Guest Columns

1. The Companion Diagnostic Strategy That Combination Product Leaders Need 9/17/2025

   In the U.S., the Office of Combination Products assigns primary jurisdiction for in vitro diagnostics (CDER, CBER, or CDRH). This article shares regulatory and commercial considerations.

2. RFK Jr. Wants Every American Wearing A Wearable. How Can Pharma Build A Business Around It? 9/16/2025

   The timing is now for pharma to be all-in on using wearables as their new business strategy, says Digital Medicine Society (DiMe) Director of Partnerships Smit Patel, PharmD.

3. Why Pharmaceutical And Medical Device Risks Must Be Analyzed By Their Risk Mechanisms 9/16/2025

   Current risk analysis methods focus on the possibility and severity of bad events instead of focusing directly on analyzing and improving the performance of systems and processes producing the bad events. 

4. Considerations For Rapid Prototyping In Medical Device Development 9/15/2025

   Rapid prototyping has taken the medical device industry by storm, but there are pros and cons that device developers need to consider.

5. Emerging Markets Are Pioneering Hybrid Clinical Trial Models For Medtech Products 8/25/2025

   This article shares insights into how Latin America, southeast Asia, and Africa are pioneering hybrid clinical trial models for medtech products.

6. Remote Patient Monitoring: A Booming Industry Across The Globe 8/20/2025

   From blood pressure cuffs to glucose monitors and pulse oximeters, remote patient monitoring solutions have emerged as a game changer. With rapid advancements in technology, the sector is poised for explosive growth across the globe.

7. Staying Ahead of Enforcement: Executive Strategies To Prevent FDA Warning Letters 8/19/2025

   This article focuses on practical strategies for medical device companies to strengthen their quality management systems and develop proactive programs that anticipate issues before they attract FDA action. 

8. Regulatory Planning In Early Medtech Development Is The Recipe For Success 8/18/2025

   Historically, many medtech companies have engaged with the FDA in a conservative way, providing only the minimum required to obtain clearance or approval. That mindset is no longer enough. 

9. The U.K. Now Classifies Ambient Voice Technology As SaMD 8/14/2025

   The core message of a new guidance issued by NHS England and MHRA is clear: ambient voice technology (AVT) tools that go beyond mere transcription to include summarization are to be classified as software as a medical device (SaMD). 

10. The Warning Letter Wake-Up Call In 2025: What FDA Enforcement Is Really Telling Us 8/12/2025

    FDA warning letters highlight recurring patterns, systemic gaps, and evolving priorities that medical device manufacturers can analyze to strengthen compliance and drive operational excellence.