In the medical device industry, we are hypersensitive to complaints. Here, we examine complaints from a business satisfaction perspective, rather than the FDA definition, and discuss how to evaluate your customer base.
Getting to this point has been a multi-year progression of technological development and regulatory evolution by both the market and government.
During a recent meeting of data integrity professionals, a fundamental question was posed by a member of the group: “How can one prevent or detect malicious intent as it relates to changes to information and the impact to data integrity?”
Harmonized standards need to be reviewed and revised to reflect requirement changes under the MDR and IVDR. The creation of Common Specifications, as well as changes to ISO 14971, further complicate the transition for med device manufacturers.
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.
Micro Systems Technologies (MST) offers an array of highly reliable flex circuit assembly solutions for ultrasound imaging used in diverse medical diagnostic areas. From 1D to 3D and beyond, the advanced flexible electronic assemblies deliver enabling capabilities in PCB manufacturing and assembly technologies.
SCHOTT Electronic Packaging and Primoceler Oy have joined forces to expand current hermetic packaging portfolios with pioneering glass micro bonding technology. This process enables the manufacture of vacuum-tight, ultra-miniature electronic and optical devices with superior reliability. This bonding method is based on laser technology and can be completed without any heat or added materials.
FLIR offers the new T1030sc Long-Wave Infrared Camera designed to capture images with 1024 x 768 pixels at 30 frames per second (fps). The camera provides high thermal sensitivity, fast raw data streaming, and a high speed interface (HSI) connection for streaming lossless HD radiometric imagery at 120 Hz or up to 480 Hz with windowing.
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.
Proto Labs is proud to introduce PolyJet technology to their 3D printing capabilities. PolyJet technology is used to provide designers and engineers with the ability to manufacture elastomeric and overmolded prototypes without investing in tooling. This technology can create 3D-printed parts comprising both elastomeric and rigid materials, as well as multiple colors.
The margin for error when it comes to critical components for medical device manufacturing is zero. That's why Accumold ensures robust production processes, extremely tight requirements, and part-to-part consistency.
Proto Labs, Inc., through its Firstcut and Protomold services, utilizes proprietary computing technologies and automated manufacturing systems to provide prototype parts and short-run production services. All parts are made by standard production methods, delivered at affordable prices, and can be delivered in as fast as one day.
B. Braun’s OEM Division delivers complete contract manufacturing capabilities for a multitude of markets including surgical, pharmaceutical and biotech. With three global divisions (Europe, Asia-Pacific and North America), B. Braun’s OEM Division offers wide-ranging and complementary capabilities resulting in new products, expanded production, cost efficiencies, and country-specific knowledge.