On July 9, 2025, the Midwest Pediatric Device Consortium (MPDC) convened its second annual showcase at the MidTown Collaboration Center in Cleveland, Ohio. This meeting brought together clinicians, engineers, regulators, entrepreneurs, and policy stakeholders to address the specific challenges and opportunities inherent in pediatric medical device development. The program featured a series of expert panel discussions that culminated in a pitch competition focused specifically on Software as a Medical Device (SaMD). The proceedings provide a descriptive summary of the event and synthesize the key themes that emerged from the collaborative discussions among these diverse stakeholders.
The MPDC is one of five Pediatric Device Consortia funded by the US Food and Drug Administration (FDA) to support the development, regulatory advancement, and clinical adoption of pediatric medical devices. Founded in 2023, the consortium operates as a multi-institutional collaboration among pediatric hospitals, academic institutions, and regional innovation organizations within Ohio. Participating institutions include Nationwide Children’s Hospital, The Ohio State University, Cincinnati Children’s Hospital, and Cleveland Clinic Children’s Hospital. These partners contribute complementary expertise in pediatric clinical care, engineering design, outcomes research, regulatory science, and technology commercialization to address known barriers in the field.
The consortium employs a structured intake and review process to assess pediatric medical device concepts and companies, utilizing a centralized digital platform to support proposal evaluation and advisory matching. Since its inception, the MPDC has engaged more than 150 advisors and reviewed project applications encompassing a wide array of pediatric clinical domains. Early outcomes associated with MPDC activities include the progression of supported projects to feasibility testing, preclinical development, regulatory engagement, and federal small-business innovation research funding. More than 50 projects from across the country have received targeted technical, regulatory, or commercialization support, with over $1 million in pediatric device development funding awarded or facilitated since program initiation.
The opening panel discussion focused on demonstrating value in healthcare, featuring professionals across the innovation lifecycle who shared perspectives on bringing products into hospital systems. Panelists represented viewpoints from hospital innovation programs, clinical care, and startup leadership, emphasizing that value extends beyond clinical efficacy to include economic impact, scalability, workflow integration, and patient safety. Health care systems increasingly rely on formal value analysis processes, requiring innovators to demonstrate measurable improvements in outcomes, efficiency, and costs. From a clinical perspective, usability, safety, and patient outcomes were identified as non-negotiable qualifications for adoption, particularly in the neonatal and pediatric spaces.
Entrepreneurial perspectives highlighted the importance of understanding payer incentives and reimbursement strategies early in the development process. Examples were provided to demonstrate that early supply chain involvement and addressing reimbursement considerations are essential for successful commercialization. Whether innovating in neonatology or maternal health, value in healthcare is multidimensional, requiring that it be clinically meaningful, economically justified, logistically feasible, and emotionally trustworthy. Panelists noted that successful adoption requires alignment among clinicians, administrators, payers, and patients, with clear articulation of clinical benefit and operational feasibility.
The second panel examined how advances in data infrastructure, artificial intelligence (AI), and real-world evidence (RWE) are reshaping post-market surveillance for medical devices. Panelists noted a shift from traditional, reactive surveillance models toward more proactive approaches that leverage continuous data streams and real-world performance monitoring. Existing post-market surveillance frameworks were largely designed for static devices and may be poorly suited for software-based and AI-enabled technologies that evolve over time. Device performance and safety cannot be interpreted without attention to clinical and operational context, as changes in staffing models, clinical workflows, or data input quality may substantially influence real-world device behavior after deployment.
Pediatric-specific challenges were a central focus of the post-market surveillance discussion, with panelists noting that small patient populations, rare conditions, and rapid developmental changes limit the usefulness of single-institution datasets. These constraints increase the importance of multi-institutional collaboration and data aggregation to improve signal detection and safety assessment for pediatric devices. Participants underscored the need to ensure that surveillance efforts intentionally include pediatric populations, which are often underrepresented in post-market data sources. Partnerships among manufacturers, academic medical centers, health systems, and commercial data providers were described as increasingly important for enabling scalable post-market studies and maintaining methodological rigor.
