Posted Jun 21, 2016 12:00:00 AM
By Bob DeAngelis
What You Should Know about What They Should Know When Selecting One
When choosing a fluoropolymer coating applicator, there are a number of criteria that should drive your selection process. An essential element when partnering with an applicator is that the coatings applicator has proven expertise in coating and handling medical device products.
Attaining exceptional product design and performance is necessary to thrive in today’s competitive business environment. There are many variables to consider regarding application requirements and selecting the appropriate solutions for medical device design and coating. There are capabilities medical device fluoropolymer (a.k.a. Teflon®) coating applicators must have to ensure they can deliver a quality experience and product. World-class quality, quick turnaround time, and seamless integration with a proven and reliable medical device supply chain is essential, and is the price of admission to participate in the medical device industry. However, not all fluoropolymer applicators are the same.
Expertise on Basic Jobs vs. Managing Projects
While many fluoropolymer applicators may be able to handle basic jobs, medical device projects require an applicator with deep experience and expertise to make appropriate recommendations regarding how to coat specialty items, such as guide wires, core wires, coils, needles, mandrels, and instruments. Why? Because only a supplier with this experience and expertise has the capability to reliably meet medical application requirements. The applicator will have developed systems, methods, application technology, formulations, as well as employ extensively trained operators. This capability allows the applicator to meet the specifications and provide the coverage and uniformity, the adhesion, and a system to protect the customers’ products from damage.
Expect No Less!
Customers should expect the following from an experienced fluoropolymer applicator when evaluating their medical device coating capabilities:
- Prior experience and established FDA filings for coating similar devices.
- Recommendations on coating chemistries with various alloys.
- Tolerance adherence based on process capabilities of the coating application technology.
- Regarding nitinol wires—the supplier’s recommendation and offerings for low-cure formulations and processes.
- Regarding hypotubes—the supplier’s recommendation and offerings that do not oxidize the outer diameter (OD) or inner diameter (ID), eliminating the need for post-tarnish removal.
- Expertise with simple to complex device geometries.
- For example, how the supplier will handle a variety of shapes and sizes for stylets, with a range of diameter grinds throughout—with capabilities for specific fixturing and masking techniques to provide exact coating deposition throughout the length of the stylet.
- The breadth of color coating options (and batch-to-batch color consistency) to meet product and brand identification needs.
In sum, the fluoropolymer coating applicator must know the “whats” and “whys” of choosing coatings for end-use applications. It is important to understand why one device should be coated with a particular chemistry over another. Should the various types of Teflon®, polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP), polyvinylidene difluoride (PVDF), or ethylene chlorotrifluoroethylene (ECTFE) be used? And once the coating chemistry is settled on, the applicator requires the knowledge about when to use aqueous-based or solvent-based coating formulations. When making the selection, the applicator must be able to provide biocompatible information and prior use experience to successfully manage medical device coating projects supporting regulatory approvals. It goes without saying, experience matters.
Proven expertise remains a pivotal link to ensuring that all the other criteria that should be on your checklist are, indeed, on it. Considerations such as medical device cleaning methods and surface preparation and focus on deposition control are important. At Precision Coating, we feel so strongly about this that we complied a checklist of six very important variables you should consider when choosing a medical device fluoropolymer coating applicator.
These six items are critical for a fluoropolymer coating applicator to keep pace with the increasing demands of the medical device industry—allowing customers to do so, as well. Download this checklist to ensure you find the fluoropolymer applicator that will deliver the results you need.