Dr. D. Kyle Hogarth1 , the director of bronchoscopy at the University of Chicago, works in a bustling ICU where he often needs to perform rapid endoscopic procedures. His procedures entail threading a tube-shaped device called a bronchoscope into a patient’s nose or mouth to access and examine the lungs and airways. This can reveal if a patient’s symptoms are caused by infection, blockages, or even cancer.
Having the right tools is essential to performing these tasks quickly for critically ill patients, but Hogarth felt his were holding him back.
Ideally, he needed a tool that would provide higher-resolution views of the lungs and inner bronchial tubes. It had to have enough suction to clear the mucus and blood clots that blocked those views and caused breathing problems in the first place. It would also need to accommodate another device to biopsy or treat the illness, which would allow him to treat patients without sending them to open or thoracoscopic surgery. There are major benefits if specialists can follow pathways already accessible through natural openings. Unlike skin or muscle, these inner organs don’t sense pain, so a doctor can biopsy or operate without painful after-effects for the patient. The technique leaves no scars and recovery time shrinks from several weeks to less than one week.
Finally, for a busy, overcrowded ICU, this device had to be extremely portable and readily available—and of crucial importance, it had to be single-use. Otherwise, the scope being used on one patient could spread infectious disease to the next, despite a highly complex manual cleaning process between procedures.
Hospitals struggle more and more with this last problem, which has become even more pressing in the age of COVID-19. “We’re also seeing more bacteria that are resistant to antibiotics,” says Dr. Brian Dunkin, an endoscopic surgeon and now chief medical officer for Endoscopy at Boston Scientific, the medical device manufacturer based in Marlborough, Mass. “It’s getting worse.”
A HISTORY OF INNOVATION
The Boston Scientific R&D team has helped address the issue of cross-contamination due to ineffective reprocessing with a portfolio of single-use scopes used in bronchoscopy as well urologic and GI tract procedures. For example, the company’s EXALT Model D Duodenoscope is a single-use device used to facilitate examination of the pancreatic and bile ducts—a complex and infection-sensitive procedure. Used with the single-use SpyGlass™ DS Direct Visualization System, physicians can directly access the interior of the pancreatic and bile ducts and concurrently treat stones or blockages. “Before Boston Scientific invented the SpyGlass System, I relied on X-ray shadows to make an estimate of what I thought was going on,” Dunkin says.
Boston Scientific focuses innovation based on unmet healthcare needs and the best use of its team’s foundational expertise, which includes flexible tubing, superior optics, and medical scopes. Another critical factor is ensuring that new technologies are accessible to the physicians and patients who need them. This means managing cost factors, from manufacturing to insurance reimbursement.
“We can make really sophisticated devices,” Dunkin says, “but if they cost a million dollars each, that doesn’t help anybody.” He adds that, compared to the capital investment required for reusable scopes, a less expensive device also opens the door to further innovation. “[With] a single-use scope, if I want to make a change, there are fewer barriers to adoption. If I have a reusable inventory and I’ve got 20 of those in the closet, it’s pretty expensive to change those out for a new iteration. But if I improve a disposable scope, that’s a good thing.”
PERSISTENCE PAYS OFF
Luckily for Hogarth, he is one of several hundred physicians who provide feedback to the Endoscopy R&D team at Boston Scientific. After exploration, workshops, and testing numerous prototypes, the team showed Hogarth an early iteration of a single-use bronchoscope. A physician’s medical instruments are like a professional golfer’s clubs—they must feel just right. This meant the single-use model had to deliver superior suction performance, while building upon a familiar design so that physicians experience a minimal learning curve when adopting the technology. Unfortunately, this iteration was not the 9 iron of Hogarth’s dreams, and he let them know—in blunt terms. “I was reading the room and you could see the look on their faces,” he recalls.
The R&D team was disappointed to miss the mark, but they took Hogarth’s feedback back to the lab. Ironically, the doctor’s subdued response to the next iteration was the signal that they had nailed it. “The scope felt normal,” Hogarth says. “It fit in my hand like a reusable; it did what it was supposed to do. My muted response was rightly interpreted as full-on love.” The scope—officially, the EXALT™ Model B Single-Use Bronchoscope—was made available in Europe in May 2021 and received FDA 510(k) clearance in the U.S. in August.
Hogarth recalls his colleagues testing out the suction of the EXALT Model B Bronchoscope by conducting races with competitor devices to vacuum up a raw egg from a bowl. “Everyone was in awe of the optics and blown away by the suction capabilities,” he says. He takes pride in the fact that this device was created by Boston Scientific to address specific challenges identified by him and his peers. “I think that’s really all you need to hear, right? Boston Scientific took the time to truly understand what we needed, and now we’ve got it.”
1 Dr. D. Kyle Hogarth is a paid consultant for Boston Scientific Corporation. He has not been compensated for his quotes within this article.