEC

– ZERO DEFECTS GUIDELINE – AEC-Q004

– STRESS TEST QUALIFICATION FOR PASSIVE COMPONENTS – AEC – Q200

– FAILURE MECHANISM BASED STRESS TEST QUALIFICATION FOR INTEGRATED CIRCUITS – AEC – Q004

HDBK– MILITARY HANDBOOK - ENVIRONMENTAL STRESS SCREENING (ESS) OF ELECTRONIC EQUIPMENT -

DOD – HDBK – 344(USAF) MILITARY HANDBOOK

– DEPARTMENT OF DEFENSE HANDBOOK ENVIRONMENTM-J STRESS SCREENING PROCESS FOR ELECTRONIC EQUIPMENT THIS HANDBOOK – MIL- HDBK-2164A

– MILITARY HANDBOOK – ENVIRONMENTAL STRESS SCREENING (ESS) OF ELECTRONIC EQUIPMENT - MIL-HDBK-344Ai

GEIA - Government Electronics & Information Technology Association– ANSI/GEIA-STD-0003 Procedures for Long Term Storage and Electronic Devices

– ANSI/GEIA-STD-0005-1 Performance Standard for Aerospace and High Performance Electronic

Systems Containing Lead-free Solder

– ANSI/GEIA-STD-0005-2 Standard for Mitigating the Effects of Tin Whiskers in Aerospace and

High Performance Electronic Systems

Others

Page 38: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

Medical Reliability

Focus on MLCC (Phase II)

Page 39: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

38

Medical Reliability for MLCC Project (Phase II)Medical Reliability for MLCC Project (Phase II)Scope of Work: • Determination of accelerated life test methods of long term leakage and

break down failures of MLCC s • Continuation of Component Reliability Project • Specific deliverables of Phase II include the following:

– Creation of a test vehicle• Design of Test board• Fabrication of Test vehicle• Population of test board with functional MLCC’s

– Creation of fixtures and test equipment cables and peripherals at NIST– Testing of DOE variables from Phase I at NIST Boulder Facility– Completion of screening experiments at NIST. – Collection of Data and Data Mining resulting failures for trends and insight– Failure analysis of Test output “Failures as defined in Phase I”– NIST coordinate Failure Analysis Suppliers– Phase II Report

Page 40: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

2500X

Ideal Construction:Free of VoidsGood Wetting and FilletNo detachment at CeramicUniform Coverage of Ag / Cu layers

Ideal Construction:Complete Barrier Layer (Ni)Formation of Ni3Sn4, Cu6Sn5

Page 41: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

Question?

Do small blemishes cause reliability concerns?

Page 42: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

“Undesirable Characteristics” in discrete components

•Plating Issues

•Many components have plating issues or shortcomings that lead to latent defects, manufacturing yield loss and scrap

•Possible Failure Locations– UBM or base layer plating– Barrier layer to base layer– Finish plating to barrier layer– Solder to barrier layer

Page 43: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

Examples of Plating Issues

• Incomplete base layers

• Leads to the following possible defects

– Voiding– Weak solder adhesion– Exposure of base Ceramic– Micro Cracking– Layer Separation– Electrical Failure or Leakage

Page 44: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

Although plating defects can occur anywhere, they are more common at the corners. Here the solder has breached the barrier and base layers at the corner of this capacitor

Page 45: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

Poor coverage of the plating on the leads to short shelf life, yield loss, scrap, poor adhesion of the solder, or latent defects

Page 46: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

Gaps in plating Ni barrier High Correlation to voiding

Page 47: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

Examples of Plating Issues

• Poor Base Layer Adhesion

• Leads to the following possible defects

– Weak solder adhesion– Exposure of base Ceramic– Micro Cracking– Layer Separation– Electrical Failure or Leakage– Peeling of plating– Full Failure of Solder Joint

Page 48: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

Internal DelaminationDifficult to detect

Page 49: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

Examples of Plating Issues

•Voiding and base material adhesion issues

Page 50: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within
Page 51: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within
Page 52: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

Examples of Plating Issues

• Poor Base Layer Adhesion• Examples – 200C reflow Sn/Pb

Good Plating Separated plating

Page 53: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

Base layer / Barrier layer Issues

• Base Layer Separation Issues

• Cracks and separation of barrier metals can lead to full failure of the joint following subsequent assembly and handling

Page 54: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

Base layer / Barrier layer Issues

• Base Layer Voiding

• Missing base layer areas could potentially lead to electrical problems, voids and outgassing.

