For 26 years, laryngologists used the Laser-Shield II, a laser-safe endotracheal tube that seemed to check all the boxes. They loved its smooth surface—perfect, it seemed, for passage along the delicate tissues of the vocal folds. They loved its flexibility—perfect, it seemed, for procedures that required ease of movement. And they loved its feel—perfect, it seemed, for a quality experience for both the surgeon and the patient.
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October 2021Then, to their surprise, manufacturer Medtronic stopped making it. There were other approved tubes for the purpose of endotracheal laser procedures, but many felt that none of them came close to the Laser-Shield II. When otolaryngologists found out it was off the market, they reached out to the company but were unable to convince Medtronic to bring back the beloved tube.
Discontinuations of otolaryngology tools and technologies can come about for a variety of reasons, manufacturers say. They sometimes happen when a component of a product becomes unavailable, with no adequate replacement. Sometimes, the revenue generated isn’t sufficient for a company to justify making it anymore. And sometimes, corporate representatives say, companies just decide that a product isn’t innovative enough any longer or isn’t worth the hassle of making it.
But when discontinuations do happen, they often take otolaryngologists by surprise, leaving them with unsatisfactory alternatives and forcing them to adjust to a tool they feel isn’t as well designed for the best outcomes. As they describe it, it’s sometimes an experience that, far from propelling them to new efficiencies with the powers of innovation, seems like going back in time, forcing them to scramble to find new sources for the instrumentation.
“We don’t have a lot of say; it just happens,” said Michael Johns, MD, director of the University of Southern California Voice Center in Los Angeles. “It seems sort of shocking when we’ve seen great advances in some of the ways we give patients care, and then economic forces lead to it going away.”
Complicated Decision Making
On the plus side, new needs can result in a replacement that’s superior to the old product, as happened with the endotracheal tube after a gap of about four years without the well-regarded version. But, originally, one of the go-to replacements for the Laser-Shield II was a metal corrugated tube that, otolaryngologists say, was stiffer and, with its ridges, could be abrasive to the tissues of the vocal folds.
“The balloon on this metal tube also was very large and not tight-to-shaft. It actually made it difficult to intubate patients who have glottic stenosis or other reasons for their larynx to be constricted,” said Jonathan Bock, MD, professor of otolaryngology–head and neck surgery at the Medical College of Wisconsin in Milwaukee. “It also obscured the view as you passed it through the vocal cords. I’ve definitely had a handful of patients whom we could easily have intubated with the old tubes. And then you had to figure out how that would affect your care for the patient. Sometimes, that can have a significant negative impact.”
Amy Van Sach, Medtronic’s vice president of marketing for otolaryngology products, said the company understands that the transition to a new product can be difficult. “It was a popular product, and it’s always difficult to adjust to a different technology,” she said. “At the end of the day, it’s about making sure that patients can get the care that they need. In some cases, we’re going to be the one that can provide existing and new tools and solutions; in other cases, there might be another product in the marketplace.”
Van Sach said decisions to discontinue medical products aren’t simple. “It’s a complicated decision-making process, especially when you’re talking about medical devices, because it isn’t like discontinuing a consumer product. These are tools that physicians do rely on,” she said. “We want to make sure that we understand if there’s still an innovative nature to the product offering. I think that’s a question that a company has to continually ask itself when it’s in the business of providing innovative solutions in the healthcare space.”
It seems sort of shocking when we’ve seen great advances in some of the ways we give patients care, and then economic forces lead to it going away. —Michael Johns, MD
Here are some common reasons for discontinuation:
Otolaryngology field size. The size of the otolaryngology field, physicians say, puts products they use at more risk than those used by larger specialties, such as cardiology. “We’re a small field, otolaryngology in general,” Dr. Johns said. “And when we break out into subspecialties—all using different little tools—we get even smaller.”
Supply chain issues. Michael Crook, chief operating officer for Grace Medical, a manufacturer in Memphis, Tenn., that makes otolaryngology instruments, said that products are sometimes discontinued because a problem in the supply chain makes a part unavailable. Issues with parts can cause a product to miss revenue expectations, hitting the bottom line of the manufacturer.
Regulatory considerations. Sometimes a product can be discontinued with regulatory considerations in mind, added Crook. Earlier in 2021, Grace Medical discontinued a disposable instrument kit that had been developed after physicians requested it, believing that full sterilization of every instrument, rather than just cleaning and decontaminating after every patient, would become the new standard. That regulation was never put into place, and the demand for the disposable kits waned, Crook said.
Customer complaints. Without a thorough vetting by end users, a product can be at risk of quickly becoming discontinued if it doesn’t suit the market, said Crook. He recalled that while he was at a previous company, a ventilation tube was made using a new manufacturing process. Engineers compared them to the old ones and saw no substantial difference, so production of the new tubes went forward. The rollout didn’t go well. “One of our biggest vent tube accounts called the first time they used the new tube and said, ‘This is a change that’s completely unacceptable,’” he recalled. Company officials realized that although the engineers had taken a close look at the instrument’s geometry and lumen—everything that had to do with its essential function—they had missed important qualities.
“The texture and feel were really strange,” Crook said. “That was enough for the customer. The company didn’t take into account the surgeon’s ‘feel’ of the new product and how long they had been using the old tubes.” Going back to the original manufacturing process was unfortunately a costly process, he said.
