Prosthetics and Orthotics

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INDUSTRY SNAPSHOT

Prosthetics is a field of medical science that involves the design and creation of man-made devices that replace something on or within the human body. Prostheses are used to replace body parts that have been removed due to disease or accidents, as well as those missing because of birth defects. While most prosthetic devices are functional in nature, some—such as glass eyes and artificial breasts—are purely cosmetic. However, prostheses often have both cosmetic and functional properties.

While the prosthetics field generally is associated with external devices like artificial limbs, it technically overlaps with other medical specialties. For example, cardiothoracic surgery involves the use of artificial hearts and heart valves, and arthroplasty involves the installation of total and partial prosthetic joints like elbows, hips, fingers, knees, and shoulders. Another related field is prosthdontics, which deals with false teeth and supportive dental structures like bridges, crowns, and dentures.

Closely related to the prosthetics field, orthotics involves the design and fitting of various braces and external appliances that correct anatomical deformities and support paralyzed muscles. Orthotics help people to compensate for muscular or skeletal problems and move in more optimal ways.

According to different estimates, by early 2004 the prosthetics and orthotics market was worth about $3 billion, some $2 billion of which was attributed to the prosthetics segment. Approximately 6,000 prosthetists—medical professionals who design and fit prostheses—served more than one million amputees within the United States and as many as 500,000 others worldwide. A prosthetic device can cost between $2,500 and $20,000 and an adult usually needs to replace it every one to three years. As a child grows, he/she will need a new one every three to six months.

The prosthetics market is expected to increase well into the twenty-first century. According to the American Orthotic & Prosthetic Association, this growth will likely be supported by a rise in chronic conditions like diabetes and vascular disease, which can lead to amputation. Another reason for the rise in demand for prosthetics is improved body armor and prompt battlefield medical care in Iraq and Afghanistan. Soldiers who may have died in previous wars are being saved, but more have lost limbs. By the end of January 2006, 387 military personnel in the two wars were treated for injuries resulting in loss of legs, arms, feet, or hands, and some had lost more than one limb. Figures from the American Academy of Orthotists & Prosthetists call for the prosthetic care market to grow 50 percent by 2020, while orthotic care is expected to grow 25 percent during the same time period.

ORGANIZATION AND STRUCTURE
Manufacturers

Prosthetic and orthotic device manufacturing is part of the larger surgical appliance and supplies industry, which in turn is a segment of the medical equipment and supply market. The American Orthotic & Prosthetic Association, a professional trade group representing patient care facilities and suppliers that manufacture, distribute, design, fabricate, fit, and supervise the use of orthoses (orthopedic braces) and prostheses (artificial limbs), had approximately 1,900 members in 2005.

In addition to a wide range of prosthetic limbs, as well as orthoses for the spine, ankle, foot, back, shoulder, and hip, the industry produces and purchases a myriad of specialized components. These include various types of adapters, assemblies, sockets, liners, gloves, locks, and suspensions. In addition, the industry uses special CAD/CAM (computer-aided design/computer-aided manufacturing) software for design purposes, different kinds of fabrication equipment, and materials such as leather, foam, grinding tools, and various resins and pigments.

PROVIDERS

Prosthetic manufacturers sell mainly to special labs and workshops. Staffed by trained and certified prosthetists and orthotists, these labs fill physicians' prescriptions for prostheses. The market for orthoses is somewhat different. Unlike most protheses, many orthotic devices are available without a prescription. In addition, only 30 percent of orthotic devices are sold to labs and workshops. The majority is sold to hospitals, pharmacies, physicians, and physiotherapists. Together, these providers serve as the main link between manufacturers and end users.

End Users

In the United States, more than one million amputees comprise the market for traditional prostheses like artificial limbs, hands, and feet. During the early part of the twenty-first century's first decade, the most common causes for amputation were chronic health conditions like cardiovascular disease and diabetes as well as certain types of cancer. As the wars in Iraq and Afghanistan continued into 2006, soldiers injured in battle but saved on the battlefield due to body armor and superior medical care comprised a larger part of the market than ever before. Industrial, farm, or automobile accidents were to blame in a smaller number of cases. In addition, birth defects were responsible for some individuals being born without certain extremities.

The target population for orthotic devices includes individuals with a broad range of physical defects or weakened body parts. While some of these conditions are present at birth, others result from injuries, disease, or poor biomechanics.

Common Devices

Technically, the term prosthetic can include a very broad range of internal and external devices, including artificial skin; facial parts such as artificial noses; glass eyes; artificial knees, hips, wrists, and fingers; artificial organs and organ parts, including hearts and heart valves; and even hearing aids and various dental apparatuses. Some of these are highly specialized and fall within the jurisdiction of other medical fields. For example, cardio-thoracic surgeons implant artificial hearts and heart valves, orthopedic surgeons perform joint replacement procedures, ocularists are professionals who specialize in working with artificial eyes, and anaplastologists craft artificial facial parts. However, the traditional prosthetic and orthotic market centers on artificial limbs and various types of orthoses.

Artificial limbs normally consist of pre-constructed, interchangeable parts. For example, it is possible for an amputee to select different knee, leg, and foot components. Prosthetists then custom fit and adjust prostheses based on an amputee's individual needs. This process involves creating a mold from the amputee's residual limb, which is used to ensure a comfortable fit with the socket located at top of the prosthesis. Traditionally, this has been accomplished by producing a plaster cast of the residual limb, which is then filled with plaster and used to produce a laminated polyester or plastic socket. In the case of transtibial prostheses, which correspond to the leg, care is taken to ensure that an amputee will not bear weight on the distal end of the limb, which includes bony protrusions. For the sake of comfort, leg amputees bear weight on the softer areas of the limb. A computer program can be used to measure the amputee's limb, and a plastics process called squirt shaping is used to craft a final, tight-fitting polypropylene socket. Different methods are used to actually secure an artificial limb to an amputee.

Replacing the natural lower leg, thigh, forearm, or upper arm is a strut, which is constructed of a strong substance like titanium. The strut protrudes from the socket and is normally covered by foam rubber fashioned into the shape of the original limb. The outer covering of the prosthesis may consist of a lifelike silicone-based compound as opposed to materials like metal, leather, or wood, which were commonly used during the twentieth century. Amputees often select highly functional prostheses with hooks or pincher-like attachments to use for some tasks as well as more cosmetic-looking prostheses for other occasions.

By the early years of the twenty-first century's first decade, amputees had several options for operating arm prostheses. One involved a harness and cable system, which used the person's body power to open and close the jaws of a mechanical pincher. Patients also could choose below-elbow...

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