Microtechnology in Medical Devices
Transcript of Microtechnology in Medical Devices
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Work presented from departments SIIT, SDI, HDIImages from other partners are with respective references
Microtechnology in Medical Devices
iNemi Roadmapping Event, ESTC 2010
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Work presented from departments SIIT, SDI, HDIImages from other partners are with respective references
Overview
Fraunhofer IZM – who we are
Scenario „Medical Devices“: Microtechnology as enabler
Drivers and Challenges
Perspectives and future requirements
Collaboration Opportunities
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Work presented from departments SIIT, SDI, HDIImages from other partners are with respective references
Information Technology
15 000Employees
app. 1.4 Bil. €Turn Over
appr. 65%Contract Research
57 Institutes
Fraunhofer Society
MicroElectronics
SurfaceEngineering/
Photonics
Materials
ProductionTechnologies
Life Science
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Work presented from departments SIIT, SDI, HDIImages from other partners are with respective references
Nanostructures
nm
Application
m
: Bridging the Gap between Chip and Application
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Work presented from departments SIIT, SDI, HDIImages from other partners are with respective references
Mission: Fraunhofer IZMWe offer:
Fast, innovative, tailor-made solutions for
your complex packaging problems
future technology and application roadmaps
We make your products
smaller
more reliable
more competitive
Mission of the Fraunhofer IZM
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Work presented from departments SIIT, SDI, HDIImages from other partners are with respective references
IZM has a continued history of developing for the medical device industry
Indicative of the interest of medical device industry in using microtechnology
First fully SMD integrated heart pace maker – 1995 (Biotronik)
First COB integrated hearing aid – 1996 (Siemens)
First FlipChip / 0201 integrated hearing aid – 1997 (Phonak)
First sensor integrated wireless „Band Aid“ – 1999 (FhG-IIS*)
First 16 channel retinal implant – 2001 (IIP Technologies)
First fully textile integrated ECG-shirt – 2004 (internal*)
First integrated cell analysis platform with 1028 micro wells – 2006 (Cochise-EU*)
First wireless neural interface – 2007 (DARPA*)
First multi marker biochip platform – 2009 (ENIAC*)
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Work presented from departments SIIT, SDI, HDIImages from other partners are with respective references
Neural Prosthesis, cranial pressureartificial retina, intraocular andextraocular pressur sensors, hearing aids,pacemaker, pressure sensor in catheter,
Prosthetic interface, textile sensors,blood pressure, sensor enhancedprosthetic glove, ECG shirt, EMG shirt,TENS glove
Medical Devices – Packaging and Integration – Areas of Application
CT Detectorsmammography Detectorsantibody detectionµF Flow Control for medicationdosing
INVASIVE
NON-INVASIVE
EXTERNALSUPPORT
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Work presented from departments SIIT, SDI, HDIImages from other partners are with respective references
Microtechnology as key enabler formedical micro systems
MST
System design
Components
Joiningtechnology
AssemblyTechnology
From System Design through components and assembly/packaging to testing!
