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Hopefully you'll enjoy the rest of the day. Uh And it's my absolute pleasure to be able to hand you over to um Professor Tony Young now, um who will be coming on on the screen in a second. Here we go. We have our next session speakers. Um He is a consultant urologist and uh he is also the National Clinical Director for Innovation at NHS England and many, many other hats. So I'll, I'll hand you over to him. Thank you. Great. Thank you so much, Emma. I just wanna check how long uh you want me to speak for 10 minutes, I think. Yeah, 10 minutes is great. You tell me how long? So, hello, uh how great to be here. Do you know the most innovative thing? I'm, I'm not gonna use any tech or slides. The most innovative thing in history are human beings. We're wonderful. We've been evolving for tens of millions of years. So that's what you're gonna get because, you know, for the next two days you're gonna see everything, aren't you? You've just heard it, you're gonna see all the robots in the A I and you didn't hear about drones I might tell you about a little bit. I know a whole load of other things. So we'll talk about that. So look, let's get started, shall we? Uh So my name is Tony Young. Um And I didn't know what I was going to call this talk and I thought about, and do you know it's been one busy week. It's just been crazy. Um So I was thinking about this on the train home on the way last night and the asset wanted a prerecord. There's just no time in the diary for me to give you some prerecord. So you're just gonna get it with the errors in now. But that's life, isn't it? It's full of errors and that's what we do with them. So, you know the question I ask people most commonly is, what do you want to do with your life? But the second thing I thought I might call this talk is don't believe the hype. So let's see how I get round to answering those two, shall we? Um So first of all, her am I? So I'm very young. I'm still a practicing consultant, neurological surgeon in South End on Sea. I'm associate medical director responsible for innovation, research, transformation, digital commercial procurement and or strategy. That's the other one at in South Essex Foundation Trust chair and director of Innovation and entrepreneurship at Anglia Ruskin University. And for the now in year 11, I'm the National Clinical Director or National Clinical Lead for innovation for the health Service in England. So a clinician who's been put in a leadership role for a whole nation's healthcare innovation. It is exciting and exhilarating and exhausting in the se and I get to meet the most amazing, amazing people, er, which give me hope in the future of surgery, in the future of healthcare and in the future of our wonderful National Health Service. So look when I started training, um as all you were doing, um I didn't think about what I wanted to do with my life because I have been told I was training to be essentially like a AAA soloist in a concert orchestra. I was gonna do one thing and I was gonna do it really well for the whole of my life, I was gonna be an expert at it. It was gonna be that one operation, that one. In fact, I do about three operations now, but I was trained to do about 60 different ones. Um And then while I was a trainee, like many of you are, I decided I wanted to transform people's healthcare through innovation and entrepreneurship and started my first business. Um I founded four companies, raised 5 million lbs and this is so I'm old now. So this is like 20 plus years ago. Um And I realized that I had to learn loads of new skills. And you heard from Matt a while a moment ago, didn't you about what you're gonna start hearing about all those things from other entrepreneurs and trainees and things. And so actually just being able to do one thing which is operate really well and look after patients and understand what's going on with them. Wasn't enough. I had to stand, understand about the commercial aspects, how to raise finance, about corporate governance, about regulatory and legal and branding and marketing and building teams and running a company. Nothing and no surgical training prepared me for that. Um And so I learned through failing and boy did I fail a lot. And then 11 years ago when um sir Bruce Ke, the national medical director and former cardiothoracic surgeon himself approached me and said, Tony, will you take on this new job at NHS England, a National Clinical Director for Innovation? I said, well, what do you want me to do? And he said, well, we want you to get the latest, greatest things taken up across our nation, grow the life, science economy in the UK, you'll become our senior clinical adviser on healthcare and life science innovation, not just at NHS England, but across other bits of government arm's length bodies, public sector, private sector and foreign governments that come and see us around healthcare and life science innovation. Um And we just want you to make England and the NHS the go to place for health care innovation on the planet, but you have no money and no power off, you go and see what you can do. Wow. So lots of blessing and air cover. And do you know one of the greatest things I could say that you can do in your lives is find an amazing mentor, a backer and someone who will help you live a fulfilled life and deliver your dreams. So that's kind of what do you want to do with your life? You know, you think, oh, I want to train to be a consultant or attending physician or whatever it is you can earn. I'm gonna go into this actually, that's just a component of fulfillment. There are many facets of your life. So look at what aligns with your values in life, what you really want to do and I'm gonna talk about that in a little bit as well and align with it and be fulfilled. And if you're fulfilled, you'll have a long, happy, hopefully wonderful career and life and you'll do remarkable things too common, isn't it? For trainees to feel exhausted and burnt out and overwhelmed? Well, if you're aligned with your values and you're living a fulfilled life through what you do, it's quite remarkable. You can be anyone