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FDA’s new draft guidance on current good manufacturing practice for medical gases closed for commentary in August. The revised draft guidance details the current good manufacturing practice (cGMP) requirements for medical gases, superseding an earlier draft guidance from 2003.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

Medtronic, Mazor Robotics close $40 million round

Mazor Robotics (NSDQ:MZOR) said today that closed the third, $40 million tranche of a deal with Medtronic (NYSE:MDT), which is due to take on exclusive global distribution rights for the Mazor X robot-assisted surgery device. It’s the third investment in the Israeli surgical robotics concern for Fridley, Minn.-based Medtronic, taking its total investment to $72 million, 10.6% stake in…

The 10 largest medtech employers – and what their workers really think

Among the 10 largest medtech employers, workers feel pride in working on life-saving products – but there’s also frustration with big corporate bureaucracy. That was the major takeaway as Medical Design & Outsourcing compiled some of the most insightful current and former employee reviews posted on Glassdoor. The 10 companies we’re counting down were the

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FDA cuts could threaten medtech innovation: Here’s why

The Trump administration’s proposed federal budget could hurt the speed and quality of FDA review times, says a top expert at Musculoskeletal Clinical Regulatory Advisers (MCRA). Glenn Stiegman, MCRA Innovation is a vital element of success for medical device companies. More than 6,500 U.S. companies are developing technologies that improve patient outcomes. This represents a

How Boston Scientific is boosting medical device value

Boston Scientific over the summer unveiled a new value-add for its implantable cardio devices: an online Trugevity calculator that lets physicians predict battery life. The idea is to help health providers quickly grasp the benefits of Boston Sci’s longer lasting EnduraLife battery technology, which the company touts has nine clinical studies and eight years of real-world

Abiomed buys Danvers, Mass. HQ for $17m

Abiomed (NSDQ:ABMD) said this week it inked a deal to purchase its existing corporate headquarters in Danvers, Mass. for $16.5 million. The company said that it opted to buy the facilities, which includes 12 acres of land and all associated buildings, structures and other improvements, through an option in its existing lease with the original owners. Abiomed […]

Millstone Medical appoints new CEO

Millstone Medical (Fall River, Mass.) announced that it has appointed Karl Neuberger as CEO, effective immediately. Neuberger began his career at Millstone as VP of operations at Millstone’s Olive Branch, Miss. loaner kit and distribution center and more recently served as chief operating officer for the company. Prior to his arrival at Millstone, Neuberger held

LivaNova heater-cooler implicated in 12 pediatric heart surgery infections

A dozen children who underwent cardiac procedures at Children’s Hospital New Orleans earlier this year have been infected with myobacterium previously linked to LivaNova’s (NSDQ:LIVN) 3T Heater-Cooler systems, according to a STAT News report. A total of 55 children had heart surgery between May and July at the facilities, with 7 of the 12 patients […]