When Fast Company placed Boston Scientific fifth on its list of the Top 100 Best Workplaces for Innovators in 2020, the publication recognized the company for developing the EXALT™ Model D single-use duodenoscope, the first device of its kind cleared by the FDA. This breakthrough solution was designed to address one of healthcare’s toughest challenges: reducing infections associated with ineffective reprocessing of reusable scopes.
According to the FDA, one in twenty reusable duodenoscopes, which are used in more than 500,000 procedures each year, is contaminated with pathogens that can cause fatal infections. Technicians must perform nearly one hundred individual steps—a process that is vulnerable to error—to clean these devices between procedures.
Designing the EXALT Model D required three years of collaboration from a cross-functional team of 150 people—five times the size of a typical product team—from six different sites across the company.
“We pulled in expertise from all corners of the business,” says Kurt Geitz, Vice President of Research and Development for Endoscopy at Boston Scientific. “Catheter development, cardiology, 3D metal printing capabilities—we left no resource untapped.”
Education brought the team together. “To succeed, everyone had to first understand the unmet clinical need and the challenges our physician customers face,” says Geitz. Beyond internal training sessions, the team invited a clinical investigator to present real-world data on infection rates caused by cleaning errors and the complexity of disinfecting duodenoscopes.
A group of ten physicians contributed to each step of the design process, providing feedback on every aspect of the device, including image quality and how it felt to hold and operate. The design team worked collaboratively with these physicians to conduct a clinical trial prior to receiving FDA clearance.
“We created an iterative process grounded in trust, inclusion and collaboration – both with customers and cross-functional company experts. That is the hallmark of successful innovation, and it’s what makes our work at Boston Scientific so rewarding,” adds Geitz.
The EXALT Model D is one of 85 new products Boston Scientific approved last year to meet the needs of customers and the more than 30 million patients they reach annually.