The medical coatings market is predicted to be strong and steady in 2025. According to Technavio—a data analysis firm—from 2024 to 2028, the global medical coatings market will grow by about $5 billion with a compound annual growth rate of nearly 6% during the forecast period.¹ An aging population is the driving force for market growth, with R&D trending toward developing advanced, multifunctional coatings for implants. 

Medical device manufacturers (MDMs) rely on a wide variety of coating and surface treatment technologies for their devices, with an equally diverse array of methods for applying them. Common types of medical device coatings include low-friction or lubricious, insulating, bio-promoting, and combinatorial. These surface modifications are designed to address key performance attributes for implants, especially osseointegration, wear resistance, and antibacterial properties. 

Traditional coatings remain a proven cornerstone of medical device manufacturing, with metals such as titanium and surface modifications such as anodization, leading the way. Yet, innovation is still present at the forefront—for example, recent developments in surface technologies are exploring multifunctional coatings that address multiple performance aspects simultaneously. These properties include improved wear resistance, antibacterial properties, and the controlled release of bioactive factors that aid in faster recovery and reduced infection risks. Advanced coatings can also minimize allergic responses by using encapsulation techniques to isolate certain surfaces when needed (cobalt-chromium, for example). 

In particular, considerable R&D is being invested in developing surface modifications and coatings that enhance the functionality and longevity of implants through osseointegration—the bonding between bone and implant—”by utilizing bioactive materials such as hydroxyapatite coatings and biocompatible metals, including titanium and its alloy Ti6Al4V,” said Francesco Bucciotti, head of global business and business development for Lincotek Medical, a Trento, Italy-based global solution provider for medical device orthopedic manufacturers. “Advanced methods such as plasma spraying, physical vapor deposition, and chemical vapor deposition are employed to ensure these materials are optimally integrated.”

Regardless of how advanced a surface treatment might be, if the process does not include a comprehensive cleaning step, even the most sophisticated coating technologies will fail. “Other treatments and surface preparations may involve adding molecular functionality or other changes to the substrates themselves, but without proper and thorough cleaning, the coating systems will not work as intended,” said David Kissel, Ph.D., and director of R&D for Applied Plastics, a Norwood, Mass.-based manufacturer and supplier of coated components for the advanced catheter industry, including PTFE-coated mandrels, wire, and hypotubes. 

Current Trends

The medical coatings market is experiencing significant innovation as MDMs, surgeons, and formulators develop advanced processes and coatings. Notable developments include hydroxyapatite-biocompatible coatings for orthopedic implants, lubricious coatings for guidewires, drug-eluting coatings for stents, and antimicrobial coatings for catheters. “Single-layer coated formulations, which reduce particulate generation and offer superior lubricity compared to former hydrophilic coatings, are increasingly popular,” stated Technavio. “Innovative coating deposition techniques such as laser treatment, low-temperature atmospheric plasma, and microblasting, are being developed for bioactive coatings on medical devices.”

MDMs are increasingly interested in finding a replacement material for perfluoroalkyl and polyfluoroalkyl substances (PFAS), which are commonly used for lubricious applications (including its subgroup polytetrafluoroethylene, or PTFE). “In light of recent news about a potential ban on PFAS materials by the FDA and the European Union by 2030, many companies are seeking alternatives to the PTFE liners that are traditionally used in catheters and guidewires,” said Bob Hergenrother, vice president of research, development, and innovation for Biocoat Incorporated, a Horsham, Pa.-based provider of lubricious hydrophilic coatings. 

Considering future regulatory measures regarding PFAS, every MDM is motivated to explore alternative materials with respect to this legacy, high-performing class of materials that will be difficult to replace. “So, understandably, the number-one request we see from MDMs is a PTFE coating alternative,” said Dr. Kissel. “This will be the ‘holy grail’ when it comes to the next generation of coatings technology because the properties of PTFE are so unique and well-suited for medical device applications.”

Two of the latest advancements in hydrophilic coating application methods “are the ability to coat a medical device’s inner diameter and apply hydrophilic coatings directly to metal substrates, without the need for a tie layer or polymer jacket,” said Hergenrother. “Avoiding a tie layer reduces a step in the manufacturing process.”

