Medical devices play a vital role in the health care industry. Guidewires, intravascular catheters, delivery sheaths, balloon angioplasty catheters, and implant delivery systems find extensive application in diagnostic and therapeutic procedures. The manufacturing processes for medical devices is a complex one because they have to match the stringent specification, quality, and safety requirements. These devices often have hydrophilic coatings to cut down friction between themselves and blood vessels and make procedures simpler by offering greater maneuverability to the physicians. But for the coatings to be effective enough, manufacturers need to be extra careful with the choice of materials. Here are some factors that decide whether a material is good enough.
Hydrophilic coatings are used on the surface of devices for providing adequate lubrication so the patient gets pain-reducing benefits during the procedure. Complex medical procedures like advancing a catheter through a blood vessel resulting in natural resistance due to static friction. A hydrophilic surface coating is capable of reducing resistance so that the catheter can slide more easily inside the patient’s body. Proper lubrication means that the entire process will cause minimal pain and discomfort for the patient during the procedure. It becomes all the more important for implantable devices like stents that stay inside the patient’s body for the long haul.
When it comes to medical implants, durability is a factor that matters a lot because surgery is considered successful only if the implant lasts for an expected period. Ideally, the coatings should offer an extended lifespan so that it does not degrade over time. When manufacturers consider the properties of hydrophilic coatings, they need to ensure that the said material would not diminish the effectiveness of the device or reduce the comfort level while in use. Apart from lifespan inside the body, it is also important to look for long storage shelf life. The coating should ensure that the sealed device stays usable and sterile inside the packaging until it is deemed to be expired.
When it comes to the effectiveness of hydrophilic coating material, safety is a factor that manufacturers need to prioritize. Safety refers to the biocompatibility of materials that the devices are made of so that there is no risk of reactions once the device enters the patient’s body. Another aspect of coating safety is pyrogenicity, which refers to the levels of endotoxin and other pyrogens as these are associated with the risk of infections in the patient. Coating separation or degradation is another concern as it may adversely impact the clinical performance of the device. It can cause complications such as inflammation at the access site, pulmonary infarct, pulmonary embolization, myocardial infarct, embolic stroke, myocardial embolization, tissue necrosis, cerebral infarct, or even death.
As a norm in the industry, medical device manufacturers have to go through an intensive procedure for process validation to get approval for their process. The purpose is to ensure that the process as well as its detailed aspects, including device coatings, are safe and effective so that the patients get the best and the safest products.