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 Nov. 24, 2021
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    Sarah Silbiger via Getty Images

    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 Nov. 23, 2021
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    Permission granted by iRhythm Technologies
    Q&A

    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 Nov. 19, 2021
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    Justin Sullivan via Getty Images

    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 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 Nov. 5, 2021
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    Spencer Platt via Getty Images

    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 Nov. 1, 2021
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    Permission for use provided by UniGroup Logistics

    Sponsored by UniGroup Logistics

    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 Updated Oct. 22, 2021
  • Deep Dive

    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 Oct. 18, 2021
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    Courtesy of Ellume Health

    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 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 Sept. 27, 2021
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    Spencer Platt via Getty Images

    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 Sept. 27, 2021
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    Justin Sullivan via Getty Images

    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 Sept. 24, 2021
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    National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Image]. Retrieved from Flickr.

    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 Sept. 3, 2021
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    Courtesy of Qiagen

    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 July 13, 2021
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    Courtesy of Abbott

    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 July 9, 2021
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    Jacob Bell

    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 June 18, 2021
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    Sarah Silbiger via Getty Images

    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 June 1, 2021
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    Permission granted by Quidel Corporation

    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 April 23, 2021
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    Dollar Photo Club

    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
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    Permission granted by Quidel Corporation

    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 Feb. 19, 2021
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    Courtesy of Ellume Health

    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 Feb. 2, 2021
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    Adeline Kon/MedTech Dive

    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 Jan. 29, 2021
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    Courtesy of Abbott
    Dive Awards

    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
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    Permission granted by Quidel Corporation
    Dive Awards

    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 Dec. 9, 2020