Medsider: Learn from Medtech and Healthtech Founders and CEOs - How To Launch Your Medical Device With a Global Perspective: Interview With Lightpoint Medical CEO Graeme Smith

Episode Date: December 27, 2021

In this episode of Medsider Radio,   we’re talking with Lightpoint Medical CEO Graeme Smith, a medtech veteran with over 32 years of experience in the industry. After joining Lightpoint earlier this year, Graeme was charged with commercializing its drop-in gamma probe, SENSEI, a revolutionary tool used in surgeries to non-invasively identify the presence of cancer. In this Medsider interview, Graeme shares his tried and true strategies for successful commercial launches and how to introduce products using a global distribution model. Before we jump into the conversation, I wanted to mention a few things:If you’re into learning from proven medtech and healthtech leaders, and want to know when new content and interviews go live, head over to Medsider.com and sign up for our free newsletter. You’ll get access to gated articles, and lots of other interesting healthcare content. Second, if you want even more inside info from proven experts, think about a Medsider premium membership. We talk to experienced healthcare leaders about the nuts and bolts of running a business and bringing products to market. This is your place for valuable knowledge on specific topics like seed funding, prototyping, insurance reimbursement, and positioning a medtech startup for an exit.In addition to the entire back catalog of Medsider interviews over the past decade, Premium members get exclusive Ask Me Anything interviews and masterclasses with some of the world’s most successful medtech founders and executives. Since making the premium memberships available, I’ve been pleasantly surprised at how many people have signed up. If you’re interested, go to medsider.com/subscribe to learn more.Lastly, here's the link to the full interview with Graeme if you'd rather read it instead.

It's absolutely essential that even if you think you've got the best idea in the world, if it's even come from a surgical team which many of the best medical devices do, that you conduct really appropriate and in-depth market research. And to involve surgeon interviews and clinical interviews for as many of the marketplaces that you're considering you are going to be active. Welcome to Medsider Radio, where you can learn from proven medsider. tech and healthcare thought leaders through uncut and unedited interviews. Now, here's your host, Scott Nelson.

Hey, everyone, in this interview, we're sitting down with Graham Smith, the CEO of LightPoint Medical. Graham is a med tech veteran with over 32 years of experience in the space with a lot of expertise in American, Swiss, and Australian companies. After joining LightPoint earlier this year, Graham was charged with commercializing its drop-in gamma probe called Sensei, which, is a revolutionary tool used in surgeries to non-invasively identify the presence of cancer. The gamma probe sinks with other robotic surgery equipment so that surgeons can read

Sensei's results from a single screen. In this conversation here, a few of the things that we're going to learn from Graham's experiences. First, designing a successful product launch requires extensive investment in market research, surgeon interviews, and clinical observations. A strong commercial plan is an absolute necessity. regulatory demands differ from market to market. Identifying and partnering with the best clinical research organizations will position you to successfully navigate the variety of differing

guidelines. Third, many key stakeholders are involved with launching a product. Strategically approaching relationships with payers, distributors, and investors will set your company up for a successful commercial launch. Okay, so before we jump into the discussion, I want to mention a few things. First, since you're listening to Medsider, you're probably aware of how expensive it is to run clinical trials. Anyone who spent time in the MedTech space knows that you typically need to commit hundreds of thousands of dollars, oftentimes millions, towards clinical research. But it doesn't have to be that way. And here's why. ProofPilot is a new kind of hybrid clinical trial platform that enables you to run decentralized studies at costs that are 40 to 80% below traditional approaches.

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platform. Get up and running quickly with an annual license fee and launch as many trials as you like with an unlimited number of participants. To get started visit medsider radio.com forward slash proof pilot. Again that's medsider radio.com forward slash proof pilot. For the medsider audience with an annual contract proof pilot will provide IRB approval for your first study at no cost. Some exclusions apply so visit medsiderr radio.com forward slash proof pilot to learn more. Okay, second, if you're into learning from proven Medtech leaders and want to know when the new content and interviews go live, head over to Medsider.com and sign up for our free newsletter.

