Highlights
- IMAGExRAY developed a portable, ultra-low-dose digital x-ray system for diagnosing dysphagia.
- Uses 80 watts of energy vs. 3000+ watts in hospitals, significantly lowering radiation exposure.
- Enables skilled nursing facilities to perform swallow studies on-site, speeding up diagnosis and treatment.
- Strong demand from medical educational institutions for teaching and research.
- Journey involved overcoming manufacturing challenges, FDA approval, and securing patents.
- Emphasizes the importance of mentorship, expert networks, and teamwork in entrepreneurship.
- Plans to expand product line to include pediatric versions for infants and children.
Summary
In this episode of The Innovators and Investors Podcast, host Kristian Marquez interviews Jacqui DiMarco, CEO, and Steve DiMarco, President of IMAGExRAY. The conversation centers around their innovative medical device—a portable, ultra-low-dose radiation digital x-ray system designed specifically to diagnose and guide the treatment of dysphagia, a swallowing disorder that is particularly prevalent among elderly populations and those with conditions like Alzheimer’s disease.
IMAGExRAY’s technology revolutionizes the traditional modified barium swallow study, the gold standard for dysphagia diagnosis, by reducing radiation exposure from over 3000 watts in hospital settings to just 80 watts, creating a compact unit that plugs into a standard wall outlet and is small enough to be transported to patients in skilled nursing facilities or even homes. This innovation addresses significant gaps in access and timing for patients, particularly during the COVID pandemic when many were unable to visit hospitals or imaging vans were barred from nursing homes.
The DiMarco’s explain the journey from concept to FDA approval and patenting, emphasizing the challenges of hardware innovation, regulatory approval, and finding suitable manufacturing partners. Interestingly, they discovered a strong demand for the device in academic and research medical environments, where it can be used as a teaching tool for future speech-language pathologists (SLPs) and doctors. The device’s software also enables automated scoring of physiological swallowing functions, providing immediate diagnostic support and reducing reliance on radiological reads.
They underscore the importance of listening to customers, collaborating with experts, and accessing support networks like SCORE and the SBA during product development and commercialization. The discussion closes with personal reflections on entrepreneurship, stressing the necessity of thinking big, surrounding oneself with capable experts, and persevering despite doubts and obstacles. The DiMarco’s anticipate expanding their technology to pediatric use and are enthusiastic about the potential life-saving impact of their device for vulnerable populations.
Key Insights
- Innovative Application of Existing Technology: IMAGExRAY took a well-established diagnostic technique (the modified barium swallow study) and transformed it by moving from analog to digital with ultra-low radiation doses, thereby creating a product that is safer, more portable, and easier to use. This kind of innovation, focused on improving accessibility and safety rather than developing a completely new technology, shows the potential of targeted reinvention in the medical device industry.
- Addressing Critical Access Gaps: The timing of the device’s conception—during the COVID-19 pandemic—highlighted major gaps in healthcare delivery, especially for vulnerable populations in skilled nursing facilities who were either isolated or had limited access to hospital-based diagnostics. By enabling on-demand testing in these facilities, IMAGExRAY not only improves patient care but potentially reduces morbidity caused by delayed diagnosis, such as aspiration pneumonia.
- New Revenue Streams for Nursing Facilities: IMAGExRAY’s business model anticipates skilled nursing facilities adopting x-ray technology to conduct modified barium swallow studies themselves, creating new revenue channels from a highly reimbursable Medicare procedure. This strategic insight aligns clinical value with financial incentives, improving buy-in for adoption in traditionally equipment-light facilities.
- Empowering Speech-Language Pathologists: The device and its software empower SLPs by providing real-time diagnostic imaging and automated scoring. This reduces dependence on radiologists and minimizes delays in care, allowing SLPs to make more informed treatment decisions immediately, which can directly translate to better patient outcomes.
- Unexpected Market Discovery in Academia: Initial assumptions about target customers—primarily skilled nursing facilities—shifted when universities and teaching hospitals expressed strong interest for the device as an educational tool. This demonstrates the critical importance of customer discovery and adaptability in startup product-market fit processes. Higher education institutions provide a steady market and credibility benefits for novel technologies.
- Challenges of Medical Device Development: The company’s experience highlights the complexity and time commitment involved in navigating regulatory and manufacturing pathways for medical devices. The FDA submission was a voluminous, highly technical document and the process took nine months, underscoring the need for specialist consultants, patience, and careful planning. Post-approval, ongoing compliance and manufacturing scalability remain key challenges.
- Entrepreneurial Mindset and Support Networks: The DiMarco’s stress mindset as a differentiator in innovation success: persistence, thinking big, and surrounding oneself with capable experts. They credit support from mentors, SCORE, and the SBA for guidance in overcoming barriers. Their story refutes myths that hardware innovation is too high barrier for startups, illustrating how strategic partnerships and external expertise enable success even for non-technical founders.
This comprehensive view of IMAGExRAY’s journey blends technological innovation, customer-centric discovery, strategic business planning, and regulatory navigation, offering valuable lessons for medical device entrepreneurship and healthcare innovation focused on underserved patient populations.
Stay up-to-date with Jacqui DiMarco, Steve Dimarco and the work they are doing at IMAGExRAY.
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