Michael Graffeo is a 20 year veteran of the medical device industry.  He discusses how to put your best foot forward, prevent reproducing the mistakes of the past, and why it isn’t just important to just present why your idea is so great, but possibly even more important to discuss why it isn’t a risky idea.


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Unknown Speaker  0:03
Welcome to the physicians guide to doctoring A Practical Guide for practicing physicians. We’re Dr. Bradley Block interviews experts in and out of medicine to find out everything we should have learned while we were memorizing Krebs cycle. The ideas expressed on this podcast are those of the interviewer and interviewee and do not represent those of their respective employers.
Unknown Speaker  0:29
Welcome back to the physicians guide to doctoring. On today’s episode, we have engineer and MBA Michael graphene who has 20 years of experience in the medical device space. He discusses why it’s not just important to have enthusiasm and a good sales pitch for why your new device is a great idea. But if you’re talking to investors, what are the ways that they can have their risk mitigated, he breaks down the four different classifications of risks you can really hone your sales pitch and why it’s not that important to worry about someone stealing your idea and how you You can minimize that risk as well. We discussed how to avoid duplicating the mistakes of the past and similar devices and how to get your idea in front of the right people. And why it’s not just important to have the idea, but to have the grit to move forward with it and stop making excuses.
Unknown Speaker  1:20
Welcome back to the physicians guide to doctoring. On today’s episode, we have Michael graph CEO, Mr. Graph EO started his education at Cornell he did his undergraduate in Engineering Physics and then got a Masters in mechanical engineering, and later in his career, got an MBA from Harvard. He started his career after college working for Johnson and Johnson went on to work in medical device sales for Hologic, the Vice President of Sales and Marketing for doing medical devices, Vice President of Sales and Marketing for over science, and then VP of business development for insulin, which is a drug delivery business unit. So he has a lot of experience as an engineer, working for metal device companies. And Michael, what is it that you’re doing now?
Unknown Speaker  2:04
Yeah, thanks, Brad. So I’ve been, for the last 20 years or so in various roles in the medical device industry. And for about six of those was in fairly small startup companies, both with my time at doing medical devices and over science. And, you know, earlier this year, I decided that I really wanted to get back into the small company startup business. And so just a few months ago, co founded a company called fluid form, which is actually in the regenerative medicine space, and we are licensing technology and bringing to market a new way to go about actually using desktop 3d printing technology to to approach regenerative medicine through 3d bio printing. So it’s very exciting technology, really kind of a novel, Greenfield space and one that we’re really excited to go make a difference in.
Unknown Speaker  3:00
Wow, that sounds that sounds really exciting. So, so regenerative medicine, what do you mean by that?
Unknown Speaker  3:07
Well, you know, the easiest way to think about it is in the long run, Imagine being able to take a 3d printer and plug in, you know, the right kind of bio ink into that and print tissue, printed Oregon, printer replacement, Oregon for transplant. That’s sort of the long run version or vision of a lot of the tissue engineering and bio printing Universe Today. I think there’s going to be a lot of really interesting technical hurdles engineering hurdles along the way and of course clinical. But in the meantime, you know, there’s there’s tremendous progress to be made, whether that’s printing things like collagen scaffolds or other types of engineered tissue to patches and then all the way out to, you know, organs. So, so not
Unknown Speaker  3:57
regenerating like an iguana grows new town. But rather regenerating like de novo you’re producing a de novo organ or tissue in the 3d printer for application. Exactly.
Unknown Speaker  4:11
Wow. That is.
Unknown Speaker  4:13
That’s exciting. That’s exciting. I’d love to delve more into that. And I think a great topic for later podcasts would be just where is the 3d printing space right now hat and how it applies to medicine? Because I think that’s, that would interest a lot of physicians. So, so, to our listeners, stay tuned for that one. But today, we’re just going to talk about how physicians, a physician with an idea for a medical device, how should the after that aha moment, where should the physician proceed from there? What are your options? So if you want to say rather than developing it completely on your own, maybe license The idea out to a device company, how would you proceed? What are your first steps?
