Kelly Yang

The AEIOU observation framework is one method that can be used to guide how you pay attention to and how you document a scenario. It stands for activities, environments, interactions, objects, and users; capturing all five allows for categorizing and contextualizing user requirements.

Throughout this first week of Clinical Immersion, I had the chance to observe in the OB ER, ultrasound appointments, and in the MFM (maternal fetal medicine) hypertension clinic. The use of ultrasound technology was a common theme in all three locations.

In the OB ER, I saw it used to visualize the yolk sac in the uterus of a patient who had presented for vaginal bleeding. In the clinic, I sat in on a variety of ultrasound appointments: dating ultrasounds done early in the pregnancy to obtain an EGA (estimated gestational age) of the fetus, comprehensive anatomy scans done around 18 weeks to check on the development of the fetus and to identify any potential anomalies, and follow-up scans towards the end of a pregnancy to monitor fetal growth in higher risk patients. In the hypertension clinic, there were basic, portable ultrasounds that could be wheeled into a patient’s room to listen to a fetus’ heart rate.

Drilling down to the designs, I’d like to focus specifically on anatomy scans. Activities: These are usually ~45m appointments and the ultrasound tech will measure and document the fetus’ size, estimated weight, facial features (e.g., for presence of a cleft lip), brain and skull, heart (including blood to and from), spine and vertebrae, kidneys and bladder, sex, as well as the fetus’ limbs (e.g., counting 10 fingers).

Environment: Anatomy scans are done in the ultrasound wing of the clinic. When patients arrive for their appointment, an ultrasound tech will show the patient to their room then step out so the patient has the privacy to change or adjust their clothing for the scan. There are several rooms on both sides of the hall, as well as bathrooms so that patients don’t have to go far. Doctors don’t usually sit in on these appointments; it’s just the tech, the patient, and anyone the patient has with them.

Interactions: Throughout the appointment, the ultrasound tech interacts with the different probes and the console of the ultrasound machine. The screen of the machine displays the sonograms and the tech can label the images (e.g., left foot) by selecting from a list or by typing it in manually and adjusting the placement with a mouse. The patient and those with them can see the exact same image projected to a large-screen TV above the foot of the table.

Objects: The ultrasound machine has a center console with a mouse and touchscreen keyboard; there are also presets on the side that techs can select as they go through a scan (e.g., a cardiac preset for when specifically scanning the fetus’ heart). There is a printing function so that patients can take certain images home (but there are over 100 total taken). Transabdominal and transvaginal probes can be plugged into the machine based on what’s being visualized. The patient is reclined on an exam table and there is a chair for guests. The TV is positioned for the patient’s (+ guest’s) viewing.

Users: The ultrasound tech is attempting to capture a comprehensive visualization of the fetus and identify if there are any anomalies. There are a lot of sonogram views that takes training to understand what you are seeing; for those, the patient is relying on the tech to share any additional information. Other views, like the fetus’ profile, are easier for the patient to identify; those are also usually the images that are printed for them.

Design: The sonograms projected onto the TV specifically for the patient’s viewing experience is a great design feature. It allows the patient to follow along through the views and see images of their baby. Since it’s a mirror of the ultrasound machine’s screen, there’s no additional set up that needs to be done during every appointment. While it includes the patient in the procedure, it also has room for innovation, specifically when it comes to helping the patient identify what exactly they are seeing. The ultrasound techs also sometimes label the images with abbreviations (e.g., 3VV is 3 vessel view). This is another opportunity area to make this a even more patient-centered experience. The ideal innovation should not add more time or effort to the ultrasound tech’s plate and should be as accurate as it currently is. A potential solution could be an AI overlay of the TV screen, translating what the tech types up into plain English (and other languages!) and maybe arrows or circles to direct the patient’s attention to specific features.

