The Future of Healthcare Is Connected & Data-Driven

This article originally appeared in MD+DI on November 30, 2022.

SANTA CLARA, CA - The opening keynote for BIOMEDevice Silicon Valley was well-attended and the topic was indeed a concerning – Developing Cloud-Based Software in a Changing Regulatory Environment.

Erez Kaminski, CEO and founder of Ketryx, a company that creates software development tools for regulated industries, delivered the opening keynote and challenged the audience to think about the combination of software and medical devices.

Creating safety-critical artificial intelligence and machine learning (AI/ML) applications in the face of changing FDA regulations is a prominent challenge facing manufacturers and regulators. While AI/ML promises to provide newer, smarter solutions for software in medical devices and biotechnology applications, its statistical nature presents challenges from a safety and validation perspective and requires subject matter expertise and purpose-built solutions to comply with FDA regulations.

New approaches to software development and understanding upcoming changes with FDA, including precertification, can improve a team's chances of building a successful, safe product that improves patient care and healthcare outcomes.