Anthony PrimaveraMedical TIG, PEG ChairMicro Systems

EngineeringA Division of MST5/4/11

2011 iNEMI Medical

Electronics Workshop

www.mst.com

2

Medical Market

• United States – 65+ year old population = 40M (2009) – US census

• Global– 65+ 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% of GDP 2015• It is estimated that current annual spending on medical

devices / electronics is 70 to 100 Billion dollars

iNEMI Involvement in Medical• As part of the iNEMI programs, there are 2 areas focused on

medical microelectronics.

• The first is the Product Emulator – which is focused on the component, equipment, assembly and cost needs of the future.

• The second is the TIG – focused on technical gaps and needs from an overall technology integration standpoint.

– Projects and sub projects focused on a specific need, gap or technology can be initiated under the TIG.

– For example – “MLCC reliability project for medical applications” was run under the TIG for the last several years.

Introduction• TIG and PEG Scope: High reliability microelectronics with a focus on

medical equipment, and devices.

• Background: The current TIG plan / chapter is a continuation of the previous chapters. It has been reviewed by members of the medical TIG group and each main technology sector has been represented. The medical TIG has been using the format defined by the PEG in that there are three main categories of technology represented overall in the medical TIG.

• Large Scale equipment – ex MRI, diagnostics, ultra sounds• Portable and smaller scale diagnostics – monitors, patient wearables• Implantable and life sustaining

5

Variation in Sector

1) Implanted products (devices implanted in a human body)• Strict regulatory procedures • Driven by battery life (low power loss) – this limits the use of certain

components such as DRAM due to high energy consumption• Validation and traceability• Long term reliability paramount• Long development cycles, primary assembly and design by OEMs

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 (SEA)• 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• 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

Since the product types within the sector are varied, medical products were grouped into three general categories.

6

Stents

PTCA Systems

IntravascularBrachytherapy

Atherectomy

Diagnostics

Glucose

Thermometers

Telemedicine

Home Health Care

Areas of Opportunity in Medical Market

Pacemakers

AICDs

Leads

AblationCatheters

Pacemakers

AICDs

Leads

AblationCatheters

AAA Systems

PeripheralStents

Neurovascular

AAA Systems

PeripheralStents

Neurovascular

ENDO--VASCULARSOLUTIONS

Beating Heart BypassSurgery

Minimally-Invasive

Vein Harvesting

Beating Heart BypassSurgery

Minimally -Invasive

Vein Harvesting

-

CARDIACCARDIACSURGERYSURGERY

EQUIPMENT

FOR

SURGERY

DATA TRANSFER AND ANALYSIS

IMPLANTABLEPRODUCTS

PacemakersAICDsLeads

Cochlear devicesPin and drug

PERSONALHEALTHCARE

Beating Heart BypassSurgery

Minimally-Invasive

Vein Harvesting

Beating Heart BypassSurgery

Minimally -Invasive

Vein Harvesting

-

DIAGNOSTIC

AND

MONITORING

AAA SystemsPeripheral Stents

Neurovascular

Beating Heart Bypass Surgery

Minimally Invasive Vein Harvesting

MRISonogramEKG, EMG

Blood Analyzer

77

Medical PEG: 2011 Chapter Focus

• Emerging markets expected to have double digit growth.• Focus on lower cost diagnostic equipment for developing

nations and rural areas. • Regional assembly, design and distribution expected to

increase 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 if health care reform legislation is enacted.

Market Environment and Economics Of Medical Electronics Market

8

Medical Market • Market Size, Electronics Revenue• 2006: 62.5 B$, 2007: 69.1B$, 2008: 75.6B$ … 9.4% Change

Medical Electronics Revenue

0

2

4

6

8

1012

14

16

18

20A

bbot

Labo

rato

ries

Agi

lent

Life

Sci

ence

GE

Hea

lthca

re

Hof

fman

-La

Roc

he L

td

Phi

lips

Med

ical

Sys

tem

s

Sie

men

sM

edic

alS

olut

ions

Tosh

iba

Med

ical

Sys

tem

s

Var

ian

Med

ical

Sys

tem

s

Company

Rev

enue

in B

illio

ns $

200620072008

Source: 2010 - G Dan Hutcheson weSRCH.com

Another Measure of Market Size – Prismark Partners

2008 2009 2010 2011 2012 20142013 2015 2016 2017 2018 2019 2020 2021

2009

$76Bn6.1% of

Electronics Industry

5.2% CAAGR2009-2015

4.7% CAAGR2015-2021

$103Bn

$136Bn

$Bn

$100

$200

$150

$50

0

N910 .bes-INEMI med

0Americas Japan Europe Asia/

ROW

20%

40%

60%

80%

100%% Production 2009−

10

Market Observations

• Many market size predictions include mostly large scale diagnostic and system equipment suppliers.– INEMI Medical PEG is not sufficiently represented in market size.

