Voler Systems partnered with G-Tech Medical, a leading startup MedTech company, to update and produce a wearable GI Motility Measurement Patch system that monitors digestive system functions. The updated device is ready for manufacturing, meets FDA requirements, and provides an improved customer experience. By fully understanding the impact of wearable technology on patient care and satisfaction, Voler Systems helps companies take their ideas and make them successful.

Problem

Gastrointestinal problems are undiagnosed about one third of the time. Monitoring digestive system function in patients with wearable technology can create a new standard of care to improve patients’ overall outcomes with reduced cost.

In light of that, G-Tech Medical created a wearable GI Motility patch system that monitors digestive system function in patients. The patch was successfully deployed in small numbers in two versions: as a hospital patch and as an ambulatory patch.

However, this prototype technology had problems including electronics that had a short battery life, inoperable onboard storage, and a questionable sampling rate. Both versions shared the same electronics but differed in battery capacity.

To be truly effective in monitoring health, wearable technology needs a battery that lasts as long as the data collection period, updates real-time data to the health care provider, takes samples at intervals that produce accurate results for diagnosis, and is comfortable for the patient to wear.

Therefore, to successfully use the GI Motility patch, it had to be small, comfortable for the patient, capture four different signals around the stomach, and have a battery life that would last for as many days as needed to capture the data.

Background

One of the crucial parts of this project was to create a wearable device that ensured data goes from the patient’s body to the data analysis software without losing data integrity or any of the data itself.

The most common problem was that the patient was not near their smartphone when the device tried to upload a data set. The device needed to recognize the smartphone was not available and send the data when the smartphone was back in range.

Voler Involvement

Voler Systems worked with G-Tech Medical to update the architecture of the system, creating a wearable GI Motility device that met all the needs of the patient and doctor while adhering to the stringent regulations on medical device technology. Improvements were realized by re-implementing existing functionality into an updated electronics architecture.

Voler engineers used their extensive experience to update the electronics architecture and developed the requirements for an improved patch. They then used the new architecture design and selected key chips to ensure that the end-product would meet the data collection needs, battery life, and provide accurate information for the doctor to analyze.

Once the project requirements were reviewed by G-Tech Medical, Voler engineers designed the electronics and firmware, constructed prototypes, and tested the prototype electronics. In addition to creating the firmware, an iOS app was designed to assist in Bluetooth implementation to receive updates and send data to the cloud.

The work was completed under budget.

The upgrade developed by the Voler engineers working with G-Tech transformed the patch into a wearable, non-invasive GI Motility Measurement device that included:

• Electronics on a printed circuit board
• Electrodes that integrated into the printed circuit board
• Flexible connections for the printed circuit board
• Four pairs of electrodes that read low-level electrical signals on the surface of the skin
• A flex-rigid circuit board solution that eliminated a connector by combining the rigid printed circuit board and flexible one. This saved money and improved reliability.
• Bluetooth wireless connection to iOS devices

Value Delivered

The architecture created a more wearable device, allowing the software to easily update over a Bluetooth connection, and created a pathway for transmitting data between the patient and the doctor.

The patches are worn for up to 6 days, collecting myoelectric data and sending it by Bluetooth LE to a smartphone.

For patient comfort, the patch is body-conforming, water-resistant, thin, light, and completely non-invasive. While sitting on the skin, it measures digestive function by measuring muscle activity in the stomach, small intestines, and colon to sense the activity of digestive organs.

The device can collect almost a half-day of data before needing to connect to a smartphone, eliminating lost data and allowing it to be uploaded to the cloud for data analysis.

Significant achievements in this engineering design include:

• Optimizing Bluetooth communications by improving the pairing ability, adding a unique serial number, and creating profiles for easier use by the patient
• Extending battery life with newer chips and less battery drain
• Improving signal sampling and timestamping
• Lowering energy use and increasing memory so data out of phone range could be stored and uploaded to the cloud once back in range
• Providing over-the-air firmware updates
• Simplifying the design with fewer components for easier manufacturing

This revolutionary wearable technology meets both market and clinical needs to create a new standard of care that improves patient outcomes and reduces costs.

"The Voler team was both very knowledgeable and a pleasure to work with, even through the inevitable challenges and setbacks encountered in any novel, complex project. We look forward to working with Voler on the next phase of development," stated G-Tech’s CEO, Steve Axelrod, Ph.D.

Need Help Creating Your Med-Tech Product?

The Journal of Nurse Practitioners states, “With digital technology, patients can be more active in their care and can better understand how their behaviors, such as exercise, eating, and sleeping, can affect their health in real-time. Health care is more accessible to patients in remote areas or while homebound” (Bove, 2019).

Voler Systems has helped many companies build next-generation wearable IoT devices for use in the healthcare sector. Contact Voler Systems today to find out how we can help you.

About Voler Systems

Located in Silicon Valley, and with more than 40 years of electronic design experience, Voler Systems continues to be a leading custom product design consulting company providing highly-experienced electrical engineering and firmware development. Voler Systems ensures delivery of quality products, on time and on budget with low risk. All projects are undertaken with good specifications, the right people, quality design, constant communication, and a smooth transfer to manufacturing.