Viewed at a high level, a large proportion of the medical device market is commoditized (think bandages and IV bags). However, there is a great deal of innovation going on, with exciting new technologies debuting across a wide range of product categories. Understanding how these technologies are differentiated from previous iterations allows us to forecast their likely impact on their respective markets.
The Council of the European Union has adopted the European Medical Device Regulations (MDR 2017/745), which were published in the Official Journal of the European Union and entered into force on May 26, 2017. Are you ready?
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.
Let’s face it: manufacturing in a regulated environment is more expensive than commercial manufacturing. With all due respect to the venerable prowess of medical device manufacturing professionals, even a lean, mean, 5S, Six Sigma, 8D machine cannot offset the cost created by a plethora of requirements, guidance documents, and standards.
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.