The Economics of Empathy: Zomee CEO Drives Accessible Femtech

POMPANO BEACH, Fla. – September 24, 2026 – The intersection of maternal healthcare and consumer technology has historically been defined by a stark divide: premium, highly engineered devices available to those who can afford them out-of-pocket, and standard, often cumbersome equipment relegated to insurance formularies. Today, that paradigm is shifting, driven by a new class of female founders who are leveraging complex regulatory frameworks to democratize access to top-tier medical devices.

This systemic shift was brought into sharp focus today with the announcement that Dina Shanowitz, founder and CEO of the maternity and baby care brand Zomee, has been named a finalist in the 23rd annual Stevie Awards for Women in Business. Competing in the "Women Helping Women – Business" category, Shanowitz was selected from a highly competitive global pool of more than 1,500 entries spanning organizations across 56 nations and territories.

The Stevie Awards, frequently hailed as the world’s premier business awards, utilized seven specialized judging juries comprising over 200 international business professionals to determine this year's finalists. While an award nomination is a standard corporate milestone, Shanowitz’s recognition highlights a much broader commercial and industry validation for founder-led femtech enterprises. It underscores a growing market demand for business models that prioritize insurance-accessible medical devices alongside comprehensive community support services.

The Business of Accessible Maternal Care

The global breast pump market, currently valued at $3.51 billion and projected to exceed $7.5 billion by 2035, has long been dominated by legacy conglomerates. Brands like Medela, Spectra, and Ameda established the early mechanical standards, while a recent wave of venture-backed direct-to-consumer brands introduced sleek, wearable technology at premium price points. However, healthcare economists note that the true frontier of maternal health technology is not found in luxury retail, but in the complex architecture of insurance reimbursement.

Under the Affordable Care Act (ACA) § 2713, non-grandfathered commercial health insurance plans and Medicaid expansion programs are federally mandated to cover breastfeeding support, lactation counseling, and breast pump equipment without patient cost-sharing. Yet, for years, the most innovative wearable pumps remained out of reach for working-class families, often requiring steep out-of-pocket upgrade fees—frequently exceeding $150 to $250—to bridge the gap between insurance coverage and retail pricing.

This is the precise access gap that Zomee was engineered to close. Operating legally as Zev Supplies Corp, the bootstrapped, family-run company distributes its portfolio primarily through contracted national Durable Medical Equipment (DME) providers. By integrating with major suppliers like Aeroflow Breastpumps, 1 Natural Way, Edgepark, and Byram Healthcare, Zomee ensures its devices qualify under the HCPCS E0603 billing code for electric breast pumps.

The company's strategic positioning allows its flagship models, including the Zomee Z2, to be offered as fully covered, zero-dollar out-of-pocket options on standard commercial and select state Medicaid plans. Even their advanced wearable model, the Zomee Fit, is positioned to require significantly lower upgrade fees compared to legacy competitors, effectively disrupting the pricing models of established industry giants.

Lived Experience as a Competitive Advantage

Venture and market analysts increasingly observe that maternal health devices engineered by legacy corporate supply manufacturers often overlook critical ergonomic pain points, such as hard plastic flanges, loud motors, and rigid suction rhythms. In contrast, founder-inventors bring clinical usability and peer-driven design directly into research and development, creating distinct competitive advantages in consumer satisfaction.

Shanowitz’s journey from a mother of five navigating her own breastfeeding challenges to the chief executive of a medical device company is central to Zomee's product architecture. As a lactating CEO, she possesses the unique ability to personally design, test, and iterate products alongside the company’s global engineering team. This lived-experience premium translates directly into the hardware.

The brand’s wearable, tubeless model, the Zomee Fit, features a hospital-grade motor capable of delivering up to 280 mmHg of suction while operating at a discreet whisper below 48 decibels. Unlike standard industry models that max out at four or five ounces of capacity, the Zomee Fit accommodates six to seven ounces and includes built-in fullness sensors with inverted-nipple correction modes. These are not merely technological novelties; they are direct responses to the practical realities of nursing mothers.

The demand for such discreet, high-performance devices has surged in tandem with legislative changes. With the federal PUMP for Nursing Mothers Act expanded in 2023 to protect an additional 9 million workers, employers are mandated to provide lactation accommodations. This legislative push has catalyzed massive consumer demand for wearable pumps that allow mothers to express milk seamlessly while maintaining their presence in the workforce.

Rigorous Regulation Meets Community Infrastructure

Beyond consumer appeal, the viability of any medical device company rests on its regulatory compliance and safety record. Zomee operates within strict federal guidelines, with its products classified as FDA Class II Medical Devices under 21 CFR 884.5160. The company's pumps require FDA 510(k) premarket clearance, demonstrating substantial equivalence in mechanical pump suction dynamics, electrical safety, and biocompatibility.

Manufactured under ISO 13485 standards and Good Manufacturing Practice compliance, the company maintains a rigorous safety profile. A comprehensive review of the FDA MedWatch and Premarket Recall databases reveals zero regulatory enforcement actions, Warning Letters, or product recalls issued against Zomee pumps since the company's inception. Furthermore, the company has expanded its clinical footprint with the recent introduction of the Mother’s Nature line, which includes a 3-in-1 Warming and Cooling Lactation Massager designed to prevent mastitis and relieve breast engorgement.

However, the hardware is only one half of the company's operational model. The Stevie Awards' "Women Helping Women" category specifically evaluates business models and operational programs designed to eliminate systemic barriers. To that end, Zomee has integrated robust community support services directly into its corporate structure. The company operates The Mom Line™, a dedicated customer support and lactation navigation service, alongside Zomee Mom Moments™, a peer-to-peer user community platform. This dual approach ensures that mothers receive not just the mechanical tools they need, but the educational and emotional infrastructure required to sustain their nursing goals.

Global Recognition for Systemic Impact

The acknowledgment from the Stevie Awards underscores a broader transition in how global business institutions evaluate corporate success, shifting focus to include social infrastructure and maternal support networks alongside traditional revenue metrics.

“Being recognized as a finalist for a Stevie Award in the Women Helping Women category is an incredible honor and a meaningful reflection of why I created Zomee in the first place,” said Dina Shanowitz, Founder and CEO of Zomee. “Our mission at Zomee is to be there for moms every step of the way, and I’m incredibly proud of the Zomee team and grateful to be recognized alongside so many inspiring women who are making a difference for others.”

The 2026 competition represents one of the most competitive fields in the program's history. Maggie Miller, president of the Stevie Awards, noted the caliber of the nominees. “As the Stevie Awards for Women in Business marks its 23rd year, we continue to be impressed by the remarkable accomplishments represented among the nominations. It is especially rewarding to see the significance a Stevie Award holds for women and the recognition it brings to their achievements, careers, and organizations. We congratulate all of this year’s finalists and look forward to revealing the Gold, Silver, and Bronze Stevie Award placements on November 16.”

The final placements will be announced at a gala ceremony at the Marriott Marquis Hotel in New York City on November 16. Shanowitz is competing against four other international female founders and corporate executives in the for-profit business division, including industry leaders from Australia and Hong Kong. Details regarding the full roster of finalists and the upcoming ceremony are currently available through the official Stevie Awards organization.