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Start-ups that inherit robotic prototypes from universities or research labs often get caught up trying to get a product out the door. Instead, they should focus on designing a product that will be competitive in the market. Following a chat with Dave Saunders, CTO at Galen Robotic, Andy Rogers sat down with Key Tech Sr. Mechanical Engineer, Danica Mackesey, to discuss the challenges and pitfalls of designing medical robotics.
Speed-to-data determines go-to-market success for medical devices. You need to inform critical decisions with user data, technical demonstration data, and clinical data. We interview med tech leaders about the critical data-driven decisions they make during their product development projects.
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Hey everybody.
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Welcome to episode 13 of MedTech Speed to Data
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a Key Tech podcast.
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I'm your host, Andy Rogers,
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VP of Business Development at Key Tech.
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Today we're joined by Danica Mackesey, partner
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and senior mechanical engineer, at Key Tech.
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We're here to talk about the episode we just recorded
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with Dave Saunders,
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CTO at Galen Robotics, Danica, welcome to the show.
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Hey, Andy, thanks for having me on.
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All right. Yeah, thanks for joining.
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So, Danica,
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you're on the show today
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because in the past
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you've worked on a lot of different products.
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Obviously, you've been at Key Tech for quite a while now,
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but you've worked on surgical robotics
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platforms in the past.
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And I would say, like myself,
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you're a good steward of solid design practices.
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You've designed to meet IEC 60601,
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and you've been to the school of hard knocks
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I'm sure, on quality, design for quality.
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So we're going to talk about all those things today
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following up on the interview with Dave Saunders.
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So again, Danica, thanks for joining
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So we
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we do talk a lot with startup companies
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like Galen Robotics that inherit either
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a university prototypes
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or they've developed their own sort of
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first of its kind prototype with blinders on
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just to get a functional prototype out the door.
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And get in front of customers.
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But, you know,
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as you've seen
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in, we find that a lot of those companies
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they're just trying
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to get their product out the door,
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but perhaps they need to start looking backwards from,
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you know, what is it going to take to
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get this product on the market.
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So that's what I wanted to talk a little bit
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about with you today in the context
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of this Galen Robotics interview we did.
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So, you know,
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what we want to talk about are
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I would say, key consideration’s
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that product designers should should take into account
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when you're
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inheriting an early prototype
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or developing your first prototype, and now
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you're ready to go to market following
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FDA design control practices.
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So the first consideration
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is clear as day with most medical device startups
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is get as much frequent feedback from your end user
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that can be the user of the product
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or your ultimate customer.
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So those activities are so important
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for defining the right requirements
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for your product early on.
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What are the user requirements
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just kind of early validation that the product you're
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developing is meeting a customer need, number one.
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Number two, that once you know you met that need,
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that the features that you're putting in place,
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you know, actually resonate with the end user.
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Danica in your experience, how have you seen
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or how have you interacted
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with users to get key insights
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early on in product development?
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Sure, it's definitely something that you think about with
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any medical device that you do.
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But when you move into the world of a surgical robot,
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where it's so important
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for those surgeons to feel comfortable and confident
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when they're performing their surgery,
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you want to make sure that you're working with them
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to really create a system that's going to augment
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what they're doing
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and not create additional challenges.
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A problem that we actually had seen
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run into at one point was a fatigue issue, where
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when there wasn't
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enough early on working together with the clinicians,
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they found that they brought something
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that was a pretty late stage prototype out to be used.
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And the motion was something that was going to be done
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for a long period of time,
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and it just hadn't had a chance to dial it in.
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And it was a new thing,
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a little bit of a stress on the wrists.
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So get out there early.
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Something that we try to do is fail as early
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as possible.
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It's so much easier to change things at that point.
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You don't have to wait
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for having all of your fancy actuators in place
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and the exact set up of the actual robot
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prototype the handles
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put some weight on the end of them
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and get them out in the hands of your surgeons.
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Have them start going through those motions
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and learn what they do
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and don't like about it, continue to iterate
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and get more things out to them.
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So we try to have as many early
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formative studies as we can with end users.
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Exactly, yeah. Galen Robotics.
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It seems like every month
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they were getting in front of
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of end users in hospitals.
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And I think my favorite part of that interview was
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when Dave said that
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if you start not hearing negative feedback
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from your end users, you start to panic.
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So just get out there
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and get as much feedback, whether it's good or bad.
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Definitely a key consideration.
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Another consideration
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that we'll talk about here, Danica.
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And you know, I'm guilty of it being an engineer.
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You get so focused on the details.
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Ask my wife
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when there's something goes wrong around the house.
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I'm always just focused on the one problem.
