How to Embrace Risk for Safer Devices

No matter what you are working on, there are risks involved. Product development is complicated.So, learn to embrace risk, and use it to your benefit to make your product safer. Think of what you can manage vs. what you can’t control.

Our guest today is Tim Moulton of Motim Industries, who shares what you can do better to manage product development risk.

Design and build a robust, viable product that's engineered for success in the market, works for users, and gets people excited!

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Some highlights of this episode include:

• Self-inflicted wounds occur when engineers go with what they know, and in turn, produce a generational product not based on the best choices; or people get hung up on implementing fundamental features that fail to add value to their product.
• Things to consider when defining the value proposition for your product: Novelty, meeting design expectations, and stepping outside of specifications.
• A new, unique, and different product can create challenges from a regulatory perspective. Novelty should be an element of risk that benefits its users.
• Identify and evaluate risks; be honest about known and unknown risks.
• Build mockups or prototypes that work, but do not need to be high quality. Focus on what you are trying to learn. You have to build to learn - start that process as early as possible.
• Risk becomes maligned. Most people perceive risk as a bad thing, so they just ignore it; however, some risks are worth taking.
• There are good risks and bad risks. The key is to identify and discuss them, then compare them to your overall vision.
• Don’t put yourself in a “Goldilocks” zone or between two requirements or risks where you don’t have the freedom to operate.

links:

Motim Industries

Greenlight Guru

Memorable quotes by Tim Moulton:

“What we’re trying to do is design a really strong, robust product that gets people excited.”

“We do get this very good perspective as to what might have been avoidable after a project - what difficulties might have been avoidable and what ones weren’t.”

“Your product has to offer something different than what’s out there. With medical devices, it’s a balance between whether you can find a predicate device or not.”

TRANSCRIPTION:

Announcer:                   Welcome to the Global Medical Device Podcast, where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the worlds leading medical device experts and companies.

Jon Speer:                     Okay product developers in the medical device industry listen up. There are things in your project, risks that are there whether you've given them the credit or acknowledged them or not, you have risk in your product development efforts, you have risk in your product.

Jon Speer:                     So, it's very important to really embrace this concept, this idea of risk and use it to your benefit. It will help make sure that your product is safer and it will help ensure better success of your product development efforts overall.

Jon Speer:                     So its really key to think about all the things that you can manage versus the things you can't control and having awareness of that. Today I'm real excited on this episode of the Global Medical Device Podcast I talked to Tim Moulton who is with Modem Industries and we really get into that topic of product development, project risk and things that you can do. So enjoy this episode of the Global Medical Device Podcast.

Jon Speer:                     Hello and welcome to the Global Medical Device Podcast. This is your host, founder and VP of quality and regulatory at Greenlight Guru, Jon Speer. Today I'm gonna touch on something that I think is very important for probably many of you in the listening audience today and that is, what you can do to better manage product development risk. I mean, there are things that you as a product developer can manage versus things that you can't control, and there are ... get in the right frame of mind the right context and really thinking about this in a more strategic way can help ensure the success of your product development efforts. With me on this conversation today is Tim Moulton, Tim is with Modem industries, he's a principle engineer. So Tim, welcome to the Global Medical Device Podcast.

Tim Moulton:                Well thanks for having me Jon.

Jon Speer:                     So, before we dive too deep today, do you mind giving the audience a little bit more information about Modem Industries and what it is that you do.

Tim Moulton:                Sure, we're a small engineering consulting firm, and we typically work with emerging enterprises or efforts inside larger enterprises. We do traditional product development with more of an analytical and technical bend to it. We do primarily medical devices, but have worked on everything from toilet valves to x-ray machines, and consider ourselves generalists. We do a lot of highly integrated mechanical and electrical design and it is primarily for the medical device market.

Jon Speer:                     Alright, toilet valves to x-ray machines. That's quite a wide array, quite a spectrum of different types of products.

Tim Moulton:                It does, it makes for a great cocktail party talk.

Jon Speer:                     I guess the thought that instantly jumped to my head, is there something that you learned from your toilet valve project that you were able to apply to the x-ray?

Tim Moulton:                It does. I fix all of the toilets for mine and my extended family whenever needed.