Unknown Speaker  5:08
Well, I think, you know, when confronted with this situation, and I’ve been very fortunate, in my experience, both with big companies, and with small companies and entrepreneurs to have seen versions of this a number of times, I think it’s important to start before saying, How do I go about doing it? to actually ask the question, why do I want to do this in the first place? One of the most common misconceptions that I’ve seen is the notion that I’ve got this great idea, and therefore, it’s worth a lot of money, and I’m going to get rich, or I’m going to supplement my kids college fund with this. And that can happen, but it’s probably not going to. And I think it’s really important to remember that right off the bat that if you’re simply trying to Bring something novel to the market because of the financial gain at the end of the day is hard. And it takes a lot of persistence and stick to it Ignis. And things go wrong that are way beyond anybody’s control. And so there has to be a bigger why there has to be a bigger reason for putting this kind of time into something, putting this kind of effort into something. And so I just want to just really emphasize up front that the most successful innovations that I’ve seen, have really come out of somebody having a burning desire to pour whatever time and energy it takes into seeing something become a reality either for the the intrinsic benefit or pleasure of seeing that happen or bringing that solution to people to solve that problem. Or from the you know, the clinical perspective have seen patients benefit from it be worth living struggling otherwise. But But seldom is the kind of personal financial ruin. iteration, an effective driver in the long run of making something happen. It’s kind of like this podcast.
Unknown Speaker  7:09
I’m doing it because I enjoy it. There is currently and likely will be zero monetary gain. And there’s just like the idea of bringing people like you with great ideas and great knowledge to share in touch with other physicians that you know, you may be answering a lot of questions they might have in a very digestible way. So, okay, So rule number one, set your expectations low, and make sure that you’re doing it for the love of it, not for the monetary gain. Okay. Now, but let’s say you, you recognize that But still, it’s something you’re extremely passionate about. And let’s say you even know someone in that works for a medical device company. What are some of the pitfalls that you see that that people should manage before They bring the idea to someone.
Unknown Speaker  8:02
Sure. Well, I think you know, one of the first things that you really want to think about, because the pitfalls are going to be different depending on the very first question, which is, what do you want out of this, you know, at the core, as a practicing physician, you know, you get to answer the question, do I really want to give this idea to somebody else? And let them run with it and be, you know, they’re in an advisory capacity? Or put in another way? Do I want to sell or license this idea to somebody? Or do I want to be the one on the hook of making it happen? And the third choice is, do I want to sit on it and tell my friends 20 years from now, I had that idea, someday in the future when somebody actually has done it on this on their own. And you’d be surprised how often that actually is the default choice because somebody can’t make the decision between seller licenses to somebody else, or double down and actually make it happen. There. But if you if you talk about those two real, you know, effective choices, either partner with somebody else, either a big company or a small company and be an advisor to it, or make it happen yourself, the pitfalls are very, very different. The pitfalls in selling and licensing the idea, well there it’s about selecting the right third party partner, whether it’s a big company or an entrepreneur, a venture capital firm that wants to put something together around it. It’s about selecting the right people to run with the idea when it’s make it happen yourself. It’s ultimately going to come down to selecting the right people but it’s the right people to work with you to make it happen. And frankly, I’d say you know, if you want to make something happen yourself, the pressure of you know, building a practice which is hard enough today, and maintaining any semblance of a personal life, whether you have a family or not, and attempting to you know, make an idea come to reality and a fledgling company. That’s, that’s a big, big, heavy ask, and something that should not be entered into lightly. So let’s
Unknown Speaker  10:07
start with a simpler one. Let’s start with just, you want to license your idea to a medical device company first. How do you? How do you be sure that they’re not just going to say, that’s a great idea? Just going to take it from you. You know, that happens all the time. In Hollywood, you see, scripts come out all the time, two or three very similar movies all released at the same time. If the if if the studio doesn’t like your script, they’re not going to buy it from you, but they can still sell your steal your idea, hire someone else to write it the way they want to see it. And there’s no recourse for you as long as they make it, you know, different enough that it’s not obviously obviously stolen. So so if I have a great idea for a widget and I approach someone about it, how do I secure that and I recognize you’re not a lawyer, right? Like, I’m I’m shorter on specifically what I’m asking you, but kind of still am. What I’m asking you, I should probably get a lawyer on the show because the last person that I had about social media, I asked her, you know, what are the legal pitfalls? But for for you, right? How do I make sure that that this isn’t just going to get poached from me?
