Guest Columns

  1. A Look At AI-Driven Medtech For Rare Disease Diagnosis 3/12/2025

    Recent advances in AI, including machine learning, natural language processing, and deep learning models, are transforming rare disease diagnosis.

  2. Lessons Learned From Vivani Medical's Study Of GLP-1 Implant 3/5/2025

    Vivani Medical Cofounder and CEO Adam Mendelsohn, Ph.D. discusses the company’s first application of the NanoPortal, including its upsides for patient adherence, its optimized trial design,  and its reception among sites and patients.

  3. Mastering EU MDR & IVDR: Certification Compliance For Medical Device Importers And Distributors 2/24/2025

    Article 16 of the European Union’s Medical Device Regulation and In Vitro Diagnostic Regulation specifically address the obligations of importers and distributors who engage in relabeling and repackaging activities.

     

  4. Mastering FDA Inspections: The Prep Work For Regulatory Success 2/21/2025

    In the medical device industry, FDA inspections are not a regulatory hurdle — they are a powerful tool for improving product quality, operational efficiency, and patient safety. Shift from a reactive to a proactive mindset.

  5. 9 Reasons Why You Should Consider AI In Analytical Instrument Qualification 2/21/2025

    AI is about to completely change the analytical instrument qualification (AIQ) landscape in the pharma/biopharma and medical device industries.

  6. Growth And Advancements In Transdermal Drug Delivery 2/19/2025

    The transdermal drug delivery system industry is seeing significant growth. Let's look at new market research, including the advanced technologies being used and the therapeutic areas seeing the most impact.

  7. Managing Contamination Risks In The Pharmaceutical And Medical Device Industries Using Relational Risk Analysis 2/18/2025

    Of all the risks associated with pharmaceuticals and medical devices, controlling contamination is one of the most important and difficult challenges. Relational risk analysis (ReRA) can help.

  8. Telehealth In 2025 And Beyond: The Future Is Bright 2/14/2025

    The DEA has announced new rules for remote prescription of controlled substances. As telehealth adoption grows, regulatory frameworks and telehealth technologies are evolving.

  9. Harness MDIC's Collaborative Resources to Strengthen Clinical Trials and Patient Outcomes 2/13/2025

    Discover how resources from the Medical Device Innovation Consortium (MDIC) can help advance clinical trials for better patient outcomes.

  10. Roche Diagnostics Guides New Alzheimer's Test Through Trials 2/12/2025

    Roche Diagnostics’ Maria-Magdelena Patru, MD, PhD discusses their plasma test and how they’re approaching its clinical trials.