MedTech Outlook Magazine: Specials Magazine

Recently, in a New England hospital, as a surgical team completed a lengthy procedure, the lead surgeon prepared to close the incision - not with metal staples or traditional sutures, but with a compact, next-generation device. She picked up a stapler that, instead of metal, inserted a series of nearly invisible, FDA-approved, bioabsorbable polymer bridges to secure the skin edges. The wound was closed quickly and securely, with no metal clips that would need removal and leave visible tracks. This quiet shift marked one of the most significant advances in wound closure in more than half a century. A breakthrough embodied by SubQ It!, the flagship innovation from Opus KSD, a U.S.-based medical device company determined to rewrite one of surgery’s oldest scripts. Rewriting the Playbook for Surgical Closure This story is rooted in a problem all too familiar to surgeons – a forced choice between closure appearance and efficiency/ time savings. For decades surgeons have known that the best cosmetic result is achieved by time-consuming, highly skilled placement of manual “stitches” beneath the skin using bioabsorbable suture material. But in this age of cost control, time is money and metal staples, which save time and provide a secure closure, are all too often the default solution. Patients with metal-stapled incisions must endure the painful removal of staples without anesthesia, a process few remember fondly. Beyond the physical pain, the piercings made by the metal staples leave “railroad track” visible reminders that can cause ongoing distress, diminished self-esteem, or even social withdrawal. “When I make presentations and show the beautiful scars that we achieve with SubQ It!, people often approach me afterward to show me their scar or to tell me about when their mother had staples removed. It seems that everyone has a bad scar experience to share,” says Charles Rogers, PhD, CEO of Opus KSD. These repeated accounts, along with the collective dissatisfaction with the compromised status quo, set the stage for long-needed innovation. The primary goal of SubQ It! is disarmingly simple: to provide a closure system as efficient as a metal stapler yet as gentle and cosmetically effective as the best suture techniques. From Unmet Need to Clinical Breakthrough The inspiration for SubQ It! began when Dr. Kenneth Danielson, a pediatric and general surgeon, was looking for a better way to close short incisions from minimally invasive surgery (MIS). His preferred technique known as the “set-back buried dermal suture” was technically demanding and difficult to perform in the tiny MIS incisions; and metal staples were cosmetically unacceptable. When introduced to Rogers, they set out to combine the two methods - meticulously replicating the complex geometry of the set-back suture within a handheld stapler device. The result is SubQ It!—a tool that empowers surgeons to achieve high-quality cosmetic results quickly and efficiently, without the learning curve or extended procedure times of manual techniques. “The setback technique is highly effective, but has not gained widespread adoption because it is technically demanding and time-consuming. SubQ It! replicates those benefits, but with speed and simplicity,” Rogers says.