0402 Capacitor

Page 55: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

Base layer / Barrier layer Issues

• Base Layer Voiding

• Voiding can be at interface or within the base layer itself.

1206 Capacitor

Page 56: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

Base layer / Barrier layer Issues

• Base Layer Voiding

• Missing base layer areas could potentially lead to electrical problems, voids and outgassing.

0402 Capacitor

Page 57: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

Internal Layer Uniformity

Page 58: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

Ceramic Cracking

• Pre Existing flaws and cracks in components can lead to post assembly failures. Especially true in large ceramic capacitor and resistor arrays

Page 59: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

Ceramic Cracking

• Corner Cracks• Can lead to post assembly

plating failures at termination

Page 60: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

Ceramic Cracking

• Corner Cracks• Sometime they are extremely difficult to detect or

notice in standard microscopy. Example

1206 Capacitor – Bright Field 1206 Capacitor – Dark Field

Page 61: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

Plating Failure / Cracking

• Poor adhesion can result in separation and failure near the bottom heel fillet region. This is made worse by design limitations on PCB real estate

Page 62: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

DOE Formation• Input from multiple signals (Field, MFG yield, Supplier Returns/ Rejects)

– Unique environmental concerns (ie, forming gas, temp, IC levels)

– Mechanism based – from Use Conditions

– Creation of Failure Pareto by NIST (NIST combined all data generically)

Page 63: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

DOE Formation - continued

• Outputs from Sub-groups combined with failure Pareto

• Groups looked for areas Unique to Medical or areas that are known factors to cause failures

• Key differences– Reflows – multiple– Burn in – temp / bias– End use environment – mechanical high cycle low strain applications– Slightly elevated but constant temp (37C)– Shipping and storage conditions similar to portable– Constant “On” 24/7 usage– Sensitivity to flaws and small defects– Severity of failure (Could result in loss of therapy, explant or patient

harm/death)

Page 64: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

Implanted

Medical Device Reliability Focus on MLCC

Grady White, Damian Lauria, Andy Slifka, Elizabeth Drexler Materials Reliability Division

Page 65: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

Outline1.

Failure source identification (Pareto development)

2.

Experimental parameters3.

Experimental setup and procedure

4.

Preliminary results5.

Beginning Phase II

Page 66: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

Pareto Development

Goal:Identify field failure sources for capacitors to obtain enough information for evaluation of proposed accelerated test parameters and procedures

Approach:-

Gather failure information from multiple (4) companies

-

Construct common terminology for all companies

-

Sort failure information into similar categories

Page 67: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

Company A

Category % of Total

decreasing importance Complaints

Stress crack Xxx

Flex Cracking Xxx

Chipouts Xxx

Packaging Xxx

Dielectric Breakdown Xxx

Termination Defects Xxx

Physical Damage Xxx

Thermal Shock Crack Xxx

Dielectric Sheet Defects Xxx

Administrative Xxx

Poor Wetting Xxx

Mechanical Damage Xxx

Delaminations Xxx

Margins Xxx

Inconclusive Xxx

Company A (cont)