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And she usually steps in behind
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means like flip the switch or something,
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something ridiculous like that.
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But like,
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from an engineering perspective,
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it's so important to take that like systems
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view particularly in surgical robotics, right.
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Where you can get dialed in as you as use the words
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just an actuator design or something like that
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and forget about the system for you.
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What do you have to add about that?
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Yeah, and I think it makes a lot of sense
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that early on you're really focused on what is that
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core piece of the technology
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and the actual part of the robotic system
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that is creating this new platform.
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But you're creating an entire system.
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Do you have a control
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module that needs to live somewhere near the robot?
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Do you have a monitor
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that your surgeon is going
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to need to look at during the surgery?
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Or a nurse needs to look at?
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Do you need to interact with the patient
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in a way that doesn't interrupt a sterile boundary?
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So you might need to consider having a plastic drape
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that you have to somehow work through.
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And these all seem like details
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when you're talking about it.
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And why would you focus on that when you just want to
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to deal with that core technology
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but if you wait too long to think about them,
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instead of it
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just being nicely integrated into the entire system,
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you're going to end up
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having to backtrack
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and make things work
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that things could be in the way
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a little bit more than would be ideal.
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And again,
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it's coming back to not creating additional problems
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and challenges.
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But you want this to work in concert
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with what's already going on in the O.R.
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And with that,
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you really need to think
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of every single piece of the system together.
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Yeah. No, that's great Danica.
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I mean, another way to think about systems
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thinking is risk based thinking.
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These are basic tenets of Key Tech product development.
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You know, when we talk about risk based
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that brought up one of that one prior project
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you had where,
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you have to think about failure modes, right?
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So you mentioned drape design
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for drape, things like that. It seemed like details.
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But another failure mode
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to think about a risk is if the robot stops working,
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how do you deal with that scenario?
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Do you want to expand on that one?
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Whenever you're looking at the risk of a product,
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you want to think about
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what are all of the ways
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that something could go wrong?
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What are the different hazards that you could foresee?
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And then what happens if that does go wrong?
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And so what you're talking about, what we had seen is
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do you need a way
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for the surgeon to take back over where
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maybe your robot was the one
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who was controlling the motion,
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but now something happened.
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You want to have a manual override.
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How is the transition from that surgical robot
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controlling the motion
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to your operator going to happen?
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You want to make sure there's not
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can imagine
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if it's something that being suspended
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in air inside of a patient,
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it can't just drop at some point.
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So you really need to consider
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what that smooth transition is
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and that's something that actually
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we found needed to be baked
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into the core mechanism design.
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So once again, don't wait
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until the end to think about this.
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It's something that you want to be
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considering throughout the design,
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and it's going to make it a much more impactful
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part of the entire mechanism.
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Yeah, absolutely.
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So thinking more about, you know, the end in mind,
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having been there, you know,
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trying to sleep the night
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before a 60601 safety test,
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this standard
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just is always lurking in medical device development,
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in particular with collaborative robotics or,
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in our next episode of the Key Tech podcast here,
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a cybernetic robot.
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Tune in, you'll hear about that one.
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But, you know, designing with 60601 in mind,
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again, you don't want to get towards
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the end of product development
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and then throw your prototype in for
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an initial 60601 evaluation.
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And fail.
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So, Danica,
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you want to talk a little bit about meeting
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60601 requirements?
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Again, just like you said,
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you want to consider it early.
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You don't want to go to a test lab and be surprise,
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do whatever you can
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in advance to really prescreen yourself.
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So if you have a lot of your surgical
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robot instruments
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are going to need to have a small footprint
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so that they're not taking up too much space.
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But you might have some pretty heavy things
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that are sitting high up on them.
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What are the tipping requirements on that?
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Do they need to move around?
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And you have to make sure that it's able
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to get over a cord on the ground without falling over
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so those are tests that are very clearly defined in
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60601, and we've taken the tests
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and just recreated them in our own office.
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And create the thresholds
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that it's going
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to need to go over,
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put the force at the exact height that they say
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and make sure that it's not going to fail
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or if it does learn from it and adapt from it.
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And then before you get up to that test lab,
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you've already seen that success.
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On the electrical side, you have a
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a pretty high
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voltage system that's going to be in direct contact
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potentially with somebody who is not able to say ouch.
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So you really need to ensure that you are considering
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what 60601 asks for are two different
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means of patient protection.
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So do you have enough distance between that
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current and air gap and the patient
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if that's feasible?
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If not, do you have creepage,
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which is going to be the distance
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that it'll have to travel or insulation
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or earth ground?
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And what we'll do is create these insulation diagrams
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that will really show all of the stack ups between
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where that
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voltage is sitting and where the patient side is.