Jon Speer:                     Alright, so you're certainly kind of in the thick of it, and I know sometimes, I will say myself maybe, I'll throw myself under the bus, I think when we think about product development a medical device professional may think, oh well product development for medical devices is way different then product development for toilets. Has that been your experience?

Tim Moulton:                It really hasn't. You have a little bit more difficulty scheduling things because of the different verifications and validations, and the different builds that you're compelled to do, but fundamentally you're still building something that needs to be a success in the market and needs to work with the users. I think that the medical device world has a little bit of a stranger decision process as to who's going to use it, who's going to be benefiting and who makes the decision to purchase it, but fundamentally what we're trying to do is design a really strong robust product that gets people excited.

Jon Speer:                     Yeah. I tend to agree with that. Folks I think, yes, there are things that are important about medical device product development. The FDA regulations for example, introduces this concept of design controls and kind of a whole lexicon of things that we need to understand, but by and large, and I'm not trying to trivialize it, don't miss hear me, but generally speak, product development is product development. Now with that being said, it is more complicated than just like, oh we're just going to design a new device and we're going to test it and we're going to take it to market.

Jon Speer:                     There's all kinds of risks that are scattered throughout the entire development effort, and sure there are products risks, like what happens if this thing goes wrong and somebody gets hurt. Those are important, but today, Tim, what you and I are going to be talking more about, from a project management standpoint, is what are the things that I need to do, how do I frame my context, my efforts, how do I gather the intel and the information that I need so that this project, and ultimately I guess, the product is as successful as it can be.

Tim Moulton:                Yeah, that's correct. I think over the years we've seen a lot of self inflicted wounds. We try to work very tightly with our clients, so we actually form one integrated team. It's difficult for us to help steer the project sometimes, but we do get this very good perspective as to what might have been avoidable after a project with difficulties might have been avoidable and what ones weren't. Certainly there are unavoidable risks. That's part of making something new, but there are also other risks that can come in and really trip you up.

Jon Speer:                     So when you say, 'self inflicted wound', give some examples. What are some self inflicted wounds that you've observed in your career as a product development professional?

Tim Moulton:                Well, some of it can be inside the device. You have an engineer, sometimes this happens with electrical, sometimes it happens with mechanical engineers, but you have somebody who's familiar in the past with a very specific technology and tries to shoehorn that in at the beginning, and maybe shoehorn is not the right word, but they go to what they know rather than going broad, and so then you end up with a generational product that's maybe based on not the most sound or well considered fundamental choices. I think that the other aspect of things is that now, you know we're all so fortunate in this day and age, it feels like we're living in the future. We hold really well design devices every day, whether they're our cell phones or laptops or some home technology now, and sometimes people get hung up on incorporating some of these fundamental features that have taken a multinational corporation years and millions of millions of dollars to incorporate in something and get hung up on something that is, maybe not as central tenant to the value proposition of their product.

Tim Moulton:                So we've seen it go both ways, but I think that those are the two big things. Either not fully considered decision on the technical side that kind of submarines into a problem later or else a UI or just general feature that ends up taking a huge amount of resources to bring to market when it wasn't central to the value proposition for your product.

Jon Speer:                     So let's explore that concept of the value proposition for my product. What are the things that I should be considering to really kind of hone in or try to articulate and define the valued proposition for my product? Because as you describe that it seems like that's really important. Kind of as you were talking I was thinking, oh this is the value proposition, that is the vision for what I expect this product to do to be all the things that I hope that it will achieve once it goes to market.

Tim Moulton:                I think it is and I think that there's a lot of modern users centric design approach that really highlights it, but I think that often it takes a strong founder or a strong project manager, I guess in this case product manager, to really define what that is, and I think what you need to do is you need to have novelty. It's a new product so you have to improve on something and you have to make sure that you improve on something and not that it's the clear benefit to the user, but you also have to provide hooks for the user to get excited about it. We do use very well designed products. The average user has a much higher expectation now then they did 10 or 15 years ago and we need to meet that expectation, but at the same time I think you have to be honest with yourself and up front and decide what of these are going to be difficult to implement and then go through them and say, if this one is not ready for primetime are we willing to hold up the product or the project because of it.

Tim Moulton:                I think that's what it comes down to, is just being able to step outside of your effort and yourself and look at your specification and what your vision for your product is up front really critically.

