Steve Duddy Founder and CEO at Duddy Executive Services Inc

 In this episode, we sit down with Steve Duddy, a powerhouse executive with over 20 years of experience leading high-impact transformations across startups and Fortune 500 companies like 3M and Johnson & Johnson. Steve shares his unique approach to uncovering hidden opportunities, turning ambiguity into actionable strategy, and executing bold roadmaps that drive outsized results. 

We dive into how he’s helped scale companies from near-zero to over $35M in ARR in under two years, his success accelerating growth through global distributor networks, and his role as an embedded executive and board director across early- to mid-stage ventures. 

With a fiercely competitive mindset, deep strategic insight, and hands-on operational expertise, Steve walks us through how he tackles complex challenges in global supply chains, commercialization in highly regulated markets, and successful exits via M&A and IPO. 

This episode is a must-listen for founders, operators, and investors in the HealthTech space who want to understand what it takes to turn overlooked opportunities into industry-defining success stories. 

Transcript

Julio Martinez-Clark (00:01.73)
All right, Steve, so thank you so much for that introduction to your journey. It's very intriguing how is it that you moved from the corporate world to the startup community, because it's a totally different mindset, right? The same thing happened to me in my life. I moved from corporate America to the startup world, and I never went back.

Steve Duddy (00:06.798)
Zoom.

Julio Martinez-Clark (00:29.91)
And I'm very thankful that I was able to transition to the startup world. moving along, Steve, let's talk about trends. I mean, now that you're an executive, now that you've gone through all these different experiences in the corporate world, in the startup community, and especially the startup community with political changes, with funding sentiments that change every year.

Steve Duddy (00:42.254)
Okay.

Julio Martinez-Clark (00:59.49)
What trends do you see happening? Regulatory trends, clinical research trends, funding trends. So what do you have to say about that?

Steve Duddy (01:09.525)
Yeah, I think they're all tied in together. And I think that every company, every investor somewhere, somehow is feeling or touching it. You know, and I think for me, what I've noticed a lot is certainly the funding trend has had a very interesting and significant feedback on organizations. And if I can kind of walk you through my train of thought, my experience here, you know, what happens with the funding is in the past,

a great idea would typically have no problem getting funded, but it's no longer great ideas that are being funded. It's now what is the return on the investment aspect of it? And it's probably more so now than ever. I saw a brilliant device coming out of one of the universities for glioblastoma. And if you had glioblastoma, a family member had glioblastoma, you would say, my God, this is

Julio Martinez-Clark (01:42.735)
Hmm.

Steve Duddy (02:07.136)
absolutely something we need to have and it helped with the margins on the removal. But what happened at the end of the day, when you take a look at what the market opportunity is and the regulatory path, you did the numbers and went, Jesus, I think we're going to have a hard time getting this funded. And so what happens is when regulatory, and then we have the issues within the FDA here, right? And so things no doubt have been slow rolling here because of

Julio Martinez-Clark (02:23.698)
Hmm.

Julio Martinez-Clark (02:31.183)
Yes.

Steve Duddy (02:35.212)
manpower, people power issues, the absence of reviewers, reviewers being let go, policy changes. And so this process has been dramatically extended. And so if you are a small company and you have investors you're depending on, these investors now kind of did a roll up and said, well, if it takes us, I'm going to make up a number, 18 months to get through the FDA process here, all things considered.

Julio Martinez-Clark (02:41.91)
Yes. Yeah.

Steve Duddy (03:03.866)
then we can expect to go and see revenue by this date, which we can then be profitable by this date, which we have an &A by this date. But the slowdown in the regulatory process has created a situation where the process has gotten much longer. And so investors are having to hang in there much longer with the current companies they're supporting.

Julio Martinez-Clark (03:10.701)
Yeah. Yeah.

Steve Duddy (03:26.592)
which means they don't have the exits they had before, which means they're reinvesting their dry powder, if you will, on their current investments. And so therefore it leaves less money for new investments. Now, that doesn't mean that there aren't some specialties out there that are still really hot to try and finding money. But because of some of the bottlenecks and, you know, I have one company that I'm advising where

Julio Martinez-Clark (03:34.755)
Yeah.

