Project Management - Best Practices and How to Choose Between Internal or External Development Teams
Bryon Bhagwandin is CEO of Recalibrate Solutions, a Denver Startup that is developing a system to monitor a child’s response to stress. Brian also has decades of experience managing development projects. In this episode Bryon shares the challenges of managing a medical device project, different models of project management, when to go to an outside development firm, what to look for when choosing one, and his advice for new project managers. He also shares a very interesting test his company is working on to help children be more successful.
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Episode Transcript
This transcript was generated using an automated transcription service and is minimally edited. Please forgive the mistakes contained within it.
Patrick Kothe 00:31
Welcome! Every project in every company that I've ever been a part of has come in early and under budget. Well, maybe that was a bit of a fib. Actually, it's a big fat lie. Managing a multi year development project is always a challenge, especially if you're in a company where you don't have all your all your resources in house. But there are some strategies that experienced program managers use to mitigate the risks, keep expectations in line and ultimately keep their projects moving. My guest today is Bryon Bhagwandin, CEO of Recalibrate Solutions, a Denver Startup that's developing a system to monitor a child's response to stress. Bryon also has decades of experience managing development projects. In our conversation, we discussed the challenges of managing a medical device project, different models of project management, when to go to outside development firms, and if you do what to look for in choosing one, and he also discusses his advice for new project managers. Brian also shares a very interesting test his company is working on to help children be more successful. Here's our conversation. Brian, welcome to the podcast.
Bryon Bhagwandin 02:10
Thank you for having me. Glad to be here, Pat.
Patrick Kothe 02:13
So Brian, we've got a more than a few things in common. But one of the things we've got in common is we both started off in pharma and then made our way to medical device. What was your journey? Like? Why did you make the transition from pharma to medical device?
Bryon Bhagwandin 02:30
I you know, the short answer to that is I felt like a fish out of water when I was in pharma. But let me let me put some, some flesh around that, that skeleton, I was hired to set up a brain scan machine. So I was hired for my expertise in physics and understanding electronics. And we were looking at central nervous system side effects in animals when when drugs and were being tested. And and I got into that, and I knew that I was in the wrong place I was working at at Eli Lilly and in the central nervous system department as a physiologist, we had a, a model for stroke. And we had some great results that we were producing. And then one day, they all went away and couldn't replace him couldn't replace him. And I tried for four, I can't remember how long and I went back into my supervisor. And I said, I cannot seem to get these results to be reproducible. And we talked about it for a while. And he was confused clearly. And he said to me, you know, rats are nocturnal. Maybe if you turned the lights out and did the experiments again, see what happens there. And I thought to myself, that's the best you've got for me. Turn out the lights and try it again. And you know, it just goes to the complexity of the whole human body in an organism system and how difficult it is I was used to pulling out a calculator, eraser and a piece of graph paper. And, you know, and calculating the results and figuring out what it meant.
Patrick Kothe 04:19
So Brian, you've been involved in product development for several different companies. I want to talk in this next section about product development. Now let's really, really kind of dig in and, and have a good discussion there. So I assume that you've picked up over your years, a lot of good lessons about good things that have happened and you've learned things on the positive side for product development, and some that there were hard lessons to learn probably on the on the negative side. So if you could kind of help help us to understand what's framed your view on product developers meant. And if you've got any stories about good good experiences or bad experiences and how they've helped you to develop your framing of product development,
Bryon Bhagwandin 05:13
let me just back up and tell your listeners that for probably a decade, my initial initiation into product development came in the form of working for an outsource development group. And so and it was in Seattle, Washington, and we had some really stellar engineers, there are a lot of mechanical engineers that are coming out out of Boeing, a lot of electrical engineers that were coming out of fluke, and a lot of software engineers that were coming out of Microsoft and and I really consider it a privilege that I had to work with such a high caliber of talent. That said, things didn't always go smoothly. And one of the things that I noticed in terms of how, how product development works is, is the problems frequently happen at the interfaces. So you've got a design problem where you're, you're, you're doing development and you've got, you know, you've got your your electrical layout that needs to happen, you've got your electromechanical and mechanical work that needs to happen, you've got your, your user interface, your software, it's where those parts meet, that that really can, can sabotage the problem and, and being able to recognize that when you start your integration, it's, that's when you need to put enough time in your schedule, to integrate when you're putting it all together and making it work. I remember one story where we were building a portable battery operated device. And we built the power budget, and the electrical engineers went through it, and we figured it all out. And we decided that with the particular battery that we had ordered, based on the power budget that we could probably get a two hours of, of runtime out of it. And we got into the lab, and we integrated all of the sub subsections and sub components together. And all the design work from everybody. And we turned it on. And, and we drained the battery in about 10 minutes. And we had about a week, before we were supposed to have a design review with the client. And we had to figure out, you know, what was going on and what that meant. And and being able to really, you know, at that point, I realized, probably we didn't, we didn't budget enough time for the integration, it's not going to work the way that you think it's going to work when you you know, the first time you turn on whatever it is that you've built. So that's that's one of the things that I think about it, I have another there's another startup company that I was hired into, after they had gotten started, sort of sort of their the way that they had built their development model is they were going to hire subject matter experts in each of the various pieces of expertise they needed. And so they had an optics