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SURGICAL PERSPECTIVES

Making the Leap

the Translation of Innovative Surgical Devices From the Laboratory to the Operating Room

Marcus, Hani J. MRCS; Payne, Christopher J. PhD; Hughes-Hallett, Archie MRCS; Gras, Gauthier MRes; Leibrandt, Konrad MRes; Nandi, Dipankar DPhil; Yang, Guang-Zhong PhD

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doi: 10.1097/SLA.0000000000001532
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Abstract

The development, evaluation, and adoption of innovative surgical devices are essential to the advancement of clinical practice.1 Despite the enormous importance of these devices to human health, the process by which biomedical innovations arising from academia find their way to translation remains poorly understood.2 Any earnest attempt to foster a more nourishing environment for translational research should be predicated on a better appreciation of this process.

The translation of an innovative surgical device has been described as a continuum of activities, punctuated by several well-defined chasms: the development of the device culminating in a first-in-human study, the evaluation of the device in clinical trials resulting in a license for use, and the adoption of the device by surgeons.3

Previous studies on the translation of biomedical innovation generally report a long lag between innovation and translation—approximately 17 years—and suggest that industry collaboration is the most important predictor of translation.4,5 However, these studies largely focus on drug rather than device innovation, and on their evaluation and adoption rather than their development. To address this shortfall, we explored the process by which surgical devices described in the biomedical literature make the leap to first-in-human studies.

A MULTITUDE OF INNOVATIVE SURGICAL DEVICES ARISE FROM ACADEMIA

We used the ISI Web of Knowledge Journal Citation Report (Thompson-Reuters, New York, NY) to identify all Biomedical Engineering journals, and the 5 basic Science journals with the highest impact factor. These journals were then searched on the NCBI PubMed (NCBI, Bethesda, MD) and IEEE Xplore (IEEE, New York, NY) databases between January 1993 and January 2000 using the Boolean search term “surgery OR surgical OR surgeon” to capture publications describing innovative surgical devices.

Devices were defined according to the US Food and Drug Administration as “...products, which do not achieve their primary intended purposes through chemical actions within or on the body of man or other animals and which are not dependent upon being metabolized for the achievement of any of their primary intended purposes.” When multiple publications were found that described the same surgical device, the earliest publication was used for subsequent analysis.

In all, 8297 article titles and abstracts were screened, of which 205 described innovative surgical devices and were included. The original articles were most commonly published in ASAIO (57/205; 27.8%) and Artificial Organs (55/205; 26.8%), and the majority of the corresponding authors were found in the United States (59/205; 28.8%) and Japan (56/205; 27.3%). A multitude of devices were observed, but most were implants (149/205; 72.7%) and constructed for a specific disease or application (179/205; 87.3%).

FEW DEVICES MAKE THE LEAP FROM THE LABORATORY TO A FIRST-IN-HUMAN STUDY

We then determined the rate and extent to which innovative surgical devices made the leap from the laboratory to a first-in-human study. A publication was considered to describe the translation of a particular device if it was clearly referenced in the article and an uninterrupted citation chain to the original article could be identified.

For each innovative surgical device, we searched through all citations to the corresponding article published before January 2015 using the Web of Science (Thompson-Reuters, New York, NY). All citations to an article were sorted according to their date of publication (oldest first) and screened to find the first clinical publication using the device. If no clinical publications were found, citations were then screened to identify articles by any of the original authors describing subsequent development of the device and, if so, the process was repeated.

Overall, 24/205 (11.7%) of innovative surgical devices were associated with a first-in-human study. Kaplan-Meier curves were constructed, and the probability of a device resulting in a first-in-human study at 5, 10, and 20 years was 7.8%, 9.8%, and 11.8%, respectively (Fig. 1).

FIGURE 1
FIGURE 1:
Kaplan-Meier graphs illustrating (A) the overall probability of a first-in-human publication over time, and (B) the probability of a first-in-human publication over time stratified according to whether there was clinical involvement (green line) or not (blue line).

Contopoulos-Ionnidis et al5 evaluated the translation of promising basic science research but, unlike the present study, they focused on drug rather than device innovation, and included work that had already been used in humans. They concluded that even the most promising basic science research, published in journals with the highest impact factors, was rarely translated; 5.0% of innovations were licensed, and 1.0% were widely adopted. In the present study, the leap from initial device description to first-in-human study represented a major barrier.

CLINICAL COLLABORATION IS KEY TO NOURISHING THE TRANSLATIONAL RESEARCH ENVIRONMENT

Finally, we evaluated the factors influencing translation (clinical involvement or not; industry involvement or not; instrument or implant; single disease or broader disease category) using log-rank (Mantel-Cox) and Cox proportional hazards models. The extent of clinical involvement was a significant predictor of a first-in-human study (P = 0.02; Fig. 1). Devices developed with early clinical collaboration were over 6 times more likely to be translated than those without [RR 6.5 (95% confidence interval 0.9–48)]. Other variables, including the extent of industry involvement, were not significantly associated with translation (P > 0.1).

In recent years, there have been several initiatives to increase the translation of innovative surgical devices.6,7 This study is the first to provide quantitative evidence to support the idea that clinical collaboration is associated with more rapid and extensive translation. Interestingly, and in contrast to previous studies, industry collaboration was not associated with increased translation.5 We speculate that the reason for this disparity lies in the varying role of clinical and industry collaboration through the continuum of translation. Early translation may be more reliant on clinicians to drive first-in-human and early clinical trials, whereas later translation may be more reliant on industry to navigate the complex and costly licensing pathway, and market devices to the wider clinical community.

In summary, improved interactions between basic, translational, and clinical researchers may facilitate the translation of innovative surgical devices from the laboratory to the operating room. In the words of Henry Ford: Coming together is a beginning; keeping together is progress; working together is success.

REFERENCES

1. Sagar SP, Law PW, Shaul RZ, et al. Hey, I just did a new operation!: introducing innovative procedures and devices within an academic health center. Ann Surg 2015; 261:30–31.
2. Volk HD, Stevens MM, Mooney DJ, et al. Key elements for nourishing the translational research environment. Sci Transl Med 2015; 7:282.
3. Drolet BC, Lorenzi NM. Translational research: understanding the continuum from bench to bedside. Transl Res 2011; 157:1–5.
4. Morris ZS, Wooding S, Grant J. The answer is 17 years, what is the question: understanding time lags in translational research. J R Soc Med 2011; 104:510–520.
5. Contopoulos-Ioannidis DG, Ntzani E, Ioannidis JP. Translation of highly promising basic science research into clinical applications. Am J Med 2003; 114:477–484.
6. Lost in clinical, translation. Nat Med 2004; 10:879.
7. McMurry-Heath M, Hamburg MA. Creating a space for innovative device development. Sci Transl Med 2012; 4:163fs43.
Keywords:

diffusion of innovations; innovation; surgery; technology

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