Category % of Total

decreasing importance Complaints

Plating Defects Xxx

Aging Xxx

Cap out of Tolerance Xxx

Wrong Chip Thickness Xxx

Disconnected Electrodes Xxx

Tombstoning Xxx

Pb/Sn

Termination Issues Xxx

Electrode Defects Xxx

Termination Defects Xxx

Green Chip Damage Xxx

Surface Contamination Xxx

Peeling Termination Xxx

Spattering Xxx

Glue Dot Adhesion Xxx

DF Xxx

Page 68: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

Company B

Complaints by Root Cause Number %

Board Flex 46 Xxx

Microcrack 29 Xxx

Customer Application 19 Xxx

Design Problem 16 Xxx

Al Contamination 13 Xxx

Inhomogeneity 12 Xxx

Thermomech. Overstress 11 Xxx

Insufficient Termination 11 Xxx

No Foundings 8 Xxx

Pre-Term Damage 7 Xxx

Silicon Contamination 5 Xxx

Mechanical Damage 4 Xxx

Leakage Site 4 Xxx

Mechanical Impact 4 Xxx

Print Defect 4 Xxx

Not Determined 4 Xxx

Organic Contamination 3 Xxx

Void 3 Xxx

Thermal Overstress 3 Xxx

Contamination During B… 3 Xxx

Contamination in Termination 3 Xxx

Exposed Electrodes 2 Xxx

Electro-mech. Damage 2 Xxx

High Destruction 2 Xxx

Overloading 2 Xxx

Page 69: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

Company C

Failure Mode Description Device #

% of Device

Total %

Failure

Leaky Ceramic Cap Xxx Xxx Xxx

Degraded, out of spec Ceramic Cap Xxx Xxx Xxx

Cracked Ceramic Cap Xxx Xxx Xxx

Loose Parts Ceramic Cap Xxx Xxx Xxx

Shorted Ceramic Cap Xxx Xxx Xxx

LeakyCeramic Cap Array Xxx Xxx Xxx

CrackedCeramic Cap Array Xxx Xxx Xxx

Solder joint, crackedCeramic Cap Array Xxx Xxx Xxx

Degraded, out of specCeramic Cap Array Xxx Xxx Xxx

DelaminatedCeramic Cap Array Xxx Xxx Xxx

Foreign material presentCeramic Cap Array Xxx Xxx Xxx

ShortedCeramic Cap Array Xxx Xxx Xxx

Solder joint, missingCeramic Cap Array Xxx Xxx Xxx

Solder joint, openCeramic Cap Array Xxx Xxx Xxx

Leaky Tantalum Cap Xxx Xxx Xxx

Degraded, out of spec Tantalum Cap Xxx Xxx Xxx

Shorted Tantalum Cap Xxx Xxx Xxx

Solder joint, electrically intermittent Tantalum Cap Xxx Xxx Xxx

Solder joint, open Tantalum Cap Xxx Xxx Xxx

Foreign material present Tantalum Cap Xxx Xxx Xxx

Loose Parts Tantalum Cap Xxx Xxx Xxx

Misassembly Tantalum Cap Xxx Xxx Xxx

Open, electrically Tantalum Cap Xxx Xxx Xxx

Undetermined Tantalum Cap Xxx Xxx Xxx

LeakyTantalum Cap Array Xxx Xxx Xxx

Overstress, otherTantalum Cap Array Xxx Xxx Xxx

UndeterminedTantalum Cap Array Xxx Xxx Xxx

Failure Mode Description Device #

% of Device

Total %

Failure

Page 70: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

Company D

Failure Mode %

Solderability Xxx

Cracks/chipouts Xxx

End termination damage Xxx

Leakage Xxx

Capacitance value Xxx

1.

The details of the failure analysis, the terminology and the interpretation of the capacitor failures all depend upon the perspective of the company providing the failure data.

2.

The identification of the sources of capacitor failure also depends upon company perspective.3.

The identifications of various failures are not always orthogonal

Therefore, combining the four sets of data into one Pareta

is not straightforward.

Conclusions:

Page 71: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

Table I A B C D

Cracks 31.2 21.2 1.1 33.8

Leakage 11.1 9.6 81.6 0.5

Termination defects 6.7 6.4 46.6

Solder issues 3.8 0 0.9 18.7

Mechanical treatment 8.2 3.6

Customer application 9.7 36.8 0.1

Undetermined 1.8 1.8 0.2

Drift out of specifications 3.1 0 1.6 0.5

Electrodes 1.5 0.9 0.6

After communicating with the four different companies that have provided data, the various failure mechanisms were combined into

9 categories (numbers in Table are %):

Page 72: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

Table II A B C D

INTRINSIC

Cracks 31.2 21.2 1.1 33.8

Leakage 11.1 9.6 81.6 0.5

Termination defects 6.7 6.4 46.6

Solder issues 3.8 0 0.9 18.7

Drift out of specifications 3.1 0 1.6 0.5

Electrodes 1.5 0.9 0.6

EXTRINSIC

Customer application 9.7 36.8 0.1

Mechanical treatment 8.2 3.6

UNKOWN

Undetermined 1.8 1.8 0.2

The previous table has been sorted into intrinsic capacitor, extrinsic capacitor (e.g., device design and fabrication, handling), and undetermined failures

Cracks vs. dielectric?

