Find Riches in Niches to Make Health Equity Possible

“Hardware is hard.”

But they failed to mention how much easier it got with the right allies on our side.

So, what’s a speculum?

Vagina-owners hate this thing. Honestly, nobody likes it.

It’s a reusable metal or single-use plastic device inserted into the vagina and used to visualize the cervix. It helps with procedures like pap smears, endometrial biopsies, and colposcopies on vagina-owning womxn.

Why did it need rethinking?

Because it’s an uncomfy, outdated tool rooted in medical racism, slavery, oppression, and misogyny.

Wait, THAT is a device used in every OB/GYN practices in America?

Yup. *facepalm*

So we rethought it. Meet the Dioptra Speculum Sleeve.

The Dioptra Speculum Sleeve is a patent-pending, FDA-funded, adolescent-to-adult OB/GYN medical device that takes the standard Metal Speculum (an outdated device rooted in historical medical racism and oppression) and improves it in patient comfort, temperature neutrality, and cost to clean.

That sounds better, no? Better for womxn. And doctors want the best for their patients.

Hospitals must love the cost reduction on cleaning reusable Dioptra Speculum Sleeves, rather than autoclaving all their metal specula, or dumping hundreds of sunk-cost, single-use plastic specula into the landfill.

WRONG.

They do, but they don’t. We invented Dioptra without intention to sell it initially, because we knew our real “customer” was the patient.

For the past 7–10 years, redesigning — or in our case, rethinking — the speculum has been a hot topic. The Atlantic headline “No One Can Design A Better Speculum” from 2014 was a cute challenge. Between this misleading message and the work of our foremothers at the design concept Yona Care and medical device company Ceek, we had to take a different tack.

We set out to rethink the device — not redesign it. We augmented the existing metal device with our Dioptra Silicone Speculum Sleeve, making it easier for medical schools, healthcare clinicians, and healthcare systems to adopt. A step change is always more likely to stick — particularly in women’s health — than a leap change.

Today, in April 2021, we have no hospitals, private OB/GYN practices, or healthcare systems to thank for welcoming our innovation. We heard over and over that Group Purchasing Organizations (responsible for buying medical devices for use in hospitals and healthcare systems) and reimbursement codes would never work in our favor.

There is no financial incentive for the existing healthcare system to adopt a device that makes womxn’s health more comfortable for womxn — even when it’s 88% cheaper to clean for medical practices, as with Dioptra.

It’s basically Financial Toxicity for vagina-owners as patients.

Here’s the bottom line, whether you’re a female founder, a medical device innovator, or working to make a deeply underserved field like womxn’s health better:

Find a niche, and you’ll find a way. There are riches in niches.

We are now completing our final prototype of the Dioptra Speculum Sleeve for exclusive use with patients of our new womxn’s healthcare company, Ruth Health, which delivers house calls and telehealth to pregnant people via a centralized AI platform. Think Amazon Prime Now (but way more human-centered) for medical home pregnancy care. Our device IP becomes a better patient experience for every vagina-owner treated with our more-comfy speculum device.

None of this would be possible without finding the right niche: The West Coast Consortium for Technology & Innovation in Pediatrics (CTIP).

Dioptra is a portfolio company of The West Coast Consortium for Technology & Innovation in Pediatrics (CTIP)

CTIP is an FDA-funded MedTech accelerator supporting pediatric device innovators from concept to commercialization. And Dioptra is a proud CTIP portfolio company.

The West Coast Consortium for Technology & Innovation in Pediatrics (CTIP) is a pediatric medical device accelerator centered at Children’s Hospital Los Angeles (CHLA) and the University of Southern California (USC). Established in 2011 and first funded by the U.S. Food and Drug Administration (FDA) in 2013, CTIP promotes the commercialization and clinical use of pediatric medical device technology.*

The world needs CTIP because pediatric MedTech innovations are grossly underfunded/undersupported and urgently needed. Womxn’s health needs CTIP because it’s yet another grossly underfunded sector of healthcare. Like the LGBTQIA+ family, the Black Lives Matter movement, and other powerful consortiums of underestimated minorities — we must stick together to fight inequity.

CTIP understands that pediatric and adolescent health for vagina-owners deeply and directly impacts the health of adult womxn.

(Not to mention that the health of adult womxn defines the health of the human race.)

We’re even more proud to announce that, thanks to the generosity of CTIP, Dioptra was awarded its second FDA-funded grant in the form of the 2021 Health Equity Flex Grant.

Thank you for your generous support as always, CTIP!

How’d we win it? We found the right “niche.”

Moreover, we found the right team with their values in the right places. They value companies like Dioptra, Happiest Baby, Gold Health, and iPill — all of which advance equity in healthcare.

What’s our Impact on Health Equity? Women’s health, like pediatric health, has been historically neglected and underfunded. Adolescent women live this dual bias during their first experiences in gynecologic, sexual, and reproductive care. Dioptra’s innovative approach to re-centering that experience around patient comfort is a much needed update to a 100+ year-old device developed through the exploitation of Black women who were enslaved in the 1800s.

Thank you, CTIP. Thank you to its Director and Principal Investigator, Juan Espinoza, MD, Co-Directors Kathryne Cooper, MBA and Yaniv Bar-Cohen, MD, and our wonderful day-to-day allies, Program Associate Nadine B. Afari, MS and Program Administrator Salima Jamal, MBA.

These are the diverse names and faces of a team that walks the walk. Their commitment to equitable innovation with potential for both financial and health outcome ROI are unparalleled.

They helped us fill our Double Bottom Line.

Featured at #LAMedTechWeek 2021

Most importantly, the riches of support, community, a robust Los Angeles MedTech startup ecosystem, and yes — a five-figure FDA-funded grant for a “femtech” hardware company no VC would dare to back — came from finding our niche.

Now, it’s time to find yours.

CTIP is currently accepting applications for its 2021 Catalyzing Pediatric Innovation Grants, their pediatric medical device competition to assist the development of medical device projects for children. They invite proposals addressing the development of novel devices and technologies for pediatric patients.

Apply here by May 3rd, 2021.

*In August 2018, CTIP was awarded a new $6.6 million P50 grant from the FDA to continue research and development of MedTech for children (Grant Number: 1P50FD006425–01, PI: Espinoza). CTIP addresses the most important component missing from pediatric device innovation: simultaneously engaging clinicians, engineers, regulators, hospital administrators, patients and the business community in the process of assessment and development of technology. For portfolio companies, CTIP fosters networking opportunities, direct and indirect financial support and guidance on issues related to, but not limited to, intellectual property, prototyping, engineering, testing, grant writing and clinical trial design. CTIP has a network of children’s hospitals, academic institutions, accelerators and incubators across the West Coast to support the commercialization of pediatric medical devices. CTIP network members include the University of California, Los Angeles; Oregon Health & Science University; University of Southern California; University of California, San Diego; University of California, Berkeley; Seattle Children’s Hospital; Cedars-Sinai Accelerator; The Lundquist Institute; Project Zygote; and Larta Institute.

Rethinking the speculum to reclaim women’s health as our own. Women and QTPOC owned. Co-founders: Audrey Wu + Alison Greenberg. LA/NYC.