“The FDA keeps a GRAS list of generally recognized as safe materials used in medical devices,” explained Kristian Killian, regional vice president at VitaTek, a vertically integrated organization located in Medical Alley and manufacturer of VitaCoat—an open-source, UV-cured hydrophilic coating. “Thus, UV-cured hydrophilic coatings can be made transparent so the market can do what it needs to do with [them].”

In the orthopedic field, a significant trend is the focus on infection management in joint prosthetics, addressing a critical demand due to persistent infection rates, particularly prosthetic joint infections. This need for infection management has driven advancements in both preventative and therapeutic solutions, including biofilm-resistant materials, advanced antibiotic coatings, and “protocols such as debridement, antibiotics, and implant retention, which reduces recovery times and improves patient outcomes,” said Bucciotti. “The rise of antibiotic-resistant strains, such as Staphylococcus aureus, intensifies this need, driving interest in glycopeptide antibiotics and biofilm-targeted treatments.”

Cobalt-chromium alloys, commonly used in knee implants, are raising concerns related to premature wear and ion release, which can cause local toxicity, inflammation, and metal hypersensitivity. To address these issues, the industry is exploring advanced coatings, such as multilayer ceramic materials, which offer improved wear resistance and significantly reduce ion release, thus enhancing implant biocompatibility. This shift is critical as the demand for durable, biocompatible knee prosthetics rises with an aging population.

Additive manufacturing (AM) continues to be a disruptive manufacturing technology, especially with titanium and polyether ether ketone (PEEK) gaining significant traction in the spine segment due to their biocompatibility and mechanical properties, which align well with complex implant designs and patient-specific applications. Anodization treatments are also available for 3D-printed titanium porous structures. These treatments maintain all the key anodization properties while leaving no residues, thus preserving the integrity of interconnected porous structures in 3D-printed implants. 

What MDMs Want 

With MDMs seeking cost efficiencies wherever they can, “technology development trends seem to be heading toward making processes that were once very costly and low volume-oriented into commercial, high-volume, cost-effective processes,” said Dr. Kissel.

For example, in the orthopedic sector, titanium and its alloys continue to drive advancements in coating materials, with high demand for commercial titanium and titanium alloy coatings. Lincotek’s TiGrowth, an advanced coating achieved through Lincotek’s proprietary CAPS technology (controlled atmosphere plasma spray), enhances osseointegration. Hydroxyapatite (HA) coatings continue to play a key role in the industry, although there is a slight decline in usage as the field shifts toward alternative bioactive coatings. In this regard, Lincotek offers a nano calcium phosphate coating that prevents clogging of porous structures and accelerates osseointegration, especially for the early stages after surgery. 

“OEMs want fair, transparent pricing without complicated business models of use,” stated Killian. “UV hydrophilic coating is a commodity (albeit a critical commodity), yet the key word is ‘commodity.’ When considering economies of scale, commodity prices go down—not up—as long as the core material prices are stable.”

“Many MDMs are also faced with the impact of 3M and Whitford (PPG) exiting the medical coating market,” said Dr. Kissel. “MDMs are starting to pivot to new coatings, which in many cases may require extensive testing and revalidation of their products.”  

When MDMs seek out a lubricious coating, they are typically looking for high durability, low particulate levels, and low friction. Given the tortuous path that medical catheters and guidewires must navigate, coatings must maintain their performance throughout the entire procedure. This ensures the coating remains effective for the duration of the device’s use and allows for smooth retrieval once the procedure is complete.

“Particulate measurements are crucial, as various regulatory agencies need to understand the types of foreign materials introduced into the body and their long-term impacts on patients,” said Hergenrother. “Therefore, the coating must be durable to avoid particulates from being rubbed off, which can lead to patient safety concerns. Low friction is also essential as it helps physicians reduce resistance during the insertion and removal of the medical device, minimizing the potential for tissue damage as the device travels to its intended location. Lubricious coatings facilitate easier trackability and pushability, giving the physician more control.”

