Guest Columns

  1. GE’s Risky Wager On Medtech

    During his company’s Investor Day in mid-November, General Electric (G.E.) CEO John L. Flannery outlined his plan for restructuring the industrial conglomerate, which has been a paragon of corporate virtue and discipline for the last 120 years.

  2. Wearable Derived Data In Clinical Trials: The Biggest Barriers Are Crumbling

    Previous articles on Clinical Leader have discussed the potential benefits of wearable devices for remote patient monitoring in clinical trials. In addition to possible increases in trial efficiency and reduction of costs, “wearables” have the potential to collect data better reflecting patient functioning and response in the real-world setting.  According to the Clinical Trials Transformation Initiative’s Mobile Clinical Trials (MCT) Program, mobile devices, including wearables, offer the opportunity to collect more complete and informative data than ever before. Mobile devices may also reduce the patient burden in clinical trials, thus enhancing the patient experience.  Companies are exploring the use of wearable devices in the post-marketing setting as well, as a component of patient care. 

  3. 5 Things Medical Device Engineers Should Know About User Research

    When designing a medical device, nothing beats direct observation of, and feedback from, the people who will be using it. Ideally, this research is performed as a close partnership between the human factors (HF) researchers and the engineers who will be working on the device.

  4. Innovation Woes, Or: How I Learned To Stop Worrying And Love My Failed Device

    Viewed at a high level, a large proportion of the medical device market is commoditized (think bandages and IV bags). However, there is a great deal of innovation going on, with exciting new technologies debuting across a wide range of product categories. Understanding how these technologies are differentiated from previous iterations allows us to forecast their likely impact on their respective markets.

  5. India Looking To Local Solutions For Domestic Medtech Needs

    For most of the last century, innovation in the medical device ecosystem has emerged from rich countries: the United States, Japan, Europe, and Australia. But today, a thriving ecosystem has developed across India, driven in part by unique needs in India and in part by the cross-fertilization of ideas, education, and capital from American sources. In this article, we look at three startups that are addressing India’s unique problems today, but may eventually bring their solutions to a global audience.

  6. EU MDR and Clinical Evidence: What You Need to Know

    The Council of the European Union has adopted the European Medical Device Regulations (MDR 2017/745), which were published in the Official Journal of the European Union and entered into force on May 26, 2017. Are you ready?

  7. The 5 Most Common Problems With Your CAPA Process

    The FDA requires medical device manufacturers to have clearly documented procedures for corrective action and preventive action (CAPA). Unfortunately, many medical device companies fail to prepare a good approach to their CAPA process, which is so important to the health and success of your company.

  8. Medical Device Cybersecurity Alerts On The Rise

    In the past 18 months, the FDA and DHS have been warning the medical device industry about the danger of cybersecurity vulnerabilities in networked medical devices. But the number of medical device cybersecurity alerts has more than tripled in the last three months. Is this an anomaly or the new normal?

  9. Safety Innovations and Discovery of New Niches Set the U.S. IV Therapy Market on the Move

    For the last 40 years, intravenous (IV) infusion therapy became as ubiquitous as cots and syringes. In the U.S., for every hospital bed, there are almost 2 electronic IV pumps used. The main challenge facing health care providers and device manufacturers is how to make this therapy safer but also more accessible

  10. A Guide to Developing Usable Instructions For Use For Medical Devices

    Medical devices can be complex and may require users to understand specific information about storage, use, disposal, or reprocessing. Instructions for use (IFU) are therefore considered part of the product user interface. Here are some critical factors to consider when developing effective IFUs.