Guest Columns

  1. FDA Vs. Congress: The Software Showdown 11/14/2022

    September 2022 will be remembered as a seminal turning point in digital health in the U.S. With the FDA’s final guidance on Clinical Decision Support (CDS) software, the FDA disregards a Congressional directive when it enacted the 21st Century Cures Act in 2016. 

  2. LATAM’s Regulatory Framework For Medtech Early Feasibility Studies 11/11/2022

    Latin America is a compelling region to conduct medtech early feasibility studies due to its ethnically diverse population, its high rate of urbanization, and more. Here, the author spotlights Colombia, Brazil, and Mexico as the hotspots for medtech feasibility studies in Latin America. 

  3. The Upper Nasal Space: Drug Delivery’s Next Frontier 11/9/2022

    Oral formulations of drugs account for up to 75% of prescriptions. However, many diseases require therapies to provide a maximal benefit as quickly as possible, and oral delivery may result in slow absorption. Enter drug delivery via the upper nasal space, which has the potential to provide a more rapid onset of activity, avoid degradation in the GI tract, and more benefits.

  4. The Global Hearing Device Market: Which Segment Is On The Rise? 11/8/2022

    In 2021, the global hearing device market experienced a double-digit growth rate and almost recovered from the impacts of COVID-19. In this article sharing market research for a forecast period through 2028, the authors cover hearing aids, cochlear implants, middle ear implants, and hearing aid batteries.

  5. India’s New Drugs, Medical Devices, And Cosmetics Draft Bill 2022 11/7/2022

    To accommodate changing requirements and encourage the adoption of new technology, India’s Ministry of Health and Family Welfare released a draft bill in July 2022 to replace the existing Drugs and Cosmetics Act 1940. What are the major areas of change and how much of an impact will there be?

  6. Should I Request A Q-Submission For My Medical Device? 10/31/2022

    Q-Submissions are a mechanism available to request feedback from the FDA. It is the pathway for a medical device sponsor to reach out to request a meeting or written responses related to a product’s regulatory strategy or testing plan. The time and money for a Q-Submission pales in comparison with what is needed to correct testing and regulatory strategies later on.

  7. RWE & Advanced Diagnostics Propel Better Patient Outcomes 10/28/2022

    Notable diagnostic advancements in data science and the scientific community’s ability to use analytic tools are playing an essential role in improving patient outcomes.

  8. Wearable Electro-Patches: 4 Development Considerations 10/26/2022

    When developing wearable sensor patches capable of providing medical-grade monitoring, we must begin by appreciating that creating a fully functional system involves some essential building blocks, all of which must work together.

  9. Autonomous Supply Chain Planning Is Within Reach 10/19/2022

    In a fast-paced industry constantly innovating — from personalized medicine to health wearables — life sciences companies must be prepared to adopt transformative technologies that can help them meet the demands of the future of medicine. Autonomous supply chain planning is not science fiction; it's here, and it's now. Building a practical road map will help.

  10. Robotic Tech’s Opportunities To Revolutionize Surgery 10/13/2022

    Innovation in robotic technology has continued to progress rapidly. This article discusses the benefits of minimally invasive robotic surgery to surgeons and patients, and it also shares an overview of the types of robotic technology disrupting the industry, such as capsule robots.