Microtechnology in Medical Devices

1

Work presented from departments SIIT, SDI, HDIImages from other partners are with respective references

Microtechnology in Medical Devices

iNemi Roadmapping Event, ESTC 2010

2


Overview

Fraunhofer IZM – who we are

Scenario „Medical Devices“: Microtechnology as enabler

Drivers and Challenges

Perspectives and future requirements

Collaboration Opportunities

3


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

4


Nanostructures

nm

Application

m

: Bridging the Gap between Chip and Application

5


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

6


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*)

7


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

8


Microtechnology as key enabler formedical micro systems

MST

System design

Components

Joiningtechnology

AssemblyTechnology

From System Design through components and assembly/packaging to testing!

9


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)

10


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)

11


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

12


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)

13


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)

14


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






15


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, …)

16


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

17


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

18


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

19


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

20


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

21


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

22


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

23


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

24


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

25


Perspectives for packaging and assembly technologyin the medical field remain bright


Trend towards higher level of intelligence over all medical areas










26


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.

Documents

Microtechnology in Medical Devices