Jon Speer:                     Yeah, those are really good insights. A couple of things, a couple of threads I want to pull on a little bit there. You talked about your device needs to have novelty, you talked about it needs to have hooks in your device or your product. I use the work device, so Tim I guess I should clarify when I say device, I almost use that synonymously with product. It just I'm a 20 year med device guy, so I use those words as synonyms, so just know ...

Tim Moulton:                You and me both.

Jon Speer:                     Okay.

Tim Moulton:                I understand that there are software products, but that's not in my world.

Jon Speer:                     Yeah, well even software products, I would even consider them devices. It's almost a generic terms, but anyway, I digress. You talked about novelty and you talked about hooks for the user. If I put on my regulatory hat I'm like, oh hang on Tim, I'm waving a whole bunch of red flags there. You talked about novelty, you talked about something unique, different, that creates a lot of ... well the head trash around that is it creates a lot of potential obstacles or challenges from a regulatory perspective, so how do you deal with that? How do you create novelty and not be so novel or unique that it creates regulatory hurdles?

Tim Moulton:                Well I think ... it's been our experience that novelty in one field isn't necessarily novelty for the general population. Touch screens took a long time to get into med devices, wireless technology is still relatively few and far between, but there are ... It might be a novel application, that might be a better way to phrase it, but your product has to offer something different than what's out there. Right? Certainly with medical devices it's a balance between whether you can find a predicate device or not, and you have to balance that ...

Tim Moulton:                Some of the novelties that I'm referring to could just be good industrial design, could just be things that don't necessarily impact your regulatory approach, but really do make a difference to the people that are using it.

Jon Speer:                     I think this is an element of risk ... I often lump things like novelty and innovation and things like that kind of in the same bucket. It's maybe it's a good idea. Maybe it's not a good idea, but you think about what we're trying to do is, we want people to be excited about our product. We want people to ... I don't know if people get excited about doing medical procedures or using medical devices, but we want the experience to be awesome, and we want the patients' lives to be impacted for the better, as a result of something that we are doing.

Jon Speer:                     I think if we can ... really get inside the head of that user and understand what it is that gets them excited and what they enjoy and how they like the digital elements or how it feels in my hand. Things like that, those are very, very important things.

Jon Speer:                     If we're just stuck in this, I got to do this me too type of product, yes, the hurdles from a regulatory perspective may be very, very low, and yes, I can prove and demonstrate and test that, but then I create other risk to my company, to my business, because I didn't change the experience.

Tim Moulton:                That's right. And I think one area that I think this is readily apparent is as simple as it sounds, but foot switches, especially medical devices that are in an operating room. There is the requirement that we have independent means of stopping, and so most of the time that's handled with a foot switch, but sometimes you end up with what looks like an organ for the surgeon to use, with all these foot switches that are underneath that.

Tim Moulton:                Some of the products that we've worked on in the past have taken a different approach to this, to actually bring something on to a handle that has two independent means of stopping. I think that you can step back and you can think through these things, and you can make the user's life a bit easier. So they don't have to take their eyes out of the field of view and make sure that they are on the proper foot switch, in this particular case.

Tim Moulton:                Without adding a whole lot of risk, certainly from the regulatory standpoint you're still covered, and the user experience is just world's better. Certainly, one particular project I'm thinking of, it would have been easy to just keep adding foot switches.

Tim Moulton:                We even considered a three foot switch assembly, but when it came down to it, that was just going to be too much. It's an easy decision to make in an engineering review, but for the users out there, you're just making their life slightly more annoying every time they use your product.

Tim Moulton:                If you can relieve that burden, then I think that you start getting users really on your side.

Jon Speer:                     Yeah, that's really good insights.

Jon Speer:                     Folks, we just want to remind all of you that talking to Tim Moulton. Tim is principal engineer with Motim Industries, and Motim is an engineering firm in the Northeast of the United States, and they do some fantastic electro-mechanical design of various devices.

Jon Speer:                     So, go check out what Tim and his team are doing at Motim Industries, M-O-T-I-M Industries.com. The topic is timely and it fits really well with what we do at Greenlight Guru, and what we do at Greenlight, is we have an eQMS software platform, and within that platform we have specific workflows that can help you better manage information around your design and development process and risk and so on, as it relates to the product development efforts.

