Trying to Innovate Radical Prostatectomy in 2002/2003

Radical retropubic prostatectomy (RRP) is a complex surgical procedure performed to remove the prostate gland and some surrounding tissue in patients with localized prostate cancer. In the early 2000’s, radical retropubic prostatectomy (RRP) was among the most technically demanding procedures in urologic oncology. Conducted through an open incision deep in the pelvis, RRP demanded not just surgical precision but also courage. Surgeons faced narrow, complex anatomy surrounded by vital structures, and patients faced serious risks—bleeding, erectile dysfunction, urinary incontinence, and prolonged recovery.

Amid this complexity, one surgical step stood out for its influence on long-term patient outcomes: the vesicourethral anastomosis. [Note: you will see it called the urethrovesical anastomosis (UVA), but I continue to hear the voice of Dr. Ruhalter in my head, "proximal to distal, Mr. Prentice, proximal to distal.” So, I will always call it the vesicourethral anastomosis.]

A Critical Juncture: The Vesicourethral Anastomosis

Often referred to as a surgical “pucker” moment, the vesicourethral anastomosis involves reconnecting the bladder to the urethra after the prostate is removed. The goal: a watertight, tension-free union of two delicate mucosal surfaces—deep in the pelvis.

Failure in this step could mean leaks, stricture formation, or incontinence. Success could mean a quicker return to continence and a better quality of life. But even for experienced surgeons, ensuring accurate mucosal apposition and avoiding stenosis in this deep, restricted space was a significant challenge.

The Walsh Era: Open Prostatectomy at Its Peak

In 2002, the dominant surgical paradigm in the U.S. followed the principles laid out by Dr. Patrick Walsh, whose anatomic approach to radical prostatectomy revolutionized the field. His nerve-sparing technique aimed to preserve erectile function without compromising cancer control, setting a high standard for functional outcomes. Still, for many surgeons, the procedure was arduous, and for many patients, the recovery was taxing.

Across the Ocean: A Minimally Invasive Future Emerges

At the same time, a few elite surgical teams in France—led by pioneers like Dr. Richard Gaston, Dr. Bertrand Guillonneau, Dr. Guy Vallancien, and Dr. Claude Abbou—were pushing the boundaries of what was possible with laparoscopic prostatectomy. Their innovations, including the Montsouris technique, were reshaping urologic surgery.

In the U.S., early adopters like Dr. Inderbir Gill at the Cleveland Clinic, were exploring laparoscopic approaches, but these procedures remained niche, reserved for only the most experienced and technically skilled surgeons.

Innovating a Procedural Step

At this crossroads of surgical innovation and unmet clinical need, Ethicon Endo-Surgery (EES) saw a strategic opportunity. With its focus on handheld, single-use instruments, EES recognized that the vesicourethral anastomosis could be the ideal target for a novel device solution.

At the time, EES had Franchise Development teams (specialized, agile R&D units designed to tackle tough clinical problems outside of EES’ status quo specialties). One such team, led by Mary Schramm, was tasked with an ambitious goal: develop a device to simplify, standardize, and improve the vesicourethral anastomosis. Such a device could reduce the “throwing and hoping” of suture in an RRP and reduce the need for advanced intracorporeal suturing skills with the laparoscopic approach, aka “sewing in a funnel.”

It was with Mary’s team that I also was able to interact with and learn from Dr. Wayne Poll, an experienced laparoscopic urologist who helped guide the team on the clinical and technical challenges.

Reflections on Vision and Timing

The work initiated foreshadowed many of the themes that continue to shape medtech today: addressing procedural bottlenecks, aligning with surgeon workflow, and focusing on functional outcomes, not just procedural completion.

The EES product idea to address the specific bottleneck of vesicourethral anastomosis never came to fruition. It was an exceedingly high technical hurdle to create a device that could enter through a transurethral approach and execute the anastomosis. The clinical need was valid, as Boston Scientific had the CAPIO device and attempted to address prostatectomy with it as well.

The challenge was not just technical; it was cultural. Robotic surgery had begun but had yet to become mainstream. In fact, EES had a da Vinci system in a lab at its headquarters. The company was thriving (at that time) selling handheld disposable instruments in general surgery, so obviously a handheld disposable instrument was the answer.

Looking back, the effective answer to the bottleneck sat in a secured lab in the EES Institute. The solution’s name was the da Vinci Surgical System.

The robotic revolution would soon take hold and redefine prostatectomy once again; the lessons from this era remain vital. When surgeons, engineers, and strategists align around a specific clinical challenge—like the vesicourethral anastomosis—they unlock the potential for meaningful innovation in patient care.

Takeaways:

1)       Two components to a bullseye. Right target, right arrow. Sometimes you have the right target (like prostatectomy) but the wrong arrow (our anastomotic device idea). Sometimes you have the right arrow (da Vinci), but it was aimed at the wrong target (heart). da Vinci + prostatectomy ended up being the right target, right arrow combination.

2)       Innovation in medtech is hard. Knowing what needs to be addressed is the start (the “R”) – but delivering on addressing the need is next-level execution (the “D”). Do you have an idea how to address the need? Can you create a device that does it once on a benchtop? Can you create a device that repeatedly does it in anatomic labs? Can you manufacture the device reliably and cost-effectively? Etc. Etc. Etc.

3)       Be grateful. Thank you, Mary Schramm ! Thank you, Wayne Poll, M.D.! I learned a lot from both of you.

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