43
Closing Technology Technology Gaps Id t Industry Collaboration for Medical Electronics
Closing Technology Technology
Gaps
I d tIndustry Collaboration for
Medical Electronics
Agenda
• iNEMI Overview• iNEMI Medical Electronics Efforts:
– 2011 Roadmap– Projects
• Outcomes of Medical Electronics Workshops:– Review of 7 proposed areas of collaboration– Results of industry poll on interest– Formation teams under development p
• Conclusions
1
About iNEMIMission: Forecast and Accelerate improvements in the ElectronicsMission: Forecast and Accelerate improvements in the Electronics
Manufacturing Industry for a Sustainable Future.
5 Key Deliverables:• Technology Roadmaps• Collaborative Deployment
4 Major Focuses:• Miniaturization• EnvironmentCollaborative Deployment
Projects• Research Priorities • Proactive Forums
Environment• Alternative Energy • Medical Electronics
Proactive Forums• Position Papers
iNEMI is an industry-led consortium of 95 global manufacturers, suppliers, industry associations, government agencies & universities. Working on advancing
manufacturing technology since 1994.
2
International Members Across The Total Supply Chain
The International Membership Incorporated Location; Number of Members
INEMI Member Business Segment Asia Europe TotalsgNorth America Region
p
OEM 14 2 2 18ODM/EMS (inc. pkg. & test services) 4 7 11Material Suppliers 5 15 9 29Material Suppliers 5 15 9 29Equipment Suppliers 8 1 2 11Universities & Research Institutes 8 2 3 13Organizations/consulting 10 1 2 13
Key Observations:• New member growth driven by Environmental & Packaging Projects plus
Totals 49 28 18 95
collaborative R&D opportunities• 160% Growth in University/Research Institutes Since 1/1/2010• 50% Growth in Industry Members Since 1/1/2010• Combined annual revenue of membership over $700B!
3
Total Global Supply Chain Integration
Current Members with Medical Focus
4
2011 RoadmapsRoadmaps
1. Overview of Process2. Medical Electronics
2011 Roadmap Technology Working Groups (TWGs)
RF Components & Subsystems
Modeling, Simulation, and Design
Passive Components
Test, Inspection & Measurement
Thermal
Connectors
MEMS/SensorsSolid State Illumination
OptoelectronicsLarge Area, Flexible Electronics Packaging & Component SubstratesSemiconductor
Technology
Management
Ph t lt i
Energy Storage & Conversion Systems
Mass Storage (Magnetic & Optical)
Ceramic Substrates
Photovoltaics
Organic PCB BoardAssembly CustomerFinal
Assembly
I f i E i t llInformation Management
Environmentally Conscious Electronics
6
Red=Business Green=Engineering Purple = Manufacturing Blue=Component & Subsystem
Roadmap Development Product Sector Needs Vs Technology Evolution
Product Emulator GroupsTWGs
Product Sector Needs Vs. Technology Evolution
som
Semiconductor Technology
Business Processes
umer
tem
s
l Pro
duct
omot
ive
m/D
ata
Co
Design TechnologiesModeling, Thermal, etc.
Prod Lifecycle Information Mgmt.
