The SEMI Smart MedTech Initiative has released a strategic outlook paper titled *Medicalizing Consumer Silicon* that examines obstacles and opportunities in moving wearable biosensors from wellness tracking to clinically accepted healthcare solutions.
Despite advances in semiconductor technologies and edge AI, wearable biosensors continue to face challenges in achieving large-scale clinical deployment. The paper identifies poor integration of semiconductor components as a primary barrier to the device performance needed for clinical acceptance.
“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,” said Gity Samadi, Senior Director, R&D Programs at SEMI.
The paper was developed with contributions from members across the semiconductor, healthcare, medical device, and academic communities, including AV, Becton Dickinson, Bosch, Brewer Science, Celtro, Intel, GlobalFoundries, Graphenea, Mayo Clinic, Medtronic, Purdue University, Rogue Valley Microdevices, STMicroelectronics, SunRay Scientific, and SEMI.
Key factors contributing to the gap between technological development and clinical adoption include 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. The paper recommends collaboration across industry sectors, academia, and government to address these issues.
“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.”
A case study in the paper compares consumer wrist-worn wearables, such as the Apple Watch or Samsung Galaxy Watch, which typically use single-lead electrocardiography (ECG), with FDA-cleared Class II diagnostic wearables like the Philips MCOT or VitalConnect VitalPatch, which use multi-lead ECG electrodes. It notes that regulatory challenges are heightened by devices blurring the line between consumer and medical use, along with limited validation standards, interoperability frameworks, data quality issues, economic incentives, and cybersecurity approaches that are often added after initial design.
The *Medicalizing Consumer Silicon* paper is available free of charge through the SEMI Smart MedTech Initiative website.
