The pneumatic cuff, a device traditionally used to measure blood pressure, has had a prominent place in doctors' offices for more than a century. As part of a year-long fellowship at Northwestern University, two clinicians and two engineers teamed up to develop a new way of measuring blood pressure: cuffless, wearable wristbands.

Researchers Sean Connell, Jay Pandit, Kyle Miller, and Andrew Wu used the platform as the basis for their company Bold Diagnostics . The “Bold Bands” provide continuous blood-pressure measurements. The system’s reports are then uploaded to a patient’s electronic medical record, allowing clinician review.

The start-up, based in Chicago, IL, recently received a National Science Foundation Small Business Innovation Research grant worth $225,000 to advance its technology and build a next-phase prototype.

The idea was the ‘Create the Future’ Medical Category  winner in 2016. Sign up now  for this year’s ‘Create the Future’ design contest. From a technology perspective, what makes your design special?

Sean Connell: I think the major clinical need we’re addressing is the lack of information surrounding your blood pressure. Traditionally, every time you go to the clinic, doctors take your pressure with the pneumatic cuff. They strap it on your arm, they pump it up, and it occludes your blood vessel to give you a singular snapshot of what your current blood pressure is at the time of measurement. To get a complete picture of cardiovascular health, however, you need more information. Having the ability to continuously measure blood pressure, unobtrusively, is going to be a significant game changer in cardiology. Who is your target user?

Connell: The beachhead market entry point is for diagnosis of whitecoat hypertension – [when a patient experiences high blood pressure in a clinic. but not in other settings]. Even if you were religiously taking your blood pressure at home, it’s going to be affected by your stress levels, the amount of coffee you drink, your working life, or your home life. You’re never going to get a complete picture of your blood pressure and your cardiovascular health in a single snapshot. It’s difficult for the clinician to appropriately diagnose patients as being hypertensive and prescribe them an appropriate medication.

Our device continuously measures blood pressure for you – you can sit back after 24 hours, and see where the blood pressure spiked, and in response to what, and how you can effectively change your lifestyle and habits to better improve health. When you drink too much coffee, you’re going to immediately see the effects it has on blood pressure. That’s going to be a driving change for the patient to eat healthier or work out more. Take me through a scenario of how the device works.

Connell: We want to confirm the diagnosis of hypertension, prescribe those patients in the clinics with these Bold patches, and they will wear them for about 48-72 hours at home. Then, Bold Diagnostics will generate a data report that is acceptable by the clinician. With that information, clinicians can determine their state of hypertension and prescribe medication from that point. How does the wearer get an alert to know that the condition is not a normal one?

Connell: With cardiac monitors, if you detect an arrhythmia and irregular heartbeat, that has immediate ramifications, like an impending heart attack or some drastic event that’s just around the corner. With blood pressure, it’s not so much the case. You can have an elevated blood pressure for months and years before you start developing some type of cardiovascular disease.

It’s not critical for the subject to know immediately when they have an elevated blood pressure, because the condition is a cumulative effect that happens over time. With this device, it’s more about monitoring for days at a time, and then using that to prescribe a drug. What’s next regarding the device development?

Connell: We really want to have a small-scale pilot launch with a sister hospital and get it onto about 1000 patients or so. For us. it’s really a data analytics play. We need a larger database, more patients wearing it for longer periods of time, to really pull out the necessary information that can show practicality. What is most exciting to you about this kind of technology?

Connell: I described a beachhead market application, which in reality, is kind of a small market opportunity in relation to the plethora of opportunities you have with it. You can imagine the device in any number of situations in a hospital. You can go so far as to saying it is possibly a breakthrough in health and wellness monitoring. Think of a FitBit that provides a wealth of information from that one data point: heart rate. To be able to have blood pressure, which has clinical relevancy, be that data point is going to be a significant change. Will the pneumatic cuff still have a role in clinical settings? Will the cuff be considered obsolete?

Connell: I wouldn’t go so far as saying that. The cuff has been used for 100 years. [Co-inventor] Jay Pandit often says: One of the very first thing you learn to do in medical school is to take a proper blood pressure measurement. I don’t see that going away any time soon, but we’re getting to a point where we’re able to do these more continuous unobtrusive measurements that provide greater amounts of data that are useful for the clinician.


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To learn more about medical design innovations, visit Medical Design Briefs .