FDA’s most recent guidance on human factors, Applying Human Factors and Usability Engineering to Medical Devices, highlights the importance of enhancing patient safety by adopting human factors engineering processes in the design and manufacturing of medical devices.
Reflecting a growing trend of minimally invasive surgeries, stemless arthroplasty is driven by the desire to facilitate smoother revision procedures, and to prevent stem-related complications.
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.
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.
First Sensor offers a family of rugged, compact cameras designed to withstand the toughest conditions, such as extreme heat, cold, or permanent vibrations. Each camera features a modular design with different interfaces and data formats for simple integration. All cameras can be adapted quickly and flexibly to customer-specific requirements.
SCHOTT Electronic Packaging offers an array of sterilizable LED modules for the fulfillment of lighting needs in harsh environment applications, including and especially devices used in the medical field that must undergo repeated sterilization processes.
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.
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.
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.
PTI's expertise and experience are ideal for complex, low-volume injection molding. They are committed to delivering the same precision and price advantages of high-volume production molds. The Low-Volume Production (LVP) molding program utilizes the latest injection molding equipment, including electric injection molding machines with closed-loop processing, and automated material handling systems. PTI also is capable of customized, higher volume production runs.
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.
Donatelle has been in business over 45 years providing medical device contract manufacturing services helping companies develop innovative and life-saving products.