GUIDING INNOVATION TO SUCCESS
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1 GUIDING INNOVATION TO SUCCESS Meeting name & guest logo June 19, 2017 Page 1
2 VALTRONIC GROUP KEY FIGURES We innovate and manufacture miniaturized and complex products More than 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 FDA registered m 2 Manufacturing 540 m 2 cleanroom June 19, 2017 Page 2
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 Cleveland Full supply chain services Design, Development, Industrialization & Manufacturing Switzerland Morocco June 19, 2017 Page 3
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 June 19, 2017 Page 4
5 EXPERTISE & COMPETENCES 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 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 June 19, 2017 Page 5
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 June 19, 2017 Page 6
7 SELECTION OF APPLICATIONS Neurosurgical Positioning Robot Deep Brain Stimulation Probe Cochlear Implant Smart Contact Lens Ultrasound Tumor Treatment Robot Insulin Pump Disposable Endoscope Insulin Pen Intelligent Pill Blood Pressure Monitoring Gastric Band Complete Transfusion System Infusion Pump X-Ray Detectors Morphine Pump Incontinence Devices June 19, 2017 Page 7
8 THE NPPD METHODOLOGY AND THE V&V EXPERTISE Phase 0 Phase 1 Phase 2 Phase 3 Phase 4 Idea-Concept Feasibility Development Industrialization Manufacturing Invention Proof of concept Real size Prototype Pre-series Production series Patent Start clinical trials User Requirement Specifications Functional Analysis & System Requirements Validation Verification System Validation System Verification Design Solution & Specification Integration Unit/Device Testing Implementation HW + SW Development June 19, 2017 Page 8
9 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 Medical Devices) Audits Quarterly UL Audits FDA registered Customer on request Planned or unplanned Notified Body audits June 19, 2017 Page 9
10 VALTRONIC MOROCCO Industrialization and Manufacturing Technology transfer and industrialization team Pre-series to high volume production Systems assembly Dedicated industrial & medical zones 2500 m 2 Assembly and Manufacturing 250 m 2 Clean room (ISO 7 & 8) Supply chain management Swiss quality at an offshore cost ISO 9001 IS June 19, 2017 Page 10
11 VALUE PROPOSITION VALTRONIC MOROCCO Manufacturing Process Transfer & Integration Integrated System Assembly Industrial Tooling, Prototype and Technology Development Infrastructure & Supply-Chain Management Managed industrial transfers of tooling and know-how for price sensitive and mature products for Medical, Industrial and Automotive Customer know-how protection (clustering) Ecosystem serving local market Electronics Packaging SMD and semiautomatic processes Micromechanics system assembly Batteries assembly & tests Customized tooling development and manufacturing Specific microassembly technology development Specific proof of concept, systems and prototypes development 2500m 2 production 250m 2 clean rooms (ISO-7) hours capacity expandable Sourcing & Dispatching Local Partners in Morocco ISO 9001 & June 19, 2017 Page 11
12 SELECTION OF APPLICATIONS June 19, 2017 Page 12
13 Valtronic Morocco Principal customers 13 June 19, 2017 Page 13
14 SUCCESS STORIES 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 June 19, 2017 Page 14
15 SUCCESS STORIES AUTOMOTIVE LIGHTING COMMUTATOR Project challenge & Valtronic solutions Assembly system Functionnal test Packaging Customer benefits Partnership of more than ten years > 1000K commutators/ year June 19, 2017 Page 15
16 SUCCESS STORIES ENGINE STARTER Project challenge & Valtronic solutions PCBA production Assemly system Functional test Packaging Customer benefits Full supply chain management June 19, 2017 Page 16
17 SUCCESS STORIES BATTERY TESTER Project challenge & Valtronic solutions PCBA production Assemly system Functionnal test Packaging Customer benefits Full supply chain management June 19, 2017 Page 17
18 SUCCESS STORIES 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 product June 19, 2017 Page 18
19 SUCCESS STORIES 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 June 19, 2017 Page 19
20 SUCCESS STORIES 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 June 19, 2017 Page 20
21 SUCCESS STORIES ANALOGUE CLOCK MODULE Project challenge & Valtronic solutions High density PCB, fine pitch SMD Production until 35kpc./year June 19, 2017 Page 21
22 SUCCESS STORIES LITHIUM BATTERY ASSEMBLY Over 13 years experience Electrode welding Assembly according to required Ah June 19, 2017 Page 22
23 SUCCESS STORIES CÂBLAGE ET FAISCEAUX ÉLECTRIQUE Différents secteurs alimentés par nos câblage Savoir faire Excellente qualité à coûts très compétitifs June 19, 2017 Page 23
24 TOGETHER WE CAN ACHIEVE MUCH MORE June 19, 2017 Page 24
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