Unknown Speaker  11:20
Yeah. And I think that, you know, the, the fear of the idea getting stolen is probably the biggest reason why you’ll find people who are sitting here today saying I had that idea 20 years ago. Yeah. And I had it before they did. And I think it’s an important, you know, lesson to learn, because what that scenario tells you is that the value of any idea is a lot less than the idea itself, and a lot more in the making the idea comes to life. Right? The entrepreneurs who are really, really successful in this world know that it Ideas are not a dime a dozen. But there’s no shortage of ideas in the world. what’s the what’s the world is short on is people who take good ideas and make them become reality. And so that’s not to say you’ve got a great idea. Yes. So what, in fact, quite the opposite, you got a great idea that’s a prerequisite for doing something with it. But it is important to say that, you know, showing up to a big company that, you know, let’s say you’ve got a great idea in the cardiovascular space, and so you show up to a company that has a valid franchise or a student franchise or otherwise, he said, I’ve got a great idea for how to how to make something better, fairly skeptically and say, Well, okay, listen, first off, you know, I’ve got an engineering team and debate in the back who has 1000 ideas on how to make this better. And as a company, we’ve got to choose how to prioritize the right idea that we can invest in and take out to the marketplace and actually make a return on. So I would say the first thing you’ve got under Stand when you have an idea is how does this idea create value. And when I say create value, not just to me, the working physician who might say, I’d really like this device to have a slightly different angle here, or a different vendor this way, or I could do a whole different procedure, if I only had this one sort of complements to this other part. But to say, you know, in the world of healthcare today, I’m just having a slightly better device is not necessarily enough to even get a big company to invest in it even if they already have the idea. So, you know, you would use the example earlier read have a novel procedure, like an office based balloon signing Class D. Right? That’s a great example of value being created for patients who now can be treated in a outpatient setting to address something that was previously not being addressed. And was causing a lot of overhang. And so you’re actually creating, you can demonstrate value being created in the marketplace. That way. You can demonstrate, you know, either transition from inpatient outpatient procedures, or people who are not being treated and therefore having a lot of costs associated with it, who now can be treated. That’s the kind of condition that is going to be a lot easier to get a company behind, then incremental improvements.
Unknown Speaker  14:28
So So when you’re creating your PowerPoint, to present to the company, you need to be able to identify the epidemiology, the statistics behind how many people are affected by this, how severely they are affected, how much it costs. And you need to have all that information at your fingertips because you need to have established exactly how much this this value is. You know, how long is a to continue with the balloon to play See, one of the things that it did is it It took what was previously done only in the operating room is and it took him to the office. I’m not advocating for this procedure, nor am I taking anything away from it, but we’re just using it as an example. Right? It took things that were only done in the operating room, it brought them to a place where they can be done in the office on select patients. And so the the value for an insurance company to now pay for this procedure is you no longer have to pay for anesthesia, you only have to pay for a facility fee. So even if the device costs a certain amount of money, you’re now saving the insurance company. So you can argue that well the device can cost up to this amount, because now the procedure to treat this is costing in total that this much less and this is how many people get chronic sinusitis. This is how many people get sinus surgery year and this is percent of the population we would expect to be able to tolerate and be appropriate for this now, outpatient procedure. This is how much money can be made from this This is why you should take my idea and help me run with it. So you need to be very what you’re saying is, when you when you, you need to get as granular as possible with your data to make the financial argument as to why this should be why this is a good idea.
Unknown Speaker  16:20
Yeah, I think that’s right. And I think, you know, to, to maybe put a little finer point on it. If you’re going to a Johnson and Johnson or a Boston Scientific or a Medtronic or an Abbott or any one of the kind of premier med device companies out there, they’ve got plenty of people who understand this landscape. So if your goal is to license something to a big company like that, you probably don’t need to go buy thousands of dollars of market research reports and get the the statistics down to the granular level. You do need, however, to be able to paint the picture and you need to be able to paint the picture so that they can then go do the work. work, because they’re going to want to vet the the numbers and the epidemiology and all the rest of it to assess whether it’s a really compelling idea or not. If you were presenting the same idea to an investor to attempt to raise money, yes, I would say you want to have all of that locked and loaded so you can paint the most compelling picture. But when you’re talking to a big company, that they’re going to have a pretty good feel for the the general market space market dynamics. But what you really need to do is to be able to paint the picture to say, here’s what the value that we can create is, and here’s why my solution is going to be able to mitigate is going to be able to achieve that. And there’s always going to be the notion and we talked a lot about it in the industry