Recently, Medtronic released a video showing how Pillcam (in partnership with Amazon) will enable home-based colonoscopy screening. Watch Giovanni Di Napoli, President of Medtronic GI sharing that vision.
Naturally, I was curious to find out more and interviewed Giovanni few days ago. In this interview, he walks us through how Pillcam and GI Genius will evolve in the coming years. GI Genius is already approved in Europe and helps endoscopists use AI in detecting polyps. Further, he reflects on whether he sees Cologuard as competition or not and if insurances would mandate payment on adenoma detection rate (ADR).
We also talked about how these developments will change the role of gastroenterologists. Do not miss this one (18+ mins) – get a glimpse into the near-future of GI.
◘ Giovanni’s journey: From a basketball coach to senior executive at a Fortune 500 med-tech company
◘ “Alexa is going to remind you: ‘you’re 45, Happy Birthday, but you should also go for a CRC screening'”
◘ Giovanni on the role of physicians: “AI is going to support the decisions but it won’t be taking the decisions”
◘ “Cologuard is going to detect cancer but PillCam will detect early cancer or pre-cancerous lesions”
◘ “If I’m a gastroenterologist, I will give more attention to beat the machine or be as fast as the machine to identify this lesion”
◘ “I don’t think AI will replace the need for a gastroenterologist. But there will be a performance matrix that you want to hit”
◘ Vision for GI: Do you see PillCam talking to GI Genius?
The Transcribed Interview:
Praveen Suthrum: Giovanni Di Napoli, president of Medtronic Gastrointestinal. Thank you so much for coming on board today. I look forward to our conversation, but first, I want to welcome you.
Giovanni Di Napoli: Thank you very much for having me. I’m looking forward to this conversation as well Praveen.
Praveen Suthrum: Great. Giovanni, you’ve recently been named the president of Medtronic Gastrointestinal, and congratulations on that. So, I wanted to first walk back on your career. I’ve learned that you were a basketball coach once upon a time. So, I wanted to understand how that journey has been? From that point of time to being a senior executive at a Fortune 500 medical devices company.
Giovanni Di Napoli: Yeah, thank you for the question. Actually, I’m very passionate about sports in general, but with a particular interest in basketball. That was my place to be since I was four years old. And I kept playing and playing until I was 15 or 16. And then I started to coach. At the same time, I was finishing my economics degree and the moment I finished my economics degree, I just wanted to check out and see what this would mean for me in terms of a business opportunity, just because I was curious. And I clicked on a link of J&J Medical Ethicon Endo-surgery. I applied for a job in Rome, and they called me. I went for the interview and I fell in love with the vision of the company and what they were doing. Also, my dad is a nurse and so I actually appreciate his work in helping patients throughout my young age. So I felt like, “you know what? I think I like this job and I want to try to give the shot”. I was not looking for a job at all. It just was a coincidence and also my father’s background that pushed me to apply for this. And I’m here now.
Praveen Suthrum: That’s awesome. And let’s talk about that some more. So what is Medtronic up to in gastroenterology?
Giovanni Di Napoli: So a little bit of history here. Covidien, which is the company that Medtronic acquired three years ago, bought a company called Barrx, I’m sure you know this radiofrequency technology to prevent esophageal cancer. And I was working for this company actually at that time. And so, I was acquired by Covidien from Barrx. And clearly, Covidien was going to invest a lot in GI as a space where procedures that could go earlier in the care continuum from surgery. And Barrx was the first acquisition. A couple of years after we acquired Given Imaging. So we acquired scale across the globe because at that time PillCam was already well-established technology in the US and also beyond the US.
With Barrx and the combination of this new technology, we were able to get out from just being one device company at that time with Barrx to become a little bit more present in endoscopy and GI markets. So the long story short is that we kept moving into BD, acquisitions… EndoFlip (Crospon) for example, one more. And now I mean, we are also in a position with this new portfolio that I’m sure today we will touch base upon the video…to be a really strong leader, not only in GI but in endoscopy in general because that’s the goal of the company.
Praveen Suthrum: Excellent. So, Giovanni, let’s talk about that video that you just referred to and that prompted this whole interview. It’s amazing. The vision for PillCam is quite amazing… you talked about a patient receiving or buying it online and receiving it at home maybe and swallowing it like a vitamin capsule. And by the end of the day, getting a notification on a mobile app about whether she has polyps or not. That’s an amazing vision for how screening for polyps can happen compared to what we do today. Can you talk about this a little bit more? And then I have follow-up questions.