from anywhere and you can change the world. So let's crack on. Um And so I've changed, I'm no longer a soloist. I kind of turned into a one man band playing lots of instruments for a while running a business. It's just, it makes a different sound from a soloist, but it makes sound nonetheless. And now at NHS England it's a bit like becoming the conductor of an orchestra. You work with loads of different people trying to coordinate them and bring them together and make it work. And it's kind of the greatest joy in my life. Well, there are lots of great joys in life to be fair. Right. What's innovation? Lots of people talk about it and they don't quite get it right. Um, because it's not invention, everyone thinks it is. No, no, no, it's not. It's gotta be new novel to your system. It's got to add, add value. It's got a scale across the system. It's got to empower patients, er, or the workforce or leadership and management and it's gotta have synergy, the components when they're added together are more than their parts. Um, and if you look at any innovation, they've got all those five features. Uh and then what scales, you know, we've seen lots of it and, you know, you're gonna see everything, aren't you? You're gonna a, I are gonna replace you. Did you know that? Don't believe it for a moment. What rubbish. I have great confidence. The surgeons will still be here for me. I've seen under the bonnets of all the big tech companies and what they're doing. Now, let me tell you your jobs are safe quite who wants that. I mean, I, do you see that little stitching video I did a moment ago. I mean, it's taken 16 years to move forward. And that crikey, I can't tell you how many thousands of people I've stitched up in that time. I'm not letting any of those robots anywhere near me and neither of my patients in Essex, neither should you. I'm not saying it won't happen one day that happened in the last six days. So I used to have a boss who called Tim Ferris. Now that's not. You all think Tim Ferris. Oh, the four hour body? No, he ran Harvard the mass gen um er PS, a different one, a great professor over there. Our primary care specialist, actually, he's spent three years on the board of NHS England being our transformation director. And he said, Tony, do you know I've seen five things that innovations have that get taken up nationally by the NHS. First of all, they have to meet a national priority. Secondly, they have to be slippery. They just have to work their way in, easily into a care pathway. Thirdly, it must reduce steps in the care pathway falsely, it must reduce cash in year. And I think that's true in any um health economy in the world. And the last one is, it must have real world evidence to support it being taken up. And if you look at anything that has scaled nationally, you're gonna hear of loads of state, you're gonna hear about robotics, you're gonna hear about digitization of paper processes and all those sorts of things you can hear. Well, if they're gonna scale Ashley, they will have those five features. I have looked at everything that is scaled nationally in the NHS. Not one doesn't have all those five. Quite remarkable, quite remarkable. So there are some features we can see. So why is this important at the moment? Why should you be innovating and doing all those things? Ok. So our new government have come in and said what we've always known three core things. Why it's important that we need to get serious about a, we need to move from disease to prevention. We know that it's true. Look at the screening programs and all the other things, the early interventions we want to do in surgery, we absolutely have to do that. We want to move from hospital to the community. That is the direction of care, personalized health care. We don't wanna wait until you're absolutely at the end stage of your disease. And we have to do some enormous operation, cutting your body. We don't wanna do that. We want to get there early and we want you to be treated at home in the community. I think you're gonna see quite a few examples coming through over the next two days where that kind of trend is happening. And then the third big move is we have to move from analog to digital. It is absolutely gonna be mission critical, the NHS app we're rolling out and actually you're gonna see huge changes happening in that we are going to do the NHS app by default. There's no way around it. It's gonna be safer, it's gonna be better, it's gonna be loads of sharing. Right. I have no idea. Often time. So, Matt, you just interrupt me cos I'm gonna keep going on a roll in case. Um, er, I, er, run over just er, er, you can be polite or just direct, be surgical and be direct. Tell you've had your time. It's over, right. So what are the challenges we face? We face a whole lot of challenges in the NHS first seek to understand if you want to be a leader in healthcare and a leader in innovation, don't go and tell everyone how to do it, go and understand what their problems is, wear their shoes, find out what's going on with them nationally. We have a crisis, 10% vacancy rate. We have 7 million people on and awaiting this. So we need to reboot and recover health inequalities laid bare by the pandemic. Net zero. The planet is on fire. We've got to sort out the NHS contributes 4% to our nation's carbon dioxide emissions, financial balance. You hear it all the time on the news and in the media, healthcare is costing more and more. We need to do different things. We need to be more productive and do them differently. I mean, the last thing is what I call the long term plan. How do we get serious about those three key things? I said, you know, prevention, moving into the community and all those things. So you're gonna look at that nationally. You can even look down at your region where you are, there'll be different health priorities. But for trainees in our nation, if you look at the last GMC survey, which looked at them, it wasn't Rosie. It really is not happy reading. What did they say? And key issues for them were wellbeing discrimination at work development opportunities. Weren't there? Rosters were issues pay. Hopefully that