Julio Martinez-Clark (03:39.01)
Yeah.

Steve Duddy (03:51.916)
boy, the FDA has been spot on on the timing on the pre sub meetings and the approval of protocols. Yet I've heard stories from other companies where dates have been postponed, it's gone into a black hole. And so all of this becomes a challenge. You know, as it pertains to the regulatory aspect of it, you know, I think founders and CEOs need to really start thinking a little bit differently about how they're going to approach their regulatory process.

Julio Martinez-Clark (04:03.757)
Mmm.

Steve Duddy (04:18.702)
I know we all have regulatory people in the United States who are probably very comfortable with and have worked with them for a long time. However, it's how do you get to that endpoint to get the data you need, to get the right data you need, to get data that's accepted in front of the FDA in a timely fashion? And so I'm aware of one of the companies that I'm advising where there was a competitor doing a study and they basically did a 180 degree turn on the application because they couldn't get the enrollment.

Julio Martinez-Clark (04:41.768)
Okay.

Julio Martinez-Clark (04:45.527)
Hmm.

Wow, really?

Steve Duddy (04:48.812)
And part of that was, yeah, and I think part of it was they didn't do their homework on the patient population. I don't think they did their homework on the inclusion exclusion. And so therefore, over a long period of time, they only got a handful of patients and that was a lot of money and time to burn. And so I go back to, I think the CEOs need to get a little bit more proactive with the regulatory teams.

Julio Martinez-Clark (05:00.194)
God.

Steve Duddy (05:15.446)
I think they need to realistically look at all aspects of the regulatory process, whether it's a breakthrough device consideration or not. Where are you going to do your trials? Who's going to be the lead investigators? How much is this going to cost? And you have to have a fallback plan. But I think a lot of times there's either a lot of trust put into a regulatory team that may or may not be the best in that particular arena.

Julio Martinez-Clark (05:32.322)
Yeah.

Steve Duddy (05:42.03)
or maybe people underestimate or undervalue the experience that somebody brings because also, you only get one shot at doing this. And so you're going to want to make sure that you've got your ducks in a row. And so that's kind of what I'm seeing out there. And I think also selecting the right location for the trial so you have that availability of the population, which is one of the big advantages to Latin America, is they don't have in many cases the same type of medicine or intervention.

Julio Martinez-Clark (05:42.145)
Yeah.

Julio Martinez-Clark (05:52.065)
Yeah.

Julio Martinez-Clark (06:06.795)
Yeah.

Steve Duddy (06:11.858)
interventional medicine that we have here. And so therefore the population to choose from is tremendous. And so, and we can talk about more of the advantages to doing business there or doing your clinical studies there, but I think the CEOs need to be a little bit more well-versed and think bigger as it pertains to the regulatory aspect of the business. And it's not just about the P &L and it's not just about a contract manufacturer.

Julio Martinez-Clark (06:36.703)
Yes, well said Steve. I think you said something very interesting here. They must have a fallback because you have to de-risk your investment here because putting all the eggs in one basket is probably not the best option. I've been doing global clinical trials, more specifically in Latin America for almost 20 years and I've seen

many situations where companies fail as you correctly stated with your example. That's a multi-million dollar example. mean, that's kind of the best example ever that somebody can give of a failed study. So anyway, so are you seeing more companies stay in the United States or are you seeing more companies going overseas? If so, where are you seeing these companies going?

Steve Duddy (07:11.158)
Okay.

Steve Duddy (07:36.034)
And so, you know, what's interesting is I have one company that I'm advising where they are from outside the US. They were they're in Korea. They actually want to come to the United States for their studies. Now, the interesting part about that, it has nothing to do with the fact that

They feel the FDA and the U S is better. It's that the application they're developing, believe it or not, does not have the patient population in their country that it does in the U S. And so it's almost, it's almost the reverse, you know, role reversal of what I just talked about. And so in this particular case, it's an application for a type two diabetes. And so the application they're talking about is very prevalent here in the States, but not so much there.

