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Webinar: Common Pitfalls of Medical Device Design and Development

Table of Contents

We had the pleasure of hosting a webinar on Medical Design & Outsourcing discussing the Potential Pitfalls of Medical Device Design and Development.

Read the transcript below or watch the webinar here.

Webinar Introduction

Jim: Welcome to our webinar. Avoiding Potential Pitfalls of Medical Device Design and Development. I’m Jim Hammer, managing editor of Medical Design Outsourcing. Thanks so much for joining us today. I’ve got a couple of housekeeping notes before we get started. First, you’ll see a variety of boxes on your screen that can be moved and resized to meet your preferences. I’ve got two boxes in particular they’d like to note.

The first is a resource box with info with an info sheet about our webinar sponsor Rev.1 Engineering. The second box is our Q&A box where you can ask questions during a webinar. We will have a Q&A session at the end of this webinar, but feel free to ask your questions as they come to you, including on demand. And if you are watching this webinar on demand.

So submit your questions. Our presenters will get back to you. A recording of this webinar will be available on Demand Medical design and outsourcing website. If you happen to run into any technical issues during our webinar, first thing you should do is try to refresh your browser and if the problem persists, you can reach out to us through that Q&A box.

So first up, thanks to Rev.1 Engineering for sponsoring this webinar and it is my pleasure to introduce today speakers from Rev.1 Engineering Chief Operations Officer Kevin Magrini and Chief Technology Officer Andy Denison. Kevin, Andy, thanks so much for being here.

Andy: Thanks for having us.

Jim: Kevin, would you mind telling your viewers a little bit about yourself and what you do?

Kevin: Absolutely. So my name is Kevin Magrini. I’m the chief operations officer. I’ve been at Rev.1 almost 13 years now. I’ve been in the medical device design and development industry since 2000. I met both large and smaller companies in the last years here at Rev.1 Engineering. It’s been all bringing first of kind medical devices from concept all the way to the market.

Kevin: So a lot of experience, and I’m excited that everyone’s here. Hopefully we get something out of this webinar and we can learn so much.

Jim: Glad to have you here. And Andy, can you tell us a little bit about yourself and what you do at Rev.1?

Andy: Sure. I have one. I’m the chief technology officer. Very similar background to Kevin. I’ve been at Rev.1… It’ll be almost 12 years now. I have a history in the medical device design and development industry since 98, working for larger companies and startups as well for mid-sized companies as well, all in cardiovascular mainly. And then kind of once getting to Rev.1, having a much wider breadth of devices that we’ve worked on in that timeframe.

Andy: So again, excited to do this and, and have this webinar.

Jim: Thanks. Warm welcome again to, to both of you. Let me get to our agenda. Here’s what we’re hoping to accomplish today. We’ve got five main learning objectives for our discussion. First, we’ll talk about why embracing flexibility in the design process is so important. Second, there’s something we talk about all the time at MDO, why do you need to be designing for manufacturing through every step of development process?

Third, why should we plan to work closely with your design team? Fourth, how to balance internal hiring with outsourcing. And finally, how do you prioritize lower up front? How prioritizing lower upfront cost development solutions can lead to spending more money down the road? We’ve got some good topics to explore, so let’s get right into the discussion with the first point on flexibility design.

Andy, this first question is for you. Can you share a time when being flexible during the design phase really turned things around for project?

medical device design and development pitfalls agends

Flexibility During the Medical Device Research and Development Process

Andy: Sure. Just maybe a little bit more philosophy on that real quick. Flexibility is really a key factor in kind of getting to the best solution in our situation for the client. There’s been, you know, numerous situations that we’ve had where we’re presented with a patent, so to speak, from a client and asking us to then develop that into a device for that client.

Andy: We tend to try have a very systems type approach to solving these types of problems. And that that flexibility really comes in handy working with the client to be able to kind of take a step back and really look at what the problem is that they’re trying to solve and what this particular patent solves. And reestablishing what that problem is, because oftentimes that leads to more solutions.