component as a medical device again, and, and they had a software group that were working for them. And they had a group that was doing the electromechanical stuff and and all of the outside skins. And they were all working independently in different locations. And they had really struggled before I arrived at getting a prototype put together and functioning Long story short, the first thing that I did with those groups is we got all of those groups together. And I had them right interface documents. And we made it real clear. Here's where your responsibilities start. And here's where they stop. And here's where the other groups responsibilities start. And here's where they stop. So that when we start integrating, we don't spend a lot of time pointing figures about how, when it was in my lab, it worked just fine. And now we get it over here into somebody else's lab or somebody else's product and you know, whatever's going on over there must have messed up the way that it works. So, you know, I put a lot of focus on those interfaces. And with medical devices, and I spent a lot of time doing diagnostic devices. I not only have the interface of the software, the the electronic, the mechanical and the electronics but I also have the interface with chemistry and so there's oftentimes wet science that's going into it that that It also is a place of interface that people need to understand and pick up. So I learned a lot of lessons on on that front. In terms of product development,
Patrick Kothe 10:11
the word interface is really interesting because you're using two different context interface of the different pieces of a product. And then the interface between the different teams or sub teams that are that are responsible for different things. So I understand on the development side of things, why the why the different parts of a product, you need to spend, spend time there put enough time in, in the product development plan to be able to iterate those as well. But let's, let's dig a little bit further into that interface between the people because in the past, everyone was at the same location. And you know, you walk down the hall or, or have have lunch together. And a lot of a lot of this stuff kind of happened as a result of proximity. But in today's world, either you're outsourcing things, or people are in different locations. And that human interface piece becomes more important. So can you talk to me a little bit further flesh out a little bit more about what you've done to help with that interface? You said, defining things, but what are some of the other things that you that you put into place to help with that human interface?
Bryon Bhagwandin 11:27
Interesting question and an interesting distinction that you made Pat, I have to, I just want to take a moment and say, it's very insightful, on your part, to recognize that there is an interface of the hardware, and that's actually the easy part to control. But the interface with the people is, is much more difficult. And I think, as a project manager, you know, with engineers, there's a lot of things, you know, I'm going to sort of crossover with a previous question, you know, what do I learned about product development? And, and how do you how do you do it? Well, one of the things I've, I've realized is that, that engineers, they in their in their paradigm, you know, if we can think in terms of a traffic light, red, yellow, and green, engineers spend a lot of time in the in with a yellow light, it's almost done, and we're going to get there, it's almost done, and we're going to get there and, and the days or weeks or weeks, and the day before it's due, you'll find out that it's not going to be done on time. And so the light just changed from yellow to red, at the very last minute. And and the reason that that relates is because not only with with the interface with the people and the schedule and the budget, there's also the interface with the people and the people that I think that's really something that, that a good project manager has to learn how to how to make that work, and how to speak the languages of multi disciplinary people. When bioengineering first came on the scene, it was you know, I used to describe it as the the application of the of the core engineering sciences to medical problems. You know, we make, we start making a defibrillator, for instance. And you, you definitely need an electrical engineer there. But the electrical engineer doesn't know anything about the capacity of the body to accept or reject certain voltages and currents. So you need somebody there, you know, to make sure that that the electrical engineers design stays in bounds of what will keep a person alive, or what will kill them. And so in the same way, a mechanical engineer versus a software engineer versus an electrical engineer, and a lot of ways they speak, they speak the same language, but in a lot of ways, they speak different languages, and then you throw, you throw medical devices into it, and the the medical piece and the regulatory piece, all of a sudden, different words mean different things to different people. And I think that's a key role that the project manager plays is to know the vocabulary of all those different disciplines and to be able to interpret them between them so that they have a clearer understanding of what it is that's expected of them. You know, a very simple example of this is if I say, if you're delivering something to me, Pat, and I say, I need that by next week. And I'm thinking because, you know, on Monday, I have a meeting where I want to show show that off to somebody and you're thinking, Okay, I've got till next Friday. There's going to be a clear disconnect that deliver always thinks it's the end of The time frame. And the requester always thinks it's the beginning of the timeframe. And so the project manager, I think is the is the is the key to keeping that running smoothly. And the peril of the project manager is that the engineer always feels like anyone in management is on the other side, you know, they're there, they've already sold out to the, to the dark side. And so it's really important that the project manager not only speak the language of various disciplines that they're managing, but but also can, can maintain their respect because of their, whether it's technical expertise, or in some other way, connect with those individuals so that they can manage them well.
Patrick Kothe 15:43
So project management is more than laying it out on a Gantt chart.
Bryon Bhagwandin 15:48
Absolutely, absolutely. It's, you know, whatever it takes to move the project forward, that's the way I would say, you know, the job of the project managers to make sure that the project is always moving forward, whatever that means.
Patrick Kothe 16:03
So in my experience, there's been different types of project managers, and they've come from different disciplines. In your experience, I mean, I've been any everywhere from r&d being the project manager, joint r&d marketing, being project manager, and office of project management, who is does nothing but project management. So there's a lot of different different models on how to do project management. In your experience, what are what are the what's the top model that you'd like to work with?
