The Challenges of Medical Device Development
Machining small-scale parts related to medical instruments, surgical instruments, surgical implants and orthopedic devices is particularly difficult because implanted devices often consist of microscopic components. Many medical devices also require machining titanium, PEEK and other biomaterials. These materials are often used because of their non-reactivity with the body. Machining small batches of these complex parts is vital because new devices or prototypes need to be refined quickly.
Exotic materials aren’t the only challenge in machining medical devices. Medical micromachining, using CNC milling and turning, is also a critical aspect of medical device manufacturing. A good inventory of vertical machining centers and multi-axis lathes are needed to have the flexibility and capacity to machine a wide range of products: from micro components to complex, reusable instruments for hip, knee and spine procedures.
The third crucial component to machining medical devices is keeping integrity with highly complex models. Using 5-axis high-speed milling and multi-axis turning capabilities allows for the machining of complex shapes in a single set-up, thus reducing high production costs and potential errors. In addition to speed, accuracy, and time savings, using 5-axis CNC milling is a cost-effective alternative to multiple fixturing for prototypes. The 5-axis CNC milling process produces a more accurate part as multiple sides of the part can be machined without losing positional accuracy.
Medical Device Contract Manufacturing
Medical device contract manufacturing companies must be diligent and aware of the many factors impacting safety and usability. Engineering and complex machining processes must meet strict industry standards in the medical market. Creating components for orthopedic devices, spine, cardiovascular, endovascular devices, pelvic, trauma, ophthalmology and other medical markets requires the knowledge of exotic metals and plastics. Attention to detail is very important as machining a micro part also requires a strict quality control department with the proper testing equipment that ensures accuracy and on-time delivery.
Above all, technicians must be highly trained, experienced, and driven toward helping clients succeed. Their work has the potential to greatly improve a patient’s way of life. Offering solutions that meet tight regulations, demands, and deadlines are required by every medical device provider. As the complexity of the parts increase, tolerances decrease. One way to meet this challenge is to use multi-function machines. There usually is not just one solution for these kinds of complex prototypes; having a machine shop that is capable of a wide range of solutions is a must.
