Manufacturing

4 takeaways from Medtronic's latest earnings report

The medtech giant on Tuesday discussed a wide range of issues impacting the company, from whether procedure volumes rebounded in November to the chances of it spinning off non-core or underperforming business units.

By Nick Paul Taylor • Nov. 24, 2021

FDA beats 2021 facility inspection target but big pandemic-driven backlog remains

The update features evidence of progress at the device division, with fewer application decisions delayed solely because of pending facility inspections or assessments.

By Nick Paul Taylor • Nov. 23, 2021

New iRhythm CEO talks Medicare pricing, larger medtech competitors, international markets

"I think the near-term noise is something that we'll work through, but the underlying technology has never been questioned," Quentin Blackford told MedTech Dive.

By Ricky Zipp • Nov. 19, 2021

Medtech sounds alarm on semiconductor shortages, asks feds to prioritize chips for medical use

AdvaMed and several device companies, including BD, Medtronic and Philips, have reiterated to the Biden administration how supply chain constraints are causing an "unsustainable" disruption to the industry.

By Nick Paul Taylor • Nov. 10, 2021

Stryker, Zimmer, Smith & Nephew warn orthopaedic headwinds to last into Q4

Third-quarter results reveal how the industry remains constrained by COVID-19, hospital staffing shortages and lower pricing in China. 

By Nick Paul Taylor • Nov. 5, 2021

3 trends dragging medtechs: Supply chain constraints, inflation and hospital staffing shortages

J&J, ResMed and Stryker are among the companies citing one of these factors as constraining growth in the current reporting season.

By Nick Paul Taylor • Nov. 1, 2021

Check all the vital signs: Logistically speaking, medical equipment deliveries are operations best left to the specialists

Medical equipment falls into the high-touch category, meaning it needs careful coordination of resources, schedules and specialized knowledge in order to deliver things seamlessly.

Oct. 25, 2021

Philips sees sleep business recovering from recall in H2 2022, analysts doubtful

William Blair analysts warn that limited provider support during the medtech's recall is hurting brand credibility and impacting Philips' ability to regain market share, while positioning ResMed as the beneficiary of "durable" share loss. 

By Greg Slabodkin • Updated Oct. 22, 2021

Anatomy of a medical device recall: How defective products can slip through an outdated system

"It truly is like we are operating in about the 1950s," one consultant noted of the process. The FDA has held two meetings in the past year to mull improvements.

By Ricky Zipp • Oct. 18, 2021

FDA labels Ellume's recent COVID-19 Home Test recall Class I event

The agency said there have been 35 reports of false positive results but no deaths reported. More than 2.2 million devices are being recalled in the U.S.

By Nick Paul Taylor • Updated Nov. 10, 2021

Amid pandemic, medtech R&D, merger activity jumped: EY report

Research and development spending at pure-play medtechs rose to a level last seen before the 2007-2008 financial crisis.

By Nick Paul Taylor • Sept. 27, 2021

Cue, Google's COVID-19 test provider, raises $200M in IPO

The at-home test maker will use the money to scale up commercial and manufacturing infrastructure to support its portable diagnostic platform. Cue Health's Friday debut on the Nasdaq valued the company at $2.9 billion.

By Nick Paul Taylor • Sept. 27, 2021

Medtechs face supply chain disruptions from semiconductor shortage: report

The AdvaMed-commissioned survey found all respondents have experienced some level of disruption to their chip supply chain, with delays ranging from two weeks to more than one year.

By Nick Paul Taylor • Sept. 24, 2021

Abbott, Quest, Quidel scramble to add test capacity as delta variant surges

Quest Diagnostics is adding testing platforms in areas of the U.S. with high demand while manufacturers of at-home coronavirus tests such as Abbott and Quidel are ramping up capacity again after the early summer slump.

By Nick Paul Taylor • Sept. 3, 2021

Qiagen joins Abbott, Quidel cutting 2021 outlook as COVID-19 test demand wanes

CEO Thierry Bernard blamed a faster-than-expected testing drop and uptick of vaccinations. Jefferies said the downgraded targets are disappointing, particularly given management's forecast reiteration last month.

By Greg Slabodkin • July 13, 2021

Abbott lays off 400 workers amid drop in demand for COVID-19 tests

The company cut its 2021 outlook in June, blaming a sharp, rapid decline in demand for its coronavirus-related diagnostics on global vaccination efforts. The downward trend is anticipated to continue, an Abbott spokesperson said. 

By Greg Slabodkin • July 9, 2021

FDA seeks feedback on distinction between device remanufacturing and servicing

The long-awaited draft guidance is meant to clarify a blurry line between the two processes. The Medical Imaging and Technology Alliance contends remanufacturing is being done by unregulated third-party device servicers.

By Nick Paul Taylor • June 18, 2021

FDA seeks 8% budget boost for CDRH to back resurgence of domestic device production

The Biden administration said its request for the Center for Devices and Radiological Health will help the U.S. reduce reliance on products from China and other countries and strengthen its ability to respond to emergencies.

By Nick Paul Taylor • June 1, 2021

Quidel shakes Wall Street with bearish COVID-19 test forecast

The company late Thursday pre-announced first-quarter revenue nearly $100 million below analyst expectations, with Craig-Hallum's Alex Nowak now calling the business unforecastable.

By Greg Slabodkin • April 23, 2021

Drugmakers flock to Vineti's fix for a cell, gene therapy problem

The San Francisco-based tech company wants to establish a patient identifier akin to a digital ID badge that could work for all types of advanced medicines and improve traceability, control costs and better ensure patient safety. 

By Jacob Bell • March 24, 2021

Quidel mulls entering new COVID-19 testing markets after another bumper quarter

The point-of-care diagnostics maker sold $678.7 million in kits in the fourth quarter, up 81% sequentially, and is assessing whether it has the capacity to support antigen tests for retail, travel, entertainment and sports. 

By Nick Paul Taylor • Feb. 19, 2021

DoD awards Ellume $231M to increase US production of at-home, OTC COVID-19 test

The Australian diagnostics company will use the funding to establish a U.S. manufacturing facility that is projected to increase production capacity by 640,000 tests per day by December.

By Susan Kelly • Feb. 2, 2021

4 key trends for medtech in 2021

With resurgence of the coronavirus and emergence of more contagious strains, COVID-19 challenges, but also opportunities, lie ahead for medical device and diagnostics companies.

By Greg Slabodkin • Jan. 29, 2021

Company of the Year: Abbott

Demand for the diversified medtech's array of coronavirus tests puts it on solid financial ground going into 2021, amid a challenging year for the medical device industry.

By Maria Rachal • Dec. 9, 2020

Executive of the Year: Doug Bryant, Quidel

The veteran of Abbott has been at the helm for nearly 12 years, setting the company up for opportunities when the COVID-19 pandemic hit in early 2020 to leverage its point-of-care antigen testing.

By Greg Slabodkin • Dec. 9, 2020