packaging of biomems devices - smalltech consulting. all
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October 22, 2008 MEPTEC October Workshop and Luncheon – SmallTech Consulting 1
©2008 SmallTech Consulting
Packaging of BioMEMS DevicesMEPTEC October Workshop and Luncheon
October 22, 2008
Dr. Leslie Field and Dr. Janelle GuntherSmallTech Consulting, [email protected]: (650) 823-2020325 Sharon Park Drive #632Menlo Park, CA 94025
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Packaging BioMEMS is like packaging MEMS, with:
– Fluidic interfaces
– Remote powering and communication
– Biocompatibility short- and long-term
– Life or death reliability
– FDA approval
Packaging of BioMEMS Devices
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No Need to Reinvent the WheelBiocompatibility has been addressed in the orthopedic and
medical community (total joint prostheses and other implants)
Technology transfer to MEMS and BioMEMS
balloon catheter
“Biomedical Microsystems for Minimally Invasive Diagnosis
and Treatment”, Y. Haga and M. Esashi, Proc. IEEE, Jan 2004.
Surface properties & biocompatibility of the package are key!
proper surface treatmentand materials choice leadsto higher reliability
use of biocompatible coatingsreduces biofouling
source: Smith & Nephew
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MEMS Packaging Trends
Wafer Level Packaging (WLP) is a rapidly evolving area: only wafer capping has been widely commercialized
(Ken Gilleo, MEMS Investor Journal, 2006)
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Packaging Methods
Wafer levelpackaging
Many advantages
Traditional ceramicreliability & small size
Source: Wikipedia
Low TemperatureCo-Fired Ceramic(LTCC)
Lower cost
source: C-MAC MicroTechnology
Near HermeticPackaging (NHP)Pre-molded injection moldedThermoplasticsCost and weight reduction
source: Foster Miller, Inc.
source: Solid State TechnologyNov. 2006
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Advantages of Wafer Level Packaging
mechanical protection for smaller, more fragile MEMS devicesimproved thermal dissipation capabilitiespotential for higher yield: devices are encapsulated early in the process, protecting them from contamination in dicing stepslower cost per device:package assembly, burn-in and final testing can take place in a massively parallel fashion
Package Burn Test DiceDo this
DiceTest
PackagePackagePackagePackage
TestTestTestTest
BurnBurnBurnBurn
TestTestTestTest
Not this:
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Challenges of Wafer Level Packaging
reliability during thermal cycling is keyNeed to match thermal expansion coefficients as closely as possible
Good thermal matching Strain minimizationMechanical strain can become significant near edges for larger dies w/greater contact densityNeed elastically compliant interconnects: metal springs vs. organic elastomers
Conformal contacts between solder bump and wafer.Better electrical performance using “bump on polymer” (pic. on right)
PROPER MATERIALS CHOICE IS CRITICAL
source: Kulicke & Soffa
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BioMEMS Challenges
Non-Si materials (glass, polypropylene, etc.)
Smooth surfaces
Traditional products BioMEMS
Surfaces with topography
Standard Si based materials
High density, sub-μm featuresLarge/thick features
(ex: to allow flow of cells)
Standard processing,Established models
Empirical testingLonger manufacturing cycles
High volume (lot size > 103) Low volume (lot size < 100)
October 22, 2008 MEPTEC October Workshop and Luncheon – SmallTech Consulting 9
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BioMEMS Challenges(Packaging Specific)
Biocompatible polymer packaging
Bio-fouling Bio-contamination
Critical issues for implantable devices
Biocompatible package a must for proper cell-surface interactions
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Packaging of Fluidic Devices
i-STAT Microfluidic and Biosensor System
Fluidic devices require robust fluid interfaces for• Flow• Pressure
To allow• Drug delivery• Sensing• Mixing• Thermal control• Acceleration – etc.
