Today’s medical equipment has gone far beyond the traditional image of a doctor’s black bag that contained a stethoscope, tongue depressor, and a roll of gauze. The variety of devices for consumer-level medical equipment has increased dramatically as capabilities associated with IoT and other advanced electronic designs have expanded.
Meanwhile, in hospitals and clinics, the ability to diagnose and treat patients continues to grow thanks to advancements in medical technology. Equipment such as monitors, scanners, surgical tools, and radiation therapy are continually being improved to provide better care.
All of these tools in the medical industry are dependent on the precise design and manufacturing of printed circuit boards. Without the high level of quality and specific capabilities that a skilled medical electronics contract manufacturer can provide, your ability to get reliable prototype circuit boards built would be in question.
Key Considerations for Your Medical Electronics Contract Manufacturer
Contract manufacturers have different strengths, and you need to find one that specializes in quickly producing high-quality prototypes. Although most CMs can assemble a printed circuit board quickly, there is a lot more to successful prototyping than just building something fast. You need a medical electronics CM with a good track record in the following areas:
- Professional relationships and connections: Supply chain management is a critical component of circuit board manufacturing that often doesn’t get talked about. Parts that are expensive, have long lead times, or are simply unavailable can add unexpected delays and costs when having your project built. Your CM should have solid relationships with component vendors and suppliers to ensure that you have an uninterrupted supply of quality parts and materials available for the production of your circuit boards.
- Engineering expertise: Partnering with a CM that has an experienced engineering staff means that they will review your design for manufacturability issues before production begins. If any problems are discovered, they will have recommendations on corrective actions to get your design ready to be built. A good engineering staff will also make themselves available to you for consultation while you are still in the design phase.
- Quick-turn, high-quality, low-volume production: For medical equipment prototypes, it is essential that your CM be able to handle all aspects of building your products. It won’t do you any good to get a project built quickly if the quality is not up to the standards needed for your medical devices. You need a CM that specializes in being able to produce your equipment quickly yet that can maintain the highest quality levels for the volumes you need.
- Traceable manufacturing processes and documentation. More so than most other industries, medical devices are required to be documented fully so that all materials and components used in their manufacturing can be traced back to their origins. This is necessary in case recalls or other regulatory actions are required, as well as to verify certification to the applicable industry standards (see more on that below).
These are key aspects to watch for when choosing a CM to produce high-quality prototypes, but there are other attributes you should keep in mind as well.
- Box build services. Having a CM that specializes in both quality PCBA production and box builds can be a real benefit to getting a new device quickly assembled. If the circuit boards and the chassis of a new product are prototyped together by the same manufacturer, you won’t have to deal with the problems of trying to coordinate multiple vendors working together.
- Locality. Working with a local manufacturer is preferable when you are prototyping new products. You will have their staff close at hand for consultation, and you won’t have to worry about communicating with people during off hours because they are halfway around the world. Prototyping medical devices–more than most products–requires a lot of industry-specific knowledge. Having that expertise close at hand is a real benefit.
Certifications for Building Medical Electronics
It won’t be enough that your chosen contract manufacturer simply has the skills and expertise you need for building your prototype medical devices. Your CM must have the industry certifications that say they are qualified to do so. There are many different certifications that CMs can have. Here is a sampling of the more common ones that you should look for:
- ISO 9001: The ISO 9000 series of standards covers quality and reliability for organizational processes, including the design, manufacturing, and testing of any electronics in a wide range of industries. Organizations are certified to ISO 9001.
- ISO 13485: This is another standard on quality and reliability that is more narrowly focused on medical products.
- IPC-A-600: This series of standards define the different classes for manufacturing, such as class two, which covers the majority of the medical devices built.
There are also many sub-standards within the groups listed above, and there are other standards that may apply as well. You will need to choose a CM that is experienced and certified to the standards that specifically apply to the products.
What You Should Expect from the CM Who Builds Your Medical Electronics
There is a big difference between simply building something fast and building something well. You certainly need your contract manufacturer to be fast, but most importantly, you need your medical equipment prototypes built well. That means partnering with a CM with the industry knowledge and certifications to provide the highest quality work possible.