How to choose the right polymer for your medical device?

Comfort. Quality. Safety. Effectiveness. As a manufacturer of medical devices, you’re aiming for all of these features in your device. And choosing the right polymer material is just one of several important aspects to consider. But how?

22 June 2023 | 3 minutes read | Share article:

Advancements in medical research, cutting-edge innovations, and better patient outcomes – medical devices have made huge contributions in all of these areas. An integral part of modern healthcare, they’ve helped save lives, treat diseases, and relieve pain. But where patient safety is paramount, there will always be challenges. And one of the most critical challenges in developing a safe, effective medical device is choosing the right polymer.

The challenge of polymer selection

As a manufacturer, selecting the most appropriate polymer for your medical device is a complex process, demanding a deep understanding of the specific medical application and properties of the polymer options available. You need to think not only about the requirements of the device itself – its functionality and its intended use – but also about the material properties it needs to have. Consider factors like sterilisation and chemical resistance: there are all sorts of polymers out there designed to withstand different temperatures and chemical exposures in different environments.

With more than 20 years of experience, IMCD’s Advanced Materials medical experts are here to support you on the technical specifications, material properties, and testing requirements for your medical device.

Regulatory requirements

When it comes to medical devices, meeting the regulatory requirements is of the utmost importance. For instance, making sure you’ve got biocompatibility certificates for the polymers used can help you be prepared before seeking approval for your device. Upon request, we can supply you with the documents you need to fulfil your local requirements.

Supplier support

Having met the challenges of the device requirements and the applicable regulations, the next step is to work closely with your polymer supplier (or distributor) to make sure you get the best possible support. You’ll want to choose a supplier that can provide input on product-related services, in combination with technical expertise. For instance, it could be helpful to understand upfront to what extent sample material (or production material at a later stage) is available, and the lead times that need to be taken into account. It’s also important to know the minimum order quantity, and to discuss what happens if it cannot be met. When it comes to your supplier, it’s essential to allow as many questions as possible – from both sides.

Guiding you through

Are you in the process of developing a new or next-generation medical device, and you’re looking for the perfect polymer? Our checklist of essential considerations gives you an overview of the key aspects to consider when selecting a polymer. Set yourself up for success and download it for free.

Still have questions? Our team of medical experts at IMCD Advanced Materials can guide you through the technical specifications, supplier dilemmas, regulatory concerns or all three. Reach out to us today!

ARTICLE BY

Jana Zietzling

Head of Product Management Medical, Advanced Materials

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Fast facts

How important is polymer selection in developing a medical device?

Polymer selection is crucial in developing a medical device as it directly impacts the device's comfort, quality, safety, and effectiveness. Choosing the right polymer requires a deep understanding of the specific medical application and the properties of the available polymer options. Factors like sterilization, chemical resistance, and functionality of the device need to be considered to ensure optimal performance in different environments.

What regulatory requirements should be considered when selecting polymers for medical devices?

How can a polymer supplier provide support in selecting the right polymer for a medical device?

Working closely with a polymer producer or distributor is essential to obtain the best possible support in selecting the right polymer for a medical device. A reliable supplier can offer technical expertise and provide input on product-related services. It is important to discuss factors such as sample material availability, lead times, minimum order quantity, and potential challenges that may arise. Effective communication and collaboration with the supplier help address questions and ensure a successful partnership.