Guest Columns

1. 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.

2. 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.

3. 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. 

4. 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. 

5. 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). 

6. 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.

7. Improving Drug-Device Combination Product Co-Development 8/8/2025

   Early recognition and mitigation of drug and device integration difficulties are critical to the success of combination products. The collaborative effort in development cannot be overstated. 

8. Latin America Is Becoming The Testing Ground For AI-Enabled Medical Device Clinical Trials 8/7/2025

   This article explains why Latin America's demographic diversity, cost profile, and accelerating digital health infrastructure make it an ideal region for AI-enabled medical device clinical trials. 

9. EMA Issues Revised Annex 11, New Annex 22, And Associated Documents On Data Governance 8/6/2025

   The EMA issued three new draft documents in July, all related to the advancement of the use of electronic technology in GMP: AI, computerized systems, and documentation. The public comment period ends Oct. 7.

10. Minimizing The Impact Of Human Errors Using Relational Risk Analysis 8/4/2025

    This article describes how a mechanism-based risk analysis approach can provide two complementary opportunities for minimizing the likelihood of a human error impacting pharmaceutical and medical device risks.