How profit enters the product development equation

Editor’s note: This is an edited version of a previously published blog post. It has been updated for clarity and style.

First, full disclosure is in order: I, along with other local urologists, attended an industry dinner sponsored by the maker of the product discussed in this blog post. I will leave it to readers to decide whether that changes either my opinion of the device the company was promoting or the lessons I took from the dinner.

The product is a single-use ureteroscope. Such scopes are not new. I saw a Chinese-made one some years ago that looked nothing like a ureteroscope, so I ignored it. At that point I was perfectly happy with my reusable fiber optic scope, so I wasn’t even thinking about a disposable scope. Over the last few years, though, I have been following the data on contamination of various scopes with superbugs (think carbapenem-resistant Enterobacteriaceae [CBE]-infected duodenoscopes) and have been wondering if I would need to change either my in-office flexible cystoscopes or my ureteroscopes as a result.

So when I learned about a new single-use ureteroscope from Boston Scientific after seeing it at the 2017 AUA meeting, I was intrigued. Further, when the company’s roadshow came to Colorado Springs, and since I had nothing else to do that evening, I took the offer. It didn’t hurt that I knew the doctor giving the talk (Thomas Chi, MD, from UCSF) and knew he was a smart and honest guy whose previous research I had read and respected.

But let’s be honest, this is not the first industry dinner I’ve attended and by no means is my intent to give a company free advertising. That said, I learned a very valuable lesson from this dinner and thought the lesson would be worth sharing.

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First, though, a little about the toy itself. The scope looks and feels like a ureteroscope and, while I have never used a single-use scope myself, I have spoken with enough doctors who have used one to feel comfortable saying that it works perfectly fine. It may not have the fanciest digital chip on the market, so if you are expecting super high-end optics, that’s not going to happen. But borrowing a phrase from Dr. Chi, “It’s in the ballpark.” For the vast majority of the work we do, that is fine. Perhaps if you are looking for a small upper tract transitional cell carcinoma, then using a nice digital scope is appropriate, but for the standard proximal ureteral stone, this scope is more than adequate.

Second, there is now published data questioning our ability to truly clean flexible ureteroscopes. Ofstead et al examined 16 reusable flexible ureteroscopes after undergoing standard sterilization and found that every scope had “visible irregularities, such as discoloration, residual fluid, foamy white residue, scratches, or debris in channels.” They also found evidence of contamination on every scope (microbial growth in 13%, adenosine triphosphate in 44%, hemoglobin in 63%, and protein in 100%).

The clinical significance of this certainly remains debatable given the low published rate of infection secondary to ureteroscopic procedures, but if bacteria such as CBE become more common in our patients, it may change our calculations. It also raises the question of whether single-use equivalent flexible cystoscopes (using a disposable sheath) should be standard of care, but the evidence for that is also minimal at best.

Next: The important lesson Dr. Rosevear learned

With that in mind, the important lesson I learned from this lecture came not from the physician discussing the ureteroscope but from that evening’s second speaker. He was a Boston Scientific-employed health economist who spoke about the state of ureteroscopy in general and ureteroscopy with laser lithotripsy in particular. While the data he presented on the rise in the number of ureteroscopic cases was interesting, it was nothing I didn’t already know. (With national data on ESWL use decreasing, it’s only logical that ureteroscopic cases will go up).

Rather, he caught my attention when he began describing what the device maker did with that information. The company approached CMS and started lobbying for increases in reimbursement for these cases. He then showed data that the company succeeded and that the reimbursement for ureteroscopic cases increased in excess of the growth rate of the cases. Of note, it was the facility component and not the professional component that went up.)

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Why would a private company lobby the government on behalf of hospitals and ambulatory surgery centers? In short, increased reimbursement means more scopes in the hands of urologists. This is yet another example of mutually aligned interests. We, as providers, get a new device in part because a company spotted a trend (the increased use of flexible ureteroscopes) and then lobbied CMS to increase the profit margin of the case on the facility side so it could sell a new product into the space. That is not a bad thing.

I certainly mean no disrespect to the product manufacturer, the health care economist who spotted the trend, the doctors who research and validate the product, or CMS for responding to the data. Rather, I think that this is a side of medicine that is not discussed but should be. In the world we live in where medical advances are often researched, tested, and advocated for not by the government but rather by for-profit companies, understanding the system makes us better consumers of the information and also better doctors.

More from Dr. Rosevear:

On-Demand and on-target: Why AUA Course Pass is worth your time

Burnout, biopsy, BPH, and more: Post-AUA review

Don’t skimp on sleep: The consequences of sleep deprivation

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