SSG provides solutions. A solution is not always evident at the start, but if you look hard enough, one can be found. Read these success stories of where SSG helped solve different challenges and help their clients succeed!
- Becoming a Primary Supplier, An SSG Success Story
- SSG’s Breakthrough Technology for PFOA-free PTFE Coating Adhesion on Stainless Guidewiresy
- How SSG Solved a Dangerous MedTech Coating Issue
- SSG Project Leads to Higher Quality Plus Faster Turnaround Time
- SSG Partners with Customers to Achieve Efficiency, Effectiveness and Economy
- SSG Assists Needleless IV Manufacturer
- SSG Quickly Delivers Coated Continuous Lengths of Spooled Wire
- SSG Cannula Project Results in Expanding Arsenal of Color Marking Technology
- SSG Applies Coating on Ball Bearing Retainer for 500,000 rpm Dental Drills
- SSG Eliminates Guesswork for Surgeons Dual Color Coated Guidewires
- SSG Chemists Duplicate Coatings to Enable Domestic Fabrication
- SSG Develops Mandrel Coating with No Touch Marks or Masking Lines
Becoming a Primary Supplier, An SSG Success Story
In 2008, a major guide wire manufacturer approached Surface Solutions Group with an opportunity for us to be a coater for all of their overflow work, as they had a coating line in-house, but could not keep up with the demand of their customers. They worked with SSG to develop a process that met all of their requirements, and over time they saw that SSG was able to consistently meet or exceed those requirements.
Today, this relationship is much different than it was several years ago. SSG found ways to reduce the number of rejects and reduce the amount of material that was being used on a daily basis. This saved the customer money over consecutive years, and got the attention of some important decision-makers within this company.
It was then that SSG received some pleasantly surprising news — we were told that we would be the primary coater of not only all of the guide wires they manufactured, but also all mandrels and cables. In fact, our customer informed us that they would no longer be coating any product in-house with PTFE. We worked to get all part numbers qualified and validated, and now all PTFE coating for this customer is done by SSG.
We became a problem-solver for this customer. With every project they have approached us with, we have found a way to reduce cost, rejects or labor, and have made an impact on their bottom line.
With our innovative approach to applying coatings in our state-of-the-art facility, we will help you solve the issues you may be having with your coating applications. We pride ourselves on being that problem-solver for our customers. If you would like to learn what SSG has to offer, please contact us for more information!
SSG’s Breakthrough Technology for PFOA-free PTFE Coating Adhesion on Stainless Guidewires
Recall is the last word a biomedical business wants to hear. But that is what struck the guidewire industry last year after a voluntary recall – that the FDA classified as Class 1– for stainless steel guidewires going back to April 2013. The problem was poor adhesion of an aqueous PFOA-free PTFE coating that resulted in flakes of coating being dislodged from guidewires during in vitro procedures. According to the FDA, cardiac arrest can be caused by coating flakes that get lodged in the intravascular system.
This problem was first noticed when flakes of aqueous green PTFE were discovered in saline tanks of operating rooms during procedures using guidewires to install stents, balloons, etc. FDA reports in at least one of these instances, the coating flakes resulted in patient injury, although not fatal. This triggered the first recall alarm. Later reports of green flakes in sterilized packages of guidewires caused more concern. Solvent-base PFOA-free PTFE coatings were not involved in any recalls by the FDA.
Much of the blame for the adhesion problem has been put on the EPA action-to ban PFOA in any form of PTFE by 2015. PFOA is one of the surfactants historically used in processing of PTFE. It has recently been declared to be a potential carcinogen and the EPA insisted that it be eliminated from all PTFE used on any products in the USA. All major producers of PTFE eliminated the surfactant and all PTFE coatings used on medical devices must comply with the EPA mandate.
Now however, the medical industry is struggling with PFOA-free PTFE delamination; specifically on stainless steel guidewires and other products-presumably caused by of the removal of PFOA. Eliminating PFOA appears to have made the new EPA compliant coatings increasingly sensitive to saline, making them more vulnerable to electro/chemical attack. Under the best of conditions saline degrades the hydrophobicity of PTFE. Wetting, or contact angles are reduced depending on temperature and length of immersion.
Most aqueous PFOA-free PTFE coatings appear to be particularly sensitive to these phenomena. When immersed in even mild saline solutions-similar to those found in surgeries (0.5-0.9%) or body fluids-the coatings tend to blister, wrinkle, and peel off.
