Literature DB >> 28196661

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

Bryan S Sack1, Rodolfo A Elizondo2, Gene O Huang2, Nicolette Janzen2, Jimmy Espinoza3, Magdalena Sanz-Cortes3, Jennifer E Dietrich3, Julie Hakim4, Eric S Richardson4, Maria Oden5, John Hanks6, Balakrishna Haridas6, James F Hury7, Chester J Koh8.   

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. LEVELS OF EVIDENCE: N/A - No clinical subjects or human testing was performed.
Copyright © 2017 Elsevier Inc. All rights reserved.

Entities:  

Keywords:  Fetoscopic surgery; Medical devices; Obstetrical surgery; Pediatrics; Technological innovations; Urologic surgery

Mesh:

Year:  2017        PMID: 28196661      PMCID: PMC5545169          DOI: 10.1016/j.jpedsurg.2017.01.067

Source DB:  PubMed          Journal:  J Pediatr Surg        ISSN: 0022-3468            Impact factor:   2.545


  12 in total

1.  Pediatric cardiac devices--an FDA pediatrician's perspective of the challenges and potential solutions.

Authors:  Francesca Dolcimascolo
Journal:  J Cardiovasc Transl Res       Date:  2009-03-13       Impact factor: 4.132

Review 2.  Fetal membrane healing after spontaneous and iatrogenic membrane rupture: a review of current evidence.

Authors:  R Devlieger; L K Millar; G Bryant-Greenwood; L Lewi; J A Deprest
Journal:  Am J Obstet Gynecol       Date:  2006-05-08       Impact factor: 8.661

3.  Pathways to approval of pediatric cardiac devices in the United States: challenges and solutions.

Authors:  Robert H Beekman; Brian W Duncan; Donald J Hagler; Thomas K Jones; John D Kugler; John W Moore; Kathy J Jenkins
Journal:  Pediatrics       Date:  2009-07       Impact factor: 7.124

4.  Health services innovation: the time is now.

Authors:  Barry Zuckerman; Peter A Margolis; Kedar S Mate
Journal:  JAMA       Date:  2013-03-20       Impact factor: 56.272

5.  FDA's pediatric device consortia: national program fosters pediatric medical device development.

Authors:  Linda C Ulrich; Francesca D Joseph; Debra Y Lewis; Robert L Koenig
Journal:  Pediatrics       Date:  2013-04-08       Impact factor: 7.124

6.  Regulation of medical devices in the United States and European Union.

Authors:  Daniel B Kramer; Shuai Xu; Aaron S Kesselheim
Journal:  N Engl J Med       Date:  2012-02-14       Impact factor: 91.245

7.  Off-label use of pediatric orthopaedic devices: important issues for the future.

Authors:  Evan D Sheha; Qusai Hammouri; Brian D Snyder; Robert M Campbell; Michael G Vitale
Journal:  J Bone Joint Surg Am       Date:  2014-02-05       Impact factor: 5.284

8.  Medicinal Leech Therapy: Friend or Foe.

Authors:  Marcia Spear
Journal:  Plast Surg Nurs       Date:  2016 Jul-Sep

Review 9.  Clinical trials in children.

Authors:  Pathma D Joseph; Jonathan C Craig; Patrina H Y Caldwell
Journal:  Br J Clin Pharmacol       Date:  2015-03       Impact factor: 4.335

10.  Anaesthesia for fetal surgeries.

Authors:  Kirti N Saxena
Journal:  Indian J Anaesth       Date:  2009-10
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  2 in total

1.  Advancing pediatric medical device development via non-dilutive NIH SBIR/STTR grant funding.

Authors:  Raphael C Sun; Ishan Kamat; Achu G Byju; Matthew Wettergreen; Michael J Heffernan; Richard Willson; Balakrishna Haridas; Chester J Koh
Journal:  J Pediatr Surg       Date:  2021-01-25       Impact factor: 2.549

2.  Factors Influencing Private Hospitals' Participation in the Innovation of Biomedical Engineering Industry: A Perspective of Evolutionary Game Theory.

Authors:  Weiwei Liu; Jianing Yang; Kexin Bi
Journal:  Int J Environ Res Public Health       Date:  2020-10-13       Impact factor: 3.390

  2 in total

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