Guest Columns

1. When A Medical Device Becomes A System: Bridging The Gaps Between Subsystems 11/4/2026

   For complex medical device systems, teams must define what must happen across subsystem boundaries, assign responsibility for that behavior, and establish evidence that the complete system performs as intended.

2. The Standard You Stopped Reading In 1996 Just Rewrote Your 2030 Audit 11/2/2026

   On Sept. 16, 2026, ISO published the sixth edition of ISO 9001. Most medical device professionals shrugged, feeling that we live in ISO 13485. That shrug is a mistake.

3. Beyond Australia: Why Medtech Startups Are Re-Evaluating FIH Trial Destinations 10/15/2026

   The advice handed to medtech companies planning a first-in-human (FIH) study has been: go to Australia. That advice is now overdue for a rewrite. Not because Australia stopped working, but because the math changed.

4. Drug–Device Combination Products: Bridging Formulation, Device, And Manufacturing Decisions 10/8/2026

   Teams must assess the drug, the device, the manufacturing process, and the environment in which the product is used as an integrated system, not as separate parts. 

5. Making The Call On Pre-Validated Packaging 10/1/2026

   The idea of pre-validated packaging sounds really good. Using packaging that has already undergone extensive testing seems fast, easy, and less expensive. Is it truly the answer? It depends.

6. What Patients Actually Want From Connected Drug Delivery 9/29/2026

   A recent survey conducted with BioPhorum members revealed that the most critical aspect of digital healthcare for drug delivery devices. Let's take a closer look.

7. Beyond Connectivity: Where Digital Technologies Create Real Value In Drug Delivery 9/29/2026

   Where can digital technologies can solve real problems for patients, healthcare providers, and industry, while avoiding unnecessary complexity? Here's where the strongest value propositions currently sit.

8. Examining The Potential Of P-tau217 To Provide Earlier Diagnosis Of Alzheimer's 9/25/2026

   P-tau217 blood tests could accelerate Alzheimer’s diagnosis. Lilly’s Nino Sireci, MD, MSc, explains the research, evidence thus far, potential clinical use, and next steps.

9. Everyone Is Only Reading The MDR Half Of Europe's Reform 9/21/2026

   The European Commission's simplification package is being debated almost entirely as an MDR story. The IVDR provisions carry the same legal force, and the window to shape them closes this fall.

10. You Can't CAPA What You Can't Classify 9/16/2026

    An LLM or agentic error can occur with no component broken in any way the QMS recognizes. Classifying it takes two fields: the error type and the error origination point.