EPISODE 4 - ADAM MORRIS
Welcome to the Impulse Spotlight where we meet with product development professionals and shine a light on the products they are most proud of.
In this episode, we talk with Adam Morris about the Sonablate HIFU device, a medical device used to remove diseased prostate tissue. Adam is the director of hardware development at Sonablate Corp., a company that specializes in medical devices.
Through anecdotal evidence we gain a better understanding around the importance of taking a top down approach to product design in order to isolate the general concept before breaking an idea down into specific requirements and criteria.
Additionally Adam provides a deeper look into the many facets of designing a product starting with concept designs and researching effective manufacturing processes before even beginning an initial prototype.
Then we discuss working through the production process all the way to releasing a product to a general consumer group and then redesigning elements in order to be medically compliant on a global scale.
Show Notes:
Click here to see more about the Sonablate HIFU device.
Podcast Transcript:
Welcome to the impulse spotlight, a podcast for product development professionals. In this episode we talk with Adam Morris about the Sonablate High Food Device, a medical device used to remove disease prostate tissue.
Adam is the director of Hardware Development at Sonablate Corp, a company that specializes in medical devices.
Through anecdotal evidence, we gain a better understanding around the importance of taking a top-down approach to product design in order to isolate the general concept before breaking an idea down in its requirements and criteria.
Additionally, Adam provides a deeper look into the many facets of designing a product, starting with concept designs and researching effective manufacturing processes, even before beginning an initial prototype.
Then we discuss working through the production process, all the way to releasing a product to the general consumer group, and then redesigning elements in order to be medically compliant on a global scale.
It's a lot to unpack, so let's get into it.
Hey Adam, welcome to the show.
Hi, Troy, thanks for having me this morning.
So, to get straight into it, I started impulse 25 years ago. I worked for a company for about three years, and I tell people I got my Master's degree in Product Development there and decided to go start impulse. How did you get into product development?
I got started, right? While I was still in college, actually, I was lucky enough to have a small company in my hometown, walked in the door looking for a summertime job between semesters in college, and they hired me for a part-time floor job, and then I stayed on after I graduated and moved into engineering and product development and ultrasonic transducers.
Very cool. What's your current role? What kinds of products do you develop?
Currently, I'm with a different company. I'm a medical device company called Sonablate Corp. I'm a director of hardware development, so in the medical device industry, that entails a lot, of course. The product we make is a primary product, is a prostate tissue ablation device for helping treat prostate cancer and benign prosthetic hyperplasia or BPH, which is very common in all men.
Is that the product you want to talk about today?
I'm going to talk about the probe on the probe housing that we have been developing and refining over the last few years.
Tell us more about that than why you choose that product and what are some of the key features or innovations about that product?
Mainly because of the requirements. The probe is designed to be held by an arm but is inserted trans-rectaly into each patient. It has to be safe to have that done. Because we use ultrasonic waves, we have to be able to directly point the beam to where we want to treat tissue. Because of its use, we have to make sure that we're mechanically robust. We have to make sure that we're chemically robust and we have to make sure that we're thermally robust because of how this is used and reprocessed.
Very interesting. This is probably going to sound like a rhetorical question, but hopefully you can give us some detail off of it. Were there any novel technologies, materials, methods that you guys use or discovered when you develop this product?
Back when we started the project originally, we had to do a very robust analysis on not only the design and mold flows and that type of thing, but we had to do multiple matrices on selection based on all those properties that I just named, the Thermal Properties, Impact Strengths, these things. Reprocessed medical devices are abused by the reprocessors. They don't care. It's like a UPS package going into the warehouse. It has to be robust. It has to be able to be handled. It has to be able to see different water wash downs, different chemical compositions ranging from soapy water, alcohol or other sterile wipes that might be used to clean off residue and then go into cleaning solutions that can be anywhere from alkaline to a city, mildly a city all the way to strong oxidizers such as hydrogen proxides and ethylene oxide.
Well, I assume that selection process was quite involved then took a long time.