You'll get access to gated articles and lots of other interesting healthcare content. If you want even more inside info from MedTech experts, think about a MedSider premium membership. We talk to experienced healthcare leaders about the nuts and bolts of running a business and bringing products to market. This is your place for valuable knowledge on specific topics like seed funding, prototyping, insurance reimbursement, and positioning a MedTech startup for an exit. In addition to the entire back catalog of MedSider interviews over the past decade,

premium members get exclusive Ask Me Anything interviews and masterclasses with some of the world's most successful MedTech founders and executives. Since making the premium memberships available, I've been pleasantly surprised at how many people have signed up. So if you're interested, go to Medsider.com to learn more. All right, without further ado, let's get to the interview. Graham, welcome to Medsider Radio. Appreciate you coming on. Thank you very much, Scott. I appreciate your invitation. All right. Well, I'm certainly looking forward to the conversation. We're on kind of two different parts of the world, right?

You're over there in Scotland. I'm here in Southern California. You know, we're spanning the blue ocean here. Absolutely, yes, indeed. All right. Your weather over there is bound to be a lot better than ours here, for sure. It might be. It might be, although it's done. We're we're. recording this kind of here in the summer of 2021 and it's starting to heat up here in California. But nonetheless, you have an extensive healthcare background Graham. So maybe in, you know, five minutes, can you kind of bring us up to speed on your kind of career trajectory leading up to your current CEO role at Light Point Medical?

Yeah, I mean, I've been in the mid tech industry specifically for nearly 32 years now. So I was recently introduced at a shareholder meeting as a MedTech veterans, so an industry veteran, which kind of, it hammered home, I suppose, just how long I have been in the industry. But I've loved it. I've loved every minute. I mean, I started my career with a company called United States Surgical Corporation in Norwalk and Connecticut. And U.S. Surgical was really quite famous and still is in many ways. because the company was very innovative. It all was kind of really advanced into new ground.

They were responsible, for example, for the global use of surgical staplers in surgery around the world. We also released the first disposable laparoscopic port, sorry, and shears and graspers when the general surgery community really started moving rapidly into minimally invasive surgeries.

So the company was quite famous because in those days, we were trained to scrub during procedures, and that's indeed how we would work. And part of our role, our job was really to build relationships with the surgical teams and nurses to offer a service that helped them with their daily work and make sure that the surgical instruments that they were using of ours, that we provided verbal technical support during the procedures. So for the surgical staplers and then rapidly into the minimally invasive world, which at that time was exploding. So US Surgical, a lot of the people that I worked with in those days

are still in contact with, and they've all moved on into senior positions and companies around the world. And many of the companies I've moved on to from the US Surgical, days had US surgical connections. I think it really was a part of my career, which was very intense, but I also learned an awful lot about the industry, about the importance of innovation, and how closely medical innovation and surgical technique work really hand in hand and integrate so that new technologies coming along to enhance patient pathways, and how the working with the surgical teams was vitally important

so that when technology advanced, surgical teams were able to take that technology for the benefit of their patients and patient pathways. So, I mean, from that time, I've had various roles, but from large corporations in the MedTech industry to startups, I've been really quite, quite fortunate and also a huge experience for me was really the five medtech startups that I've been involved with that went on to sell to and trade sales to larger medtech corporations.

One sold to Sanofi Bi-Surgery, one to Cook Medical, one to LaMetra, one to ResTech and one to what is now of artists. Those were three American companies in different surgical sectors, one Swiss company and one Australian company. So for me, my business has always been global. My interests have been global. The companies I've worked with have been global. And I think that's the nature of our industry. Our industry is very much, it's a small kind of almost cliqueish industry with enormous returns on potential an enormous impact for humanity, but the experience I've had has shown me that really when you start with a new technology, one of the key things is to get it international as soon as you can. You're never sure, no matter how clever and how deep your research has

gone, you're never sure what countries are going to take your technology up and really run with it. So we can touch on that a little bit later. I'm absolutely, my experience has shown me that there is a definite key way, if you like, to bring a technology from concept to the marketplace and everything in between. When you talk about that kind of that global mindset, you know, this came up in a conversation literally just recently with a company, a non-US company. And we were talking about one of their leaders in particular that because of his global mindset has enabled this particular company to kind of make leaps and bounce, right, versus some of the

