The Dittrick Museum is home to the largest and most comprehensive collection of endoscopes in North America. In 1989 we received the archives and instruments of the American Society for Gastrointestinal Endoscopy (ASGE), which marked their 50th anniversary in 1991. Receipt of the collection and the Society’s anniversary prompted a succession of publications, exhibitions, and lectures. But after a while, the enthusiasm waned and the ASGE historical interest declined, perhaps because an older generation of endoscopists feted each other in these celebrations, while younger (and presumably more innovative) practitioners turned from history to confront challenges and opportunities developing in their fields. We at the Dittrick turned to other projects as well. But this year we have mounted a renewed effort to update this important collection. Renovation of our permanent museum exhibit gallery devoted to diagnostic instruments prompted this decision (an that renovation was in turn motivated by a nationally important collection of diagnostic instruments donated by M. Donald Blaufox, M.D.). Our plan is to document innovation in endoscopy over the past fifteen years, identify key technical developments, and acquire representative instruments, and interview leading figures in the field. In this program we are collaborating with Michael V. Sivak, Jr., M.D., pioneer in videoendoscopy and past chair of the Division of Gastroenterology of University Hospitals of Cleveland, and innovator in endoscopy techniques and procedures Jeffrey Ponsky, M.D., Chairman of the Department of Surgery at University Hospitals of Cleveland.
For orientation, it may be helpful to briefly review the four major periods of technical development in endoscopy: 1) rigid endoscopes, 1806-1932; 2) semiflexible endoscopes, 1932-57; 3) fiberoptic, 1957-1990s; and 4) videoendoscopy, 1983 to present. In each period or era, consensus emerged that a plateau of technical development had been reached and dramatic breakthroughs would be few. These assumptions would be proved wrong again and again.
During the rigid instrument era, the introduction of the incandescent “mignon” lamp (1886) comprised a noted improvement, but optics and illumination limited successful instrumentation. Endoscopes remained a rarely-used diagnostic tool, and seldom served therapeutic purpose.
The semi-flexible endoscope era, also referred to as the Rudolf Schindler era, witnessed marked improvement of optics and greater range of use, including the advent of biopsy forceps. Innovation improved instruments incrementally, and the major advance comprised Schindler’s success in “mainstreaming” endoscopy into the routine practice of gastroenterology. Surgical applications also started to emerge, though hesitantly.
The unanticipated advance of fiberoptic endoscopy, pioneered by Basil Hirschowitz, changed everything. Fiberscopes facilitated visualization of increasingly remote portions of the body and dramatically lessened patient discomfort. Although originating in gastrointestinal endoscopy, fiberoptic technology rapidly found application in colonoscopy, laparoscopy, and related fields, with significant surgical applications emerging in the 1970s (polyp removal, cannulation of the pancreas and bile duct, &c). This was a fairly heady and productive phase of endoscope development, with major roles being played by Olympus, Machida, Fujinon, Wolf, and Storz.
Then, almost as suddenly as the advent of fiberoptics, a radically new technology, video endoscopy, sent technical development spinning. The Welch Allen Company, a traditional American maker of otoscopes, pioneered videoendoscope design in the United States in 1983. But they were soon eclipsed by Fujinon, who launched the first commercially available videoendoscope in 1985, and by Wolf, who introduced the first digital CCD (charge-coupled device) endocamera in 1986. This field progressed steadily until around 2000, when further technical development accelerated innovations and applications in endoscopy across a wide front. Documenting what transpired in the past decade is the ongoing focus of our collection development plan.
Looking around in 2010, at least in the field of gastrointestinal endoscopy, one sees an array of technologies and procedures that followed on the heels of video endoscopy, and more importantly, the mating of the computer to endoscopic instruments. In addition to gastrointestinal endoscopes proper, one can add the following: capsule endoscopy, virtual colonoscopy, stenting and dilation devices, ERCP devices, biopsy forceps, polypectomy snares and fine needle aspiration devices, foreign-body retrieval devices, hemostasis devices, anti-reflux devices and enteral feeding devices. We are presently documenting these new technologies and trying to determine what to acquire as museum objects.
As we survey this field yet other dramatic changes in endoscopic practice may be observed and considered for documentation, at least in the experience of medicine as it is practiced in the United States. Patients in America, according to the insightful commentator Atul Gawande, get “more of pretty much everything—more diagnostic testing, more hospital treatment, more surgery, more home care. The primary cause of extreme costs is, very simply, the across-the-board overuse of medicine.” This is true in the domain of endoscopy as much and even more so than in many other area of medicine and surgery. It is driven by a variety of factors including, but not limited to, patient demography and epidemiology. Market analysts usually point to an aging population with unhealthy lifestyle, leading to a demand for more endoscopy. A December 2008 analysis, for example, projected future worldwide endoscopy market expansion driven by these factors:
Growth in this market [for endoscopy] encompasses many areas, with surgery being the majority of the increase. Cancer is one of leading reasons for surgery with more than 1 million new cases of colon/rectum cancer reported each year around the world. Obesity is another reason for growth. More and more people worldwide are turning to gastric bypass (bariatric surgery) and gastric banding to aide in their weight loss, thus increasing the need for gastrointestinal endoscopy. These exploratory procedures are done both pre-operatively and post-operatively to identify possible risks during these bariatric procedures. Many of these surgeries are done laparoscopically, which is also a form of endoscopy.
