EPISODE 12 - SAM MIRES

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 today's episode we speak with a Senior New Product Development Engineer from Ambu (Am-boo), a Denmark based medical device company specializing in devices for use in anesthetic procedures. 

Born in Southern Indiana, he attended the University of Evansville where he excelled both academically and athletically, running Division 1 Cross Country while earning a BS in Mechanical engineering with a minor in Math. 

Today he resides in the Indianapolis area with his wife and 2 children, spending his free time involved with the local running community and working as an assistant coach for a nearby high school. 

Sam Mires has been with Ambu for 4 years working at the forefront of numerous successful product launches and has a keen insight into the challenges of developing medical devices in a highly regulated industry. 

In today's episode we explore the development of Ambu's Viral Bacterial Filter, a device designed to enhance patient safety during respiratory use. We discuss details of the development process and look into the technical aspects of the project such as injection mold tooling, process validation, and the importance of cross-functional teamwork.

Furthermore Sam provides insight into the importance of understanding customer needs, the push for sustainable product development, and the trends shaping the future of the medical device industry. Join us as we explore Sam's journey within product development and the lessons he's learned along the way.

Show Notes:

Click here to learn more about Ambu.

Podcast Transcript:

Hey, Sam , welcome to the show.

Hi Troy, thanks for having me.

I am glad you are here. So I started in the product development world. Almost 29 years ago, I worked for a company called Compression Engineering , learned all facets the product development. S l prototyping and all that stuff was brand new. I saw the writing on the wall after about 3 years of that and I started impulse about 25 years ago. So how did you get into product development?

So I started in product development, probably early in high school, more of getting a feel for how things were designed. I mean , I was that kid that took things apart, you know, I took pins apart all kinds of stuff apart, see how it worked. Problem was usually putting them back together. But I you know, I started just kind of tinkering with things, you know, just playing around with, you know, as a kid and then as I got into high school I got really excited about drafting, you know, an actual technical illustration and how you can, you know, design things and 2 days the 2D space in order to have something , you know, in the real world and then from there I was easily geared into. You know, actual development classes and things like that, which led me to going to the University of Evansville to study mechanical engineering and so there, you know, I was able to take more product development classes and kind of get more of a feel for it. I was, you know, fortunate enough to be part of a class that was able to do a lot of on site, hands on development with local companies . I did a course with a few of my colleagues where we prepared with business students to develop a business plan come up with a development pitch and actually give that to to the company to see if it was going to, you know, be brought to fruition and things like that. So I really got to see a little bit more of okay here is all the stuff you learn in school, but like, how does it actually apply? And if you do not want to go and get your Phd and, you know, nuclear physics , you know, what could you do with your engineering degree? So and, you know, I have always been drawn to just kind of, you know, you go to the store, we pick something up. How does that get there so? Yeah, I went to school at University of Evansville , studied mechanical engineering and I, you know, was able to get hooked up with a sporting goods company while I was down there and worked with other designers and kind of got more of a feel for, you know, this is product development, this is all it takes and that really kind of. Kind of turned my focus on to, you know, post college, my career has been in product development, anything from fork truck design and things like that to lighting and residential illumination to safety restraints and then to where I am today in the device. So it is taken me a lot of different places and really just kind of seeing how the concept gets all the way from an idea all the way to the end customer.

Very cool. You mentioned you are in medical devices now, so what is your current role and what kind of devices do you develop?

Yeah. So I work for a company called Abu. It is a Denmark based med device company. We are known for our single use products which are used for generally the role that I am in as a senior new product development engineer is our site does design for devices that are used for anesthesia procedures. And so any type of surgery that you will be put under with anesthetic gas. Our company will design the equipment or not the equipment I am sorry, the products that will support that. So breathing bags filters. Anesthetic , gas tubing for breathing circuits, things like that. And my role is to work with our rest of our company to come up with new concepts that innovate on current designs and improve whether that is from like a cost perspective or just an end to ease of use perspective. And the role that kind of it is we are tied to a manufacturing plant here in Noblesville. So that is a nice thing that is that is been really cool about the role that I am in now is that I am able to work directly with the facility. So I can see how it is being used and kind of keep those customers in mind. But it is it is all here in Central Indiana . So we are able to design we are able to build. And my role really is to work with all those different cross functional team members to bring a product to market or improve a product and ultimately to deliver something that is going to, you know, be used in a surgery setting, you know, and and be there to support someone is livelihood.

