In the medical industry, there’s no room for error.
Whether your medical device is used every day or only in emergency situations, it needs to function reliably when it’s called upon—every time. With medical devices and equipment becoming increasingly complex, however, that means designers and engineers need to pay even closer attention to detail to ensure there are no mistakes.
At Kaysun, we understand what it means to design these critical medical devices and equipment, and the importance of bringing them to market as quickly as possible. We specialize in the medical vertical, having years of expertise in the development and manufacture of extremely complex plastic components and a deep understanding of industry regulations and requirements. This is a responsibility that we take very seriously, as we know what’s at stake.
ISO Certified & CFR Compliant
There are many nuances to creating a medical device that meets industry standards, and Kaysun is ISO 13485:2016-certified and CFR 820-compliant. Our engineering department is full of plastics experts who can help you identify a medical-grade plastic with the best physical properties for your project, like being lightweight, strong, and resistant to chemicals and other natural contaminants. We also take great pride in our medical manufacturing facilities, including our clean room capabilities. In 2015, we even expanded our facilities specifically to ensure we had the most robust medical manufacturing capabilities possible.
When it comes to medical devices and equipment, we know the needs of OEMs may change drastically from project to project — whether it’s making a handheld heart monitor or dialysis machine, each project presents its own challenges. As a speciality injection molder, we can adapt to meet your needs as they grow, investing in additional equipment if needed to deliver the best end result possible. In addition, we have highly skilled engineers in-house to make tooling adjustments, saving you time and money.
In-House Assembly and Secondary Operations
Once your plastic component is finished, we have the ability to do additional assembly work in-house. If you need metal inserts added after a component is molded, for example, our team can take care of that for you. We also offer a robust line of secondary services such as welding, heat staking, and overmolding for soft grip of handheld devices. This full-service approach means OEMs can consolidate vendors and streamline the production timeline of their medical devices/products.
Scientific Molding Experts
Ensuring a plastic component is within +/- .001 inches of its intended size can be the difference between the finished product functioning reliably and early failure. In order to meet these tight tolerances, our injection molding engineers are trained and certified in the scientific molding processes, where everything they do is done with extreme precision. From part design, material selection, tool design, tool building and debugging, production, all the way to assembly, they carefully monitor every injection molding variable (e.g., temperature, flow rate, pressure and cooling time/rate, etc.) to ensure a highly accurate, defect-free medical device or component. There’s no “trial and error” guesswork; just carefully calculated and collected data that helps us recreate these ideal conditions over and over again.
When done correctly, not only does scientific molding help ensure a more reliable device by virtually eliminating all non-conformance issues, but it also helps lower costs of manufacturing medical components by minimizing the required steps and wasted materials. This emphasizes the importance of having your injection molding partner involved early in the design process, to help quickly identify the best design and process parameters and eliminate any potential defects.
For more information on how to optimize the design of your plastic parts for medical devices, including how scientific molding can help, read our whitepaper:
If you’d like to talk to one of our engineering staff about your next medical device or project, please click the button below to request a consultation. We understand the competitive landscape you’re facing and are ready to tackle your toughest design for manufacturability challenges.