Medical device development follows a well-established path. VSi understands the development process and works as a transparent partner to help you build a device that can be validated and manufactured at scale.
VSi Parylene enables medical device businesses to incorporate parylene conformal coatings into their production procedures.
We believe that a well-designed, expertly integrated, enhanced component has the potential to create a best-in-class product.
Parylene medical device coatings
Parylene is a thin film coating technology used to improve the capabilities of medical device technologies. Applied as vapour, the coating layer perfectly conforms to complex shapes and provides complete and even coverage.
Parylene coatings offer waterproof and barrier protection, dry lubricity and can act as an adhesion layer. Parylene coatings significantly reduce medical device electronic failures due to environmental factors.
VSi utilises a transparent, straightforward business model to take parts from proof-of-concept through to manufacturing, moving clients through several fundamental stages.
We also collaborate with clients to determine if parylene is the ideal solution, developing a robust process, and scaling-up for production at VSi’s facility.
The prototype stage delivers clear feedback on whether parylene is suitable for the product’s distinct end-use. Prototype coating runs provide proof-of-concept parts for testing, which allows us to offer cost-effective pricing.
If parylene is required, VSi moves to the development stage, building an efficient and consistent process, scaling to client demand. Our quality management system (QMS) ensures we have correct documentation and controls.
Following this, we move to the production scale stage, working with our clients to ramp-up to production volumes to meet their specific demands. This model is ideal for customers who require high-quality production and capacity flexibility.
Parylene conformal coating equipment for factory floor integration
As companies and their products evolve, there can be calculated profits to introducing parylene technology in-house. VSi offers technology transfer options for clients who request optimal enterprise control over cost, production, quality and risk.
VSi provides parylene coating support and equipment for clients who wish to transfer the parylene process to their factory floor, offering the PODTM parylene coating equipment and eco-system to incorporate parylene coatings onto factory floors.
Parylene medical device coatings: product development with an open, transparent approach
Through openly sharing our knowledge with our clients, teamwork is at the heart of our company approach to producing improved, customisable results. Consequently, this relationship enables our clients to offer safer and smarter goods to their end-customers.
VSi Total Solution assists clients in making more educated decisions for their business as the design of our process-driven roadmap aims to clarify value at each step of the manufacturing process.
By removing traditional barriers, VSi has made parylene more accessible to new applications and more customers with a forward-thinking business model. VSi’s services offer innovative and flexible options for incorporating parylene into more products than ever before.
Assurance and compliance with industry standards
Developing competing products for the current marketplace often requires the aid of outside partners. Innovative technologies are continually in production, and strict compliance to industry standards guarantees these revolutions make it to market.
Our quality management system supports clients through this route, offering total transparency in meeting all regulatory requirements.
VSi complies with several certifications and standards:
- ISO 13485:2016 certified
- The US Food and Drug Administration (FDA) 21 Council on Foreign Regulations (CFR) 820 compliant
- ISO 9001:2015 certified
- International Traffic in Arms Regulations (ITAR) compliant
- ISO 7 (Class 10,000) cleanroom coating facilities
About VSi Parylene
VSi Parylene is a leader in the development and production of parylene coating technology. The company’s unique parylene solutions and services are optimised for maximum transparency, reliability and process scalability.
Established in 2007, VSi Parylene, has filled the need for high-precision, high volume parylene applications that help top medical device companies produce next-generation, more durable products that improve brand value.
At VSi, innovation goes above making parylene available to its highest quality standard – we aim to advance parylene technology to a higher level of performance.
When parylene coating is an important part of a device, partnering with VSi to incorporate the parylene coating process offers device makers the ability to differentiate and enhance the value of the products provided.
The first complete parylene production system designed for seamless integration, featuring: Equipment, dimer, and worldwide installation and support.
HeartMate III™ is an advanced left ventricular assist device (LVAD) approved for use in advanced heart failure patients who require short or long-term mechanical cardiovascular support such as bridge to transplant (BTT) or destination therapy (DT).
Amplatzer Piccolo™ Occluder is one of the first trans-catheter treatments to be approved for the treatment of patent ductus arteriosus (PDA), a common congenital disorder that results in a life-threatening opening in the heart of premature infants and newborns.
NeuroSigma’s Monarch® external trigeminal nerve stimulation (eTNS®) system is a monotherapy approved for the treatment of paediatric attention deficit hyperactivity disorder (ADHD).
In response to its growing demand for parylene coatings used in critical applications, VSi Parylene has announced the expansion of cleanroom capacity at its Broomfield, CO Headquarters. This expansion creates space to support new programs for its steadily increasing medical device business.
VSi Parylene is pleased to announce the addition of Parylene on Demand™ coating equipment and ecosystem to our already established portfolio of waterproof, thin-film parylene coatings for innovative components and electronics.