The third panel addressed the increasing importance of data protection and cybersecurity in the development and deployment of digital health technologies. Panelists brought perspectives from device development, health system cybersecurity, software architecture, and risk management, emphasizing that cybersecurity is a foundational component of patient safety and system trust. Early-stage companies and clinical innovators often underestimate both the scope and cost of cybersecurity requirements, particularly as devices become more interconnected and reliant on cloud-based infrastructure. Beyond device engineering, attention must be given to data privacy, interoperability with electronic health records, remote connectivity, and user authentication, each of which introduces potential vulnerabilities in complex healthcare environments.
The panel also addressed the concept of shared responsibility in cybersecurity, cautioning that while cloud service providers offer baseline security infrastructure, responsibility for application-level security and regulatory compliance remains with device developers and deploying institutions. Contractual agreements were identified as an often-overlooked source of cyber risk, with warranties, indemnification clauses, and breach notification requirements having significant operational and financial implications. Planning for failure was presented as a central principle of effective cybersecurity strategy, with panelists stressing that breaches and system failures should be assumed rather than treated as unlikely events. Pediatric data are particularly sensitive to security concerns due to their longitudinal nature and the involvement of minors, increasing the ethical and regulatory stakes of data protection failures.
The fourth panel focused on the practical challenges of translating algorithms and software innovations into clinically deployed medical devices. Panelists represented expertise in software development, AI, and medical device commercialization, offering perspectives on balancing rapid innovation with regulatory, operational, and safety requirements. Discussion emphasized the importance of disciplined product development in regulated healthcare environments, noting that while AI and modern software tools have lowered technical barriers to prototyping, successful translation requires careful prioritization of core functionality. Early-stage teams were encouraged to focus on a limited set of features that address clearly defined clinical needs rather than pursuing broad or complex feature sets that may complicate validation and regulatory review.
A central theme of the algorithm translation discussion was the critical role of workflow and user-centered design in healthcare systems. Panelists highlighted that healthcare systems operate with diverse clinical workflows, IT constraints, and stakeholder roles, and failure to understand these workflows early can lead to usability challenges, safety risks, and barriers to adoption. Mapping interactions across multiple personas, including clinicians, patients, caregivers, IT teams, and administrators, was identified as essential for aligning product design with real-world clinical environments. Security considerations were described as increasingly intertwined with algorithm development and deployment, with the integration of AI and cloud-based services introducing new risk surfaces that extend beyond traditional device boundaries.
The final panel addressed pediatric-specific considerations in medical device innovation and the operational realities of sustaining pediatric-focused development efforts. Discussion highlighted that pediatric medical device development is constrained by small market sizes, heterogeneous patient populations, and limited availability of venture capital. Pediatric-specific startups receive a disproportionately small share of private investment, creating reliance on non-dilutive funding sources and public–private partnerships to support early-stage development. Regulatory funding caps and administrative requirements were described as additional constraints that shape programmatic decision-making, while substantial administrative, legal, and compliance work is required to support pediatric device development, much of which is not visible to external stakeholders.
The MPDC showcase included a pitch competition featuring eight MPDC-engaged pediatric medical device companies, with a focus on software-based medical technologies. The participating companies reflected a diverse range of pediatric clinical applications, including neonatal care, pain management, cardiology, metabolic disorders, neurology, sleep medicine, and oncology. Each company presented its innovation to an audience comprising clinicians, health system representatives, service providers, and investors, with awards up to $30,000 allocated based on audience ranking. Rekovar presented a neonatal intensive care monitoring platform that integrates wearable, non-invasive sensors with audio and video monitoring and AI-based analytics to support automated symptom scoring and clinical decision-making.
Other notable presentations included AngelEye Healthcare, which described efforts to expand its neonatal monitoring ecosystem through AI-enabled video analysis and pressure-sensitive sensing technologies aimed at detecting clinically relevant movement and neurological patterns in infants. OpalGenix presented a software-based decision support platform that incorporates pharmacogenetic data, clinical risk factors, and AI algorithms to guide personalized opioid prescribing across pediatric and adult populations. Atrility Medical described a device that integrates with surgical pacing wires to provide high-fidelity atrial waveform data, supporting improved arrhythmia detection without disrupting existing workflows. Kilele Health presented a wearable biosensor platform based on aptamer technology for continuous, real-time measurement of biochemical markers, initially focused on phenylketonuria with planned expansion to additional conditions.
