Diving in to the Future

Orthopedics is still very much a growing industry. Designing products to meet demand in the marketplace is essential to both maintain and increase business. So when someone sees a market need that isn’t being satisfied, well, it only makes sense to speak up!

Many preventable product disasters have happened in the past because manufacturers simply weren’t listening to the marketplace. Do you remember New Coke, later renamed Coca-Cola II? Even Max Headroom couldn’t save that one. And when was the last time you snapped a picture with your Polaroid Camera or envied the new DeLorean cruising through your neighborhood? If only they had all been equipped with a flex capacitor—then things might have gone so much smoother.

But what did these products have in common? They simply didn’t meet the needs of consumers in the marketplace. People didn’t want a new Coke, they were happy with the old one. The Polaroid Camera on the other hand didn’t keep pace with the technology available, and fewer people were willing to be left shaking a picture for 30 seconds hoping it would come out right. To survive, you have to understand the needs of the market and be willing to pursue them.

Identifying the needs of the marketplace isn’t always easy, especially with knee implants. Are doctors happy with the same old implant procedure because they are more familiar with it? Or is technology going to quickly pass by the process we use now, leaving only old Polaroid pictures of what knee replacements once were? Of course, comparing knee implants to Coke or Polaroid is not exactly comparing apples to apples, but it does give insight into the mistakes manufacturers and product developers can make when market needs are overlooked.

Each year the number of total knee replacements is increasing. As this continues, patient satisfaction will remain one of the key elements to the success equation. When the surgery is a success the patients are happy. When the patients are happy the orthopedic surgeons are happy. When the orthopedic surgeons are happy the product sees more recommendations.

This equation must be understood in light of the ever-increasing number of patients to make happy. From 1998 to 2004 the number of total knee replacements in the U.S. grew from 257,000 to 455,000 per year, according to the American Academy of Orthopaedic Surgeons (AAOS). That is a 77% increase over a six-year period. In March 2006 a study was completed by Exponent Inc. and presented at the annual AAOS meeting. This study estimates that the number of primary total knee replacements will increase a colossal 673% in the United States by 2030. That’s 3.48 million total knee replacements a year!

Along with this large rise in procedures comes great potential from a number of perspectives including increased implant sales, increased instrument sales, and a higher demand for orthopedic surgeons to name just a few. But the goal here isn’t to point out the obvious; it is, rather, to speak up about one of the more quiet needs of this market: the growing problem of post-procedure infection in total knee replacements. Delving deep into the PearlDiver database, a sample was generated of 27,888 total knee replacement patients. This sample was then cross-referenced with various forms of infections for a closer look at the current infection outcomes for these patients. The results of this sample were then divided into two categories: patients infected with Staphylococcus, and patients infected with any kind of infection related to the procedure including but not limited to Staphylococcus, osteomyelitis, and pyogenic septic arthritis. From the information provided by the PearlDiver sample, results were then extrapolated to a national level as presented below in Table 1.

Table 1: Infections in Patients After Total Knee Replacement

The estimated national numbers are based on the national numbers released by the American Academy of Orthopaedic Surgeons for 2004. Disregarding the estimated future growth rate, we are already seeing over 24,000 patients each year with some form of infection post-surgery. Should the market continue its growth rate at the velocity that has been predicted, these numbers will make a dramatic jump as demonstrated in Table 2.

Table 2: Infections in Patients After Total Knee Replacement, 2030E

Immediately we see that while 1.3% of patients contracting a Staphylococcal infection seems insignificant when dealing with 455,000 patients per year, the number of infections changes dramatically by the year 2030. The 1.3% of patients infected has gone from 5,915 patients to 45,240 patients each year, and that’s just the patients who contracted a staph infection! The total number of infections jumps from a minuscule 24,115 to a hefty 184,440 patients. Doing the math, in 2030 the number of patients with an infection will equate to over 40% of the total surgeries done in 2004!    

The possible consequences of such numbers are alarming. In many cases of infection the results are not simply patient discomfort and slight pain. Infection not only hinders the rehabilitation process; it also, in some cases depending on the type of bacteria, causes the implant to lose attachment to the bone. The result of this scenario is another surgery to remove the implant, and the use of antibiotics to free the joint of infection. After the antibiotics have been given enough time (sometimes up to three months), a third surgery is then performed to implant a revised knee. While performing a revision due to infection is a nightmare for the patient, it is unfortunately not even the worst-case scenario. Staphylococcus aureus can be the cause of a type of septicemia called pyaemia, which can be very serious and in some cases even lead to death. Because of these dark possibilities, it would be an understatement to say it is important to minimize the number of infections occurring post-surgery. There is also a second component to this infection predicament. Again using the PearlDiver sample data in Table 1: Infections in Patients After Total Knee Replacement, within three months of total knee replacement surgery only 2.2% of patients had developed some type of infection. This number does not even account for half of the patients who will develop an infection, however. On a national level in the present, over 14,000 patients will develop some type of infection after the first three months post-surgery. Assuming all things remain constant, by the year 2030 this number will increase to over 100,000 patients.

These numbers are evidence of a growing need within the marketplace for a better solution to infection prevention. From a consumer standpoint the pain and potential health outcomes are not the only concerns to be factored into this equation. Those patients who develop infections can experience higher medical costs due to treatment, increased lengths of stay at hospitals, and lost time from work or their personal life.

There are a number of steps currently being taken, although we have yet to see any long-term abatement in the rates of infection, especially among patients diagnosed more than three months after the procedure. Such steps include hospitals adopting better techniques to avoid surgical infection, and research on new methods of instrument sterilization. Also, we are now seeing biologic methods, such as absorbent dressings, being added to surgical openings to prevent infection.

Looking forward, there are whispers of implants that will be better equipped to handle infections occurring months or even years after the implant procedure has taken place. There are ideas for orthopedic implants with the ability to communicate to the doctor from inside the patient’s body when infection is present around the implant. Thoughts have even gone to implants that already contain the antibiotics necessary to ward off infection. Once the implant detects an infection, those antibiotics are released. However, we have yet to see anything fitting these descriptions being approved by the FDA.