Clinical and commercial adoption are interrelated, but not identical. Successful medical device acquisitions are predicated on a thorough understanding of how these components fit together. Before acquisition, both target and acquirer must first understand the core scientific and clinical support for the technology, as well as anticipate ongoing hurdles in front of commercial acceleration.
A validation master plan (VMP) outlines the principles involved in the qualification of a facility, defining the areas and systems to be validated, and provides a written program for achieving and maintaining a qualified facility. Master plans are written to assist an organization with validation strategies or to provide control over a specific process.
Obtaining early clearance with a narrower claim enabled this company to enter the market earlier, as well as use its own product as a predicate to collect real-world evidence — all while obtaining broader clearance and avoiding the requirement to document patient-informed consent during trials, since the device already had been cleared.
Many medical device project development teams either ignore sterilization challenges until confronted with failed tests late in development, or adopt conservative guidelines that increase cost and lead times. More deliberate, proactive efforts applied to the sterilization topics discussed here can lead to improved outcomes.
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.