Commercialization Readiness Pilot for A Comprehensive Platform for Pediatric Cranial Evaluation

ABSTRACT Delayed identification of infant head conditions is causing unnecessary medical complications and societal costs. A critical challenge in early detection is the absence of tools available to pediatric providers and parents to perform quantitative head shape assessment. Delays in diagnosis limit the opportunity for early, less invasive, and effective treatment options. In this CRP project, PediaMetrix Inc. has joined forces with four other organizations providing expertise in regulatory, reimbursement, marketing, and intellectual property to package previously developed technologies into SoftSpot TotalCareTM, and make it ready for commercialization. SoftSpot TotalCareTM will be the first mobile digital tool that will create a partnership between primary care providers, parents, and specialists, enabling 2D and 3D data collection and analysis of infant cranial malformations for measurements, monitoring, treatment planning, and follow-ups. Head malformations during infancy can be synostotic (i.e., craniosynostosis) or nonsynostotic (such as deformational plagiocephaly and brachycephaly or DPB). Both types of conditions require immediate attention and benefit from early treatment to avoid long-term health complications. The prevalence of DPB increased dramatically in recent years, from 5% to approximately 20%-30%, causing the condition to be called a pediatric epidemic. Craniosynostosis is less common, affecting 1 in 2,000 children. To improve the early management of these conditions and to prevent more complex treatment and associated morbidities, it is essential to monitor the head growth. To address this unmet clinical need, we are developing and evaluating a mobile digital tool that will enable providers and parents to capture data using a smart device and receive reports for early diagnosis and management of cranial malformations. In this project, we will determine and execute the regulatory and reimbursement pathways for several different components of SoftSpot TotalCareTM. We will use machine learning methods to perform automated data quality checks at the point-of-care immediately after the data collection to enable accurate and automatic measurement. Additionally, we will collect solution validation marketing surveys and feedback from pilot users to develop product features that accelerate the adoption of this new technology by pediatric providers and assess feasibility of using the 3D technology for other bodily deformities. The overall mission of PediaMetrix is to provide accurate decision support tools for pediatric health. This will be achieved through artificial intelligence and quantitative imaging algorithms that in combination with smartphone technological advances will be packaged as mobile digital health solutions accessible to pediatric health providers at any time and location. Successful demonstration of SoftSpot TotalCareTM will lead to a significant reduction of the number of children left with untreated head conditions in addition to lowering the associated healthcare costs and social anxiety.