one's been sorted out now. But key things, flexibility, autonomy, respect and influence. Wow. When did we lose that in training? Huh. It's an easy thing to give and that comes from leadership. That's why I'm a surgical leader in the center because we wanna get you that back. And can I do it on my own? No way. Can we do it together? Yeah. Why do you think even though I had no time I come to asset to speak this longer because I need you to come on that journey we've addressed in so many ways. I haven't got time to go through it all. Now, flexible portfolio training scheme have a look at it. We've got it over the line. I never believe we would do it. NHS England will pay one day a week for any trainee in our country who applies for it. I mean, you're gonna have to go through a process, but at least you can do it to do innovation and entrepreneurship in your, your training and it won't lengthen your training. Did you ever think that would happen? No, I didn't. We got it over the line. God, it's taking me years to do that, but it's there now. How amazing. And then the clinical entrepreneur program. Well, I could talk about that for a long time. The world's largest entrepreneurial workforce development program in healthcare that gives you a commercial coach and mentor. You've got three of them. Speaking here, you got Mark Slack, you've got Mike Cullen, you've got V Varani on your list today. I saw them earlier. So you're gonna hit, I don't need to tell you about the mentoring. Um Great days where we you connections to customers and funding and testing and trialing and great networking events and a whole range of other things. And I was gonna give you some great examples of our entrepreneurs. But actually I'm gonna say two things. Number one is read The Times in the newspaper this week, four clinical entrepreneurs on and then ap and our drone logistics company on Wednesday in the Times and all over the national news or the first example in the world of autonomous drones that's controlled by A I flying between two major hospitals in a capital city, delivering blood products and uh and pathology samples between the two sites between guys and ST Thomas's only 10 flights a day at the moment. There'll be 600. So it will be in drones line above London. Wow, who have first in the world and we did it in the National Health Service, but I could talk about all this. But actually, you've got Nadine has, has Haram Ceo approximately one of our year one clinical entrepreneurs. You got Grant Nolan from year four or five, I think with his, my op notes, what a great little thing. He's like he's, oh, that guy's on fire. You can't stop him. Re the big year two. I met him in year 10, he was so confident surgical training. I'm gonna change the world. Do I persuaded him to come on the program? What an absolute superstar. That guy is the most disruptive um surgical simulation company on the planet. And the biggest one now, I think. Absolutely amazing. And then you've got Ryan Kerstein who was one of our year one entrepreneurs who left to go to the consulting industry, who wanted to go and be a management consultant. Have you see? It's horrible. Why would you want to do that? Have all your lifestyle though? I shouldn't say that. Don't broadcast that. I didn't say have all your lifestyle to tell you. That's not true. Just the people I've met that they've all left cos they couldn't stand it. And do you know Ryan came back to surgery? He, the clinical entrepreneur program opened the way back, come and fulfill your dreams, come and have that integrity, that autonomy be fulfilled, make the difference you want to make. Isn't that why you came into surgery in healthcare? So what do I want from? I, what do you want from me? You can ask me any questions you like connect with me on linkedin. Tell me what you want. I'll try and help what I want from you. I can't do this on my own. NHS England can't do this on our own. We want to work with you. We want to empower you. We want to transform patient care patients at the heart of everything we do. We want them to have excellent care. We want them to have diagnosis and treatment earlier to prevent illness from happening in the first place. So we need to facilitate that. So I'm delighted to work with the Royal College of Surgeons with asset with anyone who will come along on this day. It won't be easy. You're gonna have to get out of your seats and roll your sleeves up and put a whole load of effort in. But that's what I've been doing for the last 30 years. Exhausting, exhilarating, wonderful the number of patients whose lives through the work we've done at who are transformed, the number of people who are alive, who still have a mum or a dad or a granny or a granddad or a brother or a sister or a partner because of innovation and what we have done at NHS England. Quite remarkable. And, you know, we can change the world. I think it's 10 minutes. Is that enough? Amazing. Thank you so much, inspirational, brilliant talk. As always, Professor Young. Thank you. Um I think we, I'm gonna give you one quick question. Um No questions. I don't do political questions in case you've got one of those, keep them. It's not political, it's not political. Um If you had to give one piece of advice for a junior doctor with an idea for innovation, what would it be? Oh, easy join the clinical on for an hour program. That's it. That's how you put to say that. Brilliant. Thank you so much. Amazing. Have a great day and a great and reach out to me on linkedin. I'll help you in any way. I joined the Clinical Entrepreneur program. I'm amazed we had 1100 trainees supply this year who would have believed it? Amazing. Great to see you. Good luck with everything. Thank you so much. Brilliant. Um So I'm delighted to be able to uh invite our next uh speaker up. Um So we've got Professor Jane Blais who is a professor of Surgery at University of Bristol and has been uh uh one of the the biggest leaders in the field of evaluation of surgical innovations and involved in the ideal collaborative, which I'm sure she'll talk about as part of our talk. Um So we'd like to have you on board Jane. Thank you. Good morning. I'm