Manufacturing: Page 2

GE, Medtronic, ResMed among 7 medtechs part of $1.4B in finalized HHS ventilator contracts

Building on more than $1.1 billion announced for GM and Philips last week, the latest batch of contracts are aimed at producing over 64,000 of the potentially life-saving devices for COVID-19 patients.

By Maria Rachal • April 14, 2020

The latest coronavirus shortage: hospital infusion pumps

A surge in COVID-19 cases is not only straining the supply of the devices that administer medications and fluids, but the potentially risky tubing that allows them to be situated in hallways to create distance from sick patients' rooms.

By Greg Slabodkin • April 14, 2020

Industry cheers COVID-19 executive order to boost ventilator supply chain

While AdvaMed has pushed back on using the Defense Production Act, the move is meant to help domestic manufacturers by removing hurdles to accessing parts and materials needed to ramp up production of ventilators.

By Greg Slabodkin • April 03, 2020

Medtechs navigate new normal as FDA shifts priorities to coronavirus

Companies are working to get diagnostics, respiratory devices and PPE to market amid rapidly evolving guidance from FDA. The agency's coronavirus-era operations may also impact work for device makers in other parts of the sector.

By Maria Rachal • April 03, 2020

FDA outlines role for 3D printing in coronavirus response, with some caution

Additive manufacturing has emerged as a tool to help bolster availability of critical devices like ventilators and testing supplies, but the agency said 3D-printed personal protective equipment may not be as effective.

By Nick Paul Taylor • March 27, 2020

How health systems are responding as COVID-19 squeezes the medical supply chain

Procurement of supplies will become more difficult if cases surge and federal stockpiles don't trickle down to the state level quickly enough.

By Deborah Abrams Kaplan • March 25, 2020

Tracking the impact of coronavirus on the medtech industry

Among the latest: As COVID-19 test sales boom, Hologic thinks its revenues this quarter may be 60% higher than last year's.

By Nami Sumida • UPDATED: Sept. 11, 2020 at 10:15 a.m.

US won't suspend China tariffs during coronavirus outbreak

The tariffs present a risk and additional cost to medical supply chains as the need for critical products grows urgent. 

By Shefali Kapadia • March 19, 2020

Medtronic pledges '24/7' ventilator production to meet coronavirus demand

The company is aiming to more than double its manufacturing capacity as GE, Getinge, Philips and others outside of healthcare commit to boosting worldwide supply of the potentially lifesaving machines.

By Maria Rachal • March 19, 2020

FDA pulls plug on routine US inspections

The move to protect staff and acknowledge industry worries about outside visitors amid coronavirus comes a week after the agency said it would postpone nearly all overseas inspections through April.

By Nick Paul Taylor • March 19, 2020

Lessons from Hurricane Maria could aid Baxter's coronavirus operations

The aftermath of the 2017 storm led to serious manufacturing disruptions to Baxter's IV business and prompted it to strengthen its supply network, which CEO Joe Almeida said might be abating challenges with COVID-19 so far.

By Maria Rachal • March 18, 2020

Intuitive Surgical among 1st big medtechs to warn of costly pandemic disruptions

Delayed placements and procedures in China and Italy may not have a material impact on the robotic surgery giant, but similar trends in the U.S. and Europe, along with reduced capital spending by hospitals, present a greater threat.

By Maria Rachal • March 17, 2020

Coronavirus spread prompts FDA to postpone nearly all overseas inspections

The agency based the decision on U.S. government travel restrictions and advisories, saying "alternative tools and methods" will help maintain oversight.

By Jonathan Gardner • March 10, 2020

$8.3B in coronavirus funding set in motion as federal agencies ramp up response

The House and Senate passed a bill with allocations for medical supplies and testing as Vice President Mike Pence met with clinical lab execs Wednesday from LabCorp, Quest Diagnostics, Thermo Fisher and others.

By Shannon Muchmore • UPDATED: March 5, 2020 at 4:08 p.m.

AdvaMed, state AGs weigh in ahead of EPA sterilization rule

About a year after FDA told the medical device industry the closure of an Illinois ethylene oxide facility could disrupt supply chains, environmental regulators are considering changes that could affect sterilizers across the country.

By Maria Rachal • Feb. 14, 2020

Moody's: Coronavirus spread in US to have mixed credit effects across healthcare

Device makers — particularly Boston Scientific, BD and Abbott — will likely see a credit negative effect from supply chain disruption, even if the outbreak is contained to China.

By Shannon Muchmore • Feb. 13, 2020

Medtech in limbo as Brexit arrives

Although the industry has lobbied for the departing member state to implement the Medical Device Regulation and stick closely to EU rules, a minister in the U.K. government said legislative alignment “just ain't happening.”

By Nick Paul Taylor • Feb. 03, 2020

Dive Awards

The MedTech Dive Awards of 2019

From TAVR's takeoff to FDA's new approaches to premarket review, these are the industry forces that left their mark on medical technology this year.

EPA wants more data from ethylene oxide sterilizers, strikes device-friendly tone

Administrator Andrew Wheeler said "medical device sterilization is vital to protecting public health" on release of a notice ahead of rulemaking that could impact sterilizers reliant on the carcinogenic gas.

By David Lim • Dec. 06, 2019

Q&A

5 insights into Dexcom's year ahead from CEO Kevin Sayer

The diabetes tech giant has "not turned on the faucet full blast" in marketing to new customers. Sayer told MedTech Dive he plans to change that as Dexcom quadruples its sensor production capacity for its continuous glucose monitors.

By Maria Rachal • Nov. 25, 2019

FDA launches pilot to speed new ethylene oxide sterilization methods

Device makers should also reduce paper in packaging "as soon as possible" to trim the amount of the gas required for effective sterilization. The agency also named its innovation challenge winners.

By David Lim • Nov. 25, 2019

AdvaMed lobbied EPA chief Wheeler on cancer report amid delay in ethylene oxide regs

A bipartisan congressional task force is pushing EPA to issue ethylene oxide regulations that rely on EPA's 2016 report on the toxicity of the gas.

By David Lim • Nov. 22, 2019

FDA clears Pentax duodenoscope with disposable part in bid to cut infection risk

Center for Devices and Radiological Health Director Jeff Shuren called the clearance "another major step toward lowering the risk of infection among patients," and said duodenoscope safety is a top priority for the agency.

By David Lim • Nov. 18, 2019

Edwards recalls Pascal valve guide sheath in Europe amid potential for embolizations

A manufacturing problem resulting in damage to the inner lining of the sheath in fewer than 1% of devices prompted the recall. No adverse events were linked to the issue.

By Susan Kelly • Nov. 18, 2019

FDA advisers: Metal implants need beefed up ingredient labels

Industry representative Whitney Christian, a toxicologist at Medtronic, told the panel that medical device manufacturers support patients' and doctors' "right to know" what's in implants and are willing to work with FDA on the issue. 

By Maria Rachal • Nov. 15, 2019