Without compromising• Device performance• Sensing, signal processing and communication• Powering, including on-board batteries• Adhesion and performance of materials used
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BioMEMS packaging and reliability considerations• Biocompatibility• Clean-room assembly• Shelf life of soft components• Feed-throughs – at wafer, modular and/or device level• Hermetic sealing (costly); moisture barriers• Implantability (requires sterilization, localization)• Mechanical stress• Ease of use, serviceability• Outgassing • Powering and communication• Precision assembly and alignment• Electrical & fluidic connection (if unreliable, can be life-threatening)• Static discharge and EM shielding• Thermal management • Waste management
Source: Steven S. Siliterman, BioMEMS and Medical Microdevices
Packaging of BioMEMS Devices
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A tool for packaging• Post-processing localized bonding
Wafer Bonding
IEEE TRANSACTIONS ON ADVANCED PACKAGING, VOL. 23, NO. 4, NOVEMBER 2000MEMS Post-Packaging by Localized Heating and BondingLiwei Lin
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Another tool for packaging• Walls and polysilicon capping structures
Encapsulation
Sensors and Actuators A 134 (2007) 11–19A flip–chip encapsulation method for packaging of MEMS actuators using surface micromachined polysilicon caps for BioMEMS applicationsHrishikesh V. Panchawagh, Faheem F. Faheema, Cari F. Herrmann, David B. Serrell, Dudley S. Finch, Roop L. Mahajan
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Materials Science
STRUCTURE
PROPERTIES PROCESSING
PERFORMANCE
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BiopolymerMorphology templates deposition of the cells
domain center
domainedge
Cells prefer certainmorphologies
By modifying surface texture, morphology and surface chemistry, there is the potential to modify interactions with biological systems, altering the performance and usability of medical devices.
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BioMEMS Challenges(Packaging Specific)
“bionic” ear implantable chipsfor drug delivery
EndoSureTM
Implantable blood pressure monitor
Source: wikipedia Source: Debiotech, S.A. Source: Georgia Tech Photo: Gary Meek
Bio-fouling Bio-contamination
Critical issues for implantable devices
Biocompatible package a must for proper cell-surface interactions
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Powering and Communication
5.2 GHz Differential LTCC Antenna and Balun for Biomedical System in Package (SIP) Application, A,. Shamim, G. Breznina, M. Arsalan, L. Roy, Antenna Technology: Small and Smart Antennas Metamaterials and Applications, 2007. IWAT '07. International Workshop on, 21-23 March 2007 Page(s):443 - 446
Powering and communication – some options• Inductively coupled loops, RF• Implantable batteries• Fuel cells• Optical methods…and with considerations of fluids and biocompatibility
Source: Steven S. Siliterman, BioMEMS and Medical Microdevices
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Reliability and Life Testing
Key reliability and quality standards for MEMS• Iso9000 series Principles for general quality management• IEEE 1332 Program for reliability of electronic systems• IEEE 1413 Methodology for reliability prediction• MIL standards If device for military use• GR standards If device has optical components• 21 CFR 800-1299 USFDA, Center for Devices and Radiological Health
Life testing• Accelerated life modelling/testing• Failure rate “bathtub”: infant mortality; constant random failures; wearout
And because it’s BioMEMS, test considerations include• Fluidics• Wireless• Biocompatibility• …
Source: Nadim Maluf & Kirt Williams, An Introduction to Microelectromechanical Systems Engineering
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Biocompatibility and FDA Approval
Required tests depend on device category and contactInitial tests• Cytotoxicity• Sensitization• Irritation• System toxicity (acute)• Subacute and subchronic toxicity• Genotoxicity• Implantation• HemocompatibilitySupplementary tests• Chronic toxicity• Carcinogenicity• Reproduction/development• Biodegradation
Source: Steven S. Siliterman, BioMEMS and Medical Microdevices
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DiagnosticsSome diagnostic needs:
– Diabetes – Infectious diseases– Cardiovascular– Respiratory– Blood Pressure– Endoscopy “lab on a pill”– Dialysis monitoring
Some measurands:– Pressure (e.g. blood, or any bodily fluid of interest)– Exhaled gases (e.g. CO2, alcohol, O2, water)– Chemistry of interstitial fluid, blood, saliva, dialysate
Location (wireless comm. and power often useful):– At home, implanted, wearable– In doctor’s office, hospital
Epocal’s flex card, a smart microfluidic card for biosensor arrays. Uses Roll to Roll processing through to finished diagnostic card, with rapid throughput in manufacturing. From Mark Wendman’s blog
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Microfluidics
www.calipertech.comCaliper Technologies
Aclara Biosciences
www.affymetrix.comAffymetrix
www.nanogen.com
The NanoChip(R) 400 cartridge …constructs the user defined panel of genetic markers on one chip
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Microfluidics
Sensors and Actuators A 126 (2006) 270–276; Parylene-strengthened thermal isolation technology for microfluidic system-on-chip applications; Chi-Yuan Shih, Yang Chen, Yu-Chong Tai
Advantages• Portability• Reduced size (and volumes)• Integration and automation• Potential for parallel analyses
Challenges• Small-scale physics• Everything is smaller• “World-to-chip” interfaces
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MEMS Glucose MonitorAdvanced BioSensors blood glucose sensor
– Flip chip assembly– ASICs, power sources and circuit components– Separate sensors, mount with electrical
connections, add the biocompatible polymer, assemble the sensor patch.