going to be talking to you about the need for incremental evaluation of innovative surgical procedures, the ideal framework. And when I say more, I'm going to be talking about the need for some better ways of doing this to improve things for patients and for surgeons and for the NHS my conflicts of interest in this area are that a long time ago, I was part of that original group that developed the ideal framework in that beautiful day in college in Oxford. It was an amazing experience. So the structure of this talk is that I will briefly describe the framework to you. I will talk a little bit about the challenges of using it and I'm going to use that to justify the need for better regulation of surgical innovation. And I think it will be by bringing in better regulation that we will be able to support better evaluation of innovation and better learning, which will be incremental. So I'll be talking a bit about the current guidance and the way it needs to change for the future. So here you go, you'll be very familiar with this table published in the lancet in 2009 and updated in the surgery. 10 years later, it describes the first in human ideal stage. One, it describes two A and two B where you have a slight changes in the procedure. Expert surgeons widen their learning with other surgeons might inr learn about the safety but also start measuring other types of outcomes, the the feasibility of doing a decent randomized trials in the field, which would be a stage three B comparative study and those three things are done as research. And then beyond that, we have the later evaluation of new procedures in the context of National audit or in registries. When you look at the long term outcomes and the long term adverse events, so it is theoretically very useful but it is very challenging to use. And there are many papers that say that but just three from Bristol one where Natalie with a group of people looked at the quality of reporting of robotic assisted cholecystectomy using the ideal recommendations. Found that few of the studies had a written protocol. Few of them described the innovative procedure, how it would be done and how it then improved. A few of them described how the outcomes changed over time as the procedure went through the phased evaluation. We look very specifically at this procedure called a Laro endoscopic method for excising benign chronic polyps. Only 11 papers you'd expect first in human then a kind of smaller case series and then the larger one and then a comparative study, it just wasn't like that at all. It was all over the place. There was no incremental evaluation of this procedure. It was as if somebody did a study without looking what anyone else had wished about it beforehand. And then more recently, we looked to see in papers that had actually labeled themselves as using the ideal framework. We looked to see how they defined their innovation under evaluation and applied, which stage of the framework was relevant to that innovation according to their definitions. And it was very difficult for people to even define the different stages of innovation. So whilst you might think, oh ideal is not valuable, I disagree. Innovation is incredibly important. Things have changed so much over the last 20 years since I've been, you know, 30 years since I was a medical student. It's incredibly important. But the reason why we need a framework around innovation is because of this. It's because everything that we do that's innovative is inherently troubled by the huge amount of bias related to the optimism of the innovator that new is undoubtedly thought to be better, but that's not necessarily the case. So something new can be difficult to define. You might think it could be the whole new procedure. It could be part of a procedure. Just the access, it could be a device that's modified. It could be that a standard procedure is then taken to a different patient group, adults to Children and that's new for the Children. It could be a first in human or first in the UK or first in your own hostel or the first time you've done it yourself, all those things are different ways of defining you. And consecutively, it's really interesting, but that's not helpful. Actually, when it comes to working out what's needed to make innovation better, because this ontological approach just ends up tying you a knot. And what we need to do in terms of our thinking is think indexical, indexical thinking, as opposed to ontological thinking focuses on the context in which the innovation is occurring. And the impact of that innovation is very practical and working with philosophers. We've written a nice little paper about this. What's really needed to understand about innovation to make it indexical, to make it deliverable within a context ie surgery in the NHS. It's a good read. And there are three things when we consider innovation as an indexical issue, three things. So one is, there's no innovation without risk. So Ben Brown says there's no innovation and creativity without failure, there's always a risk of that needs to be managed. The next one is there's no innovation, no decision about me without me, patient consent needs to be really sorted. So patients get the option whether or not to have an innovative procedure and then finally, no innovation with that evaluation. So learning from innovation needs to be shared. If one surgeon learns something, if I do something innovative, it doesn't go well, I learn from that, but I need to share it so that the same mistake isn't repeated in Bristol Birmingham of Belfast and four patients harmed. So when I learn, I need to share it so that that prevents further harm. So three things matter in terms of the index way of thinking about innovation in context. What are the risks known and unknown? What are patients told? How is consent carried out and what is learned and how is that shared? And if we can manage those things, we can innovate. Well, I believe, but we can't do that on our own. And so we need supporting in the form of the regulation of innovation. And if we support these things, well, I genuinely believe it will make innovation safer transparent, more