Since the outbreak of the COVID-19 virus, the need for rapid medical device product development has been dramatically highlighted. We all marveled at how quickly heavy equipment manufacturers switched production over to building urgently needed medical supplies such as respirators and personal protective equipment. The droves of people who stepped up with home-made protective face masks—often funding a good cause—have been positively inspiring. But for the development of new medical products, this ingenuity needs to be taken to the next level. Medical device innovators need to partner with electronics manufacturers that are equipped to handle these six challenges in the development of their products:
1. Aggressive development schedules.
2. Building a product that is robust and reliable for medical usage.
3. Trained and certified in the appropriate industry standards.
4. A documentation system for full industry tacking of components and materials.
5. Able to build to lead-free requirements as needed.
6. Experienced in the development and building of high-quality medical equipment.
We’ll examine each of these in greater detail here to give you a better picture of how the best PCB contract manufacturers can handle your medical device product development.
The Six Challenges of Medical Device Product Development that Your PCB CM Must Control
1. Schedules
Not only has the growth in the medical equipment industry escalated with more new devices available than ever before, but the competition within the industry has increased in intensity. Medical innovators need contract manufacturers that have a history of being able to hit the ground running with rapid prototyping that gets their products ready for the market imminently. This means that PCB CMs need to be prepared with design engineering, component procurement, and manufacturing teams that understand the critical nature of these schedules, and can respond quickly.
2. Production
While the goal of PCB manufacturing is to assemble circuit boards at the highest level of quality possible, this level of precision is much more critical in the production of medical equipment. These devices must be robust enough to work flawlessly in many different environments and conditions. Achieving quality like this requires more than just good soldering skills. It also includes precision in every aspect of manufacturing such as engineering, component procurement, assembly preparation, inspection, rework, and test.
3. Certification
It is also important that PCB CMs carry the certifications required to build medical equipment. Some of these include general certifications such as ISO 9001 for quality and reliability in manufacturing, or IPC-A-610 for the acceptability of printed circuit board assemblies. There are also specific certifications such as ISO 13485 which specifies the quality management system standard of devices built for the medical industry.
4. Documentation
One important aspect of building medical equipment for PCB contract manufacturers is how they document the work that is being done. The devices being built must have full traceability of their parts and materials to satisfy the requirements of ISO 13485. And as with the manufacturing of any printed circuit boards, it is important to ensure that the part can be built the same way every time. Additionally, error-free documentation is necessary for future re-designs and enhancements when they are required.
5. Lead-Free Manufacturing
As medical equipment sold in the European Union now has to adhere to the Restriction of Hazardous Substances (RoHS) directive, it is also important that PCB CMs have the capability for lead-free manufacturing. Solder that contains lead as well as other substances and materials that are considered hazardous, can no longer be used in the production of circuit boards. PCB manufacturers have to have defined lead-free manufacturing processes in place that are separated satisfactorily from their other leaded operations.
6. Experience and Quality
Building high-quality circuit boards that can withstand the rigors of the environments that they are used in requires experience and skill in all aspects of manufacturing. Not only must the CM excel in engineering, component procurement, and manufacturing, but they need to be proficient in box builds as well. PCB CMs are often requested to develop the entire device with its associated wiring harnesses, cable assemblies, and full system enclosures along with the circuit board assembly.
How You Will Benefit from a PCB CM Prepared for These Challenges
There are plenty of PCB contract manufacturers, the important thing is to work with a PCB CM that is prepared for the six challenges that we’ve discussed above. Usually, local manufacturers that specialize in low-volume high-mix production are the best suited for medical device product development. They typically build many different PCB assemblies regularly instead of focusing on the mass production of just a few. This type of business model with its rapid response to new projects works perfectly with the requirements of building medical equipment.
At VSE we specialize in low-volume circuit board builds at the highest levels of quality, and we build many different PCBs for a wide range of customers including those in the medical equipment industry. We carry numerous industry certifications including ISO 13485 and have the expertise to take your medical device project from its initial design to final manufacturing.