Cool. And what is the product you want to talk about today?

So the product I would like to talk about today is our it is our viral back to viral bacterial filter, particularly our exhalation filter, this is a product and actually have 1 here, so this is the product itself, this is a viral bacterial filter that is used. Really it is. It is kind of of the exact blur that I would like to to give just to make sure I get all the words right, so it is a viral bacterial filter that is indicated for use when the care provider decides to protect against the transference of virus or bacteria during re respiratory use. Which that is our intended use statement and really what that boils down to is when a clinician or someone is using a device to either ventilate a patient or provide respiratory care, this filter will actually protect upon the exhalation , so exhaled gas from the patient or the exiled air from the patient, so if the patient is being treated. In well, something that is really, you know, still pretty raw with everyone's minds is like during COVID , if you are dealing in a clinical setting and you are working on a patient that you may not know if they have some sort of. You know, a condition that is undisclosed , that air that is being exhaled is being captured by the filter media to kind of protect from the of that disease . So it helps with viral bacterial filtration. And it is something that it was 1 of the first projects that I started here at Abu back in 2020. And yeah, that is what I would like to talk about today.

Cool. Tell us more about it, like what are some of the key features or innovations or things people will not know just by looking at it.

Yeah. So, I mean , 1 thing and again, this is my first for a into a ME device, so I have been with Abu for almost 4 years now and as opposed to some of the other industries that I have been a part of, you know, everything really kind of comes down to certain standards for either connectivity or the way things need to be assembled so that when you know a clinical person is being able to support a patient, they know that their connections are going to fit to, you know, either standard dimensions or provide, you know, a certain level of care. What is interesting about this particular device is is more kind of how it came about, this came about really at the height of COVID , there are these types of filters, exhalation filters exist, but what makes this unique is kind of how this 1 came around from our facility itself. We have other viral bacterial filters for our circuits. So those are used for like an anesthetic setting. So if a patient is is being treated with anesthetic gas, it may be attached to a mask or a filter, and that is in more of a clinical setting, but in the case where COVID is really put a damper on how many ventilators and systems like that were available to, you know, clinicians , and this was able to be used with the resuscitator to kind of help with the keeping people ventilated, so this attaches to a resuscitator , it has ability to and that is all based and driven on the standard connections itself, but it was able to take the technology that we have been employing with our breathing circuits and kind of bring it to a different product line to enable the support for that so. Again, it is something that came about during the peak of the pandemic , so trying to adapt, you know, we had been making filters for breathing circuits and then there was this shift. And then I came in being new to all this, so it was a lot of a lot of trial by fire and working remote and working, you know, with a lot of really talented colleagues and you know, that is where this device came from. So it was a big effort from our sites and our company as a whole, both local and global to to bring this about.

Very cool. So we have literally helped design thousands of products and every 1 of those journeys is different. So walk us through kind of the journey of developing this and like what were the steps involved?

Yeah. So typically with a product like this, you know, we will work with our you know, it is it is typically, you know, working closely with our sales and marketing and then people that have customer interface to see what is the customer, what is the market really needing, what is what is next that we should be innovating on and I joined in roughly after that point where you know there was already discussions with our Tails team marketing of what the next project needed to be, typically with a project like this and this 1 in particular. We knew kind of we had we knew what we wanted to design and we knew kind of what we wanted to attach to, we knew there were constraints based on standards and connections and things like that and ISO standards , so. We pretty much kind of work together as a large cross functional team and then kind of develop this particular plan. So we have our initial plan of this is what our goal is, this is what we, you know, want to achieve , you know, in this general timeline and then we kind of developed more of a local plan based on our different activities , you know, from a quality perspective, development perspective, validation perspective and all those ideas end up coming together in our general plan that we would meet regularly throughout the project as we had our overarching timeline of key deliverables . So it is it is something that is fairly common within the industry of having like an overarching timeline with key deliverables to kind of check in and make sure you are meeting the progress. What made this a little bit unique. At least at the time, I think it is more commonplace now is just having a mix of remote local and people kind of all over the place having an input with this. So we are a global company. So we do work, you know, with people in Denmark or in China or wherever our facilities are, but having a little bit more of that mix locally to where we had people both working remotely from home and then people within the facility to work with our production or manufacturing team to help do more of like the tooling side of the project. You know, that that was something that was a bit of a challenge, but I think we found and what like I said, the talented group that we have worked with really know kind of where our strengths are and are able to kind of come along and jump in where those needs are. So we were able to kind of pull Together and really be able to deliver on each of those deliverables while still, you know, being able to meet our timeline, you know, med device is, you know, it is as it should be, you know, it is it is highly scrutinized , right, like quality. I mean , it is it is it is a medical device right. There is no There is no cutting corners, right, you have to do it right and you want to do it right because it is something that is impacting people's lives. So the fact that we were able to meet that timeline in you would say more of a not ideal situation where there is remote work. There is a little bit of a lag between check ins and things like that. Being able to kind of find those strengths and still deliver a high quality product is something that we are pretty proud with.