Additional presentations included a virtual reality-based concussion detection platform from NEOMED, which combines immersive testing with sensor data capture and machine learning-based diagnostics to provide objective concussion assessment without requiring baseline testing. Seluna Ltd presented a machine learning-based software platform for automated analysis of sleep study data to support diagnosis, severity classification, and treatment planning for pediatric sleep apnea. GRAIMED described an AI-driven decision support platform integrating imaging and genomic data to improve diagnostic accuracy and reduce invasive procedures in pediatric oncology, with potential applications including surgical planning and clinical trial matching. Following the pitch presentations, audience members ranked the companies based on perceived readiness and impact, with Kilele Health receiving first place and $30,000, Atrility Medical receiving second place and $20,000, OpalGenix receiving third place and $10,000, and GRAIMED receiving fourth place and $7,500.
In addition to direct financial awards, the MPDC described plans to provide structured post-showcase support to participating companies through an affiliated accelerator framework. Companies not receiving monetary awards were offered tailored advisory and technical assistance focused on regulatory strategy, clinical validation planning, reimbursement considerations, and commercialization readiness. This support will leverage the MPDC’s existing advisory network and partner organizations to provide time-limited, milestone-driven engagement aimed at addressing gaps identified during the evaluation process. Panelists emphasized that this approach is intended to extend the impact of the showcase beyond one-time funding decisions by supporting continued project maturation and increasing readiness for downstream investment, regulatory engagement, or clinical adoption.
MPDC engagement reflects substantial participation from pediatric medical device innovators, regional industry partners, and commercialization stakeholders. Since inception, the MPDC reviewed more than 330 project submissions and processed over 110 applicants through its funding and evaluation mechanisms. Utilizing its centralized deal-flow database and matchmaking infrastructure, MPDC facilitated coordinated engagement among approximately 80 companies and 150 advisors spanning regulatory, engineering, clinical, and business expertise. More than 50 projects have received individualized technical, regulatory, or commercialization support, and over $1 million in funding has been deployed or facilitated to advance pediatric device development by the MPDC from its inception through the end of 2025.
Early translational indicators include the progression of supported projects to feasibility testing, advancement of small-business grant proposals, and early-stage regulatory interactions. Regional symposia and educational convenings have served as catalysts for cross-institutional collaboration, connecting device developers with clinical champions, translational engineers, and potential investment partners. Collectively, these activities have broadened engagement with pediatric device innovation in the Midwest and enhanced the capacity of startups and clinical innovators to access expertise critical to advancing pediatric medical technologies. The proceedings are intended to inform clinicians, innovators, and policymakers engaged in pediatric medical device development rather than serve as a formal program evaluation.
Subject of Research: Proceedings of the 2025 Midwest Pediatric Device Consortium showcase focusing on software as a medical device
Article Title: Proceedings from the 2025 Midwest Pediatric Device Consortium showcase featuring software as a medical device
Article References: Echelmeyer, N., Noll, M., Tandon, A., Eckmann, D. M., & Criss, C. N. (2026). Proceedings from the 2025 Midwest Pediatric Device Consortium showcase featuring software as a medical device. BMC Proceedings, 20(S21), Article 22. https://doi.org/10.1186/s12919-026-00379-z
Image Credits: AI Generated
DOI: 10.1186/s12919-026-00379-z
Keywords: pediatric medical devices, software as a medical device, Midwest Pediatric Device Consortium, FDA, post-market surveillance, cybersecurity, artificial intelligence, real-world evidence, device commercialization, pediatric innovation, Proceedings, Midwest
News Source: Harold Sullivan. (November 7, 2026). Pediatric Device Showcase Highlights Software Medical Innovations. Scienmag.
