A key part of a formal Strategic Business Plan for an investor-driven, Class II medical device startup is the Opportunities and Threats section. Traditionally, I like to identify not only the Opportunities, but the initiatives that we'll take in order to maximize our targeted opportunities. The converse is true; for every Threat or Risk, I like to identify Contingencies that can be at our fingertips to mitigate the risk at hand. Here's a quick overview on how both Generative and Agentic AI...

As a 37 year veteran of the medical device and life science market, I've been through some upheavals over the years. My first experience as a medical products manager goes back to the failed attempt to revamp the U.S. healthcare system in the early to mid-1990s. It unleashed a lot of price pressures on our industry that have never really receded. We're about to experience downward pressures once again. Going forward, small to mid-sized medtech companies should assume a structurally...

Agentic AI is transforming the design and development of Class II medical devices by acting as a co-engineer that orchestrates complex tasks with minimal human intervention, accelerating product timelines while maintaining rigorous regulatory compliance. Its autonomy enables faster concept development, structured design controls, improved documentation, and real-time regulatory readiness.[1][2][3] Integrated Design Acceleration By automating and sequencing multi-step workflows, agentic AI...