of de risking investments. It’s a it’s a made up business word around saying we know that there’s four major categories of risk to any new innovation. And so the more you can address as somebody with the idea can address why these are Actually not as risky as a typical investment might be, the more you’re going to be able to get somebody on board with the vision. So those four areas are going to be things. The first is technical or feasibility, right? Can you actually design a solution that can be designed and that can be robustly manufactured? that’s actually going to deliver the result you’re looking for repeatedly? And so, you know, it’s a very different question when you have to invent some new chemistry to achieve a solution you’re looking for. versus if you need some really good engineers to sit down in a 3d modeling piece of software and design up a great drawing, right? There’s a very, very different technical risk profile. The when there’s invention required, the technical risk is going to be scored very high. And the second category is clinical risk, right? So imagine you’re able to invent the device that needs to be invented or design the device that needs to be designed. How difficult is it going to Be to run a clinical trial, that’s going to show me that it works. And so that’s there’s two parts. Number one, you know, how likely is it that we’re going to see a treatment effect? And number two, how big a trial Am I going to need? Is this going to require 600 patients and a double blind randomized trial in 30 centers? Or am I going to be able to show this is such a profound treatment effect, that I’m going to be able to do it in 80 to 100 patients in three centers, a very different risk profile and one that a company will look at really carefully. The third is actually related to clinical risk, which is regulatory risk. Is it clear that the FDA is going to know what to do with this new category of device that you’ve come up with? Is there a predicate device on the market and so it’s going to be a very similar approval process to something that already exists? Or is this totally breaking new ground and we’re going to need to be educating biostatistician at the FDA along with bio statisticians inside the company. In order to get to this process, I’ve actually been a part of both and I can tell you when you need to educate the agency on how to think about a new innovation, it’s a much riskier proposition and then you think okay you know satisfied technical we’ve satisfied clinical, we’ve satisfied regulatory, that’s that’s a huge mountain to climb. Well, unfortunately, that’s that’s actually the smallest three mountains because the fourth mountain becomes the market adoption risk. Most inventors look at an invention and think about it from a if you build it, they will come perspective. However, in today’s day and age, and every practicing physician I know is very, very aware of the value based care mentality that’s pervading the healthcare system today. Just because you invent a great product does not mean that its patients are going to have access to it. And so you need to think about what it’s going to take to get either insurance companies to pay for it or To make it so that in a, you know, capitated kind of environment, that the hospital or the office who’s buying it is actually going to be saving money out of their capitated payment. Because if you’re adding costs to the system, it’s going to have to be an absolutely incredible benefit for people to start thinking about adding cost system today.
Unknown Speaker  21:22
Wow. So, you know, it makes me think of, I think it was Warren Buffett That said, the key to investing is don’t lose money. And so it sounds like you have to say the same thing. If you’re talking about a medical device, when you’re making the argument for why should be developed. The key to the argument isn’t this is why it’s an amazing device. The key is, this is why the risks associated with developing it are mitigated or low. You have to before you can start talking about the benefits you have to start you have to start out by Minimizing the risks.
Unknown Speaker  22:02
Yeah, the interest, both of them are really important, right? I mean, you know, the by very nature, anybody who has sort of an invention or an idea, generally is going to be very good at proselytizing the benefits of that. Yeah. And the challenges like that, that’s really important. But that’s also where most people stop.
Unknown Speaker  22:20
Yeah, so I should I say, my money.
Unknown Speaker  22:23
Exactly. I don’t want to say don’t do that. Because if you show up and say, Well, here’s all the reasons why what I’m about to tell you isn’t very risky. That’s going to be pretty underwhelming. But But when you’re when you’re done proselytizing, what’s great about you know, the idea that you have you if you really want to try to move the needle, you’ve got to be able to kind of tell that story. And here’s, here’s why it’s doable. Yeah, here’s why we can actually execute on this.
Unknown Speaker  22:50
And then at what point in that do you have to contact a patent attorney, right? That’s what that’s one of the things that I was You know, when you do approach that company that we were talking about earlier? I mean, I think,
Unknown Speaker  23:04
actually, could you just recap those four risks? One more time? Just for our listeners? Sure. Yeah. So the four risks, the four categories are technical and feasibility. In other words, can you actually design something to do what you want it to do repeatedly and reliably? The second risk is clinical risk. So can you design a trial that will actually demonstrate the performance of the products both safety and efficacy? The third is regulatory risk of can you actually get the agency to approve a device like this? And the fourth and one that most people lose track of at the inventor idea stage? Is market adoption risk? What’s it going to take to get patients access to this product in the marketplace? And then what kind of, you know, sales effort is it going to take to actually, you know, get this adopted?
