While the new version of The Least Burdensome Provisions guidance does not institute sweeping reforms, it does offer new methods for medical device manufacturers to expedite the premarket review process for product approvals, as well as clarifies how both the FDA and industry can implement the least burdensome principles in practice.
It was the announcement many have been dreading — but expecting — for several months now. Dr. Scott Gottlieb, 23rd Commissioner of the FDA, announced his decision to step down after 663 days (22 months) on the job. The news is sure to raise concerns for many. But I think the biggest surprise is how equally sad thought-leaders within the agency will be to say goodbye.
How does this new set of guidelines promote more thoughtful development of mobile health applications (mHealth apps), and how can you weigh in?
When SMEs, management, and others gather to perform a risk assessment or a root cause analysis on a failure, they’re sure to achieve the desired outcome, right? Perhaps for a simple risk assessment or investigation, but success is not very likely for one that is even moderately complicated. That’s where a skilled facilitator is needed.
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.
KMC Systems offers decades of experience in solving complex medical engineering and design challenges, and in considering innovative, highly-automated solutions for the development of full-system instrumentation. KMC Systems engineers work collaboratively with customers to achieve optimal interdisciplinary solutions to laboratory automation challenges, Design for Manufacturability and Serviceability (DFM and DFS) challenges, and medical device verification and validation.
Whether you need a few pieces or a few thousand, Donatelle's highly specialized team can produce parts with near-production tolerances in as little as a few days. As part of their integrated services, they work closely with your design team to select the best polymers and metals to bring accuracy and consistency to your molded components. You can also rely on their expertise with hundreds of exotic materials, including high-temperature, implantable-grade and silicone.
Detergent 8 is concentrated to save you money, biodegradable, and readily disposable. Its penetrating wetting power saves you time. It’s free rinsing to give you reliable results and no interfering residues.
Zeus offers the FluoroPEELZ™ peelable heat shrink designed with quick and easy peel away capabilities to improve product efficiency and safety, and to accelerate catheter production.
SIMULIA’s solutions for medical device development provides a framework for engineering teams to integrate the tools they use into re-usable, deployable processes. This reduces time-consuming and error prone tasks to improve productivity and consistency, while enabling design exploration studies to find better designs and democratization to expand the user-base for simulation. Lastly, capturing these processes in the 3DEXPERIENCE® platform provides the traceability organizations need when making critical business decisions.
Flexan is committed to providing the highest quality of silicone components for medical devices. Using the highest process controls alongside the most rigorous quality tools, Flexan is able to ensure patient safety and 100 percent inspection of every single component before it ships.
Caplugs, a global leader in protective solutions since 1948, offers extensive custom molding capabilities and a catalog of products available for same day shipment for the medical industry. With more than 1,300 medical customers, a series of ISO certifications, a Class 8 certified Clean Room and a stringent quality control process, Caplugs understands the unique challenges and needs of the medical field. Whether you need a custom molded solution or an in-stock component, our dedicated team of medical experts is available to guide you through the process.
Passion for technology has driven SMC Ltd. to be a leading manufacturing partner to top medical OEM’s in the diagnostics, pharmaceutical and medical device markets. Services include program management, product launch/scale-up, product design, engineering, prototyping, strategic supply chain management, custom thermoplastics component manufacturing, assembly, reagent filling, pouching, pre-packaged drug handling, automation, testing, and packaging.
