Industry Perspectives

  1. Balancing Sustainability With Patient Safety In Medical Device Design 6/3/2024

    There is increasing pressure on manufacturers to make devices that combine safety and effectiveness with sustainability, particularly with regard to EU regulations and directives.

  2. 6 Essential Steps Of Forensic Medical Device Engineering 5/15/2024

    Forensic medical device engineering is investigating and analyzing medical devices that have malfunctioned, failed, or caused adverse events. Here are 6 steps to resolve issues.

  3. Bridging Human Expertise And AI: The Future Is Here 5/8/2024

    Discover how leveraging AI's capabilities while relying on human expertise can optimize human performance in the healthcare sector and pave the way for a more efficient, effective healthcare system.

  4. 2024 CIO Survey Reveals IT Budgets, AI Priorities For Life Sciences Companies 4/9/2024

    Clarkston Consulting conducted its third annual Chief Information Officer (CIO) Survey to understand IT budgets of life sciences companies, how AI priorities fit into those budgets, and more.

  5. Managing Supply Chain Risks Using Relational Risk Analysis 4/5/2024

    In the bio/pharma and medical device industries, you can easily model, understand, and manage supply chain risks using relational risk analysis. Here's how.

  6. Process Development With “The End In Mind” For Startups 3/20/2024

    We encounter the term “the end in mind” in product development frequently, but many are unsure what it really means and when it matters. This article sheds light.

  7. Best Practices Handling Material Changes For Medical Devices 3/18/2024

    Despite the best intentions of procurement, suppliers may impose changes in the availability of material grades. Have a process for controlling and mitigating the effects of material changes in order to reduce risk and avoid interruption.

  8. 2024 LIMS Trends 3/15/2024

    The laboratory information management system (LIMS) landscape in 2024 is a dynamic one, driven by accelerating advancements in technology and evolving industry needs. This article shares the four key trends.

  9. The 10 Most Frequently Asked Questions On Glass: Part 2 2/20/2024

    Read the second part of this series on the most common questions encountered by an expert focused in scientific affairs and technical solutions for glass.

  10. A Data-Derived Approach For Selecting Criticality Levels In FMECAs For Cleaning Process Risk Analysis 2/16/2024

    The ASTM E55 Cleaning Team, in collaboration with F04 Medical Device Committee members, felt that the commonly used three-level criticality system was inadequate for use in a science- and risk-based standard for cleaning process development, validation, and monitoring. This article will provide a detailed discussion of how science-based and data-driven criticality levels were derived, the meaning of each level, and how they can be used for guiding the selection of risk reduction and risk control measures.