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The Cycle of Innovation - The IDEAL Framework

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 5 years, and about three of four devices within 10 years.1

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: 2

  • Innovation
  • Development
  • Exploration
  • Assessment
  • Long-term Surveillance

The research associated with the first few phases includes bench science, pivotal case reports, and early case series. In the Long-term Surveillance 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.

Current FDA Approval Process

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 pre-existing devices. Only when a device does not meet the criteria for "substantial equivalence" will the manufacturer need to conduct non-clinical laboratory studies and clinical investigations to demonstrate the device’s safety and effectiveness.

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 $ 1 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 pre-existing 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.

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

 

510(k)

PMA

New Drug

Requirement for Clinical Data Demonstrating Safety & Effectiveness

Only in 8% of cases

Yes, albeit with small, short-term trials that often are not randomized

Yes, requires high-quality randomized trials (Phases I – III)

Average Cost from Application Submission to Marketing

$13 million†

$36 million†

$802 million

Average Time from First Submission to Marketing

125 days (joint)
145 days (spine)

1318 days††
(3.6 years)

4-12 years

Number of Applications per Year ‡
 

3,130

43

N/A

Application Fee

$4,000

$218,000

N/A

Modified from Kirkpatrick & Stevens 3

† Data from the mid-1990s
†† Refers to orthopaedic devices which submitted an original PMA between 2001-2010
‡ Data from 2005 4

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.

Key Points

1. One in four orthopaedic devices are no longer on the market within 5 years of approval.
2. Devices are regulated through a mechanism that allows many to reach market with limited clinical data.
3. Frameworks for surgical innovation must include processes to ensure rigorous safety and efficacy data.

References

  1. Bhattacharyya T., Blyler C., Shenaq D. The natural history of new orthopaedic devices. Clin Orthop Relat Res. 2006 Oct;451:263-6.
  2. Barkun J., Aronson J., Feldman L.S. et al. Evaluation and stages of innovation. Lancet 2009; 374:1089-96.
  3. Kirkpatrick J.S., Stevens T. The FDA process for the evaluation and approval of orthopaedic devices. J Am Acad Orthop Surg. 2008 May;16(5):260-7.
  4. Feldman M.D., Petersen A.J., Karliner L.S., Tice J.A. Who is responsible for evaluating the safety and effectiveness of medical devices? The role of independent technology assessment. J Gen Intern Med. 2008 Jan;23 Suppl 1:57-63. 

Reprinted with permission from the Fall 2011 issue of the COA Bulletin

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