Guest Columns

1. Why Medtech Should Retire The "One-Size-Fits-All" Mindset 3/23/2026

   A systemic bias in medtech design continues: a failure to account for female-specific data. Teams often resort to a dangerous shortcut: scaling down men's measurements. But we must design for the real-world diversity of human physiology for the future of care.

2. Generative AI Can Write The Code, But Who Builds In The Quality? 3/23/2026

   Code democratization demands a return to the fundamentals of quality in pharmaceutical and regulated environments.

3. 8 Tips To Make A Med Device Startup More Investable In 2026 3/19/2026

   U.S. medical device companies seeking funding this year will find that innovative tech and a stand-out prototype aren’t enough. These 8 tips can help startups become significantly more investable.

4. 3 Emerging Trends In Drug Delivery Device Pipelines 3/18/2026

   When analyzing the drug delivery product pipeline, three key technologies stand out. Check out the latest market research.

5. Closing The Adherence Gap: The Connected Health Era 3/13/2026

   Connected health is shifting healthcare from reactive to proactive by enabling providers to oversee drug delivery while allowing patients to actively engage in their care.

6. Diagnostics Rewired: From Tests To Lifelong Digital Twins 3/12/2026

   As routine labs, imaging, and information from wearables and the environment stream in, a digital twin can model trajectories and suggest next actions, turning diagnostics into a living operating system for care.

7. The Cybersecurity Void In Mexico: Why Your FDA-Compliant Device Might Still Fail 2/20/2026

   While Mexico's health authority, COFEPRIS, has streamlined registration for medical devices, a dangerous shadow regulation has emerged with ad hoc stringent cybersecurity requirements.

8. MES Is Still In The CD ROM Era But The Data Architecture Has Moved On 2/20/2026

   Many manufacturing execution system (MES) deployments still operate like it is 2005: a big install, disruptive upgrades, etc. Here's a clearer path forward.

9. Building The AI-Enabled Medical Device QMS For European Compliance 2/6/2026

   Let's take a closer look at how AI-enabled medical devices and their QMS should be compliant with the EU MDR and the EU AI Act while also adhering to applicable ISO standards.

10. New ISPE Framework Targets Uncertainty In Pharma's AI Deployment 1/29/2026

    International Society for Pharmaceutical Engineering members developed the guide to offer a risk-based framework for evaluating, implementing, and maintaining AI systems.