Medical device manufacturers and designers must overcome various challenges to succeed in an expanding global marketplace. In 2017 and beyond, medical device manufacturers will be challenged along the way from the aspects of design, research, validation, and bringing their devices to a competitive market in a cost-effective manner.
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.
For some medical device companies, an FDA visit can be scary and stress-inducing — if you don’t have your ducks in a row.
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.
FMI is committed to providing the highest quality of silicone components for medical devices. Using the highest process controls alongside the most rigorous quality tools, FMI is able to ensure patient safety and 100 percent inspection of every single component before it ships.
Laser beam profilers are the optimal solutions for increasing chances of success in the design or applications of new lasers, or when a laser system is no longer meeting the desired specifications. Ophir Photonics offers a wide range of beam profiler choices including CCD and CMOS cameras, scanning slit sensors, InGaAs and pyroelectric cameras, and pinhole and knife edge sensors.
Cardinal Health’s OEM division offers a large selection of latex-free hydrogels in bulk rolls or in slit widths. These medical device hydrogels are used in a variety of applications including ECG signaling, defibrillation, electrosurgical and iontophoretic return electrodes, T.E.N.S., wound care, cosmetics, and non-skin adhesives.
Donatelle’s rapid tooling and prototyping services help accelerate the design process and bring critical medical device products to market – faster. With an experienced team of engineers, mold designers, machinists, and toolmakers, they are able to produce near-net shape parts with near production tolerances, machined or molded, in as little as a few days.
At SMC Ltd. we understand your desire to have a single point of contact for your full medical device. With SMC’s demonstrated strength in IQ/OQ/PQ validation, our network of established and qualified suppliers, and our experience in custom manufacturing, we have the comprehensive resources in place to manage your program from conceptual design to final distribution.
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.
REVOX Sterilization Solutions is part of the Cantel Medical Corp.; a company dedicated to infection prevention and control. Our in house experts include mechanical engineers, chemists, microbiologists, quality assurance and regulatory affairs professionals. The REVOX team will work to understand your challenges, concerns, and opportunities and provide expert insight to help you decide if REVOX Sterilization is the right sterilization solution for your product or product concept, and/or operational efficiency improvement goals.