Yeah, collecting data, when we started this, of course, so many new materials come out each year, but when we started this, there were several new intermediate engineering resins that had just come out. PSU had been out for some time, probably a dozen or more years, all to MPI had been out. We were looking for something with a little better chemical resistance and a little better impact strength than those resins typically offered. And we basically ended up with PPSU or a material trade name called Raidell. There's some generic ones out there as well that has a good compromise between cost, impact strength, durability, chemical resistance is excellent. And thermal properties, of course, it's a high-glash transition temperature.
Very cool, very interesting. So we've helped design literally thousands of products and every one of those product development journeys is different. So walk us through kind of the journey of developing this product, like what were the steps involved.
Okay, so typically with a medical device, you kind of got to do some, a little bit of market research, know what people are using in their hospitals or the surgical sites, what they're using for cleaning, disinfection, what's approved by the FDA for use for different things and or sterilization. And try to be, try to hit the majority of those in your initial run. It's hard to validate every chemical out there or every process out there. So, so we start out with kind of a requirements document and say, okay, what do we have to do? Our original design was a cast product. And of course, a lot of variation in that process when we start trying to go to any volume. So we had leaking issues or processes. Some of it is dunked in liquid hydrogen peroxide solutions. And peroxide leaks in and corrode everything because it's an oxidizer. Little bit less impact strength. So we're having cracked housings or other things occurring. Silphur was the main thing. So we came up with this in term solution of sealing everything up with silicon, our TV silicon, just to get us through. But that, you know, eventually with those chemicals, that breaks down as well. So we finally made the investment and said, hey, we need to go to something that's going to be reproducible at even at low volumes, relatively low volumes a few hundred a year with a good stable resin. So we said, okay, here's the concept. We're going to go to an injection molded. Here's what the tooling is going to cost. Here's what, you know, here's the project timeline. Here's the resource needed. So we kind of developed that whole requirements and yield. Here's why we're doing it. Here's our target markets and our ROI and sell the product, get a management buy-in and so forth. So once we have that, then we say, okay, let's mock it up. Let's do concept prototype. And in our case, because of the expense of doing a big part, this probe is about 30 inches long, the housing's like three inches by eight inches by 20, 25 inches or roughly 24 inches, four pieces. So multiple, I think I counted 10 sills in this thing for those four pieces to be joined. Some critical dimensions. So we have to machine it post molding because of part shrinkage and stuff and diameters needing to be round. Not, you know, you don't always get that on big parts. So we have to kind of understand some things or other things and then finish them after molding. So what we do is say, okay, this is going to be a big investment. Let's mock this thing up. So we usually start on these types of projects with the 3D printing process. It's been a godsend over the last decade or so with product development. I think everybody in product development, I think, you know, who's that now? That not always get you to your final product for injection molding. Usually some tweaks have to be done, but depend on resins and processing parameters. So once we get through prototyping, then we'll move on to a full scale development and say, okay, fit function, look to be there through the 3D printing process. And we'll say, all right, let's cut a tool. So cut the tool prototype, check everything, refine, work with the motor, refine everything, and then cut or loose. In this case, we do, you know, build some prototypes, do some engineering verification and reports and so forth. And then the process is, okay, you did all this work. Now you do that to take 5, 10 probes and run them through a controlled, usually at a lab that's certified and validate your processes now. So in our case, in the US, we're validated with this design in ethylene oxide, which is good, but going away, there's some environmental issues and health issues with ETO and they're trying to cut it back. We're working on getting certified into vapor hydrogen peroxide and then we're certified with some liquid disinfectants, invalidated in those liquid hydrogen peroxide and some enzymatic cleaners. And then typically, once you validate a process, one technique, you basically, in your IFE, state how you validated, because not every facility will have those particular chemicals on and they may say, hey, we don't have this, but we have this as a compatible. We can easily do an analysis for them and say, yes, you should be okay. It's similar to this, the chemistry similar or whatever. It's very hard for these places to get new chemicals in. So you have to be kind of flexible, but we see a broad range of things. One of the things that occurred in this particular process, we're about halfway through it, certifying the tools and the molds and our customers in Europe don't use ETO, didn't like our disinfection process and said, hey, we're all going to these automated washers. And they're different. Some of them are cold chemicals where they just step through a cleaning of rents, a disinfection cycle in a rents and a disinfection cycle in a rents and then dry it off. Other ones use a thermal cycle that uses cleaning, disinfection, sterilization cycles and each step stepping up in temperature. That presented a whole new issue that we had to tweak the design. We didn't have to redesign it. We had to tweak some things because now in these automated washers, we had to be not only dunk proof, we had to be essentially pressure proof because of the thermal gradients cause we'd cause all the expansion on the seals that we didn't really design for. We designed for ambient temperature and all of a sudden we got to be able to go to 70 sea and maintain seals. So that kind of, and with long sections of thin walled plastic, those things are moving, right? Like the bellos. So we had to do some work there. So those curve balls always come, seems like a big project like that. We get through all that validation and then you're at the point where you can say, okay, we're ready to transfer this to manufacturing, train them. You go through the process validation with the manufacturing group and then you're ready to release the product to the general. General sales population and get it installed and service team so they can retrofit systems out in the field of the customer's own desires, that type of stuff.