Julio Martinez-Clark (08:07.39)
Okay. Yeah.

Steve Duddy (08:25.046)
And so the CEO was smart enough to say, I know the FDA is there and they'll probably be really happy if we do it there. But our population and enrollment potential is significant there. And I think that's the other thing, Julio, that I didn't touch on is I think a lot of people hesitate to go from outside the US, their comfort zone, because of fear of, you know, is the data going to be acceptable? How much is it going to cost? Do I have a good clinical group? Look.

Julio Martinez-Clark (08:25.215)
Yeah.

Julio Martinez-Clark (08:36.842)
Hmm.

Julio Martinez-Clark (08:50.536)
Yeah. Yeah.

Steve Duddy (08:54.114)
There are people like you and your team, you know, that can blaze the trail, right? If the CEO is willing to pick up the phone and go, Julio, let's talk. I mean, people understand that clinical trials in Latin America could be 30 to 50 % less in cost overall compared to studies elsewhere. It's going to be helpful to get some...

Julio Martinez-Clark (08:56.405)
Thank you.

Julio Martinez-Clark (09:04.042)
Yeah.

Julio Martinez-Clark (09:12.253)
Yes. I'm sorry to interrupt, not to mention the burn rate. Because if you get approval faster, you're going to burn less cash than waiting until the FDA or some big regulatory body approves you.

Steve Duddy (09:25.196)
Right.

Steve Duddy (09:30.442)
Absolutely. Absolutely. So the clock is ticking. So you've got these studies going on, but you also are supporting a team monetarily, you know, as you're waiting for the data. And then, you know, there are so many misnomers, right? It's well, is the data really going to be accepted? Is it good clinical practices being conducted over there? Absolutely. In fact, what people don't know also about some of these countries is the physicians that you're going to use to recruit, to do your study, they've been trained internationally.

Julio Martinez-Clark (09:37.673)
Yeah.

Julio Martinez-Clark (09:59.751)
Yes! Yes!

Steve Duddy (10:00.098)
So they understand the process of it, right? And so all you have to do is just start opening up your eyes a little bit, get outside your comfort zone if you haven't done it before, and start talking about the what ifs. Get somebody local on the ground there. Get somebody that knows the hospital system. Get somebody that knows how to work the processes there. You don't have to all do it yourself from the US. But if you're willing to do that, look.

Medtronic has been successful, especially in the device world in Latin America, Brazil, Colombia, Argentina, Edwards Life Sciences, same thing, very successful clinical trials outside the United States. So don't be afraid to step outside that comfort zone and start looking for other locations where you can get your stage two, stage three clinical work done much quicker than anywhere else.

Julio Martinez-Clark (10:31.391)
Yeah. Yeah. Yeah. Yeah.

Julio Martinez-Clark (10:54.207)
That's true. Yes, yes. Especially now, Steve, talking about trends. Another trend that I've seen in the past five years or so is countries in Latin America becoming very friendly to clinical trials. Before it was kind of a, yeah, we have the regulation because we have it. For XYZ reason, we have it. But now the approach is a little different. Countries are welcoming clinical trials.

especially in Latin America. I'm sure it's happening elsewhere, but in Latin America countries like Brazil just enacted a new law to make clinical trials a lot friendlier to investors, to sponsors. Faster approvals, more predictable approvals. Argentina in 2017, Mexico, Carrefour-Price. mean, it's modernizing the whole regulation to make Mexico a hub for clinical research.

Steve Duddy (11:41.166)
Okay.

Julio Martinez-Clark (11:51.818)
And Panama, country after country is doing that because they are realizing the impact that clinical trials have in the local populations, in patients, because they now have access to therapies that are not available today in the country. And the money that flows into the economy, higher paying jobs, et cetera, et cetera, publications from the country. So it's a win-win for everybody. The sponsor wins, the investigator wins.

Steve Duddy (11:57.998)
Absolutely.

Julio Martinez-Clark (12:21.725)
the patient wins and the hospital overall also wins.

