Manufacturing: Page 2

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

Duodenoscope reprocessors' poor work conditions exacerbate infection problem, FDA panel says

The advisory meeting followed FDA disclosing reports of three deaths, 45 patient infections and 159 cases of device contamination related to inadequate device reprocessing between October 2018 and March 2019.

By David Lim • Nov. 08, 2019

Sponsored by ZS

Streamlining your portfolio can actually improve profitability. Here's how.

Retiring products is not an easy decision, but taking this step can have a real and positive impact on the P&L, customer, cross-functional teams and the ability to drive innovation. 

By Matt Singer • Oct. 08, 2019

Sterigenics abandons effort to reopen Willowbrook ethylene oxide sterilization facilities

The company behind the major medical device sterilization plant said it is "actively taking steps to ensure customer and patient needs continue to be met by our other facilities."

By David Lim • Sept. 30, 2019

EPA delays ethylene oxide sterilizer rule timeline amid industry pushback

Separately, it is unclear how long it will be until a second proposed rule that aims to address air pollution emissions from the ethylene production process is published.

By David Lim • Sept. 25, 2019

FDA warns closure of Atlanta Sterigenics facility could impact medical device supply

Sterigenics said it aims to complete construction of technology upgrades at the plant, designed to reduce ethylene oxide emissions, by early October.

By David Lim • Sept. 16, 2019

FDA sets November ethylene oxide sterilization, duodenoscope safety advisory panel

The dual-topic expert panel will be tasked with developing recommendations for FDA on two of the largest challenges currently facing the Center for Devices and Radiological Health.

By David Lim • Sept. 03, 2019

Medline, Vantage ethylene oxide emissions caused cancer, lawsuits claim

Commercial sterilizer Sterigenics, which was forced to shut down a Willowbrook medical device sterilizing plant in February, is defending itself against at least 32 lawsuits in the same state court over similar claims.

By David Lim • Aug. 29, 2019

Sterigenics strikes deal to reopen Willowbrook sterilization plant

The closure of the Illinois facility caused millions of dollars of losses for major medical device firms like Medtronic, Boston Scientific and Smiths Medical. 

By David Lim • UPDATED: Sept. 9, 2019 at 10:41 a.m.

FDA launches innovation challenge to boost ethylene oxide sterilization alternatives

The agency also plans to hold an advisory committee meeting Nov. 6-7 to discuss how to further encourage innovations in medical device sterilization. 

By David Lim • July 16, 2019

Baxter to expand home dialysis on heels of Trump kidney initiative

Amid a push to move away from costly dialysis centers, Baxter said it expects to add and bolster facilities for making and distributing peritoneal dialysis solutions, devices and cassettes. 

By Maria Rachal • July 11, 2019

FDA hits Clinicon with warning letter over sterility failings

Inspectors found fault with the validation and calibration of processes and equipment involved in ensuring sterility of laser devices.

By Nick Paul Taylor • July 11, 2019