Andy: And even as we’ll talk further on, you know, getting ready for DFM, finding solutions that are more tailored for that in the long run and getting this product to commercialization. Also being flexible in trying to understand how what the constraints are for that device itself. Sometimes inventors are not always super aware of what the clinical setting is, and they need to have that understanding and understand what those constraints are and how those factor into their design or their solution as well.

Design for Manufacturing During Device Design and Development

Jim: Okay, Very good. Thanks.

Kevin. The next questions for you on the topic of design for manufacturing. When do you think teams should start worrying about manufacturing stuff and how does getting a jump on those considerations play into the bigger picture of medical device design and development ?

Kevin: Yeah, great question. We’ve fallen victim to this throughout our careers as well, we get tasked with a lot of first-of-kind, “is this possible” type devices that are very complex. So building a proof of concept prototype is definitely a big milestone. But if it takes such high skill to build it and we can only build one, then it’s not really a win, right?

So that’s a more of a temporary stepping-stone to keep in mind, if only high level technicians or engineers can assemble whatever you’ve designed. It’s not really a win in the long run, right? It might be a win to say “we did it!” but if you can’t assemble it and make money at it, essentially, then it’s not really a win.

So having the manufacturing in mind as you start and as you go through medical device design and development concepts is definitely a lot more powerful when you do get a concept that works. And I think it’s a kind of a common fallacy that everyone thinks once you hit your design freeze, then you just start manufacturing. And that’s very difficult to do if you haven’t put any work into the manufacturing upfront.

So that’s very costly as well. I think we get into that in some of our later topics. But thinking of that assembly in manufacturing, as you build your prototypes from from the start, pays total dividends on the back end when you’re ready to start getting into your V&V builds.

Design for Automation

Jim: Even now, it’s going to be a little bit of a follow up on that because I’ve been hearing a lot about the term “design for automation”, where people are even thinking from the very early stages, you know, how do you design a device to have, you know, automated manufacturing help take it through the process? Is that something you’re hearing a lot about or is that something people should be considering more now?

Kevin: I think it depends on what’s your what’s your end goal. A lot of the clients we work for may be startups. And so when they hear automation, it’s like, what does the volume justify that? So they may only want to make a few dozen to get through some lot release testing and some early trials potentially.

But if your goal is to get more fully automated and take it overseas to really drive all the cost out of something, that’s another level. So I think there’s different levels of design for manufacturing. And we just need to be concerned that people can build it. Maybe assembly level people can assemble this repeatedly and accurately. And then once you kind of get that down and you want to go to the next level, it’s a whole nother investment of how do I get it to that automated level where things are kind of coming off the line, so to speak?

That’s completely different levels. But yes, there’s no like one solution for all of them. It’s kind of what does that client want and what’s their timelines look like and what’s their end goal?

Transparency in the Medical Device Design Process

Jim: Thanks. That’s really helpful. Andy, let’s let’s talk a little bit about collaboration with design teams. Have you seen any especially good ways that clients and design teams are working together super well? Is there anything that really made those strategies stand out in your mind?

Andy: Yeah, and it’s something that we practice a lot of Rev. 1 and that is making sure that there’s a really tight and often communication between client and design team. And I use the term client loosely here, you know, projects that are run internally at large organizations can really view their company or their management as their client.

So I’ll use that interchangeably. And so people kind of take that and reference that as they’re thinking about it for their particular situation. It’s kind of a good mindset to have and it really helps kind of promote the buy in from the team as well. But design and development is really a process that takes place and there’s a lot of discovery that happens along the way.

And so establishing that communication and working closely with your medical device design and development and design team so that all of that information can be shared and learned along the way is really key because a lot of the decision makers for the project or the devices itself really need all of that stuff. And so where that a lot of the that comes in is failures.

There’s a lot of failures that are going to happen along the way. Prototypes that don’t work, testing that doesn’t meet output that you’re looking for. I mean, we can go on and on what those are, but really, every single one of those need to be looked at as opportunities for learning and how to get that deeper understanding of the product, what is happening with it, because that will lead to, you know, a better design or even the ability to design it for manufacturing or have a design for manufacturing.