ethical and most importantly, it'll make it more efficient, more rapid due to the rapid evidence generation sharing. Imagine that if we had an NHS in which surgical innovation was safer, more transparent and efficient. So what are the regulatory options that we have now around surgical elevation and who decides what's needed? Perhaps more importantly, when you look at the little ideal framework there in that corner, that row that I've highlighted with the arrow shows what regulation is recommended and just about all of them say within the context of research. So research regulatory approvals debatable. So you could say, well, how much of the innovation that goes on in the NHS actually takes place within a research study? And the answer is very little. It's uncommon when you look at publications reporting innovation, they don't very often report having engaged for IRS or, or um IRB approval in the state. When we look at the grants that are funded from bodies such as the MRC or the NIH R that fund early phase studies, very few of them are in surgery. They're mostly in pharmaceuticals. And when you look at early phase studies being delivered in the NIH R through their research delivery network, and you categorize them by stage of innovation, of all the studies that are meant to be delivered by the early phase of support. 97% of those studies are pharmaceutical, hardly any in surgery. And that's because most surgical innovation is coming out with a research framework. It's not within a research setting. So who decides, well as the the clinician themselves can decide just to do the innovation. Still, it's the land might call that under the radar or come back to that. Or you can apply to a new procedure committee with local clinical effectiveness committees run by the NHS Trusts or you can notify nice and nice can give guidance about regulation of innovation or just go straight to ethics themselves. How you know what are the pros and cons of these different groups. But in terms of innovating and the rater I really don't recommend it. There is very little to protect anybody in this situation. The informed consent is compromised. Because there's no specific peer review of any written information, you don't know what is told to the patient, the decisions about what is done on who and why are not recorded in the form of a protocol. And there's no reason why the outcomes be shared would be shared. So harm could be repeated and there's just the risk of litigation and surge and misery. And there's numerous cases of this. We, we are familiar with the vaginal mesh, the tracheal transplants, the metal or metal hip replacements innovation, surgical innovation under the radar really needs to stop. What about informing the new procedures committees or as they might be called the technology committees or the clinical effectiveness committees? Well, these seem like they have potential um potentially some value um before I come on to the hra so we've done a study called the Introduce Study which has really investigated New Procedures Committee in some detail. I think we're the first group that have thrown light on their practices and procedures and we collated all their policies in England and Wales. Then we approached all these trusts and we managed to get hold of 100 and 13 rather lengthy documents. And we scrutinized those with a systematic approach to find out what they were saying about the regulatory recommendations for surgery accumulation. What we found were large inconsistencies between hospitals and within them and some conflicting advice. The sort of advice that was given were things like you can have this new procedure approved with local approvals alone if more evidence is required. So if there's not enough evidence to show it's effective, we can approve it or if there's an economic impact, a few of them said they could prove it. Six of them. Ok. It's a small number, but six of them said they would approve a procedure that was first in human first, anywhere in the world, they would be happy to approve it. 88 of them said they would approve procedures that were being conducted for the first time in that hospital, which sounds sensible. But what we went on to say when we looked at those um those 88 there, first time in the hospital, you look at the star, they didn't say what other information is needed about the use of that procedure elsewhere. So if it was established elsewhere with good evidence, it would make sense for them to approve it in the hospital. But very few of them mentioned what level of evidence was required from elsewhere prior to its use in the hospital. And just to go back to the six that said they would be prepared to approve first in human procedures. The first time they have been done anywhere, another seven policies said, oh no, they must definitely go to research this as an example of the conflicting guidance. We also studied five hospitals. We studied these five new procedure committees prospectively to see how they made decisions and whether or not they notified things to nice. So over a 12 month period, five hospitals, there were 38 new procedures being considered and it was really interesting. So of those 38 new procedures, 17, just over half had no national guidance for recommendations for regulation and they followed those. But that meant there were 21 new procedures without guidance, 21 brand new procedures, no guidance for their regulation. And basically all of those were approved to set three by the hospitals. They acted like effectively like nice or like a research ethics committee and only two of the 21 were referred, notified to. Nice. In theory, all of them, all 21 would have been notified to nice for nice to decide what was the appropriate regulation. So these new procedures committees are acting inconsistently and fairly independently. It's all published those papers which show these problems. We also looked at the quality of what they said patients should, information, patients should receive brand new procedures. And we looked at um what those policies said about safety reporting procedures and um the standards weren't great. So then we come on