Yeah, that is awesome . What was the timeline? What what that look like?

So the timeline, it itself, was it I guess more or less the timeline? Kind of the best way to describe it, different groups particularly will have different aspects that they bring in that have their own general lead times or assumptions of how long things will take. So the total development, you know, took quite a while, I think from start to launch . AI believe it was a little over a year or so to kind of get everything fully built from the concept to actually out the door kind of development. But there were a few changes here and there throughout the timeline depending upon. You know, just normal pitfalls like local holidays , things like that time where production shutdown, you know, for certain reasons or, you know, municipality reasons , but the timeline itself was it was about a year or so. And that included, again, the the paperwork, which as I was new to the med device, there is a lot of paperwork and I do not mind that, which is kind of strange for a development engineer, I think, but lots of paperwork up front and then really getting into the design. And then confirming that design and our validation of our assembly process and our manufacturing process because we have all that on site and then again, tying all that stuff together at the end with all the appropriate quality and regulatory documentation .

Did that include building new injection tools or what were those pieces already existing?

Yeah. Yeah, I did. So that is 1 thing that is really cool about our site here. I have always worked with more of stampings and sheet metal fabrication and things like that in the lighting world that is. I mean , that is your bread and butter. I mean , it is it is all all metal. So this is my first time with injection molding tooling and we actually have a tool manufacturer or a tool room on site with tool makers . And we make our, you know, we make injection molding tooling, we manage it and we maintain it and we have a full mold room and extrusion room here at Abu. So that was really cool to kind of see is we have people that I believe the mold itself. We did have the mold brought in but then after you get the initial mold made any sort of modification or, you know, even down to like, tweaking of, you know, finishes and things like that. We have people on site. So we got to really get the mold in, start playing around with it and be able to kind of address some of those initial assumptions that we had or tweaks that we needed to make. So yeah, we have a full a full team here that manages that. So I got to work with some really cool people. Seeing how you get something, you know, from, you know, just a couple of pellets and then you get this, you know, injection mold apart so.

Yeah, pretty cool. You have mentioned the team several times and kind of made reference to several different areas . What what did the team look like from start to finish? Like who was involved in what were their roles?

Yeah. So the team was managed by a development engineer, 1 of our new product development engineering colleague of mine at the time and he was our point person. But we worked with local, you know, quality assurance engineering team for our documentation and our testing, you know, again with making sure that we are we are producing a high quality product. We work with several engineers from our regulatory group both locally and then internationally. So we got to work with both corporate and local. That is the kind of kind of the feel here at our site is there is a lot of collaboration between corporate and local and kind of go back and forth in that delicate working between the 2. So I mean , we had quality individuals , regulatory individuals sourcing and procurement for the different materials that we use for the assembly and also the injection molding and then. Again, we had process engineers involved, so setting up the validated processes to make sure that we are producing quality product and then yeah, then the tool makers and then the CAD CAM engineers that developed the the tooling drawings and and all the the the work that goes into making sure those tools are developed approach appropriately and then ultimately from there, you know, working closely with sales and marketing to to kind of, you know, you make a product and then you want to present it to the market. So I did get to work with some really cool individuals developing some of our artwork for it and things like that. So that was kind of an interesting side to the whole process . So not only doing hours and hours of testing but then also get to work with, you know, you know, I do not know what we used Illustrator something , you know, but just being able to work with those individuals as well. And all that too, again, local and global, so it was my I have worked with global colleagues in the past but it was really cool to, you know, be on an email chain that is essentially the entire globe, you know, of people from Europe and China and different parts of Asia . So so our team was we have a local team that primarily does the day to day aspects , but then we do have our corporate experts that will also provide inputs and direction as well. So that is a little bit of both

Cool. I assume passing the the regulatory hurdle was a key milestone. Were there any other key milestones that are achievements that the team reached during the development?

