Striving for health and happiness for all mankind
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A Novel Guide in Medical Device Innovation with Andrew DiMeo, Sr., Innovation & Design Coach at Trig was automatically transcribed by Sonix with the latest audio-to-text algorithms. This transcript may contain errors. Sonix is the best way to convert your audio to text in 2019.
Saul Marquez:
Welcome back to the podcast. Today, I have the privilege of hosting Dr. Andrew DiMeo for the second time. And today, we’re gonna try something new. I’ve been in the midst of reworking the podcast flow and so we’re gonna be doing a story line type of podcast for you. We’re really doing this in the new Outcomes Rocket 2.0. And so let me just give you a reintroduction to Andrew. He is an innovation and design coach at Trig. If you haven’t heard his episode, his first episode, it’s episode 217. Go ahead and look them up at outcomesrocket.health. You want to hear that one where we talked about medical device design and innovation, but he’s an industrial design firm specialist. He is focused on consumer insights, design and branding for medical, durable and consumer products. His design background started in New York City motion pictures before transitioning into 20 years in health and medical innovation You know, the cool thing about that is that as we were chatting about the podcast this morning, the whole story line that we’re gonna be employing on the Outcomes Rocket was such a natural thing. So and so I’m excited to get the story going here today, we’re using a story line brand to sort of do what we’re gonna do today. So with that, I want to open it up to to Andrew again. Give us a little intro, maybe things that you want to level set with the listeners today that maybe haven’t heard from you before.
Andrew DiMeo:
Right.. Yeah. So thank you so much for having me back, Saul and this is fun. You know, we’re doing this total improv and it’s gonna be an interesting journey and I’m looking forward to taking it. And so we get to start off with the character. I get to be the character of the story. I want to start off with what inspires me to do work in the medical device industry, you know, and then honestly, I didn’t think about it until around 2013. I think it was I went to I was invited to TEDMED to be part of the hive. Then I had a startup company called Novocor Medical Systems. And we got to to take the startup company there. And they asked us to come up with a six word mission statement that needed to be put up our badges. You know, I take this seriously. I said, okay, you know, if I’m going to come up with a mission statement, let’s do this thing. And I went through some levels of abstraction to try to figure out what is a what is a real meaningful mission for me. And I came up with health and happiness for all mankind. I hope that six words.
Saul Marquez:
Ahh. Health and I’m not going anyway close to it.
Andrew DiMeo:
Health and happiness for all mankind, you know, try to do yoga every morning. And that’s my dedication to health and happiness for all mankind. Whether it was like that, I was a college professor, which I was for 12 years at UNC here in North Carolina the work that I do here with Trig or back in my motion picture days. You know, I think at the end of the day, caring about mankind and everyone’s health and happiness has been my ultimate driver day in and day out.
Saul Marquez:
I love that. So as you as you stroll have you know, as you strive for health and happiness for all of mankind, what would you say have been some of your biggest problems?
Andrew DiMeo:
Yeah. You know, and I want to talk about the specific area of medical device product development as a problem that I’ve seen over and over again. You know, there’s some there’s some topics like the triple aim, reducing the cost of care, improving health outcomes, improving the clinical experience. Yeah. This is a this is an external factor that’s hitting all medical device companies and startups. Human factors. Engineering is being looked at a lot more. There’s there’s a big focus on reducing risks and hazards. And and there’s been a lot of talk lately. And this is one that I’m really excited about as to the innovative approach of product development versus a fairly all archaic stage gate model that came about through the FDA’s designed controls and their guidance, guidance document on design controls and and looking at all those factors. This is something that’s been intriguing for a long time. And and there’s this story especially of a startup company. And I’ve been involved with a lot of startups where they they catch some lightning in a bottle and they start to make progress. And they’ve got a real good solution for a real unmet need. And they get to this point where, hey, you know, we need to have a regulatory consultant come in and we need to start thinking about our regulatory pathway to commercialization. And the first thing that consultant will ask is where is your design history file, where you know, where were your user needs? Where have you reduced risk over the course of developing this thing? And oftentimes they just don’t have it. And the cost of building that is is immense. And so this is just something that I’ve observed for years. And and even as a professional in the medical device industry myself, we might be very well aware of design controls. There is this pain point of turning it on, you know, like I just want to be open and creative and not have to be constrained by the box of regulation while doing design, some sort of delaying these design controls as long as I can. But at the same time, losing the history of what went into, you know, and so this is just something that I’ve seen for a long time. I’ve been focusing on for the past year and I’m looking forward to talking to you more about that today.
