© micro systems technologies may 5, 2011...

© Micro Systems Technologies May 5, 2011 2

MST Group – 5 highly innovative technology companies

Solutions for medical devices from conceptto serial production


MST Group – Vertical Integration for Medical Device and Implant Industry

Components

Services

Products

• PCBs and substrates – organic and ceramic• LiI and LiMnO2 batteries for implants• Hermetic ceramic and glass feedthroughs

• Advanced assembly and device packaging• Design and development services

(ASIC, PCB, electronic modules, systems)• Contract manufacturing and supply chain management• Test, validation and qualification services

• Catheters• Leads and lead extraction systems• Electronic modules

January 2011

DYCONEX AGHigh-end flex, rigid flex and rigid PCBs


DYCONEX AG, Bassersdorf ZH, Switzerland

• Swiss manufacturer of high-performance, high-reliability PCBs (HDI/microvia)

• 172 employees(18% Engineering, graduate & Phd)

• 6,000m2 facility with a 600m2 class 10’000 clean room

• Customer base primarily in medical device industryand aerospace/defense;revenue: 58% US, 35% EU

• ISO 9001:2000 certified


Dyconex Design Technology Evolution

• Critical Dimensions continuously more challenging!!

Micro Systems Engineering GmbHLTCC substrates, advanced assembly and semiconductor packaging


Micro Systems Engineering, Berg, Germany (MSE)

• No. 1 in European merchant LTCC manufacturing• Expertise with all major assembly

& packaging technologies • Volume production of sophisticated

electronic modules based on organicand ceramic substrates

• 197 employees• ISO 9001 and 13485 certified

© Micro Systems Technologies May 5, 2011

Technology & Material Access

• New processes and materials– Can enable process efficiency, lower costs, higher yields, better

performance– Willing supplier?

• Medical market vs. high volume commercial/industrial potential• Medical implantable liability concern

– Willing end customer?• Qualification/requalification costs, experience, available data barriers

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January 2011

Micro Systems Engineering, Inc.System development, ASIC design and test, SMD assembly


Micro Systems Engineering, Inc., Lake Oswego, OR, USA (MSEI)

• Advanced ASIC development team• Electronic module & PCB design• System design & integration (HW/FW/SW)• Wafer probe, inspection and test• SMD assembly and automated test• State-of-the-Art traceability, quality &

reliability• 290 employees• ISO 9001:2000 certified


Supply Chain Volatility

• Supplier integration and consolidation effects– Migration of production facilities to Asia– Supplier acquisition/consolidation due to economic environment – Large supplier market focus outside of medical due to low

volumes– Willing suppliers tend to be niche players, smaller, less capable

• Narrow supply chain magnifies impact of outages– Recent Earthquakes/Tsunami in Japan

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LITRONIKBatteries for medtech implants


LITRONIK, Pirna, Germany

• One of three worldwide CRM implantbattery manufacturers

• Development and manufacturing of– LiI-based batteries for IPGs– LiMnO2-based batteries for IPGs and

ICDs/CRT-Ds• 167 employees• ISO 9001:2000 certified


Regulatory Cycle

• Typical development and full qualification cycle– Up to 2 years for new design only

• New battery technology development– 3+ years

• Narrow supplier base• Very high entry hurdles for new suppliers

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© Micro Systems Technologies May 5, 2011 16MST Group Presentation V02

Competence CenterFeedthroughs

Hermetic feedthroughs for medtech implants

Competence Center Feedthroughs


Competence Center Feedthroughs, Erlangen, Germany

• Small but mission-critical for medical implants• Design, development and production of

– Ceramic feedthroughs for connecting the headerof an implant with its electronic module throughthe hermetically sealed implant can(e.g., IPGs, ICDs, CRT-Ds)

– Glass feedthroughs forconnecting the anode/cathodeof an implant battery throughthe hermetically sealedbattery can

• 45 employees


Cost Drivers

• Volume effect– Limited market opportunity– Limited willing supply base

• Very stringent quality/performance requirements– Choice: Externally specified or internally sorted

• Implantable Market Potential Liability adder

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January 2011

VascoMedCatheter technology


VascoMed, Binzen, Germany

• Research, development and production of– Catheter technology– Temporary pacemaker leads– Leads for neurostimulation– Lead extraction systems

• 150 employees• ISO 13485 certified


Catheter technology

• New materials long development and testing times (biocompatibility)

• Long development and qualification cycle for approved product

• Own product program vs. OEM products• Sterilization and appropriate packaging required• Specific niche market small to medium volumes

automation limited• Price pressure for single-use-products


Divergence of Supply Chain vs. Market Realities

• At issue are expectations– Hearing Aid Market

• 2 year life cycles, 6 months for design to production readiness• Fast prototyping• Open to new technologies – feature driven

– Life critical implants• 5-10 year life cycles, 2 years for design to production readiness• Long development/prototype cycles• Not open to new technologies – reliability driven

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MST Group - Market Focus and Migration

Technology & quality leading to new growth markets

RELIABILITY

TECHNOLOGY


MST Group – Key Values

• Group members all have long experience in the field of medical devices and active implants

• Integrated capabilities across business units to minimize supply chain complexity, add value

• Sustainable R&D at each member business to provide enabling technologies for the future

• Group quality culture and systems derived from the requirements of life sustaining implants, “best of” view

• In-depth knowledge across group of regulatory requirements specific to each commodity

• Flexible manufacturing portfolio to meet needs from sampling to series production for varied customers

• Global support structure


MST Group – Common Supply Chain Issues

• Lengthy Development and Qualification Cycles– Impacts time to market significantly– Slows process & equipment change adoptions

• Affects cost and system performance

– Delays innovation• Circuit materials, components, plating chemistry

– Industry consolidation increases volatility in supply base• Implantable Medical Device market liability aversion

– Narrows supply base– Restricts available materials & component options– Indemnification a partial solution only – Increases product/component/material costs


Thank you!

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© micro systems technologies may 5, 2011...

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