The burgeoning development of more sophisticated medical devices is also encouraging the production of more innovative medical device coatings that are expected to improve the functionality and safety of these therapeutics.

With more than 100 new devices gaining approval by FDA since 2020, demand for coatings has never been greater. According to a new report that forecasts the distribution of coatings and surface modification technologies over the next 12 years, that demand has prompted developers to introduce more biocompatible, high-performance coatings that can meet the operational, clinical, and engineering requirements for the various devices coming to market.

“In order to gain an edge in this competitive industry, coating providers are continuously undertaking initiatives to upgrade their existing material offerings and coating solutions for medical devices,” said Pemba Lahmo, senior analyst with Roots Analysis, a market research and consulting organization that serves the pharmaceutical industry and is focused on providing views and research on key industry issues.

The Medical Device Coatings and Surface Modification Technologies Market report released by Roots Analysis in January provides an extensive study of the current market landscape, recent developments and trends, and future potential of medical device coatings and surface modification technologies. Among the report’s core elements are:

Covering key concepts and questions on medical device coatings

The report covers a list of more than 115 technologies that are currently available in the market for the enhancement of surface functions of the medical device. Some examples of these products include Cadence (VaporTech), Endura (Endura Technologies), IonGuard (N2 BioMedical), and PhotoLink (Surmodics).

 “In order to highlight the different strategies adopted by stakeholders in this industry, we have conducted a detailed company competitiveness analysis,” said Lahmo. “In this module, we have compared the coating providers engaged in this industry by scoring several relevant parameters. For each parameter, we have provided scoring based on general trends and publicly available resources. The report also answers a host of key questions, according to Lahmo, including:

Examples of the complex medical devices covered in the report include implants, surgical equipment, catheters, and other types of invasive devices. Various manufacturers are using novel surface modification technologies to enhance the physiochemical properties, frictional resistance, and, in certain cases, the layout of the substrate while adding on to the device properties, the report found. Driven by the surge in demand for various types of medical devices and the need for an array of coatings, the market is anticipated to witness a steady growth in the coming decade.

According to Lahmo, the report also sheds light on the importance of the quality of coatings and surface modification technologies as they become more utilized.

“Based on our research, whenever the process of coating a medical device is suboptimal, it leads to a number of challenges, such as uneven coating, peeling, or flaking,” she said. “This can lead to batch-to-batch variations in the medical devices as well as deterioration of medical devices over the period of time, if protection is the primary purpose of the coating. Additionally, the peels, if made of polymers, can be carcinogenic in nature, which could lead to the development of oncological disorders in the case of implants.”

 Coatings On The Horizon

At  Theradaptive Inc., a biotechnology company based in Frederick, MD, that specializes in therapeutic delivery platforms, physician Luis Alvarez, PhD, is leading a team that’s poised to deliver coatings for implants that are made of material-binding osteoinductive proteins that offer precise localization of bone formation and consistent fusion without off-target effects for dental and spinal patients.

“We are really opening the door to the delivery of full recombinant protein therapeutics as a new mode of presentation as part of an implant,” said Alvarez, who founded the company in 2016 and serves as chief executive officer. “Where others are trying to deliver small molecules or other drug-releasing modes of presentation as part of an implant, we see protein therapeutics delivery as an emerging field. We feel like we’re a pioneer in this space that will open up to more opportunities and competition.”

At the Orthopedic Research Society annual meeting in Dallas, TX, in February, the company demonstrated how coating an implant with its proteins resulted in 100% fusion compared to the 60% associated with current autograft technologies that have been linked to adverse events such as inflammation and bone growth in unwanted areas. By modifying rhBMP-2 to create a material-binding protein variant AMP2, Theradaptive has created a protein that retains bone-growth ability in a more precisely localized way. The process binds AMP2 to ReBOSSIS, a 510K-approved implant material, to create its Osteo-Adapt SP Spinal Fusion implant, reportedly a safer alternative to commercially available rhBMP-2.

“For the first time in the development of medical devices, we can very safely deliver large doses of therapeutic proteins with the control and precision of the device that’s being implanted,” Alvarez said. “In spinal fusion, which is our lead indication, we can form bone between vertebrae and eliminate the need for revision surgery. About 25% of all spinal injuries need revision, but our therapeutic forms bone so reliably that we eliminate the need for revisions. The mode of presentation that we offer is much more potent because the biologic or therapeutic is not hidden until a later release.”

Alvarez, a former war veteran who developed the concept for the targeted regeneration platform during and following a combat tour in Iraq where several of his soldiers suffered severe extremity injuries, said the company will be entering its first human trial later in 2023 for spinal fusion and Osteo-Adapt could be available to the market in 2026.