competition. And do you, I mean, would you consider that kind of part of your success across your career, kind of leading, you know, being in senior leadership positions at so many different startup companies that kind of that global mindset. And maybe speak to that just a little bit more. Yeah, sure. It's vital. It's absolutely vital. And the context that you build, usually, for example, a company like ours, one of the pathways and one of the pathways for any MedTech company is to go direct and to have direct operations in certain key marketplaces. And that, of course, works at insurers focus and gets you where you want to be as quickly as you need to be there. But the resource it takes to get there is enormous. And so what I've found over the years is

working with medical device distributors is in fact a far more effective way of utilizing the resources of companies that are focused on their own marketplaces, such as in Italy or in France and various things like that. So going with a global distributor model is really vitally important because you get a lot of activity focused in on the market with the distributors in those countries who know the KOLs and the key opinion leaders in the country, they know how to access the health service. So by piggybacking on their foundation, if you like, it gets us into those marketplaces quickly. So in my experience, this is absolutely the fastest and most effective, efficient way of bringing a startup medical device into the global marketplace.

Got it. And I certainly want to circle back around, you know, as we get kind of into the part of the conversation here, we were learning a little bit more, more about kind of lessons learned you've learned along the way leading up to LightPoint. But first, let's start with LightPoint. You know, you've, you know, you've been involved in so many different, you know, startup, Met Tech companies over the years, especially kind of over the last, over the last five. What compelled you, you know, earlier this year to go ahead and kind of take the leadership helm as as CEO of Lightpoint, you know, and I think probably, when was this was earlier in 2021, maybe just a a few months ago now. Yeah, no, absolutely. I was approached by our chairman and founder,

David Tuck, who's Boston-based, and David and I had served on a board of a company previously, so we knew each other, and I've been watching Lightpoint and its development over the years. And the appeal was immediate, because the device is very unique. It's the only drop-in probe, Gamma probe on the marketplace, specifically for effective use and minimally invasive and robotic surgery. So it ticked a lot of boxes. And the team in Lightpoint Medical, who I've known for many of them for quite a number of years as well, also really appealing. Their technological know-how, their standards in terms of how they work, everything about the company really appealed to me. And they were commercial. My last.

The last role was the CEO of a company called Osteamy Cure, which is a Norwegian-owned company, but based at the Karlinsky Institute in Stockholm. And it's also a unique device for cancer, especially those patients living with permanent ileostomies, but it's still in clinical phase. So for me, the attraction of working with Lightpoint was bringing what I consider to be my main strength is to help companies commercialize and to help med tech companies get their products to marketplace. And Lightpoint had already a CE mark, FDA, and TGA rights to sell in their respective marketplaces. So it really was a major attraction for me to take my knowledge and experience

and contacts and allow LightPoint to bring their brilliant product, Sense, to the marketplace as quickly as possible. Speaking about that product, Sensei, can you, you know, and I don't expect you to go kind of too far into the weeds here, but can you give us an idea of how this product even came about, right? And you mentioned, you mentioned David, one of the founders, but help us tell, at least at a high level, you know, that kind of that inception story, if you will. Sure. Well, at the moment in surgery, surgeons, if they're working in a specific surgery, there are very few options for them to tell whether tissue is cancer or not. At the moment, And if they suspect cancer, they have to take a biopsy and that needs to go for histopathological analysis.

And then a frozen section is usually returned and the surgical team then get their answer. Is it cancer or is it not? Which means do I take it out or do I leave it? And the taking the cancer out is one element, but the leaving behind a good tissue is also another major concern for surgical teams. So it was clear that with the development of Sensei, which is the smallest, most maneuverable gamma probe in the marketplace, designed specifically for robotics and minimally invasive use. So all those things together meant it was a winning combination, is a winning combination. So we're very excited about the technology and what we've developed.

