Guest Columns

  1. Medical Device Licensing Timelines In India To Shorten Under Proposed Amendments 8/3/2026

    India’s Ministry of Health and Family Welfare has proposed amendments to the Medical Devices Rules 2017 that will shorten manufacturing license timelines while preserving quality, safety, and performance requirements.

  2. When ANVISA's Clock Runs Out 7/30/2026

    In June, Brazil's ANVISA released a batch of clinical trial petitions because its review deadline had expired without a decision. Take a closer look at what medical device companies should know.

  3. Microneedles In Drug Delivery: From Bench To Patch 7/10/2026

    Let's take a closer look at the scientific principles, technological progress, and translational hurdles defining the present state of microneedle research.

  4. Are Document Approvals Consistent Across Sites And Appropriate? 7/9/2026

    Medical device document approvals seem to be a roadblock when you are the most pressed for time. But if the right approvers and document owners are defined appropriately, approval can be streamlined.

  5. Analyzing And Managing CDMO Project Risks Using Causal Mechanism & Effect Analysis 7/8/2026

    Since every sponsor–CDMO relationship can have widely different scopes, requirements, and procedures, this article focuses on the basic principles for analyzing and managing the risks of not achieving the relationship’s objectives.

  6. Mass Consolidation Sweeps Through Medtech Industry: What Startups Can Do About It 6/29/2026

    Mass consolidation is sweeping up small medtech organizations. Med device startups and early-stage companies that want to be part of this rebirth must develop strategies for taking advantage of the new ecosystem.

  7. Does The FDA's Plausible Mechanism Pathway Revolutionize The Way All Risks Are Analyzed? 6/23/2026

    The FDA's new guidance on plausible mechanisms represents the first regulatory guidance-driven example of where the primary information source of a risk analysis is shifted from data-based to mechanism-based evidence.

  8. Hormuz Deal Brings Cautious Relief To Pharma Packaging Supply Chains 6/19/2026

    Restrictions and fear on the Hormuz Strait have fractured supply chains, especially for primary materials used in pharmaceutical packaging.

  9. Why Your LATAM Authorized Representative Strategy Is A Market Entry Decision, Not A Clerical One 6/18/2026

    Across Latin American medical device markets, the local authorized representative that holds or manages the regulatory asset becomes the operational choke point for importation, renewals, and more.

  10. Use Of AI In FDA Inspection Activities: Strategies For Effective Preparation 6/8/2026

    Are you ready? FDA has begun to implement the use of artificial intelligence in its operations, particularly during inspection activities.