MDMs are intent on integrating 3D-printed porous structures with advanced surface treatments, such as nanostructured calcium phosphates. Nano calcium phosphate enhances 3D-printed titanium or other implant surfaces by providing a bioactive layer that significantly improves osseointegration. “The porosity of the 3D-printed structure supports bone in-growth and mechanical stability, while nano calcium phosphate coating accelerates the biological bonding process,” said Bucciotti. “Together, these features meet the growing demand for implants that promote faster recovery, better stability, and long-term durability, making nano calcium phosphate coating-modified 3D surfaces an increasingly sought-after solution in the orthopedic field.”

MDMs often worry that certain coatings—especially HA-based options—might occlude the intricate porous network in AM parts, thereby impeding bone integration. However, brushite coatings are designed to avoid this risk of clogging by keeping the porosity open and enabling rapid osseointegration and stable biological bonding. In particular, brushite can coat both the external and internal surfaces of AM structures without filling the pores, providing a bioactive layer that maintains and even enhances the intended porous network. Lincotek Medical’s Osprolife, made of brushite, can be applied as a 20-micron-thick coating that dissolves within a few weeks of implantation. It promotes bone remodeling in the early postoperative period; it stimulates bone tissue to grow into the complex porous metal structure, thus facilitating long-term secondary fixation. “Brushite chemistry can also be doped with antibacterial agents, but as brushite is resorbable, it delivers all the antibacterial agent pre-loaded in a relatively short time,” said Bucciotti. “This approach avoids many of the concerns such as toxicity and development of resistant bacteria associated with long-term exposure to antibacterial doping agents.”

For surface modifications and coatings, MDMs consistently prioritize solutions that are qualified, validated, and compliant with regulatory standards as essential requirements. MDMs are primarily focused on achieving specific properties that enhance both the functional performance and aesthetic appeal of orthopedic implants. Top properties include porosity and adhesion. MDMs seek coatings that maintain robust adhesion, especially under mechanical stress, reducing the likelihood of delamination over time and ensuring a reliable interface between the coating and the underlying material.

Other important properties include roughness, wear resistance, bacteriostaticity, and appearance and color. Combined, these properties collectively enable MDMs to deliver implants that are biocompatible and structurally sound, as well as optimized for wear resistance and infection control. By meeting both the functional and practical standards of modern orthopedic applications, these coatings play an essential role in advancing implant performance, smooth market approvals, and patient outcomes.

Advance and Innovate 

Although proven/standard coatings and surface treatments have fantastic track records, making the regulatory submittal process easier and shortening time to market, medical device companies and their coating providers continue to invest in new materials and products, often with combined properties that take performance to a much higher level, improving the patient experience.

For example, the Wyss Institute at Harvard University recently developed a coating from FDA-approved materials that can prevent blood clotting in medical devices, without the use of blood thinners.² The new material is a super-repellent thin layer perfluorocarbon (TLP) coating that was specifically designed to prevent clots and biofilms from accumulating on medical devices. This chemically inert material has already been approved by the FDA for many medical applications. The researchers developed a “simple, two-step process that can attach the coating to materials ranging from plastic to glass and metal,” according to a report on the technology. “When applied to catheters and perfusion tubing, TLP repelled all blood components and bacteria that can lead to infectious biofilms.” Cerulean Scientific, a medtech company in Durham, N.C., has licensed this technology to develop medical devices that resist clotting, obstruction, and infection. 

Recent advancements in nanomaterials focus on leveraging their unique properties to enhance the performance and safety of orthopedic implants. For example, Lincotek’s TiShield is an antibacterial coating based on nanosilver particles (AgNPs). Unlike traditional silver coatings that rely primarily on ion release for antimicrobial effects, TiShield utilizes the nanoparticle itself to prevent bacterial adhesion. “Due to their nanoscale size and shape, AgNPs can penetrate bacterial membranes directly, effectively killing a wide range of pathogens and minimizing the risk of implant-associated infections,” said Bucciotti. “This targeted mechanism of action not only enhances antibacterial efficacy but also supports the longevity of the implant surface by reducing bacterial colonization.”