Page 73: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

Experimental Test Setup

Page 74: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

Test Parameters:

Precondition atmosphere: air, forming gas

Vibration: none, 3 g

Precondition humidity: nothing, 85% RH/85

oC

Environmental

Vendors: 3 -

randomized

Sources

Temperature: RT, 85 oC, 125

oC, 150

oC

Frequency: DC, 1500 Hz

Voltage: 5 V, 100 V

Electrical

Page 75: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

-1.2

-1

-0.8

-0.6

-0.4

-0.2

0

0.2

0 20 40 60 80 100 120 140 160 180 200

Temperature, C

Hea

t Flo

w, J

Current status 2: DSC measurement of 4 capacitors

Phase change occurs at about 125 oC. Calls into question the use of 125

oC

and 150 oC

temperatures for accelerated tests.

Page 76: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

Test Equipment

Circuit elements:

- 0.1 μF capacitors

-1 MΩ

resistors

-

Power sources

-

Sorenson DC power supply

-

Keithley

263

-

Keithley

33120A (1,500 Hz)

-

96 V batteries

-

6 V batteries

Special filtered 110 V line source

Measurement apparatus:-National Instrument USB-6259

-

Single ended measurements on 32 cap coupon

-Agilent 34980A Multifunction Switch Unit- 6 34921A armature switching board-

Each board can make differential

measurements on a 32 cap coupon-

Tests on thermocouple and on precision

resistor with battery show +/-

10 nV

scatter

Test Chambers:-Associated Environmental Systems Temperature and RH chamber-Refurbished Screening Systems QRS-410T Temperature and Vibration chamber

Page 77: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

Event Detector:

1.

Continuous –

not periodic –

monitoring2.

Rapid response

3.

Detection threshold must be pre-defined –

slow trends and sub-threshold events not detected

Page 78: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

Series Resistor:

VRV

C

R

IdealMeasure the leakage current by measuring the voltage drop across a known resister.

Sampling process rather than continuous monitoring:-High sampling rate means we miss less but we get too much data to analyze-

Low sampling rate means we see long term

trends but most of the time we are not observing the voltage

There is no way that we will routinely catch sub-ms events using a sampling approach. If enough events occur during a measurement, we will observe an excursion.

We will see long term trends that an event detector would miss.

Page 79: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

Series Resistor:

VRV

C

R

IdealMeasure the leakage current by monitoring the voltage drop across a know (i.e., 1 MΩ) resistor.

Measurement concern:

RC > 1 GΩ, maybe > 100 G

Therefore, VR < 0.1% and maybe <0.001% of V

i.e., it won’t take much noise to mask the signal

Page 80: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

Series Resistor:

VRV

C

R VRV

RV

Cideal

R

RL

Less IdealIdeal

( ) ⎟⎟⎠

⎞⎜⎜⎝

⎛+=+=

++

=

++

==

V

RV

V

R

V

LV

VL

L

RR

RVRR

RRV

RR

RR

V

RRRRR

Vii

1

1statesteady

reachedhasConceii L

−== 0

Page 81: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

-0.00025

-0.00020

-0.00015

-0.00010

-0.00005

0.000000 50 100 150 200 250 300 350 400 450 500

Arb. Units

Vol

tage

(V) Cap 1

Cap 2Cap 3Cap 4Cap 5

Close-up view of the beginning and end regions

showing the change. Note that the ordinate

axis is non-physical -

it was chosen simply to

have something to plot the voltages against while

avoiding the 8-day time gap.

Slope

-0.00004

-0.00002

0

0.00002

0.00004

0.00006

0.00008

0.0001

0 1 2 3 4 5 6

Cap #

V/un

it tim

e

BeginningEnd

Preliminary results with differential measurements made with the

NI board looked very good.

