SMART Diaphragm: Two and a Half Years In and Going Strong

Each year about 15 million babies are born prematurely and over one million of these babies die, making preterm birth the leading cause of infant mortality. In developed communities, these premature babies are often given a chance to thrive by spending their first days in neonatal intensive care units (NICUs) of hospitals. But in many parts of the world, birth happens in a rural village far away from hospitals and it is impossible for pregnant mothers to make the trip once labor has begun.

Nearly three years ago, our team began tackling the challenge of preterm birth by developing a new type of intravaginal device that enables earlier detection of preterm birth. This “SMART Diaphragm” would use sensors to capture data about a pregnant woman’s cervix over time and transmit that data wirelessly to a cloud platform that would determine whether a woman is likely to give birth preterm. Since then, we have successfully developed more than 10 prototypes of the device and have worked with 20 women in clinical studies who have graciously given us permission to track them throughout pregnancy using our device.

In our journey to create a new mobile health-enabled medical device, we have encountered many challenges both on the engineering and clinical aspects of the project. From the beginning, we found traditional manufacturing techniques to create intravaginal silicone devices were too costly and impractical for small-scale prototyping. Not willing to let this stand in the way of progress, we devised an unconventional solution to the problem: we started using 3D printers to print molds for our devices and modified a laboratory desiccator to create a liquid silicone injection system. When we had devices ready to go, we realized how challenging it was to recruit patients for our study given the level of commitment that is required—we collect data across 11 visits following a pregnant woman’s standard prenatal visits.

The Vodafone Wireless Innovation Project provided the enabling funds for us to overcome these challenges for us to start testing our technology in the clinic. Our device work thus far has been published in the IEEE Engineering in Medicine & Biology Society and we are also publishing our novel 3D printed silicone injection molding technique in the Journal of Visualized Experiments so that others can learn from our failures and successes. Our technology has achieved approval by the UCSF Institutional Review Board, an institution-specific extension of the FDA to evaluate safety of human studies being conducted, to use the device in clinical studies at UCSF. We are currently applying to expand this to cover Mt. Zion Hospital & San Francisco General Hospital to gather more data and improve the device through additional testing.

Additionally, SMART Diaphragm has been tested tested and approved for safety by UCSF Clinical Engineering—this group is responsible for the maintenance, repair and safety of all hospital equipment at UCSF Medical Center. This is not a requirement for doing a clinical study, but our team is dedicated to going above and beyond in order to make sure our device is 100% safe for human subjects.

More recently, we are fortunate to have the Bill & Melinda Gates Foundation support our project, allowing our team to expand our clinical study to two additional hospitals and finally bring the “SMART Diaphragm” device to field testing in Africa.

Recruiting patients can be a challenge. In the early days, we realized we had to generate more patient education materials such as pamphlets available via our website, but we also needed to ensure our study staff are best-prepared to explain what we are trying to accomplish and why. With the new funding for this project, we are hiring new clinical study coordinators to put more hands and eyes toward creating better patient outreach materials. We also hope that recruitment will not be an issue after our new study coordinators have helped us expand to Mt. Zion & San Francisco General Hospital.

The next few years of this journey will be even more challenging than before, but we have never been more excited about the project.