Jon Speer:                     So Tim, risk, we've kind of touched on these things from a surface standpoint, but let's talk about what are some tools or techniques or tips that you might be able to provide the people to help them better identify and even evaluate risk as it relates to their product development efforts.

Tim Moulton:                I think that's the fundamental first step right there is to critically identify and evaluate the risks. I think that you do want to sit down and you don't want to say, well just because this device has this feature, it would be really easy to implement.

Tim Moulton:                I think that you need to sit down and you need to evaluate, feature by feature almost. Maybe not to that extreme.

Tim Moulton:                The risks that will really catch you up or not catch you up, or hang you up, are the ones that you don't see, that kind of blindside you, and can catch you off guard.

Tim Moulton:                I think the number one step is to sit there and to be honest and be open and say hey, is this a risk, is this not a risk?

Tim Moulton:                The flip side of that is just because something's difficult and requires a lot of work, that might be a risk as far as schedule and budget goes, just because something's difficult, it might not actually be a risk, as to whether you can get it done or not.

Tim Moulton:                I think what you really have to do is make sure that you identify the unknowns as early as you can and then work as quickly as you can to turn those unknowns into known quantities or at least things that have plans associated with them to tackle.

Jon Speer                      Yeah and certainly good insights and as a project manager, one of things I always try to figure out as early as I possibly can, there are known knowns, things that I know. There are things that I know, I don't know, and then there are things that I don't even know, that I don't know.

Jon Speer:                     So understanding kind of those buckets, if you will, would really help because the things that I know, that I know, that's gravy. That's bread and butter. I can manage that.

Jon Speer:                     The things that I know that I don't know, okay, well that gives me some insights. This may mean I have to go talk to Tim or I have to go find somebody else, or I have to do some research to put those unknowns now in a category of things that I now know.

Jon Speer:                     But the things that I want to try to understand quickly, and this is a tricky thing, is unknown, unknowns. The things that I don't know, that I don't know. Do you have any thoughts or tips or ideas about that?

Tim Moulton:                This is getting down right Rumsfeldian, right?

Tim Moulton:                I think that the number one thing is to talk to people that have been there or that have done something similar before, and I think that can be other engineers, quality people, but more often, the easy way to go is to go and start visiting manufacturers, potential manufacturers, and ask them, because they have great insight too, as to what has held up other people.

Tim Moulton:                Once you get in to tooling or assembly, if you're using manufacturers, they're very sensitive to the schedule, and they know former clients or current clients. Well, they were making this part and then they had to stop because of this, or this project was scheduled to kick of in a year and a half, but it actually kicked off in four years, and they know why that is.

Tim Moulton:                I think a lot of that is talking to people, and that allows you to kind of step outside your breadth, without actually consuming that much of your time.

Tim Moulton:                But you're right ... finding out what you don't know, I think is the hardest thing. I think that's made a lot easier by just being honest with yourself about what you don't know.

Jon Speer:                     Yeah, I think I'll again throw myself under the bus as an engineer, and I'll go back, gosh probably, almost to the beginning of my career some 20 years ago.

Jon Speer:                     I remember getting ... I was working as a product development engineer, and on medical devices, and we worked, at the company I was with, we worked pretty closely with physician, I say physician inventors. Some of them were inventors. Some of them were physicians with ideas or challenges, or what have you.

Jon Speer:                     Often times, I would get a very crude prototype, sometimes even a literal cocktail napkin sketch, kind of describing or articulating this thing that the physician wanted and this problem that he or she was trying to address.

Jon Speer:                     I'm like, well I'm an engineer. I paid a lot of money for my engineering degree. I'm pretty good at what I do. I now have enough information, based on this prototype, or this cocktail napkin sketch, plus my engineering prowess and knowledge, that I can put my head down and go design something and figure it out.

Jon Speer:                     I'm going to confess. It took me a few iterations before I realized, oh crap, that's a terrible, terrible idea. Yes, engineers you're smart people, but realize one of the things that you don't know is generally, you probably don't know how to practice medicine.

Jon Speer:                     And you may not know how devices like what you're working on, are actually going to be used. You may not know all the other things that are happening in that environment. You talked about the foot pedal example. How many other devices are already in that particular environment that already have three foot pedals?