Bryon Bhagwandin 16:39
I think that project management or project planning, which is part of project management, has to be a collaborative effort. And, and, and the people who are doing the work and the activities need to be this the input sources for the plan, I have seen some of the models that you've described, for instance, in office of project management. And office project management may decide that they have the authority, as you said, to put together the Gantt chart. And so they're, you know, they're throwing the Gantt chart together, they're saying, here are the activities that need to be done. They're saying, Here's how long those activities are going to take. And, and then they present it to the people who are supposed to do the work. And the people who are supposed to do the work say, now I, you know, I disagree with that. And, and so now we've started the whole project with some adversarial sort of feelings between the two people. And so I had a style when I was when I was doing project management of bringing the team together. And, and I think there are a lot of planning processes that use this model, where the engineers themselves had to have to write down every task that they're going to do. And if it's a big project, I like to limit it to tasks that are less than a week. And if a task is going to take you two weeks or longer, you need to break it into two tasks, I want the person who's doing the work to own it. And I want them to own the amount of time it's going to take. So that means that that I have to get their their input and buy in and an ownership early on in the project, or we're gonna have problems as we move forward.
Patrick Kothe 18:40
So let's talk about the product development process for a second, because there's 111 activity that I want to find out from you where you put it. So let's voice a customer. And that's that's developing the needs of whatever product or service that that that you're going after, does that belong inside the project management or program management system? Or is that outside of it? Is that pre setting up a product development team?
Bryon Bhagwandin 19:10
And in terms of timing? It's absolutely something that happens before sort of the development itself takes place? Because if if you don't know what, what you're building or who you're building it for, you're a bit in the dark. But I think it absolutely has to include the engineers in that process. And, you know, it may not be a dedicated team of engineers, but they certainly need to hear what's being said. I have an interesting story where a client came in, it was during the days of just after 911 and we were seeing a lot of potential domestic terrorism and even foreign terrorism on us. So And it was during that period where Department of Homeland Security got created. And this client had developed a, an Air Sampler for those incidents where someone receives an envelope through the mail with a strange white powder, right, there was a period in our in our country's history where, you know, you'd open it up, and then we don't know what that is, we don't know if it's, you know, bio warfare, and we need to do a sampling, and we exit everybody from the building. So this, this group had a, had an Air Sampler that they brought in, it was a little portable device about the size of the shoe box. And they said, We need this device to have a color screen, we would like it to be able to give audible alarms to the user, and they had the whole set of things that they they wanted from this device. And, and we went out and did the voice of the customer. And that was a little unheard of back in those days, that was you know, 20 years ago or more. And, and I can remember going out to fire departments, and and to emergency responders, and I had the opportunity to put on the hazmat suit, and the oxygen tank, and I dressed up in this whole suit. And those guys put on five pairs of gloves. Each one has a different, you know, barrier. And, and I said, Tell me how you would do your air sampling, if you got called in. And they said, well, we'd suit up like this, we'd go into the room, and we put this device on the table somewhere. And we would turn it on and let it do its thing. And then we would clean up the entirety of the rest of the room. While it was what while this was happening. And I said, So how often would you look at the screen? And they said never, it would be it would be across the room? What would you like the audible alarms to sound like, and they said, We can't hear anything when we put on a helmet. And so anything that you want to give us, we really need it to just be a bright flashing light when the thing is on, and a different color light when the thing is off. And and that will actually really give us maximum flexibility to do what we do our client who was actually manufacturing or developing this product, their perception of what they should build, and the user was really different. But but having an engineer go and and, and understand what is possible, what's not possible. And what might be important and what's not important in terms of how it's going to be developed. And asking those questions was extremely important. You know, they wanted to put little buttons and allow you to type into a screen. So you'd have an input keypad and I had these five pairs of gloves on and I couldn't even pick a pencil off the table. So we did away with the keypad we did away with the with the color screen, we did away with the key with with all of the audible alarms and you know, we built a great product that that ultimately won a r&d top 100 Design Award. So but I think that it ultimately came back to trying to understand exactly what the customer needs. And and, and filling that in. So bringing the engineers into that process early on bringing the customer into the process early on. And I think with medical devices, it gets even even more important because of the new I shouldn't say new but the the more recent requirements for for use engineering and usability engineering and and the need to actually feed the actual users input into the design is an extremely important part. So I think, as I reflect on your question, the answer is it's it's it happens during that process during the development process for medical devices.
