Pediatric medical device development by surgeons via capstone engineering design programs.

Area of Science:

• Biomedical Engineering
• Pediatric Device Innovation
• Medical Device Design

Background:

• Growing attention on pediatric patient physiology necessitates specialized medical devices.
• Limited literature exists on academic and children's hospital programs supporting pediatric device development.
• This study details a collaborative approach between a children's hospital and two engineering schools for pediatric device design.

Purpose of the Study:

• To describe the experience of pediatric device design through interdisciplinary collaboration.
• To evaluate the effectiveness of Capstone Engineering Design programs in developing pediatric medical devices.

Main Methods:

• Unmet pediatric device needs were identified by surgical faculty within a children's hospital.
• Student teams in Capstone Engineering Design programs at two universities were matched with mentors and needs.
• Prototypes were developed over an academic year, with provisional patent applications filed for promising devices.

Main Results:

• All twelve student teams successfully developed device prototypes.
• Five prototypes secured provisional patents, including innovative solutions for ureteral stent removal, kidney stone fragment evacuation, fetal surgery, and fetal monitoring.
• The developed prototypes addressed specific unmet needs in pediatric care.

Conclusions:

• Capstone Engineering Design programs, in partnership with children's hospital surgical faculty, are effective in prototyping novel pediatric medical devices.
• This collaborative model fosters innovation and addresses critical gaps in pediatric medical technology.
• The program demonstrates a viable pathway for translating clinical needs into tangible device concepts.