Micro Systems Engineering, Inc. Development and manufacturing of complete electronic modules for active implants, SMD assembly and test
Profile
Micro Systems Engineering, Inc. (MSEI) is a leading medical microelectronics development & design, system integration, and manufacturing company. Since 1979, MSEI produces Class III, cardiac rhythm management, neurostimulation, active implant, sensor, Class II, and other microelectronic devices.
MSEI’s expertise include:
- Automated assembly using the smallest SMDs with high precision on a variety of base materials in Class 10,000 cleanrooms
- Automated production, fold, underfill, device integration, and test
- Automated test processes at an ambient temperature of 37 °C
- Expertise in development and engineering of ultra low power, high voltage, RF, and sensor
- Integration of all processes into a manufacturing execution system
- Full real-time component and module level traceability systems
The company’s extensive knowledge in electronics manufacturing, however, is available not only for applications in medical technology but also for other high-end markets.
MSEI is ISO 13485 certified. The product development and manufacturing processes are part of a comprehensive quality assurance program that includes every stage throughout the value-added chain and that systematically optimizes every operating stage for reliability.
MSEI is headquartered in Lake Oswego, Oregon, roughly 10 miles south of Portland, The company employs around 450 people.
Micro Systems Engineering, Inc.
6024 SW Jean Road
Lake Oswego, OR 97035
USA
Tel. +1 (503) 744-8500
Fax +1 (503) 744-8001
info.msei(at)mst.com
Facts & Figures
| Foundation | 1979 |
| Headquarters | Lake Oswego, Oregon, USA |
| Business premises | 4 buildings, totally 111'000 square feet |
| Employees | 448 (215 in operations) |
| Products/Services |
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| Main export markets | Europe, USA, Asia-Pacific |
| Management | Tim Ellrodt |
| Quality standards | DIN EN ISO 13485:2016 |
| Memberships | IMAPS, MEPTEC, SMTA |
Medical microelectronics development & design services
MSEI is ready to provide you design iterations, from customer input through rapid prototype assembly. The company provides simulations, 3D product design, along with fast access to advanced SMD and module assembly.
- Design of PCBA, ASIC Packaging, Custom RF and High Voltage MCM's for Class III medical implantable electronics.
- Able to work with the customer to optimize partitioning of components within the housing, design of PCBA to a given 3D envelope and schematic or take in the customers already completed designs.
- Development service offerings include rapid prototyping, new component qualification, assembly process development/validation, and PCBA level verification testing.
Medical microelectronics system integration
MSEI has a proven track record with ultra-miniaturised, cost optimised, and smart medical electronics solutions: unique, systematic approaches to size reduction and functional integration, value chain control and advanced manufacturing technologies, knowledge and flexibility to offer opportunity through innovation, smart design, and the system to execute.
- Extensive know-how on low power, high voltage, high frequency applications
- Early adoption of advanced packaging and interconnects
- Leverage of strategic partnerships
- Integrated development of assembly/test from prototype to manufacturing
- Comprehensive focus on reliability from design to manufacturing, from suppliers to customers
Medical microelectronics manufacturing
Executed in a MES-controlled highly automated manufacturing environment with 100% traceability, flexible assembly, and test. MSEI offers manufacturing systems and culture derived from decades of Class III, life sustaining, medical microelectronic implant design and production.
- No-touch handling and flow, digital factory, and high efficiency.
- SAP and MES system integration with route enforcement, set-up control, equipment program control, work order management, batch management, and automatic data acquisition.
- Fully developed capabilities in underfill, wash, automated optical inspection (AOI), module image capture (MIC), and automated fold processes.
- Component selection and validation, integrated supply chain management, and process validation.
Quality
MSEI is EN ISO 13485:2016 certified. The product development and manufacturing processes are part of a comprehensive quality assurance program that includes every stage throughout the value-added chain and that systematically optimizes every operating stage for reliability.
- In-house system, hardware, software, test, and productivity tool development
- Physical factory automation and robotics, 6-axis, SCARA, Cartesion, PLC, and Machine vision
- Data automation and factory integration provides route enforcement, recipe management, source control, data collection, and non-conformance record creation
- Automated part handling, image capture, and custom image analysis software
- Well defined and repeatable processes with strict control
- Global teamwork across 9 time zones
Component quality
MSEI performs automated incoming testing of all components with real-time anomaly detection, dynamic statistical limit creation, and statistical analysis performed with integrated in-house software systems.
- Highly efficient visualization of anomalous data, reporting X-bars, histograms, raw data, Tx, and other adaptive real-time reporting
- Real-time early warning of anomalous lot and device behaviors; early prediction beyond pass/fail
- Instant reporting of equipment availability, initialization, utilization, and shut down
- Automated defect segregation in multiple test formats and all component types
- System capability 24/7 provides alerts, dashboards, adaptive to multiple levels
Traceability
MSEI utilizes an integrated ERP and MES system to manage traceability from start to end for every lot of material flowing through its plant.
- Real-time reporting from component material movement, to the device history record for serialized units consuming that material.
- Systems and specialists provide batch management with full inheritance for any number of lot-receipt-events, through incoming quality processes, engineering mode consumption, internal movements, subcontracting, and serial production consumption.
- Non-conformance tracking, MRB, and special ERP generated labeling is established.
- Incoming component testing and module level testing is data logged and real time throughout the plant, along with advanced statistical toolsets to analyze and alert to exception conditions.
- Interlocked systems provide safety for use of all material no matter what phase of the product life cycle, from engineering sample lots, through fully qualified serial production material, batch managed to to the smallest separable unit at all times.
Module quality and reliability
To assure module quality and reliability MSEI has established a fully automated module handling and test system:
- Mix-mode ICD and pacemaker testing
- 100% MES automatic test routing and recipe selection
- Maximum tester utilization - with short idle time between tests
- Fast test cycle through test suites and immediate feedback for non-conforming modules, including separation from passing modules
Publications
Assuring Reliability in Medical Device Manufacturing Using Automation and a Digital Factory
A smart, end-to-end solution for capacitor reliability yields better, more dependable medical electronic devices.
Authors: Ravi Subrahmanyan, Juergen Lindner
White Paper, January 2018
Assuring Component Reliability in Medical Electronic Devices
A smart, end-to-end solution for capacitor reliability yields better, more dependable medical electronic devices.
Author: Ravi Subrahmanyan
White Paper, October 2016
Redefining Reliability in Medical Electronic Devices
A smart, end-to-end approach to the product lifecycle yields devices that patients can count on to work right, every time.
Authors: Ravi Subrahmanyan, Fred Sporon-Fiedler, Anthony Primavera, Dabo Shen
White Paper, July 2016
Zuverlässigkeit von elektronischen Medizingeräten - ein neuer Ansatz
Ein intelligenter ganzheitlicher Ansatz führt zu Geräten, auf deren ordnungsgemässe Funktion sich Patienten stets verlassen können.
Authors: Ravi Subrahmanyan, Fred Sporon-Fiedler, Anthony Primavera, Dabo Shen
White Paper, July 2016 / German version