Silicon Labs Helps Ategenos Advance IoT in Digital Therapeutics with the SmartPatch
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Why is IoT in Digital Therapeutics Important?
Non-adherence to prescription medications, even something as simple as missing a single dose, can have devastating consequences for people managing chronic conditions. In fact, studies show that up to half of patients don’t take their medications as prescribed, making non-adherence one of the most common and costly obstacles in healthcare (NCBI, 2024). In the U.S. alone, this contributes to more than $500 billion in preventable healthcare costs each year.
This problem comes into even sharper focus when you consider that most of us have either dealt with this firsthand or know someone who has. Personal experience was one of the driving factors behind the founding of Ategenos Pharmaceuticals and its pursuit of a solution. Another factor was the founders’ belief that technology across domains, from embedded system development to low-power wireless MCUs, had advanced to a point where it could help usher in more effective, data-driven therapies that reduce waste, improve outcomes, and address the root causes of non-adherence.
First Transdermal Medical Patch Leverages Bluetooth LE to Increase Positive Medical Outcomes
The team’s deep expertise in pharmaceuticals, biomedical engineering, and electrical engineering laid the foundation for merging these disciplines, enabling the company to reformulate proven drugs with better delivery methods and add smart, connected features to monitor real-time adherence. The result of their vision is the first transdermal smart patch that provides real-time measurement of medication non-adherence. The Ategenos SmartPatch platform includes the medication itself, built-in sensors, and a communication interface, all of which are protected by patented technology. The sensors can detect when the packaging has been opened, when the liner covering the adhesive is removed, when the patch has been adhered to the skin, and when the patch is removed from the skin. A wireless MCU inside the patch responds to these changes by switching between different operating modes, including hibernation, sleep, or active mode, and sends usage data via Bluetooth Low Energy (LE).
The usage data is interpreted by Ategenos’ cloud software, which uses prescribing information from the patient’s electronic health record to assess whether a dose has been missed, delayed, or taken as scheduled, and to determine when the next dose should occur. If a critical dose is missed, alerts are sent to caregivers’ mobile devices, enabling timely intervention and helping to prevent serious consequences such as emergency room visits or hospitalizations.
The Challenge
Medication non-adherence, when patients don’t take prescriptions as directed, is a significant contributor to the progression of diseases like diabetes, heart disease, and hypertension. To address this problem, Ategenos Pharmaceuticals wanted to bring the power of IoT to therapeutics and help patients avoid the potentially devastating consequences of missing scheduled medication.
The Solution
The team set out to develop an IoT device that would not only deliver therapeutics directly into the bloodstream but also include electronics to monitor whether patients are taking their medications as prescribed. This enables caregivers to access accurate, real-time insights into each patient’s dosing schedule and provides an opportunity to intervene when a dose is missed. Timely intervention can help prevent potentially serious consequences and improve overall outcomes.
The Result
The convergence of pharmaceuticals and digitization served as the catalyst for the Ategenos SmartPatch, the world’s first transdermal patch to measure and ensure medication adherence in real-time. Integrating embedded sensors and secure wireless connectivity powered by Silicon Labs’ BG24 Bluetooth wireless SoC, Ategenos is pioneering IoT in digital therapeutics.
Merging Pharmaceutical Innovation with Embedded Systems
Bringing the smart patch to life required advancing in several areas. First, an extensive evaluation process was required to determine which medications could be reformulated for transdermal administration and to prioritize the medical use cases that should be targeted. Then, completely independent of the drug delivery system, was the sensor design, electronic architecture, and software development that would provide the smart features of the patch. Ategenos collaborated with global leaders in these areas as part of an extended worldwide development team.
Selecting the right semiconductor for the low-cost, self-powered, and disposable patch required an exhaustive evaluation process. After considering the available options, the combination of size and performance of the Silicon Labs BG24 SoC, along with its energy consumption, made it an ideal choice for Ategenos.
Why Ease of Use is Critical to Digital Therapeutic Devices
Being able to apply the patch without any manual setup is another important requirement. Ategenos wanted to create a seamless user experience, so its patch is designed for automatic cloud registration. This makes the user experience identical to any other transdermal patch. The patient simply takes it out of the box, removes it from the wrapper, and puts it on. This level of simplicity is only available with Amazon Sidewalk, a long-range, low-bandwidth community network designed to connect smart devices beyond the home. The ease of use it would facilitate was crucial to delivering a good user experience, so the team needed a SoC with support for Amazon Sidewalk.
The BG24 made it possible for Ategenos to balance the advanced device design with the memory required to support Amazon Sidewalk, secondary communication protocol support for redundancy, and the low energy consumption necessary to achieve the battery life requirements of a two-year shelf life and 7 days of operation. Finally, environmental sustainability was a key design consideration. Each SmartPatch includes a flexible printed battery and is designed for safe disposal in household waste, which the BG24 supports with fewer discrete components and RoHS compliance.
“Power consumption is central to our design,” said William Kazman, CTO, and cofounder of Ategenos. “Because our SmartPatch is attached to the body, being able to adjust the decibels and pattern of radiation, along with other methods for conserving energy, was important in selecting the semiconductor. Having the antenna design expertise of Silicon Labs and their insights into signal propagation, power use, and cloud communication helped us move faster and smarter.”
What are the Benefits of IoT in Digital Therapeutics?
Physicians and family caregivers will have access to the sensor data through an app and receive alerts if something doesn’t happen according to schedule. The alerts provide the transparency caregivers need to intervene quickly when a patient is not taking their medicine, while providing a history over time that can inform prescribing decisions. Even ensuring one medication is taken consistently can positively impact the patient’s entire regimen and improve health outcomes.
“We’re focused on solving the most urgent medication adherence challenges across cardiovascular, psychiatric, and chronic metabolic conditions areas where a missed dose doesn’t just disrupt a treatment plan, it can lead to stroke, relapse, or life-threatening complications,” said Don DeGolyer, CEO and cofounder of Ategenos. “We’re creating a smarter, safer standard of care that supports patients and gives caregivers confidence that critical therapies are being taken as prescribed.”
The Ategenos SmartPatch Platform is an investigational device, currently under development. It has not been reviewed or approved by the U.S. Food and Drug Administration (FDA) and is not available for commercial sale or distribution.