to. So I've put some black uh some red crosses. I would not recommend you to new procedures under the radar. I wouldn't, I think new procedures committees have room for improvement. However nice. On the other hand, is a very different kettle of fish and it's what the system at present is that if one is doing a new procedure, one is recommended to inform notify. Nice. If there's no nice guidance available, it's very straightforward. There's a one page document on the web where you put the details of the procedure on it. And they're nice. The first thing they need to do is to decide whether or not to develop the full guidance for that procedure or they might come back to you and say it's ok. It's just a minor modification of existing practice. Please get on with it. Now, if nice do that centrally and they are very well constituted with expert uh systematic reviewers to look at the literature, patient and public involvement, professional advice provided by the Royal Colleges or by clinical experts. They're good at making that decision. They have the funding and the time and if they say you can just do it, then what we want in the future is they would tell that to everyone across the country. So there's some equity about the decision processes, but they may say, oh, we're not sure we need to look at, we need to go down the whole process and develop full guidance. If nice decide that full guidance is needed, it takes 41 weeks, nearly nine months. And in the meantime, while waiting for the full guidance to come through, it's now recommended that the procedure is only performed within a research setting or not at all, just wait for the guidance and the guidance will then make the recommendation for the right regulation. But nice IPA who make these decisions are essentially expert in their experience and they're funded with the time and the personnel to make good decisions. And I think that's what we need to do. We need to strengthen that system. If I do make a full guidance about regulation, these are the options. They might say after 41 weeks, they might say no, you do need to do this in research only. They might say it can be delivered with special arrangements. I enhanced consent and enhanced outcome monitoring. They might say it's fine to deliver it in clinical practice or they may say no, don't do it at all. But that guidance is published. It's on the web and it's been very carefully thought about. So nice, gets the thumbs up and if nice say to do it in research, then the arrow goes to the HRA logo and if nice do it, I would recommend that II advise that we follow that advice is innovated in the context of research. It is transparent and that is the benefit. So it's clear what is written will happen, why it's being done. The patient information is clear and the risk or the unknown risks. The the choice of standard care, the reporting guidelines and the adverse event reporting are there. And also there may be independent oversight and advice about when to stop the procedure. So there's yes, there's paperwork. Yes, there's some red tape, but it's well regulated and it's transparent and safe. So the nice process for a clinician innovator screen top left for how they may go through the process of deciding whether to follow nice guidance or notifying. This is now summarized on their website. I've talked that through in the last few minutes and this is the updated process and whilst it's been updated, I don't think it's particularly well used or implemented. And there does need to be this approach. So we get incremental, gaining of evidence and the same mistakes are not made everywhere. We do need to consider the risks that are known and unknown about new procedures. We do need to give patients full informed consent and some patients may not want to undergo that new procedure. They may want to have the tried and tested and the standard treatment, they need to be allowed to make that choice and outcomes and adverse events that are accumulating from new procedures. If they're shared, there can be shared learning and incremental evidence accumulating. So we can know when to stop a procedure, when to abandon it, when to pause it, modify it or to proceed to wide scale adoption, make those decisions efficient. Um I've come back to that one. That can't be right. So I think there are big steps. We've created the new process, we've updated it, we're beginning to get it launched if you like and talked about and understood. But there are huge steps, large steps that we need to make as a community. We do need to change the culture and the practice of surgical innovation. We do need to make it safe and transparent and rapid and we need to work together to do that. Not just surgeon innovators in isolation, but the regulators and the and the methodologist, in fact, to get the right methods so that we can incrementally evaluate things and um inform the standard of care. So thank you very much for listening. I say thank you to all these people who have contributed to many of these projects. I'll be very pleased to take some questions. Brilliant. Uh Thanks so much like a phenomenal talk just, just showing the, the I guess pathway of innovation and just, I guess some of the, um you know, how to better regulate things around this to make sure that patients remain um safe. Um II guess I'll maybe start with the question and, and if wants to add any questions in the, the me chat, um we'll see if we can address them, but II guess it was sort of concerning the variation between hostels that I guess you could have showed there. Um I, I'd just be interested to know, did you get a sense of maybe why that was happening? And I guess, has there been an opportunity for that to be fed back to them and for them to, I guess, reflect on, on that kind of situation, the way the new procedure committees act independently, I think has grown up from the traditional way that surgeons have just innovated under the radar. And now they're sort of innovating within the hospital rad under the hospital radar. There's still a problem of it being not very well thought through, but in the five hospitals that we worked with over that 12 months, we