Steve Duddy (12:26.802)
Absolutely. And look, this is just my personal experience. But several years ago with one of the companies that I was running, we specifically reached out to Brazil to do some work and to get a clearance because it was a product that was in the aesthetic space. Plastic surgery, cosmetic surgery, Brazil, Argentina. Yeah, yeah, very strong. However, when we sat down with the regulatory team there,

Julio Martinez-Clark (12:45.757)
That's big in Brazil, by the way.

Steve Duddy (12:54.942)
it was clear, and again, it was early on for them, but it was really clear they were more focused on the money and the business as opposed to building a reputation of this is a great place to do your work. And so we saw within a 12 month period, a walk back of a lot of the roadblocks that caused us to hit pause. And so I think countries like Brazil and Argentina and the others are beginning to realize this is more than just a money making opportunity.

Julio Martinez-Clark (13:06.825)
Hmm.

Julio Martinez-Clark (13:13.619)
Hmm

Julio Martinez-Clark (13:24.115)
Yeah, exactly.

Steve Duddy (13:24.3)
This is a way to grow our economy. This is a way to be friendly to big companies. There's so many far reaching pieces of impact here.

Julio Martinez-Clark (13:33.93)
It's transfer of knowledge, advanced knowledge to our local economies. Yes, you're absolutely right. You know, smaller countries like Salvador. Salvador just recently changed the regulations and is now becoming a hub in Central America for clinical trials. Just like Panama is now. We've done several trials in Panama. We're conducting two trials in El Salvador, by the way. I went to El Salvador invited by the government last year.

Steve Duddy (14:00.278)
Wow.

Julio Martinez-Clark (14:02.985)
So I spent a whole week in the country and I was really appalled to see how safe it is, how clean it is, the infrastructure they have. it's a welcoming place for a clinical child. So I don't really see, I don't know if you agree with me or not, but I don't really see companies, I don't see a compelling reason why companies go to Australia or Eastern Europe. Yes, in Australia you save a little bit of money, but you have to create an entity, a local entity. You have to hire an army of

Steve Duddy (14:07.31)
Okay.

Steve Duddy (14:32.782)
Right, right. And I think, know, Julio, this is a downfall of people, businesses, that whole response of, why are we doing it? And you hear that, well, this is the way we've always done it.

Julio Martinez-Clark (14:32.869)
attorneys and accountants to claim the money back from the government wait and then the time difference and the time to fly to the country so it's not always a good investment I think

Julio Martinez-Clark (14:59.602)
Yeah.

Steve Duddy (14:59.662)
That is just one of my pet peeves and saying, okay, if you're going to be successful and you're going to be competitive and you're going to be proud, stop the whole, is the way I've always done it. If you're going to differentiate yourself, start looking at the ways to do it differently. Going to Latin America. I think, and I think you hit on this as people think for some reason that the quality of the study and the data is going to be subpar and it's so far from the truth.

Julio Martinez-Clark (15:04.882)
Good point.

Julio Martinez-Clark (15:09.723)
Yeah, yeah.

Julio Martinez-Clark (15:27.91)
Yes.

Steve Duddy (15:28.278)
And so all you need to do is, know, as CEOs, we mingle among other CEOs, it's just to pick up the phone and say, Hey, look, I know somebody at Medtronic. What was your experience there? Because we're thinking about going there. Who did you use? Right. But you need to be able to be willing to do that and not just sit with, this is the way we've always done it. But you're right. It is such a cost effective alternative rather than having to get on a plane and fly 17 hours somewhere to do something.

Julio Martinez-Clark (15:34.76)
Exactly.

Yeah.

Yes, yeah.

Julio Martinez-Clark (15:57.09)
Yeah

Steve Duddy (15:58.83)
that it's so worth investigating here, especially even if you're a senior CEO, take a look at it if you haven't already. And if your regulatory team refuses to at least entertain it, then you got a whole other issue there potentially.