So when you go through that validation before it goes over to manufacturing, is that basically like FDA approval type stuff or is it just kind of your theory?
It depends on the registration site or approved in 50 countries worldwide. Some of them are common but not quite the same, especially the big markets. They have their own little twist and turns to them and you still have to get individual approval. Now, the Europe is the sea mark. So we have the sea mark FDA China, come on, Brazil. I mean, all these big markets and they all have their own little twist on things. So typically you have a filing with each jurisdiction you're in, but you have to update with the information when you do a project like this. It doesn't, you don't have to resubmit per se, but you have to maintain all those records as a change notice with all the reports. You get audited, you make a change of your tech file like that. They come in, you do your audit, they come in and say, hey, I want to look at this. So you better have your eyes dotted and your teeth crossed. Yeah, well.
So what the timeline looked like for developing this product?
Originally because of the prototyping and the mode development and tweaking, we originally had about a two year timeline, two and a half year timeline on it. It ended up with that change right in the middle of it, actually almost toward the end of it. Almost done with the project moving in the validation. We ended up having to do some tweaks to design, which we had to redo some other things and get some testing done in Europe because of the types of devices, the auto watchers they use over there. One of the caveats with our system is the probe tip, what we call the probe tip where the ultrasonic transducer is has circulating water bath around it. So it's dressed with a sheath sealed and then there's cooled, degassed water circulating. Those water lines for that run through the probe housing and into the, what we call the probe tip, the distal end of that probe where the transducer is. So the challenge has always been when you were disinfecting because that's essentially in what we call the patient interface that has to be disinfected or sterilized each time. And that is the most difficult area to do it. So when we went into these auto watchers, they're like, okay, so how do we clean these tubes? And basically, I said, well, you've got to hook up lines to them. It's, oh, we have indisco lines here that you can hook right on. Nice. So they can, they can effectively do this in that process with gaseous processes like hydrogen peroxide, especially because hydro peroxide, you think, oh, well, that's, that's a liquid. I buy that at the drug store in a bottle and it's liquid. Yes. Under certain conditions, very control conditions, you can vaporize it. But because it's an oxidizing gas, it interacts with different materials, different ways. So with Teflon stainless steel, no problem. It can go long, you know, one millimeter diameter or emphasis for one meter, no problem. You change that to PDC, done, you can't do it. You won't do it every acts messes up the, and the gas starts condensating back into liquid in the process and you can't do, you can't do your sterilization. So it drives material selection in other ways, these processes. The, you know, the manual method that we use in liquid research requires us to have a syringe handy where they actually draw liquid out of the bath and shoot it down these water past to be able to, and then tie it off and let it soak for a few minutes and then do it again. Flush it and do it again. So you, you kind of pass in through a circulation mode there as this thing disinfects. So each of them are different, require different things. So we have to kind of analyze, okay, which process and then how is our probe going to be able to survive or work with that process?
Yeah. How much time did that end up adding to the project, having to work with the washers and all that?
Oh, it varied because it came up with different sites at different times. But overall about a year to get tested because several sites and they use different types of washers. So it presented a challenge to get in there and get them tested and, okay, this is this works and get their, their people to sign off on it as well. Yeah, yeah, amazing.