Unknown Speaker  23:55
And as physicians, we see that all the time in our offices is either device Certain medication sales reps coming by over and over and over. So that there’s there’s certainly a lot that’s just a little glimpse of, of the process that it takes in order to get market adoption. And and these frequently are medications that have been around for a long time. So it’s a continuous, clearly a continuous process. But But if you do have that idea, you know, at what point should you be contacting a patent attorney? Because that is an expensive proposition. Right question. You said it before, right? Like, people come up with great ideas all the time, but they don’t have the wherewithal or the grit to really push them through the next stages. And one of those stages is going to be protecting your idea. And a patent attorney. I don’t think is is cheap. So at what point is that necessary to protect yourself before you go telling everybody your great idea?
Unknown Speaker  24:55
Yeah, so I think there’s a couple of pieces to that that you want to kind of balance right so So number one, as we said earlier, I’m not a lawyer and I nothing that I say should be construed as legal advice.
Unknown Speaker  25:08
What I can say, though, is,
Unknown Speaker  25:12
in today’s day and age, it’s remarkably easy for anybody with an idea to get a preliminary sense of what the patent landscape looks like, right? Google patents is a great resource. If you get an idea, and you spend an hour or two one night, on Google patents, you should be able to figure out a if anybody else has ever had an idea like this, and be if there’s anything similar to it, that you could base sort of a conceptual patent structure based on and so you know, if you have the idea that hey, there actually is the potential for some freedom to operate. And that’s the legal term for you know, there’s a patent landscape or Where the idea that I have might be patentable? You know, then the next step really is to reach out to a patent attorney and have a preliminary conversation. You know, most lawyers will have kind of an initial kind of exploratory discussion without before signing any sort of an engagement. And and I would say, you know, with a lawyer is always a good idea to be super open and say, This is what I’m working on. And, you know, I’m I’d like to get a provisional patent filing in place. And I think it’s an important sort of distinction for anybody who’s not working in and around the space, right, a patent application to fully prosecute that to the point where you have an issue granted patent is fairly expensive. But to get a provisional patent application, put in place is not as expensive as you might think. To get it, what a provisional means is effectively you know, we live in a world where patents are granted based on what’s called first to file so if two competing ideas that the two guys have the same idea They submit the same patent application, the first one to get it into the patent office wins. Right, it used to be the first one to have the idea one, and then they’d have lengthy arguments over who had the idea first. Now, it’s just whoever files it first. So there’s a whole process to submit what’s called a provisional patent. What that does is kind of it saves your space in line. It says, I had this idea I am submitting it, this is the basic structure of it. And then you have a certain amount of time after that tales and get a fully fledged patent. And so I’d say if you’ve done the work on, you know, looking through Google patents, you’ve got you get the sense that this is a patentable idea, or maybe, you know, then it’s worth it to spend a small amount of money to get a couple of drawings made up and to to put together a the basic structure of a provisional patent. You know, in this case here, we’re not talking about, you know, 20 $30,000 we’re usually talking about, you know, take a zero off That. And that gets you the ability to say, Listen, I’ve got a provisional patent filed on this. And there now you should, you can feel a lot more comfortable talking about the the working details of it. So that that’s kind of the patent side, but I think it’s also important to say legally called Dibs. Yeah, exactly, exactly. This is this is the shot gun.
