Moving Fluoropolymer-Coated Medical Devices in a Supply Chain

Posted Dec 15, 2017 12:00:00 AM
By Walter Romeo

Top 3 Questions to Answer for Customers and Vendors

Ultimately, your end-users—patients, surgeons, and medical personnel—are the people who benefit from your successful purchasing and engineering decisions. If they are happy with the performance of your product, you’ve done a fantastic job. Any changes, however nuanced, in the “feel” and performance of the medical devices they (and you) count on for positive outcomes, can be consequential. The right coating deposition on your mandrels, guide wires, core wires, hypotubes, and other medical devices is vital to successful surgical procedures.

Moving Fluoropolymer Coated Medical Devices.jpgYour job requires you to find the best quality, service, and price for the products you provide your customers. What happens when you find a supply chain partner that can check off all those boxes for you, but it requires you to move to a new facility—country, even? 

We know this brings up a host of questions you need answers to before even considering moving. The concerns cover many topics, and are not limited to these: 

  • “Like-for-like”
  • Environmental controls
  • Certifications
  • “As is”
  • Quality
  • Lead time
  • Delivery
  • Workforce training
  • Patient safety
  • FDA and Notified Body approval(s), as required 

Precision Coating (PCCI) has moved product lines before—twice while transitioning after a merger. More recently, we’ve opened a medical device coating facility in Costa Rica. We are very aware of concerns that procurement managers and engineers have with the myriad elements to address when making changes in the supply chain. We will discuss the issues listed above in more detail in future articles. What we want to discuss here are the top 3 questions that have been on the minds of customers we work with. 

Top 3 Questions When Moving a PTFE-Coated Medical Device Product Line 

When considering moving the PTFE coating portion of your medical device supply chain, the top 3 questions to ask your vendor are: 

  1. Is the product you’re providing me like-for-like?
  2. What environmental controls does your new facility have?
  3. What certifications does your new facility have? 

Let’s break down each one of these questions. We’ll present the concerns you should have, and because we speak from experience with moving product successfully, we’ll offer our perspective. This will give you a comprehensive view of what you need to consider, and how a fluoropolymer coating vendor prepares and provides a seamless transition. 

1) Like-for-like 

Customer concern: Can you guarantee that I will receive like-for-like product performance? Is your facility like-for-like in equipment? Is it like-for-like in terms of chemistry? Is it like-for-like in process? The answers you need to hear from your supply chain partner are: “Yes, yes, yes, and yes, it is like-for-like.” Anything less can compromise your current supply chain. A responsible PTFE coater will deliver the design, tolerance, and performance of your product the exact same way you currently have it. Follow-on questions for the vendor should cover:

  • Instances of prior product transition
  • Testimonials from other customers who have moved product 

Vendor view: What we can tell you is that experience moving product is the best way to know both the overarching and granular details involved. Our two previous facility moves, as well as our recent one to a new country, give us added insight into what transitioning requires (qualifications, process control, equipment, etc.), how to prepare for the move (for customer and vendor), and how to anticipate and respond to contingencies along the way. We know moving product can be done successfully—we have a proven record of it. We keep product acceptability “score cards” to document consistent quality and tolerances, and also quantify production numbers. We have maintained an uninterrupted supply chain for our customers throughout it all. 

As this video attests, surgeons are very sensitive to the feel of their guide wires. They depend on consistent design and function to ensure “stiction.” As is the norm in the industry, many of our customer relationships are proprietary, but we can share this notable observation: Many customers have dependably used the many products that have been moved and have not experienced any difference in feel and performance. Think of the “feel” of items like guide wires as you would a favorite golf club, your eyeglasses, or your most comfortable shoes. At the slightest change—torn tape on the grip, smudges on the lens, or grits of sand—you sense it immediately. It can, quite literally, throw your game off. 

Surgeons feel much the same about their devices. Any changes can be very disruptive. With all of the medical wires we coat, we are charged with maintaining deposition control by replicating processes to keep tolerances exactly as they’re specified. We understand how vital it is that we deliver consistent like-for-like production and product performance.   

