Not surprisingly, the medical industry in the United States is one of the most heavily regulated. The U.S. Food & Drug Administration (FDA) has a strict protocol around medical device tracking, particularly Class II and Class III devices that are intended for life support away from a primary care facility or whose failure would likely cause serious adverse health consequences.
Injection molding partner selection is a high priority in most industries, but finding the right fit takes on particular significance when that relationship is relied upon for making critical-use products within the heavily regulated medical field.
Constantly evolving, the medical industry requires OEMs to be forward-thinking in providing solutions that address trends and challenges. One such OEM, Smiths Medical, sought to change the design of its existing pulse oximetry portfolio to include enhanced functionality and improved manufacturability. At the project’s inception, they partnered with the U.S.-based injection molding experts at Kaysun to help refine and ultimately accomplish their goals.
Advancements to polymers and injection molding technologies have contributed to widespread adoption of plastics in the medical industry. All segments of the medical industry have embraced the benefits of plastics, and are looking to incorporate more plastic in their designs in 2018 and beyond. Low cost plastics, for example, have enabled the creation of disposable plastic instruments, syringes, gloves and gowns that, in turn, help reduce the spread of infections within the hospital environment. Plastics have also replaced glass in a variety of laboratory consumables, improving lab safety while reducing consumable costs.
The medical industry is a complex network of skilled professionals, facilities and equipment that provides ongoing, immediate — and, at times, emergency — services to preserve and protect human health. It carries a unique importance, and medical device and equipment manufacturers share in shouldering that responsibility by taking all necessary precautions to help ensure the critical-use products they provide are defect-free and consistently reliable.
Price point is rarely, if ever, synonymous with value, yet it’s not unusual for OEMs in competitive industries like medical and healthcare equipment to base vendor relationships solely on the bottom line. It’s also not unusual for those short-term gains to turn into expensive long-term losses.
Given the promised speed and generally low price points, commodity injection molders are attractive to OEMs in many industries. However, deals struck with these molders — overseas and domestically — can pose potential problems in communication and quality, among other issues.
An approved vendor list isn’t meant to be static, and if you’re treating yours like it’s written in stone, you may be doing yourself and your business a disservice.
Critically evaluating vendor performance on a regular basis not only helps you identify and weed out those that aren’t consistently meeting expectations, it also provides an opportunity for vendor consolidation.
Medical grade polymers are quickly becoming the preferred material for a broad range of surgical devices. In certain applications, the robust mechanical properties of medical molding polymers allow complete removal of metal from the surgical device design. In other instances, plastic and metal components can combine to create an enhanced product, with attributes that would not be possible in either an all-metal or an all-plastic device.