Minimally Invasive Technologies

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INDUSTRY SNAPSHOT

Minimally invasive technologies include a wide array of medical devices designed to perform complex surgeries that forego traditional medical procedures that rely on massive incisions. Also called minimal access or keyhole surgery, minimally invasive surgery (MIS) has proven successful in a wide range of operations, from the removal of gall bladders—one of its most common procedures—to kidney transplants, and new applications for these technologies were being found at an increasing rate. Among doctors who routinely use minimally invasive technologies are gastroenterologists (a doctor who specializes in digestive diseases), internists, gynecologists, cardiovascular surgeons, plastic and reconstructive surgeons, orthopedic surgeons, and veterinarians.

According to a study by Frost & Sullivan, the market for instruments and equipment for minimally invasive surgery was expected to reach nearly $710 million by 2009. Some of the equipment used in minimally invasive surgeries consists of guide wires, which connect the surgical devices with their operators and help guide the instruments to their proper location; steerable catheters, soft-tipped flexible tubes designed to offer greater maneuverability within the body; sutures, the tiny thread -like materials used to sew together small incisions; micro-sized needles, staplers, scissors, and similar surgical tools; and supplemental equipment such as monitors, cables, lighting equipment, and computer consoles. Perhaps the most developed sub-market, however, is that of endoscopes. An endoscope is a medical instrument, typically a hollow tube, which can be either rigid or flexible, with a tiny video camera inside or with light-transmitting glass fibers, that is inserted through a natural body opening and allows a live picture of the inside of a patient's organ to be viewed and evaluated in the operating room during surgery.

By making two small holes in the patient's body, rather than the large incisions used in traditional open surgery, minimally invasive surgeons greatly simplify the procedure. In one hole, they insert the endoscope, and they maneuver their tiny medical instruments in the other. The internal images are projected and magnified by the endoscope onto an operating room video screen, where doctors monitor progress and their manipulation of the instruments. This high-tech procedure offers a number of advantages to patients, particularly the speed of recovery time, since patients need not heal from large incisions. In addition, minimally invasive surgery (MIS) drastically reduces patient pain and scarring, cost of surgery, and post-surgical complication.

ORGANIZATION AND STRUCTURE

In the early stage of development of minimally invasive technologies, the competition revolved primarily around bringing out new tools, systems, and equipment that simply make operations easier for surgeons to perform while keeping cumbersome costs to a minimum. By the early years of the first decade of the twenty-first century, most equipment was still fairly expensive and primitive, greatly limiting minimally invasive surgery's applicability over a wide range of conditions. Still, competition in this area was increasing, as more open surgeries were converted to MIS procedures. The use of minimally invasive surgery continued to grow during the middle years of the decade. In March 2006, the The New York Times reported that approximately 4.4 million Americans undergo laparoscopic (located within the abdomen or pelvic cavity) procedures alone each year. Surgeons in a variety of medical specialties were using the approach, when appropriate, instead of traditional surgical techniques. In addition, advancements in minimally invasive surgery allowed it to be used in a widening array of medical applications.

As of 2006, advancements were allowing the technology to be used for spinal surgery and neurosurgery (surgery on the brain, spinal cord, nervous system), in addition to minute tasks such as reconnecting ligaments in the knee, operating on infected sinuses, performing tubal ligation (female sterilization by surgically tying a woman's fallopian tubes, which carry eggs from ovaries to uterus or womb), repairing heart valves, and removing gall bladders. Companies sell their equipment to hospitals and research laboratories by emphasizing not only the efficiency of the operating process itself, but also the savings in administrative and logistic costs as well.