What appears to be a smooth, bonded no-PFOA PTFE coating on this panel, once immersed in saline for 30 minutes at 80 Fahrenheit, starts to delaminate from this 304 stainless steel panel.
Surface Solutions Group has experienced NO DELAMINATION on guidewires that were coated with closely controlled aqueous PFOA-free PTFE formulation. However, this is not a new coating but rather a comprehensive process for ensuring adhesion. The FluoroBond® process provides adhesion of the new PFOA-free PTFE coatings equal to the “old” PTFE coatings containing PFOA.
FluoroBond® is a proprietary, multi-step process involving: (1) hyper cleaning of the wire surface, (2) application of a closely controlled aqueous formulation of PFOA-free PTFE coating to the wire, then (3) highly aggressive testing (saline soak and rigorous tape testing) to ensure adhesion.
Saline Soak Test Results (.012″ dia. 304v wire)
Loss of PFOA-free PTFE adhesion on guidewire after being soaked in a 0.9% saline solution at 80°F for 30 minutes.
Essential to the FluoroBond® process, coatings ingredients and formula are very closely controlled to maximize the adhesion of PFOA-free PTFE to the hyper-clean stainless surfaces. The formula and time stage control between the blending steps for the formulation and the application of the PFOA-free PTFE is very precise.
Consistent micron tolerance coating deposition on guidewires of lengths of 2 meters and longer is a difficult task. SSG uses 100% robotic, electrostatic coating application production lines. Consistent coating thickness is what customers receive. This capability is verified with test protocols and other quality controls that prove the consistency of the FluoroBond® process.
Post-cure testing takes coating adhesion testing to a new level. First, samples of coated wire are immersed in a 0.9% saline solution and held consistently at 80° F for 30 minutes. Since this is at the upper limit of surgical saline it is considered a worst-case scenario for the coating.
Once out of the saline, the samples are rinsed, dried and subjected to a tape-pull adhesion test that is beyond conventional practices. Normal ISO 2409 or ASTM 3349-02 test tapes have an adhesive strength of .22875 LBF/in. SSG now uses tapes with 3 times the adhesive strength. Both tapes have excellent adhesion to PTFE surfaces.
Using the high-tack tape employed in the FluoroBond® process, flakes of commercially available PFOA-free PTFE coating are pulled off easily from a guidewire that has not been treated with the FluoroBond® process. (100 X)
NO SSG COATED WIRE TESTED AFTER COATING WITH THE FLUOROBOND® PROCESS HAS EVER FAILED IN SERVICE.
How SSG Solved a Dangerous MedTech Coating Issue
At Surface Solutions Group, we think that we’ve come up with an answer for a medical device coatings issue that has recently dogged the industry.
Pure polytetrafluoroethylene (PTFE) coatings for decades were the “gold standard” for coating guidewires and related products, with unmatched low friction coefficient.
But then the EPA required that manufacturers eliminate perfluorooctanoic acid (PFOA) from their PTFE formulations by 2015. The move, meant to answer cancer concerns, also appears to be related to a series of recalls involving flaking coatings.
The FDA over the past six months has announced Class I designations involving coated guidewire recalls at Medtronic (245 lot numbers) and Medline (3 lot numbers).
On April 1, Covidien issued a voluntary recall of 650 of its Pipeline embolization devices and Alligator retrieval devices after internal testing revealed coating delamination. In a communication to customers, Covidien noted that, “Delamination of the PTFE coating could potentially lead to embolic occlusion in the cerebral vasculature with the risk of stroke and/or death.”
The FDA itself now says: “There is a potential for PTFE (polytetrafluoroethylene) coating to delaminate and detach from guidewires. … Uses of this recalled product may result in serious adverse health consequences.”
The delamination problem is taking place around the same time as the reduction and eventual elimination of PFOA, which as a surfactant was thought to enhance adhesion in water-based PTFE formulations.
It is also worth noting that medical device manufacturers have starting to require saline soak testing performed at coating facilities, after reports of “green flakes” in an operating room when PTFE coated guidewires were immersed in a saline soak tank prior to an intravascular procedure. The PTFE coating process, in the past, may have been less sensitive to saline, but not anymore.
The reflex reaction for some device engineers has been to turn to resin-bonded PTFE coatings that have better adhesion to most surfaces. Many coating manufacturers also make these coatings that contain PTFE, but that is where the similarity ends.
The resin-bonded coatings are tough, tenacious, and abrasion resistant, but they have neither the extremely low friction nor flexibility pure PTFE coatings. Plus, they have limited elongation.
