The FDA’s Software Precertification Pilot Program moves away from the agency’s long-held stance that it does not “approve companies,” exploring new thinking on how to regulate by reputation and continuous improvement loops, rather than reviewing each and every low-risk product. Might there be a way to replicate this type of thinking for complex products?
Last week’s MDTX event was a thought leaders' forum for medical device innovators who design, develop, or commercialize devices. There were interesting conversations with speakers and leading-edge knowledge from experts about everything from concept to commercialization, and regulations to reimbursement. My own presentation was on recently-released FDA guidance documents and how these new expectations might influence your next product development effort.
In the past 10 years, manufacturers have used express and implied preemption to shield themselves from personal injury tort lawsuits involving PMA medical devices, but plaintiffs’ attorneys have sought to poke holes in these shields, occasionally establishing certain limited exceptions to these preemption defenses.
Fresh regulatory updates and a new generation of medical devices are expanding caregivers’ options for the early management of patients with acute ischemic stroke.
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.