Medical Device Coating FAQs

Have a question? Don’t see it here? Contact us today!

Coatings & Capabilities FAQs

Quality FAQs

Engineering FAQs

Customer Service FAQs

Coatings & Capabilities FAQs

 

What is a medical grade coating?

For decades, manufacturers of medical devices have specified many coatings that lower friction and provide electrical insulation, anti-microbial
surfaces and many more enhancements of the function of a surface of a medical device. These proven coatings are considered “medical coatings”.

 

Does Surface Solutions Group stock and apply medical grade coatings?

Yes, we have many coatings that are being used in medical devices that our customers have tested to be acceptable for guidewires,
mandrels, cannulas, silicone rubber parts, polyisoprene rubber parts, and many other medical end-use parts.

 

Does Surface Solutions Group apply PTFE coatings?

Yes, we offer many low friction, PTFE medical grade coatings. We also stock many other formulations that have been formulated and tested to provide low friction.

 

What coating thickness and tolerances can you provide?

The film thickness of most PTFE and resin bonded coatings applied to medical components is .0003”-.0006” per surface. For electrical insulation, coating thickness can reach .010” and even greater thicknesses. Coating tolerance is normally +/- .0001″ for thin films up to .0006” film builds of .0004” and +/- .0002” for films of .0006″-.012″.

 

What is the longest medical device Surface Solutions Group can coat?

SSG can coat mandrels up to 300 cm long and coiled guidewires up to 635 cm long. We can also coat continuous, reel-to-reel wire to lengths of millions of feet per spool.

 

What PTFE coating colors are available?

The most common color used is green, but blue and clear are also widely used. The availability of colors is ever expanding. We stock PTFE coatings in six different colors and offer additional standard colors. We can also formulate custom colors for our customers.

 

Can Surface Solutions Group coat Nitinol?

Yes, very successfully. SSG has production nitinol devices we coat weekly. And we have perfected coating devices that utilize both nitinol and 304V stainless steel and successfully provide low friction coatings for these devices, including our new GlideMed™ No and Low PTFE coatings.

 

We need a durable, long lasting coating. Can Surface Solutions Group provide it?

We have decades of experience coating medical devices with nano-composite coating formulations that provide extremely long wear compared to unreinforced PTFE with no nanocomposite internal.

 

What temperatures will your coatings withstand?

This depends on the resin we use. Generally, all PTFE coatings will withstand 500F. However, we have several special FDA-compatible resins that can withstand 770F for long-term usage. Low temperatures of -240 F and lower are also attainable with many of our coatings. Always check with us as to a specific need.

 

Can you recoat a previously coated part?

Yes, in most cases. Please call or e-mail us and we will advise. Generally, we need a few used or worn out parts to perform a complete evaluation. Contact us about coating previously-coated parts.

 

Can you coat a large quantity of parts?

We coat tens of thousands of parts daily. This includes guidewires, needles, cannulas and literally an A-to-Z list of devices. More importantly, we work as a strategic partner for our customers and take very seriously the delivery schedule you establish. Contact us with your delivery requirements.

 

Does Surface Solutions Group coat the ID of a long tube?

In fact, SSG coats 50-foot lengths of .125” of chromatograph tubing with PTFE, of course on the inside diameter surface. We also coat many shorter lengths.

Quality FAQs

 

Does the FDA certify coatings?

No, the US Government or any agency does not directly certify any coating. However, several avenues for independent certification exist, such as actual biocompatibility testing performed by independent test laboratories. Several levels of testing are available.

 

Does UL or NSF certify coatings?

No, each end use is specifically investigated by the agencies and if a coating is part of the design, the coating can be accepted but only as far as this single design submission.

 

Are there specific tests that qualify a coating for medical end use?

Yes, one example is ISO certification standards such as 10993-1 for short-term contact with the human body. Another test is ISO 11070: 1998(e) for mechanical testing of coatings on coated guidewires.

 

What other tests or methods qualify a coating for medical end uses?

