Advice to optimise the development of surgical robotics

In this second discussion, Andrew shares fresh perspectives on the factors shaping the next generation of surgical technology, and how PA approaches these critical milestones. (If you missed our first interview with Andrew, you can catch up here.)

What is the most common afterthought that you see in the development process?

Without question it is the Human Factors or user experience aspects of a system being considered far too late in the development process. Now I know focusing on the technology which makes your system unique is what drives investor interest and differentiation, but if you are not considering early on how the user will interact with it you will be setting yourself up for not only regulatory challenges and potential development re-work but also potential commercial failure. The key questions to ask are what are the needs we are trying to address and how are we going to meet them, so we understand right from the very start not only what we are making but why we are making it.

At PA, our Human Factors team keeps these questions front and centre throughout the development. We are constantly asking: What does a surgeon need to accomplish in a specific procedure? How can user interactions with early prototypes help inform design choices and development trade-offs? And what are the physical and digital interaction points that determine the total user experience? By answering these questions early on, and being mindful of them throughout, we can make sure we’re on the right track in everything from defining the system architecture to making early trade-off decisions before we get too far down the technical road, when it is more costly and takes longer to fix. I have seen in many cases Human Factors formative testing come as an afterthought when looking at the list of things that need to get completed for a regulatory filing, however the intent of formative evaluation is to inform the design and there is invaluable learning from these explorations which, when integrated thoughtfully into the design, can actually enable faster development timelines, lessen the chance of re-work, and increase the likelihood of commercial success on launch.

What is the importance of user interfaces in these surgical robotic systems?

Robotic systems are disruptive technologies, changing the location and approach surgeons use to treat their patients. But an artfully designed user interface that is a Interview Two natural extension of the surgeon minimises this disruption when the line between the surgeon hand and robotic controller is blurred. A seamless interface acts as mechanical replication of a surgeon’s hands and when it “just feels natural” you remove one of the early objections surgeons will have to using the system.

The interface should be easy to learn, fit all different sizes and shapes of hands, and appeal to all different levels of experience of surgeons. They shouldn’t know where the robot begins, and their hands end. And that is the ultimate experience. Beyond that, it’s not just what physically sits in their hands or what they’re controlling; it’s the digital experience as well.

At PA, we focus on the physical and digital aspects of the interface design because so much of the design is around how surgeons need to engage with the patient’s anatomy. Surgeons are being bombarded with data in the operating room from all types of devices and so the goal is to ensure for the robot the user interaction reduces the cognitive burden, where they’re not having to look at distractions on a screen or their hands constantly to process it all The best interfaces combine those digital elements with the physical to give surgeons greater control and autonomy in the operating room enhancing the entire operative experience.

What do you often recommend to surgical robot companies, start-ups in particular?

At PA, we speak with lots of organisations from start-ups to large multinationals, all looking to build complex digital surgery platforms. After we have established that this is not technology looking for problems to solve, the first question we ask all of them; is your architecture set up for extensibility?

Now there’s certainly a need for teams to get to certain milestones, to secure investment or satisfy internal program goals in the product development process. But that does not mean you cannot build your architecture to account for future development opportunities like advanced energy, imaging, or most importantly, digital capabilities yet to be unlocked.

If your architecture is set up for this from the start, companies can save a lot of time and cost down the road, not having to go back and re-architect the entire system later on. With that extensibility built in upfront, you have a great foundation to build on and the ability to go further faster in future generations.

The other recommendation we usually give, especially to start-ups, is to focus on the reliability of engineering. This requires planning, a concerted effort, and of course, expertise. Having a reliability engineer or teams for that matter is not the luxury some think it is, as the cost of high failure rates will not only erode margins upon launch but also surgeon confidence in your system. Building this in throughout the development also provides a great foundation to develop from as you look to generation 2 and beyond. And trust me, even the “best of teams who make fantastic development decisions,” as I hear often, don’t always equate to perfection in the hands of the uncontrolled commercial user. A focus on reliability will ensure the best of teams have next-generation systems to work on.

How does PA take on board the cost-competitive environment during the development process?

At PA, we work with organisations from end-to-end, looking at the entire development path and not just small segments within a larger effort. Throughout all of this, the commercial goals of our clients stay front and centre. So, what does this look like?

Overengineering all components of a system so you can hit requirements and achieve the quality and reliability mentioned before means your COGS will increase exponentially. No point in having the greatest system in the world if the acquisition cost is so high it is unreachable for even the largest and busiest hospitals and health systems. So, our focus is to make learned trade-off decisions based on lived experience at every step to ensure we can achieve the requirements without destroying the COGS in the process.

Build vs. buy: Which is best?

It all comes down to the surgical challenge you’re trying to address in the operating room, and as we just talked about, what is the commercial strategy for the system? With well-defined requirements, the next step is assessing what technological components will get you there without assuming everything needs to be custom-made. At PA, we have the luxury of pulling from experts across industries to find the right path forward in a development, but there are plenty of examples of successful such paths on the market today. For instance, look what Auris was able to do with Kinova’s medical robotics solutions. They saved valuable development time and were able to focus resources and time to end effectors and interfaces without having to burn exorbitant development capital on the arms themselves.

In fact just in the past two weeks we were working with a client who was looking at a custom development that would have taken at least 24-30 months and an additional $25MM in development costs, but a joint brainstorm of what they wanted to achieve and the collective mindshare of the team at PA allowed us to find numerous solutions in development at device companies that would fit the needs for their intended use. The subsequent meetings and potential for licensing or joint commercial arrangements allows that $25MM to stay devoted to the other differentiating aspects of their system.

However, as robotic systems become more specialised there will be plenty of cases where existing solutions don’t meet the technical demands. In those instances, building new becomes necessary. Ultimately, the decision hinges on the procedure you’re enabling, the problem you’re solving, and the tools required to get there. If off-the-shelf options can accelerate progress this is your best option. But when innovation is essential, building, and the cost and time associated with it, is the only path forward.

This article was first published in Surgical Robotics Technology.