The Market for Medical Electronics: Trends, Issues, and...

iNEMIworkshop © 20101TechSearch International, Inc.

The Market for Medical Electronics: Trends, Issues, and Challenges

E. Jan VardamanPresident

TechSearch International, Inc.

www.techsearchinc.com


Medical Electronics and Health Care Opportunities

• Aging populations– By 2025 1.2 billion people will be over 50 years old, twice as many as in 2006

• Rising healthcare costs– U.S spending more than 17% of GDP, Europe similar– Some estimates place U.S. spending at $2.5 trillion, nearly half of the $5.5 trillion spent

worldwide – Cost expected to grow from $2.5 trillion 2009 to $4.5 trillion in 2019

• Remote and emerging markets– China healthcare expenditure increased from 3.7% of GDP in 1995 to 5.6% of GDP in 2007– India proposed in 2008 to increase public expenditure on healthcare from 1% to 3% of GDP

• Personal healthcare– 33% of medical semiconductor revenue in 2009 went into consumer medical devices


Medical Electronics

Medical EquipmentMedical Therapy Wireless

PatientMonitoring

Imaging

Diagnostic

Implantable

– X-ray– CT Scan– PeT– MRI– Ultrasound

– Multi-parameter– Ambulatory Telemetry– Remote Monitoring

– Laboratory– Point of Care– Self Test

– Cochlear implants–Neurostimulators– Defibrillators– Infusion pumps– Pacemakers– Drug delivery

External – Hearing aids

$$ billions


Imaging Systems• Large box systems have small growth

– Worldwide shipments of 4,500 computed tomography (CT) systems in 2010, <1% growth rate

– Worldwide shipments of 2,500 magnetic resonance imaging (MRI) systems in 2010, <1% growth rate

– X-ray systems 72,000 in 2010, 2 percent growth rate at best

– Worldwide shipments 170,000 systems in 2010, unit growth rate of <6%

• Markets for large systems saturated (especially in U.S.), some growth in India, China, BrazilNeed to find segments with high growth

• Many probes/catheters used with ultrasound systems (million or more units per year)

– High-density substrates– Increased use of flex circuit– Drivers are small form factor

• Growth in portable handheld systems– Miniaturization in electronics required

Source: GE


• Endicott Interconnect substrate

• CoreEZ® 2-4-2 substrate• SiP assembly with flip chip

Medical Imaging: Ultrasound Application

Source: Endicott Interconnect


70 µm pitch flip chip bumps22 micron diameter bumps

14 µm lines and spaces 2 µm thick Kapton polyimide

Intervascular Ultrasound Catheter

• Flip chip on single layer polyimide• Finest pitched solder bump flip chip

interconnect



Digital X-Ray Packaging

Amorphous Silicon Panel

Source: GE


Packaging Technology in CT

• The detector is the “heart” of the system

• Insatiable desire for higher resolution, wider coverage, and faster imaging

• System design and integration to transform from linear to area array detectors

4 Slice CT Detector 1999 Source: GE


Implantables

• Cochlear implants some estimates say 35,000 per year• Retinal implants is an emerging market• Implantable cardiac rhythm devices (ICDs) includes pacemakers and defibrillators

estimated to be $7.9 billion market in 2010– Saturated market (some say declining) with main players St. Jude, Boston

Scientific, and Medtronic (50%)– One company use flex circuit for main board (4 to 6 layer structure, 2.5 x 1.5

inches)– One company uses rigid board (not HDI) with 75µm line/space

• Neurostimulators, growth rate of 9% or more– US largest market with more than 75% of global sales– Major companies Medtronic, Boston Scientific, St. Jude, Cyberonics – Use of rigid/flex

• Drug pumps– Insulin delivery– Pain medication


Retinal Implant

• Manufactured by Valtronic• Electronics includes flip chip component

Source: Valtronic


Second Sight Medical Products

• Video camera sends images to a computer worn on a belt (computer converts the video to a simplified signal)

• Transmitter send signal wirelessly to implant in the eye• Receiver send signal to electrode array (1/3-inch wide, 60 electrodes) to

stimulate retina• Optic nerve carries signal from retina to brain which perceives visual

patterns corresponding to the electrodes stimulated

Source: Second Sight Medical Products


Implantable Cardioverter Defibrillator & Pacemaker

• Smaller, less intrusive applications for implantable devices

• High density interconnect substrate

– 8 layers– 1.2-inch x 0.5-inch &

1.7-inch x 1.6-inch



Portable Defibrillators • Fast growing market for

portable versions– Philips has sold

more than 200,000 units

• Found in sports arenas, schools, airplanes, etc.

