Medical Design Briefs - October 2021 - 36

An example of a Cosm Medical biocompatible custom Gynethotics pessary.
(Courtesy of Cosm Medical)
Autodesk Fusion 360 software helps Cosm Medical run its AI-assisted
image analysis and prediction model to design custom pessaries.
(Courtesy of Cosm Medical)
far into their vagina, " Sham says. His goal is to get rid of the
trial-and-error fitting process and make pessaries personalized
and much more user-friendly: something that can be handled
without help - as simple as wearing a bra - that is put in at
the start of the day and removed to sleep.
Patients who have difficulty inserting and removing conventional
pessaries currently must return to clinics every three to six
months to have the devices cleaned and let doctors check the
health of their vaginal tissues. " We will help some of those
women to self-manage their devices to improve autonomy and
quality of life while lowering risk of complications, " Sham says.
" Many women end up going to nursing homes because of either
the burden, discomfort, and pain from prolapse or incontinence
that they can't manage at home. "
■ Custom Solutions
Custom-made medical accessories are already widely used for
other conditions, such as in orthotics, hearing, and dental. Cosm
Medical uses customization and artificial intelligence (AI) to create
made-to-order gynecological prosthetics it calls Gynethotics™,
custom pessaries that lower risks and enhance care for patients
with pelvic floor problems. Cosm Medical is part of the Autodesk
Technology Centers Outsight Network, which has provided the
team tools and support to help develop its novel system.
Cosm uses a new and proprietary ultrasound-based technique
to scan and mold a patient's pelvic floor and vaginal cavity.
Advanced technologies such as machine learning and AI
are used to analyze the ultrasound images and soft-tissue measurements,
which help clinicians personalize pessaries for their
patients. The measurements go into a parametric 3D model
using Autodesk Fusion 360. Inputs can also include a patient's
treatment goals and activity level.
Cosm can achieve this mass customization and on-demand
production through its use of Fusion 360 and Formlabs desktop
3D printers to produce high-fidelity silicone molds.
" Fusion 360 is able to take in our sizing measurements and
build a patient-specific model and mold for our device
through parametric modeling, " says Robert Lancefield,
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mechanical design engineer at Cosm. " It can then export our
molds to load into PreForm [software from Formlabs], which
simplifies the process of uploading and tracking prints on the
Form 3B. This entire process ensures the economic viability of
our product in the long term by automating many steps in the
custom-device creation process. "
The Formlabs Form 3B is a stereolithography printer
designed to print with a suite of biocompatible resins, ideal for
medical device workflows. The printers are capable of rapidly,
accurately, and cleanly producing parts. The Form 3B offers
excellent prints, a surface quality that requires minimal postprocessing,
and a tight tolerance that minimizes the discrepancies
from CAD to print. " That's helpful for us since we want
close tolerances and consistent product properties, " Lancefield
says. " With the Form 3B's resolution, we can vary our dimensions
by a fraction of a millimeter in Fusion 360 to get the properties
we need from our molds and final silicone parts. "
The Form 3B enabled Cosm Medical to continue development
in the early stages without incurring the costs, setup, and
space that industrial printers typically demand.
■ Tech Advances That Matter
At least two groups since the 1980s have attempted customized
pessaries but failed. Sham says technological progress has made
Cosm's platform both technologically and economically viable -
particularly the reduced cost and increased quality of ultrasound
imaging, AI, CAD software such as Fusion 360, 3D printing, and
cloud computing. " Ultrasound, for example, is extremely cheap
relative to what it was just a few decades ago, " he says. " The $5,000
to $10,000 point-of-care ultrasound probes you can get now are
arguably as good, if not better, than some of the $50,000 to
$100,000 ultrasound machines just a few decades ago.
" We are excited by our growing momentum and milestones
we've achieved so far on our path to serving clinicians and
patients in need by modernizing the age-old pessary, " Sham
continues. Cosm has been awarded two U.S. patents so far within
its growing intellectual-property portfolio. In addition,
Sham says Cosm has met with both the U.S. Food and Drug
Administration and Health Canada and has a clear path for
regulatory approvals in North America.
Cosm will deliver Gynethotics through a seamless digital
platform for clinicians and patients, much like Invisalign
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Medical Design Briefs - October 2021

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