Guest Columns

  1. CMS Takes Aim At Medical Device Cybersecurity – How To Ensure Continuous Medicare/Medicaid Coverage 8/4/2021

    In its June 2021 report, the U.S. Office of Inspector General declared that Medicare lacks consistent oversight of cybersecurity for networked medical devices in hospitals. The Centers for Medicare & Medicaid Services (CMS) is now considering additional ways to highlight the importance of medical device cybersecurity, in conjunction with the FDA and the Office for Civil Rights.

  2. Why We Shouldn’t Be Categorizing Digital Therapeutics As Drugs 8/2/2021

    Payers and health plans handle digital therapeutics inconsistently. They sometimes treat them as medications. The manufacturer would have a role in this determination. This article delves into what digital therapeutics are and are not, and why the industry should not be categorizing them as drugs.

  3. EMA Publishes Guideline On Quality Documentation For Medicinal Products 8/2/2021

    This new EMA guideline will become effective on January 1, 2022. It describes the information that should be presented in the quality part of a marketing authorization dossier for a medicinal product when it is used with a medical device and/or as part of a medical device. Medicinal products are similar to "combination products" referred to by the US FDA.

  4. An Analysis Of The Pelvic Organ Prolapse Repair Medical Device Market 7/28/2021

    Pelvic organ prolapse is common and may affect 50% of women, though the severity of the condition varies and, in some cases, may be resolved with non-surgical treatments. As of 2019, however, approximately 15% of American women needed surgical repair for POP at some point in their lifetime. This article analyzes the current device market and describes the opportunity for innovation.

  5. FDA Seeks Public Comment On Draft Guidance On Remanufacturing Medical Devices 7/26/2021

    On June 24, 2021, the FDA released a draft guidance, Remanufacturing of Medical Devices Draft Guidance for Industry and Food and Drug Administration Staff, for public comment in the Federal Register to help clarify whether repair, servicing, and reprocessing activities performed on devices are likely considered remanufacturing.

  6. What To Expect From A Remote Inspection -- & How To Navigate It 7/23/2021

    Regulators have moved toward remote inspections since the pandemic began, and this is likely to continue. This article presents an overview of the remote inspection process and provides advice on how to prepare for and deal with the inspection on the day, as well as how to respond to any concerns raised following the audit.

  7. Selecting The Best Human Factors Method For Your Medical Or Drug Delivery Device Evaluation 7/21/2021

    A robust human factors process is critical to product optimization and market competitiveness for medical devices and drug delivery devices, but not all companies have the resources, funding, or time to conduct such user studies. Genentech's head of human factors engineering examines the three major categories of evaluation that you should consider, the pros and cons of each, and how to select study participants.

  8. Retro-Validation: 6 Factors To Resolve Validation Deficiencies 7/19/2021

    A retro-validation is a re-execution of the method validation with the method parameters, setup, and everything kept the same as before to retrospectively cover all prior generated data. It is not the same as past validation because you would shore up the validation deficiencies or gaps. This article discusses the 6 important considerations.

     

  9. The 8-Step Checklist To Write Effective Investigation Reports 7/16/2021

    It’s always best to prevent the need to investigate a non-compliance, but if you experience a non-compliance, it’s necessary to quickly and effectively perform an investigation. The investigation report needs to be clearly understandable to anyone reviewing the report, and hopefully you'll also learn enough to make sure the non-compliance doesn't recur.

  10. FDA Releases Guidance On CMC Changes To An Approved Application: Certain Biological Products 7/14/2021

    At the end of June, the FDA released a new guidance to assist applicants and manufacturers of certain licensed biological products in determining which reporting category is appropriate for a change in chemistry, manufacturing, and controls (CMC) information to an approved biologics license application. This article summarizes the guidance.