Journal of infusion nursing : the official publication of the Infusion Nurses Society · 2026
Need-Based Innovation: From Idea to Evidence in Vascular Access.
СтатьяНазвание и аннотация: Перевод в очереди
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Blacker Christopher, Guarienti Missima Nathalia, Ljungman Gustaf, Frykholm Peter
Аннотация
OBJECTIVE: The objective of this study was to describe the Biodesign methodology and its application in developing and evaluating a new medical device to reduce short peripheral intravenous catheter dislodgement.
METHODS: First, the Stanford Biodesign method, a systematic process for designing new medical technologies, was presented in six detailed steps. Second, examples from a recently published randomized clinical trial were used to illustrate how Biodesign can be applied to identify unmet needs in vascular access, generate concepts, and validate a solution.
RESULTS: The resulting product from the Biodesign process was a type of force-activated separation device (FASD). The trial of the FASD demonstrated a 73% relative risk reduction in short peripheral intravenous catheter dislodgement in the intervention group compared with the control, with no device-related adverse events. Other complication rates remained unchanged.
CONCLUSIONS: The Biodesign methodology offers a systematic approach to innovation in infusion therapy. The FASD case illustrates how need-driven design and evidence generation can produce clinically meaningful solutions.
METHODS: First, the Stanford Biodesign method, a systematic process for designing new medical technologies, was presented in six detailed steps. Second, examples from a recently published randomized clinical trial were used to illustrate how Biodesign can be applied to identify unmet needs in vascular access, generate concepts, and validate a solution.
RESULTS: The resulting product from the Biodesign process was a type of force-activated separation device (FASD). The trial of the FASD demonstrated a 73% relative risk reduction in short peripheral intravenous catheter dislodgement in the intervention group compared with the control, with no device-related adverse events. Other complication rates remained unchanged.
CONCLUSIONS: The Biodesign methodology offers a systematic approach to innovation in infusion therapy. The FASD case illustrates how need-driven design and evidence generation can produce clinically meaningful solutions.