The FDA requires medical device manufacturers to have clearly documented procedures for corrective action and preventive action (CAPA). Unfortunately, many medical device companies fail to prepare a good approach to their CAPA process, which is so important to the health and success of your company.
For the last 40 years, intravenous (IV) infusion therapy became as ubiquitous as cots and syringes. In the U.S., for every hospital bed, there are almost 2 electronic IV pumps used. The main challenge facing health care providers and device manufacturers is how to make this therapy safer but also more accessible
Medical devices can be complex and may require users to understand specific information about storage, use, disposal, or reprocessing. Instructions for use (IFU) are therefore considered part of the product user interface. Here are some critical factors to consider when developing effective IFUs.
Facet joints are the joints between your vertebrae that guide your spine’s movement. About 10 percent of adults suffer from chronic back pain and 31 percent of those cases have facet joint involvement. There are several treatment options available including radio frequency ablation. Innovations in treatment devices are allowing providers to have a "third hand" during this procedure.
Advances in sensors, smartphones, communications, and analytics give developers new tools to build creative and powerful applications that promise to improve health outcomes and reduce healthcare costs.
As component sizes for medical devices shrink to micron size, conventional machining may not be the most efficient or consistent method for manufacturing. Learn why Micro-MIM is preferred for components with tight tolerances at high volumes.
Sustaining engineering enables the developer to plan ahead, getting the development and design of the device done right the first time, and smoothing the transition to manufacturing. KMC's executive director of engineering, Scott Leon, weighs in on the subject.
The business pain of switching suppliers, both in terms of costs and revalidation time, heightens the importance of making the right decision the first time.
Micromolding requires a high level of intimacy and attention to detail to be successful over the long run, so it’s important to work with micromolder with the capability, scalability, and sustainability to get a product from the design stage all the way to high-quality mass production.