Julio Martinez-Clark (16:15.781)
Hmm, yes, yes. You know, it's funny you mentioned that CEOs should pick up the phone and talk to other CEOs. Most of our leads, clients come from referrals. What the mouth? I mean, one CEO tells another CEO at a meeting, at an event about us and that's how, I mean, of course we do outreach, marketing and all that like everybody else.

Steve Duddy (16:31.116)
Mm-hmm. Mm-hmm.

Julio Martinez-Clark (16:43.868)
but most of our opportunities come through referrals because one CEO talks to another CEO. So going back to your experience about clinical trials overseas, in what countries have you been or have you been involved in one way or another in clinical research Steve?

Steve Duddy (16:50.07)
Right. Right.

Steve Duddy (17:03.554)
Yeah, and so we relied on Mexico for the longest time, especially in the world of ophthalmology, because we just found the, yeah, and just for the recruitment of patients. And we worked with a lot of physicians that spent a lot of time in Mexico. And so we did the work in Mexico. We actually, what's interesting too, is that some of the laws in the countries have changed where you need to conduct clinical trials in that country.

Julio Martinez-Clark (17:09.456)
Mexico.

Julio Martinez-Clark (17:19.025)
Hmm.

Steve Duddy (17:31.83)
in order to get a clearance in that country. And so China, for instance, has got to the point where, and I don't know within the last year if that's changed or not, but if you wanted a clearance there, they would dictate to you what the study was gonna look like, where you were gonna do it, how many patients were gonna do it. And I think that was a turnoff, but we looked at that possibility. Brazil.

Julio Martinez-Clark (17:33.7)
Hmm.

Julio Martinez-Clark (17:55.908)
Yeah.

Steve Duddy (17:57.056)
ultimately doing some work in Brazil and trying to get the data and it worked out really well. And so I think what you really need to do with this Julio is when you're presented with this opportunity and you need your clinical work is to try to figure out, okay, so where is the population that best fits this clinical work? And so, you know, if I've got a device that I'm looking to get cleared for type two diabetes and there isn't much of that in Brazil,

whether they're cooperative or not, I'm not gonna get the patient population in the enrollment I need, right? And so what you've got to do is you have to figure out if this is a LASIK surgery for correction of your vision, and I can get that done in Mexico because the population is there. Heck yeah, let me, I'll some of that. And the physician is down there doing the work. so...

Julio Martinez-Clark (18:27.536)
Exactly, yes.

Julio Martinez-Clark (18:42.768)
Sure. Yeah.

Steve Duddy (18:46.574)
I've done work in Brazil. I've done work in the UK. We've done a little bit of work in China, but pulled back. We've done work in Brazil. the US has always been the first stop off. But I think I've spent a switch with me and going, OK, is this the only option? Are we sure this is the only way to go? And start trying to push the envelope to look at other places and make sure, like any CEO should, what's the best decision for the company?

Julio Martinez-Clark (19:15.311)
He has.

Steve Duddy (19:16.172)
And if this is the best way to go, then let's just go do it and find a Julio and Dean that can say, hey, this is what we're doing. And then look, I should listen to you. Because that's the other thing is we were able to do the work we did outside the country with contacts we knew there. And so if you're going to get a contact there, you got to listen to them. There's nothing worse.

Julio Martinez-Clark (19:21.03)
Thank you.

Julio Martinez-Clark (19:35.449)
Mm-hmm.

Steve Duddy (19:42.572)
You and I both know this and somebody brings you on to advise them and then they don't take your advice. And obviously that's their prerogative, right?

Julio Martinez-Clark (19:48.101)
Exactly. They're looking for confirmation of what they already know or the decision that they already made internally, yes.

Steve Duddy (19:54.466)
Right. Right.

Right, right, right, right. And if you pick the right places, Julio, and this gets back to what our main point is, and you pick the right places, you're going to get good data, and the FDA is going to be totally fine with the data that you've calculated and presenting to them. Just do your homework ahead of time. But everybody's got to throw this myth out the window that it's going to be subpar, the experience is going to be difficult, it's going to be way over the top, it's going to be... Forget all that. The data is going to be great.