e / C
onsu
arge
Syst
Med
ica
Aut
o
Net
Com
Manufacturing Technologies
g, ,
Board Assy, Test, etc. Port
abl
Offi
ce /
LaComp./Subsyst. Technologies
Packaging, Substrates, Displays, etc.O
7
Thirteen Contributing Organizations
Organic Printed Ci it B d
Semiconductors
Circuit BoardsiNEMI / IPC / EIPC / TPCA
Organic PWBTWG
iNEMI / ITRS / MIG/PSMAPackaging
TWG
I t t
iNEMI / MIG / ITRS
MEMSTWG
Supply ChainM t
iNEMIInformation
ManagementTWG
iNEMI
Interconnect Substrates—Ceramic
iNEMI R d Management
iNEMIMass Data
iNEMIBoard Assembly
TWGiNEMI Roadmap
iNEMIOptoelectronics
Magnetic and Optical Storage
Storage TWGOptoelectronics
TWG
8
Optoelectronics and Optical Storage
Statistics for the 2011 iNEMI Roadmap• > 575 participantsp p• > 310 companies/organizations• 18 countries from 4 continents• 21 Technology Working Groups (TWGs)21 Technology Working Groups (TWGs) • New roadmaps on:
– MEMS/Sensors Energy Storage & Conversion– Energy Storage & Conversion
– Aerospace & Defense• 6 Product Emulator Groups (PEGs)• Medical PEG active since 2003 (for 2004 roadmap)
I t
• Medical PEG active since 2003 (for 2004 roadmap) • > 1800 pages of information• Roadmaps the needs for 2011-2021
ImpactRoadmap used by industry to identify future market & technology needs. Used by government & research organizations to identify and fund new
9
research initiatives to address industries needs.
Medical Electronics - PEG
Anthony Primavera, Micro Systems EngMicro Systems Eng.
ChairBill Burdick, GE
R h C Ch iResearch, Co-Chair
Medical Market
• United States– 65+ year old population = 40M (2009)y p p ( )
• Global– 65+ year old population will triple by 2050 .. from 516M65 year old population will triple by 2050 .. from 516M
(2009) to 1.53B (2050)– 80+ year old population will increase from 40M (2009)
to 219M (2050)• Currently, the U.S. spends 1.75 Trillion dollars … 15% of 2009 GDP 25% f GDP 20152009 GDP … 25% of GDP 2015
11
Variation in SectorSince the product types within the sector are varied, medical products were
1) Implanted products (devices implanted in a human body)• Strict regulatory procedures • Driven by battery life (low power loss) this limits the use of components such as DRAM
p yp , pgrouped into three general categories.
• Driven by battery life (low power loss) – this limits the use of components such as DRAM • Validation and traceability• Long term reliability paramount• Long development cycles, primary assembly and design by OEMs
2) Portable products (devices that are easily transported)2) Portable products (devices that are easily transported) • Cost parity with consumer / portables• Dynamic market, needs fast response … 9 to 24 month product cycle time• Mixed regulatory environment• Mostly outsourced assembly and design (Asia)• Mostly outsourced assembly and design (Asia)• Diagnostic Ultrasound in PDA size .. and smaller .. form factors
3) Diagnostic imaging devices and large scale equipment, e.g., MR, CT• Larger scale (often similar to servers or telecom equipment)• Often requires thermal management and heat sinking• Often requires thermal management and heat sinking• Utilizes commercial off-the-shelf components, when available• Development cycle is shorter than implantables• Application and design well suited to EMS environment• Often does not require clean room or sterile assembly floor
12
Often does not require clean room or sterile assembly floor
Areas of Opportunity in Medical Market
ENDO--VASCULARSOLUTIONS
CARDIACCARDIACSURGERYSURGERY
EQUIPMENT FOR
SURGERYIMPLANTABLE
PRODUCTSPERSONAL
HEALTHCARE
DIAGNOSTICAND
MONITORING
Stents
PTCA Systems
Intravascular
Diagnostics
Glucose
Pacemakers
AICDs
Leads
Pacemakers
AICDs
Leads
AAA Systems
PeripheralStents
AAA Systems
PeripheralStents
Beating Heart BypassSurgery
Minimally
Beating Heart BypassSurgery
Minimally --
PacemakersAICDsLeads
Beating Heart BypassSurgery
Minimally
Beating Heart BypassSurgery
Minimally --AAA Systems
Peripheral Stents
Beating Heart Bypass Surgery
Minimally
MRISonogramEKG, EMGIntravascular
Brachytherapy
Atherectomy
Thermometers
Telemedicine
Home Health Care
Leads
AblationCatheters
Leads
AblationCatheters
NeurovascularNeurovascularMinimally-Invasive
Vein Harvesting
Minimally -Invasive
Vein Harvesting
-LeadsCochlear devices
Pin and drug
Minimally-Invasive
Vein Harvesting
Minimally -Invasive
Vein Harvesting
-Peripheral StentsNeurovascular
Minimally Invasive Vein Harvesting
,Blood
Analyzer
DATA TRANSFER AND ANALYSIS DATA TRANSFER AND ANALYSIS DATA TRANSFER AND ANALYSIS DATA TRANSFER AND ANALYSIS
13
Medical PEG: 2011 Chapter FocusMarket Environment and Economics of Medical ElectronicsMarket Environment and Economics of Medical Electronics
• Emerging markets expected to have double digit growth.F l t di ti i t f d l i• Focus on lower cost diagnostic equipment for developing nations and rural areas.
