By Sean Fenske, Editor-in-Chief

There are a variety of companies serving the needs of the orthopedic sector. Some companies provide a breadth of offerings, while others focus on one clinical segment or even a single product. Regardless of the scope of a company’s product lines, it is rare for an organization to maintain the ability to serve every orthopedic segment. Often, there are gaps in their product portfolio.

While filling in the holes can lead to additional market penetration and revenue, the cost comes in the form of significant time and money. As such, many orthopedic OEMs are left unable to completely serve every need their surgeon and hospital customers have. Ideally, they could find a way to fill in the gaps with quality, ready-to-market implant solutions.

Fortunately, Lincotek had similar thoughts on this challenge. As such, they crafted a strategy to address it and the customers could benefit from being able to fill out a product portfolio gap or expand into a new segment. To help explain Lincotek’s solution, several representatives from the company responded to inquiries in the following Q&A—Francesco Bucciotti, Head of Global Business and Business Development; Mukesh Kumar, Technology and R&D Director; Enrico Sandrini, Product Management Director; and Troy Walters, Product Development Director.

Sean Fenske: Why is Lincotek offering ready-to-market implant solutions?

Francesco Bucciotti: Lincotek is offering ready-to-market implant solutions to help OEMs in reducing the time to market and lower the expenses associated with product design and regulatory approval, making it easier for them to expand their product offerings. This solution ultimately benefits their customers by improving their competitiveness and meeting market demands more quickly.

To solve this, Lincotek leverages its expertise in product development, regulatory affairs, and complete supply chain manufacturing. At this time, Lincotek is providing solution with a hip system with CE marking achieved and working on several development projects in the USA in the field of spine and sport medicine. Note that some of these products and solutions we discuss are not currently for sale in the U.S. or pending approval.

space

space

Fenske: What advantages do the Lincotek offerings provide?

Enrico Sandrini: In Europe, where the MDR has completely changed the pathway to a CE mark clearance for products, OEMs are facing challenges in terms of being innovative and expanding their product offerings. With our line of implants, we enable these companies to have their own equivalent device in-house to help supplement their actual product offerings. Our device can serve as an equivalent device and that’s the value we provide to companies. So as Francesco mentioned, we’re addressing speed to market access through this line to better serve our customers.

Troy Walters: On the U.S. side, things are a bit different compared to the EU with regard to the regulatory environment. Regardless, the challenges we’re trying to address are similar as we’re still focused on alleviating time-to-market concerns. We’re providing these solutions to ease the process for our customers to put products onto the market. However, we’re also giving our customers the ability to utilize our quality system to avoid some of the regulations they have in their quality system when launching a product. In addition, we are leveraging our products to help them address manufacturing challenges they may have.

Mukesh Kumar: Compared to other contract manufacturers, Lincotek is unique in its solutions to OEMs. We can help in the design of the implants, working either as an extension of the OEM design team under its QMS or contracted to design the OEM’s idea into a clinically viable solution working under Lincotek’s QMS. Further, Lincotek can manufacture the device using its internal manufacturing routes such as casting, forging, machining, porous plasma spray, and additive manufacturing.

However, Lincotek has more to offer—it has technology aimed to enhance bone in-growth into the porous structure, including HA^nano Surface® from Promimic. If an OEM is interested in designing with additive manufacturing and needs help with a validated porous structure that was designed with powder removal, machining aid removal (cleanability), and meets all the requirements of modified metallic surface as stipulated in the FDA guidance document, Lincotek has a ready-made solution that may be adopted by the OEM. If an OEM is looking for a unique solution to encapsulate CoCr implants to address metal sensitivity, Lincotek has solutions available to discuss.

Lincotek has the mindset of statistical process controls on “special processes” where robust validation of extreme process conditions fully characterizes the process. This is difficult upfront work, but comes in handy during audits.

Fenske: How do these implants differ from what’s already available on the market?

Sandrini: With regard to orthopedic devices we’ve developed in Europe and considering Lincotek is a technology company, we’re able to include our most advanced innovations on these devices. We’re able to address the most important clinical needs of implants—allergy, infection, and wear. This is what differentiates our devices from existing devices.

Our implants are the only CE-marked devices with technologies to address infection. We provide a complete hip system and a dual-mobility configuration without any nickel or cobalt—completely nickel- and cobalt-free. These implants are cementless as well as cobalt- and nickel-free. This is what makes the Lincotek offering unique compared to the rest of the market.

Walters: In the U.S. market, we have launched several products to help supplement a company’s existing line. For example, we’re presenting SportLinc, which can be leveraged to fill holes a company has in its sports medicine or foot and ankle offerings. In the orthopedic market, some companies and their reps don’t have access to certain products, or market segments are being controlled by larger companies. So, for us to be able to fill some of those holes for smaller organizations by filling out their portfolio is the target for a product like SportLinc.

With another example, SpineLinc, we focused a bit more on the specific advantages of the product and how these devices are sold on the market. The goal was to have a 3D-printed porous structure inside of a machined plate structure. We spent significant time on each component functioning separately as well as ensuring those product features worked correctly when combined. In addition, we have the ability to add HA^nano Surface® to the porous structure to help differentiate the product.

Kumar: Enrico mentioned the nickel- and cobalt-free implants we are developing; I’d like to add a comment about that. We have developed a technology to enable the 3D printing of entire femurs in titanium. Printing is one challenge, but doing it accurately to maintain shape and the porous structure while also providing a polished surface upon which an OEM can apply a coating they think would be conducive for articulation is a different level. Currently, Lincotek is offering this solution of 3D-printed titanium knee with a validated porous structure to the OEMs to incorporate into their own products. Of course, the OEMs can choose to use their own porous structure or use our expertise to make their own titanium knee.

