Hydromer is ISO 9001:2015 certified with TUV Rheinland of North America. ISO 13485:2016 is certified with BSI. 

FDA registered. Hydromer is ISO 9001:2015 certified with TUV Rheinland of North America. ISO 13485:2016 is certified with BSI.

Future-Proof Medical Devices With Durable UV-Cure Coatings

Table of Contents

The medical device industry is under strict oversight from regulatory agencies, health care providers, and consumers. For a coated-medical device to be considered safe for use they continue to perform safely and effectively after multiple uses. Medical devices need to comply with regulations, even after being sterilized and being subjected to chemical exposure. 1,2 That is where medical device coatings come into play. 

Surface-treatment coatings applied to device surfaces help ensure the long-term performance and safety of devices used on patients. 

Among the different types of medical coatings, UV-cure hydrophilic coatings are gaining popularity. This is due to their highly durable and flexible properties, fast curing times, and compatibility with many different types of materials used in the construction of medical devices.3 Modern coatings, such as Hydromer® Inc.’s HydrUV™ advanced UV-cure coatings have been shown to meet the increasingly high demands of the medical device industry.4 

In this article we will discuss the role of hydrophilic, UV-cure coatings in the medical device industry. We will also explore how these coatings provide superior durability, faster production, and resistance to harsh sterilization methods. At the end, we will explore specific advantages of advanced Hydromer’s new HydrUV™ and how it can enhance device longevity and safety across applications ranging from surgical instruments to wearables.

Understanding UV-Curable Coatings

UV-curable coatings are polymeric materials that undergo crosslinking when exposed to ultraviolet light. Conventional thermally cured coatings require heat and long cure times. UV-curable systems, on the other hand, cure within minutes, forming a dense, uniform, and highly durable surface layer.3

Key Features of UV-Curable Coatings

  • Fast Curing: Polymerization through UV light occurs quickly. This allows for rapid production rates and lower energy usage.
  • Low Emissions of Volatile Organic Compounds (VOCs): UV coatings create very few VOCs and therefore meet environmental and worker safety requirements.
  • Excellent Adhesion to Many Different Substrates: These coatings provide good adhesion to plastics, metals, and composite materials. This allows them to adhere effectively on a wide variety of common materials used in medical devices.
  • Excellent Durability: The crosslinked structure of durable UV-cure coatings provides excellent mechanical strength, resistance to chemical attack, and repeated sterilizations. All of these factors are essential for use in a medical environment. This means that the medical devices will be more durable, and last longer. 

UV-curable coatings provide mechanical strength, chemical resistance, and biocompatibility. This makes them suitable for all types of medical devices, including disposable and reusable devices such as surgical tools and wearable monitoring systems.

The Importance of Durable UV Coatings in Healthcare Devices

Medical devices encounter harsh operational conditions. This creates a clear need for durable, medical coatings that protect the devices from exposure to such harsh conditions. 

Common Processes that Can Damage Conventional Coatings

  1. Repeated sterilization: Autoclave, ethylene oxide (EtO), gamma radiation, and plasma sterilization can degrade conventional coatings.5
  2. Chemical exposure: Disinfectants like alcohols, quaternary ammonium compounds, and enzymatic cleaners can damage unprotected surfaces.6
  3. Mechanical stress: Handling, implantation, and transport impose physical strain that can induce microcracks, delamination, or abrasion.7
  4. Biological contact: Fluid or tissue exposure increases the risk of biofouling, microbial growth, and corrosion.8

The Consequences of Poor Device Surface Durability

Poor surface coating durability due to the above-mentioned processes and harsh conditions may result in: 

  • Shortened device lifespan
  • Increased failure risk
  • Infection control issues
  • Regulatory non-compliance
  • Higher replacement and operational costs

Applying durable UV-cure coatings that are hydrophilic helps mitigate these risks by providing mechanical reinforcement, chemical protection, and a smooth, sterile interface.

HydrUV™: A Next-Generation UV-Curable Coating

HydrUV™ is Hydromer’s newest line of advanced UV curable coatings for medical and life sciences applications. They provide balanced mechanical strength, chemical resistance, regulatory compliance, and optimal performance over the course of a device’s lifetime. 4,9

Technical Advantages of HydrUV™ 4,10,11

  1. Exceptional Adhesion
    HydrUV™ is a premier hybrid-coating product that safely bonds (adheres) to a variety of substrates. These include polymers (PC, PEEK, TPU), metals (stainless steel, titanium), and hybrid composites. Thus, it provides the required surface integrity for all components within a device assembly while minimizing the potential for delamination between component assemblies.
  2. Resistance to Sterilization and Chemicals
    The coating can be exposed to multiple autoclave cycles at high temperatures, ethylene oxide sterilization, and plasma sterilization. These films are also unaffected by typical cleaning products. As a result, devices maintain their surface integrity and performance characteristics after numerous sterilization cycles.
  3. Mechanical Strength and Flexibility
    HydrUV™ provides the best balance of hardness and flexibility. This prevents the coating from being scratched or abraded. It also helps the coating from cracking when bent due to its flexibility.
  4. Surface Functionality and Hydrophilicity
    The coatings’ tailored surface properties help reduce fluid adhesion, microbial growth, and biofouling. The result is a safer, more hygienic environment for patients and employees in a clinical setting.
  5. Rapid UV Curing for Efficient Production of Devices
    UV curing permits faster production cycles. It reduces the amount of energy consumed during the coating process. It also lowers the overall operational cost of applying the coating while preserving the physical and functional characteristics of the HydrUV™ coating. These coatings are suitable for automated coating lines.
  6. Biocompatibility and Hemocompatibility
    UV-Cure  HydrUV™ is a biocompatible and hemocompatible coating. The coatings are formulated for use on cardiovascular, circulatory, neurovascular, urological, and vascular devices.