Saul Marquez:
So it’s the it’s the design controls and it’s tough, right? Because on the one hand, we’re in a very regulated industry. On the other hand, you want to have this innovative way of getting things done without having to do all of the documentation. So but then you lose history. So you’re just kind of in this like place where, you know, it’s difficult. And so every every every designer wants to create great products, every every company paying for product design wants to have amazing products that benefit patients and help the clinicians do their job. What would you say during the process that you’ve had and the things that you’ve learned? How did you meet that helped you figure it out or who did you share ideas with that helped you come up with the process that works?
Andrew DiMeo:
Yeah, you know, it’s been I feel lucky, blessed. How do you want to describe it? To be on a journey that’s exposed me to the first living it, studying biomedical engineering, going and working as a design engineer for a large medical device company and just being thrown into design controls and saying, okay, well, you know, this this was my first moment of building some empathy of what it is to be a design engineer working within these constraints and then moving on to being a college professor and teaching it. And, you know, if you assign the students to read the guidance, document design controls enough times, you yourself start to build an appreciation of it. That’s well beyond the cursory read, well beyond looking at the famed waterfall diagram. And I’m thinking maybe most listeners might know what the waterfall is. And if you don’t, I encourage you to look at it, but don’t let it get locked in there. But there was some there were some groups that I interacted with along the way. I mean, I got the opportunity in in the days that I was teaching biomedical engineering design, it was it was like the heyday of of teaching design and biomedical engineering. And there was a group that came together that included thought leaders from places like Stanford and Johns Hopkins, Georgia Tech, etc. And we all discussed the challenges that we faced in teaching biomedical design and being around those thought leaders certainly impacted all of the ingredients that went into this design history for already ideation, which which is a preview of where I’m going. But then it was the Wallace Coulter Foundation. I don’t know if you’re familiar with with Wallace Coulter. He’s he was the inventor of the Coulter counter start or the company that became Beckman Coulter, the Coulter corporation. And then when he passed away, he left his entire fortune to a foundation called the Wallace H. Coulter Foundation. And that foundation provided grants to biomedical engineering professors that would work with medical doctors. And they set up some schools around the country. There’s what’s called Coulter schools. So this is like Duke, Georgia Tech, Drexel. Just as a few examples are some of the Coulter schools that have big grants from the foundation. And in sort of this lightning strike of opportunity, I was asked by the Culture Foundation to help form a new we call it Coulter, a new training program, boot camp, two and a half day workshop where students would be indoctrinated into that Coulter commercialization process, as well as the needs driven design that goes into medical device product development and being part of that culture team and all of the amazing experts that were pulled into teaching culture college just opened my eyes to the all of the many facets that go into it, you know, as myself as a design engineer. I wasn’t necessarily thinking about all of the market side things, you know, the market size, the regulatory pathway to approval, the intellectual property, all of the medical economics. There’s just there’s many complex pieces that go into it. And it goes on from there. You know, there’s other experiences. Being an entrepreneur myself and starting a couple of medical device companies living that having to raise money from venture capitalists. I mean, you know, it’s one thing as an academic to try to get a paper submitted through peer review. It’s another thing to sit in front of a bunch of venture capitalists who are deciding whether or not they want to hand you a couple of million dollars. Yeah, that’s a whole another level, you know. So it’s really like a lifetime of experiences that that brought me to to this particular moment.
