Medical devices have unique requirements based on their intended use and industry regulations, so knowing which high-performance plastics are right for your medical device can be tricky. This guide provides a comprehensive overview of how to choose the right medical-grade plastics for medical devices and tools.

What Is the Purpose of the Medical Device?

When looking for medical-grade plastics, the first question to consider is whether they will come into contact with the human body and, if so, for how long. Choose biocompatible plastics that are hypoallergenic and safe for long-term contact for any single-use device that must contact the human body. If you’re looking for multi-use components, you’ll need to consider biocompatibility as well as mechanical strength, sterilization, and chemical resistance.

The intended use of your medical device significantly impacts the materials and plastic supply distribution you choose. Always check the track record of materials and whether they follow regulatory rules for optimal patient safety.

Are There Regulatory Requirements for Medical Injection-Molded Devices?

Check whether your medical device must be manufactured in a white room (an ultra-clean, controlled space that prevents contamination) or meet other regulatory standards. There are three major regulatory standards that high-quality plastic products must meet for use in the medical field: CGMP, ISO certification, and FDA registration. There are, of course, more specific certifications depending on the intended use of your medical device.

For example, ISO 9001: 2015 certifies that plastic manufacturers meet quality management standards, essential for patient safety. CGMP (Current Good Manufacturing Practices) and FDA regulations certify that a plastic supply company follows government regulations. Other certifications include Installation Qualification (IQ) and Operational Qualification (OQ), essential for reliable, consistent, and safe medical use.

Choose Plastic Resins Based on Function

Your device’s intended use dictates the demands it will have to meet, so you’ll want to invest in plastic components that suit those demands. For example, if you need a strong device housing, you’ll want to invest in durable materials like polycarbonate or ABS. There are many custom plastic materials with unique attributes and advantages, like flexibility, strength, and rigidity. Choose the high-performance plastic material that meets your needs to maximize efficacy for patients and medical professionals.

Know If You Need a Biocompatible Plastic Resin

Biocompatible plastics are a staple of the medical field. They are designed to interact with the human body without triggering an immune response, exacerbating allergy symptoms, or harming patients. If your plastic device will be inside or in contact with the human body for a long time, you’ll need specialized materials to ensure safe use.

There are many ways to find biocompatible materials, like searching for FDA-regulated plastic resins or using product sourcing sites. One of the most reliable ways is to trust a plastic supply company with industry expertise. They can advise you on the best plastic resins for your intended use and supply accurate components with custom plastic fabrication.

Common Medical Devices Made from Plastic Molds

One of the benefits of high-performance plastics is their versatility. They can be used to make various medical devices and equipment, especially through custom plastic fabrication, which results in precision measurements and reliable functionality. Knowing which components can be manufactured with high-performance plastics will make it easier to decide. Some of the most common examples include syringes and needles, diagnostic equipment housing, surgical tools, and drug delivery systems.

You can streamline your supply by choosing a comprehensive custom plastic fabrication service from New Technology Plastics. We work with high-performance and general-purpose plastics to design, produce, and distribute medical tools and devices. Our in-house engineer team and advanced CAD-CAM software ensure each product meets your specifications. Call us today at 866-687-0700 or contact us online to request a quote.