So again, failing, failing fast, getting to those points is really critical. Also to making course corrections for the project in real time is really critical as well. So being able to see when you know a design is kind of leading off path a little bit is deviating from where the end points are wanting to be, you know, being able to collectively work with your team very quickly again, to kind of course correct and get things moving in the right direction is really important.

So, again, that leads into more, transparency with your team, too. So we’ve definitely seen times when information or not all information is shared with the medical device design and development team and they’re tried to give very specific tasks to try and keep them focused. I feel like that kind of line lends itself a little bit more to the management side of stuff, but it’s been our understanding that the more transparent you are with the team and helping them understand where things are at, what challenges are there, they’re actually more provide many times solutions to those challenges and help move the project forward more quickly.

And it maxes and maximizes their engagement with the project and their desire to solve the problem with you. So and again, that communication all also kind of comes in that scope creep is really normal in a project. The deeper understanding is of what’s happening, how the product was intended, or sort of to work. Discovery happens, you realize it needs to do this instead, and so you have to shift gears so that communication again, working closely with that team, sharing that information, just gets everybody on the right page, the same page, and progressing the project in a positive direction.

Jim: Well, very good.

Failure Isn’t Always Bad During the Design Process

Kevin: Couple of things to add to that real quick. So some of the majority of the projects that we take on tend to be very complicated or large, and it’s just tough to figure out where to start. Right. So we like to try and break it down into smaller wins that we can get right. And I think along with that goes, I just kind of wanted to piggyback on what Andy said about the failure.

I think that it seems to be gaining some momentum in the industry finally, which is good because typically if you fail, it’s seen as a as a negative thing or a bad thing and you know, you’re not doing your job well. We try and kind of flip the script on that and we kind of reward people for how fast they can fail.

It sounds kind of funny, but let’s let’s really break something down into this basic of deliverables we can to get some small wins. And when you fail on those, analyze why and try not to fail again for the same thing if you can. And then as that goes along the way, you start getting small wins that add up to big wins.

So the failure thing is good and I really like to promote that, even though it’s kind of counterintuitive. Right. So I’m glad you brought that up.

How Often do We Meet with Clients?

Jim: We’ve got a question from the audience. That is a good one. Instead of saving this for the end, I think I’ll just bring this up right here. They’re wondering how often do you meet with an average client for updates or is there kind of a range or guidance that you can give to show how often you’re going to be in touch to keep that flow of information going back and forth?

Andy: We have formal updates, usually on a weekly basis. So these are scheduled, planned, you know, with slides summarizing, you know, our current position on the technical aspect of the project testing that was completed, next steps, challenges that we’re having or there’s maybe multiple designs that are being shared and there’s discussions around that. And then we also provide project management updates and financial updates if the client wants in that setting.

But they’re really free to contact us any time during the week through email calls and stuff like that. And again, that goes back to that course correction too. So as the client gets other information or other things and they need to disseminate that to us, we’re ready and ready to take that on immediately so that we can course correct it.

Same thing for us. If we discover some big problem, we don’t wait till the following week to do an update. We’ll do it immediately with them. Again, it’s that speed and that communication is key to kind of getting the best result for the client.

Transparency and Communication is Vital All the Time

Kevin: And that transparency rate, that’s super key. Like we’re never afraid to tell our clients everything we failed at and kind of what we think going forward we shouldn’t do. But at the end of the week or the month, the clients should never be surprised at where we are, right? They should know, Hey, we’re checking a little over budget or we’re behind schedule.

We’re ahead of schedule. The more open and transparent we are just seems to work better for everyone involved.

Jim: Very good. Very good. And do either of you have any examples of where maybe your clients come to you after working somewhere else and that the communication wasn’t there and things really went off the rails and you were able to kind of help get things back on track?

Kevin: Absolutley.

Andy: To say maybe we’ve definitely been approached by several companies, you know, with them sharing unfavorable interactions with other companies or other places where they, you know, people took what their requirements were and then disappeared and didn’t engage with them back for a month or two. And then when they came back, it was obviously not in the direction that they wanted to go.

So they were, you know, disappointed and upset. So, you know, and then they were excited about how we did it. So, I mean, we’ve had those specific things that have happened to us over the years.