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And that's something that we can present along with
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getting the testing done
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to show that we've really considered 60601
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and the patient and operator safety throughout.
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Yeah, you can definitely get lost in those standards.
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So one of the one other I guess recommendation we,
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we provide to startups early on is these test
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labs will come in and provide a free or not a free
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for a small fee
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and evaluation of your product against that standard.
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I mean that's money incredibly well spent
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where you have,
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in some cases
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the folks that are actually
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going to be running the tests
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and signing off
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on your documentation saying, hey,
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you know, have you considered this,
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this aspect of the standard or this failure mode
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make sure you meet this requirement or here's
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how we're going to run this this water ingress test,
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because this is how we see,
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your product falling against the standard.
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So I don't know.
00:12:00:08 - 00:12:01:22
I've taken advantage
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of that service, I don’t know Danica,
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if you've been a part of those at all.
00:12:04:13 - 00:12:05:02
Yeah, we've
00:12:05:02 - 00:12:08:04
definitely had conversations with Test Labs early
00:12:08:04 - 00:12:11:12
on to to understand certain things.
00:12:11:12 - 00:12:14:06
You could fall into one category or another.
00:12:14:15 - 00:12:15:03
And again,
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it's just not something
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you want to be surprised about later.
00:12:17:12 - 00:12:20:12
So have the conversations, understand it
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a little bit more about how
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they will perform the tests
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and sometimes just an hour on the phone with somebody
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can make a huge impact on what your plan is
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after that.
00:12:31:08 - 00:12:32:22
One other consideration,
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when you're trying to transition
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from an early prototype
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to a commercially viable medical device product
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this is going to sound kind of old fashioned here,
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but just good design practices.
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Cabling is one area.
00:12:46:20 - 00:12:48:08
Danica, I know you worked on a project
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where cabling was was a key concern.
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Do you want expand on that one?
00:12:51:16 - 00:12:52:05
Sure.
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It’s definitely not the most exciting part
00:12:54:23 - 00:12:57:03
of designing your system,
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but I can imagine that
00:12:58:16 - 00:13:00:13
there are a lot of electrical connections
00:13:00:13 - 00:13:01:18
that are going to need to be made
00:13:01:18 - 00:13:03:14
from the front end of your robot
00:13:03:14 - 00:13:04:23
all the way to the wall.
00:13:04:23 - 00:13:08:19
And so how can you make sure that your cables aren't
00:13:08:19 - 00:13:09:23
going to get in the way,
00:13:09:23 - 00:13:12:02
first of all, of any articulation
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that needs to happen.
00:13:13:22 - 00:13:16:11
But then beyond that, this is something that isn't
00:13:16:11 - 00:13:19:11
just a prototype that's being shown off once or twice.
00:13:19:11 - 00:13:21:05
It's going to live in a hospital
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and it's going to need to not have cables
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breaking from where
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as you are going through the entire lifetime of it.
00:13:28:13 - 00:13:29:19
So think about
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with cable routing,
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do you have space for it to route?
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How are you able to secure it in place
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and make sure it has
00:13:37:15 - 00:13:38:19
the smooth articulation
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when it needs it
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and the structure
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when you need to keep it in place?
00:13:43:10 - 00:13:45:12
So we've definitely seen that,
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I've seen it on the surgical robot platform,
00:13:48:09 - 00:13:51:00
but it's in almost any one of our designs
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that has something moving
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that we really try to think about that
00:13:54:14 - 00:13:57:00
early on between the electrical engineers
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and the mechanical engineers
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and even the industrial designers,
00:14:00:04 - 00:14:01:07
making sure that
00:14:01:07 - 00:14:02:08
it's not all a sudden
00:14:02:08 - 00:14:03:18
creating an eyesore
00:14:03:18 - 00:14:05:14
that you didn't intend to be there.
00:14:05:14 - 00:14:07:02
And another way to get that feedback
00:14:07:02 - 00:14:07:20
that we've seen
00:14:07:20 - 00:14:09:19
is just working with manufacturers, right?
00:14:09:19 - 00:14:11:21
So it could be a cabling vendor.
00:14:12:05 - 00:14:14:13
So you don't have just a bunch of EE’s twisting,
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twisting cables together, twisting wires together.
00:14:17:04 - 00:14:18:01
And calling it a cable.
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They get feedback from folks
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that make these for a living.
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Both on the component
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and at the assembly level.
