2022-223 A Bioanalytics-Enabled and Hollow Microneedle-Based Wearable Technology for Personalized Medicine

­Summary:

UCLA researchers in the Department of Electrical and Computer Engineering have developed a minimally-invasive wearable device that continuously monitors pharmaceutical concentrations in a user to optimize the drug’s dosage.

Background:

The annual cost of medication-related morbidity and mortality due to non-optimized pharmacotherapy was estimated as $528 billion, equivalent to 16% of total US health care expenditures in 2016. Thus, personalized medication is required to achieve widespread well-being. The medication dosage is usually dependent on the drug manufacturer's suggestion, which is based on statistical averages from trials with a very limited patient sample size. Consequently, the suggested dosing may fall beyond an individual's optimal therapeutic concentration window, resulting in adverse effects and ineffective treatment. 
To promote personalized medication, therapeutic drug monitoring (TDM) is often utilized to measure the concentration of medication in a patient’s blood, and ensures the consumed concentration is both safe and effective. However, current TDM solutions are time-consuming, labor-intensive, and expensive. Patients are committed to frequent blood draws and long wait times that prohibit adequate and timely intervention. Therefore, there is a need for new TDM solutions that can continuously measure the circulating concentration of a drug. Clinical staff may adjust the dosage appropriately to optimize a patient’s health and well-being. 

Innovation:

UCLA researchers led by Professor Sam Emaminejad have developed a wearable, minimally invasive device that can monitor drug concentrations within a patient. The innovation can serve as a critical component to solve the grand healthcare challenge: non-optimized medication therapy. It incorporates both real-time sensing and machine-learning based analytical capabilities together. The actual monitoring device is in a typical body worn patch design, which limits discomfort and intrusiveness for the end user. From the manufacturer’s perspective, this simple design, in comparison with the traditional sensor-on-microneedle fabrication, is more scalable and practical for widespread implementation. 
The mechanical features and fouling resistance of the device have been extensively tested in experiments, and the findings have shown substantially improved mechanical robustness and bio-fouling resistivity. Compared to the classical way of assessing personalized medication dosing, the UCLA invention can achieve real-time monitoring with a minimally invasive method to measure the circulating medication in the interstitial fluid (ISF). This invention can also investigate the performance profile of a broad range of drugs, both electroactive and non-electroactive, due to the versatile sensing interfaces with built-in signal enhancement capabilities. In the matter of data analytics, this solution utilizes the physiologically inspired machine learning inference models to predict the drug’s performance profile with an improved accuracy for different end users. Furthermore, due to its ease of integration with sensors, the versatility of the sensing interface, and the data analytics techniques, the solution as a whole can be easily adapted with other types of wearable medical applications that are used for real-time monitoring of various health metrics.

Potential Applications:

•    Wearable therapeutic drug monitoring
•    Large-scale drug development investigations
•    Wearable smart medical devices to monitor health metrics
•    Feedback-controlled drug delivery system 
•    Completes the data collection method for patient-reported outcome for Center of Medicare and Medicaid Service (CMS) 

Advantages:

•    Monitors and analyzes the profile of medication efficiency
•    Minimally-invasive 
•    Robust 
•    Anti-biofouling features
•    Real-time information accessing, collecting, and transmitting capabilities
•    Versatile sensing interface and enhanced sensing ability 
•    Accurate analysis of collected pharmacokinetic data 
•    State-of-the-art machine learning techniques to provide personalized prediction

Development to Date:

A prototype is currently being developed.

Related Papers (from the inventors only):

Lin, Shuyu, et al. "Noninvasive wearable electroactive pharmaceutical monitoring for personalized therapeutics." Proceedings of the National Academy of Sciences 117.32 (2020): 19017-19025.

Emaminejad, Sam, et al. "A wearable freestanding electrochemical sensing system." Science advances 6.12 (2020): eaaz0007.

Reference: UCLA Case No. 2022-223

Lead Inventors:  Dr. Sam Emaminejad and Dr. Shuyu Lin
 

Patent Information:
For More Information:
Joel Kehle
Business Development Officer
joel.kehle@tdg.ucla.edu
Inventors:
Sam Emaminejad
Shuyu Lin