• Regional assembly, design and distribution expected to i i I di d Chiincrease in India and China.
• High Growth of Tele-Medicine using multi functional portable devices.
• Continued migration from prescriptive to preventive medicine will drive increase in portable/wearable medical monitoring devices.
• Unknown business implications and potentially increased regulatory changes could materialize based on health care legislation/court challenges.
14
$Bn$200
MEDICAL ELECTRONICSKc310.bes-INEMI med
$77Bn6.2% of
Electronics Industry
$150
($85Bn in 2010)
2009
$150
2009
5.0% CAAGR2009 2015
$103Bn$100
2009-2015
$50
DRIVERSHealthcare infrastructure build-out in developing countriesGraying population and explosion of chronic disease cases
02008 2009 2011 2013 2015
Graying population and explosion of chronic disease cases
15
Trends and Market Drivers in Medical• Increased health awareness and preventive care leading to anIncreased health awareness and preventive care leading to an
increased demand for diagnostic and imaging systems.• Healthcare demands of 78M “US baby boomers”, et al. …
clinician shortage global aging technology expectationsclinician shortage, global aging, technology expectations• Development of higher power systems capable of higher
patient throughput, higher resolution, and a greater ability to discriminating individual tissue types, et al.
• Medical video imaging … for specific applications
16
Current Market Drivers in Medical• Implantable therapy devices continue to be a growing market area• Implantable therapy devices continue to be a growing market area
and have expanded beyond pacemakers and implantable cardioverter defibrillators (ICDs).
• The average YoY growth rate for implantable products has beenThe average YoY growth rate for implantable products has been between 15-18% for the last 10 years.
• A shift towards remote monitoring has increased demand for “external wireless telemetry”
Example: An estimated 200,000 patients are currently enrolled in home / remote monitoring system.system. These systems are communication devices that interact with the implanted device and a host network system.
17
Digital HealthIn past 10 years, growth, innovation and miniaturization p y , g ,
have lead to major advances in medical electronics manufacturing and the therapies they deliver.
• Patient care enhancement- New and Unique Medical Products
M it S t- Monitor Systems- Sensor Technology- Improved Diagnostics
• Wireless technology for data transfer
- Instant and remote monitoringsta t a d e ote o to g- Power transfer by RF- Off-load computing & data storage
to remote host system, outside the
18
to remote host system, outside the device.
Diagnostic Imaging• Patient centric clinician centric environment• Patient-centric, clinician-centric environment
– Comfort– Workflow
• Demands for higher resolution maybe abating• Demands for greater imaging volumes not abatingabating
• Anatomy defines package volumes– More bits per cubic inch translates to p
higher functional densities• Portable systems for “baseline” diagnostics
19
Estimated PCB Needs/Costs
PCB Technology (FR4 baseline) Cost 2009 2011 2013 2015 2021 Comments
2 layer flexible $ per cm2 0.25 0.24 0.23 0.22 0.2
Implantable materials, Connectors, sub-assemblies, components, etc.