00:14:24:03 - 00:14:25:16
And, you know, we're seeing that across
00:14:25:16 - 00:14:26:21
all the projects at Key Tech
00:14:26:21 - 00:14:30:00
you have to get manufacturer insights
00:14:30:18 - 00:14:31:07
early,
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like at the point where we're talking about where
00:14:33:05 - 00:14:33:13
we're doing
00:14:33:13 - 00:14:36:07
an early assessment of these university prototypes
00:14:36:23 - 00:14:38:06
how are you going to assemble this thing?
00:14:38:06 - 00:14:40:11
What's the the ultimate cost of the product?
00:14:40:20 - 00:14:42:08
Will it be reliable?
00:14:42:08 - 00:14:44:09
And does meet your business goals?
00:14:44:09 - 00:14:47:09
So, you know, a lot of considerations here,
00:14:47:09 - 00:14:49:10
certainly we can sympathize
00:14:49:10 - 00:14:50:13
with start up companies.
00:14:50:13 - 00:14:52:10
Most of the surgical robotics
00:14:52:10 - 00:14:54:19
folks that we talk with, our startups,
00:14:54:19 - 00:14:56:19
you're working on a six month
00:14:56:19 - 00:14:57:14
sort of timeline
00:14:57:14 - 00:14:58:12
all the time,
00:14:58:12 - 00:14:59:22
trying to get to the next milestone
00:14:59:22 - 00:15:01:12
to get more funding and things like that.
00:15:01:12 - 00:15:03:18
But, so we recognize that,
00:15:03:18 - 00:15:04:11
you know, you kind of
00:15:04:11 - 00:15:06:18
have to just focus on what you can
00:15:06:18 - 00:15:08:20
what's most important for the business at the time.
00:15:09:05 - 00:15:11:01
Certainly we can talk on a podcast
00:15:11:01 - 00:15:13:07
all day about all the things you need to worry about.
00:15:13:07 - 00:15:16:03
But sometimes there's only budget for so much.
00:15:16:03 - 00:15:17:14
So we can sympathize there.
00:15:17:14 - 00:15:20:05
But I think, Danica, you'd agree that, you know,
00:15:20:05 - 00:15:22:05
you really need to focus on these areas
00:15:22:05 - 00:15:24:16
like getting to the user, thinking at
00:15:24:21 - 00:15:26:10
the system level.
00:15:26:10 - 00:15:29:19
Considering the risks, focused on 60601
00:15:30:05 - 00:15:32:08
and make sure what you're making is manufacturable
00:15:32:08 - 00:15:33:20
so that it's reliable
00:15:33:20 - 00:15:35:15
and you don't get tripped up.
00:15:35:15 - 00:15:37:15
When you go from design to manufacturing,
00:15:37:15 - 00:15:39:08
that can be a headache too.
00:15:39:08 - 00:15:41:09
So you want to get that feedback early on.
00:15:41:09 - 00:15:43:15
So. All right, Danica, anything else to add?
00:15:43:15 - 00:15:45:21
I'm not doing as much design work these days
00:15:46:09 - 00:15:47:10
as you are.
00:15:47:19 - 00:15:49:10
Yeah, I think it really is.
00:15:49:10 - 00:15:52:08
You said a lot of it about how there is that
00:15:52:08 - 00:15:54:15
that core technology that I think
00:15:54:15 - 00:15:56:17
is usually the main focus.
00:15:56:17 - 00:15:58:17
But just trying to take a step back
00:15:58:17 - 00:15:59:09
and think about
00:15:59:09 - 00:16:02:11
what is everything that's going to be impactful,
00:16:02:18 - 00:16:04:21
what's the entire system that you're looking at
00:16:05:02 - 00:16:07:07
and what are all of the hazards?
00:16:07:15 - 00:16:10:13
It's something that with everything that we do,
00:16:11:01 - 00:16:13:15
we really want to make sure is thought about early.
00:16:14:21 - 00:16:16:07
I think the big thing that we've said
00:16:16:07 - 00:16:17:21
this whole time is just don't
00:16:17:21 - 00:16:19:05
leave it to the end
00:16:19:05 - 00:16:21:08
because it's always so much harder to come back.
00:16:21:08 - 00:16:24:18
So if this isn't your area of expertize,
00:16:24:18 - 00:16:26:04
what partners can you bring in place
00:16:26:04 - 00:16:27:15
so that things can be happening
00:16:27:15 - 00:16:31:19
in concert with each other and not separate islands?
00:16:32:12 - 00:16:33:23
Great. Well said, Danica.
00:16:33:23 - 00:16:35:19
All right. Well, that's it, everybody.
00:16:35:19 - 00:16:38:19
So thanks again for tuning in to Medtech Speed to Data
00:16:39:07 - 00:16:40:05
a Key Tech podcast.
00:16:40:05 - 00:16:42:00
We'll see you guys soon. Thank you.