Saul Marquez:
Fascinating. And, you know, it’s neat to talk to somebody like you and Andrew where, you know, you’ve had such a rich history of, you know, diving. Diving deep into and becoming a student of what you do, you know, you get your PHD in and design and biomedical engineering. You’ve done incredible work across the landscape and, you know, med device startups and professor. And we don’t do it alone, right. We always we always find that guy that sort of helps give us some direction for the for the for the leaders listening today. Well, what would you say is is a summary of the plan? That’s that’s helped you be successful.
Andrew DiMeo:
Yeah, well, it all comes together right now and something that I’m calling design history file ready ideation.
Saul Marquez:
So let’s let’s park there for a second, because I know I know that you you do this every single day. And so and so what I want to do is myself understand it better and the listeners to really capture the value of what you just said. So design history. File ideation.
Andrew DiMeo:
Ready. Design history. File ready ideation.
Saul Marquez:
So tell us a little bit more about that. Break that down for us.
Andrew DiMeo:
Well, let’s just first get on that ready part. You know, if if if you remember, if you can recall back to HDTV. Ready? You know, I don’t know if you could remember those days getting you this TV before there was a signal, but the TV was ready. Right. And so, believe it or not, the ready part is inspired from that. But it’s it’s this concept of the year ahead of your time right now. Again. Well, I want everyone to be ahead of their time. We’re sort of that time as designed controls, OK? And there is this pain point of turning on designed controls. And what I want you to do is I want you to be ready for that day. And whether you’re a startup company that’s never heard of design controls. Or your inexperienced medical device design professional has been doing it forever, and you just you just are pushing away that known pain point. I wanted to provide a set of tools that would allow allow you to be creative and iterative and think outside the box and open and free form. But at the same time, build those building blocks of design history file. And capture that history so that the day that you turn that key, the day that the regulatory consultant comes in and says, OK, you know, we need to implement a quality system, we need to implement design controls. You have something that you can say. We’ll take a look at this. And it’s like a gold mine. They look at it and say. Holy cow. You know what? This is unbelievable. I can’t believe you put this together. So that’s that’s the inspiration. You know, and I can certainly dive deep into it.
Saul Marquez:
I love it. No, I love it. Right., you’ve sort of pain in for us. This is this is what the plan will get you. You know, like unlike the majority. And the reason why that regulatory person is surprised is that this is not the usual Right.. And you’ve put together a plan to help people get there. Right.
Andrew DiMeo:
Right.
Saul Marquez:
Tell us about it.
Andrew DiMeo:
So so last year when we talked, I was just putting out something called the Diligence Dashboard.
Saul Marquez:
Yep, I made a little note on that. I remember I was going to ask you because you’re at the beginning of the diligence dashboard a year ago.
Andrew DiMeo:
Right. Yeah. We had just launched this as as a way to holistically look at the the business risks of any medical device. And so this is a technology risk. The market risk, the intellectual property risk, the regulatory pathway and reimbursement and other medical economics. And can you look at this holistic way? And in what the example that I used, if if you’re not familiar with with something called business model canvas by Alex Walter, at the end of the day, what the business model canvas is and what the genius of the business model canvas is, is it’s a a way to graphically look at a business model rather than a piece of paper that’s got a bulleted list that I’m trying to fill out. It’s a whiteboard. And, you know, it’s large format paper. It could be a chalkboard. It could be using a digital whiteboard tool like mural or battery. But you’re looking at the business model and and you can see how pieces work together in The view just changes how you look at a business model, whether it’s just genius.
Saul Marquez:
Yeah. And I like that idea, by the way, because, you know, rather than being linear sequential, everything is laid out and you’re able to make connections that otherwise maybe you would not have.
Saul Marquez:
Right.
Andrew DiMeo:
Yeah. Yeah, absolutely.
Saul Marquez:
I like that idea.
