Incredible Advancements in Medical Device Automation
As new technologies and process are developed in the manufacturing industry, the types of medical devices that can be assembled are ever expanding. Devices from simple medical instruments to surgically implanted devices are produced through a variety of automated assembly processes.
How is ultrasonic welding used in medical device assembly?
Ultrasonic welding has had a positive impact on medical device manufacturing. Ultrasonic welding is an ideal process for joining plastics for medical devices as it is an inherently clean method of joining medical plastics without the need for solvents, adhesives and curing. The plastic joints can be accomplished with low cycle times and minimal hold time required for the joint to be made structural.
What does a medical device automation builder do?
A medical device automation builder will work with a medical device manufacturer to suggest product design changes that make the product suitable for automation and develop a process that is efficient based on the automation required. The process is then scrutinized for failure modes to ensure that measures are implemented to ensure that a bad medical device cannot be built. From that developed process, the assembly system is designed, built, debugged and validated prior to shipment to the end user for production.
What types of medical devices can be produced through automated assembly?
There are so many diverse approaches to medical device assembly systems. From 3D printing innovation to progressive robotic welding assembly design, the Medical Device assembly industry has made some incredible advancements in medical device automation technology.
As a recent example of medical device assembly innovation, Innovative Automation has designed, built and shipped a system with the requirement of assembling a biofluid collection container. Innovative Automation developed the V model validation protocol with the assistance of a validation consultant. The URS (User Requirement Specification), FRS (Functional Requirement Specification) were generated to define how the equipment needed to be designed and commissioned.
The assembly included the base container, cap, swab, a liquid preservative and a label. The entire process was completed on two rotary dial tables. The base, cap and swab are loaded to the dial tooling from vibratory feed systems. The preservative is a dispensed liquid. The swab is assembled and fixed to the cap with an ultrasonic welding process. Finally a label is automatically generated and applied. The process rate is one part per three seconds.
The FAT (Factory Acceptance Test) was successfully executed at Innovative Automation and a similar SAT (Site Acceptance Test) was successfully executed where the product is manufactured. The validation protocol and supporting the qualification protocols ensured our customer was able to bring the product to market under FDA regulations 21 CFR Part 11.
This is just one example of the many interesting applications we work on in the medical device assembly industry. Interested in working on a project of this nature? Join our team of medical device automation professionals.