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The future of healthcare is being reshaped by the rapid advancement of biosensing technologies embedded in wearable devices and the rise of machine learning, generative AI, and agentic intelligence , technologies that promise non-invasive monitoring, personalized therapies, and a fundamental shift in how care is delivered. Yet despite this progress, most of these innovations face significant barriers for clinical adoption.

This paper from the SEMI Smart MedTech Initiative examines why. It identifies the root cause as the "Missing Middle", a persistent gap between promising innovation and scalable real-world deployment. While digital health products continue to proliferate rapidly, only a fraction have achieved the clinical validation needed for broad healthcare adoption. The problem is not a lack of innovation. It is a lack of alignment across biosignal acquisition, algorithm validation, regulatory pathways, cybersecurity, interoperability, and reimbursement models that were not built with these technologies in mind.

Drawing on ECG monitoring as a case study, the paper maps these structural barriers and argues for a shift from isolated product development toward integrated, platform-based systems , built through coordinated cross-sector collaboration that aligns technical innovation with clinical workflows, regulatory frameworks, and sustainable economics from the start.