Suitable Devices for Durable UV-Cure Coatings

1. Reusable Surgical Instruments

Surgical instruments sterilization through heat and mechanical means is a rigorous process. The use of UV-curable coatings on devices increases their lifespan, retains surface properties on the exterior, and minimizes microbes’ adhesion to their surfaces. All of these help manage infection control while also enhancing dependable clinical use.12

2. Wearable Devices

Wearables experience daily user handling and exposure to moisture and environmental conditions. Application of UV-curable coating increases the longevity, durability, and comfort of wearable surfaces while providing a consistent performance and ability to sanitize them.13

3. Diagnostic Instruments

Point-of-care analyzers and lab equipment both require a precise, smooth surface for the performance of fluid handling and optical clarity. UV-curable coatings provide chemical resistant, low-friction surfaces. They also help the devices perform consistently, allowing reduced time, equipment maintenance, and improved diagnostic accuracy. 14

4. Implantable Devices

The surface integrity of an implant device has a direct effect on tissue compatibility, corrosion protection, and biofouling. UV-curable coatings provide long-term stability, offer a functional coating on devices that extend their life, and help ensure patient safety.9

Learn more about Hydrophilic Implant Coatings.

How Durable HydrUV™ UV Coatings Help Future-Proof Medical Devices

Several trends are shaping the future of the medical device industry, and device makers will need to meet these trends in order to keep thriving.

Some of the biggest trends in the medical device market include: 

  • Devices with extended usability and life 
  • products that have the highest level of cleanliness and safety 
  • Standardization of medical device regulations between countries (i.e., global/multinational); Increased use of environmentally sustainable means of creating and producing medical devices 

Hydromer’s HydrUV™ technology, allows OEMs to produce innovative, durable, and high performance devices. In turn, their products will be well suited to meet these trends and provide patients with long-term safety and reliability. 

By utilizing HydrUV™ coatings, manufacturers of medical devices can:

  • Increase the longevity of medical devices.
  • Deliver repeatable and reliable performance in challenging environments
  • Simply the regulatory pathway to market
  • Lower their production and environmental impact 

Conclusion

In the medical device industry safety, performance, and regulatory compliance are of utmost importance. Surface coatings can be used as strategic enablers in the area of device development. In particular, highly durable UV-cure coatings, such as HydrUV™ offer enhanced durability, fast curing times, multi-substrate adhesion, resistance to sterilization, biocompatibility, and tunable surface properties. These benefits offer a coating that helps manufacturers future-proof their medical devices. 

For device manufacturers, deciding to use UV-cured coatings should be viewed as more than just adopting a new technology. It should be looked at as making a strategic business decision to enhance patient safety and operational efficiency as well as competitiveness in the global marketplace. HydrUV™ medical device coatings give manufacturers a dependable means to address the growing pressures being placed on their devices by the global healthcare industry today and tomorrow.

References

Click to see all references for this article.

1. World Health O. WHO global model regulatory framework for medical devices including in vitro diagnostic medical devices. 2017;

2. Cheng M. Medical device regulations: global overview and guiding principles. 2003;

3. Patil RS, Thomas J, Patil M, John J. To shed light on the UV curable coating technology: Current state of the art and perspectives. Journal of Composites Science. 2023;7(12):513. 

4. Hydromer. HydrUV™: Revolutionizing UV Medical Device Coatings. https://hydromer.com/hydruv-revolutionizing-uv-medical-device-coatings/

5. Beh CC. Sterilization Techniques of Biomaterials (Implants and Medical Devices). Biomaterials and Biopolymers. Springer; 2023:255-269.

6. Aranke M, Moheimani R, Phuphanich M, et al. Disinfectants in interventional practices. Current Pain and Headache Reports. 2021;25(4):21. 

7. Chong MSK, Teo YE, Teoh SH. Fatigue failure of materials for medical devices. Degradation of Implant Materials. 2012:303-328. 

8. LoVetri K, Gawande PV, Yakandawala N, Madhyastha S. Biofouling and anti-fouling of medical devices. Biofouling: Types, Impact and Anti-Fouling. 2010:105-128. 

9. Hydromer. UV Curing for Medical Devices: Role of PEG, PVP, Chitosan. Hydromer. https://hydromer.com/uv-curing-for-medical-devices-role-of-peg-pvp-chitosan/#:~:text=Materials%20like%20PEG%2C%20PVP%2C%20and,%2C%20and%20drug%2Dreleasing%20stents.

10. Hydromer. Why HydrUV™ Hydrophilic Medical Coatings Use UV-A Curing. https://hydromer.com/why-hydruv-hydrophilic-medical-coatings-use-uv-a-curing/

11. Hydromer. Medical Device Coatings. Hydromer. https://hydromer.com/medical-device-coatings/

12. Ding W, Zhao Z, Jiang L, Jian X, Song Y, Wang J. Preparation and evaluation of a UV-curing hydrophilic semi-IPN coating for medical guidewires. Journal of Coatings Technology and Research. 2021;18:1027-1035. 

13. Mendes‐Felipe C, Oliveira J, Etxebarria I, Vilas‐Vilela JL, Lanceros‐Mendez S. State‐of‐the‐art and future challenges of UV curable polymer‐based smart materials for printing technologies. Advanced Materials Technologies. 2019;4(3):1800618. 

14. Soucek MD, Ren X. UV-Curable Coating Technologies. In: Tiwari A, Polykarpov A, eds. Photocured Materials. The Royal Society of Chemistry; 2014:0.

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