Packaging of BioMEMS Devices - SmallTech Consulting Consulting_102208.… · October 22, 2008...

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



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



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



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)



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



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:



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



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)



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



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



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




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



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



Materials Science

STRUCTURE

PROPERTIES PROCESSING

PERFORMANCE



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.



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



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




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



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




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



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



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



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



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



Flexible polyimide packaging

Diverse packaging for pressure sensors



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.



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.



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



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



Auditory Prosthesis

For this device, a leakage pathmust be built-in to the package



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 - SmallTech Consulting Consulting_102208.… · October 22, 2008...

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