So tell us a little bit about your team, how many people were involved in what were their roles?
Typically, a project like that's going to involve one or two design engineers doing prototypes in the CAD work and doing the 3D printed prototypes and building mockups and testing function. Make sure we don't mess up linear emotion or rotor emotion or how the thing senses temperature or how water flows through that probe tip, all of that stuff has to be checked and validated, make sure it verified, make sure it doesn't, we don't impact that with anything we're doing. So typically two people will plus your project manager, which is typically me. And then as we get through that verification, typically a quality engineer would be involved to sign off and make sure we did, hey, yeah, you met this and every all that looks good. Then we move, once we move to validation and we start talking about manufacturing, finish tooling and that type of stuff, you're pulling in quality control people, you're pulling in manufacturing service teams, clinical teams to all kind of members. So you can end up with a cross functional team with a dozen people on it for a project like this because you got instructions for use that have to be written by the clinical team, service procedures by the service team. How do we build it out on the floor and manufacturing? So all those people have to be involved and then how do we test it? How do we verify it? QA is not going to sign off until you have a way to verify it's doing what it's supposed to do every time. So we have special test in manufacturing, pressurized, dunk test, leak test, I mean all kinds of things to make sure every unit is sealed properly.
So, cool. With all the products that impulse us develop over the years, there's always been some kind of challenge that comes up and I know you've mentioned a few, but I'll go ahead and ask the question anyway, just in case there's another one. What was the biggest challenge you and your team faced developing this product?
The injection molding models because of how big the parts were, like each, there's two halves, there's two end caps within, there's two halves that bait in the middle and you got thin walls and then they've got a draft and opposite direction because the way the cores had to be pulled on the molds. So you got this draft and then you got this joint in the center of this, each of those parts is about eight inches long. So every one of those has to come in with a certain dimension and a certain bow, maximum bow on those length of those sides so that that seal, it's in the center of those, when those two meet, we've got kind of one seal that seals on two surfaces. So we have kind of a redundancy there as a backup and it has to fit just so or you won't seal consistently. That was the hardest part and I think really the whole thing, rest of it's all mechanical, it draws down together but having that draw down parallel and consistent over that seal and that seal, seal every time is probably the hardest part of that whole thing. But it was just a lot of tooling revisions to get it to end up. That, well, and their process control of how they, you know, how fast their cycle time goes, what temperature, what pressure they're shooting at, that type of stuff. If they dial that, they got that dial in pretty good, the batch will run pretty good and we won't have any issues.
Yeah, interesting. You mentioned earlier 3D printing, what other, were there any other kind of prototyping processes that you employed during the development?
Depending on the type of device, we may use cast parts, that's kind of expensive to do, to build a tool because you got to build a negative anyway. And then of course machine parts, typically that, you know, if it's reasonably simple, with 3D printing, the thing I like about 3D printing is you can do things much more complex and you can necessarily do in one part that may take two or three parts and machine parts going together or cast parts going together before you go to injection mode. And 3D printing is proved, you know, that with the right setup and the right design, it's actually pretty cost competitive into the low thousands and volume now.
So, yeah, I've actually, there's a client of ours recently moved a pretty big part, they're 100% 3D printing it for production now. Yeah. And the materials that are available, yes, expanding rapidly. And our problem is, the production was, you can use carbon fiber, you know, it's a PLA with carbon fiber in it. So, it was very cost competitive for him.
Yeah, resolution was an issue most of the time, you know, everything looked really rough and stuff, but some of the printing methods they got now are getting down to resolutions of one to two thousand, you can't even see, you know, the roughness, the roughness goes away, we're having our, our, our probe tip, what we call our probe tip, we're actually working on a 3D printing process for it. It's kind of a cast part, it can't be injection molded or a machine. So, it's like, it's cast and it's very expensive and very complex. And with 3D printing, we can do a lot of things we can't do with a cast or machine or injection molded part in how we handle water pass and other design details that make the, make the system the tip more efficient and it's, it's almost a cost factor of 10. Are you better?
