How Wearables Are Transforming Oncology Care With: Samara Barend

Transcript Summary

What separates consumer wearables from medical-grade devices?

The clinicians explain that wellness trackers (like sleep and activity rings) lack FDA oversight and generate noisy data, whereas medical-grade wearables require rigorous validation, clinical accuracy, and clear CPT pathways. Samara Barend emphasizes that TempShield was built as a survival tool, offering a high-precision temperature signal that oncology teams can reliably act on.

Why did AION Biosystems focus on temperature as the core signal?

Barend describes how infection remains a leading cause of preventable mortality in cancer, particularly in hematologic malignancies. Temperature is a strong, early physiologic signal, but historically difficult to measure accurately outside the clinic. TempShield required extensive validation against a medical-grade oral thermometer and additional testing across age groups to achieve FDA clearance.

What inspired the development of TempShield?

Barend recounts her father’s life-threatening leukemia-related sepsis during COVID-19. The experience revealed how reactive temperature checks can fail and how continuous monitoring could detect sparks before they become emergencies. Early clinical deployments showed TempShield’s ability to identify pleural effusions, urinary infections, thrombosis, and sepsis risk days before symptoms.

What has real-world monitoring revealed?

In community oncology settings, TempShield users experienced 90 percent lower mortality and 79 percent fewer hospitalizations when worn for at least 60 days. Most early temperature spikes were not false alarms, but early indicators of infection or complications that clinicians could intervene on.

How did TempShield secure reimbursement success?

Because adherence is high (120–180 days on average), AION collected strong RPM billing data using CPT codes 99454 and 99457. Barend clarifies what FDA 510(k) clearance means, how predicate devices work, and why accuracy standards remain higher in oncology despite meeting regulatory requirements.

How do clinicians evaluate the utility of new wearable data?

Oncologists express enthusiasm for continuous insights that correlate symptoms with activity, glucose trends, or heart rate variability. However, concerns remain around interoperability, EMR integration, and alert fatigue. Wearables must fit into existing workflows or provide their own triage and analytics layers.

Where could continuous monitoring prove valuable next?

The group discusses early detection in heart failure, pregnancy-related hypertension, neuropathy monitoring via gait analysis, sweat biomarkers, and early cognitive impairment detection. These use cases rely on identifying reproducible patterns long before symptoms appear.

How will continuous data fuel future treatment decisions?

Doug Flora explains how patient-specific digital twins will simulate chemotherapy tolerance, toxicity risk, and disease progression based on longitudinal biometrics. Just as sports simulations project athlete performance, oncology may soon run thousands of virtual treatment scenarios for each patient.

What questions should healthcare leaders be asking?

Barend advises focusing on one high-value signal rather than overwhelming clinicians with multi-signal noise. Others caution that some patients may not want continuous data due to anxiety or social implications. The group stresses the importance of psychological support and clear triage protocols as data volume increases.

How can health systems adopt these tools sustainably?

Teams must transition from episodic to stream-based care models, supported increasingly by AI-driven workflows. Simplicity, reliability, and narrow use cases are essential for provider adoption, along with clear definitions of who is responsible for responding to alerts.