2 layer Rigid $ per cm2 0 025 0 02 0 015 0 012 0 008Portables, Sensors, sub assemblies components
Implantables
2 layer Rigid $ per cm2 0.025 0.02 0.015 0.012 0.008 assemblies, components
3 layer flex $ per cm2 0.4 0.4 0.35 0.35 0.33d packaging, subassemblies, implantables
4 layer flexible $ per cm2 0.5 0.5 0.45 0.45 0.4 implantables
6 layer flex (with micro vias) $ per cm2 1 0.9 0.85 0.8 0.75 implantables - High Power
4 layer conventional $ per cm2 0.013 0.013 0.013 0.013 0.013 External / Consumer products
4 layer - embedded capacitor / resistor $ per cm2 0.25 0.25 0.23 0.2 implantables
6 layer conventional $ per cm2 0.018 0.018 0.018 0.018 0.018externals, patient monitoring, wearables
implantables patient
Wearables
4 layer w/ microvia $ per cm2 0.18 0.18 0.15 0.12 0.12implantables, patient monitoring, wearables
6layer rigid (with micro vias) $ per cm2 0.2 0.2 0.18 0.15 0.15 implantables - low power
6 layer, blind/buried $ per cm2 0.2 0.2 0.18 0.15 0.15 implantables - low power
6 layer - embedded capacitor / resistor $ per cm2 0.3 0.3 0.28 0.2 Implantables
14 layer, no blind/buried $ per cm2 0.45 0.43 0.41 0.39 0.36 Diagnostic, telecom
28 layer, blind & buried vias $ per cm2 1.17 1.1 1.05 1.05 0.95High end imaging, high speed telecom, data storage
Large Scale
20
Digital Health: New Horizons• Miniaturization / Nano• Miniaturization / Nano
• MEMS• Self or bio powered systems• Localized measurement – ex lab on a chip• Gaseous and biological sensors – military and homeland security applications
• MEMS and Implantable Devices are a rapidly growing market segmentNew Research / Growth Areas• Bio-chemical sensors • Alternative power and rechargeable Batteries• Wearable, patient monitoring systems• RF telemetry offloading diagnostics from primary deviceRF telemetry, offloading diagnostics from primary device• Nano-scale materials, coatings and conductors• New High Density Batteries MnO2, may lead to 10+ year life• Very small scale systems:
– Battery for artificial retina (Sandia)
Technology advancements are predicated on resolving complex challenges including materials management, energy
t i t d t it li bilit d ti t f t
21
constraints, data security, reliability and patient safety.
iNEMI Projects
45+ Projects and Initiatives
8 Technology Implementation8 Technology Implementation Groups (TIGs) Plan and Direct their Project Portfolio
Medical TIG active since 2005
The Project Booklet can be downloaded at: http://thor inemi org/webdownlohttp://thor.inemi.org/webdownload/newsroom/Deployment_Projects.pdf
22
Medical Electronics; An Example Project• Projects and InitiativesProjects and Initiatives
– Medical Components Reliability Specifications- Completed 2008– Medical Reliability for MLCC’s Phase 2 Completed
• Goal: Determination of accelerated life test methods of long term leakage and break down failures of MLCCs
• Steps: – Design of Test board - Fabrication of Test vehicle– Population of test board with functional MLCC’s– Creation of fixtures and test equipment cables at NIST
Impact• Preliminary Results Indicate noise and temperature dependent leakage vary by manufacturer.
– Testing of DOE variables at NIST Boulder Facility– Collection of Data and Data Mining
• Participation of eight firms have reduced the effort of each firm to 1/8 of the individual effort and can result in improved common reliability requirements.