Patrick Kothe 24:26
I think in my experience, it's kind of it's on both sides. Because whether you call it skunkworks or early product development or however you do it, there's some idea and whether it gets funneled through marketing, sales, r&d, clinical, however it comes in there's there's a spark of an idea and in order to to see if this is going to be something of interest to the development team or to the company You need to flesh it out a little bit. So, so that's outside of it, and then you say, Okay, there's, you know, we believe that there's something here, we're gonna take it further. And then as it comes inside the process, I believe that that customer needs analysis, everything needs to be vetted, everything needs to be challenged, every every different component of the product needs to have documentation behind it from from a user standpoint, you need to define all the way out your regulatory your clinical needs, your, your sale, sales, price, your cost needs, all of those things need to be fleshed out for this project. And that's kind of the early early phase of the project. But the germ of the idea kind of sits outside the project management system. And then and then it kind of come comes in, once that ideas in and you get through that needs analysis piece, and you start to start to say, Okay, we've got something here. And we validated all of these assumptions. Now it comes down to a point of, okay, we want to build something. So there's a choice that companies have. And you mentioned earlier that you worked for a company that was an outsource company. So you got projects from from other companies. So there's a choice that companies have, I'm either going to build it myself, bring in all the talent to be able to build it myself, or farm the whole project out or farm up pieces of it. So talk to me a little bit about your decision process, as your as your as you're at that point, where am I going to build it or buy it.
Bryon Bhagwandin 26:50
And this, you know, I don't know how much of this is my personality, and how much of it is really wisdom from my own experience, but I like to own as much of it as I can. And so I always start with the premise that I'm going to build it. Now, then I go through an analysis and say, Well, what's it going to take to build it? How big is the project? How long is this going to take? How many people do I need, how much of that expertise do I already have, how much of it is how many, how much of that resource is available to me. And so I sort of do the, the analysis of availability, expertise, length of time, you know, it's a, it's a pretty hard sell, to bring someone on board as a full time employee, knowing that eight or 10 weeks from now, or, you know, eight or 10 months from now, I'm not going to have full time work for you. But I want you to be fully vested, and 100% here. Because, you know, it is a very intensive sort of cycle of work when you're developing something. But then once the product has been integrated, and is working, and you need to go out and start doing verification, after you've done verification, and start doing validation with customers and and pilot studies, what do you do with the people that, you know, you've brought on board, and if you're bringing really skilled talent on board, you're, you're paying them for their expertise. And, and so that's, that's a huge factor that that I think, needs to be considered. The other side of it is when you start outsourcing, it's important to to realize the limits of an outsource team, they may be very skilled at an engineering and product development. But they are not going to be in a position to balance the the business trade offs that a startup company has to make. When they're developing a product. You you ask the engineer to develop something, there's not always only one way to do that. And and there's not always one price tag for that. And most engineers in a vacuum would prefer to build a Maserati as opposed to a Chevy Malibu. And, and some companies can't really afford or don't need the Maserati. And then when you have to make those decisions, in the process of development, we could go this way or we could go that way. We could, we could put more of our resources into this aspect. We could be more accurate here. We could, or more precise, I should say, in terms of our design, is that really where we should do it, it's going to cost more money to do it that way, the owner of the device, the manufacturer of record, as they used to call them, really has to be able to make those decisions and recognize that they can't just turn that over to the engineer, and think that sort of in a vacuum, it you know, in a, in a closed, closed room, the right decisions are going to be made. And so there has to be a good, clear and plentiful interactions with whoever it is that you're outsourcing to. So I think those are the two things that I think about in terms of how outsource and then you did bring up a third scenario where you bring some of that in house and you outsource others. And, and I think most of the occasions when I've done that, it's because there's a a specific, highly specific skill set that I need. And I don't, and it leaves room for a lot of mistakes. For instance, you know, not everybody has an optical engineer on staff, who understands doing optics design. I'm in the middle of a project right now where I'm, I'm working with molecules and saliva. And, you know, I don't come across a lot of resumes where people are saying, I, you know, I'm a, I'm a saliva expert,
Patrick Kothe 31:41
Major League Major League pitchers.
Bryon Bhagwandin 31:44
So, so there's, you know, there are some things where you go out, and you say, I would, you know, I would like to bring this person in. And, and, and oftentimes, that works extremely well, when you have a group of talented engineers in house, and you bring in a subject matter expert, and you want to integrate them. You know, these the, the engineers are, if they're sufficiently curious, which they should be they, they want to hear what that person has to say, and they want you know, and they want to really take, take that direction and, and instruction for how their design integrates with whatever that expert is doing. Or if
Patrick Kothe 32:25
you've got something that's finite, like biocompatibility testing, and there's labs that go out and do that, instead of bringing that in, it's a lot easier to
Bryon Bhagwandin 32:32
Oh, group. Oh, great. Yeah, I was gonna say, I didn't know you want to go into that level of detail, but certainly, right, like, nobody's gonna set up their open field testing lab, you're absolutely going to sort of, you're going to outsource that, because there are groups out there that you can do that with.
Patrick Kothe 32:48
So you, you've raised a couple, a couple of points about it. You can't just hire somebody to do your work for you. You can hire them, but you have to be intimately involved in the decisions as they're going through. It's not just here's a contract, go build this for me, somebody inside the company is going to be managing and helping to make the make the decisions along the way. That's that's kind of best practice. But let's assume that you've got a project and you do your analysis, and you say, I need to bring some expertise in here to help to design and build this build this product. What are you looking for in a company? What are you know, when you're interviewing different companies? What should you be looking for them? And what are some good good companies doing that? Others aren't?
