Kirsten Drabek

This week, I began my OB/GYN clinical immersion in labor and delivery. It would be impossible to start without acknowledging the miraculousness of childbirth. I had the opportunity to scrub in and observe a cesarean section on my first day. Though this procedure dates back to the 1500s, the speed, precision, and artistry required to ensure the safety of both mother and baby was breathtaking. There is a long list of maneuvers and incisions named after their pioneers:  Munro Kerr, Joel-Cohen, and Patwardhan. For the physicians utilizing them, these are second nature, performed through muscle memory rather than by name. Watching the moment a baby was born, and seeing the mother, baby, and family meet for the first time, was unforgettable. It was a profound reminder of the emotion and humanity that is illuminated by medicine.

For my first week, I focused on the integration of technology in the birthing process. There were three notable devices that were consistently used or considered in each case.

First, during induction, a cervical ripening balloon, either single or double, is often used to assist with cervical dilation. Saline is pumped into the balloons (up to 80 mL each) to facilitate elective induction. However, this Foley device has its drawbacks. It can sometimes slip inward, causing increased pressure and discomfort for the patient, or slip out entirely. In some cases, it wasn’t discovered until 30 minutes to an hour later, due to the rotation of check-ins on patients.

Second, during vaginal deliveries, vacuum-assisted devices like the Kiwi-Omni-MT and the Mity One-Piece are used to help guide the baby down the birth canal during contractions. These vacuum caps, made from pliable materials such as plastic, silicone, rubber, or polyethylene, are placed over a 2–3 cm area of the baby’s flexion point—between the anterior and posterior fontanelles. Negative pressure (typically 15–23 mmHg) is applied to assist in the delivery. While I haven’t yet seen this device in use, I look forward to observing it in action and learning more about its advantages and limitations.

Lastly, during both vaginal and cesarean deliveries, the care team used a Triton infrared (IR) depth sensor to calculate quantitative blood loss (QBL). Previously, clinicians estimated blood loss visually, a method prone to error as highlighted in my interviews. With the Triton system, nursing staff can scan blood-soaked materials and suction contents, and the device distinguishes blood from amniotic fluid to provide a more accurate measurement. During the cesarean section I observed, the device was able to quantify approximately 267 mL of blood loss where the surgical staff estimated 3oo mL. However, there were technical issues: one blood-soaked cloth wasn’t accounted for, and attempts to reset the machine were unsuccessful. I asked the physician team how much they rely on the Triton during procedures. They shared that while the device is a helpful supplement, their decisions remain primarily based in clinical judgement, grounded in their direct observations. This made me wonder about the reliability of the device, whether its limitations stem from human input errors or from flaws in the technology itself.

Primary Data Focus:

This week, I had the opportunity to observe the Maternal Fetal Medicine Clinic, which specializes in high-risk pregnancies. During these appointments, nearly every patient encounter involved the use of a fetal heart rate monitor utilizing Doppler technology. The specific device used in the clinic was the Sonicaid Digital Doppler. Despite the device having a visible display that automatically calculates the fetal heart rate, I observed both a PGY-2 resident and an intern manually calculate the heart rate using the wall clock. After one of the appointments, I asked them about this seemingly redundant practice. Both explained that their attending had advised them that the machine’s readings are less accurate than manual calculation. However, they still found the amplified sound from the Doppler helpful in timing the beats. This interaction made me curious about the actual sensitivity and diagnostic reliability of the digital Doppler. I began to wonder whether these devices are accurate enough for diagnostic use or are intended more for basic screening and clinical impressions.

Secondary Literature Review:

On Huntleigh Diagnostics’ website, the Sonicaid Digital SR2/SR3 Display Doppler is described as “highly sensitive” for general-purpose screening of the fetal heart, beginning as early as 8-10 weeks of gestation.1 However, upon further review, the device lacks any publicly available, clinically validated sensitivity or specificity data. Determining its true diagnostic performance would likely require internal audits or data requests from the manufacturer. The device includes two interchangeable probes, a 2 MHz and a 3 MHz option, which allow clinicians to choose between greater depth penetration (2 MHz) and improved sensitivity for early gestation (3 MHz).1

Patent Review: 

Sonicaid holds multiple patents related to the Digital SR2/SR3 device. The device’s distinctive design, featuring a 3×3 pattern of circular speaker openings, is protected under U.S. Design Patent USD1067436.2 One of the earliest associated patents, US3813654A3, covers the circuitry and diagnostic apparatus used for fetal heartbeat monitoring.