Giovanni Di Napoli: So the idea was how can we disrupt this market? One of the things that I always remember when we acquired Given Imaging at the time of the Covidien was the future of PillCam COLON and how this technology could reach millions of patients that today don’t want to go through a colonoscopy and they are not compliant. So we started from there and we understood that the technology as it is today, is not ready for prime time, is not patient-friendly. And it doesn’t allow the GI to be able to really leverage this innovational technology to accelerate diagnoses and also potentially even diagnose more patients in the future. And one of these partnerships that we were able to establish with the teams in Seattle, where we spent a couple of weeks, two and a half years ago, we sat down together with them.
We painted a picture of the perfect world, which is what you saw in the video. I’m home, I’m 45. Alexa is going to remind you that you are 45, Happy Birthday but you should also go for a CRC screening because CRC is the most preventable cancer, but still, the least prevented. So and then we thought why not ship the device at home and just go through this technology like would take a normal capsule, a vitamin pill, and then through AI and through also additional innovation that we are bringing to market it connects this with a gastroenterologist and in case of any positive finding, have the opportunity in the same day to also perform a therapy. So we want to go from start to finish. And that’s the reason why we believe this technology can really impact our patients across the globe. I mean, it’s one more weapon that we have on top of the other screening tests.
So we are currently in development and we are willing to start a pivotal trial early in 2022 where I’m pretty sure we need to go through to get FDA approval. But I would say the work we have done in the last 18 months tells us and tells me also that we are on the right track to stick with the timeline and also with the promises we have with this technology.
Praveen Suthrum: So in this vision, what is the role of the physician?
Giovanni Di Napoli: Oh, it’s critical because AI is going to support decisions, but it won’t be making decisions. So AI is going to provide the most meaningful images and videos to the GI to make a sound decision about that patient eventually the GI is also going to decide whether the patient needs to come for a colonoscopy, a follow-up, or doesn’t need to come for a follow-up. We actually believe this technology is going to enable them to see more patients in the endoscopy suite and treat them earlier in this stage of cancer development.
Praveen Suthrum: So let me ask you a different kind of question here and bring up liquid biopsy and other alternative ways of detecting cancer, which are coming up. So from that standpoint, let’s assume that the vision for liquid biopsy, which is taking a blood test and screening for cancer, does come true. And as we know, the holy grail, there is not to detect just one, but 15 different types of cancers with one sample. So let’s say that does come true then of what your vision is for PillCam would it go along with that or would it compete? Any thoughts that you have there?
Giovanni Di Napoli: I think our position is going to be different than liquid biopsy. Liquid biopsy, as far as I know now can detect cancer or Cologuard can detect cancer. But you know, PillCam Genius is going to detect early cancer or precancerous lesion. So which is where actually the most impactful therapy can be made. So polyps and adenomas. So if liquid biopsy won’t be able to have a high level of sensitivity for these precancerous lesions, I think is going to be positioned in a very different way. Also, if you think about it PillCam Genius would be the only test that can visualize the lesion, could be the only test that can localize the lesion. It could be the only test that can size also the lesion. And I think for endoscopy, being able to see visualize, size, and localize the region is critical if you need to have a follow-up colonoscopy to remove that lesion, I think that our value proposition is going to be different than liquid biopsy.
We respect what they’re doing. I know there is a lot of investment there. I think is going to add that one more component in the armamentarium of tests available for those patients who need to get screened. And I think now with the age going from 50 to 45 eligible for screening, even more patients will need to get screened. So even in terms of capacity, I think we can also be one of the options. Plus, I believe our technology is going to be attractive on the technology side and I think is going to be very patient-friendly and that these also will be, in our opinion, a good plus to have into our technology.
Praveen Suthrum: Very good. Let’s talk about GI Genius now. It has been approved in Europe, and from what I understand, you are going through FDA approval in the US. Can you share a little bit more about GI Genius as a product and what stage is it in right now?
Giovanni Di Napoli: Yes, so we are very proud of GI Genius. We were the first to be in the market with artificial intelligence to have detection during colonoscopy. And the partnership with Cosmo Pharmaceutical in Italy is working really well. So the European approval came last year just before UGW, and we were very happy to be able to showcase our technology. And the technology is ticking off. We have many units already placed in different markets. Clearly, it is not as fast as we were expecting because COVID-19 had a very huge impact. As you know, the number of colonoscopies and patients going to the hospital from last February, especially in Europe, went really down. And this also impacted many opportunities that we were working with our team in Europe.
So I can tell that before the second wave, which happened just a month ago in Europe, things were getting much better. So we are patient, we are focusing on clinical outcomes and we are focusing on a center that actually can also support education. And I don’t know if you know, but also we have partnered with the ESGE, which is the European society in Europe, and we provide a very important grant for clinical investment on the AI during colonoscopy, I think is about 1.5 million dollars investment. And also we are going to provide the technology to generate this data, especially these days because going for a colonoscopy is very important, can prevent cancer. So we hope this will accelerate the recovery of the backlog.
