Jun 25, 2026 · 39 min · 9 segments
Ever wonder why brilliant scientific breakthroughs sometimes crash and burn before they hit the market? It’s not usually because the science was bad; it’s because the operational strategy was missing…
At the end of the day, I sit here in my seat, similar to yours, in working with our clients to articulate and communicate what it is that they do, how they do it, reach their audience properly, especially in a regulated space like MedTech.
There are things that you can say and, of course, things that you cannot say or claim.
Where do you see the intersection of those two things where on the marketing side, you need to be able to proclaim that your device can do these things or has the ability to fight something from a biotech standpoint or a pharma standpoint? Where do you see that intersection of that? marketing and communication, and then being able to articulate to the regulatory bodies like the FDA what the technology is capable of doing.
There is, and it's an important one, right? Because You know, and I have very, very many examples that I can give specifically as to how the interaction goes between, I'll say, the commercial teams and the operational teams that are developing the product, even the R&D teams that are developing the product.
Because you kind of have to think about the entire lifecycle of the product, right? You go from the laboratory, you've developed an example product that we developed years ago and I was involved with at Ethicon, the first antibacterial suture.
Big deal, right? You're developing an antibacterial suture for the first time, and who better than Ethicon to do that, the world leader in sutures, right? So from a laboratory perspective, you got this wonderful petri dish that shows that this suture, when surrounded by microorganisms, actually affects them and doesn't allow the microorganisms to grow on the suture.
That's a big deal, clinically speaking, right? So you go from that idea in the R&D and in the lab, and you say, how do I produce that? Right? How do I produce that? So the first step is, can I scale this? Can I produce this in large quantities, right? And what's the manufacturing process? And then you start asking yourself the question earlier in the process, early in the development process, not only can I make it, but how do I prove it? How do I prove its efficacy? How do I prove that it does what it's supposed to do? Right.
And what can I say about what it does? And you start thinking about those things because you're really starting to think about what's the FDA going to require for me in order for me to be able to show that I'm doing these things.
And then you start asking yourself the question, and what will I tell? What will I say to the client? to the user, to the physician in this case, the surgeon in this case who's going to use that suture, what can I say to them? And of course, from the marketing perspective, we want to say, this thing is the greatest thing since sliced bread.
We want to make these fabulous claims, right? And then you got the legal and the regulatory folks going, oh, wait, hang on a second.
We can't make that leap, right? So that's where The engineering community, the scientific community, and the commercial community have to kind of put their heads together creatively and say, what is it you're wanting? What's the message you want to say to the world? What would be the ideal message? This suture helps to prevent infections.
And then you start working backwards as to... what can we actually prove in the lab? And what can we actually manufacture consistently and efficaciously? And then what evidence can we create that provides the FDA sufficient evidence to say, yep, you can make that claim, right? So the key to all of that that I've just said is a real tight communication and an early communication between the commercial teams of what they want to be able to say about something when they finally get to launch this product, and what the scientists and engineers are developing in the lab, and what the manufacturing guys are thinking about how they're gonna match, all that should not be done in silos.
And oftentimes the companies that fail at that end up paying the price that they say, well, I got a great idea, I can demonstrate it in the lab.
One, I can't either produce it or I can't prove it, and I can't say what I really wanna say in the market.
At the end of the day, I sit here in my seat, similar to yours, in working with our clients to articulate and communicate what it is that they do, how they do it, reach their audience properly, especially in a regulated space like MedTech.
There are things that you can say and, of course, things that you cannot say or claim.
Where do you see the intersection of those two things where on the marketing side, you need to be able to proclaim that your device can do these things or has the ability to fight something from a biotech standpoint or a pharma standpoint? Where do you see that intersection of that? marketing and communication, and then being able to articulate to the regulatory bodies like the FDA what the technology is capable of doing.
There is, and it's an important one, right? Because You know, and I have very, very many examples that I can give specifically as to how the interaction goes between, I'll say, the commercial teams and the operational teams that are developing the product, even the R&D teams that are developing the product.
Because you kind of have to think about the entire lifecycle of the product, right? You go from the laboratory, you've developed an example product that we developed years ago and I was involved with at Ethicon, the first antibacterial suture.
Big deal, right? You're developing an antibacterial suture for the first time, and who better than Ethicon to do that, the world leader in sutures, right? So from a laboratory perspective, you got this wonderful petri dish that shows that this suture, when surrounded by microorganisms, actually affects them and doesn't allow the microorganisms to grow on the suture.
That's a big deal, clinically speaking, right? So you go from that idea in the R&D and in the lab, and you say, how do I produce that? Right? How do I produce that? So the first step is, can I scale this? Can I produce this in large quantities, right? And what's the manufacturing process? And then you start asking yourself the question earlier in the process, early in the development process, not only can I make it, but how do I prove it? How do I prove its efficacy? How do I prove that it does what it's supposed to do? Right.
And what can I say about what it does? And you start thinking about those things because you're really starting to think about what's the FDA going to require for me in order for me to be able to show that I'm doing these things.
And then you start asking yourself the question, and what will I tell? What will I say to the client? to the user, to the physician in this case, the surgeon in this case who's going to use that suture, what can I say to them? And of course, from the marketing perspective, we want to say, this thing is the greatest thing since sliced bread.
We want to make these fabulous claims, right? And then you got the legal and the regulatory folks going, oh, wait, hang on a second.
We can't make that leap, right? So that's where The engineering community, the scientific community, and the commercial community have to kind of put their heads together creatively and say, what is it you're wanting? What's the message you want to say to the world? What would be the ideal message? This suture helps to prevent infections.
And then you start working backwards as to... what can we actually prove in the lab? And what can we actually manufacture consistently and efficaciously? And then what evidence can we create that provides the FDA sufficient evidence to say, yep, you can make that claim, right? So the key to all of that that I've just said is a real tight communication and an early communication between the commercial teams of what they want to be able to say about something when they finally get to launch this product, and what the scientists and engineers are developing in the lab, and what the manufacturing guys are thinking about how they're gonna match, all that should not be done in silos.
And oftentimes the companies that fail at that end up paying the price that they say, well, I got a great idea, I can demonstrate it in the lab.
One, I can't either produce it or I can't prove it, and I can't say what I really wanna say in the market.
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