• Revenue from the other market sectors within medical not well estimated, e.g., implantables– Medtronic– St Jude Medical– Boston Scientific– Biotronik– ELA Group 20+ B$ / year– Cochlear– Med-el– Advanced Bionics– Others

1111

Sector Overview • PEG: What makes medical unique from other sectors?

– PCBs: one layer flex is missing, e.g., glucose strips

– PCBS: 4-6 and higher layer count flex circuits

– Reliability: pressure environment missing (hyperbaric chamber and scuba testing) … implantables

– Reliability: MRI safe, compatibility

– Reliability: bends/folds mechanical robustness

– Business: how to capture regional design / manufacturing for point of use applications.

– Business: many suppliers not willing to sell into medical market.

12

Trends and Market Drivers in Medical

– Increased 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 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

13

Current Market Drivers in Medical

• 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 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. These systems are communication devices that interact with the implanted device and a host network system.

14

Digital Health

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

• Wireless technology for data transfer

- Instant and remote monitoring- Power transfer by RF- Off-load computing and data storage

to remote host system, outside the device.

In the past 10 years, growth, innovation and miniaturization have lead to major advances in medical electronics

manufacturing and the therapies they deliver.

15

Diagnostic Imaging• Patient-centric, clinician-centric environment

– Comfort– Workflow

• Demands for higher resolution maybe abating• Demands for greater imaging volumes not

abating• Anatomy defines package volumes

– More bits per cubic inch translates to higher functional densities

• Portable systems for “baseline” diagnostics

16

Example of Differences:

Medical PEG Roadmap HighlightsDominant US regions: MA, MN, CA, AZDominant EU regions: Ireland and GermanyDominant SEA regions: Malaysia, Singapore

Future Dominant Regions: China, India

Supply Chain Locations 2009 2011 2013 2015 2021System Design N.America/Europe N.America/Europe N.America/Europe N.America/Europe N.America/Europe Implantable, (portable and externals mostly Asia)System Fabrication N.America/Europe N.America/Europe N.America/Europe N.America/Europe N.America/Europe Implantable, (portable and externals mostly Asia)Processor Design/Fab N.America/Europe N.America/Europe N.America/Europe Asia Asia Implantable, (portable and externals mostly Asia)Display Design/Fab Asia Asia Asia Asia Asia externalsMemory Subsystems Asia Asia Asia Asia Asia externalsComponent Design N.America/Europe N.America/Europe Asia Asia Asia Implantable, (portable and externals mostly Asia)Board Assembly N.America/Europe N.America/Europe N.America/Europe N.America/Europe N.America/Europe Implantable, (portable and externals mostly Asia)PCB Fabrication Europe/Asia Europe/Asia Europe/Asia Asia Asia AllComponent Procurement N.America/Europe N.America/Europe N.America/Europe N.America/Europe N.America/Europe Implantable, (portable and externals mostly Asia)Final Product Assembly N.America/Europe N.America/Europe N.America/Europe N.America/Europe N.America/Europe Implantable, (portable and externals mostly Asia)

17

• Example of differences• Consumer portables are weeks to years; implantables are years

– Heavily influenced by regulatory– Product qualification time lengthy – Long production times (Geography Dependant)

Medical PEG Roadmap Highlights

Cycle Time Typical Product/Best Case 2009 2011 2013 2015 2021

Time to add EMS

Elapsed time for qualified, production product delivery once a supplier is chosen. Includes qualified documentation system. Weeks 12 (104) 8 (104) 6 (78) 6 (78) 4 (78)

Externals, (Implantables in brackets)

NPI Cycle Time

Elapsed time from alpha proto release to production release w/ long lead & all alpha parts available Weeks 16 (104) 14 (104) 12 (78) 10 (78) 6 (78)

Consumer and portable, (implantable and Class 3 externals in brackets)

Product Production Life Length of time a product is produced Years 10 9 7 7 7

7 year minimum in some geographic locations

18

Estimated PCB Needs/Costs

Implantables

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

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

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

Wearables

Large Scale

19

Estimated Assembly Costs

Driven by Diagnostic and Externals

Implantables have very special assembly needsTraceabilityHermetically SealedClean Room Assembly

