oem technology needs - inemithor.inemi.org/webdownload/pres/med_elec_may11/oem_tech_needs.pdf ·...
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OEM Technology Needs
Peter Lampacher, Head of Design and Development of Vibrant MED-EL
presented by Martin Kerber
iNEMI Medical Electronics Workshop, May 4-5, 2011; Santa Clara, California
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Technology needs – Outline
• Advanced Packaging• MEMS• ASIC technologies• Lead-free assembly• Reliability characterization of electronic assemblies• Packaging solutions for implantable electronics outside a
hermetic housing• Interactions between medical equipment and implantable
electronics, with a spotlight on MRI safety
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Advanced Packaging• Miniaturization in active implantable devices is driven by
following requirements:– Increased demand for more functionality
• Sensing of body signals• Signal conditioning• Signal processing algorithms of increasing complexity• Stimulation signals• Communication to outside world
– Need for small package size• Anatomical circumstances• Surgical ease
• Miniaturization leads to:– Higher density boards– Substrates with many layers– Smaller components, active and passive– Advanced Packaging
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Advanced Packaging Challenges
• Chip Scale Packages (CSPs)– Wafer-Level Re-distribution– Small dies with high number
of I/Os– Standoff– TC mismatch– Underfill– Solder joint reliability
from Toshiba website (http://www.toshiba-components.com/)
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Rigid-Flex Substrates
• Required for– High density interconnect– Microvias– Complex geometries with optimum usage of available
volume– 3-dimensional configurations
• Challenges– TC mismatch– Flexing (micro-motion)
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MEMS
• Micro-Electro-Mechanical Systems
• Sensor– Accelerometer– Gyroscope– Pressure sensor– Chemo sensor– Bio sensor (Lab on chip)
• Actuator– Micro valves (drug delivery)
from MEMSnet website (http://www.memsnet.org/)
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MEMS challenges• Access to Fabrication
– Design– Prototyping– Manufacturing
• Packaging– Many devices need to be in contact with the environment and at the same
time be protected from the environment– Integration with CMOS– Wafer-Level processing– 3D-Integration– Through Silicon Vias– Hermeticity
• Signal conditioning• Testability• Reliability
from Faun AB website (http://www.fauninfrared.com/)
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ASIC technologies
• Active implantable medical devices frequently use ASICs for different reasons:– Technical:
• Need to design smaller devices with more features• Full control of all design aspects
– Commercial:• Relatively high cost of ASICs can be justified for AIMDs• Competitive advantage – no need to wait for technology
upgrades of e.g. microcontrollers
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ASIC Supply Chain
• The supply chain for ASICs is particularly complex
• Long-term availability of processes is important for medical device OEMs
• Areas of concern are shown on the following slide
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Single Chip Design
Mask Set Production(Reticles)
Plain Wafer Production
Wafer Bumping
Wafer Testing
Packaging Tape & Reel
Wafer Dicing
Wafer Dicing
Chips on Foil (Verification Purposes)
Fab
Designer
Wafer-levelprocessing
Test house
Typical supply chain of an ASIC
Circuit board assembly
Assembly
Can be problematic
Can be problematic
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Lead-free assembly
• Per EU directives (2002/95 – RoHS and 2002/96 – WEEE) medical products are (still) exempt from RoHS requirements– Leaded assemblies are still allowed– Long-term commercial availability of leaded
components is uncertain– Most concern with respect to implanted system parts
Pb?
A CSP-and-MLCC-and-others-on-flexhybrid on a 6-layer FR4
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Reliability characterization of electronic assemblies
• Several approaches:– MIL-HDBK-217 is still used and supported by FMEA / Reliability
Prediction software• Latest version is rev. F change notice 2 from 1995 (!)
– HALT / HAST testing• „1000h test“ (per MIL-STD-883)• 85°C / 85% rH testing (JEDEC Standard No. 22 -A101)
– Combined approaches (e.g. long term saline soak)
• Electronics reliability is an important contribution to overall device reliability. Other components (e.g. hermetic seals) also contribute and have to be considered.
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Example...
• One-stop shop for reliability and safety?
• MIL-HDBK-217 is advertised to be globally accepted
• There is a clear need for updated/improved reliability design and test standards
from Reliacore website (http://www.reliacore.eu/)
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Packaging solutions for implantable electronics outside a hermetic housing
• Novel implant applications currently emerging...– some examples shown from the Healthy AIMS EU
project– Conventional hermetic packages difficult to use for
these applications
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Glaucoma sensor
from Healthy AIMS website (http://www.healthyaims.org/)
Obviously no room for a conventional hermetic encapsulation
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Retina implant
from Healthy AIMS website (http://www.healthyaims.org/)
Obviously no room for a conventional hermetic encapsulation
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Intracranial Pressure Sensor
from Healthy AIMS website (http://www.healthyaims.org/)
The whole device has to be surgically placed inside the cranium!
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Challenges ...
• Materials• Test methods• Permanent exposure to moisture: Implications
on electronics design– Limited selection of components, substrates
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Interactions between medical equipment and implantable electronics
• A well-known symbol...– but many users of pacemakers
and other active implants are in need of MRI examinations.
• FDA approved the first pacemaker with „MRI conditional“ labelling in Feb 2011.
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MRI evolution... and interactions with other medical devices
1.5T 3T
Specialized sequences
Fast gradient switching
0.3T
More heating
Induced voltages
...
Images from MED-EL, Medtronic websites
Time
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Marketing of MRI manufacturers
• Improvements of clinical use (high resolution, fast scans)
• ... but how about compatibility with medical implants?– Adoption of standardized „implant-safe“
MRI sequences by the manufacturers could contribute to improve the situation
• Potentially applicable to other diagnostic devices
Images from Siemens Medical and GE Healthcare websites
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Summary – 1
• Advanced Packaging– Packaging topics already addressed in iNEMI projects– Address in a separate project out of the Medical TIG?
• MEMS– Packaging issues related to IC packaging– Potential area for iNEMI activity?
• ASIC technologies– Many semiconductor manufacturers are with iNEMI, but not
many wafer foundries– Potential area for iNEMI activity?
• Lead-free assembly– iNEMI is a leader (Board assembly TIG)– Potential synergy?
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Summary – 2
• Reliability characterization of electronic assemblies– A component-level project was completed (MLCC project).– Industry participation for a follow-up project?
• Packaging solutions for implantable electronics outside a hermetic housing– Future topic– Within scope for iNEMI?
• Interactions between medical equipment and implantable electronics, with a spotlight on MRI safety– Major topic in implant industry– Any way to address this through iNEMI?
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Questions?