The Surface Equation
Varied players in the surface modification and coatings process weigh in on current trends affecting the sector.
Contributing Writer
Surface modification and coatings is a segment of the medical products industry that attracts relatively little attention from the casual observer, but below the surface (no pun intended—no, really) it’s a veritable hotbed of activity.
Orthopedic Design & Technology recently chatted with representatives of companies doing business in widely varied aspects of the sector and found that not only is change the operative word, “rapid change” is even more commonly used to describe the present-day climate. The participants were varied not only by the market space within which they operate, but also by dint of being from three different countries.
They included:
• Ulf Brogren, president and CEO of Promimic AB, a Goteborg,Sweden-headquartered firm that is developing a hydroxyapatite(HA) nano surface that has been shown to accelerate
osseointegration of implants.
• Patrick Beauchemin, lead engineer at VisionX Inc., of Pointe-Claire, Quebec, a maker of equipment for automated imaging, visual inspection and high-accuracy measurement of medicalimplants and a wide range of parts for other industries, aerospace and automotive among them.
• Tim Gibson, sales manager at Rosler Metal Finishing of Battle Creek, Mich., a supplier of surface finishing equipment and consumables.
• Magnus René, president and CEO of Arcam AB, a Molndal, Sweden-based company that is focused on an additive manufacturing technology, Electron Beam Melting, for production of complex, dense metal parts.
• Jeff Trogolo, Ph.D., chief technology officer of Sciessent, a Wakefield, Mass.-based company that is focused on its silver-based Agion products for reducing infections in various healthcare settings.
• Ray Fontana, segment manager for the global medical services unit at the U.S. headquarters in Rockaway, N.J., of IonBond, a provider of thin-film PVD, PACVD and CVD coating technologies.
• Brian Krehlik, sales manager at FMIMedical Instruments located in Madison, Ala., a contract manufacturer of orthopedicmedical devices.
These companies each have a different niche in the sector, some making equipment and related products, others doing the work of surface modifications or coatings. A centerpiece of the discussions was what these companies are hearing from their customers—what they want to see from suppliers to help them move forward.
A Market Full of Opportunities
Rosler’s Gibson described himself and his company as being “cautiously optimistic.” He said that “if you take a look at the different segments we’re involved in, medical is lagging a little bit in this recovery,” especially compared to the big uptick the firm has seen in its automotive and construction industry segments. “That’s not discounting medical, though; medical is still running in the high single-digit, maybe 10 percent or 11 percent growth per year,” Gibson said. “While it has been very steady for us, we’re not seeing the extreme pickup we’re seeing in other industries. Gibson said Rosler actually has been helped by the stagnation in some of those implant markets.
It’s causing manufacturers to look at ways they can improve operations, processes and make better hips and knees that will last longer in patients and look better aesthetically.
“It actually has helped drive our business where we can bring our technology in and say, ‘Mr. Customer, we can cut maybe two or three steps in your operation, give you better control as far as lot-to-lot reliability and greatly reduce your scrap factor because we’re moving the human operator out of the picture. At the end, each knee is going to look the same aesthetically because you don’t have an operator sitting there manually buffing the knee.’”
Promimic’s Brogren said what’s really interesting is the new implant material that has been developed over the past few years and currently is being developed.
“We have seen PEEK [polyetheretherketone] becoming a huge material in spine, and it’s coming on strong even as a material for other types of uses, such as suture anchors,” he said, adding that there are promising knee applications for PEEK, as well as use in trauma plates.
“You also have pyrolitic carbon,” Brogren said. “There are some companies doing silicone nitrite implants, etc. These new implant materials open up new challenges and new opportunities for coating companies. So you have new materials that you want to use for different reasons as an implant material and they will bring new things to the table. On the other hand, you need to have great integration between these new materials and the bone, and of course there’s the opportunity for us.”
Trogolo said Sciessent’s antimicrobial product, Agion, which is a silver ion, is used in a number of different applications.
“In the medical area, we presently are used in catheters and devices like that. We’re working on a couple of other types of applications. On the surface modification side, that would be where we would go in onto a device as part of a coating. But we can also think of it in terms of, if you add our material, which is a fine ceramic powder, to a polymer, then what we’re really doing there is changing the surface characteristics by providing a source of silver periodically across the surface of the product to deliver silver for antimicrobial purposes. That’s really what our customers are focusing on.”
