Guest Columns

11. 5 Best Practices For Responding To FDA Form 483 Inspection Observations 9/1/2023

    How you respond to FDA Form 483 observations will determine if they escalate into more serious consequences, such as a warning letter or enforcement action. You don't want that. Follow this 5-step action plan to make sure the findings are properly addressed.

12. What Is The Future Of Hysteroscopic Morcellators In The U.S.? 8/21/2023

    In the gynecological devices market, hysteroscopic morcellators systems have emerged as an innovative technology for minimally invasive surgery. This article shares new market research on this topic, including an overview of the products currently on the market.

13. 7 Patient Benefits Of IoT-Connected Medical Devices 8/14/2023

    Patients want better experiences, in particular, more control over their health, more open communication with care providers, and better access to care services. One of the most promising approaches is to use the Internet of Things (IoT), which consists of interconnected devices and sensors that exchange data via the internet.

14. Korean GMP: MFDS Requirements For On-Site And Document Audits of Medical Device Manufacturing Plants 8/8/2023

    If your medical device or in vitro diagnostics company is looking to enter the South Korea market, you will need to comply with the Korea Good Manufacturing Practice (KGMP) standards and requirements. This article shares a thorough overview of the requirements, including new information about audits that went into effect at the beginning of 2023.

15. The Current & Future Outlook For Precision Medicine In Women’s Health 8/7/2023

    The promise of shifting away from a “one size fits all” strategy in women’s health is most clear in advances in breast cancer care, but more recent activity shows precision medicine is possible across many aspects of women’s health outside oncology.

16. Agile Software Development In Bio/Pharma & Medical Devices, Part 3 7/25/2023

    Computer software/systems validation testing are used to validate software under GxP environments. Parts 1 and 2 of this article series shared Agile methodology with regard to the phases of planning, team structure and collaboration, software architecture, and more. In this final installment, the author discusses software release, configuration and change management, CAPA, and more.

17. 5 Key Factors To Gain Regulatory Approvals for Innovative Rapid Diagnostic Devices 7/24/2023

    COVID-19 demonstrated the power of rapid diagnostics on a global scale, but the path forward is still complex for in vitro diagnostics (IVD) developers and medtech leaders. This article outlines five factors to consider in order to enable efficient, smooth regulatory approval of your product.

18. Phototherapy Devices: Where Is The Field Headed? 7/21/2023

    Patients living with chronic skin conditions are increasingly turning to light-based therapy – known as phototherapy – as an alternative to topicals or biologics. Let's look at the different wavelengths of UV light used, as well as recent advances in UVB light sources to use in next-gen devices.

19. Materials Innovation: Propelling A New Era For Medical Devices 7/19/2023

    Medical device designers are increasingly challenged by the limits of what the materials at their disposal can do. How can device manufacturers begin to consider what the alternatives to standard materials might allow for in a given medical application? And what would that process look like?

20. The Importance Of Software Validations For Medical Devices 7/17/2023

    It’s in your best interest to be as rigorous and thorough as possible when testing software that runs your medical device. If a device has a software issue/fault, the patient's life could be in danger.