Bryon Bhagwandin 33:40
Really good question. I, I think that you know, when I was working in the in the outsourced engineering, World of product development, we used to have a saying that we didn't share with our clients, which is they wouldn't be here if they knew what they were doing. And, you know, you're there people who are outsourcing product development, it's because they don't understand how to do product development themselves, or it doesn't make sense for them to do it. As we discussed earlier. If it's the former, where I've got to find somebody who has this, this expertise, and I've got to get them to do it for me, then you're asking someone to qualify, a skill set that they don't know anything about. And and the the general default is, let me find somebody who has a portfolio of clients that are high profile. And that's not always especially as a startup company. You don't always want to go to, you know, let me let me hire the product development firm that the fortune 500 companies are hiring. Well, you know, what I have found is those fortune 500 companies that are hiring them. They get the A team. And you come in as a startup company, you get the B team or the C team. And, and it may not be a great experience for you. So it just to be practical. But one of the questions that I like to ask from a product development when I'm interviewing product development firms is, how much repeat business do you have? How much repeat business do you have from from companies that I've never heard of before. And, and I think, you know, going back to another that other analogy I gave you, the Maserati versus the Chevrolet, there are a lot of talented engineers out there doing doing product development work. But if they're building modular audience for people when they need Chevrolet's, they don't get a lot of repeat business, because the cost is too high. Or they're, you know, it was over done, it was over built for them. And, and so the customer doesn't come back. But when I see a firm that has a lot of repeat business, and people are satisfied with it, and coming back and willing to pay again, I perk up and I listen. And I pay less attention to I mean, I want to see what their what their portfolio looks like. And usually, you'll find with a product development firm, they're, they're happy to show those off, and they're happy to talk about what they did with the, with the product. But um, and I think that's a better way of identifying good product development firms for a startup company, as opposed to the the brand or logo that comes with the large company that might be recognized, you know, there's not a lot of margin in the product development. In the product development world, having having been intimately involved on that side of it, the sales cycles are hard, and you know, everything has to align, if you put yourself in the shoes of the, of the development house, they've got to find clients who have the budget, and the they found the need, and then that particular product development house is in in front of their minds to move forward. And so there's a, we used to, we used to say that, you know, if we had four weeks of runway, in our, in our bank account, we were doing pretty well. Oftentimes, it was a two, you know, we get two weeks before we, you know, the next project would come in, and we know that we'd be profitable. So, and there's not a lot of margin. You know, if you're working time and materials, and you're paying your overhead staff and your rent and all that equipment, etc, etc. So it's, it's, it's important to have enough of a relationship that you recognize, if I want to be successful, I want my product development firm to survive, I want it to survive for the for longer than them to just get the project done. I want them to be there for support when it's in the marketplace. And when you know, I need to sort of do some service and I need to unwind whatever may be going wrong. So. So there has to be an understanding with the firm that says you're you have a business to run. I have a business to run, you know, let's partner together as opposed to, I like to think of it as a partnership as opposed to just a vendor.
Patrick Kothe 38:39
So, Brian, you're in the middle of product development right now. And I'd like to talk about recalibrates solutions, and the problem that you're solving and how you're approaching product development right now. So if you can just explain a little bit about the problem that you're solving with recalibrate and who your customers are.
Bryon Bhagwandin 39:04
Sure. Thank you for asking. So recalibrate Solutions is a company that was born out of a venture generator, it's it's a pretty unique situation here in Denver. There's a serial entrepreneur who started a group called X Genesis. It's a nonprofit. And his goal is to see the American entrepreneurial spirit applied to some really wicked problems every year, or actually every probably six months. I think he does it twice a year. He he will go out his he and his team will pick a theme and then we'll go out and curate 10 Wicked problems and they will put a dossier together. And then he also recruits 10 entrepreneurs who are between opportunities looking for the next thing that they're going to do. And and then there is a amazing volunteer community in in the Denver area and he brings them together. Back in 2017, I went through this program, the theme was health, not health care, but health. And, and there were all kinds of problems 1010 health related problems that include things like food deserts in America fordable housing because your zip code affects your health as much as anything else. And there was another problem called toxic stress that I had I you know, I knew both of those words, but not when they were used together. And toxic stress. It is the overstimulation of a child's stress response system in the absence of a buffer. And for children, a stress buffer is usually a caring relationship with an adult, I used to describe this as PTSD. And children described it that way, because the subject matter expert that that spoke about this topic presented, presented me with a slide of a combat veteran who had been diagnosed with PTSD, looking at stress hormones across the day from that individual, and then an 18 month old who is experiencing toxic stress, and looking at the same stress hormones across the day. And you could not tell the the combat from the 18 month old, unfortunately, it only gets worse, because in the developing child, if you see this kind of dysregulation in the stress response system, it also disrupts brain development, and disrupts immune system development. And it results in mental health issues in young kids, and it results in learning disorders in kids, and then later in life because of a compromised immune system development. It results in substantial increase for seven of the 10 leading causes of death in America.
