Manufacturing reliable medical parts is a foundation of successful long-term clinical trials. These components ensure accurate test results, safeguard patient safety, and meet stringent regulatory requirements. For medical device companies venturing into clinical trials, understanding the process and collaborating with expert manufacturers can make all the difference.
At Extreme Molding, we recently partnered with a medical equipment company to manufacture silicone components for their clinical trials. Using injection molding, we delivered precise, high-quality parts that seamlessly integrated with the client’s plastic injection-molded components. Here’s what we’ve learned from that experience and how it applies to manufacturing specific parts for the medical sector.
In clinical trials, precision and reliability are non-negotiable. Each medical part plays a vital role in generating accurate data, minimizing variability, and ensuring patient safety. Manufacturing defects or inconsistencies in the healthcare sector can lead to trial delays, increased costs, or compromised results. This highlights the importance of manufacturing dependable medical components for trial success.
Creating medical components for clinical trials presents unique challenges, such as:
Success starts with aligning on inspection criteria early in the process. During our recent project, we followed ISO 13485 procedures to maintain tight process control and ensure quality. The client provided specific inspection criteria, which we met by implementing tailored manufacturing and inspection controls.
Addressing potential risks upfront - such as variations between prototype and production tooling—is equally important. Clear communication with the client about these risks enabled us to set realistic expectations and ensure a smooth process.
Selecting the right materials is critical for manufacturing specific parts for the medical sector. Materials must meet performance requirements, comply with safety standards, and align with the unique needs of the clinical trial. In our case, the client pre-specified the silicone material, and we ensured its performance matched the trial’s demands.
Compliance with regulatory standards, such as ISO 13485, is essential in medical parts manufacturing. This certification ensures that processes are validated, documented, and controlled to produce reliable components. Our commitment to ISO 13485 enabled us to deliver consistent results while adhering to stringent healthcare industry standards.
Rigorous testing is a crucial step in ensuring the reliability of medical components. During our recent project, minor deviations in wall thickness occurred due to a core shift during injection. By maintaining clear communication with the client, we identified the issue, tested the parts, and obtained approval for deviations. This adaptability minimized delays and maintained trust.
Collaboration between manufacturers and medical device companies is fundamental to successful clinical trials. From the outset, we engaged in clear communication with the client, discussing design requirements, risks, and production constraints. Their use of plastic injection molding for some components aligned seamlessly with our injection molding of silicone parts, creating a cohesive solution.
In this project, the client used plastic injection molding for their main components but required silicone parts to complete the assembly. Injection molding provided the precision and consistency needed to meet their unique demands. This blend of technologies underscores the importance of working with a manufacturer that can complement your existing processes.
For companies embarking on clinical trials, here are our top recommendations:
At Extreme Molding, we specialize in manufacturing reliable components for the medical sector. Whether you need help with silicone injection molding or integrating with other technologies, our team is here to support your clinical trial success. Contact us today to learn more about our capabilities.