However, Surface Solutions Group (SSG) of Chicago has discovered that by using new stringent surface preparation techniques and adjusting how the coating is applied makes the problem go away. The new coatings adhere as well as the old ones did.
Applying low-friction films to biomedical products-from stainless steel, titanium, nitinol, and even plastic or glass-has been our exclusive focus. For the guidewire problem, we were able to bond pure PTFE-containing no PFOA-so tenaciously that delamination is eliminated, even after saline exposure, tape test, mandrel wrap test, and cross hatch/ boil and fingernail tests.
This is how the process works:
The wire surface is hypercleaned, and then the coating is applied in a controlled environment, using a robotic system to keep precise control of all the physical parameters (pressure, feed rate, and electrostatic level) in the spray system so that only an exact amount of coating is deposited to the wire. Finally, every individual part can be saline and tape tested, per the OEM’s requirements, if necessary.
Both patient and physician benefit from the SSG breakthrough. The patient benefits from the improved safety of guidewires that won’t delaminate. The physician benefits from guidewires that, once again, deliver the smooth tactile “feel” that he counted on from wires that were coated with the original gold standard coating.
SSG Project Leads to Higher Quality Plus Faster Turnaround Time
A medical device manufacturer in search of a new supply source for PTFE coated 3-wire stylets approached SSG. They required consistent coating quality and quick turnaround times; needs which were not being met by their current provider.
SSG turned to its worldwide network of strategic partners with high quality manufacturing facilities through which it obtains stylets, wire, coils, spooled wire and mandrels. We acquired the 3-wire stylets the customer needed and provided a precise PTFE coating with unrivaled uniformity, adhesion and smoothness.
The customer was delighted with the high precision PTFE coating we applied at our in-house, state-of-the-art coating line. They also appreciated the rapid turnaround time.
SSG Partners with Customers to Achieve Efficiency, Effectiveness and Economy
In 2003 SSG identified an opportunity to help a customer that was coating their guidewires in house. Their process was inconsistent. Our goal was to apply the PTFE coating to the customer’s guidewires and eliminate the internal production quality issues, coating costs, coil-bound heavily coated rejects and quality costs associated with sorting through guidewires to find rejects. By partnering with this large customer, we were able to develop precision coating of guidewires on a prototype automated coating line to prove the SSG method was a vast improvement in consistent coating application. This was followed by the construction of an ultra-accurate coating line for large scale production. SSG now PTFE coats millions of guidewires per year for the guidewire industry.
As a result of the success of this preliminary work, SSG invested in additional equipment to develop a second state-of-the-art coating line. This equipment not only accommodates larger production orders but also takes coating deposition accuracy capabilities to a higher level than previously thought possible. The line coats guidewires in lengths up to 485 cm. Our stringent quality system ensures accurate and uniform PTFE coating with no glue-like binding between coils.
Our customer/partner decided to take advantage of SSG’s increased level of efficiency, effectiveness and economy by outsourcing all the coating work for their 94 guidewire lengths. It relies on our ability to PTFE coat, round or flat guidewires, with diameters ranging from .018″ to .038″ and lengths ranging from 145 cm to 485 cm.
SSG has processed more than 3 million guidewires for this customer with virtually zero rejects over the last three years while saving it as much as 70% on PTFE raw material costs through the precision of our state-of the art coating line. SSG is proud to offer services to this medical device manufacturer to help them stay ahead of their competition.
SSG Assists Needleless IV Manufacturer
A manufacturer of needleless intravenous IV components was having significant problems with its silicone plungers, which were housed in a rigid plastic housing. The high friction silicone rubber valves were lubricated with silicone oil or grease to allow low friction, consistent valve action. Oil migration issues resulted in valve tears, valves sticking in open or closed positions, and inconsistent valve action. Contamination problems as well as valve malfunction resulted when silicone was applied improperly.
The manufacturer approached SSG for help in addressing these problems. It needed a way to lower the friction of the silicone rubber surface, while eliminating the need for the costly silicone lubricant it was applying to silicone valves. SSG was also asked to add anti-microbial properties in response to an increase in Hospital Acquired Infections.
SSG had previously developed a Slick SilSM coating to reduce the friction properties of silicone rubber that we determined would work for the customer’s application. Our chemists modified the existing formula with a silver ion technology additive to deliver necessary anti-microbial properties. The new coating was tested and proved to provide the customer with a high performance, low friction coating system as well as a 99.9% bio-pathogen kill rate.
