Medical Design Briefs - November 2021 - 7
MEDICAL CATEGORY WINNER
Halo Speculum - Invented by a Female for the Female
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
T
he history of the speculum dates
back to the 1840s 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, " says Dr.
Fenster. " 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 overmolding
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 sidewalls 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 the team's 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 hysteroscopies, hysterectomies, and
pap smears. Assessing just hysterectomies,
600k hysterectomies are performed each
year. The surgical-grade Halo unit price is
$70, so at 20 percent of just the hysterectomy
market, the Halo would grow profits
of almost $9 million 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.
Medical Design Briefs, November 2021
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Medical Design Briefs - November 2021
Table of Contents for the Digital Edition of Medical Design Briefs - November 2021
Medical Design Briefs - November 2021 - Intro
Medical Design Briefs - November 2021 - Cov4
Medical Design Briefs - November 2021 - Cov1a
Medical Design Briefs - November 2021 - Cov1b
Medical Design Briefs - November 2021 - Cov1
Medical Design Briefs - November 2021 - Cov2
Medical Design Briefs - November 2021 - 1
Medical Design Briefs - November 2021 - 2
Medical Design Briefs - November 2021 - 3
Medical Design Briefs - November 2021 - 4
Medical Design Briefs - November 2021 - 5
Medical Design Briefs - November 2021 - 6
Medical Design Briefs - November 2021 - 7
Medical Design Briefs - November 2021 - 8
Medical Design Briefs - November 2021 - 9
Medical Design Briefs - November 2021 - 10
Medical Design Briefs - November 2021 - 11
Medical Design Briefs - November 2021 - 12
Medical Design Briefs - November 2021 - 13
Medical Design Briefs - November 2021 - 14
Medical Design Briefs - November 2021 - 15
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Medical Design Briefs - November 2021 - 17
Medical Design Briefs - November 2021 - 18
Medical Design Briefs - November 2021 - 19
Medical Design Briefs - November 2021 - 20
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Medical Design Briefs - November 2021 - Cov3
Medical Design Briefs - November 2021 - Cov4
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