Guest Columns

11. Human Factors Engineering Considerations For Medical Device Packaging 2/27/2023

    As an integral component of product design, human factors engineering should be applied at the onset of a product-design initiative and carried out throughout the complete development process. This article shares key regulatory considerations and usability considerations for medical device packaging.

12. US Interventional Cardiology: 2 Segments Showing Greatest Market Growth 2/24/2023

    The U.S. interventional cardiology market, worth over $3.5 billion, is seeing technological innovation and consolidation. This is influencing notable market growth in two segments in the market, which this article discusses.

13. How Is The Diabetes Management Device Landscape Evolving? 2/23/2023

    Diabetes management has only seen incremental improvements until the last decade or so. Francine Kaufman, M.D., an endocrinologist who has served as president of the American Diabetes Association and chaired the National Diabetes Education Program, shares the notable recent achievements in the space and how the future of the field looks.

14. Ablation Devices: The Current Landscape & Emerging Technologies 2/21/2023

    By delivering high levels of energy (thermal, electrical, mechanical), ablation causes local cell death in order to meet a therapeutic need such as cancer, irregular heartbeats, nerve pain, and chronic bronchitis. This article discusses the established technologies, recent advances, and emerging technologies.

15. Medical Device QMS Cybersecurity: Threat Modeling 2/17/2023

    The FDA considers threat modeling fundamental in your premarket submission and expects you to include system level risks in its creation and deployment. But how do we go about threat modeling for our device? And how do we build the requisite QMS infrastructure and processes? This article shares a four-step strategy.

16. New EU Directive Marks Cybersecurity Regulatory Paradigm Shift For Bio/Pharma & Medical Devices 2/15/2023

    The EU's new Directive 2022/2555 on the Security of Network and Information Systems (“NIS2”) mandates cybersecurity risk management measures and reporting requirements for all segments of our industry, including labs; CROs and CDMOs; and manufacturers of APIs, bio/pharmaceuticals, and medical devices.

17. How To Maximize Your Medtech Booth At Trade Shows: During The Trade Show 2/14/2023

    In an earlier article, I covered best practices for pre-show planning. In this article, I share the "do's and don'ts" for your medtech booth during the trade show.

18. Our Weather Forecast For Medtech Business In 2023 2/8/2023

    We outline the key medtech takeaways from the Annual J.P. Morgan Healthcare Conference held in January, as well as the medtech trends that we will be watching this year.

19. The 8 Key Takeaways For FDA Inspections In The Food And Drug Omnibus Reform Act 2/7/2023

    With President Biden’s signature, the Food and Drug Omnibus Reform Act of 2022 (FDORA), part of the larger Consolidated Appropriations Act of 2023, became law on Dec. 29, 2022. FDORA expands and modifies the inspection authority of the FDA in several key areas, including alternative tools to inspection, mutual recognition agreements, bioresearch monitoring, and more.

20. 3 Lessons U.S. Healthtech Companies Can Learn From The Cerebral Investigations 2/6/2023

    Regulatory oversight and scrutiny of healthtech companies has emerged as a priority for the U.S. federal government. Facing triple investigations by the Federal Trade Commission (FTC), Department of Justice (DOJ), and Drug Enforcement Administration (DEA), Cerebral has become a cautionary tale for healthtech companies looking to provide telemedicine services across the U.S.