had regular meetings with them and we absolutely fed back to them. And I think they all found it incredibly helpful. There are examples of in innovations that were discussed independently during that 12 months. The same innovation being done in two hospitals, they both made completely different decisions about the regulation. And when we subsequently shared it to them, they were fascinated, they wanted to know why and they definitely benefited from it. I think the the difficulty is the business of notifying nice. It's not, the process is not difficult, but the way that nice respond is almost incomprehensible. And they need nice need to sort of learn to speak plain English and to reply efficiently and make it clear what's going on. So we're equally working with nice in, in in some depth, to uh to strengthen their systems and to optimize how, how the communications occur. But the whole launching of that new updated process is gonna happen over the next year or two years as we try and get some more projects up and going around this area. Brilliant. Um, I suppose just we'll wait for any other questions from the, the audience. Um, I, II guess from your kind of perspective, what, what tend to be the sort of common pitfalls that people might come across in the sort of, I guess maybe that more early stage of surgical innovation and, you know, particularly for, for kind of trainees, you know, have you got any advice for, you know, how we can potentially avoid that? I think the, the big thing is in surgery we've done brilliantly over the last 20 years to sort out randomized trials. There's no doubt we're very good at them now and trainees get it, they're involved. Brilliant. We've kind of, we've definitely gone from comic opera to, you know, sort of symphony standards in RCT S, but it's the, how to, how on earth do we do the early phase stuff? How do we evaluate innovation? We don't actually know and trainees definitely don't know. There are no courses, there are a few role models, there are just these crazy innovators if you like that, don't that do do it under the radar? So what we're doing and we just had funded is um we are bringing together surge and innovators in biomedical research centers across the country. There are 20 biomedical research centers, 13 of them are involved in this project with a new translational research, collaborative and one of the pieces of work is to develop a training um course for trainees and how to do evaluate ethically scientifically and efficiently um early phase innovation. So that will be launched next year. And we also hope to modify the API scheme, the Associate Principal investigator scheme for early phase studies working with the NIH R cos at the moment, it all focuses on the later phase. So there really is gonna be opportunities for mentoring, for training and for api schemes for practically apprenticeship skills in early early phase evaluation and, and and do get in touch about that. We're keen to work with more trainees on that, right? And maybe just last question just to finish up. Um uh I think there is a question we had from the audience around how much innovation, you know, have, have you got a sense of how much innovation does occur under the radar? Um Or is that one of those sort of unknown unknowns? It is a bit of an unknown unknown. I think that the only way you can measure it is first of all, the new procedures, committees, have we in our monitoring of their decisions, that was their decisions, but we also tried to get them to record their corridor conversations. So there's the element of surgeons chatting to the chair of the new procedures. Oh or, or there's often the procedures, committees are led by anesthetist and literally they're in theater and they go 00, what's this you're doing? And that sort of thing and the other way you can tap on it is through the procurement departments when surgeons start ordering you kit and then someone goes, oh, what's this for? And then it all gets sort of. So I think there's still a lot um there's things that get published without any ethics approval, without new procedures, committee approval, show you that what that did go under the radar, but obviously so much doesn't get published. Uh I mean, I think it says wearing a out still brilliant, thanks so much. Um I think uh we might move on to the newer speaker. So I think Roberta, I think you're I see. Oh yeah. So I'm very happy to introduce our next speaker, which is Doctor Mark. Um He is um gynecological surgeon by training. Um but is probably better known to most of you as the co-founder and current Chief Medical Officer of CMR Surgical. And I'm sure a CMR Surgical does not need much of an introduction to all of you, well known company at the forefront of surgical innovation and also innovating with innovation by innovating robotic surgery. And really, um we also want to say a big thank you to CMR Surgical because they've been so committed to supporting really the next generation of surgical innovators and being great supporter of asset as well uh providing kind of um unwavering support. And um so it is a great pleasure um to listen to your presentation for our audience to also um have a listen to your presentation and get to know all of your expertise. So, thank you very much. Uh Good morning everybody. Um I'm Mark Slack co-founder and Chief Medical Officer of Cr Surgical. And it's an absolute pleasure to be presenting today to your Innovation um summit. As you know, we work very closely with asset over the last few years and um love the work that you're doing. Um This is a taped um presentation to make absolutely sure that you got it on the day. Um But I will be um waiting after the presentation to take any live questions um that you might have, I have a standard um declaration conflict of interest. I was previously an academic in Cambridge. Um I have a few companies that I'm director of and I sit in the Life Science Council of the University. So this is the versus of CMR robot and started in 2014 as an idea between five of us and developed through up and into. And there are beautiful looking robot you see now on the right hand side, the robot was