Advanced Process Laboratory Manufacturing Challenges for the Medical IndustryGeorge R. WestbyDirector AP LaboratoryDirector AREA Consortium

A Broad Solutions PortfolioSurface Mount 2 Modular Product Lines: Genesis, Advantis sharing technology

Currently launching new generation – Semiconductor & NPITripled market share in high-speed chip placementStrong established market share leader in flexible fine pitch

Insertion Mount 3 Products: IM Series 88 – Axial, Radial & Jumper WireStrong position: 90+% in Americas/Europe; 50% AsiaNew generation with increased throughput introduced in 2010Several new generation functionalities being introduced

Automation, Solar 3 Product lines: Polaris, Polaris Junior & ConveyorsLaboratory Services & Manufacturing Process DevelopmentCustom Automation, Integration and Odd-form AssemblyInfrastructure in Binghamton & Laboratory in Shanghai

Feeders 7 Product Lines: Universal, Siemens, Panasonic, Fuji feedersComponent, direct die wafer (Innova/Innova+) and label feedersOnly third-party feeder manufacturerManufactured in Rochester, New York

Spare, Service & refurbishments

Universal’s Advanced Process Laboratory

• Founded in 1987• First and most complete Advanced process

laboratory in the industry generally accessible to customers

• Founded first Consortium 1992• Became profit center 2002• Provide

– Research and Development– Process audits and support– Prototyping– Root cause failure analysis– Knowledge transfer and training

• Complete analytical laboratory• ITAR Compliant• ISO 9001 Certified

Three Fully Automated Assembly Lines• DEK Infinity and Galaxy Screen Printers• GSI Lumonics 8100 Laser Inspection System• Universal GSMx/GSMxs Placement Machines• Vitronics Soltec 730 XPM/1030N/XPM3 Ovens with Nitrogen

atmosphere• Asymtek Century 720/1000 Dispense systems• Metcal BGA3500/Air-Vac DSR 24 Rework, Airvac DRS-25

Rework stationAdditional Equipment

• FEI Environmental Scanning Electron Microscope with EDXA

• Perkin Elmer Materials Analysis System• Analytical Tools• Dage high and low speed ball shear / pull equip• Akrometrix PS-200 TherMoire’ system • Reliability Test Equipment

– Thermal Cycling / Shock– High Temp and Vacuum Ovens– Liquid Shock Chamber– HAST Test Biased / Non-Biased– 85C / 85% RH Chamber

Additional Analytical Equipment Syracuse University

• GC/MS - Gas Chromatograph / Mass Spectrometer

• ICP/MS - Inductively Coupled Plasma /Mass Spectrometer

• IC/MS – Ion Chromatography / Mass Spectrometer

• NMR - Nuclear Magnetic Resonance• Laser Ablation Mass Spectrometer

S3IP Analytics and Diagnostics Laboratory Binghamton University

• Zeiss Supra 55 VP, Analytical Ultra High Resolution FESEM + EDAX Pegasus EDS + EBSD • PHI 5000 VersaProbe X-ray Photoelectron Spectrometer• FEI FIB: Dual Beam-SEM/FIB • JEOL TEM: 200-kV Field Emission Transmission Electron Microscope • Dantec PIV Particle Imaging Velocimeter • VT-Eye Ultra-fast Laser Confocal Imaging System • PANalytical X-Ray Diffraction • Phoenix X-Ray Imaging • Rigaku Small Angle Scattering and Large Angle Scattering Tool. • Zeiss Axio Imager M1M Advanced Upright Compound Microscope • Zeiss AxioVert 200 Advanced Inverted Compound Microscope • Zeiss Discovery V 12 Advanced Stereo Zoom Microscope • Zeiss Computer Workstations 25A Imaging Processing Systems

S3IP Analytics and Diagnostics Laboratory Binghamton University

• Atomic Force Microscope• Ellipsometer • Profilometers: stylus and optical • Differential Scanning Calorimetry (DSC), • Thermo Gravimetric Analyzer (TGA), • Thermo Mechanical Analyzer (TMA), • Dynamic Mechanical Analyzer (DMA), • Thermo Gravimetric Analysis with Mass Spectrometry (TGA/MS), • Thermal Diffusivity System (TDS), • Plate/ Plate Rheometer.