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Work presented from departments SIIT, SDI, HDIImages from other partners are with respective references
Active Implants
• Active implants optimize diagnostic, therapy and thereby the overall quality of life of patients
• Micro system technology allows to realize the active functionality in an acceptable implantable form factor
• Example: Pace maker, cochlea-implant, cortical pressure sensor, hearing aids, glucose measurement systems, video endoscopse, brain computer interfaces, retinal implants, intraocular pressure sensors
Augeninnendruck Sensor(Kooperation mit Mesotec)
Retina‐Implantat(Kooperation mit IMI)
Drahtloses Brain Computer Interface(Kooperation mit Uni Utah)
TelemetrischerHirndrucksensor
(EU Projekt HEALTHY AIMS)
Herzschrittmacher(Kooperation mit Biotronik)
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Work presented from departments SIIT, SDI, HDIImages from other partners are with respective references
Ageing in Autonomy and Dignity
• Sensory and AAL assisted life allows high autonomy pertaining high safety to the elderly patient
• Ubiquitous availability of services due to micro system technology• Example: Safety bracelet, fall detection, monitoring of dementia,
stroke rehabilitation assistance
Notfallsignalgeber(Kooperation Uni BW)
Lokalisierungsmodulfür demente Patienten(Kooperation mit Nanotron)
Sensorisch unterstützteOrthese für
Schlaganfallpatienten(Fraunhofer Vorhaben RIT)
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Work presented from departments SIIT, SDI, HDIImages from other partners are with respective references
Patient Care
• Cost reduction and optimization of patient care by autonomous monitoring (tele-health)
• MST as enabler for autonomously (re) acting sensor/actuation scenarios
• Examples: Sensor nodes, autonomous energy supply, intelligent vital data sensors
Autonom vernetzterSensorknoten
Mikrobrennstoffzellezur Verlängerung derBetriebsdauer von
Sensorknoten
In Textil integrierte EKG Elektroden undElektronik mit Telemetrieanbindung
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Work presented from departments SIIT, SDI, HDIImages from other partners are with respective references
Patient Care
• Neonate monitoring to optimize survival rate of early born• MST as key enabler for 21st century care• Example: Breath detection, blood gas monitoring, movement
monitoring
Mikrotechnisches Mikrofonzur Integration in einen
Atemlautsensor(Sonion MEMS, DK) Drahtloses Pulsoxymetriesystem
integriert in einen Handschuh(Kooperation mit TU Berlin)
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Work presented from departments SIIT, SDI, HDIImages from other partners are with respective references
Emerging: Bio-Inspired Sensors and Therapy
• Merging biology and electronic in smallest form factor • Micro system technology is –again- enabler• Example: Drug- and pathogen detection, cancer therapy using electronically
selected killer cells,
Detektionsplattform zur Identifikationvon vielversprechenden autologen
Tumor-Killerzellen, EU Projekt COCHISE
Neuronen auf nanostrukturiertem UntergrundSensorik z.B. für Nervengifte(Kooperation mit U. Rostock)
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Work presented from departments SIIT, SDI, HDIImages from other partners are with respective references
Perspectives for packaging and assembly technologyin the medical field remain bright
Trend towards heterogenous systems
Trend towards higher level of intelligence over all medical areas
Trend towards autonomously powered implants
Trend for improved and individualized means towards rehabilitation
Trend towards Point of Care Diagnostics and Therapy
Trend toward automatized administration
Trend towards heterogenous systems
Trend towards autonomously powered implants
Trend for improved and individualized means towards rehabilitation
Trend towards Point of Care Diagnostics and Therapy
Trend toward automatized administration
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Work presented from departments SIIT, SDI, HDIImages from other partners are with respective references
Integration of different functionalities such as miniature sensors, actuators, photonics, signal processing, data transmission, power supply
with a high degree of miniaturizationand flexibility
Into a critical environment with biocompatibility,hermeticity and longevity challenges
Hetrogenous System Integration for Medical Devices
In a package, that is
specifically designed tooptimally meet the individualapplication requirements(shape, volume, weight, …)
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Work presented from departments SIIT, SDI, HDIImages from other partners are with respective references
Medical Devices
offer a vast field to applymodern assembly andpackaging techniques usingmicro technology
Biggest challenges
-biocompatibility, sterility-robustness over lifetime-energy autonomy-Q/A-full system level testing-assembly processes forsensitive small components
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Work presented from departments SIIT, SDI, HDIImages from other partners are with respective references
Medical Device Challenge:Miniaturization and Robustness
•Highest functionality on smallest footprint using flip chip technology•Withstands rought treatment•Adapted to the agressive ear ambient (humidity, wax, dust, …)
Calls for precision assembly, mechanical handling of sensitive parts, folding, full traceability, and encapsulation-to-shape