Works Cited:

[1] Sonicaid SR2/SR3 Digital Doppler – Huntleigh Healthcare. Huntleigh Healthcare. Published December 6, 2024. Accessed July 14, 2025. https://www.huntleigh-diagnostics.com/products/sonicaid-digital-sr2-sr3/

[2] ​​Huntleigh Technology PLC. Fetal Doppler. US patent USD1067436 S. Issued March 19, 2024

[3] Barnwell JW. Diagnostic apparatus for monitoring fetal heartbeat. US patent 3813654 A. Issued May 28, 1974.

Desirability

Primary Observations:

Activity – Transvaginal ultrasound scan

Environment – Clinic rooms, 4C clinic

Interactions – Ultrasound technician with patient, ultrasound technician maneuvering the ultrasound probe

Objects – Samsung Transvaginal Ultrasound probe, lubrication, Samsung US device, technicians badge

Users – Ultrasound technicians and physicians

Secondary Observations:

The transvaginal ultrasound scan is often considered invasive and sensitive as compared to other ultrasound scans. Although the technique to maneuver the transvaginal ultrasound probe is standardized, there is no standardized professionalism or positioning of sonographers to improve patient comfort during the procedure.¹ In recent years, there has been a 66% increase in reported sexual assaults of patients from 2003 to 2013 against physicians and ultrasound technicians.² There is a call to action to improve patient safety and comfort while undergoing transvaginal ultrasounds.

Need Statement:

Patients undergoing transvaginal ultrasounds experience greater discomfort and emotional distress than with other ultrasound procedures, indicating a need for enhanced procedural safety and/or training without reducing efficacy of the scans.

Feasibility

The greatest factor limiting feasibility are the procedures and protocols placed in each hospital and the type of ultrasound machine. Guidelines for sonographer sensitivity are frequently site specific and less regulated. As for the ultrasound machine limitations, UI Health uses the Samsung ultrasound device, pictured in Image 1, which is only compatible with Samsung ultrasound probes. The Samsung V5-9 Endocavitary Probe, priced at $6,000, features patented ergonomic enhancements, including a rotatable head as described in US Patent 10159463, aimed at improving operator comfort and patient accessibility.³ In contrast, the MD Pro Transvaginal Probe designed for the P50 Soloscan is more cost-effective at $2,000 and offers a thinner, smoother material to enhance patient comfort.⁴

Viability

To determine units/year in regards to total addressable market (TAM), the number of ultrasound scans per year in the U.S. was first assessed. In 2023, there were 59.8 million ultrasound scans in the U.S. with about 2/3 of them transvaginally.⁵ Therefore, the units/year estimation is about 39,860,000. As for cost, the UI Health Price and Transparency Model states that the cost of a transvaginal ultrasound is $600 out of pocket, but $180 with discounts applied.

TAM = 39,8 million units/year x $180 = $7.2 billion/year

Works Cited

[1] Collins K, Hamlyn T, Bruxner G, Kothari A. Dangers in the dark: Calling for a safer practice of transvaginal ultrasonography. Australasian Journal of Ultrasound in Medicine. 2020;24(1):5-12. doi:https://doi.org/10.1002/ajum.12234

[2] Thomson N, Moloney P. Protection against allegations of sexual assault when undertaking ultrasound examinations. Ultrasound. 2016;25(1):58-61. doi:https://doi.org/10.1177/1742271×16676223

[3] Chang W, Kim S, Kim D, et al. Ultrasonic diagnosis apparatus and control method thereof. US patent 10,159,463. December 25, 2018.

[4] Transvaginal Probe for P50 Soloscan Ultrasound. Tiger Medical. Published 2024. Accessed July 21, 2025. https://tigermedical.com/products/transvaginal-probe-for-p50-soloscan-ultrasound-mdpe104ks?srsltid=AfmBOoqfXv6GuobERKH4ClDtI-HwJsOR-C-JIwUBrdDDOqlTuCubL-hJ

[5] Won D, Walker J, Horowitz R, Bharadwaj S, Carlton E, Gabriel H. Sound the Alarm: The Sonographer Shortage is Echoing Across Healthcare. Journal of ultrasound in medicine. 2024;43(7). doi:https://doi.org/10.1002/jum.16453

IDEO Model

Regarding the IDEO Model and peer-to-peer feedback, I believe that ideas in this space are strong in it’s feasibility and is desirable for all users, but lacks a clear financial interest. There are weaknesses in the TAM calculation. The TAM was calculated to be a 7.2 billion dollar space, which is accounting for a most likely inflated amount of transvaginal scans. Also, not every scan would be considered unsafe due to the variance of how they are performed by physicians and ultrasound techs or can go unreported due to patient fear and/or stigma. The market should be looking at legal costs, missed work for suspended or fired professionals, and personal costs to patients in addition to the emotional and psychological burden that an unsafe scan may cause.  Prevention of this problem is what makes the idea profitable, as lawsuits and malpractice can be variable by case and can be considerable financial losses for hospitals and healthcare professionals. This great variability makes TAM estimates unquantifiable.

