Jeff says: To take advantage of increasing interest in antibiotic bone cement, Dr. Karl Erban needed help answering important questions about its efficacy and safety. Answering those questions has led to decades of commercial success.
How It Started
In 1975, while working as the Assistant Director of R&D for Howmedica, I came into contact with Dr. Karl Erban, an orthopedic surgeon working in Germany, who had conceived of a new kind of bone cement containing antibiotics. His particular mixture of antibiotics had the potential to prevent latent infections which commonly occur after hip replacement -- a problem eliciting growing concern. He added antibiotics to the cement at the time of surgery in amounts which would leave the strength characteristics of the bone cement unaltered.
Making the Case
Dr. Erban's cement was not the first antibiotic bone cement on the market -- in fact, it was one of two competing products. Nevertheless, the market for antibiotic bone cement was only just emerging, and a clear winner had not been established, largely because of a lack of hard data backing up the efficacy and viability of antibiotics in bone cement. This was a moment of real opportunity, because whoever could create this data package first would become a market leader.
Creating such a data package was exactly the kind of value I could bring to Dr. Erban, because Howmedica was the leading manufacturer of bone cement world-wide. His greatest advantage was that the cement had already been used by over 1,000 patients in Dr. Erban's clinic -- yet, beyond the fact that they had not come back to report latent infections, there was nothing to prove that it had been effective. Similarly, there was no published clinical research supporting the efficacy of the antibiotics he used, the mechanical integrity of the augmented bone cement, or the ratio of cement to antibiotics. Furthermore, Dr. Erban mixed the cement himself in the operating room. Significant work had to be done before his patient-by-patient approach could be adapted to a mass-production pharmaceutical blending process.
I was incredibly enthusiastic about the cement, and once I came on board I marshaled a small team of scientific, manufacturing, and marketing professionals to make the case for the product and refine its manufacturing. With several orthopedic surgeons, we drew up a protocol and performed an exhaustive study of the efficacy of the antibiotics used in the cement. We published results about the antibiotic bone cement in an international journal of scientific research. And we refined the manufacturing process until it could be commercialized, even finding one of the few sites in the world -- Pfizer in Karlsruhe, Germany -- where the delicate, aseptic pilot manufacturing could take place.
Today's Antibiotic Simplex
Eventually, we further refined the manufacturing and moved it to a plant in the UK where a patented aseptic filling process was developed. That manufacturing plant is still in use today. By 1978, Simplex Antibiotic Bone Cement had been introduced in Europe by Howmedica, and since then it has generated nearly $40 million in sales. It remains a part of toolkit in many orthopedic surgeries in Europe. Howmedica, now Stryker Corporation, remains the world-wide leader in bone cement.