He said that there are “obvious concerns” about the large number of infections that are associated with devices and people are looking at strategies to reduce the cycle of infection, or interrupt it at various stages.
“One of the contributing things that the industry is looking for is having an antimicrobial surface on devices. So we help those companies pursue that with silver,” he explained. Of silver as an antimicrobial coating, he said: “It’s well understood, it’s widely evaluated from a safety standpoint, so customers are looking to us to help incorporate our technology into their devices and benefit from our knowledge and experience of how to test and evaluate and process the materials for the 510(k) [U.S. Food and Drug Administration (FDA) device clearance process] that they have to go through.”
According to Arcam’s René, the manufacturing machines his company makes can streamline the coatings and surface modification process.
“It is possible to produce parts where advanced porous infrastructure is integrated in the part itself,” he said. “ So weintegrate porous coating with the manufacturing. We bring a way to make those products in one shot instead of a multistep process, reducing costs and making the product more integrated than the traditional product, and also to make trabecular structures that are more advanced.”
Beauchemin said his firm’s inspection systems are aiding firms with requirements for device history—being able to collect device history automatically, basically documenting the manufacturing process and the quality of the products.
“This cradle-to-grave information for devices is a big, big deal,” he explained. “One of the issues that [device manufacturers] have had in the past was that the comparators didn’t allow any of this device history information to be recorded. For example, if you talk about coatings like plasma coatings—we see a lot of those—it’s very important to control tolerances quite tightly on plasma coating. It’s difficult to do, but once you’ve put in all this effort to control this properly, you need keep some kind of a record, the device history of all this. You need to document it.”
The second trend Beauchemin noted was tighter tolerances.
“Tolerances are getting tighter and tighter, so accuracy requirements on instrumentation are getting tighter and tighter as well,” he said. “If I had to give a third thrust, I would say the paperless shop floor is also something that companies want to see happening. Having a whole bunch of paperwork move around the shop floor along with parts often is not a natural fit.”
So, Beauchemin said, “the ability to have all this electronic information follow parts automatically just by scanning a bar code on the part or on the router or traveler, whatever, and having all the appropriate information automatically saved and tied in with that bar code is a big deal.”
IonBond’s Fontana said, “The orthopedic large bone sector is where we have been working for over 20 years providing coatings for instruments and implants. This sector has slowed down in the last few years due to high unemployment, regulatory concerns and the new healthcare law, but we see a good future for surface enhancement coatings that can deliver a high level of quality of life on large joint implants, giving them a longer life.”
Of indications that economic recovery may be finding more solid footing, FMI Medical’s Krehlik acknowledged that there has been a slight uptick in the industry, but he remains“cautious that this is still a ‘fake/false’ economy,” noting continuing reports of high unemployment numbers nationally. “I believe OEMs have been holding tight with their current products, stretching them a bit longer than originally planned [with repeat orders] and are just now [over the past few months] starting to open up a bit for development of new products and releases.”
Relationship Development
Asked how his company develops a process with a new customer, Arcam’s Magnus said, “It’s almost always a new product they want to have on the market, they have an idea of how they want to design it, and then they come to us and as always when you start working on a new manufacturing process, if you want to manufacture it in a certain way, you might want to design it in a different way. The design is often tied to the production process.” He said that in working with the customer for a while, Arcam may recommend design changes for a next-generation product. “That happens quite often,” he said. “We do a lot of work with our customers to help them achieve the kind of functionality that they want in the best way.”
Rosler’s Gibson said that many variables go into developing a process for a given customer.
“I would say that 80 percent of everything that we sell here is derived from a custom process that we develop through running trials at our test laboratory here in Battle Creek. We take a customer’s part, whether it be a bone implant, a screw, a knee, a hip, and we sit down with the customer and really determine what the scale of the program is.”
He said Rosler develops a custom process for each individual customer.
“The end customer typically will come to our facility; we’ll run trials with them; we will duplicate what we did, and then they’ll order the consumables and the equipment that make up that process. And then we go down and install these processes on their facility floor and ensure that the samples that were run in our test lab can be duplicated in the production process on their floor.
