Guest Columns

  1. Improving Drug-Device Combination Product Co-Development 8/8/2025

    Early recognition and mitigation of drug and device integration difficulties are critical to the success of combination products. The collaborative effort in development cannot be overstated. 

  2. Latin America Is Becoming The Testing Ground For AI-Enabled Medical Device Clinical Trials 8/7/2025

    This article explains why Latin America's demographic diversity, cost profile, and accelerating digital health infrastructure make it an ideal region for AI-enabled medical device clinical trials. 

  3. EMA Issues Revised Annex 11, New Annex 22, And Associated Documents On Data Governance 8/6/2025

    The EMA issued three new draft documents in July, all related to the advancement of the use of electronic technology in GMP: AI, computerized systems, and documentation. The public comment period ends Oct. 7.

  4. Minimizing The Impact Of Human Errors Using Relational Risk Analysis 8/4/2025

    This article describes how a mechanism-based risk analysis approach can provide two complementary opportunities for minimizing the likelihood of a human error impacting pharmaceutical and medical device risks.

  5. Medical Device Innovation In Brazil: Success Stories And Future Opportunities 7/28/2025

    Brazil is rapidly establishing itself as a powerhouse in medical device innovation. This article shares market opportunities, success stories, and strategic recommendations for medical device manufacturers.

  6. Critical Considerations For IP & Patents For Emerging Medical Device Companies 7/11/2025

    As the medical device industry continues to expand, intellectual property (IP) considerations — especially those concerning patents — are critical for medical device innovators and manufacturers.

  7. Brazil's Competitive Edge: Infrastructure And Operational Advantages For Medical Device Trials 7/10/2025

    Explore the practical advantages that position Brazil at the forefront of medical device clinical trials in the region.

  8. Audit Trail Compliance And What To Look For In Mitigation Software 7/9/2025

    In the pharma/biotech and medical device industries, the audit trail is important to have for accountability, data integrity, repeatability to create an event for investigation, and regulatory compliance.

  9. Cybersecurity Risk Management In Medical Devices: Practical Implementation Of FDA's 2025 Final Guidance 7/7/2025

    The FDA has issued its much-anticipated final guidance on cybersecurity risk management in medical devices, effective June 2025.

  10. Designing Wearables That Are Truly Patient-Centric 7/7/2025

    There’s a distinct need to create wearables that interweave seamlessly into an individual’s lifestyle, encouraging adherence and gathering long-term, accurate diagnostic data.