One of the mornings this week when I was in the clinic, I was walking with an OB/GYN to see a patient who had come in for a gestational diabetes appointment. As we passed the hallway where the Huntleigh portable ultrasound machines usually sit, there were none there. The doctor needed to check the fetal heart rate during this appointment, so she asked the medical assistants if they had seen one or if they knew if one had already been wheeled into the patient’s room; they also weren’t sure. We continued into the patient’s room and it turned out that someone had already moved the ultrasound into there, which was great for this appointment – but what if other patients down the hall also needed one and their doctor was looking too? There weren’t enough machines for every single room, which is why they were kept in a central location in the hall. On another day, while I was on the L&D and OB ER floor, there was a similar search for a portable ultrasound; multiple doctors asked could only provide suggestions on where it might be, but they weren’t exactly sure of its last location either.

I am someone who loves and needs AirTags – in my wallet, on my keys – and these equipment searches made me curious if there was some sort of real-time tracking that was available for hospital devices and worked in a clinical setting. In 2023, a team at the Northwell Health Long Island Jewish Medical Center published results from a study¹ they conducted in their emergency department to explore the impact of a Real-Time Location System in addressing the decreased efficiency and increased frustration of their providers in locating their mobile otoscope/ophthalmoscope carts around the department. 30 ED providers were asked to go find two of these carts – one with a Tile device (which uses Bluetooth) and one without – and the research team recorded the time it took and collected notes on how the experience was for the providers. This task was conducted to mimic the actual working conditions and scenarios of the ED. The results showed that without the Tile, it took the providers an average of 92 seconds to find a cart, vs. the 25 seconds it took when there was a Tile on the cart. Without the Tile, only 13% of providers found it within 30 seconds; that increased to 73% of providers who found it in under 30 seconds with the Tile. The team emphasized that addressing this pain point would help with delays in workflow and frustration levels among the providers – without the Tile, two-thirds of the providers reported frustration in finding the cart. With the Tile, this decreased to 3% of providers. This study concluded that implementing something like the Tile in EDs helped address the challenges that the department was facing in finding medical carts, a scenario that was very similar to what I observed in the OB/GYN department with their portable ultrasounds. I really appreciated how simple and inexpensive of a solution it was to just stick Tiles onto medical devices!

Beyond AirTags and Tiles, there are other inventions to address medical device tracking. Focusing on the equipment tracking part of this patent, “Systems and methods for tracking and monitoring patients and medical equipment in a healthcare environment”² goes smaller scale than tracking a device cart. This patent describes a Bluetooth system for tracking individual medical instruments, tools, and even consumables that are found on a tray. Each item contains a tracking device composed of a microprocessor, communication module, and transceiver that provides users continous updates on the contents of the tray. This system addresses the time spent looking for equipment and additionally allows providers to track the usage, maintenance, availability of devices. The inventors also point out that this system could help minimize equipment loss as a result of misplacement of theft.

It’s always interesting to think about what’s being done in other industries to address similar problems, and “Bluetooth Low Energy Tracking Tags for Livestock Tracking”³ seems like it could be relevant and adapted for tracking medical equipment. This patent describes a system that similarly uses Bluetooth, as well as RFID chips, to communicate with an external reader and transmit data. Because this was developed for livestock, this system has the capability to track over varying distances, which I think could be critical. I know that my AirTag sometimes has trouble if I’m in the opposite corner of my apartment – now think of how big a hospital floor is. The system described in this patent also provides users the ability to download data for any analysis needed.

References

1. LoGalbo, S., Trojanowski, S., Slusser, A., Iyeke, L., Jordan, L., & Richman, M. (2023). Speedy and satisfying: Real-time Location System increases Emergency Department efficiency and decreases frustration with finding medical equipment. medRxiv. https://doi.org/10.1101/2023.11.20.23298180
2. Systems and methods for tracking and monitoring patients and medical equipment in a healthcare environment. (2009, October 29). WO Patent No. 2009132328A2. World Intellectual Property Organization.
3. Bluetooth Low Energy Tracking Tags for Livestock Tracking. (2023, August 17). U.S. Patent Application No. 20230255179A1. U.S. Patent and Trademark Office.

