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Is Surgeon Driven Innovation the Future for Medical Device Development?

Wed, 09/04/2013 - 2:57pm
Fiona Haig, Manager—Surgical Sector, Sagentia

Anyone who has ever been in an OR with a surgeon will know that pleasing them with your new device is no mean feat! So should we be looking at surgical innovation in a different way? Is industry completely misaligned to the needs of the surgeon and should we be looking to our surgeon customers to drive our approach to innovation?

At Sagentia, we recently undertook a survey to canvas both medical device developers and surgeons who are the direct users of those devices to further explore surgical device innovation pace and direction.

The results, on the whole, show a good alignment between the surgical community and medical device developers. Both groups gave the same level of importance to features including ease of use, navigation support, and the usefulness of additional data during a procedure (such as tissue/pathology identification). However, there were a couple of areas that provide food for thought in terms of how, as developers, we might address innovation in surgery.

Ease of Use
Both groups agree that “ease of use” would be the most important development in surgical instrumentation, but what does that really mean? Sagentia has seen a big push in the application of “human factors” in device design over the last few years; but is ease of use really about workflow, ergonomics, and color coding for surgeons or is it about allowing them to do more with what they have? Might, in fact, this ease of use be about employing human factors in its more holistic sense to truly understand and address an unmet need? Might “ease of use” be using one instrument rather than three or being able to exchange a laparoscopic instrument without losing the target site for example? Although ergonomics are clearly important, we believe that it is actually by spending more time fully understanding the individual unmet needs behind each instrument that developers will make their devices easier to use in the eyes of the surgeon.

‘Smart Instruments’
Different areas of surgery have adopted different levels of technology in their instrumentation. The traditionally more conservative instrumentation used in the orthopedic community has seen augmentation with navigation and niche sensor products in the last 10 years but has not adopted technology innovations to the level that general surgery has with energy-based devices, complete robotic surgery, and single incision procedures. Is this because surgeons don’t feel the need for it, or will the market not tolerate the price of it? Shouldn’t it come down to whether there is a clinical benefit from it? For that, surely we should be looking to those people who are using our products to affect those clinical outcomes?

Our survey showed that the percentage of surgeons who felt that the inclusion of sensory feedback in an instrument is extremely important was 77% higher than the medtech respondents. This doesn’t necessarily mean that industry is out of touch with its users—several of those respondents in the medtech industry, while acknowledging this desire from surgeons, were skeptical as to whether the market would tolerate the inevitable cost increase the inclusion of such technology would create. This is perhaps a rather realistic view given the survey showed that surgeons rated cost as the primary barrier to the adoption of new technologies such as surgical robotics. So, can the wants of surgeons truly drive our industry during these times of austerity? I would like a Porsche 911, but it doesn’t mean I am willing or have the means to pay for one!

Surgical Robotics
We have seen a great deal of R&D activity in surgical robotics over the last five years. Start-ups have been springing up across the globe, hoping to capitalize on the buzz that Intuitive Surgical have led with its da Vinci system, but with the majority of surgeons in our survey viewing robotics as purely a marketing tool, is there really a market need for innovation in this area? Over 70% of surgeons we surveyed make little or no use of surgical robotics, although the medtech community felt that the primary reason for the lack of a more prolific uptake of robotic systems in surgery is the dearth of availability of such systems in hospitals rather than their cost. However, if surgical robotic systems could be made more cost effective then this would increase their likelihood of availability within hospitals and, as such, result in more common use by the surgical community. The majority of medical device developers we asked believe that the future of surgical robotics lies in smaller, more procedure-specific devices and we believe through this approach, we can achieve production of more robots that are more affordable and better targeted.

Surgical robotics is an area where I strongly believe that the medical device industry needs to lead innovation that will drive better clinical outcomes, which surgeons ultimately desire. By going back and looking at the fundamentals of surgery, we can understand the true, clinical objective, and use technology to achieve these objectives in ways that a surgeon’s mortal eyes and hands cannot. We can deliver energy to places deep in the body through minimally invasive incisions; we can use enhanced visualization to give surgeons more information than their own eyes ever could in order to improve decision making; and we can perform lengthy procedures in a fraction of the time by tying together pre-operative planning, imaging systems, and robotic technologies to quickly identify surgical sites in seconds. All this can only be driven by technologists.

So in my view, surgeons clearly still have a big role to play in the innovation of surgical devices, but it is our responsibility as technologists to take their clinical experience and push the boundaries of what is surgically possible through the appropriate application of technology in order to deliver better outcomes for patients.

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