Jim: Sure. So that’s maybe red flag to watch out for if you’re not hearing back for a long time, something might be getting in and out of sight.

Andy: Yeah. Reach out. You know, demand that they’re communicating with you.

Kevin: Or if everything is just rosy and golden, the whole time, it never is. Right? So we don’t try to hide behind that either.

Andy: Very good.

Balance Between In-House Hiring and Outsourcing Medical Device Development

Jim: All right. Well, we you know, MDO, we’re all about outsourcing. So, Kevin, maybe we can talk a little bit about that balance between hiring and outsourcing. You know, when you do something in-house versus when you find somebody else, what sort of advice might you have on, you know, figuring that right mix between bringing people on board and outsourcing?

Kevin: Yeah, that’s a good topic. And it goes to why we started this whole company essentially if you maybe just think of it as this from a startup standpoint. If I want to start up a company and I have this great idea and then I have to go look for someone to help me with that idea so I can be an effective CEO of that particular company and I can bring on this resource.

I need somewhere for him to sit and some hardware for him or whatever. And I try and pick someone that’s the best skillset for what I want. And what tends to happen is then as we get going, the scope kind of creeps a little bit. And then now I need, you know, in addition to this one employee that I have, I might need someone else that has a little different skill set.

And then as you move through the project, that just amplifies. So now you’re hiring a good amount of people and one hopefully they work well together because of the whole H.R. side of things and you want to make sure you have all the skills that you want at the time that you need them.

And then as you move through the project, you may not need a few of those resources anymore because now your project’s in a different phase and you might need a different set of resources. So trying to keep a cap on that and not run it so it’s too expensive is difficult. And I think that’s one of the advantages that we can offer, is if we build that team and we’re continuing to always build that team.

And so when a client contracts with us, we can offer only the resources that they need at that time. And then that could morph. And it’s kind of fluid throughout the project and it shifts and they might need more maybe quality support on the back end or more manufacturing support in the back end, and we can shift with that.

And then also it’s a little bit different concept to think about that If we resource a project with one headcount, that doesn’t necessarily mean one person. So what I mean by that is if I have one full day of hours to build, say I’m building eight or 9 hours in that day, that could be four or five people building a couple hours at a time or contributing to that project at a time.

And you’re getting four or five different perspectives. And you know, everyone has their own strengths. And especially as you move through a project, it might go a little bit more into Andy’s wheelhouse than mine or vice versa. And we can both contribute to that project as one full time headcount. But it’s two of us or three or four or five of us, right?

So that really gives you a lot more bang for your buck. And then when you’re done, you just turn off the faucet and you don’t have to keep paying, say, like your R&D guy when you’re going through clinical trials or whatever the example may be. If you don’t need that resource, you don’t have to pay for it if you’re outsourcing it, right?

And then all the other systems and softwares and all the expensive stuff is in place if you outsource, usually at least with us and, and everyone kind of jives and works and knows how each other’s strengths and weaknesses are. So it’s a more maybe a better shot on goal. Right. And it ends up, I think, cheaper in the long run because you’re only utilizing the skill you need for the amount of time that you need it.

And your pool of talent is a lot larger than if you were to start it up by yourself. So kind of long winded answer. I’m sorry for that, but I don’t know any anything else you can think of on that.

Andy: I think you describe it really well, I think where you see a lot of the benefit that Kevin was talking about is in the brainstorming or conceptualization side, you know, getting multi pool ideas on a whiteboard very quickly is super beneficial to solving the problem instead of resourcing a single person and then relying on that person to come up with the solution.

So having that functionality here has been super beneficial and has yielded some really nice designs and ideas for our clients.

Benefit of Outsourcing

Jim: Very good. Very good. Thanks. And we’ve got another question came and seems like a good one for this kind of topic about why not hire one engineer to work permanently in the house versus paying for an engineering company?

Kevin: Sure. So kind of like what I talked about or Andy just mentioned as well. Like we how I’ll be honest, we never really get easy projects. So it’s very often that we kind of bang our heads against a wall and we’re not sure what to do next. And we have to kind of dig deep and figure that out.

