Making parylene more accessible to the medical device industry
Parylene is a high-performance, conformal coating used to enhance the surface properties of critical medical device components. Surface treatment benefits include dry lubricity, the US Food and Drug Administration (FDA) approved biocompatibility and effective barrier protection against moisture, chemical and electrical damage. For over four decades, Parylene has been a safe component used in medical devices.
VSi Parylene offers new, forward-thinking Parylene coating solutions for medical device companies looking to enhance device reliability and performance.
What are your company’s latest contributions to Parylene technology?
VSi Parylene is changing up the status quo by making Parylene technology more accessible. Since its discovery over 50 years ago, Parylene coatings have been available almost exclusively through third-party service providers. This service-only model has added cost and supply chain complexity at the expense of widespread accessibility. For customers unable or unwilling to ship outside their supply chain for days at a time, Parylene has not been an option. This is no longer the case with our new Parylene On Demand (POD™) integrable production systems.
Can you explain how Parylene On Demand helps manufacturers access Parylene more easily?
An in-house POD™ coating system streamlines and simplifies the manufacturing process by eliminating the need for companies to ship out parts. By removing this bottleneck, companies can reduce technical risk, costs and lead times from days to hours. Developed in response to customer demand for a complete, standalone Parylene production system, POD™ is easy to transfer into any original equipment manufacturer (OEM) or contract manufacturer (CM) factory. Designed for maximum flexibility, VSi Parylene offers traditional and hybrid coating services for customers who need to start by outsourcing Parylene and later bring the proven process in-house.
How has Covid-19 impacted manufacturers that use Parylene in their products?
The most affected businesses have been those that rely on multi-source, just-in-time supply chains that move parts for processing worldwide. Shipping delays, shutdown mandates and supplier capacity created disruptions for these manufacturers, including those that outsource Parylene coating. Covid-19 highlighted the need for insight into critical suppliers and their own suppliers to predict the impact of shortages and stoppages on output. As a result, VSi Parylene has seen an increase in interest for customers that want to bring Parylene in-house.
What are some of the medical technologies trends that use Parylene?
Parylene plays a significant role in enabling cutting-edge electronics in medical devices. Three new major MedTech trends driving demand for Parylene include non-invasive Internet-of-Things (IoT) based medical monitoring devices, minimally invasive surgery robotics and implantable organ-assist medical devices. Parylene is especially attractive to these novel applications as it provides engineers with a powerful, differentiating tool with a proven track record of FDA approval. Non-electronic applications include using Parylene as an adhesion tie layer to help attach drugs to combination devices for improved dosage control.
What are the key considerations when choosing a Parylene vendor?
Look for a Parylene provider that provides a winning combination of flexibility, expertise, and transparency. You want a provider with a flexible business model who can meet the needs of your business now and in the future. This provider should display a deep understanding of the medical device manufacturing and development process. If they do, they will likely have a quality management system (QMS) that is the International Organisation of Standardisation (ISO) 13485 certified, to help streamline Parylene integration and avoid costly headaches on the road to FDA approval. Lastly, pick a vendor who values customer transparency to ensure what you create together will produce better, more customised results for your specific application.