SEMI warns wearable biosensors face clinical hurdles

SEMI has published a paper on the barriers to bringing wearable biosensors into clinical use. The study was developed through its Smart MedTech Initiative.

The paper, titled Medicalizing Consumer Silicon, argues that advances in device components alone will not be enough to turn consumer wearables into tools accepted in healthcare settings. Clinical adoption, it says, depends on stronger integration, better signal quality, trusted data, validation and clearer regulation.

The work drew on contributions from experts across the semiconductor, healthcare, medical device and academic sectors. Named 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.

SEMI presents the paper as an effort to address a gap between rapid technical development and slower clinical uptake. It identifies differences in biosignal acquisition, software interoperability issues, the use of artificial intelligence alongside data privacy concerns, uneven regulatory frameworks and human factors such as comfort and consistent use.

One of the central arguments is that wearable biosensors face a systems problem rather than a single engineering hurdle. Manufacturers, the report says, must address how sensors, software, validation and regulatory requirements fit together if devices are to move beyond wellness tracking into diagnosis, treatment planning and monitoring.

Gity Samadi, Senior Director of R&D Programs at SEMI, said poor integration remains a major obstacle despite progress in semiconductor components.

"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 Samadi.

"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," Samadi added.

Consumer divide

The paper uses cardiac monitoring to illustrate the divide between consumer devices and products cleared for medical use. Wrist-worn wearables such as the Apple Watch and Samsung Galaxy Watch typically use single-lead electrocardiography, while diagnostic wearables cleared as Class II medical devices, including Philips MCOT and VitalConnect VitalPatch, use multi-lead ECG electrodes.

SEMI argues that while the distinction may appear technical, it reflects a wider difference in intended use, validation and oversight. Devices marketed to consumers for general wellness reach the market under a different set of expectations from products used to support clinical decisions.

The report says this grey area creates classification problems when consumer devices begin offering functions that resemble medical applications. It also points to limited validation standards, gaps in interoperability, inconsistent data quality, unclear economic incentives for wider deployment and cybersecurity measures that are too often added after development rather than built in from the start.

Data trust

Another recurring issue is whether clinicians can rely on the information generated by wearable biosensors. In consumer markets, frequent use and convenience may be enough to support adoption, but healthcare settings require data that can be interpreted consistently and tied to treatment decisions.

Bharath Rajagopalan, Director of Strategic Marketing at STMicroelectronics, said the value of wearable devices in healthcare depends on the quality and usability of the information they produce.

"Effective use of wearable devices can provide key health insights, help with diagnosis, aid in treatment planning, and track treatment effectiveness and adherence," said Rajagopalan.

"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," Rajagopalan added.

The emphasis on cross-sector coordination reflects the makeup of the group behind the paper. By combining input from chipmakers, medical device companies, clinicians and academic researchers, SEMI presents the challenge as one that cuts across supply chains and regulatory boundaries rather than sitting with any one industry group.

The paper also highlights the role of human factors, including how comfortably a device can be worn and whether users will continue using it consistently over time. Those issues can directly affect signal quality and data completeness, which in turn shape whether information from a wearable device is useful in clinical practice.

Its recommendations focus on collaboration between industry, academia and government to tackle these issues together. The paper is available free of charge through the Smart MedTech Initiative website.