Industry Perspectives

31. 5 Recommendations To Maximize CSV/CSA Outcomes 7/17/2024

    The computer system validation (CSV)/computer system assurance (CSA) process is correlated with other departments besides IT and quality. Accordingly, all stakeholders must think ahead and define what they need.

32. Bacterial Endotoxin Testing, Part 1: Overview 7/16/2024

    All injectable drug products and implantable medical devices that come into contact with the bloodstream or spinal fluid are tested for endotoxins. This article provides an overview of bacterial endotoxin testing and the LAL method.

33. System Failure Mode & Effects Analysis (SFMEA): An Alternative Approach For Analyzing Risks 6/26/2024

    Your company likely uses risk matrices and FMEA for analyzing risks. This article describes an alternative approach for conducting a system failure mode & effects analysis.

34. Medical Device Assembling And Packaging: Should You Outsource? 6/18/2024

    Medical device assembly and packaging are often afterthoughts, but they are critical decisions. Consider these crucial factors to make the right decision for your device and your company.

35. 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.

36. 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.

37. 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.

38. 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.

39. 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.

40. 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.