Praveen Suthrum: So let’s talk a little bit about the gastroenterologist’s private practice standpoint. So they rely on reimbursement from insurance, now with the technology like AI in the endoscopy room coming, their ability or people using the technology, their ability to detect polyps goes up because the AI is going to help them do that. But there are several people out there who may not adapt soon enough and then maybe using old technology. So do you see at some point insurances mandating a certain base level of Adenoma Detection Rate so that endoscopists do not have a choice but to advance in the use of technology? Do these conversations come up in your discussions internally?
Giovanni Di Napoli: Yeah, I think you got the point. I mean, GI Genius and AI in general for colonoscopy is going to have gastroenterologists to be somehow more precise where it actually is not possible to be precise. You know, I always make this analogy. Do you want to be patient number one of 15 that day or you want to be the last one to be seen by the gastroenterologist? I’m sure, you know, fatigue plays an important role in detection. If you have AI technology helping you throughout the day, you can keep your level of performance the same. And I think this is also shown by multiple studies. And I think this has to be taken into account also for payors as well as from society.
I know there is a task force looking at the ADR, and if this is going to be possible to be over a certain percentage. I think with AI it is going to be possible. If the insurance is going to pay on top of what they are already paying, I don’t know yet. I think I also see a future where also patients can have ask. And not because I don’t trust the gastroenterologist because he or she will make the final decision. But again, performance is going to be critical. And you want to get the performance anywhere in the US in any place you go for a colonoscopy. And I think these technologies will help to get there.
Praveen Suthrum: If you examine how technology moves, let’s take the example of Google Maps as an app, or let’s take the example of Siri or Netflix. At the early stages of these technologies, I remember clearly when I used to drive before how much I used to the member streets and how less I remember now or my need to remember streets has steadily declined. So I’m wondering if all of this will get to the point where the endoscopist will be completely guided by the AI? You know, if we advance forward enough, will we reach a point where the AI is going to do pretty much handhold and guide the endoscopists on what he or she needs to do?
Giovanni Di Napoli: You know, I actually see this on the opposite side, If I’m a gastroenterologist supported by artificial intelligence, GI Genius in this case, during my procedure, I’m actually going to pay more attention to somehow beat the machine or be as fast as the machine to identify the lesion. And I was in a couple of cases in the UK last year when we launched the device, and I could tell that the feedback was, “Oh my God, I want to be faster. This is going to give so much training opportunity for our GI fellows because they will learn quicker.” So I think if you know how to utilize it, the technology is going to improve your performance and keep it stable.
I don’t think AI going to replace the need for a gastroenterologist and an endoscopist to perform colonoscopy. Not at all. But yes, for sure there would be performance metrics that you want to hit. And if the performance metric is to find a certain amount of polyps in 10 patients, you want to be at that standard. It’s almost like a benchmark. And so I think it’s going to give you more motivation to stay attentive, to stay focused during the procedure together with the machine. So that’s the way we see AI working, especially in colonoscopy.
Praveen Suthrum: Do you work with the insurance industry at all related to the financial aspects of the technology that you launch?
Giovanni Di Napoli: Yes, we do. And our leader is working very close to them to understand also needs and opportunities.
Praveen Suthrum: Giovanni, my final question, trying to connect all these dots is do you see PillCam talking to GI Genius internally? And if you have to fast forward five years or even beyond, what are we going to see? What is the vision for GI?
Giovanni Di Napoli: So we have technologies in our portfolio that can be genius powered, which means we’re going to offer more and more solutions to our customers with artificial intelligence. GI Genius is the first of this solution. You mentioned, are we going to be able to connect the dots with GI Genius and PillCam? I would say the answer is yes. There are multiple solutions. Think about EndoFlip for Motility disorders. Think about Manometry. Think about pH impedance and all of these technologies that can be Genius powered. And we have a huge investment in place with over 30 plus engineers in Israel. And also the partnership with Cosmo is really strategic and important. So we believe that we can go faster and we can bring disruptive innovation, genius powered into the Endo-suite.
Praveen Suthrum: And from the lens of an endoscopist or a gastroenterologist, how would that vision play out? What would they be doing differently five years from now?
Giovanni Di Napoli: I would say data is going to support the decisions. And I also would say that we’ve simplified the workload of our customers in order to be able to perform more procedures on the same day and see more patients and prevent more cancer.
Praveen Suthrum: Giovanni, thank you so much for spending time today and sharing what Medtronic is up to in the space of GI. Was there anything else that you wanted to share before we close?
Giovanni Di Napoli: No, thank you very much. And I’m very happy to be in this business. I promise Medtronic is in GI to stay and also to invest. And you will see more and more coming from our company.
Praveen Suthrum: Thank you so much. Giovanni.
Giovanni Di Napoli: Thank you.
By Praveen Suthrum, President & Co-Founder, NextServices.