Smartphone speculum in lieu of standard speculum

Two young sister entrepreneurs hope their Smartphone Speculum, “SmartSpec,” will gain widespread acceptance as a physician and patient-friendly substitute for a standard speculum.

The hardware for the novel device consists of a low-cost, single-use, plastic vaginal access probe whose size and insertion techniques were inspired by a transvaginal ultrasound probe. The current probe design easily attaches to a smartphone with a 3D-printed adapter.

The software component embedded in the phone allows physicians to shine light and capture images through the hardware, and record patient details, all while protecting patient privacy.

The goal is for a clinician to first connect a smartphone to SmartSpec, and then be able to perform a variety of routine diagnostic and other minor procedures while viewing from the smartphone screen.

Besides improving the patient pain experience with the probe’s small diameter, the device is expected to improve a physician’s posture and ability to visualize the anatomy.

A 50-patient OUS (Outside of the United States) study of routine gynecologic procedures using the SmartSpec in outpatient clinics was presented at the 46^th AAGL Global Congress on Minimally Invasive Gynecology.

“We wanted to determine how well SmartSpec could help visualize the vaginal wall, cervix and facilitate transcervical uterine access,” said lead author Nika Shroff, 18, a senior at Amador Valley High School in Pleasanton, California, who plans to pursue engineering and medicine.

For the study, the gel-lubricated probe was first introduced into the vagina to locate the cervix. Subsequent steps varied, depending on the primary procedure, which ranged from simple vaginoscopy and cervix inspection to insertion of an intrauterine device (IUD).

In addition to gauging patient discomfort, the study had the user evaluate the adequacy of lighting, and visualization of the vaginal cavity and cervix using a 5-point scale. Ease of use of other instruments, including a vulsellum and forceps, plus IUD, through the access channel in the probe, was also assessed.

“The study found that patient pain scores were lower with the SmartSpec than with a standard speculum: roughly 3.4 versus 6.1 (on a scale of 0-10), respectively,” said co-author Ria Shroff, 20, a junior at Rensselaer Polytechnic Institute in Troy, NY, where she is triple-majoring in biomedical engineering, product design and pre-medical studies.

Furthermore, the study concluded that visualization quality was comparable to a standard speculum in a clinical setting. “Because the light source of the smartphone provides the ability to directly light the cervix through the probe, visibility and ease of use were enhanced,” Ria explained.

Nika and Ria started conceptualizing the SmartSpec as a summer project in 2016, in an attempt to make a difference in society. 

“With a background in product design and computer graphics, our father has been involved with medical device innovation and physician training for about 20 years, in cardiac surgery, electrophysiology and women’s health fields,” Nika told Contemporary OB/GYN.

Both sisters had previously completed summer internships at their father’s place of employment, medical-device firm MicroCube, where they learned about device innovation, creative problem solving, design and development. The company was also one of their key resources for pelvic anatomy knowledge, as well as for access to prototyping facilities and pelvic simulators.

In addition, the two sisters spent time in the United Kingdom and Europe, meeting gynecologists and observing a variety of gynecology procedures.

“Early on in the project, we learned that over 260,000 women still die every year from undiagnosed or untreated cervical cancer in low-income and middle-income countries, simply because basic screenings such as Pap smear and HPV testing are impractical and unaffordable,” Ria told Contemporary OB/GYN. “We saw these obstacles as an opportunity to make a bigger impact and to make a difference through simple innovations.”

Besides primary care physicians, non-expert healthcare professionals like midwives can take SmartSpec pictures of the cervix after application of acetic acid (VIA) to help detect precancerous cells.

The two sisters note that a smartphone is a commodity that many people in underserved regions possess. “Open architecture of the platform creates intriguing telemedicine possibilities, from training and telediagnosis to real-time remote guidance via secured private chat platforms,” Nika said.

The ability to integrate the device with electronic health record (EHR) systems is also on the horizon.

During development of SmartSpec, Nika and Ria realized that beyond providing a solution for cervical cancer screening in developing countries, the device had the potential to replace the traditional speculum. Thus, they started pursuing two markets: ob/gyn and primary care, and underserved areas of the world.

SmartSpec is a Class IA device that is expected to receive CE, or "Conformité Européene" mark by the end of December, followed by eventual US Food and Drug Administration approval.

The one-time purchase of the attachment to a smartphone will retail for less than $10, with the disposable probes much less costly.

Nika and Ria Shroff report no relevant financial disclosures.

REFERENCES

Shroff N, Shroff R, Thakur Y, Thakur V, Penketh R, Tas B. Smartphone Speculum: Design, Development and Initial Experience. [AAGL abstract 101]. J Minim Invasive Gynecol. 2017;24(suppl):S41.