Available online 9 February 2026, 151585

Author links open overlay panelAnjali D. DeshmukhShow moreAbstract

Surgical innovation can improve patients’ lives yet untested procedures can pose serious risks, especially for children. Clear ethical guidelines and responsible oversight are essential to determine when and how pediatric surgical innovation should safely proceed. However, distinguishing ethically permissible clinical adaptation from innovation benefiting from additional review presents definitional challenges, creating a regulatory “grey zone.” This Article reviews how courts, federal agencies, state legislatures, and private regulators shape the regulation of surgical innovation, with a focus on challenges unique to pediatric surgery. Well-designed surgical innovation committees offer a practical governance mechanism to protect pediatric patients, promote responsible innovation, and provide clinicians with clearer guidance, particularly when committee composition intentionally integrates surgical, clinical, ethical, and caregiver perspectives.

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Access through your organizationSection snippetsWhat is surgical innovation?

Surgical innovations can potentially transform patient outcomes, and untested procedures pose serious risks. Responsible surgical innovation must be appropriately regulated to advance the standard of care, with vigilant attention to patient safety, transparency, and evidence-based practice, especially for children and vulnerable populations.1 Improved understanding of the ethical and legal frameworks governing pediatric surgical innovation may enhance protections for pediatric patients while

Regulating grey zone innovation

Grey-zone surgical innovation is indirectly shaped by state and federal agencies, courts, state legislatures, and private actors in at least five ways. First, state boards of medicine set the training and licensure requirements for practicing surgery, limiting who is legally able to innovate. They also take disciplinary actions against surgeons whose innovations fall outside acceptable variations of the standard of care.14,18 Private physician associations, such as national boards of medicine,

Challenges of pediatric surgical innovation

In pediatrics, persistent research gaps can make grey zone surgical innovation a necessary gamble.18,31 There are well-recognized global disparities in pediatric surgical research.32 Children participate in and have fewer opportunities to participate in clinical trials, leading to less high-quality evidence and limited statistical significance.7,33,34 Pediatric trials constitute only 20% of the total number of trials registered in the National Institutes of Health clinical trials registry, of

Author information

Anjali D. Deshmukh, MD, JD is a board-certified primary care pediatrician and a associate professor of law at Seton Hall University School of Law in Newark, New Jersey.

Declaration of competing interest

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

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