Whether designing a prototype or looking for a company for medical device molding of already developed parts, choosing the best possible company for the job is essential.
There are many different needs for medical device molding including in blood and body fluid analysis and testing, artificial heart components, parts for orthopedic devices, catheters, surgical equipment and a wide range of different devices and components. Some of these are very small and detailed while others may be larger and simpler in design.
Regardless of the specific parts required for a medical device molding order, it is essential to choose a service that can provide full compliance with the specified tolerances. They should also be aware of the applicable FDA regulations and requirements, particularly if they are involved in prototype development of new and innovated technologies yet to be approved.
Selection of Materials
One of the most important forms of support a medical device molding company can offer is to assist in selection of the most appropriate materials given the type of conditions the component will operate under.
Knowing the latest in polymers, high-temperature thermoplastics, resins and thermoplastic elastomers will be critical. However, there is also an increasing demand for bio-resorbable resins, which many researchers now work with to help reduce the risk of tissue damage and stress on patients.
There are some companies offering these specialized services that also provide production of dental implants and dental devices. This experience and versatility can assist in reducing the number of groups involved in the production of medical or dental components, reducing the risk of missed deadlines and delays.
Range of Experience
Not all companies providing molding services have experience in the medical field. Since there are very specific requirements including the need for cleanroom micro molding and to be ISO 13485 certified for many medical device molding jobs, choosing an experienced, established, and reputable company is the best option.
Look for a company with extensive medical molding experience as well as the actual latest in technology and equipment on-site. A few companies have global reach and can carefully select specific jobs for production facilities that are uniquely designed to handle these types of demanding requirements.
It is certainly worth the time to go online and learn about the different companies offering medical device molding services. Review information, ask questions, and learn about the company before placing an order.