For decades, several types of coatings have been successfully used to coat guidewires, cannulas, probes, etc. An example is ISO 11070: 1998 (e) test that has been used to qualify coated guidewires. History and specific tests has created a “body of knowledge” as to which coatings have been used without any negative results. SSG has all of these coatings in stock. SSG cannot and will not directly certify any coating for any end use.

 

How can a medical device manufacturer get a coating approved?

SSG can provide a list of laboratories that will perform the appropriate tests to provide the manufacturer with the data.

 

Do you have any biocompatibility testing performed on your coatings?

Certain SSG formulated coatings have been independently tested for ISO 10993-1 and other appropriate testing for medical devices for short-term contact or a limited time in the human body. This will allow our customers to potentially reduce the time it takes the manufacturer to qualify a device for a medical end use. Please contact SSG for updates as to test results.

 

Does SSG have any coatings for devices used for implantation in the human body, such as arthroscopic implants?

No, furthermore, SSG will not consider any coating application for long-term residence in the body. This is a decision more related to the legal climate rather than the strength of modern coatings and the decision by the Board of Directors of SSG.

 

Our designers have strict masking requirements. Can SSG provide repeatable and accurate masking?

Yes, our seasoned team has dozens of devices and techniques to mask per your requirements. We realize repeatability is a mandatory requirement and have proven techniques and materials to provide precision masking. Additionally, our team may suggest methods to provide your designers with the results they need without the additional costs of masking. Allow us to provide our recommendation as to alternatives to
masking.

 

What temperatures are our parts subjected to during the coating process?

This depends on the specific coating. Many of our medical applications are catalyzed or are two-part resins that require room temperature or UV cure (no substrate temperature). We will provide cure temperature during the Solutioneering Form coating analysis for your specific job. The maximum temperature of processing is 750f for many medical grade coatings.

 

How does your staff understand how important a job is to us, the customer?

We involve every staff member in a Gainsharing program. Our affiliate, Orion Industries Ltd., has pioneered this type of management and fiscal sharing program. Every production team member receives a monthly check, which is related to perfect quality for each and every job, meeting delivery dates, employee attendance, shop cleanliness, and several other measurables, which our management considers extremely important. Any SSG staff member can stop a job at any stage of production with no negative consequences.

 

How do you assure coating thickness is correct?

We have developed many non-destructive tests. Each dimensional job is pre-measured in incoming quality testing to establish the statistics related to the specific job. In the shop, many devices like laser micrometers, scales, jigs, CCD cameras, CCD micrometers, digital microscopes with micron accuracy measurement software and a combination of innovative devices to help assure the coating thickness is correct. In most cases, the final cure of the coating is performed after all coating thickness measurements have been verified.

 

How do you measure electrical resistivity, static bleed, conductivity, insulation and other electrical requirements?

Electrical testing can be influenced by many factors. It is essential that your engineers coordinate and compare specific equipment specifications for comparable testing. We have Hi-Pot, Holiday, wet bulb testing, saline sponge testers, resistivity testers, Valley Lab endoscopy current generators and more devices to measure coating electrical requirements.

 

Will your coatings provide finished dimensions required on our blueprints?

Yes, to achieve a go-no-go or a precise, not-to-exceed coated dimension, we need to coordinate a measurement procedure with your staff. We recommend both SSG and our customer use the exact same measurement device. Then, we will absolutely guarantee that the coated parts meet a specific dimension.

 

Are you ISO approved?

Yes, we are compliant to ISO 13485:2016.

 

Do you have a quality manual?

Yes, we do have a quality manual, and our Quality Director will be happy to meet with you to discuss the manual and our procedures.

 

Can we conduct a quality audit at your facility?

Yes, you can conduct a quality audit at our facility. We have many each calendar year. Please contact our Quality Director to set up an appointment.

What quality standard do you meet?

Our quality control program is based on C=0 Sample Plan.

Engineering FAQs

 

What coating do you recommend for our unique and unusual end use?

We provide an easy to use Engineering Evaluation Form that helps you explain to us what you need a coating to do. All aspects of coating performance including Low Friction, Corrosion Resistance, Temperature Capabilities, Cure Temperature and many more capabilities plus the exact operating requirements and the substrate material are simultaneously considered. Click here to complete our Engineering Evaluation Form and an SSG technical consultant will contact you.

