Excerpt
Are we truly upholding the notion that our children are the most valuable good of our society? One could argue that the lack of adequate medications and medical devices designed specifically for them tells a different story. I distinctly remember being taken aback during a company summit a few years ago when a board member made a startling statement to the entire audience: "We have no interest in funding research for children." It is unfortunate that health-care businesses, both pharmaceutical and medical device companies, do not consider sick children a lucrative market. Fortunately, childhood cancer is a rare disease, further diminishing the profit potential. The authors of a thought-provoking paper [
1] echo what has been discussed in the previous publications, revealing that off-label use accounts for as much as 75% and 79% of medical devices and medications, respectively (with up to 35% of medications being unlicensed!) [
1‐
3]. While there is a lack of data on the use of unlicensed medical devices in pediatric practice, it would not be surprising if the numbers were similarly alarming, if not higher. Merely downsizing existing devices will not suffice in most cases, as the size of implantable devices may not align with the evolving organs of growing children. So, how can we tackle this issue? There is no easy answer, but both the FDA and the EU are making efforts to address and alleviate the situation [
4,
5]. The FDA has established Pediatric Device Consortia, which brings together experts from various fields, including clinicians, engineers, and researchers, to promote the development and accessibility of medical devices for children. Additionally, the FDA encourages medical device manufacturers to consider pediatric populations during the development and testing phases [
4]. Similarly, the EU, through the Medical Device Regulation (MDR), has incorporated provisions for medical devices intended for pediatric use and has supported the European Network of Pediatric Research at the European Medicines Agency (Enpr-EMA) to generate high-quality evidence for pediatric medical devices. However, further measures are necessary to truly address this pressing issue. The authors suggest that in the near future, regulatory bodies should streamline their processes to allow pediatric interventional radiologists to utilize medical devices off-label for high-volume, low complexity cases without facing legal repercussions in the event of complications. In the long run, the authors express their desire for medical device companies to collaborate with the increasing number of pediatric interventional radiologists worldwide, aiming to conduct research and develop a wider range of medical devices explicitly approved for use in children [
1]. But more measures need to be considered, the ability to use large registries to provide clearance and include in the IFU of the devices its use in children is a possibility. The approval of processes more than devices themselves like in bioabsorbable implantable devices could also help, artificial intelligence can contribute to the development of personalized medical devices that are tailored to children´s unique characteristics, such as anatomy, genetics, weight, and other relevant consideration. These approaches can improve treatment outcomes and patient satisfaction. But the final answer must come from a common effort from regulatory parties, private companies, public entities, and health-care providers and obviously be compliant with the ethics. …