Assembly Costs Cost 2009 2011 2013 2015 2021 Comments

Board Assembly Cost ¢ per I/O 0.28 0.25 0.23 0.19 0.19

Implantable costs are several X cost due to process and equipment validation, traceability requirements and clean room assembly

Final Product Assembly Cost $/unit 12 10 8 6 5

Can be 10 to 20X cost for implantables, due to welding and hermetic container assembly, clean room requirements and traceability,

Packaging Cost 2009 2011 2013 2015 2021 Comments

IC Package Cost ¢ per I/O 0.21 0.18 0.16 0.15 0.15 Externals / Imaging productsPackage Cost (High Density Ceramic/w/ Area Connector) ¢ per I/O 6 5 4 3 2 Externals / Imaging products

Package Cost (High Density µvia Laminate w/ Area Connector) ¢ per I/O 5 4 3 2 2 Externals / Imaging products

Connector Cost ¢ per I/O 2.1 1.9 1.6 1.3 1 Externals / Imaging products

Energy Cost $/Wh 0.5 0.4 0.3 0.25 0.2 Externals / Imaging products

Memory Cost (Flash) $/MB 0.23 0.2 0.18 0.15 0.1 Externals / Imaging products

Memory Cost (SRAM) $/MB 0.23 0.2 0.18 0.15 0.1 Externals / Imaging products

Cost of Test as a ratio to assembly ratio 0.4 0.4 0.5 0.6 0.6 Externals / Imaging products

20

Product NeedsSize constraints on implantables will drive M0402, 1005 and embedded passives in next few years.

Parameter Descriptions Metric 2005 2007 2009 2011 2017Passive Components - Implantables Passive Devices: State of the Art (productioType/Size 0201 case 0201 case M0402 M0402 1005 caseEmbedded Passives Passives fabricated into th# per sq. cm 2 4 8 16Max. Ohms State of the Art (productioohms / sq. 400 600 700 1M 1.2MMax. Capacitance State of the Art (productioμF / sq. 0.1 0.1 0.2 0.3 0.5Min. % tolerance State of the Art (productio% 0.05 0.05 0.04 0.04 0.03

Passive Components - Externals Passive Devices: State of the Art (productioType/Size 0201 case 0201 case 0201 case 0201 case 0201 caseEmbedded Passives Passives fabricated into th# per sq. cm NA NA NA NA NAMax. Ohms State of the Art (productioohms / sq. 400 600 600 700 1MMax. Capacitance State of the Art (productioμF / sq. 0.1 0.1 0.1 0.2 0.2Min. % tolerance State of the Art (productio% 0.05 0.05 0.05 0.05 0.05

• Major Focus currently on “Medical Grade” Capacitors. iNEMI Medical Component Project Currently just finished.

• Goal: determine Reliability test requirements for Medical Grade classifications

21

Product Needs

Reliability Needs are Driven by Implantables

Medical often uses “Harsh Condition Testing” for reliability• 1000G drop / shock 3 Axis• 2,000,000 plus bend / deflection cycles• -55 to + 150C thermal cycle testing• Scuba and hyper baric chamber

Reliability - Implantable Metric 2007 2009 2011 2015 2017Temperature Range Deg C - Deg C "-40 to 80 "-40 to 80 "-40 to 80 "-40 to 80 "-40 to 80 Product Screening TestTemperature Range Deg C - Deg C "-55 to 150 "-55 to 150 "-55 to 150 "-55 to 150 "-55 to 150 Qual.TestTemperature Range Deg C - Deg C "0 to 100 "0 to 100 "0 to 100 "0 to 100 "0 to 100 Ship / Shock TestMechanical Flex Test Number of Cycles Cycles to Pass 250,000 1M+ 2M+ 2M+ 2M+ Simulate Sub-pectoral implant movementVibrational Environment (PWB level) G²/Hz 1000 1000 1000 1000 1000 Random Vibration Use Shock Environment Gs & ms to Pass 500G 3 axis 500G 3 axis 1000G 1000G 1000G Impact ResistanceAltitude Feet 40,000 40,000 40,000 45,000 45,000 Must be Gamma Emmision Safe for Shipping

Medical – 5 year plan (Implantables)Product Drivers:Active Implantable Medical Devices

Reliability for life-critical applicationsDevice size/volume/weightProduct life cycle management

