Collaboration Fuels Success in Single-Use Device Development in Endoscopy

Increasing patient safety. Improving clinical outcomes. Enabling rapid innovation. These are just a few of the many benefits fuelling the trend toward single-use devices in the field of endoscopy.

Endoscopy is a minimally invasive procedure that allows doctors to look at the inside of a patient’s body using an endoscope – a long, thin tube with a camera on the end. Traditionally, scopes are reusable and are reprocessed, or cleaned, between procedures. But the complexity of properly cleaning a scope – a time-intensive, multi-step process – leaves vulnerable patients at risk for infection.

Understanding that no reprocessing solution can guarantee a completely clean scope, the Boston Scientific Endoscopy team set out to replicate and even improve the functionality of traditional scopes in single-use formats. Kurt Geitz, vice president of Endoscopy research and development, leads these efforts with a team of cross-functional leaders from R&D and beyond.

In the past two years, the team has successfully released two new single-use devices: the EXALT™ Model D Single-Use Duodenoscope, used to facilitate the examination of the pancreatic and bile ducts, and most recently, the EXALT™ Model B Single-Use Bronchoscope, used to examine a patient’s lungs and airways.

The progress made with single-use devices represents a turning point in the field of health care and how endoscopy is done. We talked to Geitz about his team’s approach to innovation, the benefits of single-use technology and what’s next, as the trend toward single-use devices gains momentum.

Q: What drives innovation in endoscopy at Boston Scientific? How does the team decide what new solutions to go after next?

A: We’re not in the business of defining the problem based on the solution we can provide. Some folks might say, "Hey, we have all this great technology. Why don't you use technology X somewhere?" I don't think that's the right way to do it – it’s like trying to ram a square peg into a round hole. If we understand the needs of the patient and challenges to the doctor, the solutions come to the floor.

For example, when we started the development of single-use devices, we began with the duodenoscope because of the infection risk associated with reprocessing, and at the time, there wasn’t a single-use option available to doctors. It was an opportunity to address an unmet need.

The duodenoscope is one of the most complicated scopes on the market and we relied on physician feedback throughout the development process to ensure we got it right.

Q: How do you engage with physicians to guide the innovation process?

A: It’s an iterative process involving engagement with physician advisors. So, with respect to both single-use scopes, Boston Scientific had a cross-functional development team as well as a group of physician advisors of whom we’d routinely ask questions as we worked on the designs developed by our team. We observed them in their practice and asked them if we were going after the right problems. When we made design decisions, we went back to those advisors for confirmation that we were still on the right path.

Once we finalized the design and were developing the product, we invited a larger group of physicians – those who provided feedback throughout the development process and those who didn’t – to test the device and further confirm that it was hitting the mark on form and function.

Q: Most recently, your team released the EXALT Model B Bronchoscope; can you elaborate on what factors led the team to develop this device?

A: Bronchoscopes are most often used in the intensive care unit (ICU) to clear blockages – like excess mucus – from the lungs and airways. Patients in the ICU are already vulnerable and more susceptible to infection, so reducing the risk of infection was the primary driver.

Early on, we researched design opportunities by asking physicians what they liked about the existing tools, and what they saw as limitations. We wanted to understand if there was an unmet challenge that we could solve. Physicians were looking for the ability to both see and easily navigate to wherever the obstruction was, and to suck out the obstruction as quickly as possible, so we focused on visualization and suctioning.

The EXALT Model B Bronchoscope launched in Europe and received clearance from the U.S. FDA earlier this year. Already we’re receiving positive feedback on both the visualization and the suction. Another thing we’re hearing is that ergonomically, it builds upon a familiar design so that physicians experience a minimal learning curve when adopting this technology.

Q: What are some of the other benefits of single-use devices in endoscopy?

A. Beyond eradicating the risk of infection due to inadequate reprocessing, the technology behind the single-use scopes gives us a nimbleness to address clinician needs and iterate at a faster pace.

We can make changes or improvements to the single-use devices without considering the expense and challenges of replacing existing inventory, like we do with reusable devices. Working with a single-use platform opens the door for faster innovation.

There are also cost considerations. Single-use scopes don't have to be cleaned, inspected, dried, stored for reuse, etc.; this saves staff time and reduces costs. Still, doctors use these products often in routine procedures, so from the beginning, we tried to make sure that we could meet the cost targets for the customers. This included limiting the number of parts used in assembly and developing a robust and clear R&D process to avoid unnecessary redundancies – all without sacrificing quality.

Q. Looking ahead, what’s next for endoscopy at Boston Scientific?

A: We’re just scratching the surface of what’s possible through minimally invasive procedures, which are safer, more cost effective and lead to better patient outcomes. As innovators, it’s up to us to stay in lockstep with physicians as they continue to push the boundaries on minimally invasive approaches so that we can deliver the right tools.

And, the transition to single-use devices gives us a nimbleness to address clinician needs and iterate at a pace that has never been seen before. By applying what we’ve learned in developing single-use devices, we can develop endoscopes with capabilities that aren’t available, or maybe even possible, in a reusable format. We are experiencing a turning point in endoscopy, and I’m excited to be at the forefront.