In the Maternal Hypertension Clinic this week, it was really interesting to observe how patients shared their at-home blood pressure readings with their doctors. High blood pressure is a significant concern during pregnancy because it can lead to serious complications for both the mother and baby. It can reduce blood flow to the placenta and restrict fetal growth or cause placental abruption. Pre-term delivery may be necessary to mitigate risks to mom and baby and the feared complication is progression to pre-eclampsia.

Multiple readings that were out of range would affect course of treatment going forward to better manage BP. In between visits (one or two weeks, depending on the patient), patients are told to take and record their blood pressure daily at home. There is a mechanism for the patient to manually input the data into their MyChart, but the patients that I saw just came in with their readings written in the Notes app on their phone. During the visit, the doctor looks over the list of readings, counting the number of readings over 140/90. For the higher readings, the doctor will ask the patient if she remembers if something occurred that day (e.g., stress, diet, sleep) that could’ve impacted their BP, but most don’t recall – I mean, hey, if you asked me if I had more salt or was frustrated last Thursday, I couldn’t tell you. And while patients are supposed to take their blood pressure every day, one of the patients explained that she only recorded her BP when she felt off. Before the end of the appointment, the OB/GYN will walk through hypertension/pre-eclampsia symptoms with the patient, explaining the basics of the physiology of high blood pressure using analogies, and just really making sure that the patient understands warning signs (e.g., knowing when a headache isn’t a headache, when feeling “off” isn’t just being tired from pregnancy) and that it is pertinent they seek urgent care. On another hypertension note – but in the U/S clinic – I was with a tech who was scanning a patient who had been marked as high-risk and therefore had to come in for bi-monthly scans. The patient explained that she just experiences “white coat hypertension” and that all her readings at home have always been normal; they just spike when she’s in the clinic. This was something she experienced pre-pregnancy too.

With these observations, it seems like there is an unmet need for OBs to get the complete, daily blood pressure readings of their patients and to have a record of it for analysis in order to tailor the course of treatment to each patient. Another perspective is that patients need an easier way to manage their blood pressure readings at home. This includes a simpler way to share their readings digitally with their healthcare team, a place to note if there were any events that impacted a BP reading that they can share with their doctor to provide more context, and maybe a place that provides the same information that the doctor goes over at the end of the appointment about the physiology and symptoms so that they can go back to it for reference. There is an opportunity for digital, remote monitoring.

Feasibility

The remote patient monitoring market is saturated, but the unique IP opportunity here could be in the combination of a remote monitoring device + a gestational hypertension specific interface + materials tailored for the education, engagement, and empowerment of this patient population + EHR compatibility or another way to easily share the data with providers.

Commercial Solutions & Features

BabyScripts Blood Pressure Monitoring: full device kit, integration with multiple EHRs, antenatal & postpartum programs, symptom logging, automated triggers, HCP dashboard, patient education

PregnaScan (EU): measures HR & variability analysis, blood pressure diary, weight diary, event diary; data is processed in cloud and shared with physicians

Withings BPM Core: not pregnancy specific, but Wi-Fi enabled blood pressure cuff, ECG, and digital stethoscope; can set reminders, instant patient-friendly BP interpretation/feedback; can share data with care team

Viability

General Market Assessment: Policy-wise, theres currently a lot of focus on maternal health equity, disparities in neonatal health outcomes, and expanding maternal health care coverage. The remote patient monitoring market has been growing through the pandemic and beyond. There is also a rise in patient expectation for telehealth and connected devices and their ability to share information with physicians digitally (e.g., smart watches, Withings BPM core). We are also seeing an increase in payer engagement in the preventative health space.

Total Addressable Market (TAM): 3.7M (# US births/year, CDC) x 14.6% (HDP prevalence, CDC) = 53k patients x $25/month x 6 months = $8M