Yeah, I think 1 of the biggest achievements and kind of our milestones that are really important is our process validation. So in order to make sure that you have, you know, a quality product before you can really begin, you know. And get your testing through to make sure you are producing a quality product, you need to be able to show that I can produce it you and have the capability to make them, you know, routinely, right? So that was a big a big win for our team was when we we are able to meet all of our process qualification and we completed that. So there is it starts from making sure the you know, your initial setup of your tooling and making sure everything. You know, bits correctly and you know, all the way from like an installation of making sure all your equipment is installed, but then moving all the way down to like, okay, I want to run this part here are our parameters , I need to make sure that I can make this part consistently. So when we were able to pass that And, you know, meet all those requirements there. That was a big win because then we knew we have a really good product here and then we were able to kind of move forward with the rest of the project. And then ultimately that is that is kind of the gatekeeping role. I mean , for a lot of I would say not even just this project, but like anything really in the device as well is when you meet those meet those milestones , you are able to move forward in the project and continue.

Sure . Did you guys do the validation internally or did you use like 3rd party?

Uh, we did it internally, yep. So we have a great team of manufacturing and process engineers. We do work really well. As I know, cross functional team is kind of kind of lost some of its meaning , I think over the last several years because it is a cool buzzword or, you know, like it is a word that means a lot, but does not mean a lot at the same time, but we really do work the way that we run our our teams here, we use an adaptation of the Scrum process that is typically used in more of like software development. So we when we meet as a team, we will meet and have a whole bunch of items that we want to complete within a given Sprint . So I give a couple weeks of time and it is a real condensed way of meeting all these different things to move on to the next item and meet our milestones , so. When it comes to like validation, I was exposed to all those different processes . So all the validation work, all the protocols and all the executions that we had to do something that I was never really exposed to, I got to work with process engineers to kind of see how that process process works. What we need to do to make sure we are doing things correctly and appropriately and do see more of kind of an insight to what all these different roles, you know, do on a daily basis , so. We have like like I said, our internal manufacturing and process engineering team, they own that process , but it was neat to be alongside and support them and also gain experience because I think the more experience you gain outside of your own little bubble, you know, you want to. Well, we will cop as unsilo yourself. You want to you want to get out there and kind of see from other perspectives . So it was it was that is 1 of the biggest takeaways I got from the whole project was. There is so much more involved than just creating a drawing and then you tell someone to make it like that is it is huge, so that was a pretty cool thing to see.

Yeah. Yeah. I can imagine with all the products we have developed, there is always some kind of hiccup or challenge or something that comes up. What was the biggest challenge you and your team faced developing this?

I think the biggest challenge for this 1 in particular, I believe was still kind of more of just like even though we worked well remotely, I think it was having somewhat of a challenge of a disconnect of who is on site, who is not on site. So a lot of that was overcome really by just strong leadership and delegation. So our project leader, you know, he did a really great job of making sure like if someone so was able to come in and do this testing then so and so can pivot and they can do this, you know, and everyone really was able to kind of come around and that idea of. You know, if I am not physically there, what can I do to support what can we continually do to push the project along and to meet our goals and I think just being able to be. Agile and quickly pivot was a big deal because that was something that was difficult because I think at the time I was only in the office a couple times a month just just the situation we were in. But, you know, if we had someone on site was like, hey, while I am in, I am going to I am going to be able to get this and this and this done. Can you work on this? And then we will, you know, if something switched and I was in the office, I am like, well, I am here, I can can test this, this and this, and then can you handle this so. It really highlighted the ability to be more flexible and to be agile in those situations , which I think we have been able to successfully carry on post COVID . But at the time, I mean , everyone was trying to figure that out too, but that was probably the biggest challenge was. Kind of knowing where everyone was and how could we keep moving along when we physically could not be, you know, in the same room?

Yeah, if you could go back and change 1 thing about developing the product, what would it be?