Next, SSG developed a bulk process to chemically bond its Slick SilSM to the entire outside surface of its customer’s silicone valves. Testing determined the cost saving bulk process to apply Slick SilSM provided both values the customer needed, low friction and low cost. Production volume is now more than a million pieces per year. Valves are processed at SSG in a class 100,000 clean room that matches the environment in which the silicone valves are molded.
SSG decreased costs and eliminated the need for silicone oil lubricant. The customer now has a superior product at a significant cost saving.
SSG Quickly Delivers Coated Continuous Lengths of Spooled Wire
A major guidewire manufacturer was working with a coating applicator source that continued to insist on a six week lead time for PTFE coating applications. Delivery time failed to improve over many months. The resulting “bottleneck” in production made it impossible for the guidewire manufacturer to fill its orders on schedule. Their customers were threatening to take their business elsewhere.
The guidewire manufacturer needed a new supply source for PTFE coated continuous wire lengths. Their management needed to find a manufacturer of continuous coated wire for coils and mandrels who could deliver quality product on time as needed. They approached SSG to process an initial order of 10,000 – .020″ x 175mm 304 V stainless wire lengths for customer evaluation. SSG used its FluoroMed® ON2-115 coating system to apply .00015″ to .0003″ per side.
SSG’s proprietary coating’s adhesion and strength easily exceeded the customer’s coiling process, however friction properties were 15% higher compared with the previous supplier. In response to this outcome, SSG chemists were able to quickly reformulate the FluoroMed® coating system and created a lower friction FluoroMed® ON2-115A. The modified material is ultra strong. It maintained the superb adhesion and now met the lower friction needs while passing all the coiling and path testing. The customer was delighted and transferred all of its continuous wire coating business to SSG.
SSG applies PTFE, FEP and PEEK coatings onto spooled wire with diameters ranging from .001″ to .040″. Coating thickness ranges from .0015″ to .0003″ per side. We offer a wide range of PTFE coating colors including green, clear/natural, blue, grey/white, black, flesh, purple and orange. Other custom colors are available on request.
SSG has strategic relationships with wire manufacturers from coast to coast. We routinely buy wire and apply coatings to customer specifications to supply domestic and international customers with coated spooled wire on continuous reels. Many of our customers take advantage of SSG stocking programs for overnight shipment on demand.
SSG Cannula Project Results in Expanding Arsenal of Color Marking Technology
A large medical device manufacturer needed PTFE coating applied to cannulas requiring precise masking on the proximal end. The coating had to demonstrate low friction properties and maintain coating adhesion during the grinding process to produce the beveled end. It required good dielectric resistance since the cannulas would be used for soft tissue biopsies and exploratory procedures. Contrasting color markers that would not flake had to be placed at specified intervals as depth markers.
SSG sampled coatings on cannulas to ensure they could withstand the beveling process. Prototypes were then fabricated from the white PTFE-coated cannulas which were verified for dielectric properties. While initial results were good, the customer required increased electrical resistance. SSG chemists reformulated our FluoroMed® coating to meet customer needs. Adhesion during the beveling process was excellent.
Next SSG was challenged to create contrasting color banding without the use of ink, paint or coating ablation. SSG turned to its patented Visi MarkSM technology to create exacting depth banding integrated into the white PTFE, to blueprint requirements. This was accomplished with no ink, no paint and no ablation. The resulting white cannula has black distance bands, visible from any angle.
SSG has used what it learned on this early project as a foundation for many other primary and contrasting color marking capabilities in our ever-expanding arsenal of Visi MarkSM technology. New color combinations include many primary colors. In addition, Visi MarkSM can provide optional alpha-numeric markings on the barrel of the cannula for lot code, manufacturing date or manufacturing identification code.
SSG Applies Coating on Ball Bearing Retainer for 500,000 rpm Dental Drills
A bearing company that manufactured dental drill ball bearings approached SSG for help. The manufacturer explained that dental drills performing at very high speeds have special low friction requirements. The goal is to lower friction to use less air and insure consistent power delivery. Less air is needed to drive the drill when there is less resistance.
The bearing manufacturer needed to work with a company that could not only address coating difficulties associated with the small size and complex shape of the bearing retainers but also handle large production runs. The precision application requirements were not met by any prior coating firm. Issues that plagued them included high fall out rates due to coating imperfections, including lumps of coating on critical surfaces, non-uniformity, bare spots, fish eyes, voids and coating on the back of the retainer.
