The development team that develops the surgical robotic system comes from a variety of different
disciplines.
We have traditional mechanical, electrical, and software engineers, as well as specialized
skill sets and control system design, user interaction, human factors, and a clinical
engineering role that bridges the gap between engineering and clinical use.
The design cycle for a large product development cycle like da Vinci has many key phases, but
also is very iterative.
We start off in really needing to understand what we call the product requirements where
we spend with time with the users to really know what their needs are and exactly how
the product should perform.
Once we have that input, then we go and we build several sub-systems and prototypes to
really evaluate the performance and the usability of what we learned.
There's significant iteration in that process and really trying to get to exactly what the
users want.
We do internal testing to make sure that performance is as we need it.
We also bring back those users to make sure that we actually have reflected what their
requirements were and what learned from them during the product requirements phase.
Once we have that, we've iterated several times, we get to our final design where we
say we’ve got the requirements.
We have the specifications.
And we go and we build a product that represents those.
We then move into a final verification and validation phase which takes that product
and goes through a rigorous set of verification and validation.
Oftentimes, during that cycle, we will find things.
We'll iterate back some small design changes and we work through that.
And eventually, we come out with a product that's ready for release.
At that point in time, we typically have a FDA submission through the regulatory body
to get the product approved for use in the field.
And then we also have internally an important transition phase to take it from engineering
to manufacturing to make sure that these can be manufactured in a reliable and repeatable
way.
The da Vinci system is a heavily regulated device, and the FDA recognizes certain standards
that we take into consideration in our design, and they become specifications and requirements
for what we need to achieve with our design.
They also come out with industry guidances on certain topics that they're interested
in.
Patient safety is top priority during the design process, and this is accomplished by
doing a comprehensive risk assessment of the product.
And we start off with a clinical risk assessment where we look at use of the product inside
the operating room and what potential risks there are in while it's being used, and identify
mitigations that are necessary to implement.
The engineers take this as design input and use it for selection of components such as
motors and sensors, and then also from a software perspective identify what the characteristics
of the algorithms that monitor use to ensure that if a failure occurs that it transitions
itself to a safe state.
We also look at it from many other aspects such as human factors, cyber security and
really understand what the potential risks there are looking at it through those lenses
and in what mitigations we need to implement.
The da Vinci cannot be designed in isolation because you really need to take into consideration
the environment that it will be used in.
When we're in operating room, there are many other devices, and we need to understand how
we interact with those devices.
There's also things such as our instruments that will need to go through the reprocessing
cycle to be sterilized, and those types of things have to be considered –
early on in the design cycle so that we can make sure that the product can withstand those
procedures and processes.
For many channels where our feedback comes in about the use of our product and desired
features and so we accumulate a list of those.
We really look and understand exactly what impact they could have.
Some of those requirements come in that we need to look at to see if we need to satisfy
a certain standard that FDA is pushing, a new one that came up, and those we have to
put a certain prioritization on it.
But feedback and capability requests from the field, we really understand what is our
target market, what procedures are we trying to enable, and we'll prioritize those in the
appropriate way.