Unknown Speaker  28:27
But I also think it’s important to say, you know,
Unknown Speaker  28:31
anybody working in kind of the entrepreneurial space within, you know, trying to raise money with investors knows that you get kind of the same dance, right? I’d like to share with you a whole bunch of stuff about my company in order to make you want to invest in it. But, you know, I, you as an investor only want to see the non confidential stuff that I can share. Because you look at 1000 investments a year and you don’t want to be tainted by having non disclosure agreements with anybody and everybody Well, the same thing is going to be true Most ideas that are generated by a physician talking to a company, they’re usually not going to want to sign a nondisclosure agreement right up front. And in the few that do, what they have is they usually have processes in place, which means that the people who are going to hear the pitch, if it’s in a non disclosure situation, are people who are going to be, you know, not in any way qualified to technically evaluate it. So I’ve seen it some organizations, they’ll sign a nondisclosure, but then they’ll assign like a special group of people who have nothing to do with anything that’s going on at the company to evaluate this idea, because, you know, let’s suppose I’m the head of r&d at a big company, and we’ve got 25 research projects going on. Well, if my company signs an NDA with an inventor who comes in and pitches something, and we decide not to do it, and that was evaluated by you know, a couple of people but I had three projects that were substantially similar to that going on? Well, now my company is really at risk, right? Because I’m going to bring something like that to market two years from now. And the inventor with the idea is going to come and say, Hey, that was my idea. And I shared it with you, under nondisclosure, and you stole it from me. Right? So companies know about this risk, and they don’t want to expose themselves to it. So you will either find that companies won’t sign a nondisclosure agreement, in which case you have to figure out how to have a non confidential discussion of your invention. Or they’ll sign a nondisclosure agreement. But none of the people who are actually knee deep in this kind of project will review it. And therefore, it’ll be either a business development person or a marketing person from another division, or maybe a technical person that is a consultant to them that they bring on to come in and take a look at this. So you know, that’s a balance and that’s a trade off you got to decide whether you want to insist on having a confidential discussion. We can get into the details. Or if you’re going to find a way to have a non confidential discussion, you describe the idea in concept. But you keep it sufficient that even if they had, if you gave them this non confidential information, they wouldn’t really know how to actually do it without talking to you more.
Unknown Speaker  31:17
God. So you’re, what you’re really saying is, you’re more protected than you think you are. Because that they’re, they’re, in essence trying to protect themselves as well. And their ability to invest in this space.
Unknown Speaker  31:31
Yeah, I will say, you know, the, the, the idea of the big company as sort of the Big Bad Wolf who’s just out to steal ideas from anybody who might happen to inadvertently share with them, you know, it’s grounded in some experience. There’s certainly folks who have had ideas stolen and who are rightfully upset about that. But by and large, I’ve seen, you know, every organization I’ve ever participated with, I go to great lengths to avoid that because they don’t want that. That’s not good. for their business in the short term or in the long term, and it’s certainly not good for their relationship with the physician community. And they rely on that relationship for a lot of what they expect to do, again, short term and long term. So I would never say you know, walking unprotected and just count on the the processes that are in place to protect you. But I would say if you if you do the right thing, and either file provisional patents, or let’s suppose that your ideas are not patentable, but that you’ve got some unique amount of know how on how to make it happen, right, so then you say, all right, I’ve got these trade secrets on how to actually do this. And I’m not going to share those with you in the conversation until we get further down into the into the process, because those are those are my trade secrets. Right. And this is very common with with a lot of industry where, you know, the How to manufacture it, or the how we make the design work where other people have failed, those sorts of things. Maybe we can’t patent it, but because we know how to do it. We’ve we can prove that it works.
Unknown Speaker  33:03
That becomes a unique defensible position.
Unknown Speaker  33:06
I think we’ve ended up spending most of the time, mainly discussing, not device development specifically but more idea development and approaching really someone like you, or someone else in your field who can then run with that idea how to protect yourself why it’s really not as necessary as, as I thought to be as on such a defensive position. But because because we’re going to be wrapping up. Do you have any final thoughts? Anything that that I didn’t ask you that it is important for a physician to know maybe some common pitfalls? If you do have that idea? You’re going to be approaching the company. And, you know, maybe some common mistake or two that you see on your end from the physician side?
Unknown Speaker  33:58
Sure, yeah. You know, the
Unknown Speaker  34:01
I think about innovations as either zero to 100 innovations, you know, doing something that nobody has ever done before, or one too many innovations, ie, there’s something that’s been done before, I’ve got an idea on how to do it better, how to do it faster, how to do it easier, how to do it less expensive. And I would say the vast majority of the innovations that, that I’ve seen, the vast majority of the ideas and companies that I’ve ever seen in my career are the one to many kind, zero to one innovations are very unique, and I’ll set those aside for a minute.
