Sofya Kristesashvili

Good design – Dexcom sensor. This design was very useful for pregnant diabetic patients. It tracks glucose levels without the need for continuous finger pricks. The data is sent directly to the patients’ phones, and doctors are also able to analyze the results. Analysis depends on clinical interpretation.

Activity: A doctor analyzed Dexcom sensor data to understand their patient’s glucose levels over time. The sensor is located right under the patient’s skin, so continuous at-home needle pricks are not needed.

Environment: Small clinic room, doctor’s office.

Interactions: Doctor talked to patient. Doctor used a computer to view and analyze patient glucose level data over time.

Objects: Dexcom sensor, computer.

Users: Diabetic pregnant patients and doctors.

Bad design – Doppler. This design had a few issues. The doppler was attached to a clunky stand, which made it very difficult to move around. When reading the fetal heart rate, the numbers tended to bounce around and were also staticky, making them inefficient. Though there were also dopplers on the walls of some of the rooms, these were not comfortable to use.

Activity: A doctor used a doppler on a pregnant patient to measure fetal heart rate. The doctor applied gel on the stomach and then proceeded to use the wand. The monitor then displayed the heart rate of the fetus. The numbers jumped and bounced around.

Environment: Small clinic room.

Interactions: The doctor greeted the patient and described what the doppler was used for. The doppler had to be brought in from outside the room and bumped into other objects. An object in the room had to be moved aside for it to be in a comfortable spot. The doppler was then used on the patient.

Objects: The doppler and its stand, gel, and hospital bed.

Users: Doctors and pregnant patients.

Observations:

This week, I had the opportunity to shadow the ultrasound department of the obstetrics and gynecology clinic. I observed ultrasound techs perform scans on pregnant and non-pregnant patients. I also got to see the attendings of this department analyze the ultrasound images taken by the techs.

The ultrasound machines used in this department were the HERAW10 Elite models by Samsung. These high-performance systems featured fast processing speeds, 3D rendering, customizable scan presets depending on the patient details, and a wide range of adjustable settings such as frequency, depth, and gain. There were multiple transducers that the technicians could use depending on the type of ultrasound test they were performing. There was a wand transducer used for vaginal tests as well.

However, over the week, I observed that the techs had concerns over the ergonomics of their workflow when using the transducers. They have to apply constant pressure on the location of the scanning, which can also depend on the body fat amount of the patient. The more body fat, the more pressure that has to be applied. Additionally, their arms may need to be in awkward positions to get good scans, with bad posture as well. Many of the scans were performed on pregnant patients to perform anatomy tests on the fetus inside, which also resulted in having the technicians be in uncomfortable positions as the fetus moved inside the uterus.

Secondary research: “We Don’t Talk Enough About Overuse Injuries in Clinicians Using POCUS”

According to a peer-reviewed (secondary-data) paper on clinician injuries in ultrasound, at least 90% of ultrasound technologists experience pain from their scanning, and about 20% leave the profession due to musculoskeletal issues [1]. There is an overall lack of ergonomic equipment in ultrasound, and the sonographers also may have to use awkward arm positions to get proper scans [1]. Awkward rotation of the hand, poor posture, and poor hand grip can all lead to injuries. The most common injuries are RSI (repetitive strain injury) of the shoulders and neck, carpal tunnel injury, and lower back injuries [1].

Patent: Robotically Assisted Medical Ultrasound (US Patent 6,425,865)

When researching solutions, not many came up. Most were focused on the posture and behavior of the sonographers themselves: activities such as stretching wrists before and after tests and maintaining proper wrist and back posture during the tests.

A solution I did find was a robotic arm that assists the technologists in their scans. The patent mentions that ultrasound technicians often have to stand in awkward positions or continuously exert force on a specific area, leading to musculoskeletal injuries. The proposed patented solution was to use a robotic arm under the control of an operator and for this device to have a pressure threshold so as not to harm the patient. The operator instructs the robot arm in its positioning over the surface of the patient.

Though this design can be beneficial to the technicians, a few considerations need to be made. This includes the speed of the test, as operating a robotic arm may not be as specific as operating the transducer itself. Also, pressure and force are applied based on the type of patient (pregnant vs. general tests) or based on the body fat percentage of the patient. Investigating this issue sounds very interesting to me.

References:

[1] Fox, Traci, et al. “We Don’t Talk Enough about Overuse Injuries in Clinicians Using POCUS.” POCUS Journal, vol. 8, no. 1, 26 Apr. 2023, pp. 5–7, ojs.library.queensu.ca/index.php/pocus/article/view/16075/10686, https://doi.org/10.24908/pocus.v8i1.16075. Accessed 21 May 2023.

