Cedric Perben, EMEA medical application development, Eastman Chemical Company explains
Today’s medical device designers and original equipment manufacturers (OEMs) are increasingly under pressure when developing or improving medical devices. One of the biggest decisions they make is selecting a material for their device — the right choice helps meet the end-user’s needs while the wrong choice can lead to issues later.
High-performance polymers are the future of medical devices, as they help better address patient needs and last longer. However, the choice doesn’t end there. Key considerations still need to be made when selecting the most appropriate high-performance polymer for device design. These considerations often include ensuring the material offers chemical resistance, sterilisation stability, design flexibility and superior clarity.
Another key consideration is finding a supplier that offers much more than just a product. From project initiation to product launch, offering technical expertise and sharing application development insights can help ensure a high-performing polymer is right for a specific device.
Check the boxes
A checklist is the simplest way to ensure a material is meeting a device’s every need, especially when navigating the many advantages of high-performance polymers. Cipher Surgical made sure to check all of the boxes when improving its OpClear device, ultimately selecting Eastman Tritan copolyester. To eliminate the need to remove a laparoscope from a patient during surgery, OpClear allows a surgeon to clean the lens of collected liquid, fatty residue and other contaminants with a short, controlled jet of carbon dioxide and saline. By decreasing, or even eliminating, the necessity to remove the laparoscope for cleaning, the device reduces operative time and maximises patient safety.
1. Will your device need to withstand contact with harsh drugs and destructive disinfectants?
As more hospitals are pushing to reduce cases of infections and treating patients with the best medication available, many devices need to be able to withstand aggressive disinfectants and harsh drugs, such as those used for oncology patients, without breaking down. In fact, hospitals are standardising the use of harsh disinfectants in their processes to ensure simplicity and consistency.
Although the first generation of OpClear was a success, the device was made with nylon, which reacted poorly to certain cleaning chemicals, inhibiting the product’s full potential. To prevent the device’s early breakdown, Cipher chose Eastman Tritan copolyester for their next-generation device. The material is resistant to a large spectrum of fluids used in hospitals, including aggressive cleaning disinfectants, powerful drugs including those used in oncology, drug carrier solvents and lipids. This resistance helps decrease the risk of the device cracking and discolouring, therefore increasing patient safety.
2. Will your device need to undergo sterilisation and come out unscathed?
Many devices used in hospitals need to undergo sterilisation processes — such as e-beam, gamma radiation and ethylene oxide (EtO) methods – to reduce the bioburden to a safe level while also minimising changes to the final product’s physical and optical properties. These processes can affect a device’s colour and clarity, and also cause cracking and loss of critical properties. A material must be able to withstand sterilisation processes and remain unscathed after repeated uses.
When redesigning OpClear, Cipher needed a material with sterilisation stability because the device underwent these processes prior to every use. Eastman Tritan copolyester is resistant to sterilisation techniques without jeopardising the polymer performance, offering no risk of colour shift to yellow – which can cause devices to be seen as contaminated – and no physical property malfunctions.
3. Will you need to see the substances inside your device?
Devices made from crystal-clear material provide healthcare personnel with unobstructed views that let them more easily — and quickly — see foreign substances, bubbles, fibres from sanitising cloths and fluid levels, which helps keep patients safe.
For OpClear, a material with superior clarity allowed for visual confirmation that the device was working, as well as helped keep the laparoscope visually similar to what surgeons are used to. Eastman Tritan copolyester offered the clarity Cipher was looking for, especially as the material remains just as clear after the device’s intended use and sterilization.
4. Will you need additional support in terms of technical expertise and application development?
To better understand how a material can be worked to fit specific design needs and how it should be tested, designers and OEMs can consider aligning with established companies that have expertise in these new materials and are willing to work together. Collaboration from the onset — and throughout the value chain — can help ensure the right material is selected, the design process runs smoothly and the product is brought to market as seamlessly as possible.
- o improve the original OpClear, Cipher worked closely with Eastman’s technical and application development experts and those from moulding company Ci Medical Technologies. The collaboration ensured each company’s expertise was used to optimise the moulding process with the new material.
Reviewing the checklist
Access to high-performance polymers that better address customer and end-user needs allows designers and manufacturers to meet the growing demand for medical device innovation. With some simple considerations – and by using an easy checklist to make sure a material meets a device’s needs – designers and OEMs can better assess which material is right for them.