Revolutionizing Breast Health
Our Solution
How we helped a startup have their proprietary sensor technology adopted by a conservative and discerning market
The Result
Turned a novel and complex sensor technology into an FDA-cleared (K181672) Class II medical device that saves lives by making women want to get screened.
The Story
Breast cancer screening saves lives, yet millions of women delay or avoid it every year. Fear of pain, radiation exposure, and intimidating clinical environments creates a silent barrier—especially for women with dense breast tissue, where traditional mammography is less effective. Suretouch BeXa set out to change that reality.
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The ambition was not just to introduce a new diagnostic technology, but to redesign the experience of early detection itself—making it gentle, approachable, and something women would actually choose to undergo. Our role was to help transform a highly sensitive tactile sensor into a medical device that physicians could trust, regulators could approve, and patients could experience without fear.
THE CHALLENGE
Humanizing the "Scary" Exam
Medical diagnostics suffer from a “fear factor.” Mammography—the gold standard—is often synonymous with pain, anxiety, and cold, sterile rooms. This creates a barrier: compliance drops, and early detection is missed. Our challenge wasn’t just to house a sensor; it was to design an experience that felt organic, approachable, and fundamentally human. We needed to take a super-sensitive tactile sensor technology and wrap it in a form that felt like a reassuring extension of the physician’s hand, not a piece of intimidating machinery. And one that protected the sensor as well.
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Clinically, the objective was rigorous. We needed to productize a proprietary pressure-based elastography technology (originally developed by Pressure Profile Systems) into a handheld device capable of documenting abnormal breast tissue with high repeatability. The device had to be radiation-free, density-independent (effective on the 40% of women with dense breast tissue who are often underserved by mammograms), and robust enough for widespread field use. The product integration challenge was in maintaining the signal integrity of the capacitive sensor array while ensuring the device met strict FDA Class II requirements for electrical safety and biocompatibility.
OUR SOLUTION
Soft Touch, Hard Science
Industrial Design & Ergonomics
We rejected the “box with a probe” aesthetic. Instead, we sculpted the Bexa device to fit naturally in the palm, facilitating a “gliding” motion over the breast tissue.
- Form Factor: We utilized continuous curvature surfaces to eliminate dirt traps and create a “blobject” aesthetic that is visually soft and non-threatening to the patient.
- Physician Interface: The grip geometry allows for precise application of pressure without fatigue, crucial for exams that require mapping the entire breast volume.
Sensor Integration & Engineering
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The core technology detects tissue elasticity—malignant tumors are harder than benign tissue.
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- The Array: We engineered the housing for the proprietary capacitive sensor array (tactile sensors) to float effectively over varying body contours. This ensured that the pressure map generated (visualizing lesions as small as 5mm) was free from artifacts caused by the device housing itself.
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- Feedback Loops: We integrated visual indicators that provide real-time feedback to the user, ensuring the scan speed and pressure remained within the optimal range for accurate data collection.
Prototyping for Clinical Trials
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Before mass production, we produced high-fidelity functional prototypes used in initial clinical data gathering. These units were instrumental in the validation studies that compared Bexa’s efficacy against standard manual palpation (CBE) and mammography.
Manufacturing & Production Liaison
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We didn’t just design it; we supported the venture as they prepared for scale. We appointed and coordinated with the appropriate moulder in Shenzhen to transition from machined prototypes to injection-molded production parts, resolving tooling challenges, materials for easy cleanability and hygiene, and ensuring the parts met the tight tolerances required for assembly and sensor performance.
THE OUTCOME
Data & Impact
The transition from “SureTouch” to the modern “Bexa” system has created a new category in breast health: Documentation of Clinical Breast Exam (CBE).
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- Clinical Efficacy: The device achieved FDA clearance (K181672). Clinical studies have shown Bexa to have a sensitivity of approximately 90% for masses down to 5mm, significantly outperforming traditional manual exams and rivaling mammography in dense breast tissue.
- Market Impact: Bexa is now deployed in corporate health programs and clinics globally, marketed as a “pain-free, radiation-free” alternative that provides immediate results at the point of care.
- Adoption: By removing the pain and radiation barriers, Bexa has seen 90%+ acceptance rates in workplace screening programs, dramatically increasing the number of women screened early.
Why it Matters
We helped turn a complex sensor technology into a tool that saves lives by making women want to get screened. We proved that medical devices don’t have to be cold or painful to be effective—they can be beautiful, smart, and empathetic.