Thinking about wading into robotic surgery? We’ve got some advice for you

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Senhance TransenterixThere are a handful of companies in the robotic surgical space. But that is about to change. There is ample evidence that the robotic surgical device market is going to explode in the next 3 to 5 years.

We recently spoke with Todd Pope, CEO of TransEnterix who said there is a lot of opportunity in the market: “If you look at Europe and the U.S., there are 4 million open procedures and 6 million laparoscopic procedures done each year.”

Pope noted that even critics of robotic surgery agree that the technology space is growing. “I don’t think there is any analyst that doesn’t have the market growing by 300–400% over the next 5 to 7 years.” Pope said he is looking forward to others being in the market because it will drive more interest, more applications and more opportunity to find out where a robotic surgical application can make a difference and expand markets.

But the robotic surgical device market has a high barrier to entry – and the big competitors have more than a decade of experience under their belts. With that in mind, we thought it might be important to share some advice to those firms thinking about entering the fray.

For that advice, we turned to product development firm Sagentia, which  recently developed a downloadable white paper entitled, “Insights from the operating room: How does robotics change the established protocols for developing next-generation surgical instruments?”

The Sagentia paper offers 5 steps to begin thinking about robotic surgical device design from a user perspective, outlined here:

Step 1: Consider your ethnographic approaches

Ethnography and voice of the customer (VOC) research elicit the full range of stakeholder requirements for any new medical device development. These tools provide extensive contextual experience directly from within the operating room. Successful VOC research projects require an understanding of the setting (e.g., the operating room); current products, approaches and technologies being used; who the stakeholders are; and, finally, how the outcomes of the VOC work will be used and fed into the product development process.

Step 2: Fully understand the setting in which the device will be used

The location of individuals during a robotic surgery and the movement of staff throughout the case may differ compared to traditional surgery. These differences can lead to changes in procedure, steps and timing.

In a robotics case, surgeons are often not operating from within the sterile field. Instead, they work from behind a seated robotic console from where they control robotic arms and view the surgical site in 3DHD.

However, they might be scrubbed in and patient-side at first, to assist in selecting the initial incision site and robotic port placements. The surgeon (or assistant) may need to scrub back in at the close of the procedure to suture up each of the robotic port incisions and apply a local anesthetic to each incision.

There are several other healthcare professionals – including an anesthesiologist, a rotating nurse and 2 additional nurses – situated within the surgical field next to the patient. The rotating nurse is responsible for several activities including the robot-specific activity of docking the robotic surgery platform to the patient bed. The surgeon guides the robot next to the patient. The nurses within the surgical field may have varying levels of responsibility, depending on how an individual surgeon or hospital conducts robotic operations. The main assist, or PA, in the sterile field is responsible for the introduction of tools and robotic devices into the body cavity during surgery and may also control a laparoscopic grasper through an additional incision or assist port. This assist port may be used in certain procedures to provide support and tension to tissue, when needed, and assist in the manipulation of products within the body.

Step 3: Understand the current approaches and technologies used

What is the current gold standard? What products are care providers using to treat patients and why are they selecting them? Robotic platforms are constantly working to become less invasive: Port sizes are getting smaller, and companies are exploring technologies that may remove the need for an incision altogether. The need to make surgery easier and minimize the chance of complications is at the heart of the growth in robotic technologies. It is also fundamental to any new product introduction that manufacturers demonstrate to regulators and other stakeholders the effectiveness of their offering compared with current tools and techniques.

Step 4: Identify and understand the needs of all stakeholders

The added dimension of the robot as an interface between surgeon and patient complicates the OR stakeholder interactions but also opens up an opportunity. Regardless of whether it is open, traditional laparoscopic or robotic, surgical goals are similar. You want to access the surgical site in question, perform the necessary steps to treat the problem in a minimally-invasive manner, close up the access wound sites and prepare the patient for postoperative recovery. In each scenario, you have a surgeon, an anesthesiologist, several nurses and support staff. However, there are nuances to the workflow, staffing and training that may impact associated product needs.

The added dimension of the robot as an interface between surgeon and patient complicates the OR stakeholder interactions but also opens up an opportunity. Regardless of whether it is open, traditional laparoscopic or robotic, surgical goals are similar. You want to access the surgical site in question, perform the necessary steps to treat the problem in a minimally-invasive manner, close up the access wound sites and prepare the patient for postoperative recovery. In each scenario, you have a surgeon, an anesthesiologist, several nurses and support staff. However, there are nuances to the workflow, staffing, and training that may impact associated product needs.

Meanwhile, the surgeon is remote from the patient and the robot is now patient-side. This may become a consideration to aspects such as tool exchange and introduction or response to complications which, in the extreme, may require converting to an open approach. An exciting aspect of the new robotically-assisted OR is not just accommodating these practical differences but capitalizing on the new capabilities the robot can provide. Improved stability, dexterity, ease of access to otherwise awkward locations all have the potential to open up new procedural techniques and there would undoubtedly be consequences to the ancillary products that are needed in these cases.

Step 5: Understand that you are developing against a moving target

You need to ensure that your project will still be relevant when it delivers. The operative care environment can be a busy place. When it comes to providing care, there are numerous products available and, across providers and geographies, different policies in place. Combine with this, the pace of innovation and resulting surgical approaches emerging, it becomes increasingly important to clearly define the scope for any new research or development project and fully understand how the results will be employed for next-generation builds. Next-generation robotic platforms are likely to include machine learning and advanced intra-operative imaging capabilities allowing surgeons to detect risks and change surgical approaches in real time. There are tools that can be used to combine contextual research with future market trends to help build a picture of the unmet needs of that future world. In a dynamic area such as this, adopting these kinds of techniques will help ensure current innovation efforts will address those future requirements.

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