In addition to this 3D-printed offering, we have developed technology to encapsulate both titanium and cobalt chrome implants on the articulating side and on the bone side. We are demonstrating through cell culture studies how these coatings can enhance bone in-growth within the porous structure, addressing the needs of the press-fit market.

space

space

Fenske: Do customers need to adopt all the solutions (hip, knee, spine, sports, etc.), or are they available based on each company’s specific needs?

Sandrini: There is no need to adopt everything; this is an open platform. The customer will select exactly what’s needed, whether that’s one device within the hip product portfolio, for example, or perhaps the entire line. It could be one knee implant or the entire portfolio.

With this a-la-carte-style offering, our customers could address a new segment they may not have offered previously. For example, let’s say we have a customer that only provides trauma products. The company has never supplied hip devices. They work with Lincotek and our capability to supplement their product line; now they are growing their hip business in parallel with trauma. Our open platform equals free choice for customers—use everything or just a single solution.

Fenske: How can Lincotek, apart from offering its own device designs, further support its customers’ needs in getting devices to market?

Sandrini: Lincotek is uniquely positioned to accelerate the development process for our OEM partners by sharing information from our device approvals. Our broad database of predicate devices in the U.S. to support a 510(k) and equivalent devices in the EU to support a CE mark under MDR provides a robust regulatory and technical foundation OEMs can immediately leverage.

These strategic assets allow OEMs to streamline regulatory pathways by building upon devices that have already been successfully registered and validated. As a result, the need for additional clinical or pre-clinical testing can be significantly reduced, enabling faster time-to-market and lowering both development risk and cost.

The value we bring goes even further as our approach is not limited to offering off-the-shelf solutions. We actively engage in co-engineering processes with our partners, adapting existing platforms to meet specific clinical, technical, or commercial requirements while ensuring full regulatory compliance. This collaborative model enables OEMs to focus on differentiation and innovation, while relying on Lincotek’s proven platforms as a solid and efficient starting point.

Walters: Moreover, by structuring strategic Statements of Work around our device database, OEMs can benefit from a streamlined and industrialized path to product development—one that minimizes design iteration cycles and leverages existing performance data. Combined with our end-to-end capabilities—ranging from design and prototyping through to manufacturing and regulatory support as well as cleaning and packaging—we act not just as a supplier but as an integrated partner committed to turning validated knowledge into a real competitive advantage.

In essence, our device database is far more than a collection of products: it’s a powerful enabler for OEMs looking to bring innovative medical technologies to market faster, safer, and with greater confidence.

Fenske: Does Lincotek support the full process including delivery to the customer with the company’s branding/labeling?

Walters: Lincotek’s role as a solution provider includes that aspect of the process. As a full-service partner, we want to be able to incorporate design, manufacturing, and packaging as well as personalized services for each unique customer. With these types of products where we’re utilizing devices developed inside of Lincotek that are available to our customers, we will be able to incorporate our customer’s labeling and branding in the U.S. It follows a similar, private-label mentality in Europe. We also remain mindful of regulatory considerations and follow the necessary FDA and ISO regulations to ensure the product enters the market correctly.

Fenske: Do you have any additional comments you’d like to share based on any of the topics we discussed or something you’d like to tell orthopedic device manufacturers?

Sandrini: I would like to share the first experience we had in rolling out this model to the market. Four years ago, after developing the product and obtaining a CE mark for the complete portfolio, we entered into a license agreement with an OEM that was focused on trauma. The company obtained its own CE mark under MDD and is now selling its offerings throughout the world—its own products. Lincotek was instrumental in helping this take place, from our devices and concepts, as well as the support Lincotek provides through our entire supply chain service. We provided them with ready-to-go surgical theater instrument sets and sterile packaged products.

Kumar: Enrico brings up a good point about how Lincotek managed the supply chain from ideation through to part-in-a-box with the company’s label. However, another example of how we help OEMs is to have them think about their product, not only from a material aspect but with value-added capabilities that could be included early in the process. We’re constantly developing technologies through our internal R&D facilities; if some of these are incorporated early, there might be additional advantages in product and instrument design. For example, now OEMs know that 3D printing may provide benefits during the design and manufacturing processes of the implants, but they may be unclear on using such technologies for instruments. Using 3D printing on instruments, OEMs can also consider how to design the tool in terms of cleanability and/or ergonomics. One-off instruments to address the specific needs of a surgeon are generally expensive and time consuming. How can this be addressed economically? We are validating a process of 3D printing instruments where one-off instruments with specially requested features are easier to manage. Moreover, with this technology, OEMs can address issues of instrument tray weight reduction, instrument cleanability, ergonomics, etc. If an OEM can identify a pain point, we can review the multitude of solutions we offer and see what fits.

Walters: With regard to Lincotek’s R&D efforts, we further benefit from our internally developed products with the ability to take an R&D project—whether a new surface treatment, manufacturing method, material, or process—and incorporate it into them. We then secure approval for it, which allows our customers to leverage that approval for their own product. This calls back to our discussion earlier in helping to get products to market faster. Through this effort, we better understand what is required for the regulatory environments throughout the world. Since we’ve already addressed those challenges with our product, we can share that experience with our customers.

For more information or inquiries, please contact francesco.bucciotti@lincotek.com.

Click here to learn more about Lincotek >>>>>