“We don’t just sell equipment; what we sell is the total process, so the OEM or a first-tier supplier will come to us with a knee or with a hip and say, this is what I need to get to. Many customers are pushing the envelope to where they’re trying to take it as coming out of the casting, going to the grinder, and then directly in to us,” Gibson said. “We also supply the consumables that are actually doing the work within the machines, and then we also tie in the wastewater treatment.”
Brogren of Promimic hopes that the first implant with the HA surface will be on the market next year.
“We start off with a feasibility project,” he said. “They send us implants and we coat them, supply a surface analysis and show them how our surface would look on their implant. The next step is setting up an agreement on how to take this to the market; that is where we are with a couple of implant companies today. The next step will be that we supply them with the know-how of how to set up the process on their production line, and of course, negotiate a commercial license. Then we can supply them with the coating solution and work can begin.”
Meeting Challenges
Trogolo spoke of the challenges that are presented in producing medical devices.
“When we’re blending into the polymer, we want to make sure that it’s well-blended into the polymer and that we’re maintaining the materials characteristics of the polymer that the catheter, for example, is made out of,” he explained. “We want to make sure that our material is homogeneously distributed across the surface in an even concentration.”
Sciessent doesn’t sell coatings, but works with coating companies that are suppliers to its customers.
“We want to make sure that the coating is going to stay on,” he said. “The main issue with coatings, especially with medical devices, is making sure that it’s durable and that there is adhesion and the coating stays on. If the coating falls off, then obviously the antimicrobial is not going to be any good.”
The main challenge to the company, according to Trogolo, is “getting the right level of the active ingredient into both of those contexts, in delivering the antimicrobial to the surface of the device at the appropriate concentrations. And that’s a result of doing the experiments, adjusting the loadings, measuring the silver that’s at the surface.”
Trogolo said that safety is “certainly one of the premier tenets of anyone looking around for antimicrobials and safety from a ‘What can go wrong with this device?’ standpoint,” he said.
“If it’s a catheter, it could get infected; if it’s an implant, it could get infected, so that’s certainly one of the facets of all this. With a permanent implant you have two levels of concern. There is the acute infection that is associated with the surgery that put the device into the body, then there is the chronic infection concern where it is something that happens a year, two years, three years down the road.”
Rosler’s Gibson said each new relationship with a customer offers its own challenges. In fact, Rosler terms the way it looks at each company’s needs as addressing “the problem.” As an example, he said that, “as we’re getting into ceramic-coated knees, as we’re getting into some of the new alloys being used, it’s providing a real challenge of coming up with the solution. But the way that we address the market and work with our customer base, every program that we run here presents a challenge of its own.”
Promimic’s Brogren had a different take, saying of his firm’s technology, “It’s a very simple process. It’s so simple that sometimes the customer has trouble accepting that it is so simple. You just dip the implant, remove the excess costing solution, short heat treatment and you’re done. So I don’t foresee any real technical problems.”
Regulation’s Impact: Different or Similar?
Magnus said Arcam sees no fundamental differences in regulation between the United States and Europe.
“We do not make products that have to be regulated,” he said, “but our customers are. We do support our customers in their regulatory processes, and we do that in both Europe and the U.S. and in Asia. From our perspective, what we need to be sure to do to support our customers’ regulatory efforts is fairly similar in the U.S. and Europe—it’s about the same thing that we have to go through. The process itself is different for them because in the U.S. you have the FDA as a centralized authority for approvals, while in Europe it’s more diversified with Notified Bodies doing much of that work. But I don’t think that the approval on our product itself is much different in the U.S. or Europe.”
Promimic’s Brogren agreed.
“The implant industry itself is an international industry, so you have to meet the regulatory requirements both in Europe in the U.S.,” he explained. “In fact, we are bringing a new technology into the market and did a 510(k) on a generic dental implant; that’s the first indication we have done. It got approved couple of months ago, so that’s the first device having our coating on it. We have established a test protocol with the FDA and we know what kind of questions they will raise when we bring a new device with the coating on, and that is very good.”
Fontana said the tightening of regulatory requirements will impact new product development and innovation in America. “While it is necessary we need to make sure that we are not forcing the large OEM companies to do business elsewhere. The impact we have seen is a pullback across the board on newer initiatives and a just-in-time requirement on existing products.”
Jim Stommen, retired editor of industry publication Medical Device Daily, is a freelance writer focusing on the medical product sector.