Halo Speculum -- Invented By a Female for the Female

Votes: 7
Views: 3511

The history of the speculum dates back to the 1840’s when” the godfather of gynecology,” Marion Sims, performed dozens of surgeries, without anesthesia, on enslaved women using a spoon he bent backwards.

As a gynecologist for the past 15 years, the speculum that I use to perform exams on my patients is millimeters away from the original model.

Why have a bill that opens up and down, when a female introitus has a circumferential opening? Why have cold hard metal when women have tremendous sensitivity in the vaginal canal? Why have one basic shape, when body habitus and pregnancy can alter anatomy from patient to patient. We knew women deserved better, so we created the Halo speculum.

What are the potential benefits?

The Halo speculum is composed of over-molding soft silicone sleeve on flexible surgical steel sheet and medical grade Nylon handles. The design allows the speculum to be rolled up as small as a tampon. When placed in the vagina, it gently expands and retracts the sidewalls. This way, it does not need excessive stretch to retract the side walls like the duck bill. The spiral accommodates all diameters of the vaginal canal regardless of the size of the patient, increasing ease of the procedure for both the surgeon and patient.

The composition of the Halo speculum incorporates multilayer technology. The outer silicone layer provides comfort, and the inner layer of flexible surgical steel sheet provides secure structural support. As proven in our lab and the operating room, the speculum does not collapse with a moving patient.

Halo’s versatility extends well beyond the conventional speculum use cases. For vaginal procedures like vaginal morcellation during hysterectomy and electrosurgery during cervical cancer procedures the steel and silicone make it possible to perform these procedures safely in the vaginal canal without injury to the sidewalls. The vaginal cuff can easily be closed, as the Halo provides perfect exposure of the top of the vagina. No additional hands are needed to hold the speculum as it is completely self-retaining. The Halo replaces all metal retractors with one simple one-size-fits all design.

Given that the Halo provides perfect exposure of any woman’s internal vaginal anatomy, it can be used in all procedures in and out of the operating room that depend on visualization of the cervix such as LEEP, colposcopy, endometrial biopsies, intrauterine device insertions, office hysteroscopy, hysterectomies and pap smears. Assessing just hysterectomies, 600k hysterectomies are performed each year. The surgical Grade Halo unit price is $70, so at 20% of just the hysterectomy market the Halo would grow profits of almost 9M a year.

Femtech has grown in magnitude and now incorporates robotics, flexible scopes and radio frequency ablation, but we forgot to improve the most fundamental medical instrument that gynecologists use every single day- until now. Women deserve to have Halo as the new standard in healthcare.

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  • Name:
    Mitchell Tung
  • Type of entry:
    Team members:
    Tamatha Fenster, MD, MS, FACOG Minimally Invasive Gynecologic Surgery
    Director of Biotechnology & Innovation, Fibroid & Adenomyosis Center
    Assistant Professor of Obstetrics & Gynecology,
    Weill Cornell Medicine, New York Presbyterian
    Mitchell Tung, Sr. Industrial Designer, OneWorld Design & Manufacturing Group
    JJ Lees, Founder, President, Artisan Medical Devices
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  • Mitchell is inspired by:
    It is Dr. Tamatha Fenster's vision to provide doctors with a new tool to diagnose female patients on the very personal and private part of their body. It is also to offer patients with a degree of comfort through the medical procedure. I am glad that I can be part of this creative and innovative exploration to bring Dr. Fenster's vision to live.
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