Simplified supply chainLow market-segment unit volumesRoHS complianceCombination devices

2011 2013 2015 2017

AttributesHuman life criticalMaterials for implantablesReliability (Mechanical, electrical)Design for implantable use conditionsVolume, weightEnergy source dependentPLIM criticalBuilt/Tested close to marketRoHS – Out of scope

AttributesHuman life criticalMaterials for implantablesReliability (Mechanical, electrical)Design for implantable use conditionsVolume, weightEnergy source dependentPLIM criticalCoTS+ componentsBuilt/Tested close to marketRoHS – Out of scope

AttributesHuman life criticalMaterials for implantablesReliability (Mechanical, electrical)Design for implantable use conditionsVolume, weightEnergy source dependentCoTS+ componentsBuilt/Tested close to marketEnsure Sn/Pb supply chain continuity

AttributesHuman life critical & non-criticalMaterials for implantablesReliability (Mechanical, electrical)Design for implantable use conditionsVolume, weightRenewable/self-generating energy sourceCoTS componentsBuilt/Tested globallyRoHS – In scope

Deployed TechnologyHermetic canIndividual simulation tools (electrical, thermal, mechanical)Seven-year energy sourcesCable interconnectsNon-RoHS compliant materialsRF data gatheringSiP, MEMS sensors

Deployed TechnologyImproved materials for fluid sensorsStandard medical component test methodsIntegrated design toolsSeven to nine-year energy sourcesMedical component standardsNon-RoHS compliant materials

Deployed TechnologyLimited integration of simulation toolsIncreased use of nano particles in materials/packagingTen-year energy sourcesRoHS compliant materials

Deployed TechnologyIntegrated simulation tool suite (electrical, magnetic, mechanical, thermal)Wide spread use of nano technology in materials/packagingRoHS/future directives compliant materials/processes

Research & DevelopmentAdvanced reliability componentsStandard medical component test methodsMedical component standardsNano-materials for packaging higher voltage capacitorsAdvanced SiP and MEMS sensorsMedical device interoperability

Research & DevelopmentIntegrated simulation tool suiteNano-materials for component reliabilityNano-materials for packaging advanced sensorsRoHS compatible components/processes

Research & DevelopmentImplantable energy sources based on kinetics/thermal parasiticsRoHS/future directives compatible components/processesComplete remote reprogramming/reconfiguration of product featuresDirect tissue/biological interface to electronics/sensorsMRI and other diagnostic compatibilityAdvanced retinal control systems

Research & DevelopmentDirect tissue/biological interface to electronics/sensorsMRI and other diagnostic compatibilityAdvanced retinal control systemsAdvanced biological sensors / chemical sensors for defense and social applications

Gap Analysis <5 Yr TacticalMedical Technology Needs Summary Template

Priority < 5 Years (Tactical) Gaps/Needs Category Comments:

H 2nd Level assembly transition to Wafer Processing Centers D3D packaging driving need for precision equipment, clean room

facilities, etc.

L Lack of sustainability (e.g. recycling) standards for portable, large machines S Procurement, end of life, and reuse driving cost considerations

H Existence of tin whisker potential on high density component boards S,DTin component coatings and finer spacing has caused more potential

for whiskers

H Lack of counterfeit mitigation capabilities for materials S No certain counterfeit mitigation processes exist for critical products

H Materials and processes for manufacturable, reliable 3D assemblies D/O 3D = interposers, transition from mechanical to field directed control

M Tools and methods to support failure analysis of high volumetric IO density D Densities exceed existing capability; Heisenberg challenge

M Connectors and connectorization to support fine pitch, area array IO D/O IO densities and features are FAR outpacing connectors

M Organic substrates are 95% feature capability D Materials properites define dimensionsal stability, et al.

M Manufacturable packaging designs,&, processes for Sensor (MEMS, et al.) D "Open" package and harsh environement challenges

H Relaibility and manufacturability of alternates to gold surface finish D Historical reliability data is based on nickel gold pad metal stacks

H Business model to support advanced packaging for low volumes BTypical packaging houses will not engage with low volume customers

(especially medical)

M Assess growing multi-RF impact to health and wellness S Impact of RF environment

M Increase seamless interoperability between devices and EMR/EHR O Not consistent

H Increase the usability for disabled persons S,D Driven by aging of the population

H Bioinformatic manipulation to impact clinical outcomes S,D Translation of data to diagnostics

M Bio compatible materials for header feed-thru that are solderable O,DVery limited materials can be used for tissue or bloodstream

applications.