APL Organization

Consortium

Failure AnalysisProcess Development

AREA Consortium Research TopicsPb-Free Characterization • Effects of Aging on Solder Joint Reliability• Optimization of Solder Properties• Damage and Crack Growth in Solder• Reliability of Backward Compatible Assemblies• Low-Ag Containing Solders

Reliability and Modeling• Reliability: Evaluating Relevant SMC’s• Reliability of “Bowed” PCB Assemblies• Microstructure Based Reliability Modeling• Effects of Solder Ball Size on Thermal Cycle

Reliability• Interpretation of Accelerated Test Results for

Different Component types• Effects of Service Relevant Load Histories on Lead

Free Solder Reliability

Printed Circuit Board Issues• Pad Cratering: PCB Laminate Evaluation in

Mechanical and Thermal Environments• Pad Cratering: Reliability Consequences of Pre-

Existing Cracks• Pad Cratering: Material Characterization• Creep Corrosion

Advanced Packaging and Assembly• Reliability of 0.3mm Pitch Lead-Free CSP’s• Package on Package• Printing for Reliabile 0.4mm Pitch CSPs

Surface Finish• High Speed BGA Shear Testing• ENEPIG as a Surface Finish

Materials and Process• Thermal Interface Research• Conformal Coating and Sn Whiskers

Industry and Product Scope

Disk Drives

Military

Satellite

Cell Phones Components and HybridsMedical

Medical Market Demand

• As the world population ages the need for health care is rapidly rising• Funding options for health care has become a major cornerstone of the

political parties and become the single most pressing national debate• Current US expenditures on health care are currently approximately

16% of the US GDP and increasing rapidly• Demand for medical support devices is increasing with improved

health care options and general demand

Source: OECD Health Care Data 2009

Manufacturing

• As demand for medical devices has increased the available funding for health care is increasingly challenged

• Improvements in health care technical devices has driven increased complexity and as a result an increase in manufacturing challenges

• Device manufacturers are driven to EMS providers to reduce costs and preserve margins

• With the bulk of EMS companies resident in ASIA the concern among many OEM’s is to maintain high product quality and reliability which in turn creates an opportunity for US based EMS companies

• Medical manufacturing depending upon the product classification will require component level traceability

• Increased complexity in manufacturing requires an awareness of new manufacturing processes and materials

• Development of complex assembly processes for high density assemblies will require close cooperation between CEM’s and OEM’s

Benefits:Visibility: Tracks which components went on which boards or circuits

Tracks product: In the event of a product recall, allows you to recall only the affected boards

Ensure quality: Identify which boards need to be reworked before they go out the door

Comp. ID : 12345Lot: 23

Comp. ID : 12345Lot: 24

• Software keeps track of each board completion (using board serial bar code)

• Reel bar codes identify component, lot number, and supplier

• Software records when each reel was mounted on the machine, and the date & time of every component placed on the board / circuit

• Component traceability is achieved by cross referencing board complete, component reel mount, and time/date stamps of placements

• Database transfer tables allow easy access to the data

Requirements:

Components Packaging Technology & Trends

Source: Prismark

Insertion mount

Surface Mount

Emerging surface mount technologies

Emerging surface mount technology

0201

010050402

10um accuracy

Process and Reliability Areas of Concern

• Lead free solder assembly• Mixed solder assembly• PoP assembly and reliability• PCB materials selection & testing• Repair• MLF/QFN assembly• Component underfilling• FC assembly & underfilling• No-flow assembly of FC• Pad finish test protocols: plating process control & product screening• Mechanical test protocols & procedures• Thermal cycling protocols & acceleration (lead free)

Manufacturing Solutions - Complex Assemblies

Definition Implementation MachineDesign EfficiencyConcept Ramp to

Volume End of Life

• Process and Materials Research and Development

• Product Layout and Design

• Process Design

• Applications Review

• Process Development

• Process Solutions

• Prototyping on Manufacturing Equipment

• Process Optimization

• Design for Manufactur-ability

• Process and Equipment Optimization

• Reliability Testing

• Qualification

• Assembly Equipment Solutions

• Integrated Process Solutions

• Process Scale-up• Failure Analysis• Incremental

Production Capacity Increase

• Worldwide Scalability

• New Products Support

Percutaneous Medical Device

IVUS Catheter• provides an ultrasound image from

inside a coronary artery • used to diagnose and assess

vascular and structural heart disease

The Assembly • flexible PI substrate • PZT (receiver/transmitter) • multiple flip chip die • 22 µm bumps on 70 µm pitch

“These are the finest pitch, soldered interconnect flip chips in volume production

anywhere in the world today.”

Development and Manufacturing Partnership for World’s Finest Pitch Soldered Flip Chip Interconnect

APL Laboratory• Defined packaging concept, re-designed substrate• Developed complete assembly process• Assembled prototypes • Assisted in qualification process• Conducted analytical and reliability testing• Provided automation solution and associated

fixturing

70 µm pitch flip chip

14 µm lines and spaces

Endicott Interconnect Technologies• Developed a state-of-the-art flexible substrate to

support the packaging concept• Manufactured the flexible circuit • Provided assembly services per the

manufacturer’s specifications.

Medical Application

Conclusion• The Medical OEM is faced with a broad array of challenges:

• Increased demand • Increased complexity of assemblies• New and more expensive material set• No lead solders / mixed alloy assembly• Increased cost pressures• Contract manufacturing base largely located in ASIA

• However close partnerships with suppliers offers improved opportunity for cost and technological improvements• Partnership with material suppliers to insure consistent quality• Partnerships with equipment suppliers to develop tooling and

processes to insure high yields and reliability