Every component of a medical device must withstand intense regulatory scrutiny before reaching the market. For design engineers and manufacturers, the approval process is rigorous for the device itself as well as for each material and component within it. Lubricants are not exempt from this scrutiny. While often hidden within the mechanics of syringes, auto-injectors, surgical tools, or diagnostic equipment, lubricants perform essential functions such as reducing friction, damping shock, and ensuring reliable performance of the medical device over time.
When these lubricants are intended for use in medical environments, often they must also be biocompatible, which requires passing the stringent ISO 10993 series of tests that evaluate cytotoxicity, systemic toxicity, and skin irritation. Although there is no official category designation for “medical-grade lubricants,” the industry increasingly looks to formulations that can meet these toxicity and irritation benchmarks, especially when there is potential contact with living tissue. Device manufacturers must simultaneously consider whether a lubricant improves performance and whether its inclusion will jeopardize the medical device approval process.
Why testing matters
The approval process for medical devices is both costly and time consuming. Failure after submission to a regulatory body for biocompatibility can mean significant delays, lost investment, and even the need for complete redesigns. Lubricant suppliers that pre-test their products against relevant ISO 10993 endpoints are therefore helping customers remove a major source of risk.
Unless they have met all required endpoint testing, biocompatible lubricants are not designed for implantation. However, when used in external or transient contact devices, these materials must still undergo testing to demonstrate that they do not produce detrimental cellular responses and are suitable for incidental contact with the human body. With this assurance provided by lubricant suppliers, manufacturers can move forward with confidence that their lubricant will meet biocompatibility regulatory requirements. This allows design teams to focus on the performance benefits a lubricant offers, such as motion control, durability, or assembly precision, rather than worrying about unexpected compliance setbacks.
The medical device industry emphasizes data driven assurance and performance validation. Lubricant suppliers support this by providing clear evidence through test reports that demonstrate compliance with regulatory standards, compatibility studies across plastics and elastomers, mechanical behavior, and performance under sterilization conditions.
This reliance on verifiable data gives manufacturers and regulatory bodies confidence in lubricant selection. By sharing transparent, measurable results, suppliers strengthen trust and help device designers move forward with clarity. This is an especially critical factor in a field where delays or failures can carry significant financial and reputational costs.
Sterilization and harsh environments
Medical devices may be required to endure a range of sterilization methods before and after use. From gamma radiation and ethylene oxide to steam autoclave, each protocol places unique environmental stresses on device components, and lubricants that degrade under these conditions can compromise device performance and integrity.
Biocompatible lubricants must therefore be engineered to withstand both regulatory and functional demands. Their ability to withstand sterilization without breaking down, leaching, or altering mechanical performance is a crucial advantage. For example, damping greases used in auto-injectors must reliably control spring forces, timing, and “feel” even after enduring terminal sterilization like gamma and possible variation in storage conditions. In many cases, lubricants offer a cost-effective alternative to more complex mechanical redesigns, solving problems of tolerance stacking, shock absorption, and wear prevention in scalable ways.
Material compatibility and expanding portfolio
One of the most pressing concerns in medical device engineering is compatibility with the wide range of materials used. Plastics now make up more than 80% of a typical medical device, and interactions between lubricants and polymers can lead to embrittlement, swelling, or reduced performance.
Traditionally, silicone oils and greases dominated this space as they are known to be chemically inert, biocompatible, and well tolerated by the body. While effective in some applications, silicone formulations fall short in others, particularly in bearing or metal-on-metal contact points where durability is essential. To address these gaps, suppliers have developed a broader portfolio of base oils, including polyalphaolefins (PAOs), esters, and perfluoropolyether (PFPE) formulations, that expand an engineer’s toolkit.
PFPE-based lubricants, for instance, are compatible with virtually any material, making them ideal for O-rings and seals. PAO lubricants offer proven performance in connectors and metal on metal interfaces. By moving beyond silicone, medical device designers gain flexibility in addressing complex material pairings without compromising performance.
Biocompatible lubricants offer versatility across a wide array of medical device categories, from powered surgical tools and diagnostic equipment to advanced assembly processes and robotic systems.
Addressing industry misconception
A common misconception is that a “medical-grade” lubricant represents a recognized certification. In reality, the term is often used loosely as a marketing phrase. Without ISO 10993 data to support it, the designation carries little weight. Forward-thinking suppliers focus instead on transparent testing and clear documentation, helping device manufacturers navigate claims and identify trusted solutions.
Another misconception is that lubricants are merely an add-on that can help prevent friction. In fact, their role is often more expansive. By mitigating wear, controlling motion, and compensating for dimensional variances, lubricants directly influence reliability of medical devices, resulting in improved user experience and patient outcomes. In auto-injectors, for example, damping greases determine how smoothly a drug is delivered and how comfortable the process feels to patients.
Meeting emerging challenges
The miniaturization and automation of medical devices are creating new demands on lubricants. As devices shrink and tolerances tighten, the margin for error narrows. Automated surgical tools and robotic systems require lubricants that not only reduce friction but also preserve precision under continuous, high intensity use. At the same time, regulatory and environmental pressures are reshaping the industry. Concerns about PFAS “forever chemicals” in certain lubricant thickeners have driven demand for alternatives. Some suppliers have already responded with damping greases specifically formulated without PFAS, allowing customers to meet both compliance requirements and sustainability goals.
FUCHS Lubricants, the world’s largest independent lubricant supplier, has positioned itself as a leader in this evolving landscape through its medical segment and legacy expertise in lubricants. The company maintains an ISO 13485 quality certification and tests products from its NYEMED product line against ISO 10993 biocompatibility requirements for cytotoxicity, systemic toxicity, and skin irritation.
Rather than offering a one size fits all solution, FUCHS engages closely with customers to evaluate the interactions between materials, operating environments, and specific application demands. For example, engineers must consider whether a device will face gamma sterilization, involve delicate elastomeric seals, or require damping forces for controlled motion. FUCHS’ consultative process helps ensure that the lubricant chosen meets functionality and regulatory benchmarks and keeps the product on track for approval.
The company partners with medical device designers through each step, from initial prototyping to post-production support. Sales engineers and research and development experts collaborate closely with customers, helping to navigate design challenges and select the optimal lubricant for each application based on materials, environment, and performance demands.
FUCHS invests in custom formulation projects when standard solutions cannot meet unique application needs. Collaborating directly with design engineers, the company has delivered industry-first solutions, such as PFAS-free damping greases, to address evolving regulatory and customer requirements while ensuring both compliance and exceptional performance.
FUCHS has a broad base oil portfolio to include silicones, PAO (“synthetic hydrocarbon”), PFPE and ester chemistries, offering device designers options that extend far beyond traditional choices.
Future of biocompatible lubrication
As medical technology advances, the role of reliable, compliant lubrication becomes increasingly critical. Biocompatibility serves as a foundation that prevents lubricants from becoming a hidden obstacle in regulatory approval, allowing manufacturers to focus on achieving performance, precision, and enhanced patient outcomes through advancements in formulation.
By anticipating regulatory changes, expanding material compatibility, and partnering closely with device manufacturers on complex design challenges, suppliers like FUCHS empower the industry to deliver innovative, high-performing medical devices with confidence. This proactive, data-driven approach is minimizing regulatory and operational risk and driving the next generation of medical device innovation and reliability.
Joseph Sahl is head of global business segment-medical, FUCHS Lubricants
