Recently I had the privilege of co-presenting a session at the RAPS 2017 Regulatory Convergence with former colleagues from Regulatory & Quality Solutions (R&Q) and members of the FDA. Read more about the session here.
These tales prove that it's possible to snatch victory from the hands of regulatory defeat when responding to adversity with open-minded persistence.
Medical device manufacturers that are considering adding or expanding connectivity options should think carefully about what they are trying to achieve, and develop a strategy that balances the risks and rewards.
Perhaps no area of healthcare is experiencing more dynamic growth and providing more value for the money than diagnostic testing. According to an EvaluateMedTech report from last year, annual world-wide sales of in vitro diagnostics (IVDs) are projected to swell to over $70 billion by the year 2022.
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.
A key aspect to a successful medical device development project is a dedicated outsourcing partner who can provide engineering expertise that includes sustaining engineering. 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. This article discusses the importance of sustaining engineering, and 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.