Jon Speer:                     Like you said, are you going to teach the surgeon to become an organist? Probably not. It's really important to try to wrap your head around that.

Jon Speer:                     For me, it got to the point where, oh, I want to get in to this mindset of prototyping and kind of the term that's in vogue these days is an MVP, minimally viable product, and we can talk about that.

Jon Speer:                     For me, I always wanted to build a prototype, get it in to the hands of the people who know about this procedure or this type of product and so on, and evaluate and learn from that, and then iterate, and iterate, and prototype, and iterate, and prototype, and iterate.

Jon Speer:                     How do you operate? How do you work with those types of scenarios?

Tim Moulton:                You know, it's funny. As you were talking about that, I was just thinking about a project we did a few years ago that was for a surgical robot, and efforts like that involve very complex and expensive parts.

Tim Moulton:                We really didn't build many early prototypes that would be considered true prototypes, but what we did build was about five or six different wooden mock-ups, where we used cabinet hardware and we have a CNC router, so we used routed or machined wooden parts.

Tim Moulton:                We kept building these wooden robots. What we do is we would play act. We would make sure that the arm lengths that we had could reach all the areas of the spine that we needed. We mocked up an IV pole. We mocked up anesthesia tubes, all of that. We made sure that we weren't trying to occupy the same space as something else. We even got so far as rolling a few of these into an operating room after hours. It was funny, at one point the client asked us if we were ever going to make something that wasn't wood. But, we did. We made one prototype, and it worked.

Tim Moulton:                It was sized correctly. It had handles in the right spot. I am a strong believer in the build to learn, and prototype early. I think that you also have to be careful to manage your time there, and not think a bunch of time on the quality of that prototype. What are you trying to learn? If it's about space, if it's about math, if it's about proportions, then, even cardboard or foam core might be able to get you there.

Tim Moulton:                The flip side of that is, sometimes on a mechanism or something else, you just need to get in and start designing early. I certainly had similar experiences as you, Jon, and probably more recent than I care to admit, where we thought we could nail something in a single iteration, and it took more than that, or at least partial iterations.

Tim Moulton:                I believe that you have to build to learn, and that you have to start that process as early as possible. You're always going to learn something unanticipated, so you might as well try to start learning that as early as you can.

Jon Speer:                     Yeah. I mean, there is uncertainty in product development. I know folks listening to this, I know you're smart people. Many of you have probably done this many, many times before, and in my experience in product development, I'm pretty sure this is accurate, I don't think there was ever a single time that we got it right the first time. It's tricky, you want to talk about risk, because sometimes we build timelines and Gantt charts and project schedules on the assumption that we're going to get it right the first time.

Jon Speer:                     We fall into traps. One project comes to mind from several years back, we were designing an electrical mechanical device. It was a pump product. Boy, this was a complicated thing, but we didn't treat it as a complicated thing. We didn't appreciate the risk in this project. It involved a brand-new printed circuit board, and a lot of other electrical components that were going to plug into this board. It had mechanical components. It had different disposable elements, and that sort of thing.

Jon Speer:                     Our schedule allowed for us to do one board build. And Tim, I know you've got some experience with this, or I would have to imagine you do. We allowed for one board build, and those boards had to be perfect. Well, they weren't. Then, we needed to do some electrical safety testing, and that ad to be perfect based on our schedule, and it wasn't. Let's just say we didn't set ourselves up for success; we set ourselves up for failure.

Jon Speer:                     I think a big reason for that was because we didn't appreciate the risk that was involved. I think, sometimes risk, I think it's maligned. When people think about risk, the perception is, "Oh, this is a bad thing. This means that something's going to go wrong." I think sometimes people, at least in my observation, they just ignore risk. Because, if we ignore it, it's not there. We believe that if we have it, it's bad. What are your thoughts about that?

Tim Moulton:                I mean, I think that's right. I think that you're right in that it does get maligned, because you only talk about it when it's currently hurting you. So we're in a similar situation right now where we have an electrical noise issue. We've had to change the way that we've constructed the cable. We probably could've avoided that by just splitting out those signals into a very small circuit board, and three or four months ago, just doing a quick sanity test. We would've found that we had an issue. We did something that was short of that, but I think at the time, if we were truly honest with ourselves, we would've acknowledged that it was not 100 percent equivalent.