And the clear pathway that led us there really was the deep. engineering and scientific and clinical knowledge within light point medical's team very talented and deeply set and understanding oncology and cancer surgery really well and you know from the point of view of what they've developed I think is brilliant and it was one of the main appeals for me joining light point medical got it no that that's super helpful and just for my reference I'm looking at the light point site right now which is light point medical.com is this a probe that just plugs right into an existing hardware system or is it completely kind of its own closed loop system? Well, it has its own control unit, which gives an auditory and visual signal as to whether

tumor is there or not. And also, we've very cleverly interfaced the software and the hardware to work with large robotic systems that are currently in situ around the world. And when a surgeon is working on a robot, they tend to have their head down and very focused. It's one of the attractions of robotic work in that they're not losing their perspective as they're working if they're having to look left, right, forward up. So in a robotics console, they're looking down and at one particular aspect of their surgery. So our control unit insets onto the robotic screens that the surgeon is looking at, the screen they're looking at, so they don't need to look up or look over to see our unit.

It actually interfaces onto the robotic systems that we're working closely with at the moment. Got it. Very helpful. With that said, we'll circle back around maybe here in about 20 minutes and talk a little bit about what's next for Light Point in Sincay. But we'll take kind of a pause on that particular subject and really focus more in kind of of some of the key insights and lessons learned that you've kind of garnered over the course. of your, you know, your extensive career in MedTech, Graham. And, and maybe, you know,

considering that your wheelhouse is commercial, I want to ask you some, you know, some other questions about, you know, regulatory approaches and, um, and clinical data, a strategy around clinical evidence. But let's start with commercial first. Um, you touched on this a little bit already, but are there, you know, when you think about some of your best, you know, commercial launches, right? Um, whether it's, um, whether it's an existing product, kind of existing product, family in the market or whether it's something brand new, are there a few things that come to mind when you think about what makes a successful commercial launch for an early stage med tech company? Oh, wow. Yeah, I mean, that's a very good and broad question. I think that now,

the way things are now, I would say it's absolutely essential that even if you think you've got the best idea in the world, if it's even come from a certain thing. surgical team, which many of the best medical devices do, that you conduct really appropriate and in-depth market research. And to involve surgeon interviews and clinical interviews, for as many of the marketplaces that you're considering you are going to be active, you can often get blinded by a tremendous idea that is going to be extremely difficult to launch into the marketplace. And now with evidence-based medicine being strong, on the agenda of not just the surgical teams,

or the management of hospitals and with very closely guarded budgets, then you need to make sure that no matter how good you think your idea is, that there is indeed a marketplace and that you can access it. So I would say, first and foremost, market research prior to launch and appropriate surgeon interviews to get the feedback from the people who will be using the device,

I would say that's vital and very, very important. Yeah, that's a super interesting comment because I remember it's similar to something Dan Rose mentioned. He's the CEO of Limflow. And he's over in Europe as well right now. But he mentioned that very same thing. Like market in-depth market research was something that was absolutely crucial, right, for their launch and is sometimes, you know, underappreciated, right?

And I guess from my experience, I'm not sure if this resonates with you. is I think most folks that have been around a little bit understand the need for market research, but maybe not the level of market research that's really needed to validate something. And so have you seen that across the board, different sort of different layers of market research? And like, how do you? Yeah. We engage, and we're doing it right now. We're investing in surgeon interviews, which can often, well, there are markets,

the key markets that we're aiming to approach and with the surgical specialties that we're looking to engage with. So we've got very specific questions. We've got very specific pathways we need to have clarified. And that effort is really, really worthwhile. So even though we've now effectively launched, we've already, our first sales are coming in, we still haven't stopped with the surgeon interviews and surgeons development because we'll find all. almost certainly, the clinical teams will show us markets that we haven't even thought of. And that happened recently when we, this kind of social media activity around my appointment happened. I was approached by a key professor at a big London hospital and his comments were.

And he was in a surgical specialty in general surgery that we hadn't even considered at this early stage. And he said, Graham, this is exactly what we're looking for. We've been waiting for a device like this. So all of a sudden, the interest from the clinicians drives our focus, and we're now exploring a clinical study with that professor to make sure that we can, number one, prove efficacy, safety, all the normal demands that any MedTech device now has from the regulatory authorities.

