Every industry in the global market space utilizes electronics and electronic assembly with box build capabilities in a variety of applications. The medical industry is certainly no exception. Technology in heart rate monitors, pulse oximeters, MRI machines, CT scanners, surgical instruments, and flexible PCB assemblies are just a few common examples of where medical electronics assembly and box build manufacturing occurs in the medical industry.
Industrial Support Inc. guides OEMs and other potential customers on medical electronics assembly and box build manufacturing with specific process implementations, practical considerations, and quality management guidelines.
What Medical Electronics Assembly Means
Electronics assembly is broad terminology, but breaking it down means a focus on printed circuit boards (PCB). PCB design is the first step in the process of medical electronic assembly and arguably the most important. When design considerations have been made and finalized, the actual process begins starting with surface mount (SMT), then to through hole (THT), and ends with inspections, testing, and validation.
Outside of electronics assembly, the box build manufacturing process incorporates bigger concepts such as the finished product. This means adding enclosures for the electronics assemblies, control features including wiring and routing, labeling, programming, and calibration.
Traditional Process Flow
While not every process for medical electronics assembly and box build manufacturing is going to follow the exact same processes step by step, there is a way to generalize the process by concepts.
- Identify and define the assembly’s requirements, enclosure constraints, electrical architecture, and regulatory targets.
- Manufacture, build, and validate PCB assemblies and sub-assemblies (as necessary) by using common production methods including SMT, THT, AOI, and ICT. Additionally, perform functional testing procedures throughout manufacturing and assembly to ensure builds perform as designed.
- Integrate PCB assemblies into one singular piece by joining assemblies together with harnesses, power supplies, sensors, displays, and other mechanical hardware into the builds enclosure.
- Perform calibration as required and all final testing requirements.
Quality and Compliance Measures
One of the advantages of knowing the industry of your medical electronics assemblies and subsequently, the box builds themselves, ahead of time allows for proper expectation between customers and manufacturers on quality management and compliance measures.
Ultimately, quality comes down to impacting three parties: patients, customers, and manufacturers. When assemblies are manufactured as designed, with quality at the forefront, patient safety is ensured, customers receive the builds they expect, and manufacturers maintain reputation.
Medical electronics demand quality and precision and stringent quality management protocols should be in place including proper records keeping and documentation on all tests and validations performed. If a manufacturer is ISO 9001 certified, customers can expect detailed record keeping in place with full reports on the entirety of the manufacturing process.
Trust Industrial Support Inc. For Your Complete Medical Electronics Assembly Services
Since 1995, Industrial Support Inc. has served as the manufacturing company that other manufacturers trust to perform the services they aren’t equipped for. This includes medical electronics assembly and box build services.
From delicate medical devices to arcade games, our team has a wealth of knowledge and expertise in crafting the assemblies your team, and by extension, your customers need in order to perform their daily operations.
Utilizing a high-speed wave soldering process, we excel in assembling circuit boards and electromechanical components, and provide a comprehensive array of custom wiring, cables, wire harnesses, and plug end connectors.
As an AS9100 (D) with ISO 9001:2015 certified company, we employ just-in-time shipping, Kanban scheduling, and vendor-managed inventory to effectively manage our customers’ costs. Our production volumes span from custom products and rapid prototypes to both low and high volume runs. All our services are flexible and can be expedited based on specific requirements.
Contact ISI today to learn more about our services and how we can best serve your needs.