Guest Columns

  1. AI-Enabled Medical Device Manufacturers: Are You Prepared for Evolving FDA Oversight? 11/1/2024

    As the FDA continues to develop and solidify its guidance and regulations on AI, medical device manufacturers should prepare to navigate new legal challenges, as well as evolving safety and compliance risks.

  2. Computer Systems Validation Pitfalls, Part 2: Misinterpretations & Inefficiencies 10/29/2024

    In part 2 of the authors' series on computer systems validation pitfalls, they cover misinterpretations and unnecessary "nice to haves" that waste execution efficiencies.

  3. Adaptive AI-Driven Medical Devices In The U.S.: Ethical Considerations 10/28/2024

    With the usage of AI in medical devices, ethical concerns center on patient health data, safety, and privacy, which adds an additional layer of complexity to design and development.

  4. Life Sciences Cybersecurity Incident Management: The End-to-End Approach 10/24/2024

    Life sciences companies are focusing on smart manufacturing, digital supply chain, and leveraging AI/ML. A good cybersecurity incident response plan can make the difference between a cybersecurity incident versus crisis.

  5. A New Approach To ISO 14971 For Better Medical Device Risk Analysis 10/23/2024

    This article puts a new lens on the risk model in Annex C of ISO 14971 using relational risk analysis to describe a better approach for understanding and managing medical device risks.

  6. The Regulatory Affairs Function Is Evolving. Are You Evolving With It? 10/10/2024

    The regulatory affairs function is no longer a "one size fits all" function, the decision to outsource or insource the function is growing more complex, and specific AI tools can help regulatory processes.

  7. The ABCs Of PCCPs (Predetermined Change Control Plans) 10/10/2024

    The FDA’s Predetermined Change Control Plans (PCCPs) tool aims to ease the regulatory burden of updating AI/ML algorithms. Software-enabled medical device companies that master this tool will be able to more rapidly improve their device products.

  8. Computer Systems Validation Pitfalls, Part 1: Methodology Violations 10/9/2024

    When computer systems validation work is not performed according to protocol instructions — by cutting corners on quality outputs with the focus on profit as the main driver — this can result in drug and device companies losing profits and efficiencies.

  9. Sterility Assurance: The Fundamentals 10/8/2024

    Sterility assurance is a critical aspect of the production of drugs and medical devices. This article covers the fundamentals, including the key components of an effective sterility assurance program.

  10. Developing An Effective Patenting Policy To Protect AI-Enabled Medical Devices 10/7/2024

    The FDA categorizes AI-enabled medical devices as types of SiMD or SaMD innovations. This patent lawyer provides practical recommendations and considerations.