Page 82: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

0

0.0005

0.001

0.0015

0.002

0.0025

0.003

0.0035

0.004

0.0045

0.005

0 50 100 150 200 250 300 350

Time (h)

VR

If a 32 capacitor coupon is tested by the NI board, the measurements must be conducted in a single-ended, rather than a differential, mode. Under these conditions, noise from the ground overwhelmed the signals of interest.

Single ended measurements made on as-received, thermally cycled, or indented capacitors detected nothing but noise.

Measurements made on a single capacitor the had been pretreated by thermal cycling through the Curie point 10 times. The applied voltage during the test was 100 VDC.

To eliminate this problem, all measurements of test boards are being made in differential mode using the Agilent system. To further reduce the possibility of noise, DC measurements are being made with batteries as a voltage source.

Page 83: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

Information on Boards:Cable # Coupon V T(

oC) Vib Pre-Treat Mfg Reflow

1

4 96 DC

125

no

no

B

32

5 96 DC

125

no

no

C

23

7 5 AC

125

no

no B

34

73 6 DC

125

no

no

B

25

16 5 AC

125

no

no

A

16

34 6 DC

125

no

no

C

1

Experimental parameters used on the coupons currently being evaluated

Page 84: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

96 V, DC: Coupon 4

0

0.00001

0.00002

0.00003

0.00004

0.00005

0.00006

0.00007

9/29/20080:00

10/4/20080:00

10/9/20080:00

10/14/20080:00

10/19/20080:00

10/24/20080:00

10/29/20080:00

Time at Temperature

StD

ev (V

R/V0

)

Cap 22Cap 6

96 V DC: Coupon 5

0

0.00001

0.00002

0.00003

0.00004

0.00005

0.00006

0.00007

9/29/20080:00

10/4/20080:00

10/9/20080:00

10/14/20080:00

10/19/20080:00

10/24/20080:00

10/29/20080:00

Time at Temperature

StDe

v (V

R/V

0)

Cap 16Cap 30

Page 85: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

Summary:

1.

To reduce noise, differential measurements are being made2.

Capacitor behavior vs. t appears to be different between manufacturers and for different applied voltages at 125 oC

3.

The power law behavior we expected to see, corresponding to damage accumulation has not yet appeared.

4.

The scatter in the data increases linearly with time for both voltages 5.

At 96 V, outliers appear, increasing in number and magnitude with time (corresponding to clusters of events?).

Page 86: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

DOE Formation - continued• Phase 1 testing

– As a result of the DOE formation, FMEA, Pareto, and Use Conditions, preliminary experiments were performed on test boards / components. Initial testing was performed to give input to phase II PCB design, electrical hardware setup and criteria for failure.

– Measured as received and pre-stressed components. Subjected to high temp and bias to determine leakage breakdown.

– Performed at NIST Boulder

• DOE Completion (128 Cell Matrix)

– Optimized to balance variables (Texas Instruments performed the analysis using Jump Software)

– Main variables are: (Temp, Vibration, forming gas, Voltage, Voltage type AC/DC, number of reflows)

Page 87: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

86

MLCC DOE Project (Phase II)MLCC DOE Project (Phase II)Objective: • The Medical Component Reliability team determined X number of

environmental conditions were wanted to investigate in the DOE:– Temperature– Voltage Level– Type of Voltage– Atmosphere Precondition– Humidity Precondition– Vendor– Number of Reflows

• 128 run DOE is required to determine all main affects and two way interactions

– Team chose a 0.1uf 16V X7R MLCC in an 0603 package– 128 Serialized coupons were built to support DOE. Each coupon having 32

components for electrical testing and 3 components for mechanical testing

Page 88: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

Medical Reliability Focus on MLCC

(Phase II)

Jerry Peasley Micro Systems

Engineering Inc.November 14, 2008

Page 89: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

Medical Reliability Focus on MLCC

(Phase II)

Jerry Peasley November 14, 2008

Page 90: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

89

Medical Reliability for MLCC Project (Phase II)Medical Reliability for MLCC Project (Phase II)

Objective: Establish a mechanistic test strategy for lot based anomalous behavior detection of MLCC capacitors

