Implementing repeatable processes keeps risks in check, and helps ensure a consistent, quality product. The team should flow chart production for the entire device. Describe what is required at each step. From that description, simple design or fixture changes can be identified to produce efficiencies that improve manufacturability. For example, a mold could be designed such that its gate and injection locations do not interfere with fixture locations. Or, molds might be tweaked to improve material handling by changing the part orientation. This simple change can allow automation to flow more smoothly by making it easier for machines to access the part.

Also, having requirements for assembly automation in hand could simplify the mold design. Then put the processes through computer simulation, with software such as Moldflow or finite-element analysis, to identify problems or opportunities for improvements.

When choosing manufacturing methods, keep in mind where the product will be made. Different facilities have different strengths. Matching capabilities to requirements helps ensure that the correct skill sets exist to support the manufacturing process needed for the design.

Packaging, shipping, and more

Sterilization also affects the package and product design of a disposable device. Unlike reusable devices, which are often sterilized at the healthcare facility, disposable devices are sterilized before leaving the manufacturing site. The device and packaging must be designed to accommodate sterilization. With disposable devices, this usually means selecting materials compatible with ethylene oxide gas or gamma sterilization. Each process requires different product and package designs. Generally, products and packaging are intended for use within five years of the sterilization date.

Other logistical and environmental factors should also be considered when designing a disposable medical device. For example, where will the device be stored? Will it be refrigerated? Some hospitals have large storage facilities while smaller outpatient clinics have limited space and need the smallest packaging available. Shipping costs may also be a concern. Consider overall device weight which is influenced by everything from material selection to packaging.

Obviously, disposable devices eventually must be disposed of, which often means incineration. However, disposal can include other methods. State and federal regulations and rising landfill fees are pressuring healthcare providers to reduce the amount of medical waste they generate. Medical-device manufacturers that design smaller and lighter devices may have the upper hand as healthcare operations scrutinize waste volume and weight.