Desirability

Primary Observations:

Activity – Transvaginal ultrasound scan

Environment – Clinic rooms, 4C clinic

Interactions – Ultrasound technician with patient, ultrasound technician maneuvering the ultrasound probe

Objects – Samsung Transvaginal Ultrasound probe, lubrication, Samsung US device, technicians badge can hang onto patients legs and inner thighs during the scan (some technicians would remove badge entirely)

Users – Ultrasound technicians and physicians

Secondary Observations:

The transvaginal ultrasound scan is often considered more invasive and sensitive compared to other ultrasound scans. Although the technique to maneuver the transvaginal ultrasound probe is standardized, there is no standardized professionalism or positioning of sonographers to improve patient comfort during the procedure.¹ In recent years, there has been a 66% increase in reported sexual assaults of patients from 2003 to 2013 against physicians and ultrasound technicians after scans.² There is a call to action to improve patient safety and comfort while undergoing transvaginal ultrasounds.

Need Statement:

Patients undergoing transvaginal ultrasounds experience greater discomfort and emotional distress than with other ultrasound procedures, indicating a need for enhanced procedural safety and/or training without reducing efficacy of the scans.

Feasibility

The greatest factor limiting feasibility are the procedures and protocols placed in each hospital and the type of ultrasound machine. Guidelines for sonographer sensitivity are frequently site specific and less regulated. As for the ultrasound machine limitations, UI Health uses the Samsung ultrasound device, pictured in Image 1, which is only compatible with Samsung ultrasound probes. The Samsung V5-9 Endocavitary Probe, priced at $6,000, features patented ergonomic enhancements, including a rotatable head as described in US Patent 10159463, aimed at improving operator comfort and patient accessibility.³ In contrast, the MD Pro Transvaginal Probe designed for the P50 Soloscan is more cost-effective at $2,000 and offers a thinner, smoother material to enhance patient comfort.⁴

Viability

To determine units/year in regards to total addressable market (TAM), the number of ultrasound scans per year in the U.S. was first assessed. In 2023, there were 59.8 million ultrasound scans in the U.S. with about 2/3 of them transvaginally.⁵ Therefore, the units/year estimation is about 39,860,000. As for cost, the UI Health Price and Transparency Model states that the cost of a transvaginal ultrasound is $600 out of pocket, but $180 with discounts applied.

TAM 1 = 39,8 million units/year x $180 = $7.2 billion/year

Works Cited

[1] Collins K, Hamlyn T, Bruxner G, Kothari A. Dangers in the dark: Calling for a safer practice of transvaginal ultrasonography. Australasian Journal of Ultrasound in Medicine. 2020;24(1):5-12. doi:https://doi.org/10.1002/ajum.12234

[2] Thomson N, Moloney P. Protection against allegations of sexual assault when undertaking ultrasound examinations. Ultrasound. 2016;25(1):58-61. doi:https://doi.org/10.1177/1742271×16676223

[3] Chang W, Kim S, Kim D, et al. Ultrasonic diagnosis apparatus and control method thereof. US patent 10,159,463. December 25, 2018.

[4] Transvaginal Probe for P50 Soloscan Ultrasound. Tiger Medical. Published 2024. Accessed July 21, 2025. https://tigermedical.com/products/transvaginal-probe-for-p50-soloscan-ultrasound-mdpe104ks?srsltid=AfmBOoqfXv6GuobERKH4ClDtI-HwJsOR-C-JIwUBrdDDOqlTuCubL-hJ

[5] Won D, Walker J, Horowitz R, Bharadwaj S, Carlton E, Gabriel H. Sound the Alarm: The Sonographer Shortage is Echoing Across Healthcare. Journal of ultrasound in medicine. 2024;43(7). doi:https://doi.org/10.1002/jum.16453

1. Jane arrives to her first ultrasound after IVF treatment. She is in the waiting room, excited to see if any of the follicles stuck.
2. She is called from the clinic room and escorted by an ultrasound technician to a dark room.
3. She is told to change into a gown. A curtain is drawn to give her privacy and the technician leaves the room while flipping the lights off. Jane waits in the dark after she changes.
4. The ultrasound technician arrives and adds lubrication to the paitent’s belly. Quickly, she is able to see the follicles in her uterus and is filled with excitement.
5. The technician informs Jane that they will complete a vaginal ultrasound now. Jane says okay knowing that it may help her know more about her future baby.
6. Jane is immediately uncomfortable by the ultrasound but does not know if she should ask to stop.