– The sensor based on glucose oxidase reaction with blood plasma from capillaries in the dermis.
– biochemical coating - sensor in place 3 - 7 days– Docking port for electronics assembly with
amplifier, ADC, wireless transceiver, power source– encrypted digital data to wristwatch-sized
monitor/recorder module– In future combine the CGMS with an insulin pump
to produce a closed-loop system—an artificial pancreas. Source: http://www.devicelink.com/mddi/archive/03/06/003.html
1 mm long x 200 um wide
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Pressure Sensors22 million disposable blood pressure sensors*from Mechanical Engineering magazine, june 02
Global MEMS Pressure Sensor Market
911
1,254
1,0531,150 1,172 1,206
800
1,000
1,200
1,400
2005 2006 2007 2008 2009 2010
Mar
ket i
n $M
Yole Developpement Market Research
IC Sensors 1620 piezoresistive disposable blood pressure sensor
CardioMEMS EndosureTM
wireless AAA implantable blood pressure sensor FISO Fabry-Perot in-vivo
pressure transducer
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Flexible polyimide packaging
Diverse packaging for pressure sensors
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Diverse packaging for pressure sensing applications
www.mesotec.com
Fluid interfaces and packaging vary according to wide-ranging needs
• “Simple” tubes on standard cans with damping• Implantable devices• Wireless power and communication• Flexible and/or transparent packaging• Pkg can include channels & manifolds
NovaSensor Device: Source: Nadim Maluf & Kirt Williams, An Introduction to Microelectromechanical Systems Engineering
CardioMEMS The EndoSure®sensor is approximately the size of a paperclip. It is a hermetically sealed circuit encapsulated in fused silica and silicone, and is surrounded by a PTFE-coated nickel-titanium wire. The sensor contains no batteries or internal power source, but is instead powered by RF-energy provided by a proprietary electronic antenna.
October 22, 2008 MEPTEC October Workshop and Luncheon – SmallTech Consulting 27
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External Valve Control for Hydrocephalus Shunt
Codman® Hakim™ Programmable Valve (CHPV)Used for Hydrocephalus
The CODMAN® Programmable valve offers the ability to optimize the opening pressure of a shunt system before and after implantation. ... The programmable valve allows a surgeon to non-invasively change the opening pressure between 30mm H2O and 200 mm H2O in 18 steps; negating the need for revision surgery to alter the valve pressure. … The opening pressure … is changed through the use of an externally applied, codified magnetic field.
Surgeon can change valve set-point non-invasively with external magnet.
October 22, 2008 MEPTEC October Workshop and Luncheon – SmallTech Consulting 28
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Disposable Insulin NanopumpTM
http://www.debiotech.com/debiotech.html• MEMS technology using Si and glass
biocompatibility• Precise control of nL volumes• Prevent under/overdosing and detect occlusions, other problems• Small size: 1/4th the size of existing monitors• Proprietary hermetic packaging• In the U.S. alone, 60 million people are affected by diabetes• 15% of worldwide health spending goes toward treating diabetes.• 450,000 people now wear transportable insulin pumps worldwide.
sources: Debiotech website; Advanced Packaging
Subcutaneous drug deliveryDebiotech piezoelectric insulin pump
Switzerland
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Retinal Prosthesis
Flexibility and durability are key for applications in the eye
Sensors and Actuators B 117 (2006) 107–114Scalable high lead-count parylene package for retinal prosthesesDamien C. Rodger, James D. Weiland, Mark S. Humayun, Yu-Chong Tai
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Auditory Prosthesis
For this device, a leakage pathmust be built-in to the package
October 22, 2008 MEPTEC October Workshop and Luncheon – SmallTech Consulting 31
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Packaging BioMEMS is like packaging MEMS, with:
– Fluidic interfaces
– Remote powering and communication
– Biocompatibility short- and long-term
– Life or death reliability
– FDA approval
There are many choices , constraints & flexibility
Packaging of BioMEMS Devices