Guest Columns

  1. 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.

  2. 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?

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. Pharma 4.0 Software Methodologies In Biopharma And Medical Devices 10/10/2022

    The life sciences industry has been using computer software testing methodology to validate software that is categorized to be GxP in alignment with the principles of good automated manufacturing practices and Industry 4.0 standards. This article discusses the methodologies of computerized system validation, computer software assurance, and the Agile approach.

  9. Tips For Your Virtual Meetings With The FDA 10/7/2022

    It seems unlikely that the FDA will return to in-person meetings. This author, an FDA veteran, shares tips for pharma, biotech, and medical device companies on many aspects of your virtual meetings with the FDA: optimal timing of your first meeting, the video/teleconference experience, and more.

  10. FDA User Fee Programs Reauthorized: FDA’s CBER Is A Clear Winner 10/6/2022

    Last minute, squeaky clean! After years of planning, negotiation, and input, the user fee reauthorization bill was passed and signed into law on the very date that the programs were scheduled to sunset. This article sums up the key takeaways, CBER's reorganization with new product-specific offices, and more.