Patrick Kothe 42:05
Does this disruption? Is it permanent? Is it something that just part of that person? Or is it something that can be resolved,
Bryon Bhagwandin 42:14
it is absolutely something that can be resolved, we have not as a as a community, I think people are beginning to realize that mental health and childhood adversity creates a lot of long term problems. And unfortunately, up to this point, what we've what we've recognized as symptoms are behavioral issues. So a child acts out a child is unable to to stay focused. Now we've sometimes I think misdiagnosed, that is attention deficit disorder, and we've medicated you know, treated that with medication, when sometimes it is potentially a problem with a dysregulated stress system. That happened before the child ever started showing behavioral symptoms. And so the gold standard is to look at stress hormones, and see when the stress system is, is activated. And and if we could monitor that in a in a real time way, we can see when a child's activate stress activation is is occurring in sort of abnormal levels. And when it's occurring and abnormal levels, and we can identify when we need to step in and do some, some intervention. So we have done it just just to sum this up, we've developed a five minute saliva based cortisol sensor that can be used at point of care, and it's a disposable test that cost a few bucks.
Patrick Kothe 43:47
So cortisol is is what you're what you're measuring. That is the target that that shows whether some whether someone is dysregulated or not.
Bryon Bhagwandin 43:57
Yeah, yeah. So cortisol plays an extremely important role and in our metabolism. In our activity levels, in a lot of the just normal daily activity. They estimate that every cell in the body has about 100,000 cortisol receptors. So and that's why it has such far reaching effects in terms of development. But, but it also has this other parallel utility, where we call it the fight or flight or freeze response. I'm taking a hike and a mountain lion or bear crosses the path and I stopped in my tracks and my eyes dilate and the hair on the back of my neck stands up and you know, the blood is shunted from my trunk to my extremities just in case I need to run or I need to fight. And so that is all a consequence of the stress response system and the single most accurate response or action measure of the level of response comes to cortisol. That's what we chose to target it. Yeah, it was strategic that we're looking at cortisol we have, we have some other other hormones that we would like to look at. But you know, this being about product development, we have chosen, chosen to look at one first, because it's a regulated medical device. And it will allow us to be more time efficient, I think and cost efficient in getting our regulatory clearance to just pick one, one molecule that we're going to look at and then add to that supplementally in the future.
Patrick Kothe 45:40
So cortisol is a level that you're going to take a test on, and it's going to be at that level at that point in time. So you consider if someone is taking a heart rate reading, and at one point in time, they're in the doctor's office, heart rate is 115. For example, 10 minutes later, it may be down to 55, depending on you know, how that patient is doing. So the cortisol would be a similar thing, I would think the cortisol level would be taken at one point in time, it may or may not one reading may or may not tell you anything, because it could have been in the flight or fight or flight area. So how does it How does a technology like this work? Are you looking at monitoring a patient over a period of time to say that there's a constant elevated level? Or what are you looking for?
Bryon Bhagwandin 46:35
Great question, Pat. And, I mean, you connected those dots really fast. And and you use the right language, because because this is not a diagnostic, we're not coming in. Like, you know, I think my child has strep, you know, we'll do a strep test diagnostic test, it's once and done. It either is or is not, this is a monitoring tool. When a child goes to the pediatricians office on a regular basis, I mean, I think there are 15 recommended wellness visits in the first five years of life. Every time they come into the office, we monitor their their cardiovascular system and their respiratory system, we look at the auditory system and the visual system, and we even look at the autonomic nervous system, and we tap their knee and wait for the reflex. So we're monitoring all of these systems. And we're monitoring them to determine whether or not this child is developing in a healthy and normal healthy way. But one thing that we're not monitoring is the stress response system. And so this is a monitoring tool, where we would like to say, you know, the value proposition is it has to be, it has to be inexpensive enough that I can throw it in the trash after every visit, and not feel like I'm breaking the bank, you can go out and get cortisol measurements. As a matter of fact, you know, there are some endocrine problems that people have with our endocrine system, where they don't produce enough cortisol, they produce too much. And you can get a central lab test, it takes, you know, 48 hours to get the results back. And the average reimbursement from the insurance companies is 50 bucks, we can't be adding $50 to every pediatric wellness visit. And so we certainly don't want to be having a 48 hour wait time, we want to do something now we want to do it fast, we want to do it inexpensively, we want to do it in such a way that it doesn't put the child into stress. So we can't we can't use blood, we don't want to scare the kids away from the pediatrician because every time they go to the pediatric office, they want to stick you know, jab a needle in their in their finger or you know, wherever so, so we elected to try and to use saliva, which is a very non non invasive as as fluid samples go from the biofluids go and, you know, the average pediatric visit is 14.2 minutes. And so we want the results in you know, a third of that time, half of that time so that we can find out. And as you said, it's a snapshot, right, we'd love to have a video camera. But unfortunately, at this point, technology only allows us to really take still photographs. So we just want to assemble some photographs and look at what it you know, what, what is the trend here? Are we within the normal ranges at any given time? And then we have to also understand that sometimes we may get out of bounds and it It's okay. You know, if if, if I have a child, let's say I'm a pediatrician, and I'm testing Sally and, you know, I noticed that her she's got elevated cortisol levels, they're they're outside of the normal ranges. I talked to mom and I find out that she fell in the parking lot before we came in. Well, okay, we're gonna throw that test away or just you know, we'll make a note of it in her chart and we'll go on you know, we'll see you again in six months and Find out what happens, you know, or we might find that actually, we have suppressed levels of cortisol. And I talked to you know, I talked to dad, and I find out that, that Sally was really close to her grandfather and her grandfather just died two weeks ago. Well, it's okay for Sally's cortisol levels to be depressed a little bit. But, you know, we would like to bring her back in three months, and, and if, if, if they're still suppressed, then it is potentially going to create problems in the future, let's get in there and give Sally some tools to be more resilient to help her work through these issues that are starting to have an effect on her physiology. So she doesn't have to live with the consequences long term. So, so the value proposition is fast. So it can be done in the office, inexpensive, so that I could do it as a monitoring tool. And, and then, of course, it has to have some clinical utility, you know, it has to improve outcomes. And as I stated earlier, we're this is this is an early, a way of detecting early when a child is starting to dysregulate. So that so that my intervention is much more cost efficient, if you will.