Primary Observation: ECV (External Cephalic Version)

Activity: A doctor explains to a patient the ECV procedure they will need in order to rotate the fetus inside the uterus to a safe birthing position (head first). Two doctors (four hands) have to perform this procedure, and apply a lot of pressure to successfully flip the fetus. The patient had fear about pressure and pain. Anesthesiologists use epidural to combat pain, pressure feeling remains. In case of fetal heart rate stoppage, emergency cesarean section must be performed.

Environment: Hospital room, operating room.

Interactions: Doctors, surgical techs, anesthesiologists, nurses, patient & fetus: all interact together.

Objects: Epidural needle, hospital bed, surgical drape, monitoring devices.

Users: Ob/gyn doctors, anesthesiologists, surgical technicians, nurses, patients.

Secondary Observation: 

• In 2019, 10,783 people underwent ECV procedure [1]
  • 48.5% successful, 51.5% unsuccessful [1]
• Underused procedure: 20%-30% people eligible are not offered it, raising chance of Cesarean. [1]

Needs Statement: Pregnant patients with breech presentations have limited and often uncomfortable repositioning options, desiring a safer, more tolerable aid to support fetal repositioning beyond the standard external cephalic version procedure.

Feasibility:

• Patent: Fetus delivery assisting device (US12213702B2)
  • Breech correction, but invasive
• Patent: Maternal-fetal monitoring system (EP1776041A2)
  • Tracks fetal presentation, alerts of breech, enabling early ECV
• No commercial device solution exists

Viability:

• No direct device competitors or companies
• US TAM = 10,783 (pts/year) * $500 =$5,391,500 (using vacuum device for delivery
• US TAM = 10,783(pts/year) * $3,000 =$32,349,000 (using patient positioner assistance tech)

References:

[1] Dekker, R. (2017, September 26). Evidence on: Breech Version. Evidence Based Birth®. https://evidencebasedbirth.com/what-is-the-evidence-for-using-an-external-cephalic-version-to-turn-a-breech-baby/

Revised needs statement:

OB/GYN clinicians performing external cephalic version (ECV) need a safe and more controlled assistive tool to increase success rates and improve both maternal and fetal safety during the breech repositioning procedure.

This updated need statement shifts the focus from pregnant patients to the clinicians responsible for performing ECV. This change frames the problem through the lens of the physician and emphasizes the clinical outcomes, such as increasing success rates and minimizing risk, as the main concern. Unsuccessful ECV procedures often result in cesarean sections, which carry higher complication risks, making procedural efficacy and patient safety top concerns for clinicians.

Desirability:

Although ECV is generally safe, there are known risks, including fetal heart rate deceleration and the potential to induce labor, which may result in an emergency cesarean section. While serious complications occur in fewer than 1% of cases, the procedure’s average success rate is only about 60%, and roughly half of attempted ECVs still result in cesareans due to failure of fetal repositioning [1]. Patients with breech presentations make up 3%-4% of term pregnancies [2]. Since cesarean sections increase the risk of hemorrhage, infection, and longer recovery time, vaginal delivery remains the preferred option for low-risk patients. Therefore, a method that increases success rate and reduces risk of complication is very desirable to clinicians.

Feasibility:

Currently, there are no commercial tools that directly assist in the mechanical execution of ECV. Existing technologies are limited to monitoring systems that provide feedback on fetal positioning or well-being but do not aid with the physical manipulation of the procedure itself. General patented solutions are also focused on fetal/maternal monitoring systems.

However, introducing an assistive device would pose engineering challenges due to the delicate balance between applied force and fetal/maternal safety. The device would need to be highly adaptive, intuitive for clinicians, and safe in the event of rapid changes in fetal condition. All of these challenges may affect the solution’s size, cost, and regulatory path.

Viability:

The absence of existing commercial solutions or direct competitors shows a clear gap in the market. There is a strong demand to decrease the rates of cesarean sections, which in turn raises demand to aid the ECV procedure to increase its success rates. However, patients with breech presentations make up 3%-4% of the term pregnancy population, so this solution would target a relatively narrow patient population. That being said, improving outcomes in these high-stakes cases still represents very significant clinical and quality of care value.

To redo last week’s TAM calculation using the 3%-4% statistic:

3.5% of 3.6 million term pregnancies = 126,000.

TAM = 126,000 * $500 = $63,000,000

TAM = 126,000 * $3000 = $378,000,000

References:
[1] Shanahan, Meaghan M., and Caron J. Gray. “External Cephalic Version.” PubMed, StatPearls Publishing, 13 Dec. 2023, www.ncbi.nlm.nih.gov/books/NBK482475/ .

[2] Dekker, Rebecca. “Evidence On: Breech Version.” Evidence Based Birth®, 26 Sept. 2017, evidencebasedbirth.com/what-is-the-evidence-for-using-an-external-cephalic-version-to-turn-a-breech-baby/.

Storyboard for the External Cephalic Version procedure needs statement.