Guest Columns

1. Why Are Life Science Companies So Poorly Prepared For RIM's Future? 5/11/2026

   Most organizations have modernized their global regulatory information management (RIM) systems and improved data quality. Yet modernization and readiness are not the same thing.

2. Why Your MES RFP Is Failing Before It Starts 5/6/2026

   Many manufacturing execution system requests for proposals fail. Not because vendors cannot deliver or the tech is immature, but because the requirements are written backward.

3. Complaints Into Practical Action: Human Factors Drug Delivery 5/5/2026

   Post-market HF are more than a quality metric, they help teams diagnose issues, guide fixes, and improve real-world usability of drug-device products beyond validation.

4. Transforming Medtech Company Workflows Through AI Adoption 5/4/2026

   Despite huge investment in intelligent tools, results are patchy. Ownership is unclear, integration is limited, and teams grapple with fear of replacement. So how can medtech companies escape this vicious cycle?

5. Causal Mechanism And Effect Analysis (CMEA): FMEA's Simpler, Effective Alternative 5/1/2026

   This article describes causal mechanism and effect analysis (CMEA) as an alternative to failure mode and effect analysis (FMEA) for analyzing and managing the industry’s risks.

6. Selecting The Right eQMS To Maximize Quality Maturity 4/23/2026

   Let's take a closer look at the current electronic quality management system (eQMS) landscape in pharma/biotech and what a future-ready eQMS must enable to support continuous improvement.

7. Lilly's Unified Mindset For A Global Parenteral and Device Manufacturing Network 4/17/2026

   Eli Lilly and Company's one-team mindset aims to templatize facility design while remaining nimble enough to react to new manufacturing breakthroughs.

8. Minding The Gap: Submission Strategies For Combined Use Combination Products 4/17/2026

   For combination product regulatory submissions, there is no one-size-fits-all approach. Regulatory pathways and application types vary across global health authorities.

9. New Sustainability Mandates In Brazil And Chile Are Quietly Disqualifying Medical Devices 4/15/2026

   The integration of environmental criteria into Latin American medical device procurement is not a temporary policy experiment; it represents a structural market transformation. 

10. Drug-Device Combination Products: 4 Evolving Platforms For 2026 4/10/2026

    Biologic advantage won’t come from better biology alone, but from delivery technology and designing the full experience around patients, providers, and supply chains.