The world of medicine and medical professionals is replete with terminology. They have specific definitions for every object, item and material that comprises their world. This extends over to the manufacturing of anything considered a medical device. Contract manufacturers are required to understand specifically the definition and characteristics of the medical devices entrusted to them for production.
What Is a Medical Device?
Food and Drug Administration (FDA) define a medical device accordingly:
“an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory(http://www.fda.gov/AboutFDA/Transparency/Basics/ucm211822.htm )” It must be officially recognized by either National Formulary or the United States Pharmacopoeia. It must also serve one or two specified purposes:
1. Human or animal diagnosis, cure, mitigation, treatment or prevention of disease
2. An instrument that does affect either the structure of bodily function and achieves its results without employing chemical or similar reactions or actions
As such, a medical device can also be referred to as an instrument, an appliance, material or even software. The components required can be for implants, or surgical and dental equipment. Designing and production of these items requires the involvement of scientific and practical minds. This includes medical professionals, research specialists, and the technological wizards and practical medical machining performed by employees of medical device contract manufacturers.
Medical Machining
When a company produces medical devices through CNC machining, this is medical machining. It is a challenging field for many shops since it involves the production of small or even microscopic parts. Among the challenges facing companies who contract to produce medical devices are the following
* Small lots
* Increasing part complexity
* More intricate detail
* Tighter Part tolerances
* Tight Delivery requirements
* More demanding materials e.g. titanium
Possible solutions lie in suitability of the technology. It must be capable of meeting the high standards and specifications demanded by the client and the governmental organizations. For some companies, the installation of multi-axis equipment will help to improve production quality, volume and reliability.
Medical Device Contract Manufacturers
For shops who want to specialize in the production of medical devices, the stakes are high and the work demanding. The client wants high quality product produced as quickly as possible. Not only must the cycle times be fast, they must also meet the precise specifications demanded by the client. If a medical device contract manufacturer wishes to be successful, it must produce quality product using the fastest and most accurate technology available including the use of any multi-axis system.