Andrew DiMeo:
And and so imagine the diligence dashboard, those factors that I talked about in this holistic view. Right. And and you might have some really cool technology. Let’s say it’s some new coding for an implant to minimize revision surgeries saying a hip implant. So you got this new coding? Yeah. Well, you know, if you look across your technology risk and your market size, etcetera, what is the. What happens if you’re a coding company versus you’re a hip implant company? Just that one change in how you look at the business changes that whole landscape, everything. And and so this this canvas view of diligence was the beginning of design history, file ready ideation. What happened since we last spoke is the other the other three pieces. It becomes a four canvas tool that all works harmoniously together.
Saul Marquez:
OK.
Andrew DiMeo:
And I’m going to try to help you visualize this in your mind or the listeners visualize this in your mind. So first you’re you’re visualizing a canvas, a large format paper or a whiteboard, and the top left whiteboard has your diligence dashboard on it. Those factors we talked about. Then there’s a board on the top right. And on the top right, I call the waterfall canvas,.
Saul Marquez:
OK.
Andrew DiMeo:
And I’ll get to it. Then there’s a board on the bottom left. And this is around human factors, engineering. And then there’s the board on the bottom. Right. And this is around risks and hazards. So you can draw on a piece of paper for four boxes in a grid quadrant and lay that out, right. And and so I can take it through each one. The waterfall canvas is it’s another way of looking at the FDA is waterfall diagram. You know, if you’ve looked at that guidance document closely enough, there’s a couple of nuances. One is the FDA says this is an example. It’s not like B one, and it’s used to demonstrate how inputs relate to outputs and how user needs relate to the medical device and how you verify and validate those things from a visual perspective. And it’s a it’s a great diagram underneath it there’s some fine print that says, you know, in practice this is going to be iterative. Well, in practice, what has happened over the past 20 years is people have taken that diagram and it’s turned into a piece of paper, which is a stage game. When in standard operating procedure form, it just becomes a stage game of user needs to inputs to outputs to medical device. When you transform that to this canvas, it becomes something that you can look at all at once and realize that it can be iterative, that you can go around many, many times. And as you go through the design process, it informs new inputs. Which informs new outputs and informs new user needs, which informs what the device might be someday.
Saul Marquez:
So so, Andrew, you know, I’ll I’ll pause here and just say it. Folks, if you’re listening to this and you’re a designer and you know what Andrew’s talking about, or maybe somebody on your team is doing the designing and medical device, the tragic result is that people can fall into the trap of. This is the way it goes. This is the process. But the beautiful sunrise and opportunity here is that Andrew is giving us all a new way of looking at it. And I don’t want that to be lost. So I’ll let you keep, keep keep chatting to us about this. But I want to make sure to highlight that. And would you agree or disagree with what I just said?
Andrew DiMeo:
Yeah, absolutely. It’s.
Saul Marquez:
That’s the insight.
Andrew DiMeo:
Yeah. It’s like the genius of the business model canvas of Right.. Not like it’s the whole new business model.
Saul Marquez:
Right. Right.
Andrew DiMeo:
Literally just looking at it a different way.
Saul Marquez:
And it’s giving you permission. Right. like you could. You don’t have to read the fine print that you just kind of magnified.
Andrew DiMeo:
Yeah. Yeah. I mean the the FDA honestly is not forcing you to follow. The waterfall right there. They’re just using it as an example. And that in and of itself can be mindblowing. You know, like we can implement whatever process we want just so long as we document what that process is.
Saul Marquez:
What happened to you, Andrew, when you when you made this realization? What happened to you?
Andrew DiMeo:
I mean, for me, it allowed me to see the beauty of the example, I mean. The example given within the guidance document is indeed a beautiful one that highlights some key. Necessary items to ensure safety and effectiveness of devices during design. It just opened my eyes to. How pervasive a little tiny thing can be in that little tiny thing being just a picture. That gets transformed to a standard operating procedure within a company. And to know that to know that I was hired in 2000, whatever something one maybe to go work at a medical device company and. Be indoctrinated into this stage game. And and be blinded to this other view.
