MedTech in Pediatric Care: From Idea to Certification

Can you imagine a pediatric healthcare today without MedTech solutions? Without a support of technology, both hardware and software? Why do they play a crucial role in disseminating and personalizing patient care, especially for the youngest ones? Children require a dedicated approach and specialized medical solutions that not only address their unique physical needs but also consider psychosocial aspects. This article aims to present a condensed guide to MedTech innovations in pediatric care – from conception to obtaining necessary certifications. The discussion will cover both technological and medical aspects, emphasizing the harmonious integration of these fields to create effective and safe solutions for the youngest patients.

Is the Idea Enough for MedTech in Pediatric Care?

The development of medical devices for diagnosing and treating children and adolescents must consider growth, psychosocial maturation, physiology, and pathophysiology, while avoiding inappropriate application of parameters tailored to adult patients. For example, in the field of cardiology diagnostics, it is necessary to consider different heart rate norms for young patients, which, like blood pressure, change with children’s growth. Digital platforms and medical devices must be able to cope with these changes and appropriately adjust the information provided to the doctor. The global pediatric healthcare market could reach a value of approximately 640 billion PLN by 2025, considering the 1.8 billion young people worldwide – making it an attractive area for development. 40% of the global population is under 24 years old, which creates significant future market opportunities in healthcare. Effective development of medical devices in pediatrics requires collaboration between different professional disciplines and organizations supporting financing, development, clinical research, certification, and commercialization of medical products. According to various sources, between 75 and 90% of MedTech innovations fail. Therefore, it is worth noting that just talking about the beautiful idea of innovation in MedTech is not enough; execution is key.

Stages of MedTech Development

The development of innovative MedTech solutions in pediatric care goes through several key stages, starting from conception and ending with advanced clinical tests. The initial stages, such as TRL 1 (Technology Readiness Level), focus on exploring concepts and assessing basic technological feasibility. Then, in stages TRL 2–4, the project goes through the design and verification process, considering increasingly complex technical aspects. As the project progresses, TRL 5–7 focuses on technology integration in a real-world environment, until complex clinical tests, and at levels TRL 8–9, transitioning to production and commercialization. Are there any measures that will help better understand how to effectively bring a product from the idea stage to commercialization, while maintaining the highest safety and efficacy standards, especially in the context of caring for the youngest patients?

Feasibility Study as a Set of Knowledge about a Medical Device

A medical device is a synergy of initial need, equipment, software, design, and the so-called human factor, which is inevitable for the use of a medical device. The latter element, in its own way, results from the previous ones and often determines whether a given device will achieve market success. Let’s remember that medical devices are evaluated by users, both professional and unqualified consumers. We want to have some form of “pleasure” in using them. Especially if we consider that we most often use medical devices out of necessity, not by choice. The importance of the feasibility study phase in the MedTech area is crucial for achieving the mentioned synergy and increasing the success of the product project. It is at this stage that decisions are made relevant to:

• Setting assumptions and requirements (at a lower cost than in later stages of development).
• Determining the schedule and costs of production.
• Conducting business tests of the medical device’s potential.
• Refining and iterating product concepts.
• Developing an efficient resource utilization plan in the product development process.
• Adapting to MDR/IVDR/CE/FDA/ISO requirements for effective market introduction.
• Creating the basis for preparing the production process.

This allows early detection of potential technical problems and the development of strategies to avoid them. Additionally, it enables determining the necessary resources, time, and costs to achieve project goals. Failure to conduct a proper feasibility analysis carries the risk of investing significant resources in projects that may ultimately not yield the expected results.

Tight integration of business, technological, and medical elements

In the key aspect of developing MedTech innovations in pediatric care, there is a need for a tight integration of business, technological, and medical elements – much like in almost any type of healthcare. Some duties and rights are universal and apply to all innovations. There are no shortcuts, although it would probably be a tempting vision. Harmonizing these three key areas with regulatory aspects and product user (and payer) friendliness determines its potential for commercialization. From a general perspective, we observe a significant shift in healthcare delivery approach. There is a move away from a hospital-centered approach towards a local or home environment, with an emphasis on support, integration of medical devices, and promoting self-care. This evolution will inevitably contribute to improving the quality of life for children with chronic diseases, allowing them more time for education and social integration, while reducing the number of days parents have to take off from work. This direction is achievable through the development of medical devices capable of performing complex functions, yet easy enough for unqualified users to operate.

Medical Device Certification Strategy

The certification process plays a crucial role in ensuring the safety, efficacy, and regulatory compliance of innovative MedTech solutions in pediatric care. What barriers might we encounter before a medical device reaches the commercialization stage? Although there are many differences between medical devices for adults and children, in the European MDR regulations, nor in key harmonized standards, there are no specific requirements regarding safety/biocompatibility assessment of medical devices for children. The special mention of children and minors only concerns the presence of CMR substances (carcinogenic, mutagenic, or toxic to reproduction) and/or substances disrupting the functioning of the hormonal system in medical devices in connection with specific treatment methods or labeling of products. Medical device certification should remain at the top of the priority list, considering Quality Management System certification and obligations arising from standards specified by MDR and CE regulations.

Why is MedTech in pediatric care an attractive area for startups?

MedTech in pediatric care is an incredibly attractive area for startups for several key reasons. Firstly, the dynamic development of technology opens up new opportunities for creating innovative solutions specifically for children. Sensitivity to the unique medical and psychological needs of the youngest patients generates demand for creative and user-focused products. Secondly, the pediatric care market is an area where there is a significant gap in access to advanced technologies. Startups have the chance to fill these gaps by offering modern, effective, and safe solutions, improving the quality of care for children. Thirdly, certification processes in pediatric care, though demanding, can serve as a kind of protection for startups, as obtaining certification confirms the high standard of product safety and efficacy. This increases trust among both patients and business partners. Additionally, the rapid growth of the MedTech market for children and support from governmental institutions and health organizations create favorable conditions for the growth and expansion of startups in this sector. Ultimately, the combination of technological potential, societal need, and support for innovation makes MedTech in pediatric care a fascinating field for entrepreneurs with passion and commitment to improving the health of the youngest.

Summary

I had the pleasure of talking with founders who have great ideas regarding children’s health. For many of them working on medical technologies, the relative lack of innovation in pediatric and neonatal care presents an opportunity. Integrating innovative technologies into caring for sick children requires a comprehensive approach, considering various models supporting technological development. Financing models, hardware and software technologies, feasibility studies, and medical regulations – all these elements form a comprehensive structure that may not always accelerate the development process of modern medical tools at first glance, but makes working on them a responsible process and allows for a holistic approach to technology implementation in pediatric care.

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Sources:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8706877/#B6-pharmaceutics-13-02178
https://theypfoundation.org/campaigns/1-8-billion-campaign/
https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745
Chamley C., Carson P., Randall D., Sandwell W. Developmental Anatomy and Physiology of Children – A Practical Approach. 1st ed. Elsevier Churchill Livingstone; London, UK: 2005.