GUIDING INNOVATION TO SUCCESS - CFCIM · GUIDING INNOVATION TO SUCCESS Meeting name & guest logo....
Transcript of GUIDING INNOVATION TO SUCCESS - CFCIM · GUIDING INNOVATION TO SUCCESS Meeting name & guest logo....
June 19, 2017 – Page 1
GUIDING
INNOVATION TO
SUCCESS
Meeting name& guest logo
June 19, 2017 – Page 2
• We innovate and manufacture miniaturized and complex products
• More than 1’000 projects since its creation in 1982
• D&D Specialists for Class I to III devices
• 350 qualified employees worldwide
• More than 70 skilled Engineers
• ISO 13485 + FDA registered
• 25’000 m2 Manufacturing
• 540 m2 cleanroom
VALTRONIC GROUP KEY FIGURES
June 19, 2017 – Page 3
LOCATIONS & ACTIVITIES
• Les Charbonnières, Switzerland
Design, Development, Industrialization & Manufacturing
Microtechnology Competence Center
Full supply chain services
Complex System builds
• EPFL Lausanne, Switzerland
Headquarters
Innovation Center
• Casablanca, Morocco
Semi-automatic Volume Manufacturing
Full supply chain services
• Cleveland (OH), USA
Full supply chain services
Design, Development, Industrialization & Manufacturing
Cleveland
Switzerland
Morocco
June 19, 2017 – Page 4
VISION & MISSION
Our Vision
• To be the Worldwide successful
partner for innovative healthcare
devices
Our Mission
• To enable our partners to improve
patients’ quality of life through medical
device innovation, development and
manufacturing at highest quality
standards
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EXPERTISE & COMPETENCES
The D&D Team• Project Managers
• Electronic Engineers
• Mechanical Engineers
• Firmware + SW Engineers
• Layout Engineers
• Manufacturing Engineers
• Process Development Engineers
• Test Engineers
• Quality Engineers
• MD PhD
• Miniaturization
Hybrid Technology assembly on board (e.g. CoB, FC, CoFC, MCM, SMD)
3D die assembly (e.g. 150 um pyramid assembly)
3D component assembly (e.g. 3D-CSP,, 3D PCB)
• Complex turn-key medical devices
From concept to production
High precision Mechatronics
Multi-technologies, multi-sources and multi-skills
Design for Manufacturing & Test for Manufacturing
• Automated Volume Manufacturing
June 19, 2017 – Page 6
PRIMARY MARKET SEGMENTS
• Medical
Electronic miniaturization
and high-precision complex
devices
Active implants
Medical grade wearables
Portable equipment
Medical equipment
• Advanced industrial
Electronics for miniaturized,
high-reliability & -complexity applications
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Smart Contact Lens
Ultrasound Tumor Treatment Robot
X-Ray Detectors
Intelligent Pill
Incontinence Devices
Infusion Pump
Complete Transfusion System
Blood Pressure Monitoring
Insulin Pump
Cochlear Implant
Deep Brain Stimulation Probe
Neurosurgical Positioning Robot
SE
LE
CT
ION
O
F A
PP
LIC
AT
ION
S
Insulin Pen
Disposable Endoscope
Gastric Band
Morphine Pump
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THE NPPD METHODOLOGY
AND THE V&V EXPERTISE
Idea-Concept Feasibility Development Industrialization Manufacturing
Phase 0 Phase 1 Phase 2 Phase 3 Phase 4
Integration Unit/Device Testing
System Validation
System Verification
Implementation HW + SW Development
Design Solution & Specification
Functional Analysis & System Requirements
User Requirement Specifications
Verification
Validation
Invention Proof of concept Real size Prototype Pre-series Production series
Patent Start clinical trials
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QUALITY MANAGEMENT SYSTEM
• Certifications
ISO 9001:2008
ISO 13485:2012
All Project Leaders certified
• Regulations & Compliance
21 CFR 820 (Quality System Regulation)
Directive 93/42/CEE (Medical Devices)
Directive 90/385/CEE (Active Implantable
• Audits
Quarterly UL Audits
FDA registered
Customer on request
Planned or unplanned Notified Body audits
Medical Devices)
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Industrialization and Manufacturing
• Technology transfer and industrialization team
• Pre-series to high volume production
• Systems assembly
• Dedicated industrial & medical zones
2500 m2 Assembly and Manufacturing
250 m2 Clean room (ISO 7 & 8)
• Supply chain management
• Swiss quality at an offshore cost
• ISO 9001
• IS0 13485
VALTRONIC MOROCCO
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VALTRONIC MOROCCO
Managed industrial transfers of tooling
and know-how for price sensitive and
mature productsfor Medical, Industrial