• Estimated Savings per team member of 2 man years of engineering resources from this project alone. • Quantified Value: $250K/year (US Dollars)• Quantified Value: $250K/year (US Dollars)
23
Medical Electronics Workshops held in pBerlin, Germany &
Santa Clara, CA
O t i d tifi dOutcomes indentified Top Priorities for
Collaboration
Medical Workshop - Participating Companies
HEI IHEI, Inc.
ipdia
25
ipdia
Medical Workshop - Participating Companies
(Reinhardt Microtech)
26
Building Industry Support
• Clarify the 7 potential initiatives for Medical Electronics collaboration– Identified priorities from the two iNEMI Workshops
• Share the process moving forward to engage key industry players in collaborative R&Dindustry players in collaborative R&D
• Provide inputs on specific organizations priorities to be involved
• Define the steps and timeline for follow through to create effective collaborative projects
Th t d li lt d b i i t– That deliver results and business impact.
27
The Top Seven Areas for Medical Areas for Medical
Collaboration
1) Lack of Standards for Reliability Testing for Implantable Productsp a tab e oducts
• Problem: Absence of expertise and proven/accepted best known practices in reliability for the medical products.
• Desired Project Goals:C t lib f th h i f f il b d t t– Create a library of the physics of failure by product type.
– Develop a reliability test suite library that is specific to the failure modes that are most effective with addressing body to device interaction.
– Address unique needs for bare die encapsulation & for bare die modulesdie modules.
– Once these are in place; creation of a “probability of failures occurring” dbase can be more effectively put in place.
29
2) Need to Develop Specifications for Medical Electronics Productsect o cs oducts
• Problem: Every component/supplier that is purchased for high reliability medical products today must be individually
lifi d di l i d tqualified – no medical industry specs– This also drives suppliers crazy as OEM’s have different
requirements for similar productsScope includes outsourced factory capabilities– Scope includes outsourced factory capabilities
• Desired Project Goals:• Standardization of specifications for medical components
d di l f it th t t th t t fand medical mfg. capacity that meet the test, performance, and reliability needs of medical products– Implantable & Wearable
• Include DFM and DFT expertise from the Research Institute’s and key suppliers in setting these specifications
30
3) Lack of Effective Supply Chain Support in Medical Electronicsed ca ect o cs
• Supply Chain Development Areas of Potential Focus:– Create Best in Class OEM/Supplier Operating Agreements– Address critical supplier/OEM issues that impact supply quality
and availability– Clarify medical market priorities for Medical Rare Earth Metals &
Pl ti /Pl ti i d t / t i ti lPlastics/Plasticizers and create/sustain action plans– Develop electronically transferrable data declarations for
components that meet specific needs of medicalC t ff ti b i d l t t NPI Ch C t l– Create effective business models to support NPI, Change Control, Requalification & Long Life Product Support
– Reach workable/supportable requirements regarding liability indemnificationindemnification
• Team to prioritize these areas as part of the Statement of Work (SOW) development.
31
4) Create Industry Wide Reliability Performance Qualification MethodsQua cat o et ods
• Deliver evaluation methods, statistical models for lifetime predictions, and confidence levels of those predictions p , pwhile utilizing extreme stress conditions for:– Portables– Imaging – Implantables
• Desired Outcome:• Desired Outcome:– “MIL equivalent” for medical applications– Team will need to first do a current assessment ofTeam will need to first do a current assessment of
related efforts and studies – IPC, CALCE, Auburn, etc.
32
5) Replicate the iNEMI MLCC Project Reliability Study for Implantable SubstratesStudy o p a tab e Subst ates
• Next Steps:– Replicate the MLCC project for substratesReplicate the MLCC project for substrates.– Team formed to define envelope and scope of project
to be undertaken.– Must include multiple nodes of the supply chain in the
operative team.NIST participation viewed as key to success– NIST participation viewed as key to success.
• Desired Outcome:– Development of design rules and guidelines that meetDevelopment of design rules and guidelines that meet
the use condition reliability requirements.
33
6) Define Product Design Requirements that Deliver MRI/XRAY & Implantable Compatibilitye e / & p a tab e Co pat b ty
•Define imaging protocol that are more friendly to patients with implants.