M Lack of overall traceability standards S Includes procurement through (worse case for implantables) recycle

M Lack of component validation and traceability standards D,S Still no standard for medical components

M Increase battery longevity and reduce size D Mainly for implantables and portables

Gap Analysis >5 Yr Strategic Research

Priority > 5 Years Strategic Gaps/ Research Needs Focus AreaResearch Designation Comments:

MUltra high densiy and small form factor batteries for sensors and implantables, portable devices Min / ME / AE

Mat, Mfg small sensors, injectable or implanted small form factor, ex retina

MHigher Cap and Resistive value & precision materials for embedded substrate cores Min / ME

Mat, Mfgsize reduction for embedded passives

M Magnetic core material compatible with MRI fields ME Mat, D Implantable devices

M "Lab at home" medical devices ME D Portable / injectable systems possibly using MEMS

H Off-line validation tools for decreased product introduction lifecycles ME

Mfg,Std Long validation and regulatory cycles dampen innovation, e.g. peripheral clients in portables require 510(k) resubmission

MHigher feature resolution for substrates and packages e.g. frequency, density, thermal Min / ME Mat

Package and interconnect features = semiconductor features

H Printed circuits (electrical. mechanical, thermal, optical, acoustic) Min / ME Mat,Mfg

Heterogeneous materials and fully additive processes; compatiblity with conventional and advanced/future packages and assembly processes

H Supply chain shortages of rare earth and precious metals ME Mat,D The technical advantages are hard to replace

M Electronic textiles Min / ME / ET Mat,Mfg

Lightest, least obtrusive, most flexible interconnect; fledgling technology with little to no second level assembly capability

M Curved, flexible electronic assemblies ME / ET Mat,MfgElectrical device function and assembly design and reliability on highly curvilinear surfaces

H Seamless interoperability between all medical devices ME D,IM MRI to tablet to mobile to EHR etc.

H Energy scavenging device for implantable use ME D

Extended battery life is possible if bodies kinetic and/or thermal energy is captured and used to top off batteries

M Materials for implantable radios ME MatWireless communication for implantable sensors & dispensors

H Wearable health monitoring systems ME Mat,Mfg

Design integration and assembly for "undetectable", contact and contactless sensor systems with on-board power and intelligence … wireless?

25

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

Shock

Delivered

Tachy Arrhythmia TherapyExtending the lives of people whose

hearts beat too fast

Medical Market: Example Technology

26

Heart Failure Therapy

– 5 year mortality rates as high as 50%

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

TINES

STEROIDCOLLAR

GUIDE WIRE

ELECTRODE

Medical Market: Example Technology

Lead Technology

Pacemakers – Currently the largest medical device market

US Annual– 750,000 patients diagnosed with this condition annually– 500,000 implants annually

27

Digital Health: New Horizons

• Miniaturization / Nano- MEMS- Self or bio powered systems- Localized measurement – ex lab on a chip- Gaseous and biological sensors – military and homeland security applications.

• MEM’s and Implantable Devices are a rapidly growing market segment.

New Research / Growth Areas- Bio-chemical sensors - Alternative power and rechargeable Batteries- Wearable, patient monitoring systems- RF 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 constraints,

data security, reliability and above all, patient safety.

Additional Drivers – new shapes requires electronics to bend, flex and be curved to end use geometry.

KODAK 1500 Intraoral Camera

Sayaka Endoscope Capsule In situ,

Smart contact lenses for health and head-up displays Glucose monitoring applications – U of Washington

New Innovation and application drive…

• True 3D packaging methods• Higher silicon integration and package density• Smaller and more energy efficient devices• Electronic circuits need to conform to the application

shape• Flexibility in base materials – printed and textile circuit

boards• Smaller batteries, energy harvesting, recharge efficiency• Increased Rf telemetry and power conversion

30

Medical PEG• 2011 Chapter Focus

– Technical / Environmental Issues• Significant risk: Supply chain availability of Sn/Pb components.• Increased activities in lead free and solder-free interconnections.• Supply chain changes, mergers and disruptions.

– (ex ASIC suppliers)– Expected to get worse in short term. – Additional in-sourcing and growth of vertically integrated

manufacturing will continue for medical electronics.• Increased focus on power management, increased battery life,

rechargeable batteries and form factor.• Continued development of sensors, telemetry from with and

around the body, and implantable neuro devices will shape market in next 5-7 years.