Offering Alternatives
When things are done correctly, offering alternatives suitable to customers is a crucial part of the discontinuation process, said Crook. “You should reach out to your key users and let them know the reasons for discontinuing a product and ask them to comment with a couple of suggestions that the company might consider as an alternative,” he said. “It’s really frustrating for a surgeon to all of a sudden find out that an instrument that they’re accustomed to using, that’s important to them, has suddenly been discontinued, with no alternative. That’s when you get issues.”
Finding parts for discontinued products can be a challenge. An Aura XP laser, made by manufacturer AMS, was stopped after the rights to the product were sold to another company, said Dr. Johns. So, otolaryngologists, still with a supply of the laser itself, managed to find a supply of fibers through rental companies so that the laser could continue to be used.
It’s a complicated decision-making process, especially when you’re talking about medical devices. … We want to make sure that we understand if there’s still an innovative nature to the
product offering. —Amy Van Sach, vice president of marketing, Medtronic
When a pre-carved silastic block used for thyroplasty procedures was discontinued by Medtronic a few years ago, physicians learned to carve the shape they needed from an older-style brick-shaped block, said Dr. Bock. While the pre-carved block had a ridge already cut into it for placement in a base, the uncarved ones required the surgeons to carve out the ridges themselves before carving out the implant needed for the patient.
Although the workaround was successful, it wasn’t without issues. “It’s clear rubber—you can’t see where you’ve carved it very well,” he added. He has also accidentally cut the bottom piece too far, leaving too fragile of a piece to fit in the base. When it ripped off, he had to start all over again.
Van Sach said that, unfortunately, the pre-carved block didn’t match the company’s focus on innovation. “In that particular instance, over time the block was less innovative than it had been when it was first introduced, and I think that was a key consideration there,” she said.
Notification and Communication
There’s no true, defined process for notifying the medical community about whether a product is under consideration for discontinuance, at least in the formalized way in which a government agency has an open call for public comment when new regulations are being considered, said Van Sach. But, she noted, her company uses a “continual medical feedback loop” involving communication at conferences and during in-person interactions, sales interactions, market research studies, and physician panels to gather information and notify physicians of new product releases and potential discontinuations.
Although there’s also no formal policy at Medtronic on how much notice the company gives to physicians before a product is taken off the market, Van Sach added, the general practice is “to give as much notice as possible.”
Dr. Bock agreed that better communication leading to these discontinuations could help physicians ready themselves. “It’s certainly nice when they can loop in the practitioners who are using the products extensively before they make decisions, to see if there’s some way to sustain the product until we have an adequate replacement,” he said. “I don’t blame the manufacturer for having to make business decisions, but at the same time it can be harsh and can affect patient care.”
“What I would hope is apparent about the way that we work with customers and with physicians anywhere in the world is that we do our best to make ourselves a trusted partner,” Van Sach said. “We do work to be innovative and to provide solutions that give the most benefit to the greatest number of people.”
Thomas R. Collins is a freelance medical writer based in Florida.
Discontinued Favorite Products
Here are a few products that have been discontinued in recent years, along with details on how the otolaryngology community adapted:
Product: Laser-Shield II laser safe endotracheal tube
What Physicians Liked: Smooth surface, soft touch, flexibility
How Physicians Adapted: Physicians used a stiffer, rough tube and advocated for manufacture of a new tube by another company.
Product: Netterville pre-carved Silastic implants
What Physicians Liked: A ridge at the bottom fit easily into a base for further carving, and the shape made for easier use during procedures.
How Physicians Adapted: Physicians learned to carve the ridge out of a brick-like block of material and used more time during procedures to carve out the implants.
Product: Aura XP KTP laser
What Physicians Liked: Familiarity and ease of use; this was a core working tool for laryngologists.
How Physicians Adapted: With the laser itself still available to use, laryngologists found fibers for it through medical equipment rental companies.
Product: Cymetra injectable material for vocal fold augmentation
What Physicians Liked: Texture and injectability
How Physicians Adapted: Physicians switched to other materials more commonly used in the cosmetics sphere.
Anatomy of an Alternative Product
When Andrew Georgilis, president of Cincinnati-based Bryan Medical, went to conferences several years ago, he would hear something over and over in the exhibit hall when he asked otolaryngologists what they wanted: “Make us an endotracheal tube.” The tube they had liked the most had been discontinued.
Finally, he decided to give it a go. The result was a silver lining to what was otherwise a disappointing fact of life in otolaryngology: Products that physicians like and that contribute to good patient outcomes are discontinued with no available replacement, but sometimes a new product can emerge.
Georgilis’ company initially worked on a new tube, and although the first lab testing went well, the final testing in porcine models failed. He created new prototypes based on advice from otolaryngologists and ran them past six focus groups to get feedback.
Aaron Friedman, MD, associate professor of clinical otolaryngology, head and neck surgery at the University of Cincinnati in Ohio, showed Georgilis a paper he had helped research on the ideal characteristics of a laser-protected endotracheal tube. Based on the paper’s results, the traits most prized in a tube were flexibility, surface smoothness, and a tight seal.
The newly developed Tenax tube was approved in the fall of 2020 and is currently in use at 60 centers. “The new tube works quite well, although it is expensive comparative to tubes we use in our practice,” said Jonathan Bock, MD, professor of otolaryngology–head and neck surgery at the Medical College of Wisconsin in Milwaukee.
Albert Merati, MD, chief of laryngology at the University of Washington in Seattle, sees the new tube as an illustration of what can happen when physicians work with manufacturers on products needed for patient care, he said. “Otolaryngology is a small field with deep knowledge, so speak up on products you need when you have the chance.”