•Device compatibility requirements understood and details defined.
•Align and leverage off other groups working this g g g p gissue.
• Involve key players from imaging and y p y g gimplantable firms.
34
7) Preparing for Pb-Free and RoHS 2020
Problem: No industry body is working on steps to prepare for Lead Free medical products for RoHS 2020
And having lead free capability would greatly ease– And having lead free capability would greatly ease procurement and EMS qualification
Desired Project Goals:- Investigate extensions required from iNEMI high reliability
lead free work/learning’s to medical products and RoHSlead free work/learning s to medical products and RoHS needs.
- Investigate if indeed Reliability targets and tests are incl si e of medical prod ctsinclusive of medical products.
- Create new knowledge base on surface finishes that are bio compatible.
35
Specific Interest Levels by Initiative
36
Strong Levels of Interest from OEMS and Suppliers!
F th S t Cl From the Santa Clara Workshop:
Many Potential Areas of Focus in
Medical PackagingMedical Packaging
Packaging Challenges – Many AreasPackaging Breakout Group of the Medical WS Agreed to Meet
and Prioritize!a d o t e
Categories High Voltage Implantable
Low Voltage Implantable
Non-implantable (contact)
Non Implantable (non-contact)
Biocompatibility - Limited/expensive Problem but less Problem but lessBiocompatibility -conductors
Limited/expensive materials
Problem but less critical
Problem but less critical No Issue
Biocompatibility -insulators
Materials Performance
Materials Optimization
Materials Optimization No Issue
Current Carrying
Flex circuits
y gCapacity, Mech. Characteristics,
Assembly Issues
Limited Supply base, High cost
Cost is big issue, Formability, flexibility
Circuit density, display connections
High reliability interconnects
RoHS compatibility, fine pitch
RoHS compatibility, fine pitch
RoHS compatibility, fine pitch
RoHS compatibility, fine pitchinterconnects fine pitch fine pitch fine pitch fine pitch
Passive Integration Capacitance Density Capacitance Density Capacitance Density Capacitance DensityPassive
PerformanceLess than 5%
variationLess than 10%
variation Capacitance Density Capacitance Density
RF Transparency N/A Big Issue Issue for sensors N/A
3D Not Mature -
Requires Infrastructure Dev.
Not Mature -Requires
Infrastucture Dev.
Not Mature -Requires
Infrastructure Dev.
38
Status of Medical Project Formation Project Formation
Teams
Medical Project Status • Based on member interest & prioritization following formation teams are• Based on member interest & prioritization, following formation teams are
underway:Develop recommendations for reliability testing of implantable products (see description #1):o Leadership indentifiedo Several calls have happened; Broad industry participation initial meeting
will happen on Sept. 13th Develop Specifications for Medical Electronics Products (see desc. #2):p p ( )
o Leadership in place (U Md CALCE and MedEl) Scheduling of calls in process
Create Industry Wide Reliability Qualification Methods (see desc. #4):o Leadership identifiedo Leadership identifiedo Initial SOW outline completed; First call held; o Regular call schedule being developed
• We expect to form teams on initiatives #3 and #6 soon – working on the p gsolidifying the right project leaders.
• Details for all proposed initiatives on iNEMI website.
40
Conclusions• iNEMI has a proven methodology for effective• iNEMI has a proven methodology for effective collaboration:– Roadmapping– Gap analysis– Projects
• Our global supply chain membership is a strong• Our global supply chain membership is a strong contributor to collaborative R&D success.
• Recent workshops have helped crystallized industry f f l i i di l l t ifocus for closing gaps in medical electronics.
• Project formation teams are underway to develop definitive plans for industry action.
• For further details register on our website and sign up to follow updates on medical related projects.
41
i iwww.inemi.orgEmail contacts:
Bill BaderBill [email protected]
Bob PfahlBob pfahl@inemi [email protected]