• Small size requires small form factor

• Future products may have to use Pb-free components (conventional solder unavailable)

• May need to underfill CSPs

Source: Philips


Neurostimulators

• Artificial spinal implant

Source: Valtronic


Hearing Aids

• Worldwide hearing aid sales of 6 million per year– 5% growth rate

• Hearing aid and module makers include Beltone, GN Resound, Gennum, Oticon, Phonak, Siemens, Starkey Labs, Valtronic, Widex

• Variety of substrates, some use of flip chip– Laminate– Ceramic– Flex circuit


Starkey Labs Hearing Aid

Source: J. Dzarnoski, Starkey Labs

• Typically four-layer flex circuit• Components assembled with SnPb or Pb-free solder• May contain flip chip mounted parts, passives down to 0201• Protected by conformal coating


Camera Pills

• Camera pills– 3D Plus uses flex circuit– ADL Engineering in Taiwan uses PoP

Source: ADL EngineeringSource: 3D Plus


Treating Diabetes

• Diabetes affects 200 million people worldwide with projections for 366 million people by 2030, 21 million in the United States– $132 billion spent on diabetes and its complications– Four major company account for 90% of market for glucose monitoring

(Roche Diagnostics, LifeScan part of J&J, Bayer, and Abbott Labs), other players include Arkray, Home Diagnostics, and AgaMatrix

– U.S. accounts for 40% of global market for self-test and monitoring• Self-monitoring blood glucose market estimated to be $9 billion, but meters

and test strips under price pressure– TechSearch International research shows that glucose monitor strip

sells for less than $0.64 each– Unit volume growth strong, but dollar value growth slowing– U.S. accounts for 40% of global market for self-test and monitoring


Blood Sugar Sensor

• Cicor provides flex circuit for blood sugar sensor• Flex circuit with 25µm lines and spaces

Source: Courtesy of Cicor


Wireless Applications for Medical Electronics • Home Health Care

– Insulin delivery– Monitor heart rate and blood pressure

• Management of chronic diseases (heart failure, infectious disease, psychiatric disorders)

– Digestible sensors (activated by stomach fluids after swallowing)

– Sends signal to microelectronic receiver under patient’s skin storing info on drug, monitors body’s response to medication

– Use mobile phone/internet to provide information to care givers and health care professionals

• Working with implantable devices– Wireless sensing and communication to

manage heart failure and aneurysms• Zarlink’s RF transceiver SiP designed to link

implantable to base station– Mixed IC technology (SiGe, CMOS) in

SMT package– Provides better performance (shorter

interconnect lengths)

Source: Proteus Biomedial


Challenges and Issues

• Greater need for low power devices• Some segments have small unit volumes• High volume applications have increasing price pressure• Qualification period can be long• Risk of liability can be high• Requirements for suppliers can be challenging

– Quality– Testing– Pricing


Interconnect Stress Testing (IST)(A requirement for most medical-electronics PWB/substrate products)

IST is an accelerated reliability test which was developed from the “power cycling” test originally developed by Northern Telecom.

The purpose of the test is to detect any plated through hole (PTH) barrel cracking and inner layer metallization to PTH barrel interconnect separations, when subjected to DC current induced thermal cycling. The metallization in the inner layers is exercised until an initial failure is uncovered.

The methodology was designed to replace/support traditional accelerated stress testing and microsection analysis. The methodology was approved and released by IPC in the IPC TM-650 manual with test method number 2.6.26.

Source: PWB Interconnect Solutions Inc.