Patrick Kothe 51:18
And I imagine that what we've experienced over the past couple of years with children being home and added stress on them, I'm sure that this is resonated quite well with parents and clinicians.
Bryon Bhagwandin 51:33
Oh, my goodness, Pat, every time I turn around, just today, I was driving home, dropped my daughter off at school and driving home and there was a report on the radio that said 90% of young people are, are having are struggling with their mental health and wellness. As a consequence of the pandemic, before the pandemic, it was estimated that 12 to 15% of kids were were living with a dysregulated stress system. So that would be approximately, you know, there are 74 million kids in the US at any given time. So you go figure, after the pandemic, they've estimated that it's probably doubled. So that means one in three kids are are in a state where there's, you know, they're they're dealing with something that's going to have consequences, serious long term consequences.
Patrick Kothe 52:35
So your test is going to help with identifying those that may have dysregulation, it's also going to be a monitoring tool to measure effectiveness of a treatment.
Bryon Bhagwandin 52:48
Yes, that's correct. And, again, a fast catch on your part. I mean, most of the time, when a when you come into the pediatricians office and and the pediatrician does their battery of monitoring assessments, they're all normal, it's a minority of measurements that are concerning and abnormal. In the same way, if we, we would like to see this adopted a similar sort of fashion we're looking at at healthy development on those abnormal children of those kids that we find there are struggling, we go into some kind of intervention program that that one would hope you'd start with something that can be administered at home with the caretaker would be a caretaker centric intervention. The caretaker is just given some instruction and some help and some things that they can do. You know, in my mind's eye, I have a vision where, you know, I go into my my physician's office, and I, my lipid count comes back and I have high cholesterol, he pulls out a piece of paper and says, you can eat what's on the top half of that page, and you can stay away from the things that are on the bottom half. I'm hoping that, you know, we would like to be able to provide a similar sort of cheat sheet for parents to be able to say, hey, you know, spend five minutes or 10 minutes a day, doing the things on the top half of the page with your children. And keep in mind, the things that are on the bottom half of the page might might not be so healthy for your kids right now. And let's let's get them regulated, in more severe and longer term cases, cases that are caught at later in, in their process. You might have to go to a counselor and at that point, the counselor would be able to use this monitoring tool. Whether they're using art therapy or just verbal therapy or journaling, therapy, whatever it might be. In the initial stages, you administer this test and you try and determine is their physiology returning to to a healthy normal state. If it's not, then let's, you know, let's rapidly pivot and and try a different, try different therapy. And if it is, then we're happy. And when we get back to normal, let's turn back to, you know, being kids.
Patrick Kothe 55:17
A couple of quick, quick questions that are interrelated. What's the regulatory pathway? And is this an OTC product?
Bryon Bhagwandin 55:24
Yes, and yes, it is a regulatory pathway through a 510. K, the predicate device will be that central laboratory test that we talked about earlier, that would take 48 hours to run, we will not be making any claims other than it's a quantitative cortisol test. And so we can use that that Eliza test that comes in the central predicate. And then, as far as over the counter, we have debated this over and over, we think the fastest way to profitability, and to reach the most amount of kids is through the pediatric office. But our system is so easy to use, that it can be administered at home by parent, it's unclear once we get more traction in the pediatric office will decide whether or not this will be something that the pediatrician sends home the prescription, or whether or not it's just something that's purchased over the counter at Walgreens or CVS.
Patrick Kothe 56:21
So where do you sit right now? Where are you? Are you still in development? Are you designed freeze Where are you we are
Bryon Bhagwandin 56:27
in development, we feel pretty confident about our about the chemistry development. And about the test and about you know, we've we've basically met and verified the specs on on the performance of the test, we would like to as far as what needs to be developed with a custom reader that his handheld probably will be about the size of a small TV remote battery powered and then have a connection to a phone and and the data would then be transferred to the cloud and stored in the cloud. And then the user would own that data, first of all, so it gives parents and empowers the parents to actually see what's going on with their own kids and their own it because this is useful for adults as well as children. So they could see their results. But they could also give permissions to to healthcare workers and physicians to look at that data and put it make it part of their permanent medical record.