Tim Moulton:                We were doing exactly what you just said. We've had to go through another spin of boards. There have been some other things that have taken a little bit longer, so everything's still on track, but it is something that, looking back, I wish we would've done a little bit differently. But, I think that this current, shall we say problem that we're in the middle of, is due to a critical user interface component that's on a handheld portion of a device with a base unit. It has been identified that this is key to the success of the product, and it's key to the user interaction.

Tim Moulton:                I think that this is a classic example of a risk that is not bad, a risk that is worth it. We have, it's a small screen that's out on a portion of the handheld. If that's not there, it's much less compelling for the user to use. I think we've all seen endoscopes and stuff where people have to turn their head and look at a monitor, or a surgical tracking solution where you're moving your hands, but you're looking at a monitor. This had the ability to have your eyes stay where your hands were.

Tim Moulton:                I think that this is a risk that is worth taking, because it provides the user with something that they're going to expect, and it's worth the effort because it's a key component of the product. I think that, in some ways, the novelty of your product demands risk in order for you to make it happen. So, I think that there are good risks and there are bad risks. I think that the key to determining the good risks and the bad risks is to identify them, and discuss them up front, and weigh them, versus the difficulty that it'll take to get through them.

Jon Speer:                     I want to encourage people, whether it's project risk or product risk. I want to encourage people to make that something that you'll try to identify as early in the project as you can. If you can do it on day one, and you can just brainstorm, you can write a list of all the risks that you see with this effort that you're about to embark upon. Knowing that, or having that as a baseline from a product standpoint, is very important because if I know where my high risk areas are, the things that potentially have the propensity to cause some sort of patient issue and user issue, harm if you will, I can use that as a guide from a development standpoint to make sure that I'm mitigating and addressing those risks through my development efforts.

Jon Speer:                     I think the same holds true from a project standpoint. It's just being aware and embracing the concept of risk, having a risk-based approach. I know it's cliché these days in the world of quality management systems, they'll talk about risk-based approaches. This is the way products get better; this is the way product development processes get better, is to embrace risk as a core foundation or tenant of your efforts.

Tim Moulton:                I think also, if you take that list of risks and you compare it to what your vision for the project is, if you don't see a correlation between those, then maybe there are other approaches that you can take. Or, you can trim your approach, or maybe add something to your approach, as well. From a project standpoint, I think it's key that you're putting your time and your effort into things that are going to be worth it.

Jon Speer:                     Really well said. So Tim, I know we've talked about a lot of different concepts, a lot of different ideas, a lot of different philosophies on how to embrace risk. So, before we wrap up today's episode of the Global Medical Device Podcast, any final thoughts that you'd like to share with the audience that we haven't covered yet?

Tim Moulton:                I'd say the only other thing that I'd like to stress is to not put yourself between a goldilocks zone, between two requirements or two risks where you don't have the freedom to operate. A spinal tap would say you can't turn the power up to 11. Sometimes, at the very beginning, you can reframe things, and give yourself a little bit of freedom in the future. Whether it's a tolerance stack, whether it's a power issue, whether it's a weight, something like that. If you're bumping up against a requirement, or between two requirements at the beginning of your project, that's only going to get more difficult.

Tim Moulton:                My very first medical device project ever was for a handheld injection device. There was a spring in it. At some point later in the development project, that spring needed to get stiff. I had not given it enough space. There was just no space to make this spring stiffer, so it had to get softer. We ended up having to switch to a stainless wire for it, that was then with round ends. On this thing they're making millions of, we had to add costs because I just didn't give enough leeway to operate later. I didn't think that I was going to stay up late running spring calculations for something nine months later, but that taught me a valuable lesson.

Jon Speer:                     It's a really good point. Folks, I want to thank Tim Moulton. Tim is the principal engineer at Motim Industries, look them up. They're product development experts, they certainly do a lot of things, anything from toilet valves to x-ray machines. A really great firm that you should be aware of, so go to motimindustries.com. And Tim, thank you so much for being my guest on the Global Medical Device Podcast today.

Tim Moulton:                No problem, thanks for having me, Jon.

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