So that’s difficult to do by yourself. We tend to do like Andy says, we hit those kind of walls where we don’t know what we want to do next all the time. And so we pool everyone together, all of our engineering resources, and just get a big whiteboard and and some pizzas and have at it right and let the ideas flow.

And then that one engineer on the project can go back and develop those and maybe they have five or six new leads to follow that they would not have thought of. You know, we also encourage, you know, there’s no there’s no dumb ideas. So we throw things out. And even though it seems a little off the wall, sometimes it spurs another conversation that leads to something that’s that’s valuable.

So in that respect, I’ve been at a small company where I’m the only engineer, period, and that’s a little scarier and harder to And it just takes a lot longer, right, to come up with different ideas that it might be out of the box when when you when you work on one project, you tend to kind of get pigeonholed into your ideas.

The best idea. And you go and it’s if you don’t have other collaboration happening, it’s it it’s not as efficient, I guess I’ll say. And so that’s what’s nice about having our group of people together that that are used to solving very complex problems it’s much more efficient and rewarding and quicker and cheaper. If you can have a lot of collaboration.

And so doing that by yourself is, is not easy.

Andy: Yeah, we all get stumped at some point, you know, hit a roadblock, a mental block, you know, and you just need someone to look over your shoulder and say, Am I crazy? You know? Or I really don’t know exactly how you would make this. And it can be a 15 minute conversation with someone saying, that’s easy.

You just do this. And then that frees the person up and then they can continue to move. So having that availability to progress yourself is, you know, super valuable and difficult to have when it’s just one person doing that.

Kevin: Gotcha. Right. And then kind of follow up on that, too, that that a lot of the experiences we’ve had in the past from clients, I think you mentioned it earlier, Jim, that may have gone somewhere previously. And then they come to us and then they’re bringing their good and bad experiences from that client to ours is, you know, we never when our clients to be surprised at the end of the month when we send them an invoice.

So kind of the ways we get around that and in this could be good if you’re working with someone that you’re outsourcing work to is again the full transparency. But not only that, we use kind of software that shows everything that we’re working on down to the minute on every project because we may be doing a dozen at a time.

So we’re only charging you for what the time we’re putting into your your project. And at the end of the month you get a full break out of that to see, Hey, where did all my money go? This is exactly where it went. You know, yesterday I worked on this, this, this, this and this for this amount of time.

So, again, full transparency on that. It’s another benefit of outsourcing. And then, like I said, if you’re getting an you’re paying for one engineer, but five engineers are giving you, you know, half hour here in our there or whatever the time is, that’s another benefit to outsourcing but that’s, you know.

Prioritizing a Lower Upfront Development Cost Could Cost You More

Jim: Very good That seems like a good way to maybe segue into that fifth learning objective on prioritizing our development solutions. Can you talk about a time when going for the cheaper option upfront ended up costing more down the line? You know, what happened and what did you learn from it?

Kevin: Yeah, and you may take it or you can take it to do.

Medical Device Prototypes and Funding

Andy: Yeah, I would. I mean, we can’t speak about specifics, but sometimes working in the startup world, it can be a little bit more difficult where it’s some business decisions to kind of deal with that exact thing where the money isn’t there to put into the development for at the time.

They just need to get to that prototype in order to secure that next round of funding. And then they’re going to have to go back and kind of really work on that further development. So whereas, you know, maybe someone who’s a little has the capital for that longer run and is ready can make that investment on the back side to, to ease the DFM side up downstream in the later part of the process.

We’ve definitely experienced that a lot because, you know, and we’ve seen both sides of that, you know, having worked with, you know, smaller clients, you know, single to three person companies all the way up to some of the you know, the big large companies. So, you know, everybody kind of has a little bit of a different approach. And I guess that’s the other thing, too, is, you know, hopefully you can, you know, resourcing with an outside firm, You know, they can tailor kind of what they can provide to you based off of what your needs are.

You know, so that’s another kind of like key thing. So I didn’t get.

Kevin: Back into that too. So it’s like you said, if we’re working with a smaller medical device design and development company, they may be a little bit more short sighted and for good reason to, you know, if I’m in doing some builds, then I want to get to my prototypes and I maybe don’t want to do a lot of the DFM because I can’t afford it.