The leading manufacturers of minimally invasive technologies are either large, multinational firms (often specializing in both medical and optical instruments) or smaller specialty companies engaged in partnerships with larger medical and diagnostic firms. Johnson & Johnson's subsidiary Ethicon Endo-Surgery has been a long-time market leader, and so has Tyco International's United States Surgical Corp. Multinational Japanese firms Olympus Optical Co., Inc. and Fuji Photo Optical Co., Ltd. (also known as Fujinon) have produced many of the top-selling endoscopes. These companies enjoy the built-in credibility of their established lines of scientific instruments as well as their expertise in camera equipment, research that can easily be applied to endoscopic technology. Other significant players in the industry include Boston Scientific Corporation, Endoscopic Technologies, Inc., and endoscopy pioneer Karl Storz GmbH & Co.

Endoscopy Proves Flexible

Endoscopes have been adapted to enter many regions of the body that were previously accessible only via large incisions. Endoscopy, which literally means looking inside, can be performed for diagnostic or therapeutic reasons. These might include evaluating a source of pain, taking biopsies, removing foreign bodies and abnormal growths, arresting bleeding, reshaping or reconstructing tissue, and placing tubes or stents.

Endoscopes may be either rigid or flexible. Rigid endoscopes contain a solid rod lens developed by Harold Hopkins, a physicist, who was largely responsible for making modern medical endoscopy a practical reality. Flexible endoscopes use a fiber-optic bundle, also developed by Hopkins, which maneuvers around curves and bends but provides poorer resolution than the solid rod lens. The most common endoscopes, named after the body part interior they examine, are called colonoscopes (entire colon and rectum), cystoscopes (bladder and urethra), fiberscopes (fiber-optic endoscope), gastroscopes (stomach), hysteroscopes (cervix and uterus), laparoscopes (abdomen, pelvis), sigmoidoscopes (sigmoid colon area), peritoneoscopes (abdominal, pelvic), and proctosigmoidoscopes (anus, rectum, colon).

Although minimally invasive surgery (MIS) is considered the "gold standard" in diagnosing and treating some diseases, it is nonetheless still an invasive technique that carries risks and requires a level of training that is not yet standardized. Although benefits to the patient can include shorter hospital stays, reduced pain, and fewer complications, these advantages can be offset by other risks. Because the manual and visual skills required for these procedures can be very different from those required for conventional surgery, the surgeon's skill and experience, as well as careful patient selection, are especially important in determining a successful outcome.

According to a memo in Health Care Strategic Management, several factors impact endoscopy growth. A growing population of older Americans will be more likely to require medical procedures using endoscopes for virtually all medical specialties. Additionally, Medicare and managed health care organizations have experienced savings resulting from reduced recovery time and related costs.

BACKGROUND AND DEVELOPMENT

Minimally invasive technology traces its roots back to the earliest endoscopes, employed in the early twentieth century, that were basically small telescopes with a light on the front end through which doctors peered. The widespread use of endoscopy was challenged by determining how to safely get enough light into a body cavity and how to transmit realistic visual images. These considerations served to limit the initial scope of application for endoscopic procedures and many old-school physicians remained skeptical. Karl Storz is recognized as the father of cold light endoscopy, developed in the 1960s, which made incandescent bulb mounting obsolete. Storz's discovery opened the door for capturing diagnostic findings in images. He also built the first extracorporeal (outside the body) electronic flash. Eventually, as the hardware developed, so did the attitudes of the collective medical community, who eventually came to accept the technology for diagnostic and therapeutic application.

In 1988, the field finally got onto its present course when doctors first used a tiny endoscopic camera and tiny medical tools to remove a gall bladder, after which the use of MIS became more accepted. Though the use of the procedure spread quickly, the established medical community remained slow to accept it. A meeting of leading professionals called by the National Institutes of Health (NIH) in 1992 resulted in a rather hesitant approval for laparoscopic invasive surgery. A statement issued still held that traditional, open surgery "remains a standard against which new treatments should be judged." Moreover, despite the boom in demand in the late 1980s and early 1990s, the onset of managed care pushed pricing considerations to the forefront, thus holding industry growth in check as firms struggled to get their latest products to the market at affordable prices and drove out many smaller competitors in the process.

Because of such economic pressures, claims were made...

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