We'll make sure we comply with those. So, yeah, that's vital, really, really key. Very good. And on that note, on the top of, kind of of regulatory and clinical kind of pathways. Let's chat a little bit about that because, you know, most of your, you've got, you've got a lot of experience with some innovative, innovative technology, you know, which, you know, oftentimes comes with some regulatory, unique regulatory challenges, right? And clinical data is just, is, you know, a crucial part of that.

So when you think about some of this, you know, early, these new kind of, you know, innovative, early stage sort of med tech products, how do you know, you typically think like Sonsei, right? Sensei's a great example. Like how I know Light Point already had a C.E. Mark, right? And they were, you know, pretty far along. It sounds like with the FDA pathway. But, you know, are there a couple pieces of advice that you can kind of offer up to other, you know, other med tech leaders that are kind of in the same boat and try to figure out kind of what the best approach is, you know, for their regulatory approach for their specific product? Yeah. For sure. I mean, really my strongest advice and my own experience is

don't underestimate the time and effort and finances necessary to get through the current regulatory demands internationally. There isn't a market that's worth approaching now that doesn't have its own unique sets of demands. And so you need to partner with the best notified body you can find and the best clinical research organizations to help you with your clinical data and not underestimating those elements as a key piece of advice I would give to any startup company because, as I said earlier,

evidence-based medicine is the path now. It's what everybody is demanding of every MedTech company. And to get your product to market, you really need to prepare for some significant work even before you can sell a single product. Got it. And when it comes to, you mentioned, you know, the general surgeon, right, that kind of had reached out, you know, when you were appointed CEO of Light Point. And it sounds like he was, you know, he expressed some interest in potentially partnering on some clinical data or some clinical studies. How do you typically manage through that approach when you've got, you know, a strategy that's needed for, you know, maybe a particular regulatory approach? But then you've got, you know, physicians that maybe are, you know, reaching out kind of an in an

bound sort of fashion wanting to collaborate. How do you balance those two? Well, it's really quite exciting when the clinicians approach us like that, because it's a sure sign that you have a winning product on your hand when what's called IIS studies or investigator initiated studies are cropping up all over the place. And we have one, we have Germany, Netherlands, France, Spain, Brazil, Australia. and now London in the UK.

And these are all studies that have started along the path from interest within the clinical community. So they've looked at your product. They can see it can help with their patient pathways and they want to invest their own time, effort and money and doing some research on your product. Now, that's one side of things, which is great. You can support where necessary,

And of course the funding is their responsibility, but there often would be training. There would be necessary kind of technical advice and technical support that we would need to give to those units to make sure that they use the product correctly, that all the necessary standards were in place, etc. But it's very encouraging when IIS activity is underway because it shows, again, that you've got something the surgeons and the clinicians are looking at and thinking, that's interesting. And they're very, very busy people. So you only really get their time these days when you have something of interest to them. But that kind of clinician initiated study, for me,

is the best kind. When you've got your own multi-centre studies underway, you plan the endpoints, you plan what you need to prove as the kind of necessary endpoints to get you. onto the marketplace successfully, but an IIS study could lead you in directions where you really don't know the positive benefits that will show from the activity that comes from their initial interest and their research. So it's the two are kind of side by side. They're hand-in-hand, company-sponsored studies plus the initiated studies, the investigative and initiated studies. Again, all part of the equation these days to get a product to market. You need clinical data.

Hey there, it's Scott. And thanks for listening in so far. The rest of this conversation is only available via our private podcast for MedSider Premium Members. If you're not a premium member yet, you should definitely consider signing up. You'll get full access to the entire library of interviews dating back to 2010. This includes conversations with experts like Renee Ryan, CEO of Kala Health, Nadine Miarid, CEO of CVRX, and so many others. As a premium member, you'll get to join live interviews with these incredible medical device and health technology entrepreneurs. In addition, you'll get a copy of every volume of Medsider mentors at no additional cost. To learn more, head over to MedsiderRadio.com forward slash premium.

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