Patrick Kothe 57:28
And where are you with financing or you're raising now or what's the situation
Bryon Bhagwandin 57:33
we are we're in the throes of a initial financing round for that development effort. It's a small round, we think that it will take us in about 18 to 20 months, we think we'll be ready for submission after we fill this round. And so we're looking for about a million and a half.
Patrick Kothe 57:54
So Brian, really fascinating technology, big problem that's going on. And sounds like you've got a really good plan to bring some technology out that could really make some big differences. And a lot of patients lives a lot of parents lives as well. So good luck with the project. Final question I've got is kind of around this, this issue of product development, because you've got so much experience with it. And imagine that there's a there's a young woman who's running their first project, product development program. So she's excited to get moving on it has the responsibility for it. What types of advice would you give her
Bryon Bhagwandin 58:47
just two things that come to mind straightaway, I have yet to see a project be completed on time, under budget, the difference between a, you know, a good project manager and a great project manager is the way they handle the crisis. And the crisis will come. So, you know how do you handle the timeline that's slipping and and and recognize that that can come about because of feature creep that can come about because making decisions that are inappropriate to the needs of the of the product and spending too much money as a consequence. So that's that's one thing that I would say is recognize that it doesn't, it doesn't happen according to plan and the way that you handle it outside you know when it when the crisis happens is extremely important. And the other thing that I would say is pay attention to the details and make sure that the engineers are paying attention to the details. A couple of quick stories. You know, I had a mechanical engineer worked for me His job was to design the gantries and the and the external skins for a particular product. We got ready to do integration And we wanted to put the whole thing together. And this young mechanical engineer, didn't see fasteners on his on his punch list. So we didn't have any fasteners. And he said I was I drew up the parts, I had the made, you know, I did the inspections, here they are product design, pay attention to the details. I had another. I had another situation where a, we had a deadline, and the client was supposed to have a particular presentation in place. And so we were supposed to get this done. And we kept waiting for a particular component that wasn't coming in wasn't coming in, was it coming in? I started asking the the engineer who was responsible for ordering that. And I said, What is that going to be here? And they told me, and it was a week later than we when we were supposed to be done. And I said, Why did you order that if the delivery date was beyond the target date for our completion. And he said, I just thought it was a better deal. And I just thought that was really the right product that should be ordered. And so he said, and I told you that I wrote down, you know, we're going to get it on this date. And I said, you're going to have to treat me like an idiot. I'm not looking at the calendar, every time you type in a date, I'm assuming that you're working to the dates that we're working to. You needed to say this will be a week late. I think that being able to, to ask your engineers to treat you like a dummy. And to have enough security, to ask your engineers to think about you that way is extremely important. Please tell me in words of one syllable where we're not making things happen where they're supposed to, don't expect me to go, oh, I don't remember what date we said we were going to have that done. Let me go look at the calendar, and then come back to you and say, Why do you think that was? Okay. So those are a couple of examples where, you know, I have you know, now when I when we start talking about integration, I start checking with my engineers, did you? Did you get the fasteners? Did you order those? Are we really ready to start putting this together? Are we going to make our dates, you know, are these things done correctly, and, and if you've made any unilateral decisions, I need to know that you've made them that are out of bounds. And I need to know why. And probably you ought to be asking for permission before you start before you start making those. So paying attention to the details is what the project manager is supposed to
Patrick Kothe 1:02:42
be doing. Product Development rarely goes in a straight line. As Brian discussed, there's new information that always comes setbacks to absorb. And then there's always the unforeseen issues that need to be managed. A few of my takeaways. First, he discussed interfaces, and why interfaces are critical to a successful project. And those interfaces were not just the project and budget and how things come together from a project standpoint. But more importantly as the interfaces between people, and breaking down barriers and making sure that good communication is there between the people to the project, because that's who's going to drive it and make it successful. The second thing is when we talked about engineers writing down their own activities, because that's what gives them their ownership. They own their own deliverable. They write it down, they think it through they own their deliverable. And they own the process for for thinking through how the project needs to come together. And also, I really liked that he says, If it's less than a week, put it down, if it's more than a week, break it down into multiple tasks. The final thing was augmenting your team and and the way that he approached bringing outside help into an organization, you really need to assess what you have, and assess what you need. And if there's a gap there, you can either bring that from the outside into your company, or you can hire a firm to help you with the development. But what you need to do is have a commitment to whatever direction that you're going to go in, you're committed to the people if you're bringing them into your organization, you're you need to be committed to them for a long time, not just the period of the of the project and then let them go. That's not fair to anybody. Same thing with your commitment to a development firm. If you want to go after the best price and leave leaving an unprofitable partner out there. That partner is not going to be around when you need them for your next project or to troubleshoot something on your current project. So you need to be fair to those to those partners as well. Thank you for listening. Make sure you get episodes downloaded to your device automatically by liking or subscribing to the mastering medical device podcast wherever you get your podcasts. Also, please spread the word and tell a friend or two to listen to the mastering medical advice podcast as interviews like today's can help him become a more effective medical device leader. Work hard. Be kind
