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Pediatric medical device development by surgeons via capstone engineering design programs
Bryan S Sack1, Rodolfo A Elizondo2, Gene O Huang2
1Department of Pediatric Urology, Boston Children's Hospital/Harvard Medical School, Boston, MA.
Insights
Collaborations between children's hospitals and engineering schools effectively develop novel pediatric medical devices. Capstone Engineering Design programs successfully created prototypes, with some securing provisional patents, addressing unmet pediatric needs.
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.
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.