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Work presented from departments SIIT, SDI, HDIImages from other partners are with respective references
ECG Respiration and Movement EMG*
Medical Device Challenge:Large Area Sensing, Washability and Feeling
•Textile electronics for distributed sensors by large areaelectronic integration
•Washability @ 60/95°C for hygiene reasons•Look-and-Feel for patient acceptance•Robustness and safe performance by redundant wiring
* Col
labo
ratio
n w
ith P
hilip
s
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Work presented from departments SIIT, SDI, HDIImages from other partners are with respective references
Sensor 1 Sensor 2 Sensor 3Read out electronicantenna
Medical Device Challenge:Large Area Sensing, Repeatability and Comfort
EC Project: STELLA
•24/7 monitoring requires continuous energy supply•Thin integration allows for high patient compliance•Large area manufacturing offers low cost solution•Stretchable interconnects allow „band aid“ like usage
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Work presented from departments SIIT, SDI, HDIImages from other partners are with respective references
EC Project„Healthy Aims“
Medical Device Challenge:Miniaturiziation, Biocompatibility and Wireless Data
•Biocompatibility of the system with encapsulation in silicone/parylene•Miniaturization using flip chip sensor integration•Subdural sensor and subcutaneous electronic module
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Work presented from departments SIIT, SDI, HDIImages from other partners are with respective references
Medical Device Challenge:Miniaturiziation, Biocompatibility, Wireless Data, Longevity
•Wafer Level Redistribution and Bumping for Miniaturization•Flip Chip Assembly for Miniaturization•Hermetic lidding for longevity•Wireless energy and data•Silicon-on-Silicon integration for performance and longevity•Biocompatible choice of materials and encapsulation
Collaboration with University of Utah within a NIH Grant
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Work presented from departments SIIT, SDI, HDIImages from other partners are with respective references
Medical Device Challenge:Rehabilitation and Ambient Assisted Living
Sensor assisted home rehabilitation allows shifting ressourcesfrom „normal“ care to critical care, without sacrificing success
Distributed sensors with multimodal fusion enable optimum rehabilitation e.g. for trauma or stroke patients
Distributed multi-parameter sensors allow 24/7 care to eldercitizens e.g. suffering from mild dementia
IT with distributed sensors (vital parameters, ..) and communication elements(cameras, omnilocated microphones, ..) together with multiprocotcol enabledinfrastructure allows families to take back elements of care from the health caresystem
Requires: Small Distributed Sensors, Intelligent Amenities,Intelligent Interfaces suitable for existing buildings
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Work presented from departments SIIT, SDI, HDIImages from other partners are with respective references
Medical Device Challenge:Point of Care Diagnostics and Therapy
Complex diagnostic systemscall for integrated sensors andsample treatment with low cost implementation strategies
Packaging is key to achieve this
-µ-fluidic/µ-electronic integration-Sensor/actuator integration-µ-fluidic and µ-electrical interfacesto the outer world
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Work presented from departments SIIT, SDI, HDIImages from other partners are with respective references
Challenges for MST in the medical device arena
•Precision requirements to component pick/place
•Wide spectrum of substrate materials (rigid flex textile)
•Wide spectrum of used components calling for different joining techniques)
•Wide spectrum of joining techniques (glueing, soldering, welding, laser)
•Wide range of substrate sizes (mm to m)
•Small product, small number/p.a., high quality requests
•High requirements to certification, difficult to implement (e.g. folding…)
•Limited use of „little helpers“ e.g. surfactants, de-bonding matrerials due
to biocompatibility issues
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Work presented from departments SIIT, SDI, HDIImages from other partners are with respective references
Perspectives for packaging and assembly technologyin the medical field remain bright
Trend towards heterogenous systems
Trend towards higher level of intelligence over all medical areas
Trend towards autonomously powered implants
Trend for improved and individualized means towards rehabilitation
Trend towards Point of Care Diagnostics and Therapy
Trend toward automatized administration
Trend towards heterogenous systems
Trend towards autonomously powered implants
Trend for improved and individualized means towards rehabilitation
Trend towards Point of Care Diagnostics and Therapy
Trend toward automatized administration
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Work presented from departments SIIT, SDI, HDIImages from other partners are with respective references
Syopsis• Medical devices have started to accept the possibilities of micro system
technology
• Market demand calls for devices „at“ or „in“ the human being, leveragingmicro system techniqes
• Wide range of possibilites for MST from component, manufacturing to test
• Challenged by heterogenous technologies in one product, small production volumes with high efforts for market access (Certification…)
• Upfront risk for a new product is high. Access to regulated markets adds difficulties, but also market chances.