Correlation of Ease-of-Use to Evaluation Trial Conversion, Customer Retention, and User Complaints for the Adoption of a Novel Surgical Device

摘要

Stainless steel stapling to close a surgical patient's skin has been a fast alternative to suturing since the introduction of sterile metal skin staples in the 1960-70 s. Metal skin staplers grew to be a commodity in the operating room as a common user technique emerged across many undifferentiated models. The 2005 introduction of a bioabsorbable poly-Lactide/poly-Glycolide staple that captures symmetric bites of subcuticular tissue from within an incision required early-adopting clinicians to learn a similar, but not identical, user technique. The subcuticular placement of the INSORB staple meant new users could not see the modality's staple-to-staple spacing as they could for percutaneous metal skin staples. Without the final visual confirmation of placement and spacing, many early users were uncertain on how to judge their first experience. The 2009-10 refinement of the stapler's human factors to provide more certainty of correct use was a critical milestone to move past early adopters into the early majority [1] on the technology adoption curve.