Industry Perspectives - Design & Development

61. 4 Strategies for Medtech Compliance With FDA’s Upcoming Computer Software Assurance Guidance 10/6/2021

    As the FDA finalizes and publishes the Computer Software Assurance (CSA) guidance later this year, companies that have not already started the transformation process to CSA should get started now. Here are 4 strategies to be successful.

62. COVID-19 Vaccine Benefit-Risk Analysis/Ratio Using Real World Data 10/6/2021

    For National Immunization Awareness Month, we're highlighting timely vaccine manufacturing-centric articles such as this one, covering a method by which benefit-risk analysis can be objectively carried out to arrive at a benefit-risk ratio. The article provides a relevant, contemporary example of how it can be used to calculate COVID-19 vaccine benefit-risk.

63. Medical Device Biocompatibility Testing: Best Practices & How To Minimize Risks 10/4/2021

    In Part 1 of this two-part series, the author discussed strategies to ensure biocompatibility success from an organizational standpoint. In this second article of the series, he discusses some of the ways to ensure biocompatibility study successes and how to minimize risks.

64. 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.

65. 3 Reasons Why Medtech & Digital Healthcare Companies Should Consider Direct-To-Cloud Connectivity for IoMT 9/29/2021

    A critical part of the digital health ecosystem, wireless connectivity is a key enabler for medical devices that can be used by patients at home and on the move. For example, connected drug delivery devices enable pharma companies to offer remote monitoring, while wearable sensors enable continuous remote diagnostics. This article explains 3 reasons why you should consider direct-to-cloud connectivity for your product.

66. How I Developed The Next-Gen Prostate Biopsy System 9/27/2021

    Once prostate cancer is suspected, a prostate biopsy is required to establish a diagnosis. The transrectal biopsy has been the standard of care for several decades, but it has limitations and presents several risks. That's why I developed a new, safer, more effective biopsy system, and here's how I developed it.

67. 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?

68. 9 Pitfalls To Avoid In Data Integrity in Pharmaceutical and Device Development & Operations 9/22/2021

    The first article in this series examined 5 common misconceptions in data integrity (DI). In this article, the author now shares 9 example areas where he has seen significant DI implementation problems in pharmaceutical and medical device companies.

69. How To Build An Exceptional Medical Device Biocompatibility Program 9/17/2021

    In recent years, biocompatibility and compliance with the ISO 10993 family of standards have been an area of significant attention. Demonstrating biocompatibility is an integral part of any device development. This article explains how to integrate a biocompatibility toxicologist into your team and his/her role within the development process.

70. How Do We Achieve The Promise Of Using Digital Health Measurement? DATAcc Leads The Way 9/15/2021

    Digital health measures are redefining our understanding of health and disease by changing what we measure and how we measure it. It is the perfect time for the field to build the digital health measurement toolbox with intention – and build it right. The Digital Health Measurement Collaborative Community is a new pre-competitive collaboration dedicated to this, and you can get involved!