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

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

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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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

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.

Medtech complaint handling: Is there something to complain about?

Medtech complaint handling appears to be a work in process, according to Sparta Systems’s recent quality management market survey. The 2017 survey – which had 148 respondents in highly regulated industries including medical devices (23%) – found that nearly a quarter of those who answered did not have a well-defined and adopted complaint handling process. Only

The 20 largest medical device companies in the world

When it comes to the largest medical device companies, it’s a changing cast of players – as demonstrated once again in Medical Design & Outsourcing’s latest 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

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Webinar about combination products: Bridging the gap between pharma and medical devices – Oct. 18

Wednesday, October 18, 2017 11:30am EDT / 8:30am PST   We will provide a new understanding of key topics that separate the regulatory and quality process for drugs and combination products/drug delivery devices.  We understand the process for drug development and certification varies greatly from the process for medical devices.  We will cover the intricacies

FDA’s medical gas guidance offers clarity to manufacturers

FDA’s new draft guidance on current good manufacturing practice for medical gases closed for commentary in August. The revised draft guidance details the current good manufacturing practice (cGMP) requirements for medical gases, superseding an earlier draft guidance from 2003. A review under FDASIA in 2015 noted that minor guidance updates and better inspector training would improve the regulatory […]

Eastridge Workforce Solutions acquires Operon Resource Management

Eastridge Workforce Solutions (San Diego, Calif.) recently announced that it has acquired Operon Resource Management (Lowell, Mass.). The financial details of the deal were not disclosed. Operon’s medical device recruitment solutions will add on to Eastridge’s history of helping medtech manufacturers with their workforces. The clients from both companies will have access to specialized services that

Webinar: How late 2017 has changed medtech – Oct. 11

Wednesday, October 11, 2017 2:00 PM EST / 11:00 AM PST       When it comes to news out of the U.S. government: one word could sum up what it means for the medical device industry: “uncertainty.” It was true at the start of 2017. And it is even truer today. The effort to

Medtech stories we missed this week: Sept. 15, 2017

From Acera Surgical and Telos Medical’s partnership to Xtant Medical’s 510(k) clearance, here are seven medtech stories we missed this week but thought were still worth a mention. 1. Acera Surgical partners with Telos Medical for Restrata wound matrix trial Telos Partners announced in a Sept. 14 press release that Acera Surgical has chosen Telos to

Nypro reopens renovated Illinois design and manufacturing facility

Nypro has officially opened the doors of its recently expanded Gurnee, Ill. location after having a ribbon cutting ceremony that included Mayor Kristina Kovarik and other company officials. The facility has almost doubled in size with the new expansion and is bringing 60 new jobs to the local area. The expansion also enhances specialized capabilities