On the other side of the equation, market analysts have recently cited cost-saving advantages and improved patient outcome as key factors driving the demand for minimally invasive surgery and other endoscopic procedures:
The aggressive focus on controlling healthcare costs has resulted in growing demand for less expensive and minimally invasive procedures. Given the escalating opportunities and demand for MIES [minimally invasive endoscopic surgery] procedures, several medical equipment manufacturers are concentrating on developing sophisticated highly functional products/processes. Endoscopy systems occupy a unique position in the total medical device market with applications extended to several areas in medical surgery, particularly in cancer. Endoscopic procedures are less risky, less painful, and involve lesser patient recovery period, when compared to traditional methods. Laparoscopy, bariatric surgery, and arthroscopy are rapidly growing segments, occupying a significant share in the global endoscopy market.
I would propose that endoscopy is spurred by innovations that are transcendent, by which I mean a few key advances – digital imaging, robotic surgery technology, &c – that can be applied across a spectrum of otherwise disparate surgical domains previously pursued as distinct and separate medical specialties. But one may also explain the success of endoscopy in certain areas as being driven by equipment makers’ marketing strategy, on the one hand, and by consumer — excuse, me, patient — demand on the other. In 2001 the market research firm Frost & Sullivan signaled that endoscopy companies could build new relationships to maximize the market potential of their products:
“Future market success is dependent on the use of superior marketing and management strategies that build customer relationships,” says Frost & Sullivan Medical Device Industry Analyst Charlie Whelan. “Market competitors must differentiate themselves, based on the variety of nontangible benefits they offer customers, and not just on their products’ quality. Using a sales message backed with evidence showing how endoscopes and their systems benefit patients, surgeons, and the facility’s bottom line, manufacturers can position themselves as problem-solvers rather than merely product providers,” says Whelan.
Examples of the success of this building of new customer relationships may be seen in direct-to-patient marketing of technologies and procedures, augmenting the frequency of elective surgery or more high tech forms of surgery. Two examples will illustrate this impact: gastric banding via endoscopic surgery, and robotic surgery for prostate cancer. Even for those accustomed to television and print (and web) advertising of pharmaceuticals, this new cultivation of consumer medical demand is alarming.
It has been said that obesity is the third great epidemic of the 21st century, after malaria and tuberculosis. Endoscopy offers a surgical way to deal with obesity when behavior modification fails. One popular alternative to bariatric surgery (to reduce stomach capacity) is gastric banding, an approach that originated in Sweden in 1985. Gastric banding underwent clinical trials in the United States in 1995, leading to FDA approval by the FDA in 2001. Since that time LAP-BAND® adjustable gastric banding system by Allergan and the REALIZE® gastric band by Ethicon have emerged as leading variants of this technology. Whatever the merits of each product, much of their success may be attributed to cultivation of patient loyalty. On their respective websites prospective candidates for gastric banding may learn more about the technology, the experience of satisfied customers, and are invited to join advocates (or rather, the support group?) for each system. The effort here is clearly to cultivate product loyalty and patient identity associated with the gastric band technology.
In the United States, robotic surgery moved forward significantly in 2000 when the FDA approved the da Vinci Surgical System for adult and pediatric use in urologic surgery, general laparoscopic surgery, gynecologic laparoscopic surgery, and general non-cardiovascular thoracoscopic surgery. Since then, it has caught on dramatically in certain sectors, notably prostrate surgery. In the past eight years it has gone from under 10% to around 90% of prostrate surgeries in the United States. And yet there are no statistics that demonstrate that robotic surgery is any more safe or effective than conventional laparoscopic surery (who knew that laparoscopic surgery would be considered “traditional” and low tech?). We do know that it is correspondingly more expensive, requiring significant capital expenditure ($1.4 million per unit, plus technical support and training; over 1100 units worldwide today). Such expenditures (or “investments”) incentivize use, particularly when the surgeons are the investors. And the numbers involved are significant: one in six men will face prostate cancer in America. So, in the United States at least, marketing hype drives the spread of endoscopic and robotic surgery, as much as patient well being. Understanding and documenting this trend is just as important as knowing what to collect for the medical museum of today and tomorrow, for it explains how we adopt and use medical technologies.
10 Nov 2010 Thomas