and Automotive
Customer know-how protection (clustering)
Ecosystem serving local market
Electronics
Packaging
SMD and semi-automatic processes
Micromechanics system assembly
Batteries assembly & tests
Customized tooling development and
manufacturing
Specific micro-assembly technology
development
Specific proof of concept, systems
and prototypes development
2500m2 production 250m2 clean rooms
(ISO-7)
800’000 hours capacity expandable
Sourcing & Dispatching
Local Partners in Morocco
ISO 9001 & 13485
Manufacturing
Process Transfer
& Integration
Integrated System
Assembly
Industrial Tooling,
Prototype and
Technology
Development
Infrastructure
& Supply-Chain
Management
VALU
E PRO
POSIT
ION
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SELECTION OF APPLICATIONS
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Valtronic Morocco Principal customers
13
June 19, 2017 – Page 14
AUTOMOTIVE BRAKING SYSTEM
Project challenge & Valtronic solutions• Design & production of electronical systems, including sensors to detect failures in truck
brakes• Very demanding environmental constraints
Customer benefits
• Production Up to 240kpc./year
• 1.5Mpc. made in total
• Cost optimization through miniaturization and process transfer over «smart cost»
industrial scheme
High density PCB SMT Die attach Chip-on-Board
SUCC
ESS S
TORI
ES
June 19, 2017 – Page 15
AUTOMOTIVE LIGHTING COMMUTATOR
Project challenge & Valtronic solutions
• Assembly system
• Functionnal test
• Packaging
Customer benefits• Partnership of more than ten years• > 1000K commutators/ year
SUCC
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TORI
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June 19, 2017 – Page 16
ENGINE STARTER
Project challenge & Valtronic solutions
• PCBA production
• Assemly system
• Functional test
• Packaging
Customer benefits
• Full supply chain management
SUCC
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June 19, 2017 – Page 17
BATTERY TESTER
Project challenge & Valtronic solutions
• PCBA production
• Assemly system
• Functionnal test
• Packaging
Customer benefits
• Full supply chain management
SUCC
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TORI
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June 19, 2017 – Page 18
SENSORS ASSEMBLY
Project challenge & Valtronic solutions
• Incorporated COB & SMT to make the product
possible.
• COB mounts integrated circuit chips directly to
a circuit board with contact pads facing away
from the board.
• Fine wires are bonded between the die pads
and PCB pads for the desired circuit
configuration.
• Built complete packaged productSUCC
ESS S
TORI
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June 19, 2017 – Page 19
HOME BLOOD PRESSURE MONITOR
Project challenge• High level quality FMCG product• Provide system with low production costs
Valtronic solutions• Device with improved electronics and fluidics• Improved assembly process• Full supply chain management
Customer benefits• Fast industrialization• Production ramp-up to 100,000 units per year • Production at Valtronic Morocco
Electronics Fluidics Assembly process Supply chain management
SUCC
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ELECTROMECHANICAL GASTRIC BAND
Electro-mechanical implant with external unit to control band opening/closing
Project challenge• Class III implant• Complex manual assembly
Valtronic solutions• Accurate diameter regulation for minimal patient discomfort• Assembly in clean room
Customer benefits Group synergy: partially manufactured in clean room in Morocco Management of complex supply chain
Internal Ø 19 to 26 mm 75 mechanical parts External control unit Clean room assembly Riveting process with platinum
SUCC
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June 19, 2017 – Page 21
ANALOGUE CLOCK MODULE
Project challenge & Valtronic solutions
• High density PCB, fine pitch SMD
• Production until 35kpc./year
SUCC
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June 19, 2017 – Page 22
LITHIUM BATTERY ASSEMBLY
Over 13 years experience
• Electrode welding
• Assembly according to required Ah
SUCC
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TORI
ES
June 19, 2017 – Page 23
CÂBLAGE ET FAISCEAUX ÉLECTRIQUE
Différents secteurs alimentés par nos câblage
• Savoir faire
• Excellente qualité à coûts très compétitifs
SUCC
ESS S
TORI
ES
June 19, 2017 – Page 24
TOGETHER
WE CAN ACHIEVE
MUCH MORE