This annual survey of medical device professionals provides insight into how device development has changed in the past 12 months, current views on market challenges and trends, and the potential implications of these findings.
The latest version of ISO 13485 already contains several requirements that do not exist in 21 CFR 820. In advance of the new proposed rule’s release, this article presents a summary of the potential changes’ impacts on medical device manufacturers once the proposed rule becomes final.
Despite the best efforts of those directly responsible for data integrity, human error will still find its way into the equation and undermine the efforts. The potential for human error is directly and indirectly impacted by the corporate culture, the national/regional culture, and the quality culture of an organization.
Reimbursement rates have not risen as rapidly as device and medical supply costs, putting cost pressures on hospitals. This, in turn, increases pricing pressure on device manufacturers, as consolidated health systems have more negotiating power.
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.