The use of light-emitting diodes (LED) for UV-curing coatings is an advancing technology that appeals to MDMs that want to improve their production efficiency. Unlike conventional UV lamps, LED lights cure coatings at a much faster rate, which is particularly important in high-volume manufacturing. This rapid curing capability for hydrophilic coatings and other surface treatments leads to shorter production cycles and reduced lead times. In industries where a quick time-to-market is a competitive advantage, these benefits are crucial.

Regulatory and FDA challenges related to surface treatments and coatings, especially for medical devices, continue to evolve. “More stringent requirements are being introduced—for example, changes in accelerated aging tests that now include both high humidity and heat,” said Hergenrother. 

The FDA and other regulatory bodies require that medical devices undergo extensive testing to ensure they maintain their safety and performance over time. Accelerated aging tests simulate long-term conditions and help predict how materials will perform over the lifespan of the device. “The interaction between heat and moisture can accelerate the breakdown of polymeric materials, making it even more critical for manufacturers to ensure that their coatings are resistant to such environmental stresses,” added Hergenrother.

In January 2024, the FDA issued a draft guidance document titled “Characterization of Metallic Coatings and/or Calcium Phosphate Coatings on Orthopedic Devices,” which updates earlier guidelines from 1995 and 2000, particularly superseding prior guidance on HA coatings and plasma-sprayed metallic coatings. The draft raises the possibility that aging tests may soon be required for titanium coatings despite the well-established durability of metallic elements like titanium. Additionally, the guidance now regulates dual-layer coatings more explicitly, addressing areas that may have previously been ambiguous. The draft indicates testing evidence will be required for both single-layer and dual-layer coatings, which could increase the overall testing burden. 

“Medical device manufacturers will also want to consider whether their approach needs to be adjusted and catered to the specific nature of the coating, given the ongoing innovation in this field,” stated Ryan Siskey (et al), office director and principal for biomedical engineering and science at Exponent, an engineering and scientific consulting firm. “For example, polymeric substrates and additive manufactured materials are briefly discussed in the proposed guidance, but will require additional considerations during the design process.”³

In the U.S. and the EU, regulatory agencies have implemented policies to ensure medical devices using biocompatible coatings meet safety and performance standards. For instance, the Active Implantable Medical Devices Directive regulates high-risk devices, while the FDA has various clearance and approval processes. Medical coating manufacturers must adhere to these regulations due to the high risks involved. “However,” said Technavio, “separation issues, such as peeling, flaking, shedding, and delamination, do pose challenges. The FDA has analyzed the impact of coatings separation from intravascular medical devices. These regulations present hurdles for vendors, and the increasing number of separation issues may lead to more stringent regulations, potentially hindering market growth in the next few years.”

In the medical field, the stakes are high. Patient health and safety are paramount. Surface treatments and coatings must perform as intended or patient injury or death could result. An ever-present concern is the risk of hospital-acquired infections, biofilm accumulation, and contaminated medical device surfaces. Coatings must also be durable enough to withstand sterilization cycles without compromising their chemical and mechanical properties. “The medical coatings market must address these significant challenges to ensure high-quality healthcare and patient safety,” stated Technavio.

One of the best ways of achieving this is through collaboration. MDMs seek out innovative surface-treatment partners with deep expertise that can work together to solve some of their toughest coating challenges. This is most successful when surface treatments are discussed in the design for manufacturing stage, preferably in the earliest design efforts. 

Sometimes a little “art” is required to develop a surface treatment that meets all the performance parameters expected for a medical device, which can be complex or even first of its kind. 

“There is no one best medical device coating,” said Todd Paulsen, vice president of Formacoat, a medical device contract manufacturer based in Chaska, Minn. “Developing a wide network of experienced coating vendors, and accessing their technologies and expertise, enables us to tackle intricate coating challenges. We work with over 45 different coating formulators that offer over 90 different coating chemistries and technologies. They use these different technologies to address the specific needs and challenges of each device in creative, robust, and cost-efficient ways.”

References

1. tinyurl.com/mpo250401
2. tinyurl.com/mpo250442
3. tinyurl.com/mpo250443

Mark Crawford is a full-time freelance business and marketing/communications writer based in Corrales, N.M. His clients range from startups to global manufacturing leaders. He has written for MPO and ODT magazines for more than 15 years and is the author of five books.