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The project has published a report, coordinated by EIT Health Spain, which analyses the state of pediatric innovation and includes recommendations to boost the pediatric and maternal health innovation sector in Europe.
The i4KIDS- EUROPE project, coordinated by SJD Barcelona Children’s Hospital, has just presented the report, “Challenges and Opportunities for Effective Pediatric Innovation in Europe”. The report examines the current state of innovation in pediatrics, highlighting challenges and opportunities, and proposing concrete measures to drive development of specific solutions for maternal and child populations.
The report shares the results of extensive research including questionnaires, interviews and workshops with prominent fetal, pediatric and maternity health professionals, research institutions, the business sector (SMBs, startups, large businesses), patient associations and institution representatives from 16 European countries.
Analysis has revealed the barriers hindering the development and adoption of specific pediatric innovations including financial, business, human resource and cultural barriers, policy and regulatory issues, and problems with infrastructure, covering how these barriers vary in different countries.
The majority of medical devices are not designed and validated for use in those under the age of eighteen.
Main barriers to pediatric innovation
50% of drugs used in pediatrics are used outside their approved indication, age, dose or route
The absence of formulations, dosage and studies specifically designed for children means that almost half the drugs used in pediatrics are not specifically approved for this population group. In neonatal intensive care units, this figure rises to 90%, reflecting virtually complete dependence on adjusting treatment formulated for adults.
This makes accurate dosing difficult, increasing the risk of side effects or ineffective drug treatment. The risk of toxicity and side effects is also increased as the absorption of medication in children differs significantly from that of adults, even more so in neonates, who are particularly vulnerable due to their physiological immaturity.
Devices designed for adult bodies
Medical staff must often adapt pacemakers, cannulas and surgical equipment designed for adults, to be able to use them in pediatric patients. This practice increases the risk of complications as proportions, materials and functionality are not optimised for a child’s body. These modifications can also compromise clinical outcomes by not providing the same level of accuracy, efficacy and safety as devices specifically designed for children.
An opportunity to invest in a market demanding more pediatric solutions
Only 1.6% of the venture capital investment in healthcare is allocated to projects related to pediatrics, a surprisingly low percentage considering that children represent 25% of the current world population. Comparatively, projects for adults seize the majority of funds due to their larger potential market, although this is not in line with the market’s real needs.
In Europe, the majority of calls for public funding are still targeted at conditions prevalent in adults, development of startups dedicated to pediatrics is not encouraged.
Regional inequalities
The majority of financial, human and technological resources are concentrated in countries with advanced innovation ecosystems such as Germany, France or the Netherlands. In contrast, moderate and emerging regions especially in Southern and Eastern Europe face a lack of infrastructure, funding, and collaborative networks, limiting the advancement of pediatric innovation. These disparities perpetuate a fragmented system where advances are not shared equitably
This reduces the overall efficiency of the European pediatric innovation ecosystem and limits access to innovative treatment and personalised technology for children in less advanced regions.
Proposals include increasing public and private investment, easing regulations, facilitating the adoption of innovation, and supporting the creation of pediatric innovation infrastructure in hospitals.
Key actions to boost pediatric innovation
The i4KIDS-EUROPE report aims to reveal the deficiencies in pediatric and maternal health and promote their inclusion in the European agenda, using successful cases from different countries as models to adapt or generate new solutions.
In the area of funding, it emphasises the need to increase both public and private investment, earmarking specific resources for pediatric projects in European programs and introducing tax incentives to promote business participation. In addition, it proposes the creation of interim funding mechanisms to allow promising projects to continue once initial funds have been exhausted, as well as a change in investors’ mindset towards a more social-impact driven approach rather than immediate financial return.
In respect of the regulatory environment, it recommends making legal frameworks more flexible using tools to facilitate supervised research in pediatric developments, whilst simultaneously reviewing and updating existing regulations to prioritise treatments targeted at childhood diseases.
To improve the commercialisation and adoption of innovation, measures are proposed to reduce barriers to entering the market, especially for startups and small businesses. This also underlines the importance of reinforcing public and private sector collaboration.
In terms of human resources and infrastructure, the report emphasises the need for an internal innovation team in hospitals, dedicated to pediatric innovation to address the unmet needs of patients.
The document also highlights the importance of raising awareness of pediatric and maternal innovation through the creation of digital platforms which centralise information on funding opportunities for projects and success stories.
Transform pediatric innovation
Arnau Valls, director of i4KIDS and coordinator of i4KIDS-EUROPE, emphasises, “Investing in child health is not only an ethical necessity, but also a key strategy to secure the future of our society. This report represents a crucial step towards highlighting existing gaps and ensuring that all children in Europe have access to the healthcare they deserve”.
The document has been coordinated by EIT Health Spain, which forms part of the European Institute of Innovation and Technology (EIT), a European Union organisation, and has been developed in the i4KIDS-EUROPE project framework. Their objective is to stabilise a European ecosystem of inclusive and effective pediatric innovation and to stimulate competition and European economic growth in the area of pediatric innovation.
This consortium brings together eight multidisciplinary European institutions: SJD Barcelona Children's Hospital, the Institut de Recerca Sant Joan de Déu, Helsinki University Hospital (HUS), K.I.D.S. Foundation Children's Hospital Innovators Club, Poland, EIT Health Spain, the Inveniam Group, Children's Clinical University Hospital, Latvia and Region H Mary Elizabeth's Hospital, Denmark.
"The i4KIDS-EUROPE project represents a unique opportunity to transform the panorama of pediatric innovation in Europe, dealing with one of the most neglected areas in the field of health. There is an urgent need for specific solutions for children’s health and this project offers visibility of the most disruptive innovation in this area”, Izabel Alfany, Managing Director of EIT Health Spain.
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