South Korean regulators change new medical device regulations

By Stewart Eisenhart, Emergo Group The South Korean Ministry of Food and Drug Safety (MFDS) have made updates to two significant medical device regulations that came into force earlier in 2017, and published one draft update as well. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post

Qosina touts new bioprocessing components

Qosina recently announced that it has a line of bioprocessing components that are in stock and ready for shipment. The new bioprocessing accessories include Pharmafluor tubing, barbed connectors and flanges, sanitary flanges, press-in barbed plugs and compression fittings. The accessories also include tube and flange clamps in a variety of sizes and colors that can be

This sweat-powered biofuel cell could create better wearable devices

Engineers at the University of California at San Diego have created a stretchable sweat-powered biofuel cell, and it could enable better wearables. The biofuel cells use energy from sweat to generate 10 times more power per surface area than other biofuel cells that are used in wearables. The researchers claim it could be used to

The 10 largest medical device companies in the world

Mergers & acquisitions continue to change the medical device landscape, as reflected in Medical Design & Outsourcing’s new Big 100 list. We pulled financial regulatory filings and reached out to major companies in some cases to create a list of the 100 largest medical device companies in the world, ranked by annual revenue for their

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The startup pivot: How to rethink your medical device company

In the medtech market, startups have to be flexible; the startup pivot is crucial. “Companies have to morph as they go,” said Maria Palasis, CEO of bioresorbable drug delivery system company 480 Biomedical. Palasis explained that startups, and even mature companies should expect to shift their technology in one way or another through the course of

Raumedic to install IT control systems for Industry 4.0 advancement

Raumedic has announced its new IT-based quality-assurance and production control system that is designed to help raise the quality of standards and efficiency of its production process. The system is set to be installed in all of Raumedic’s production facilities in Germany and the U.S. by 2019. The company recently reached an agreement with the

Brentwood buys Mexico cleanroom facility

Brentwood Industries (Reading, Pa.) has expanded its manufacturing capabilities by purchasing a cleanroom facility in Tijuana, Mexico. It plans to open the facility in early 2018. This new purchase is the second facility of Brentwood’s that is dedicated to customers thermoformed medical packaging. “We’ve been evaluating expansion into Tijuana for a number of years, particularly considering

What’s next in 3D printing prototypes

Tony Holtz, Proto Labs 3D printing is advancing, especially for medical device applications. Printer developers are making leaps when it comes to achieving finer resolution and prototypers are improving steps for secondary processes. The 3D printing technology has enabled improvements in micro resolution features and clarity for lenses and microfluidics. The improved secondary operations have created

How to design a successful embolic protection devices clinical trial

Embolic protection devices could reduce risks of interventional cardiac procedures such as TAVR, but their efficacy is hard to prove. David Novotny, Novella Clinical The embolic protection device (EPD) market is expected to grow into a billion-dollar industry if the device becomes the standard safety protocol for transcatheter aortic valve replacement (TAVR) and other interventional

How electrical currents could monitor lung functions from an ICU bed

Electrical currents from an electrode-filled belt could soon help monitor important bodily functions like lung function, according to Austrian researchers. Electrical impedance tomography (EIT) is a new imaging technique created by a collaboration between Technische Universität Wien, Medical University of Vienna and the University of Veterinary Medicine Vienna. The electrode-filled belt is applied directly on

Medtech innovation: Here’s how you speed it up

Here’s how medtech can speed up its processes and tap into innovation, courtesy of Peter Douglass, director of technical operations at Proto Labs. Innovation in the medtech space is what every company wants. And there are many theories on how to get there. One is that improving the speed at which you develop will naturally

Hurricane Maria poses threat to med device hub in Puerto Rico

Hurricane Maria is posing a threat to medical device and pharmaceutical manufacturing plants in Puerto Rico, according to a new Bloomberg report. The island is home to facilities for Johnson & Johnson (NYSE:JNJ), Pfizer (NYSE:PFE), Amgen (NSDQ:AMGN), Merck, Medtronic (NYSE:MDT) , Abbott (NYSE:ABT), Stryker (NYSE:SYK) and dozens of others, according to the report. Most of the companies created facilities in Puerto Rico due to tax incentives, Bloomberg reports.

Russian regulators changing medical device, IVD regulations

By Stewart Eisenhart, Emergo Group The Russian government has indicated that it may loosen some rules for registration of medical devices and in vitro diagnostic products (IVDs) but also increase regulatory reviews of more substantial registration changes in the coming months. Get the full story here at the Emergo Group’s blog. The opinions expressed in

China has a new medical device classification catalog: what you need to know

Grace Fu Palma, China Med Device The China Food and Drug Administration (CFDA) recently unveiled its new “Medical Device Classification Catalogue” – which has significant implications for medical devices registrations or renewals. The new catalog, announced Aug. 31 after a previous draft release and feedback period, goes into effect in less than a year – on Aug. 1, 2018.

FAIs: When do you use conventional versus digital inspection methods?

Tony Holtz, Proto Labs First article inspections (FAIs) can be time-consuming and costly, but they are a necessary step in getting medical devices from product design to production. Medical device manufacturers are likely familiar with the process, although most leave it to suppliers to handle. Even if that is the case, device makers should get