Playing the Game
When it comes to medical devices, no average or sub-par printed circuit board assembly (PCBA) is going to cut it! In this live-action game of Operation, the consequences are real, and the assembly is accountable.
As a premier manufacturer of printed circuit boards, PGF Technology Group fully understands the importance of proper PCBA design for medical devices and systems. However, some may find the design process challenging since many factors must be considered. These factors include safety requirements, cleanliness standards, industry/application-specific regulations, and more. That’s why our team has put together the following guide, which goes over some of the key considerations to keep in mind when designing medical PCB assemblies.
Safety First
Accuracy and precision are crucial to avoiding the buzzer. Many medical devices are designed to perform vital functions while living in or on the human body for extended periods, such as insulin pumps and pacemakers so that any malfunction can put the patient’s life at risk. That’s why manufacturers must design and build these products and their components carefully to ensure patient safety. PCBA manufacturers should consider the operational and environmental conditions (e.g., fluid exposure, temperature), their effect on the product, and the measures needed to combat those effects.
Cleanliness Is Close to Godliness
A clean workplace is a safe workplace. This saying is especially pertinent in the medical industry, where cleanliness can significantly affect the health and wellbeing of patients and the performance and lifespan of devices. That’s why PCBA manufacturers will often use materials that form surfaces that are easy to clean and disinfect and incorporate strict cleaning practices into production operations to remove any residues left behind from manufacturing processes. Additionally, according to the cleanliness of product clause in ISO 13485 Medical Devices — Quality Management Systems — Requirements for regulatory purposes, organizations need to document product cleanliness or contamination control requirements.
Read the Rule Book
To properly play the game, you have to know the rules. In the medical industry, products are subject to numerous regulations outlining how they should be designed, manufactured, used, etc. Knowing, understanding, and following them is essential to the success of a product.
ISO 13485
Firstly, one of the most critical regulations relevant to medical PCBAs and other electronics is ISO 13485, which establishes the requirements for quality management systems for companies involved in one or more of the lifecycle stages of a medical device or the supply of products. The 2016 update of the standard brought the requirements in line with those already mandated by the FDA.
Companies can be certified to this standard, meaning their quality management system has been verified to meet its strict requirements. The requirements aim to ensure the production of high-quality medical products that are safe and effective, which is why many countries require medical device companies to attain certification. In addition, ISO 13485 certified companies benefit from higher customer satisfaction, greater customer trust, and better credibility.
IPC Class 3 Standards
Other specifications to consider are the IPC Class 3 Standards. Companies that meet these specifications value skill, constant improvement, and intense scrutiny. They know that a buzzer in the game signals a life or death scenario, so practices must be monitored and perfected.
PGF Technology Group maintains the ISO 13485 compliance and IPC Class 3 Standards for any project connected to medical devices.
What’s the Use?
In addition to safety, manufacturers must keep in mind the usability of PCBAs. For example:
- Is SMT or thru-hole assembly appropriate? Manufacturers should reference the specific design requirements from the client to ensure that they utilize the best method of assembly. This process may include prototypes to review board real estate and functionality.
- How small is too small? While it can be tempting to go with the smallest PCBA design, a design that is too small can limit the complexity of your device. You need to ensure enough space to incorporate all components for a fully operational and reliable instrument.
- What is the min/max amount of energy input? Determine the circuit’s energy to run during typical and peak operation.
Making It Easy
Anyone who has built an IKEA item understands the pain caused by a hard-to-assemble project. Without clear-cut instructions and imagery to demonstrate design, the process can become prolonged. Medical PCBA designers can eliminate this pain by designing with assembly in mind; assemblers should not have trouble reaching and mating cables to connectors, soldering connections or placing other essential components. Additionally, the assembled product should be testable using various methods. Some examples include visual assessment, Solder Paste Inspection (SPI), X-ray scanning, In-Circuit Testing (ICT), and Automated Optical Inspection (AOI).
Medical Device Solutions at PGF Technology
Want to learn more about the critical design considerations for medical PCB assembly? Ask the experts at PGF Technology Group! As an ISO 13485 certified company specializing in PCBA, we can answer or address any of your questions and concerns. Importantly, you can check out our eBook, Key Considerations for Medical PCB Assembly, to overview the vital considerations to keep in mind when designing and assembling medical PCBAs.
At PGF Technology, we have the knowledge, experience, and certifications to deliver PCBA solutions that meet the most stringent specifications. Contact us or request a quote today if you want to partner with us for your medical PCBA needs.