And it seems like we’re saving a lot of money and my yield might be 30% and I’m okay with that. Just give me a dozen catheters or whatever we’re building or piece of equipment. Everyone that’s in med device knows that that kind of once you kind of lock in, you’re locked in. And then trying to make those changes now is a lot more costly and time consuming.

So if possible, if you can do it upfront and then it saves you dividends on the back end and as we mentioned before, so trying to get once you kind of validate and you get into that lot, then making the changes that get that much more expensive and time consuming. So we’ve we’ve definitely seen all aspects of the of the spectrum on that topic.

Andy: I think some of the other activities that you can do is really evaluating what your technical risks are for the project and identify bring those with, you know, management or and the team and then coming up with a strategy for how to mitigate those as quickly as possible because it may you know, I’m trying to think back to times now.

There may be a couple where we’ve had some stuff presented to us and, you know, we’ve and said to them, we don’t think this is possible, you know, and we weren’t really willing to engage with them. And then they would come back and said, look, here’s a certain amount of money. We definitely want you to work on it for a little bit and prove to us that it can’t be done, you know, But we want you to give it a shot.

And so we’ve done some of that and some of them we’ve proved ourself wrong and figured out that there was a solution. But we have had one or two where we were able to physically show them where the limitations were in their design, that it wasn’t possible to do what they were trying to do. Oftentimes in the situation of trying to pack too many features into a single device it’s just too much stuff in a small package.

Right. And that’s usually what it comes down to.

Audience Q&A

Jim: Great well Kevin and Andy, I think that does it for my questions but I want to get into the really important questions. We try to save a lot of time here for the medical device design and development questions from our audience. And I can see that we’ve already got some questions for this Q&A session have been submitted there in the queue. But as a reminder, anyone in the audience, if you haven’t had a chance to submit your question, please do so now using the Q&A box and a reminder for those in the future who will be watching this on replay, you can still ask questions through the Q&A box and handicapping their team will be able to get right back to you with information that you need specific to your question.

When Can I Start Looking for a Medical Device Design and Development Partner?

So looking through the Q&A queue, let’s start with the question is a question about someone’s got a device concept and, you know, we’re wondering how much of that design, you know, sounds like, you know, figuring out the entire design before you start looking for a development company is it’s probably too far to get down the road.

So how much of that design needs to be done before somebody starts looking for a development company? I mean, I hear it all the time. You don’t want people necessarily come to you with with napkins. Right. But how far do people have to be done with a design to to start this conversation?

Andy: I’m fine with napkins. We’ll take them.

I actually think that for us I think we kind of like that because like I said earlier in the webinar, being able to engage with a team earlier on in that process when you’re not committed to a design or a solution or a design is helpful because again, it goes back to multiple things. We’re talking about having more eyes and more brains looking at and evaluating the concept, the design, the problem that needs to be solved, different constraints for use of that device or design and factoring all that in will kind of help develop it and kind of get the project moving in the right direction sooner.

Instead of spending a lot of time and energy trying to develop it out to the point that you think you need it to before you take it and then have to take that big step back to actually get it going to where you need to. So I would actually encourage that napkin discussion.

Kevin: Right. That kind of plays with like if we have a smaller client come in and they’re fairly down a path. We may question that like you said and figure out the real problem they’re trying to solve. And there might be alternate solutions that might be more cost effective, better, quicker. And again, that’s another benefit to having a dozen people look at it versus if you’re by yourself cranking down it down a pathway.

So if we’ve seen it all, we’ve seen people that don’t even have a napkin yet. If there’s a half baked idea in their head all the way to someone that might come with some prints or prototypes.

Andy: Yeah.

Kevin: Yeah, exactly. So either way, I think it’s it gets back to you with what’s the what’s the real problem we’re trying to solve? And it’s easy to get down a path and kind of forget what that is, I guess. Right? So, yeah, we’re open to all of that.

What is a Good Medical Device Commercialization Profitability Goal?

Jim: Yeah, very good. Thank you for the question here. What’s a good profitability goal when we get to production?