Julio Martinez-Clark (20:15.812)
Yeah.

Steve Duddy (20:26.69)
This is providing you do the homework and you get the right people. It's like anything else, right? You get a great team. But do your homework, understand your application, understand the audience, understand the availability, understand the team on the ground there because you're going to rely on them, and then just put your head down and run.

Julio Martinez-Clark (20:43.994)
Yeah, yeah, yeah. Great point, Steve. So Steve, what do you think about what's happening politically in the United States in regards to the layoffs at the FDA? Is that pushing companies to change their plans? What's the sentiment that you see in the market?

Steve Duddy (21:03.83)
I think it's created a lot of uneasiness. think people still have faith that somewhere, somehow this is going to rectify itself. I think companies, if they're smart, are leaving more time in the expectation of how long it's going to take to get through each of these stages. I think you also need to be realistic with the person you're dealing with here now.

may not be there at the next stage, right? Because we used to be able to rely on, there used to be people that were there forever. They cut their teeth at the FDA. Yeah, and they stayed there till retirement, right? And so you have to understand that the team you're working with there, and by the way, the team that we're working with, they're good people. You know, they like the fact that, you know, that we're going to be supportive of them and understand how much work. Look, if they have

Julio Martinez-Clark (21:34.213)
Hmm, that's a good point, yeah.

Julio Martinez-Clark (21:40.357)
for 30 years.

Steve Duddy (22:01.326)
12 reviewers and they let 12 reviewers go and each reviewer has 20 files on their desk they're responsible for. There are now 240 applications in there that are in a black hole, right? And so it's not the individuals, but just recognize the individuals may get to a point where they're going, I don't want to do this anymore either and I'm out of here. And so you've got a new face. And so you just have to deal with it, right? We might be disappointed. We might've liked that person.

Julio Martinez-Clark (22:13.753)
Yeah, yeah, yeah, yeah.

Steve Duddy (22:30.658)
But the turnover is inevitable, and it's probably going to continue until things sort themselves out. So plan realistically on the time frame. Plan realistically on the budget. Make sure you've got the best team possible that's working for you, where the person says, hey, I'm going to pick up the phone. I know so-and-so there, and they're going to get me feedback. And you know they're going to get that response, right? You with your team.

Julio Martinez-Clark (22:54.468)
Yeah.

Steve Duddy (22:58.956)
you know, a couple of people here in the States that I've grown comfortable with and saying, I got the best team on it, you know, plan realistically. And look, here's the other thing. Be upfront with your employees and your board, right? The board is going, it's going to push you to, wanted it yesterday, right? Cause this is going to impact if you're, if you're publicly traded, it's going to impact my, my, my company value, valuation, stock prices, right? Be realistic with it. This is what we're up against. We're optimistic because.

Julio Martinez-Clark (23:11.652)
Hmm.

Julio Martinez-Clark (23:16.504)
Yeah.

Steve Duddy (23:28.728)
but be cautious and don't be too overzealous on this because you're gonna get caught short with somebody's gone, somebody's taken their place, they took somebody from this division and moved them over to this division. Look, we had an inspector show up in the medical device company that did food inspections. And so this is just the environment we're dealing with. And so expect the unexpected, but like I said,

Julio Martinez-Clark (23:48.439)
Wow.

Steve Duddy (23:56.814)
Under-promise and over-deliver is probably the best way to go on this.

Julio Martinez-Clark (24:01.643)
Good, good words, good wisdom Steve, thank you for that. Alright Steve, so what exciting projects are you working on right now?

Steve Duddy (24:10.348)
Wow, so I've got a couple Julio that I'm very excited about. I've got one company that's got a needle and needle free drug delivery device. And I look at this for, there's so many applications, but one of the ones that's jumped out and we're having some strategic discussions over is the use of the device for immunotherapy for skin cancer. You know, there are so many drugs being developed right now, but it's critical that the drug gets delivered

Julio Martinez-Clark (24:20.271)
Hmm

Julio Martinez-Clark (24:32.964)
Wow.