Do you have internal 3D printing or do you send all that out to? No, we don't currently have some other engineers have their own little personal printers, but in kind of a play around prototyping stuff if they, so desire, typically we outsource that currently because the methods and the materials we need are all, you know, almost engineering, resin type. And that's, that's an expensive machine that we're not really with, with the volume that we're doing, okay, what's the payback?
You know how that goes?
Yeah, yeah.
So switching gears a little bit just to kind of start wrapping up. What are some of the trends that you kind of see emerging in product development?
The improvement of CAD modeling software, digital twins and virtual type interfaces. I think those are going to become big. Eventually you might see some impact from AI in this industry. It's being used in medical, a lot for diagnostic applications, but not really for, for, like, what our product is, you know, where we use sound to treat disease, it hasn't really made an impact by any, even in the research realm hasn't really made an impact there, but on the diagnostic side it's, it's making huge impacts. And then of course, the continuing evolution of 3D printing. You know, when, right now, the last trend line, I saw for 3D printing was cost competitive up to the point where you're at 2,500 parts a year or something, and then you should go to injection molding if it's moldable, figure out how to do it. I think that number is probably approaching 5,000 a year now to go through because of the size of platforms that you can print on and the heights that they can print on with great accuracy. I know this probe tip we're working on, they can print 12 at a time on the thing. Well, that's one month's production for us. So, you know, it's, for that, it's great. We've got other applications where we're looking at a 3D printed part that will be in the thousands. So it's how cost effective. I think that that's going to be the end road. As they drive, they're going to become more and more cost effective against other high volume techniques like injection molding or, you know, other forms of, even on the metal side, printing is becoming really good.
Yeah. Yeah, I've seen some applications where people are printing 3D and then they'll just like a cast part and then they'll go machine anything that's critical and it's in production. So, yeah. If you could go back and change one thing about developing the product you've been talking about, what would it be?
And fourthly, this one's just come back to the forefront. So, at the time we didn't have the resources to do this, would have been a major overhaul on some, some, maybe some redesign as some of the internal frameworks on the probe, but the appetite wasn't there for it at the time. Would have been a much bigger, longer program involved more resources. But, you know, as I mentioned before, the probe housing current is four pieces. It has an end cap, two middle housing parts that are fairly substantial in size and then what we call a collar that actually screws down on the internal frame and kind of compresses everything together. When we started endeavoring into that project, it was like, why are we doing this? This is how we're having a cast because that was kind of the limitations of casting at the time. Was to make that whole thing except for the back end cap, one piece, redesign it a little bit so it still fit the internal, but, but, eliminate and consolidate three parts into one. So we only have an end cap where the cable connects in and then one housing with seals in it that slides over and we only have to worry about seals at the front. We'd eliminate six seals, I think. We'd end up with four seals maybe in the whole thing that way. Of course, tooling investments a little more for a big piece like that, but it would have made life easier for manufacturing service, development, maybe would have been a little bit. There's other issues we'd have to resolve, but that was probably the biggest issue we wish we could have done at that time.
So we're reflecting on, maybe you've done this a couple of years, so we're reflecting out all the challenges and successes and everything you've encountered developing products, what words of wisdom would you share with those looking to make a significant impact in the product development industry?
Look at all your problems from a holistic view, try to get a top level view before you get into the dirty details. And once you get that holistic view and that's kind of like, okay, from the clinical side, they're saying, from marketing side, they're saying, from all these different inputs, okay, from a cost impact, from a function impact, try to pull all that into a high level view. And then break down and get those requirements defined really well. And then lock it down. The biggest disruption to any product is resources, finances, or a change in requirements.
Awesome, Adam. This has been great before we wrap up. Is there anything else you'd like to mention with regards to the product or product development in general?
Sure, if you're interested in knowing what Sonablate does or what they can do for anyone, you know that might have a prostate issue. We have over 50 sites, like pushing 75 sites alone in the US, three here in Central Indiana that use our system. Check it out at sonoblate.com.
I will put that website in the show notes and everybody go check them out.
So I appreciate being on.
All right, thanks for having me Troy.
We'll talk to you soon.