Featured


  • 3 Critical Considerations for U.S. Medical Device Commercialization

    3 Critical Considerations for U.S. Medical Device Commercialization

    the step-by-step process of working with the FDA to bring a medical device to the U.S.
    Online Exclusives Michael Lynch, Managing Consultant, Intertek 05.18.18

  • Hearing Aid Companies Sivantos and Widex Merge in $8 Billion Deal

    Hearing Aid Companies Sivantos and Widex Merge in $8 Billion Deal

    The merged company is now a top three contender in the hearing aid market.
    Sivantos 05.18.18

  • Digital Health | Electronics
    Mike on Medtech: Voice-Enabled Medtech

    Mike on Medtech: Voice-Enabled Medtech

    Sean Fenske and Mike Drues discuss voice-enabled medtech and its potential in healthcare.
    Sean Fenske, Editor-in-Chief 05.17.18


  • Diagnostics
    Modular Blocks Could Enable

    Modular Blocks Could Enable 'Plug and Play' Diagnostic Devices

    Modular blocks could allow labs around the world to cheaply and easily build their own diagnostics.
    Videos Anne Trafton, MIT News Office

  • Cardiovascular | Surgical
    Surmodics Acquires Embolitech Thrombectomy Tech for $5 Million

    Surmodics Acquires Embolitech Thrombectomy Tech for $5 Million

    Surmodics’ design, development, hydrophilic coating technology, and manufacturing capabilities will advance the platform.
    Business Wire 05.14.18

  • Materials | Surgical
    Boston Scientific Responds to

    Boston Scientific Responds to '60 Minutes' Transvaginal Mesh Report

    The company released an open letter denying 60 Minutes' claims of using a counterfeit Chinese plastic for its mesh products.
    Boston Scientific 05.14.18


  • Surgical
    Dräger Medical Recalls Fabius Anesthesia Machines Due to Production Step Error

    Dräger Medical Recalls Fabius Anesthesia Machines Due to Production Step Error

    The recalled anesthesia machines contain excessive oil not removed during production, which may cause ventilation to fail.
    U.S. Food and Drug Administration 05.10.18

  • FDA Seeks Permanent Injunctions Against Two Stem Cell Clinics

    FDA Seeks Permanent Injunctions Against Two Stem Cell Clinics

    Actions part of a comprehensive approach to the oversight of regenerative medicine products.
    U.S. Food and Drug Administration 05.10.18

  • Sirtex Receives $1.4B Counteroffer from Chinese Investment Firm

    Sirtex Receives $1.4B Counteroffer from Chinese Investment Firm

    The Sirtex board of directors has determined to engage with CDH Investments to further understand the conditions.
    PR Newswire 05.07.18


  • Contract Manufacturing | Surgical
    Integer to Divest Advanced Surgical and Orthopedics Lines to MedPlast for $600 Million

    Integer to Divest Advanced Surgical and Orthopedics Lines to MedPlast for $600 Million

    Move provides Integer financial flexibility; acquisition bolsters MedPlast’s portfolio.
    Integer Holdings Corporation 05.04.18

  • A Services Convergence: A Review of Medtech

    A Services Convergence: A Review of Medtech's Consolidating Supply Chain

    A survey of mergers and acquisition activity in the medtech outsourced manufacturing market.
    Bill Ellerkamp, Contributing Writer 05.03.18

  • Contract Manufacturing
    Developing the True Partnership: A Full-Service Outsourcing Roundtable

    Developing the True Partnership: A Full-Service Outsourcing Roundtable

    Successful OEMs recognize their top service providers as development partners instead of transactional suppliers.
    Sean Fenske, Editor-in-Chief 05.03.18

  • So Fruitful Together: An M&A Roundtable

    So Fruitful Together: An M&A Roundtable

    M&A is a key component of evolving business strategies that will enable companies to better compete in a value-driven market.
    Michael Barbella, Managing Editor 05.03.18

  • R&D & Design
    Designing from Finish to Start

    Designing from Finish to Start

    When developing products for a value-based environment, it can be helpful to consider the end result first.
    Steve Maylish and Vicki Caiati 05.03.18

  • Diagnostics
    Theranos: Not Long for the Business World?

    Theranos: Not Long for the Business World?

    It won’t be long now. With a skeleton staff, dwindling finances, a sullied reputation, and a disgraced leader under criminal investigation, embattled blood testing firm Theranos Inc. seems veritably destined for a terrible, miserable, no goo…
    Michael Barbella, Managing Editor 05.03.18

  • Pharma Industry’s Growth—What Can Medtech Learn from It?

    Pharma Industry’s Growth—What Can Medtech Learn from It?

    Global revenues for our sister industry—pharmaceuticals—continues to grow (Table 1). By 2022, worldwide pharmaceutical sales are projected to reach an estimated $1.4 trillion at a CAGR of 6.4 percent from 2001 sales of $390 billion.2 That…
    Maria Shepherd, President and Founder, Medi-Vantage 05.03.18

  • The Right Vendors Foster Growth: Why Firms of All Sizes Need to Outsource

    The Right Vendors Foster Growth: Why Firms of All Sizes Need to Outsource

    I  was working as a product development engineer at AcroMed (a spinal implants manufacturer that was acquired by DePuy in 1998), when I noticed a gap in the medical device industry. There were plenty of companies coming up with great ideas for d…
    Dawn A. Lissy, President & Founder, Empirical 05.03.18

  • Software & IT
    Embracing the Digital Evolution for Content Management

    Embracing the Digital Evolution for Content Management

    Digitalization, global expansion, and changing compliance requirements are driving medical device manufacturers to rethink their commercial models with a specific focus on content management. The industry’s move toward digital has caused a prol…
    Terri Howard, Director of Commercial Strategy, Medical Device and Diagnostics, Veeva Systems 05.03.18

  • 13485:2016—Beyond the Risk Management File

    13485:2016—Beyond the Risk Management File

    Many companies currently are transitioning from ISO 13485:2003 to ISO 13485:2016, the updated standard drafted to help medtech firms evolve with the industry and address changes in the underlying ISO 9001 benchmark. Some companies, however, are findi…
    James A. Dunning, Principal, QPC Services LLC 05.03.18

  • Medical Devices and the Political Climate of 2018: An Update from the Swamp

    Medical Devices and the Political Climate of 2018: An Update from the Swamp

    The November midterm elections have the potential to shift the power balance, leadership, and legislative agenda of Congress, which would certainly have a sizable impact on the medical device industry. In addition to what lies ahead, current actions…
    Jeffrey J. Kimbell and David C. Rudloff, Jeffrey J. Kimbell & Associates Inc. 05.03.18