How do you protect our proprietary design?

SSG has Mutual Non Disclosure forms that are executed by an officer of SSG. Or, we can use your company’s form to provide Non Disclosure security to protect your design.

 

How long does it take for a prototype to get coated?

After we receive your information noted on our Engineering Evaluation Form, we can answer that question in short order. Generally, 3-5 workdays is sufficient for us to coat and return your coated parts to your firm. Click here to complete our Engineering Evaluation Form and an SSG technical consultant will contact you.

What substrates can you coat?

All metals including stainless, monel, titanium, nitinol, aluminum, brass, copper, silver plated copper, zinc, and pot metal. Non-metallic includes all types of plastic and filled plastics and most rubber including polyisoprene and silicone.

 

Can you provide anti-microbial coatings for our parts?

Yes, SSG has partnered with several suppliers of anti-microbial materials and we can provide coatings that kill e-coli, staph, strep, and dozens more pathogens. Contact us for more details or check our web site for more anti-microbial coating information.

 

Can you supply our engineers with a data sheet or MSDS on your coatings?

Yes, we will provide your firm with the appropriate information sheet on the specific coating we apply to your parts.

 

What is the heaviest weight that you can handle?

Our maximum weight on a 42” square skid is 3000 pounds. Layer sizes will reduce weight limitations. Please contact us for details.

 

What is the longest length that you can handle?

Our maximum length is 13 feet but width, weight and height will reduce this number.

 

What is the thinnest substrate that you can handle?

The thinnest substrate that we coat is .002”. However, part configuration may move this thickness value up.

 

What is the tightest tolerance that can be held on coating thickness?

The tightest tolerance on coating thickness depends on part configuration and the coating being applied. In certain circumstances we can hold +/- .0001” with prior agreement of our engineering staff. Contact us for details.

 

What is normal surface preparation?

There is a wide range of normal surface preparation. Part configuration and customer specification dictates the surface preparation. The ultimate would be solvent cleaning, preheat of 750°F to burn off any residual oil and grease coupled with a grit blast to white metal. Again, not all surfaces can withstand these treatments. Our staff needs to test several preparation and coating methods to determine the optimal surface preparation.

 

What coatings do you have that will resist sterilization?

Most of our coatings will resist gamma radiation sterilization. Many customers use ethylene oxide and virtually all of our coatings will withstand ethylene oxide. Autoclave sterilization is used and that requires more specific part/end use testing.

Customer Service FAQs

 

How do I get a quote?

Send us a completed Engineering Evaluation Form, and a technical consultant will contact you to discuss your project. We may need a raw part, prints, and/or sketches. Click here to complete our Engineering Evaluation Form.

 

What are your payment terms?

Our payment terms are Net 30.

 

Do you take any credit cards?

Yes, we accept American Express, MasterCard and Visa.

 

Do you take electronic payments?

Most assuredly, we take national and international wire transfers.

 

How do you ship?

We will ship per customer dictate. When not specified, we ship UPS, Fed Ex, or common carrier.

 

Do you have any outside sales or tech people?

Yes, our technical sales team will make outside sales engineering visits to discuss your project, if needed.

 

Can I tour your facility when I come out?

Yes, we welcome customers to tour our facility. There are certain areas that are not accessible due to proprietary processing.

 

What is your warranty?

We warrant that the coatings we provide for prototype qualifications are the exact same coatings used for production along with the exact processing procedures. Our internal system uses a bar-code scanning method to assure processing procedures. Also, our Gainsharing program incentivizes staff for perfect execution of all jobs. Conversely, the entire staff loses Gainsharing remuneration of any job that is rejected.

 

How late are you open? What are your hours?

The receiving hours are from 8:00 A.M. to 11:00 P.M. CST. Our business hours are from 8:30 A.M. to 5:00 P.M. CST. Our production processing averages 12 hours per day, 6 days a week to meet our customer deliveries.