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METPECSMTAMed2011 © 2011 TechSearch International, Inc. Packaging and Assembly Trends in Medical Electronics E. Jan Vardaman President TechSearch International, Inc. www.techsearchinc.com

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METPECSMTAMed2011© 2011 TechSearch International, Inc.

Packaging and Assembly Trends in Medical Electronics

E. Jan VardamanPresident

TechSearch International, Inc.

www.techsearchinc.com

METPECSMTAMed2011© 2011 TechSearch International, Inc.

Medical Electronics

Medical EquipmentMedical Therapy Wireless

Patient Monitoring

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

METPECSMTAMed2011© 2011 TechSearch International, Inc.

Imaging Systems

• Large box systems have small growth

– Worldwide shipments of 4,500 computedtomography (CT) systems in 2010, <1% growthrate

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

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

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

• Markets for large systems saturated (especially inU.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

METPECSMTAMed2011© 2011 TechSearch International, Inc.

• Endicott Interconnectsubstrate

• CoreEZ® 2-4-2 substrate

• SiP assembly with flip chip

Medical Imaging: Ultrasound Application

Source: Endicott Interconnect

METPECSMTAMed2011© 2011 TechSearch International, Inc.

Intervascular Ultrasound Catheter

• Flip chip on single layer polyimide

• Finest pitched solder bump flip chipinterconnect

Source: Endicott Interconnect

METPECSMTAMed2011© 2011 TechSearch International, Inc.

Analog to D

igital a

nd Amplificatio

n Modules

Digital X-Ray Packaging

Amorphous Silicon Panel

Source: GE

METPECSMTAMed2011© 2011 TechSearch International, Inc.

Packaging Technology in CT

• The detector is the “heart” of thesystem

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

• System design and integration totransform from linear to area arraydetectors

4 Slice CT Detector 1999 Source: GE

METPECSMTAMed2011© 2011 TechSearch International, Inc.

Implantables

• Cochlear implants some estimates say 35,000 per year

• Retinal implants is an emerging market

• Implantable cardiac rhythm devices (ICDs) includes pacemakers and defibrillatorsestimated to be $7.9 billion market in 2010

– Saturated market (some say declining) with main players St. Jude, BostonScientific, and Medtronic (50%)

– One company use flex circuit for main board (4 to 6 layer structure, 2.5 x 1.5inches)

– One company uses rigid board (not HDI) with 75 m 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

METPECSMTAMed2011© 2011 TechSearch International, Inc.

Retinal Implant

• Manufactured by Valtronic

• Electronics includes flip chip component

Source: Valtronic

METPECSMTAMed2011© 2011 TechSearch International, Inc.

Second Sight Medical Products

• Video camera sends images to a computer worn on a belt (computerconverts 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) tostimulate retina

• Optic nerve carries signal from retina to brain which perceives visualpatterns corresponding to the electrodes stimulated

Source: Second Sight Medical Products

METPECSMTAMed2011© 2011 TechSearch International, Inc.

Implantable Cardioverter Defibrillator& Pacemaker

• Smaller, less intrusiveapplications forimplantable devices

• High densityinterconnect substrate

– 8 layers

– 1.2-inch x 0.5-inch &1.7-inch x 1.6-inch

Source: Endicott Interconnect

METPECSMTAMed2011© 2011 TechSearch International, Inc.

Portable Defibrillators

• Fast growing market

– Philips has soldmore than 200,000units

• Increasingly found insports arenas,schools, airplanes,etc.

• Small size requiressmall form factor

• BGAs and CSPs

• New products withPb-free components

Source: Philips

METPECSMTAMed2011© 2011 TechSearch International, Inc.

Neurostimulators

• Artificial spinal implant

Source: Valtronic

METPECSMTAMed2011© 2011 TechSearch International, Inc.

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

METPECSMTAMed2011© 2011 TechSearch International, Inc.

Starkey Labs Hearing Aid

• 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

METPECSMTAMed2011© 2011 TechSearch International, Inc.

Camera Pills

• Camera pills

– 3D Plus uses flex circuit

– ADL Engineering in Taiwan uses PoP

Source: ADL EngineeringSource: 3D Plus

METPECSMTAMed2011© 2011 TechSearch International, Inc.

Treating Diabetes

• Diabetes affects 200 million people worldwide with projections for 366million 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 metersand test strips under price pressure

– TechSearch International research shows that glucose monitor stripsells 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

METPECSMTAMed2011© 2011 TechSearch International, Inc.

Blood Sugar Sensor

• Cicor provides flex circuit for blood sugar sensor

• Flex circuit with 25 m lines and spaces

Source: Courtesy of Cicor

METPECSMTAMed2011© 2011 TechSearch International, Inc.

Wireless Applications for Medical Electronics

• Home Health Care

– Insulin delivery

– Monitor heart rate and bloodpressure

• Management of chronic diseases (heartfailure, infectious disease, psychiatricdisorders)

– Digestible sensors (activated bystomach fluids after swallowing)

– Sends signal to microelectronicreceiver under patient’s skinstoring info on drug, monitorsbody’s response to medication

– Use mobile phone/internet toprovide information to care giversand health care professionals

• Working with implantable devices

– Wireless sensing andcommunication to manage heartfailure and aneurysms

Source: Proteus Biomedial

METPECSMTAMed2011© 2011 TechSearch International, Inc.

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

• If Pb-free is required, what issues will be encountered?– Sn whiskers?

• Requirements for suppliers can be challenging

– Quality

– Testing

– Pricing

METPECSMTAMed2011© 2011 TechSearch International, Inc.

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

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

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

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

Source: PWB Interconnect Solutions Inc.

METPECSMTAMed2011© 2011 TechSearch International, Inc.

The Future

• Vision

• Mobility

• Limb replacement

• Better treatments forcancer

METPECSMTAMed2011© 2011 TechSearch International, Inc. 23

Better Cancer Treatments

• Cancer, autoimmune diseases,chronic heart failure, critical limbischemia, metabolic disorders

• Disposable kits for Cell Therapy

• MEMS chips embedded into fulldisposable fluid paths, sterilizedand closed cycle

Stem or modified cellsPatient

MEMS chip

Bone marrow or cord blood

Disposable kit

Sorter

Re-transfusion

Patient

Peripheral blood

Disposable kit

CTC Sorter

PersonalizedCure

SortedCTCs

OptimizeChemotherapy

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

METPECSMTAMed2011© 2011 TechSearch International, Inc. 24

How it Works

Lens and

Detector

Laser

Excitation

Region

Inlet

Sort Out

Waste

Out

Diverter

MEMS chip, independent

channels

• Single fluid input with

manifold

• Laser-driven fluorescent

detection

• High speed sort valving

• (25,000 cycles/sec/channel)

• > 2 x 108 cells/hour

• Binary output: selected &

deselected

Source: IMT

METPECSMTAMed2011© 2011 TechSearch International, Inc.

Conclusions

• Increased adoption of advanced packages

– Fiip chip

– WLP

– BGAs

– CSPs

– SiP

• The future for medical electronics is bright

• Many start-up companies developing new products with newtechnologies

• Major advances can be expected in

– Implantable devices…increased miniaturization

– New portable products for imaging etc.

– Increased use of wireless products in patient monitoringand diagnosis

– Improved treatments for cancer and other diseases