Implantable Medical Device Coating Case Study
A leading medical device manufacturer reached out to Plasma Ruggedized Solutions (PRS) with an urgent issue related to an implantable pacemaker device. Facing an unexpected shortage of key electronic components, the company was unable to maintain inventory levels needed to meet patient demand.
The Technical Challenge
The client required a biocompatible coating solution that aligned with IPC J-STD-001 standards and met the tight tolernaces dictated by their device specifications. The team believed that only automated spray equipment could consistently achieve the 1 mil tolerance for their urethane Parylene conformal coating application. In addition, product longevity and reliability were essential given the implantable nature of the pacemaker.
When PRS engineers discussed using a hand spray application for medical device encapsulation, the client expressed concerns over human error and the ability to achieve precise tolerances and repeatability. To prove the efficacy of our approach, we offered to coat a small batch of units at no charge for evaluation.
The Process
After carefully reviewing the medical device company’s design and specifications, we applied Parylene conformal coating material to the units via our proprietary CVD application. Our process involves applying the coating at ambient temperatures and using specialized vacuum equipment to create a uniform thickness. The result is a hermetically sealed medical component fully protected from moisture and impact.
The Results
A few days after receiving the units, a team of several engineers, buyers, and managers from the medical organization visited our office to discuss the results. The team was shocked because they received a 100% first-pass yield on the samples we provided. This was a significant improvement over the 60-70% yield they experienced with other companies they had approached.
We achieved such precise tolerances with the biocompatible medical device coating that the team was surprised we had completed the process so quickly and with such precision. Our engineers presented a Power Point presentation and wire diagram process map delineating the macro steps of how we applied the Parylene to the implantable medical devices. coating without robots or automated processes.
The customer left approximately 20 additional units with us to see if we could achieve the same results. Once again, our specialized CVD encapsulation process produced a 100% first-pass yield. Their team was impressed that we could produce such exceptional and repeatable results without robotics and asked to observe our spray coating process.
Our precision, repeatability, and quality resulted in a 2-year relationship with the company. We helped them revise and develop their manufacturing processes and restock their facility with approximately 100,000 units.
We have a strong commitment to quality assurance and meeting the stringent guidelines required by the medical industry. Our engineering staff, teaming with our quality and production personnel are a key reason for the high first-time yield performances and the precision application of the Parylene material. lPart of our quality assurance process involves giving conformal coating sprayers several months of hands-on training before allowing them to work on client products. We go above and beyond to ensure consistency and quality in our medical device coatings.