Steve Duddy (24:39.694)
to a specific part of the tumor in order for the patient to get 100 % of the effect. And look, what makes a good injector or injection from a bad one is just a better educated guess, right? But when it comes to putting this drug into a tumor, you got to be precise. And so with these devices, you can literally dial in the speed of the injection, the volume of the drug to be injected, the depth that you want it injected.

Julio Martinez-Clark (24:45.891)
Yeah.

Steve Duddy (25:08.982)
Ultimately, it could allow more patients globally to go to more doctor's offices to get this treatment. So that's one of them. The other one I briefly mentioned is a device for type two diabetes, which, you you look at this and saying, okay, I think, you know, they're finding more and more over time, drugs like ozempic are not going to be a forever drug for patients. And so this potentially has the ability in a seven minute procedure.

Julio Martinez-Clark (25:17.602)
Okay.

Julio Martinez-Clark (25:22.466)
Okay.

Julio Martinez-Clark (25:31.021)
Yeah.

Steve Duddy (25:36.772)
to treat the duodenum in a way that the body metabolizes differently and it helped change the course of diabetes. found it extremely exciting. And I have one more recently that is a touch free mammography system where this really gets into, do I get into, you know, you talk to any woman that's had a mammography and they go, my God, it's excruciating. I hate doing it, but this ice you literally can lay on the table and within minutes.

Julio Martinez-Clark (25:41.219)
Mmm.

Julio Martinez-Clark (25:46.018)
Yes.

Julio Martinez-Clark (26:01.101)
Yes.

Steve Duddy (26:06.19)
get your mammogram, hands off, nobody's going to touch you. And so I think there's one, know, the technology is amazing, but the experience is going to be a life changer. And hopefully, a detector earlier for those people, those women that decided they were going to put it off a year because they just hate the experience, won't mind in this particular company, the business model is going to be different. It's going to be a concierge type service where you get pampered. You know, we know that this is not something you want to be here for.

Julio Martinez-Clark (26:10.477)
Hmm.

Steve Duddy (26:34.744)
but we're going to make this as pleasant for you as possible. And by the way, even the mammogram is going to be comfortable. And so those are the three top ones that are the most exciting to me. I've got some others that I'm looking at, but those things I think have some real potential here to change the course of medicine.

Julio Martinez-Clark (26:51.519)
Excellent Steve, I'm so glad that you're involved in these amazing breakthrough technologies. well, I think we're getting close to the end of the show. Steve, any final words of wisdom? What would you say to a newer CEO that is just starting to look for options for advisors? How do people find you? mean, that type of things.

Steve Duddy (27:16.494)
So I'm on LinkedIn. You can just go right to my profile, Steve Duddy. You can shoot me an email, duddy.steven at gmail.com. You can go to Duddy Executive Services, Inc. on the internet and find me. And the word of advice I have for new CEOs, if you have to do a clinical study, don't lock yourself into the fact that it's got to be here. Pick up the phone and call Julio and let him talk to you about the different opportunities that you.

Julio Martinez-Clark (27:40.994)
Hmm.

Steve Duddy (27:44.994)
may have out there that may be better for the company and better for the investors and better for the patients. And so I think thinking differently is the key here.

Julio Martinez-Clark (27:51.808)
Yes, yes, yes.

Exactly. having a free conversation, 15, 20 minutes, 30 minutes, it doesn't hurt. the CEO will gain a lot of experience and will see another perspective, right? I think that's useful. And also, it's important to differentiate here the type of clinical trials we're talking about, Steve. I get this question a lot.

Steve Duddy (28:10.592)
Absolutely. Yeah.

Julio Martinez-Clark (28:22.326)
They usually ask me, don't the FDA require that patients come from the United States? And the answer that I give them is, listen, there are two types of studies that we're discussing here. One is the first in human.

Steve Duddy (28:35.866)
Hm.

Julio Martinez-Clark (28:36.032)
the proof of concept or the early feasibility phase of the clinical work that you need to be involved in. And the other is the actual pivotal study that you do in the United States. That's a second phase. So I usually get involved and I think what you and I are discussing here is the first in human phase where companies finish their animal testing and they are looking for destination.

