Thus far on this surgical robotics start-up journey we have walked through our recommendations on how to strategically scale up your engineering team with fiducial responsibility. Now that you have a (virtual) room of talented and motivated people it’s time to push everyone to design and build… right? Not quite. 

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At each stage of the development process, you are going to be building something different. Early on, you may be trying to construct a functional prototype that demonstrates key milestones and, more importantly, shows progress to the investors. As you progress however, you will have to build a system that takes into account all of the development concerns and not just a few chosen requirements. In either case, making sure your team is working efficiently towards the same goal will be your main challenge. So how do you employ guidance and create unity without slowing down progress? 

With a cohesive technical vision as your guide, the primary focus for you and the core team should be to create your system architecture. For the same reason you would not build your dream home without blueprints, you cannot plow ahead without a sound understanding of how all the pieces will fit together. The strongest system architectures provide a blueprint that clearly describe how a device is made up of separate components and, more importantly, how each of these parts are related to one another via various interfaces.  

It is all about efficiency in execution. Done well it will enable projects to stay on time from one technical milestone to the next, on budget from one funding round to the next, and lay out the full map of development to ensure trade off decisions are made with a systemic picture in mind. 

The system architecture helps maintain the technical vision and guides your team at each development stage. During prototyping, it lets you identify how to divide top-level requirements into separate modules that can be handled efficiently by the new team. It also lets you choose how other concerns (i.e. safety and reliability) may affect later design decisions and whether or not to make those trade off choices now or to build them in later.  

Core technical vision 

As you progress, the system architecture will allow you to manage the additional concerns and specifications that come with regulated medical device development, without losing sight of the core technical vision that should be baked into every facet of the design. The tradeoff decisions between physical modules, performance targets, and safety requirements are the difference between teams that constantly progress versus teams that are endlessly iterating.   

Let’s also look at it from a people management perspective. Your system architecture should enable you to make learned engineering decisions on how to divide up your newly hired team. Your blueprint will guide the formation of collaborative multidisciplinary sub-groups that can push the entire product forward via parallel pathways.  

The detailed plan will give each group appropriate sizing, clear direction, and will require the cross pollination of ideas with the transparency needed to ensure all components will eventually marry together successfully. This will give your senior team members the opportunity to upskill their new colleagues and lead from the front in the development process. It allows them to lay down the guide rails for development for the larger team and be confident that it won’t go off track. 

Your people will see and feel the success as they collaboratively work together and thrive in the efficient progress they are making individually, as a team, and as a company. All the while your technical vision will continue to play through the process via smart design choices, responsible cost decisions, and the inevitable conflict mitigation. A sound vision leads to sound decisions which will create life changing products. 

Performance requirements 

At this point you either agree or think this approach is a waste of time. If it’s the latter, let’s imagine for a moment you choose to go from hiring to building without doing any of the aforementioned work. You build an instrument team and a robot team but do not lay out the top-level performance requirements that need to be achieved by both groups. These choices are left to the individual teams to decide on. If you have been down this rabbit hole before you are either shaking your head or smiling as you know what is coming.  

Either way, this scenario will inevitably lead to delays and a high burn without progress as teams strive to make their own task ‘easier’ at the expense of the design efforts of the other team. In addition, if the design choices are made without an understanding or care for how the two components will be used together, you run the risk of over complicating aspects of the development process, resulting in employee dissatisfaction and frustration. Confusion will arise over what is the specific interface definition versus what is the rationale for the modular requirements. Caught in the middle will be you and your executive team trying to solve these problems while attempting to keep momentum moving forward.  

In my previous life, I was working with a robotics start-up which had a clear understanding of what the robot needed to do. However, the various teams did not have a cohesive vision of the robot as a system nor had they considered how the individual functions of the system should be modular yet still work together. Don’t get me wrong – the team was fantastic. Motivated, bright, and teeming with enthusiasm. But despite great people, the top-level, system-wide requirements and performance targets were not met. 

There was never a separation nor allocation of these requirements into different modules nor an understanding of how they would eventually come together. The respective teams were solely focused on meeting the individual performance targets of their modules. And while some of these modules worked as expected, the combination did not result in the desired system performance. What it did do perfectly was burn cash!  

Launching a medical device company 

And that is something no one can afford. Some analysts have postulated that a box of air would cost north of $150,000 and take more than five months just in regulatory costs and time for FDA approval. Bottom line, with everything that is required for launching a medical device company, from creating your company and IP landscaping to quality management systems and V&V, even the most straightforward robotic device requires $40-80MM in R&D spend to get through to submission. With that tight of a margin why squander a single hard-earned raised penny with anything but sound vision and strategic architecture planning? 

In closing, let your technical vision guide your new team. Document it in every aspect of internal communications so that it becomes the goal for the architecture you build. Allow that vision to lead you and your core team to a blueprint that determines how everything will come together to change medicine. And from there you will have given your engineers the most efficient runway to sprint towards milestone after milestone and eventually commercial success. 

As we continue to explore the topic of bringing transformational medical products to market and advising start-up companies towards profitability, we will explore our advised steps along the pathway to success. We look forward to having you join us for those discussions. Here’s to being the architect of your own success in 2021! 

Author
Andrew Savarese
Vice President, Surgical Robotics & Advanced Surgical Systems

Andrew has spent the past 15 years helping start-ups with the growth and utilization of surgical robotics and image guided systems. He currently leads the commercial effort to help clients realize the robotic platforms of tomorrow.