Although this is a tall order, it can be made easier by breaking it down into components. One of the first and most important decisions an OEM must make when developing medical devices is choosing the right material. It is important to maintain focus on the end product as this can impact shipping prices, ease of use for healthcare professionals, and the crucial health and safety of patients. Choosing the correct high-performance polymer is key to creating an end product that will best meet the user’s needs.
There are many considerations when looking at high-performance polymer features, and taking these features one by one can help streamline the decision-making process. Among primary considerations are chemical resistance and sterilization stability. It is imperative that medical devices are able to withstand strong drugs, chemicals, and treatments they will encounter on a regular basis.
Other important considerations include material clarity, durability, and weight, all of which affect the quality and performance of the end product. OEMs should also consider materials from providers that offer support from project initiation to launch. Additional expertise and insights that are provided every step of the way can help ensure a high-performing polymer is right for a specific device and the process that follows will run smoothly.
In the hospital environment, the need to mitigate infection risks and enhance patient safety and comfort has significantly increased the demand for higher-performing plastics with improved chemical resistance. As more hospitals are pushing to reduce cases of hospital-acquired infections (HAIs), devices need to be able to withstand increased use of aggressive medical disinfectants, such as isopropyl alcohol and formaldehydes. In addition, as pharmaceutical companies continue to advance cancer treatment medicines, these devices must endure harsh new oncology drugs.
Exposure to many of these chemicals can cause cracking, crazing, and haze in many plastics, as well as lead to compromises in performance, product life, and the safety of the device. When choosing a material to be used in fluid-path and drug-administering medical devices, OEMs should make sure the plastic is resistant to the substances it will come in contact with. Certain copolyesters on the market can offer chemical compatibility with various medical disinfectants and oncology drugs to ensure the highest performance.
Evolving government regulations paired with financial incentives for HAIs has resulted in a heightened focus on patient safety. This calls for a material that retains color and functional integrity following sterilization by ethylene oxide (EtO), gamma irradiation, and e-beam methods. This sterilization is required to reduce the bioburden to a safe level while also minimizing changes to the final product’s physical and optical properties.
For patient confidence and safety, medical devices need to remain crystal clear and aesthetically pleasing while maintaining functionality. Sterilization processes, however, can affect the color and clarity of these devices. It’s important for OEMs to use materials that can undergo radiation and EtO sterilization without loss in properties and with minimal shift in color. Certain offerings perform well under applied or residual stress, and undergo no haze or color shift due to sterilization.
There are a few materials to choose from when considering sterilization stability. One option is polycarbonate, which can crack in the wet, hot environment of autoclave sterilization or when exposed to strong disinfectants. In comparison, polypropylene can be autoclaved but may then become brittle and lose clarity, reducing the safety and dependability of the product. Devices made from copolyesters can undergo radiation and EtO sterilization while maintaining strength and clarity.
When dealing with certain devices, such as those used for blood contact illnesses and diseases, an unobstructed view into a crystal-clear device is absolutely essential for patient safety. When the success of a procedure depends on a healthcare professional’s ability to view foreign substances and fluid levels, it is imperative that the medical devices being used are absolutely clear. Recognizing potential issues, such as air bubbles, and ensuring any medicine is delivered properly can prevent further health complications and infections. Crystal-clear devices also appear to be cleaner, and when clarity is compromised, the sterility and safety of the device can become questionable.
Certain materials on the market are completely transparent initially, as well as after many uses and after undergoing sterilization. This enables healthcare professionals to easily see and respond to an issue at hand, so they can quickly get back to treating their patients.
Durability and Weight
Hospitals are becoming more competitive, and expensive new technologies can give them the cutting edge. As a result, hospitals are looking for new ways to cut costs. Another consideration for OEMs is the weight of the final product and how it will affect shipping costs. OEMs should consider a lightweight yet durable material early in device development to ultimately save on shipping.
Another way to reduce shipping costs is through increased durability. Tougher products require less packaging to keep them safe, which also results in less package weight. Durability is also important for impact strength, shatter resistance, and peace of mind for products that are used repeatedly. When a device is handled regularly, it is extremely important that it not fail. For healthcare professionals, maximum durability provides confidence that their tools will stay strong time after time, so patients remain safe under their care.
As patients also look for ways to cut costs, many are opting to spend some recovery time at home instead of a hospital bed. This often requires them to take medical devices with them. In these cases, it is convenient for the devices to be as lightweight and transportable as possible.
Support Offered from Material Supplier
To better understand how a material can be worked to fit specific design needs and how it should be tested, OEMs can align with established companies that have expertise in these new materials. Collaboration early in the process and throughout can help avoid false starts and limit manufacturing disruptions.
A trusted supplier will best understand the material at hand and should act as a reliable partner in problem solving and achieving a common goal. OEMs can consider looking for an offering with technical services to guide manufacturing, proper tooling, processing, testing, and secondary operations. With an expert to guide every step of the way, the product can be brought to market as seamlessly as possible.
Breaking It Down
When considering materials to be used in medical devices, no two high-performance polymers are the same. Each differ in regard to clarity, weight, durability, chemical resistance, and sterilization stability. No two suppliers are the same either, and when an OEM is making a choice, it is important they receive the best service and support as well. The material chosen can affect price, shipping, ease of use, dependability and, most importantly, patient safety.
With so much at stake, choosing the correct material may seem like a tall order. Taking a material’s features into consideration can simplify this task. These features can be matched to the role and performance requirements of the device, so an OEM can easily decide on a high-performance polymer that fits the bill.