Kevin: A profitability goal, as you said, as much as possible. It’s hard for us to say we work on so many different things that it could be something that’s a very high volume, low complexity that might not have a very high profit margin and that could be some device that has no reimbursement yet or whatever.

Right? So and it’s a very high dollar disposable device. Profits are going to be fairly higher for that one potentially and lower for the other ones. I don’t know that I can comment more on profitability then. Yeah, as much as you can get.

Jim: Very good. And that’s kind of thing, if you want, we can always follow up outside and if anyone has a specific question, feel free to reach out to presenters after if you don’t want to? Feel free to reach out after it through the contact information and you can get more of a one on one response.

Kevin: You’ve got one more thing. I think it’s also two. There’s different phases, right? So, you know as your volumes go up, you may have to go elsewhere to get lower costs and get your profits up if you need to go overseas or or to Mexico. Potentially. This is different, Right? So right out of the gate, it may not be exactly what you want, but you’re getting on the market and getting your exposure and then you might have to take it to the next level.


What is the Most Expensive Part of Getting a Medical Device to Market?

Jim: Perfect. Next question for either of you guys. What’s the most expensive part of getting a project to market?

Kevin: Good question. You would take a crack at it? Yeah.

Andy: Yeah. I was going to say, just, you know, based off experience, it’s definitely in V and V – that’s where we typically tend to engage with people, it’s really on that side, you know, because obviously there’s a ton more. We’re generating all of the testing and the documentation needed for the device.

At that point, you’re developing, you’re building more and more devices for the testing that are needed in that phase of the project as well. So that tends to be where we see a lot of the higher end. Now, granted, you know, going into commercialization and building launch quantities and sales and marketing, all that kind of stuff, If you’re factoring in that stuff, then you know, that could probably definitely trump it.

Kevin: In clinical trials, right?

Andy: Yeah, and clinical trials as well. Yeah. So again, kind of comes back like what Kevin was saying depends on the class of the device, you know, and all that kind of stuff.

How Do I Know if My Development Company is Overcharging Me?

Jim: Well, a quick question here. How do I know if my development company is overcharging me?

Andy: Good question. I think that might have to come with, you know, looking at what your options, you know, there are different firms out there and comparing and then also just kind of really looking at, you know, again to like Kevin was saying the transparency that we have with with our clients where we have that detailed list of what was worked on and how long it took to complete those tests.

So you would if a supplier is an outsourced unit is working with you, you should be able to get that so that you can evaluate it and make that determination. If you feel like the amount of time spent for specific tasks or whatnot are reasonable. And if you’re getting the results for that time and effort.

Kevin: If I think I mentioned earlier, we track everybody’s time, everyone on their project to the to the minute literally so that you’re paying for what you only what we did and you know exactly what we did. So I think things to watch out for would be if you you know, you’re not getting very good communication and you just get a bill at the end of the month without like, hey, here’s exactly what we what we did and what we accomplished on, on a pretty minor level, right?

So that’s where I would worry if you’re not seeing that right.

Is Design for Commercialization a Really Distinct Phase?

Jim: I’ve got a question here about in your experience, is DFC normally a really distinct phase? Are there ways to make it into your main design processes that create more cost visibility earlier?

Kevin: I think that’s always a that’s that has to be on our minds as we go. Because again, like I said, if you make a prototype and it works, that that’s fantastic. And I don’t take any glory away from that. But if it, you know, $2 million worth of labor and materials to make that work, then it it’ll never get to market.

Right. And so with this kind of the trend of the question, I don’t know, but that’s what I’m doing. So that’s always in the back of our head to do. How do we make this cheap as possible and still meet all the requirements? And because of that, right. We’ve seen plenty of devices that that that make it through concepts, but they don’t they it is difficult to get more funding or something because the cost is too high.

It’s probably not going to make it all the way. So that’s definitely always in our in our minds.

How Do You Ensure the Final Product Meets Clinical and Regulatory Requirements?

