"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" Blacker et al (2026).

Short peripheral intravenous catheter dislodgement

Abstract:

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.


Reference:

Blacker C, Guarienti Missima N, Ljungman G, Frykholm P. Need-Based Innovation: From Idea to Evidence in Vascular Access. J Infus Nurs. 2026 Sep-Oct 01;49(5):261-268. doi: 10.1097/NAN.0000000000000651. Epub 2026 Aug 25. PMID: 42695517.