In the past, regulatory requirements that were laxer than U.S. rules made the EU almost a no-brainer as an entry market for many medtechs. However, the advent of the MDR and IVDR has tightened EU regulations and added implementation challenges. Are Latin American markets the answer?
There exist far fewer pediatric devices than adult devices on the market, meaning one of the most vulnerable patient populations also is one of the most underserved.
The U.S. gastrointestinal (GI) endoscopic device market is increasingly focusing on specialized procedures, propelling the launch of innovative devices that address unmet medical needs and drive overall market growth.
Most mHealth does not have to meet the FDA requirements for application of human factors and usability engineering. Thus – to date -- the processes used to design and assess mHealth have been widely variable and developer dependent.
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.
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.
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.
PCO introduces the new pco.dicam C1 and as the first intensified camera systems to exploit the full performance inherent to scientific CMOS sensor technology. The camera features optical coupling of 25 mm high resolution image intensifiers, an excellent high efficiency tandem lens system, and a 16 bit 4 MPix sCMOS sensor.
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.
REVOX has put together a team comprising engineers, chemists, microbiologists, project managers, business consultants, and quality and regulatory professionals that are subject matter experts with strong expertise and experience in their fields. REVOX can work to enable sterilization technology to work to its fullest potential for medical devices. The company offers rapid 30-day sterilization development, materials and microbiological laboratory testing, supply chain optimization services, and regulatory development expertise.
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.
Starting with the specifications phase, through design, prototypes up to volume production, the MST Group is your reliable partner for turning any of your ideas into a marketable product.
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.