Steve Duddy (28:46.574)
Thanks.

Julio Martinez-Clark (29:03.977)
because they, outside of the United States usually, because they see the challenges in the United States. XYZ challenges, there are many that we can discuss in another episode, but the challenges force these companies to go overseas and they have this first in human experience. They gather the data, quality data, ethical data, cost effective data actually, because you activate a site.

Steve Duddy (29:14.923)
No.

Steve Duddy (29:30.295)
This is.

Julio Martinez-Clark (29:33.536)
faster than in the United States and you save a lot of money on hospital fees. So you use that data to speak with your strategics, right, your potential buyers. use that data to speak with your investors to get them excited about the next chapter of the company. You already hit a value inflection point, value creation point in the trajectory of the company and also because you're already

Steve Duddy (29:39.192)
Yes.

Steve Duddy (29:43.278)
Right. Right.

Steve Duddy (29:59.606)
Thank you.

Julio Martinez-Clark (30:00.842)
prove that the device is safe and efficacious in humans. And you speak with the FDA about a pivotal study in the United States, which is going to give you the market clearance. So there are two different conversations happening here. The first in human conversation is usually the conversation that I have with companies, and it's probably the conversation that you have initially with the founders or with the CEO. And the pivotal is a larger conversation that involves a discussion with the FDA and negotiation with the FDA.

Steve Duddy (30:11.0)
Right.

Julio Martinez-Clark (30:29.973)
where the FDA will likely tell you, based on your device, based on the indication of use, I think you should do 70 % of your data should come from the United States, right, and 30 % from overseas. And so I think that's important for the audience to differentiate between the two clinical trial discussions that usually companies have with me and with advisors like you.

Steve Duddy (30:42.238)
Good day.

Steve Duddy (30:57.928)
Correct. Correct. And I think to your point, when you're talking with the FDA about this, put it all out there, right? Don't try to do, as I say, an end around where you have one discussion and then later on you have a change and you shoot them an email. No, no, no, no. Talk with the FDA upfront. I have a company that I'm working with that wanted to know, could they do the animal studies in their country rather than in the United States if the site, you know, practice GCP?

Julio Martinez-Clark (31:04.383)
Hmm.

Julio Martinez-Clark (31:11.156)
Hmm.

Julio Martinez-Clark (31:20.307)
Okay.

Steve Duddy (31:25.834)
And the FDA said, great. You know, if you're comfortable and you can prove to us that GCP is being followed there, we have no problem with you doing it. And by the way, it's more cost effective there than doing it here. But the big thing is talk to the FDA about it upfront, right? Nobody likes surprises. Tell them which, and if they're going to disagree with you, find out now, not when you do your submission and go, well, they're not accepting the data because, right? But do it now. They're there to help you. They're there to help you.

Julio Martinez-Clark (31:25.951)
Yes.

Julio Martinez-Clark (31:33.536)
to work.

Julio Martinez-Clark (31:41.524)
Yeah.

Julio Martinez-Clark (31:48.958)
Yes.

Exactly.

Steve Duddy (31:55.894)
And so your regulatory team and the CEO should be on those calls. You you own this and the FDA, just tell them what your plan is and work with them to get to a point where everybody's happy.

Julio Martinez-Clark (32:09.725)
Yes, yes, well said. All right, Steve, thank you so much for being on the show. I really appreciate you being so open and so eloquent about your experiences. And I hope people get a lot from your wisdom. And yeah, thank you.

Steve Duddy (32:31.96)
Thank you, Hulu. Thank you so much. Thank you, first of all, for the opportunity to chat to your audience. But also, thank you for what you do, because I think it offers pharma, mid-device companies a different alternative that they haven't tapped into before. And I wish you all the best. think you're doing a great thing.

Julio Martinez-Clark (32:49.225)
Thank you, Steve, I appreciate that. All right.

Steve Duddy (32:51.544)
Thank you. All right.