IST MethodologyThe IST consists of passing a predetermined constant DC current through a specifically designed PWB coupon. The current causes the Cu metallization in the inner layers, including the vias, to increase in temperature proportionally to the measured resistance and amount of current supplied to the coupon. For reliability testing, the temperature of the inner layer circuits are normally raised to a maximum of 150ºC. Once the specified resistance/temperature has been achieved, the system turns off this current and cooling begins. After the 3 minute heating stage the coupons are forced air cooled for approximately 2 minutes, enabling the coupon to return to ambient, this constitutes a single thermal cycle.

The system automatically repeats this temperature cycle over and over, measuring the resistance continuously until a rejection criteria is achieved; rejection could be set at a predetermined increase in resistance or a pre-set number of cycles. All test conditions/parameters are automated; the operator presets them before IST testing is started.



A Sampling of Companies That Require IST Reliability Testing for Their Product:

Company BusinessAlcatel OEMCompeq (Taiwan) PWBHewlett Packard OEMHitachi (Japan/Singapore) OEMIbiden (Japan) PWBLG Electronics (Korea) PWBMotorola OEMNan Ya PWBRaytheon OEMResearch in Motion (RIM) OEMSamsung PWBSt Jude Medical OEMToppan (Japan) PWBTyco PWBYamamoto (Japan) PWB



Critical Issues in the Supply Chain (April 29, 2011)• Prolonged impact on the supply chain as a result of Japan’s earthquake,

tsunami, and subsequent nuclear power plant disaster– A human tragedy that also impacts the electronics supply chain– Shortage of electrical power impacts many operations even if no

damage (many operations energy intensive in this region--copper foil etc.) and shortages will continue, summer etc.

– Logistical issues being resolved including transportation of raw materials and finished goods, workers to plants, Fukushima area still a problem

– Plant location is critical, some Japanese companies shifting operations to other locations if possible

– Japan’s METI survey shows 60% of facilities running again, supply chains my not fully recover until autumn, but 90% of production facilities in survey expected to be back in operation by mid-July 2011

– Companies looking for alternate suppliers for a variety of materials throughout the supply chain

– Some companies will qualify alternative materials, requires much time for reliability testing

• Silicon wafers– Silicon wafer plants of SUMCO and Shin-Etsu Chemical damaged,

where possible production moved to other locations


Critical Issues in the Supply Chain (continued)

• Backend supply chain is complex, variety of packaging material issues, many being resolved

• BT resin– Mitsubishi Gas Chemical reported its plants were shut down– One MGC plan is now operational with at least 25% capacity, plans to

increase capacity– MGC now importing persulphates used as polymerization catalysts– MGC had a one month’s supply of BT resin– Hitachi Chemical’s plant producing E679 was shut down, but has

resumed production– Substitute resins may be possible and investigations are underway but

qualification takes a minimum of two months and most likely much longer


FC Substrate Qualification Time Line

Time (weeks)0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25

Engineering Build

Qualification

Incoming Engineering Evaluation

1. Assembly2. Preconditioning3. Testing4. Failure Analysis5. Report

1. Assembly2. Preconditioning3. Testing4. Failure Analysis5. Report6. Quality Review 7. Test Review

(all tests in parallel)

Source: TechSearch International, Inc.


The Future

• Vision• Mobility• Limb replacement• Better treatments for

cancer

iNEMIworkshop © 20101TechSearch International, Inc. 29

Better Cancer Treatments

• Cancer, autoimmune diseases, chronic heart failure, critical limb ischemia, metabolic disorders

• Disposable kits for Cell Therapy• MEMS chips embedded into full

disposable fluid paths, sterilized and closed cycle

Stem or modified cells Patient

MEMS chip

Bone marrow or cord blood

Disposable kit

Sorter

Re-transfusion

Patient

Peripheral blood

Disposable kitCTC Sorter

Personalized Cure

Sorted CTCs

Optimize Chemotherapy

Sorts rare cells from blood samples and retain viability

Optimized and personalized drug(s)

Continued blood sample monitoring with precise measurement

Cancer Theragnostics

Cell Therapy

Diagnostics

Rx

Source: IMT


The Future: The Bionic Age

• Vision: So that the blind may see• Hearing: So that the deaf my hear• Mobility: So that the lame may

walk• Limb Replacement: So that the

cripple may become whole

The Market for Medical Electronics: Trends, Issues, and...

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