Unknown Speaker  34:41
When it comes to a one to many innovation,
Unknown Speaker  34:44
one of the things that I’ve seen over and over again, is that folks who have those ideas and who are trying to make them happen. Don’t pay attention to history. And I think that’s a really big pitfall Oftentimes, there are really good reasons why things are the way they are. And if you’re seeking to change the way things are, you may be wildly successful at it. But it’s really important to understand why things are the way they are in the first place. If you’re looking at a category of product that had an FDA Advisory Committee, for the approval of the first product of its kind, go back to the FDA website, find the FDA panel pack, read the transcript of that meeting, you’ll probably learn a lot you’ll probably understand where some of the misgivings were. where some of the problems with the clinical trial design, where were some of the operating problems of the product might be go out and look at things like the FDA mod database. That’s the database where manufacturers and users report device problems. Understand what kind of problems happen with categories of devices that you’re looking at. Talk to people who’ve tried to do develop these products before, you know Google search will give you, you know, 10 2030 companies in a given space who’ve tried and failed. And finding failed companies in a given space is a great learning opportunity to understand and what really happened there. A lot of those folks, if you connect with them in LinkedIn and drop them in a note and ask, Hey, like to talk to you, I’m kind of working on something in this space, they’re happy to share what went wrong, the more you can understand about where the pitfalls are, the better because when you go to a big company, you’re going to talk to somebody who is well educated on that space, and who may have looked at all those companies before that failed. So when they look at you, they’re going to say, Well, I don’t understand how this is any different from things I’ve already seen before, passed on and then watched fail. And so I’d say that’s a huge pothole that a lot of people aren’t aware of. I run into that over and over again.
Unknown Speaker  36:50
So that I think leads into and just correct me if I’m wrong into what my final question was going to be, which is, how do we get in touch with the Right company. And I think you kind of implied that in there is if you have a similar if there was already a similar idea out there, they had their trials, they had their problems. You get in touch with someone on LinkedIn who would develop the similar device. That person is probably going to be well acquainted with the industry, and is going to be able to point you in the right direction. And I think it’s from How to Win Friends and Influence People, right? There’s no sweeter son sweeter sound and the sound of your own name. So you ask someone who developed a device I’m sure they’re passionate about. I’m sure they’d love to talk about it. get their input on it, read everything about it beforehand. Certainly they’re going to be flattered that you did this research on their great idea. And then you connect with them, you talk to them, you pick their brain, and then they can probably point you in the direction of what next steps you can take.
Unknown Speaker  38:01
In your journey, would you would you agree with that?
Unknown Speaker  38:04
Yeah, I would, I would say that some of those folks might even be willing to make a few introductions for you. But I’d also add that in addition to those folks, you know, the simplest way to think about who to reach out to, is to look at who is already selling products that are like yours. Because at the end of the day, these large businesses, they have sales forces that cost a lot of money, and they’re always looking to give that Salesforce more to sell. That’s their best way to get, you know, more return on the investment in the Salesforce. So if you have a product that would be sold by, you know, a rep from, you know, one of the large major companies if you have an idea for a product that would be highly complementary to that. You want to talk to those companies. And that’s where you know the idea of talking to you know, you will not take the same product and talk to striker as you would going and talking to Hologic, because their products don’t overlap, they don’t compete with one another. And you might have a very different conversation with Medtronic than you would with Philips, again, because they have just a fundamentally very, very different product set. So, you know, understanding who makes products in this space, and then, you know, narrowing down your search that will help you know who to go talk to
Unknown Speaker  39:27
great. This was extremely enlightening. We really didn’t cover one thing that I I that I wanted to that we talked about beforehand, which was bursting people’s bubbles as to how challenging it can be to take your idea and, and and make it real but that’s that’s totally fine. That was this was a very, I think encouraging talk. You really gave a lot of positive ideas as to how people can make their their dreams reality at least At least rather than developing it themselves, but but developing really fleshing out their ideas, mitigating the risks and then selling their idea to someone who can who can take it to completion.
Unknown Speaker  40:13
Well, I think that after, you know, after making the the assertion at the beginning, that you’re not going to make any money doing this anyway, I’m glad to hear that most of the rest of the tone was optimistic. Yeah.
Unknown Speaker  40:26
So as long as it’s your passion, and that’s why you’re doing it and you’re not expecting to make any money and be able to retire on this alone. But you also can be a foot in the door in that space and making connections and, and great things happen from there. So Mike, thanks so much for for talking to me and taking the time to do this and enlighten us how we can really take our ideas and and make them real and good luck with fluid form. I really look forward to seeing what you
Unknown Speaker  40:55
do in the biologic 3d printing space.
Unknown Speaker  40:58
Thanks so much. Have a pleasure. Online this has been a blast.
Unknown Speaker  41:04
That was Dr. Bradley Block at the physicians guide to doctoring. Find all previous episodes on iTunes, Stitcher, Google podcasts or wherever you get your podcasts and write us a review. You can also visit us on facebook@facebook.com slash physicians guide to doctoring. If you’re interested in being a guest or have a question for a prior guest, send a message or post a comment.
Transcribed by https://otter.ai