I think the biggest thing that if I could go back, I would I think it would be more on being more hands on with the validation initially because I have been part of a lot of projects as of late in the last few years . Where I have been more involved with validation and more involved in kind of what that looks like. And I think at the time I was still more comfortable in my wheelhouse of testing and writing protocols and things like that from like more of the verification side. Which is more on the development side, but being more exposed to the process and kind of finding opportunities to support that, I think that is what I would probably go back and do. Because I think a lot of questions I had post projects and kind of moving forward would have been clear, you know, had I had more experience and just getting a little bit more of an understanding , I definitely have a much deeper respect for all that kind of not that I did not, you know, I obviously respect those, you know, it is it is a lot of work, but I do not think I quite understood. The gravity of like passing your validation, like, okay, yeah, that is cool, that is a great job but like, really kind of understanding why it was such a big deal because it does allow you to proceed, you know, I think going back and having a better hands on experience would be what I would probably do.

Sure . That makes sense . Just a few more questions before we wrap up. Kind of shifting gears away from the product a little bit. What are some of the trends that you see emerging in product development from from your perspective?

I think 1 of the biggest things, especially in med device and not just a meta device, but I have seen it just because of the proximity is the need for sustainable product development, which I understand kind of comes as an odd statement from someone who works at a single use, you know, plastic, but so and I get that and that was my first thing, you know, a little bit kind of like so how does this kind of work because obviously we want to be good stewards of the planet and our resources and how does that help? So, you know, I think we at Abu and lots of other companies are making that trend to what is the what is the most sustainable way, you know that we can make our products because we still stand by our single use products and you know and it is, you know. To prevent, you know, transference of any sort of contamination like we think that is an excellent product and the mindset, but to have things made from renewable resources so alternate to alternate plastics , alternate materials and things like that, just kind of taking that that leap into those new materials . I see that happening a lot recently is a lot of companies are looking at either their carbon footprint, which is something that is been talked about for several years . But then even something as much as, you know, bio plastic, things like that, you know, where can we capture different materials from and then how can we be smarter about, you know, how we are producing. So just like looking at it from I see I see the trend looking at, you know, the components itself, but then like looking at the full supply chain of kind of like what are all the inputs that go into making your product? And seeing the full impact of, you know, how can you be a better a better steward of your of your resources , you know, and which is goes 2 ways , right? Like it is being more cost effective in a sense where if you can be more efficient then that is going to be better for for, you know, the company in General , but it is worthwhile because , you know, we have a limited amount of resources and, you know, you want to make sure that you can do things responsibly and kind of putting more onus on the company to to really kind of get pushed into that realm. I see that a lot is the culture is being telling companies to like, well, we want something that is going to be more planet friendly and I think that is where the next big thing is is, you know, you can make all these great things and it is awesome , but, you know, how can we do it in a responsible way and.

Sure . Yeah, that makes total sense . Reflecting on the challenges , successes , things that you have encountered in your experience developing products, what words of wisdom would you give somebody looking to make a significant impact in the product development industry?

I think the biggest thing that I have taken from, you know, my relatively green create career has been to know your customer and that does not necessarily mean know the consumer and you should know your consumer do not get me wrong, but know your customer and that that could be your you know, your next level customer, your production operator, your your contractor, you are working with manufact capture your thing, I think a lot of times. You know, and as rightfully so, you need to know what your consumer wants and understand the market, but if you are designing something that can make it just a percent easier or a percent more comfortable for someone to like, actually assemble and take their feedback. You know, if there are suggestions that is why I think it is a you know, I am very thankful to work at a manufacturing facility and I know that is not always the case but knowing knowing your internal customers , you know, they are going to teach you a lot of, you know, how can you improve your processes , how can you improve for design, for manufacturing ? You can not forget about the person who is going to be physically assembling or or building your product, you need to know them and you need to listen to them. Take their advice, you know, and take that into account when you are developing a product because if you can not if someone if you are designing the best product out there but no 1 can assemble it or it is a pain to assemble , you know, it is not going to go very far.

Yeah, that makes sense , awesome . This has been great before we wrap up. Is anything else you want to mention with regards to the product or product development in general?

I just say like, I just spend some time, you know, for new development engineers inspiration comes anywhere so there is I like to say there is no there is no dumb ideas or no crazy, you know, random ideas that out there that can not spur on new innovation. So always be looking around and seeing how you can improve. But yeah, that is that is what I have from product development.

Yeah, awesome . Before we finish, is there any like is can somebody find the product online if they want to learn more about it?

Yeah, you can learn more about us. You can visit Abu Usa com and check out the products that we have and yeah, that is where you can find it.

Awesome. All right. I will put that in the show notes. Awesome, this has been great. Appreciate you doing this, Sam .

No, no, I appreciate you reaching out. It is been a lot of fun.