title: Pediatric medical device development by surgeons via capstone engineering design programs.
abstract: BACKGROUND
  There is a need for pediatric medical devices that accommodate the unique physiology and anatomy of pediatric patients that is increasingly receiving more attention. However, there is limited literature on the programs within children's hospitals and academia that can support pediatric device development. We describe our experience with pediatric device design utilizing collaborations between a children's hospital and two engineering schools.
  
  
  METHODS
  Utilizing the academic year as a timeline, unmet pediatric device needs were identified by surgical faculty and matched with an engineering mentor and a team of students within the Capstone Engineering Design programs at two universities. The final prototypes were showcased at the end of the academic year and if appropriate, provisional patent applications were filed.
  
  
  RESULTS
  All twelve teams successfully developed device prototypes, and five teams obtained provisional patents. The prototypes that obtained provisional patents included a non-operative ureteral stent removal system, an evacuation device for small kidney stone fragments, a mechanical leech, an anchoring system of the chorio-amniotic membranes during fetal surgery, and a fetal oxygenation monitor during fetoscopic procedures.
  
  
  CONCLUSIONS
  Capstone Engineering Design programs in partnership with surgical faculty at children's hospitals can play an effective role in the prototype development of novel pediatric medical devices.
  
  
  METHODS
  N/A - No clinical subjects or human testing was performed.
authors.affiliation: Department of Pediatric Urology, Boston Children's Hospital/Harvard Medical School, Boston, MA.
authors.forename: Bryan S
authors.initials: BS
authors.lastname: Sack
authors.affiliation: Division of Pediatric Urology, Department of Surgery, and the Scott Department of Urology, Texas Children's Hospital/Baylor College of Medicine, Houston, TX.
authors.forename: Rodolfo A
authors.initials: RA
authors.lastname: Elizondo
authors.affiliation: Division of Pediatric Urology, Department of Surgery, and the Scott Department of Urology, Texas Children's Hospital/Baylor College of Medicine, Houston, TX.
authors.forename: Gene O
authors.initials: GO
authors.lastname: Huang
authors.affiliation: Division of Pediatric Urology, Department of Surgery, and the Scott Department of Urology, Texas Children's Hospital/Baylor College of Medicine, Houston, TX.
authors.forename: Nicolette
authors.initials: N
authors.lastname: Janzen
authors.affiliation: Department of Obstetrics and Gynecology, Texas Children's Hospital/Baylor College of Medicine, Houston, TX.
authors.forename: Jimmy
authors.initials: J
authors.lastname: Espinoza
authors.affiliation: Department of Obstetrics and Gynecology, Texas Children's Hospital/Baylor College of Medicine, Houston, TX.
authors.forename: Magdalena
authors.initials: M
authors.lastname: Sanz-Cortes
authors.affiliation: Department of Obstetrics and Gynecology, Texas Children's Hospital/Baylor College of Medicine, Houston, TX.
authors.forename: Jennifer E
authors.initials: JE
authors.lastname: Dietrich
authors.affiliation: Division of Pediatric and Adolescent Gynecology, Departments of Surgery and Obstetrics and Gynecology, Texas Children's Hospital/Baylor College of Medicine, Houston, TX.
authors.forename: Julie
authors.initials: J
authors.lastname: Hakim
authors.affiliation: Division of Pediatric and Adolescent Gynecology, Departments of Surgery and Obstetrics and Gynecology, Texas Children's Hospital/Baylor College of Medicine, Houston, TX.
authors.forename: Eric S
authors.initials: ES
authors.lastname: Richardson
authors.affiliation: Oshman Engineering Design Kitchen, Department of Bioengineering, Brown School of Engineering, Rice University, Houston, TX.
authors.forename: Maria
authors.initials: M
authors.lastname: Oden
authors.affiliation: Department of Biomedical Engineering, Dwight Look College of Engineering, Texas A&M University, College Station, TX.
authors.forename: John
authors.initials: J
authors.lastname: Hanks
authors.affiliation: Department of Biomedical Engineering, Dwight Look College of Engineering, Texas A&M University, College Station, TX.
authors.forename: Balakrishna
authors.initials: B
authors.lastname: Haridas
authors.affiliation: Business Development and Planning Department, Texas Children's Hospital, Houston, TX.
authors.forename: James F
authors.initials: JF
authors.lastname: Hury
authors.affiliation: Division of Pediatric Urology, Department of Surgery, and the Scott Department of Urology, Texas Children's Hospital/Baylor College of Medicine, Houston, TX. Electronic address: cxkoh@texaschildrens.org.
authors.forename: Chester J
authors.initials: CJ
authors.lastname: Koh
mesh_terms: D002648:Child; D004738:Engineering; D004867:Equipment Design / Q000379:methods*; D005180:Faculty, Medical; D006776:Hospitals, Pediatric; D006801:Humans; D000071252:Mentoring; D010372:Pediatrics / Q000295:instrumentation*; D016730:Program Development; D013043:Specialties, Surgical / Q000295:instrumentation*; D066231:Surgeons; D014481:United States
keywords: Fetoscopic surgery; Medical devices; Obstetrical surgery; Pediatrics; Technological innovations; Urologic surgery