The bearing manufacturer recognized it needed the help of a very precise applicator that had the ability to precisely apply a uniform PTFE coating with zero imperfections while meeting production deadlines. With this in mind, management came to SSG for help producing a precisely-bonded coating on the “cup” side only of each half of the pair or retainers that hold the ultra-precision miniature ball bearings while they function at up to 500,000 rpm. In addition, the coating is autoclave able for cleaning purposes.
The SSG team developed an entirely new coating application method after analyzing quality control photos and data the customer provided on our FluoroMed® Engineering Form. We created a precise and reproducible production process to apply PTFE that met customer specifications on each and every part SSG coated.
Upon completion of our research the customer sent us 500 prototypes for trial processing. The prototype runs proved the SSG process, which led to SSG to ramping up volume to meet customer needs. Our repeatable coating process delivered the precision coating results from part to part with no coating imperfections at production volumes of 50,000 parts per lot. Later processing improvements included an SSG developed optical recognition system to verify coating accuracy of each miniature part after coating.
SSG Eliminates Guesswork for Surgeons Dual Color Coated Guidewires
The advent of PTFE-coated guidewire for medical applications began a revolution in the way surgeons perform many procedures. At the same time, it has necessitated the need for new and better fabrication of materials. Surgeons need to be able to assess the rotational position or torque of the guidewire they use. They need to know that the guidewire is moving as desired by the surgeon. With the normally green PTFE coating, this is very difficult as there are no reference marks on a guidewire.
Senior engineers from many medical fabrication companies have approached SSG with issues related to surgical needs and we have worked with them to develop solutions. The first challenge SSG was faced with was applying a pure PTFE white stripe to the length of a 175 mm guidewire. We produced a Visi MarkSM green guidewire with a white stripe that helps the surgeon by providing feedback with reference to “torquing” of the guidewire.
News of our white stripe success brought more inquiries. Customers expressed a need for a spiral pattern of contrasting colors. This “barber pole” was the next evolution in the Visi MarkSM process. SSG began to produce guidewires with a spiral pattern that transmits rotation information and lets the surgeon determine guidewire movement with accuracy.
The SSG team then went on to create guidewires with millimeter markings for measurement purposes. This allows surgeons to determine distances, length of balloon requirements, length of lesion or blockage, and more by having a millimeter pattern permanently bonded to the guidewire in a high-contrast color of pure PTFE. Once again, Visi MarkSM used no ink or paint, nor used coating removal to create contrasting color. Visi MarkSM markings are made of high color contrast, pure PTFE material.
SSG provides all engineering, material and Visi MarkSM patterns to suit our customers marking requirements. The medical grade PTFE coatings we apply to cannulas, single wire-strand and coiled construction guide wires are produced in green, blue, purple, grey, black, white and tan. Contrasting PTFE markings are available in white, black and other contrasting colors or to your custom color specifications.
SSG Chemists Duplicate Coatings to Enable Domestic Fabrication
For decades, Baxter Medical relied on a German manufacturer for endoscopic and surgical instrumentation. With usage on the rise in the early 1980’s and an increasing demand worldwide, Baxter found itself faced with three- to four-month backlogs and the inability to fill orders. They had to find a domestic component provider in order to supply surgeons with the equipment they required.
Baxter approached the SSG team with its problem. Our chemists immediately went to work to analyze and identify the insulating coating used by the German company. We purchased testing equipment, applied the coating, and tested instrumentation for film integrity, dielectric strength and electrical insulating values. SSG successfully developed a process to replicate the coating.
Our success meant Baxter was able to meet increased demand. Baxter went on to bolster its market share and secure its position as a major industry provider.
SSG Develops Mandrel Coating with No Touch Marks or Masking Lines
SSG was approached by a high-tech Israeli company that needed a specialized mandrel in numerous lengths with round ends. Their application required a very precise PTFE coating with a tolerance of +/- .0002″. We were able to obtain the mandrels, per print, through our worldwide, high quality supply chain. We then applied (+/- .00015) ultra-pure PTFE coating with no pigment. This high-purity PTFE, extraordinarily thin coating thickness demanded incredible deposition accuracy and had to be delivered with no touch marks or masking lines.
SSG’s process ensured the mandrels were untouched by human hands during PTFE application. We developed assembly line procedures that delivered high quality automatic coating, part after part. The client was delighted with our advanced techniques and consistent and accurate PTFE application techniques.