Articles From Our Expert Network

  1. A Quantitative Benefit-Risk Analysis & Benefit-Risk Ratio Using Real World Data: Part I 10/4/2021

    This article introduces a novel model of benefit-risk by taking a bottom-up approach using the _risk of the therapy_ and comparing it to _risk of no therapy_ to quantify risk and benefit with the same scale. This overview is relevant not only to the pharmaceutical and biotech industries, but also the medical device industry.

  2. FMEA Vs. System Risk Structures (SRS): Which Is More Useful? 9/24/2021

    In this article, Mark Witcher, Ph.D., discusses the many failure modes of FMEA and risk priority number (RPN), comparing and contrasting it with system risk structures (SRS) and adjusted risk likelihood (RPN). He concludes that one of these is more useful than the other for pharma and medical devices; which one is it?

  3. The Top 3 Trends Driving Demand For Patient Monitoring Equipment 9/20/2021

    Beyond the temporary spike in demand caused by the COVID-19 pandemic, the patient monitoring equipment market is also expected to grow at a moderate rate for the foreseeable future. But what are the top 3 trends for this growth?

  4. Digital Health Apps & SaMD: Incorporating Privacy In Design & Development 9/1/2021

    Some digital health apps are regulated by the FDA and other regulatory bodies, and some are not. But all software as a medical device (SaMD) and digital health apps have a common expectation: privacy. This article delves into the related regulations and how to go about developing your app or SaMD using the 7 principles of privacy by design.

  5. How Has COVID-19 Affected Europe's Vascular Access Devices Market? 8/30/2021

    Detailed analysis of the impact of COVID-19 on single-use medical devices for vascular access in Europe has provided some interesting market insights. Most notably, this includes a spike in demand for central venous catheters (CVCs) as well as syringes and needles.

  6. The 5-Step Checklist For A More Mature, Robust Quality Management System 8/20/2021

    Whether you are preparing for a pre-approval inspection, have the corporate desire for continuous inspection readiness, or are engaged in a LEAN initiative to clean up and strengthen your quality management system (QMS), further maturing your QMS can be helpful to ensuring a robust, comprehensive, and compliant QMS.

  7. Prefilled Syringes: Best Practices For Using X-Ray Analysis To Assess Container Closure Integrity 8/18/2021

    The process of assessing integrity of the filled syringe is generally more complex than the process of assessing glass vials due to the presence of more sealing areas. This article looks at the broad requirement, together with a recent innovation for integrity testing based on X-rays.

  8. 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.

  9. 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.

  10. 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.