Precision Coating has moved entire processes for the fluoropolymer coating of urinary, peripheral vascular, and cardiovascular devices (among other products). When we move product, we:

  • Use the exact same equipment
  • Repeat precise deposition
  • Rely on the exact chemistries needed to replicate specified fluoropolymer coatings 

2) Environmental Controls 

Customer concern: Deposition control relies on a number of variables to ensure consistency. One variable involves the relative environment: specifically, temperature and humidity. If a product will be coated in a similar environment to what it is currently in, this may not be a factor. It should be considered if the new production facility is in a much different type of environment (for example, if it were moved to a tropical environment). A high-humidity environment needs to be strictly monitored to maintain humidity levels that are conducive to fluoropolymer coating. During application, excessively humid environments can have an effect on the viscosity of the coating solution, which can influence deposition, and ultimately, performance for the end-user.   

Coating can be compromised by uncontrolled temperature and humidity.  This brings up the question of shelf-life and storage. It’s good practice to keep this in mind, during or after production and delivery of your PTFE-coated medical devices. Determine the following as they relate to atmospheric influences within the facility (yours or vendor’s) that would subject your product to:

  • Sunlight
  • Gases, vapors, or particulates from peripheral processes (finishing, painting, etc.)
  • Condensation
  • Temperature fluctuations 

Vendor view: Strict environmental controls must be maintained for all levels of material handing:

  • Initial receiving and storage
  • Coating procedures
  • Peripheral processes
  • Post-production storage
  • Packaging
  • Shipping and delivery     

We have controls in place to maintain a consistent internal environment every day—regardless of the weather, even in our Costa Rica facility. The systems we depend on go beyond overall climate control for the facility; they also extend to the robotics that apply the coating. The controls are “dialed in” to ensure that the conditions are optimal for application of precise coating deposition and tolerances. The process is calibrated and automated so we can ensure the necessary production outcomes in any location.   

3) Certifications 

Customer concern: Every customer needs to know that the materials and final product they entrust a supplier with will be handled with consistency to produce the same quality and performance over time, along with high standards for customer satisfaction. Implicitly, this requires the supplier to create qualified and validated processes for production, quality, and customer service. ISO certifications communicate that these processes are in place. To attain ISO’s quality management certification, a company must demonstrate ongoing adherence to the stringent qualification protocols, committing to a policy of continuous improvement. Customers may also have ISO certifications in their facilities, so they recognize a similar culture in a supply chain partner. 

Another common scenario involves customers with regulatory obligations further down the line, such as FDA registration. The supplier may not be required to have this same FDA registration, but that FDA registration requires that the supply chain partners be ISO certified or qualified as a “critical” supplier in a method considered to be equivalent or acceptable.    

Vendor view: Maintaining the current ISO certification works to keep a company culture on the same page—achieving (and surpassing) measurable metrics for quality, reproducibility, and deliverability for customer satisfaction. We see our role with customers as a true partner in their supply chain. As we noted above, to fulfill the like-for-like protocols, we must deliver exact depositions, tolerance, and product performance, repeatedly. We are able to do so by having qualified and validated processes in place for production, quality, and customer service, all of which are benchmarks of the ISO standards.    

Precision Coating is committed to the highest quality customer and product service. We hold certificates of registration for ISO 13485:2003 and ISO 13485:2012. These certifications ensure PCCI’s ongoing commitment to continuous improvement, customer satisfaction, and sustainability in medical applications, military applications, and commercial applications. 

Big Shoulders 

We recognize that much responsibility rests on your shoulders. As a dedicated supply chain partner, we share that responsibility with you. PCCI Costa Rica is committed to moving your supply chain with seamless, transparent, and replicable reliability. We have the years of fluoropolymer coating expertise, a proven record of successfully moving product lines, and easily check off the boxes above for the concerns you may have for relocating your medical device product line. 

We’d be happy to discuss this further with you. Contact us now and we’ll answer any questions you have.   

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