Barriers to Adoption of Novel Technology

The evolution of orthopedic surgery is closely associated with the introduction of new implants and technology. The ushering in of novel technology creates a financial conundrum that places the physician in the middle of conflicting interests of the hospital, device manufacturer, third-party payer, and governmental regulatory agencies. The oath that we take as physicians is to provide the best possible outcomes for our patients at the lowest possible risk. The reality of clinical practice in the United States is that we must also partner with our affiliated health systems to keep them financially viable—that is, “no margin, no mission.” To provide the most up-to-date care, we must work collaboratively with third-party payers and the device industry by aligning our varying objectives, interests, and motivations.

For technology that does not meet clearance criteria based on similarity to a predicate device, the first step in the process of introduction to the medical marketplace is a rigorous pre-market approval (PMA) by a neutral regulatory agency, such as the United States Food and Drug Administration (FDA). Once the new device or technology passes both a minimum of a non-inferiority comparison to available technology and demonstrates a reasonable safety profile, physicians are allowed to offer these new products to informed patients. Using the market model of health care, surgeons and patients should engage in the shared decision making (SDM) process to determine individual risk-benefit profiles and decide whether they wish to use the new technology or product. This market-driven model of product introduction would lead to the increased use of the best technology and the decline or abandonment of products deemed to be ineffective or cost-inefficient.

There are currently several impediments to the seamless application of this patient care model. Insurance companies are often reluctant to reimburse for new technologies, stating they are experimental, even when initial investigations suggests otherwise. At the same time, the device manufacturers often charge significantly higher prices for new technology. These higher prices are necessary to cover the exorbitant costs of the regulatory process itself. The system comes to a halt as surgeons are unable to provide access or study new technologies due to increased cost and lack of reimbursement.

From the perspective of insurance companies, the primary aim appears to be cost containment. In the short-term, new technology always presents increased costs. Successful technologies provide better care and cost-effectiveness in the long term. Unfortunately, insurance companies do not have long-term outcomes or efficacy data at the introductory time point to know whether a technology will be cost-effective. Insurance companies may benefit by obtaining counsel from unbiased, experienced surgeons with knowledge of the specific clinical market. Onboarding surgeons early may enable third-party payers to selectively allow the introduction of new technology or devices with a beneficial risk-benefit ratio, while holding back on those technologies or devices with less favorable safety profiles.

Device manufacturers seek to maximize sales for a given new technology in order to defray the high developmental costs associated with product development, the regulatory process, and eventual marketing. High initial sticker prices tend to limit access to technology and subsequently limit clinical studies that might achieve the desired threshold of clinical efficacy. Though counterintuitive, decreasing initial sales prices might benefit companies in the long-term by increasing sales volume, encouraging scientific analysis of the product, and fostering permanence of the technology.

As surgeons, our primary goal is to maximize value by improving outcomes and minimizing costs. The determinant of whether a new technology, implant, or technique becomes the gold standard is rigorous scientific evaluation demonstrating clinically meaningful improvement in value. The onus is on us to work in conjunction with insurance and device companies to eliminate inefficiencies that halt us from utilizing and studying promising new technology.

Supplemental Material

FAI774574-ICMJE – Supplemental material for Barriers to Adoption of Novel Technology

Supplemental material, FAI774574-ICMJE for Barriers to Adoption of Novel Technology by Nitin Goyal, Daniel D. Bohl and Kamran S. Hamid in Foot & Ankle International