Saul Marquez:
Yeah. You will. It was. It was like an awakening. Yeah, I think that’s so cool, man. And, you know, we could often get blinded and that does result in really, you know, lack of satisfaction. And, you know, that that picture you painted for us at the very beginning of our talk here, you know, this this space where you you were just like constricted by these guidelines and wanted to create and just this tug, this tug and this lack of satisfaction to now. Wow, a pathway. And so, Andrew, I know that there’s three other pieces, but, you know, really like the time is, is we’re running out of time. So but what I would like to do is, you know what? Why do you think the listeners that are interested in going above and beyond just like average in their design, why should they take action on this? And where can they find out more?
Andrew DiMeo:
Sure. So why? It goes back to the mission improve health and happiness for all mankind. I mean, at the end of the day, we’re all on the same mission together, you know, and this is what Outcomes Rocket is all about. If I’m understanding Right., you know. Yes. And and to me, the diligence dashboard. If it should improve the outcomes, I mean. For you, for the startup company, and it’s never heard of design controls, I want I want you to be ready for the day that regulatory consultant comes in. I don’t want that to kill your company. I want your company to succeed and get over that hurdle. For the professionals working in medical device companies, I want the joy of your daily work to increase. I want you to go to work happy knowing, hey, you know, we can do iterative design and it’s totally allowed and we can rethink how we do our jobs and make it more blue sky and more fun. While meeting the requirements of design controls. You know, I mean, so it’s about making people happy in their jobs. Improving health.
Saul Marquez:
I love it.
Andrew DiMeo:
That’s why.
Saul Marquez:
It’s a big reason. It’s a wonderful reason and really cool. And, you know, 20 years of doing this. Wow. You know, there really is, you know, an opportunity here for folks to maybe you’re five years into it. You don’t have to wait 20 years. And there’s an opportunity for you to take advantage of the insights that Dr. Andrew DiMeo has has uncovered. Where can they find out more? And maybe simply and of course, you guys listening and you know, we prompted this format today and hopefully you’re enjoying this. I had fun with it, how about you, Andrew?
Andrew DiMeo:
Yeah, this is a nice free flow to know what was going to happen.
Saul Marquez:
So and you’re good at it. You’re a great guy to start this with that side. Thank you for that. And you know, so. So maybe you have a place where people can go. And if not, let’s just send them to your podcast page on the Outcomes Rocket where we could put something on there for them if they want to learn more.
Andrew DiMeo:
Yeah. If you go to trig.com. So it’s trig.com. Write it on the home page. If you scroll down a little bit there’ll be a link to design history file ready ideation.
Saul Marquez:
Nice. So you have it on there.
Andrew DiMeo:
Yeah. It’s right on there. And it’s a free resource by the way. There’s an it’s for the price tag of your name and your email address. And I may even follow up with you, but it’s a free resource. And what happens is if you if you fill out a form, you get a 20 page guidebook that you can read and implement in your classrooms and implement it in your businesses. And in you know, a year ago, I had the top left canvas in version 1.0. Today, there’s four canvasses and it’s version 3.0. Tell me what you don’t like about it. Send me some notes and say, hey, you know, this is cool, but. These things don’t work or this is what I love about it, because I hope if it’s August or 2020 and I’m back at outcomes rocket. Yeah, we can be talking about like, hey, what’s new in the world of design history, file ready aviation. This thing shouldn’t be a static thing. It should grow with the times.
Saul Marquez:
I love it. I love it. It’s a great invitation for everybody listening that wants to take a look and dive deeper into this. There’s no there’s no reason to stay behind. You know, Andrew’s opened up his book and is inviting you to check it out. Trig,com. If you want to learn. Scroll down. You’ll find it there. There’s a link. And with that, Andrew, just man, I just want to say thank you again for spending time with us. And thanks for helping me try this new model.
Andrew DiMeo:
It’s been really fun. And thanks again for having me back.
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