Approach:Designed experiment to identify key factors (based on FMEA and Use Conditions, part of Phase I)Custom test vehicle design and fabrication - assembly of MLCC components from multiple suppliers using industry standard methodsDevelopment of automated testing infrastructure (fixtures, equipment, cables and peripherals) over 15k data points per test instanceTest and analyze data

o Failure Analysis with Supplierso Identification of test methodology with consensuso Phase II Report

Page 91: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

90

MLCC Project DOE MLCC Project DOE –– StatusStatus

• Electrical Test– All 128 coupons have completed initial electrical test– Parameters tested:

• Insulation Resistance• Capacitance• Dissipation Factor

• Post Reflow Test is also completed on all 128 coupons– Attend November 14, 2008 meeting at FDA to hear preliminary

results

Page 92: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

91

MLCC Project DOE MatrixMLCC Project DOE Matrix

Variables and Levels based on FMEA and Medical use conditions

Couponnumber= row

number X1=Vibration X2=Temperature X4=Voltage X6=Cyclic_Voltage X5=Atmosphere_Precondition X3=Humidity_Precondition X7=Vendor X8=Number_of_reflows1 YES 125 C 96 volts 1500,50% Biphasic Forming Gas NONE Vendor C 3 reflows2 YES 85 C 6 volts DC NONE NONE Vendor A 3 reflows3 YES 125 C 6 volts DC Forming Gas NONE Vendor C 3 reflows4 NO 125 C 96 volts DC NONE NONE Vendor B 3 reflows5 NO 125 C 96 volts DC NONE NONE Vendor C 2 reflows6 YES 85 C 6 volts DC Forming Gas 85 / 85 Vendor C 3 reflows7 NO 125 C 6 volts 1500,50% Biphasic NONE NONE Vendor B 3 reflows8 YES 85 C 6 volts DC NONE 85 / 85 Vendor C 2 reflows9 YES 125 C 6 volts 1500,50% Biphasic NONE 85 / 85 Vendor A 3 reflows

10 YES 125 C 96 volts DC Forming Gas 85 / 85 Vendor B 3 reflows. . . . . . . . .. . . . . . . . .

128 YES 85 C 96 volts DC Forming Gas NONE Vendor C 2 reflows

Focus area

Page 93: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

92

Initial Test SetupInitial Test Setup

Design

Automated Test

Test Rack

Nearly 15,000 Datapoints

Assembly- Multiple suppliers- Multiple reflows

Page 94: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

93

Test ParametersTest Parameters

• MLCC – 0.1uf 16V ±10% X7R• Capacitance and Dissipation Factor

• 1khz 1Vrms• DC Leakage

• 16V – measured at 10, 15, 30, 45 and 60 seconds• Converted to IR

• Reflow Environment

Page 95: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

94

Capacitance (Farads)Capacitance (Farads)

8.75E-08

9.25E-08

9.75E-08

1.03E-07

1.08E-07

1.13E-07

A B C

All Data Grouped by Vendor

Page 96: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

Df

0.0%

5.0%

10.0%

15.0%

20.0%

25.0%

A B C

95

Dissipation Factor (%)Dissipation Factor (%)

All Data Grouped by Vendor

Outlier

All Data Grouped by Vendor with outliers removed

Df

0.0%

0.5%

1.0%

1.5%

2.0%

2.5%

3.0%

3.5%

4.0%

A B C

Page 97: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

96

Dissipation Factor (%)Dissipation Factor (%)

All Data All Data with outliers removed

Page 98: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

97

Insulation ResistanceInsulation ResistanceIR

1.00E+08

1.00E+09

1.00E+10

1.00E+11

1.00E+12

1.00E+13

A B C

Outliers

Insulation Resistance (ohms)Insulation Resistance (ohms)

Page 99: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

98

All Data All Data with outliers removed

Insulation Resistance (ohms)Insulation Resistance (ohms)

Page 100: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

99

Next StepsNext Steps

• Complete DOE and analysis at NIST Boulder Facility• Complete Failure Analysis with Suppliers• Identify key test for anomalous behavior detection• Publish Phase II report

Page 101: Medical Components Reliability Specifications Meeting ...thor.inemi.org/webdownload/newsroom/Presentations/... · Medical Technology Trends - - Sectors • Global trends defined within

100

www.inemi.orgEmail contacts:

Jim McElroy [email protected]

Bob [email protected]