The Cycle of Innovation: The IDEAL Framework

Mohit Bhandari, M.D., MSc, FRCSC
Department of Surgery and Department of Clinical Epidemiology & Biostatistics, McMaster University
Hamilton, ON

Orthopaedic surgery is a highly innovative specialty. The rapidity of innovation often outpaces the opportunity to conduct scientifically rigorous studies to ensure patient safety and efficacy. The cycle of innovation, in its current state, often results in the removal of one in four new devices from the market within five years, and about three of four devices within ten years¹.

Barkun and the Balliol collaboration proposed a framework for bringing new products to market. Innovation, according to Barkun, is defined as "a new or modified surgical procedure that differs from currently accepted practice, the outcomes of which have not been described, and may entail risk to the patient"². Stages of surgical innovation are summarized in an IDEAL framework: Innovation, Development, Exploration, Assessment and Monitoring². The research associated with the first few phases includes bench science, pivotal case reports, and early case series. In the Monitoring phase, Barkun and colleagues suggest the use of registries and randomized trials. While this approach clarifies the methods of surgical innovation, it may not entirely reflect the current state of bringing new orthopaedic devices to market.

Both medical devices and drugs are regulated by the Food and Drug Administration (FDA) in the United States. Most medical devices are primarily evaluated on their ability to prove 'substantial equivalence' to previous or preexisting devices. Only when a device doesn't meet the criteria for 'substantial equivalence' will the manufacturer need to conduct non-clinical laboratory studies and clinical investigations in order to demonstrate the device's safety and effectiveness. However, the process of obtaining FDA approval for a new drug is considerably more rigorous and costly (Table 1). Regulatory approval of a drug requires a series of phases including safety studies, dose response studies, pilot randomized trials and pivotal (definitive, confirmatory) randomized trials. The time associated with drug development can span over a decade - and the costs for a 'blockbuster drug', approximately one billion dollars. A device, on the other hand, is often regulated through a 510(k) mechanism, which allows the manufacturer to obtain rapid market approval of a medical device by demonstrating 'substantial equivalence' to a pre-amendment or preexisting device. This process requires substantially less evidence, can be achieved at significantly lower costs and is the preferred route for most, if not all new devices in the field of orthopaedics.

Is the current standard for bringing new orthopaedic devices to market ideal? It would certainly appear that the current system is problematic, if not seriously flawed. The FDA is underfunded and severely under-resourced. It functions in what has been referred to a series of "crisis-regulation" cycles and is in need of reform. Fundamentally, the process of bringing devices to market requires high signal, low noise (less bias) studies that provide compelling evidence of safety and efficacy. One might argue that the current approach to bringing devices to market with limited clinical data and 'strategic marketing' is frankly intolerable - and if left unchecked, potentially dangerous to orthopaedic patients worldwide.

Table 1. Comparison of New Drug, 510(k), Premarket Approval (PMA) Regulatory Processes

Modified from Kirkpatrick & Stevens³

* Data from the mid-1990's

† Refers to orthopaedic devices which submitted an original PMA between 2001-2010

‡ Data from 2005⁴