Industry Perspectives

71. Increase In FDA Inspections + Whistleblower Complaints = Heightened Compliance Scrutiny 3/27/2023

    We are seeing a significant increase in manufacturing facility inspections by the FDA and other health authorities globally. We are also seeing an uptick in whistleblower complaints. Why? And how can you navigate it? This article examines the issue.

72. Dispelling 4 Common Myths Of Data Quality Governance 3/9/2023

    Achieving robust data quality governance doesn't need to be an unwieldy prospect. Here, we dispel the four common myths of data quality governance and share the three phases of a good data quality governance program.

73. ICH Guideline Q9(R1) On QRM, Part 2: Subjectivity & Supply Continuity 3/7/2023

    The long-awaited revision to ICH’s harmonized tripartite guidance on Quality Risk Management, Q9(R1), was adopted on January 18. This article focuses on the guidance's new topics of subjectivity and the role of QRM in addressing product availability risks.

74. ICH Guideline Q9(R1) On QRM, Part 1: Formality & Risk-Based Decisions 2/28/2023

    The long-awaited revision to ICH’s harmonized tripartite guidance on Quality Risk Management (QRM), Q9(R1), was adopted on Jan. 18, 2023. While the primary principles of QRM in this new version remain consistent with the original 2005 document, the revised guidance has four new subsections. This article examines the topics of formality and risk-based decisions.

75. Human Factors Engineering Considerations For Medical Device Packaging 2/27/2023

    As an integral component of product design, human factors engineering should be applied at the onset of a product-design initiative and carried out throughout the complete development process. This article shares key regulatory considerations and usability considerations for medical device packaging.

76. New EU Directive Marks Cybersecurity Regulatory Paradigm Shift For Bio/Pharma & Medical Devices 2/15/2023

    The EU's new Directive 2022/2555 on the Security of Network and Information Systems (“NIS2”) mandates cybersecurity risk management measures and reporting requirements for all segments of our industry, including labs; CROs and CDMOs; and manufacturers of APIs, bio/pharmaceuticals, and medical devices.

77. What's Behind The ASTM E3263 Standard Revision? 1/17/2023

    ASTM has published the revision of ASTM E3263 Standard Practice For Qualification Of Visual Inspection Of Pharmaceutical Manufacturing Equipment And Medical Devices For Residues. This article, written by the ASTM revision team, explains the reasons behind the revision and delves into the key updates.

78. 6 Key Inbound Value Chain Considerations For Medical Device Companies 1/13/2023

    Medical device companies were hit especially hard during the pandemic. In 2023, key inbound considerations for medical device value chains will need to include sourcing strategies that enable dependable supply and rapid innovation, sophistication in balancing cost and risk, and agility and transparency in managing uncertainty.

79. What's Wrong With The Medtech R&D Department? 11/22/2022

    Executives, staff members, and investors of medical device companies commonly ask, “What’s wrong with the R&D department? What’s taking so long?" This article discusses five common culprits and the common thread solution that could solve all of them.

80. Wearable Electro-Patches: 4 Development Considerations 10/26/2022

    When developing wearable sensor patches capable of providing medical-grade monitoring, we must begin by appreciating that creating a fully functional system involves some essential building blocks, all of which must work together.