Jim: Very good. Got another question here. It’s a little bit a long one. How do your medical device design and development engineering teams effectively incorporate commercialization consideration from the outset of the design process to ensure that the final product not only meets clinical and regulatory requirements, but is also optimized for market acceptance and scalability? That’s part one. Can you provide insights or examples and methodologies or frameworks that facilitate this integration without compromising innovation or design efficiency?

Andy: Yeah, I think it really has to come in stages, right? So, you know, the cost of goods or, you know, with price targets and things like that, some of the projects that we work on, you know, have those as constraints for the project. So we’re looking at those actively along the way because if we can’t get to those, then there’s not a product for this particular.

And so, you know, we will work very diligently to try and come up with design solutions that will them to that goal. Again, those goals are like Kevin had mentioned, you know, they have to change and vary along the way depending on where you’re at in your phases or of the product itself. So, you know, again, those high commercialization goals may be that at the point which it’s moved overseas and now you have, you know, much lower labor rates and so on and maybe even sometimes your material costs come down dramatically and it’s a little bit easier to kind of get to those goals.

So having, you know, staged goals, if you will, at what phase of the project you’re on are kind of really key, you know, in order to make those considerations and get to the end position that you want to get to. But then thinking about commercialization at the time that you’re even trying to build one prototype to see if it’s feasible is not super practical.

Kevin: Right. And I think again, the medical device design and development misconception from and not it is what it is, but and I would probably think this if I had never gone through med device either, but as soon as you get a prototype, you’re ready to start manufacturing. And that’s kind of the common thought, right? And that’s it’s not the case.

And I think there’s like we talked about before, there’s many levels of design for manufacturing in many phases. And again and again, he said it’s all based on the volumes you want and the and the kind of the times that you want to get those. So keeping that in mind, you know, having familiar with different options and trying to, you know, do the keep it simple concept and repeatable we spend a ton of time on the EVM and fixturing and kind of various levels of automation.

Right So that that’s a good question. I think we answered it. I don’t know if if not feel free to make Mark on it.

Andy: Yeah.

Who Owns the IP You Create?

Jim: Yeah, yeah. You can always take another look at that in the written record of the Q&A and reach back out to them if you have any more thoughts. We got a question here about the IP. Who owns the IP? If I work with a development company.

Andy: We assign all of the IP to the client. So we have one does not own any IP. So that’s it’s, it makes it very clear. Otherwise it gets, you know, very sticky and difficult again to put some strain on the relationship. So it’s really cut and dry. If we’re working on your project and we disclose ideas to you, you own those.

Jim: What’s the best way to kind of work out some of those when you’re working with a a design firm or a development firm? AH is that the kind of thing where you’re bringing in outside counsel? Do you have your in-house counsel that works on those IP agreements?

Andy: I know those are built into our contracts and so we do not have any IP counsel in house because we’re not filing or managing any IP for REV one. We will work with the client’s IP counsel in order to generate any disclosures that are needed patents or, you know, anything of that that is needed for pursuing that IP for the client.

I think that’s pretty, pretty easy.

Kevin: Yeah, but that may not be a common practice in medical device design and development. So I know a lot of other firms don’t operate that way. So we’ve also worked with clients that maybe are manufacturing at a contract manufacturer somewhere and they want to kind of lift it and make some design changes or take it somewhere else. And it’s not very easy to do that if they don’t own all the IP on that.

So they may not get you know, this could be a lot more work to answer that somewhere. So that’s kind of the other end of the spectrum, I think, as well.


Jim: All right, Very good. I think we’re going to wrap up the Q&A session here and start winding down. Just want to thank for their questions and any questions that we didn’t get to. We can follow up with email and once more, if you’re watching this webinar on demand, please feel free to ask questions. And Kevin and Andy and their team will get back to you.

And if you enjoy this webinar and you want to share it as a reminder, this webinar will be available at our website You’ll also receive a link in your email that you can forward to someone you know who you think might enjoy this webinar to share from them. I’ve been getting a few emails about that after recent webinars, so there’ll be a link right in the email that you can forward to people.

So thanks again, Kevin and Andy for sharing your expertise as well as to everyone engineering for sponsoring this webinar. And of course, thanks to everyone in our audience for attending. We hope to see you soon again at another medical design and outsourcing webinar.