SEMI Initiative Identifies Hurdles, Opportunities for Clinical Wearable Biosensors

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Breakthroughs in semiconductor technologies and edge AI are accelerating the rapid advancement of wearable biosensors, but despite the pace of innovation, wearables still struggle to scale beyond everyday wellness into clinically accepted healthcare solutions. To help bridge this gap, the SEMI Smart MedTech Initiative examined the systemic barriers between biosensor innovation and large-scale clinical deployment in its strategic outlook paper, Medicalizing Consumer Silicon.

“Even with today’s accelerated innovation for individual semiconductor components, poor integration is a primary barrier inhibiting the device performance required for clinical acceptance,” said Gity Samadi, Senior Director, R&D Programs at SEMI. “The core technologies that measure biomarkers in both consumer and clinical tools are similar, but the biggest differences come down to validation requirements, intended use of the device, and regulatory context. Members of the SEMI Smart MedTech Initiative authored this paper to help mitigate today’s limited alignment across stakeholders, with the goal of improving integration to create wearables that are robust enough for use in real-world healthcare settings.”

Developed through the SEMI Smart MedTech Initiative, the paper includes contributions from members including experts across the semiconductor, healthcare, medical device and academic communities. Contributors included representatives from AV, Becton Dickinson, Bosch, Brewer Science, Celtro, Intel, GlobalFoundries, Graphenea, Mayo Clinic, Medtronic, Purdue University, Rogue Valley Microdevices, STMicroelectronics, SunRay Scientific and SEMI.

The paper posits that the disparity between technological development and clinical adoption arises from several factors, including variations in biosignal acquisition, software interoperability challenges, integration of AI and data privacy, inconsistent regulatory frameworks and human factors such as comfort and consistent use. Its recommendations center on collaboration across industry sectors, academia and government to address these challenges holistically.

“Effective use of wearable devices can provide key health insights, help with diagnosis, aid in treatment planning, and track treatment effectiveness and adherence,” said Bharath Rajagopalan, Director of Strategic Marketing at STMicroelectronics. “For this to be possible, data must be trusted, clear, and usable for clinical decision making. Because the effort to acquire actionable data and streamline regulatory frameworks spans multiple disciplines and industries, the SEMI Smart MedTech Initiative is working to convene key stakeholders to address the structural issues to enable reliable and scalable adoption.”

That cross-industry input gives the paper a broader view than a single company or market segment could provide, bringing together technical, clinical, regulatory and adoption perspectives on what is needed to move wearable technologies from consumer wellness applications into clinically accepted healthcare settings.

Consumer vs. Clinical Biosensors: Case Study

Consumer wrist-worn wearables like the Apple Watch or Samsung Galaxy Watch typically rely on single-lead electrocardiography (ECG), which captures the electrical activity of the heart from one viewpoint. In contrast, FDA-cleared, Class II diagnostic wearables like the Philips MCOT or VitalConnect VitalPatch use multi-lead ECG electrodes.

While this core difference is simple, the regulatory environment for wearable ECG devices is complex. Such regulatory challenges often arise from difficulty classifying consumer devices with functionalities that blur the line between consumer and medical use. This concern is further exacerbated by limited validation standards and interoperability frameworks, inconsistent data quality, unclear economic incentives for scalable deployment, and cybersecurity protocols that are often retrofitted instead of developed from device inception.