modeled on the human arm. This is completely different from all other robotic systems which enables it to hold the instruments end on and therefore, gives a better reach greater variability without needing an enormous size to achieve that. And you can see in this picture the size that we have achieved. So around a patient, it's no higher than about 5 ft seven inches and has small bases. It is mobile, it is modular um and it enables the replication of laparoscopic surgery with the same port positions and the same procedural steps, which we think is a real advantage. The company has had a relatively meteoric rise from the start. In 2014, we went live in humans in 2019 and we progressed through a series of trials and experiments to the point that we now have um regulatory approval to do thoracic surgery, colorectal surgery, upper gi um gynecology, urology. And we are currently running clinical trials in transoral robotic surgery and in pediatric surgery. So, very excited about the program, the company has raised a lot of money to develop because these are very complicated, very expensive bits of kit. And um we went um with one of the biggest um raises ever in the history of med tech in 2021. But what about innovation? Because that's what you asked me to speak about. What are the characteristics of an innovator and you can read for these and I won't go through them all again, but you really have to have an open mind as an innovator. You've always got to be on the lookout um for something that might be able to be done um better, you must be willing to be lonely and on your own. When people don't agree with you and, um, you don't just follow the dogma and there are lots of characteristics of an innovator. What is the age of a successful innovator? Well, people all have an assumption that the, um, youngsters that they've read about who started things like Facebook. Um, that's the average age and in fact, the lowest success rate for innovators is in their twenties and the highest success rate is in the mid forties um to the mid ff And in fact, usually the successful innovators have failed some time before. Um in the past. Um You've also got to be careful about personalities. I mean, these are two doctors, one on the left from Theranos, she um had an idea, she raised billions of dollars um all against an absolute story that she had made up and the man on the right equally so was using 3D plastic reconstruction to try and do to kill transplants um with um the reported failures that went with it. And also remember that any idea in the modern world is subject to a hype cycle. And if you look here, you'll see any one of a number of um next um best thing um fading a little bit after it hit its peak. That will be interesting to see where A I goes um as well because even there, we suspect there has been a slight hype cycle. Um Innovators need to be a bit of a Cassandra and Cassandra um was the goddess. She had the power of prophecy, but she had the curse that nobody would listen to her. And innovators have got to be used to dealing with that because when they come up with the idea, generally speaking, people will very often are not. Um believe them and try and poo poo it. So I'll give you some aspects of my journey which I was asked to recount. Um and we will start with the blood transfusion. Um, blood transfusion has been common since the 19 forties. Um, previous standard of care when I was a junior doctor was to transfuse it. Um, hemoglobins of, of less than 100 that's dropped down to about 80 in most hospitals, but it's still used excessively and we see it in office and guy need surgery a lot. Um And um, I did a lot of work on blood in my career and was the author of the Royal Colleges re of guidelines in 2007. And um, the change in medical practice as an innovator is extremely difficult. The um, you know, we produced a green top guideline. The people didn't really believe it or like it, we didn't put an educational program around it and there's an estimation that it takes roughly 17 years to get people to change to a new and better way of practicing. So this is a paper I wrote as a senior registrar shortly after arriving in the UK. It was the first Sacrospinous Culex series in the United Kingdom. Not previously done. I submitted it for publication um with my coauthor and they wrote back to say an amazing paper. They loved it, but they didn't see the name of the consultants on it. So I wrote back to him and said, I didn't know where in the International Committee of Journal editors said you needed a consultant name. It had to be the person who initiated the person who executed and the person who wrote it up and they agreed to publish it. And I was triumphant and then wondered why I struggled to get a job for about the next two years as they thought, what an arrogant individual. This was another of my earlier inventions, which was a urethral pressure measuring device um for people with urinary incontinence. I sold this Johnson and Johnson. Um and I did a deal where I made 4% of profit, not realizing that the subsidiary company in J and J is never in profit because all its money goes back to center. What I should have been asking for was 4% of sales. But there is another side to this one as well. It was more accurate than conventional urodynamics, better test retest reproducibility and it was being sold for 80 lbs a test. So of course, this didn't do particularly well because the surgeons were making 600 lbs a test on the old ones in their own pockets. So not only was it more expensive, the profit margin for the user was higher and therefore this wasn't a very successful innovation. And then once upon a time there was a scandal that hit this country which was around your continence. Um, by about the eighties, seventies, late seventies, eighties birch was the standard of practice for, um, um, urinary stress incontinence. And then an operation came out in 95 by one of the big farmers called the TVT, which they said was solution to incontinence, tension, free, low risk of, et cetera, et cetera. And this is so bloody good that I wanted to have this operation. And um it was first described 95 market leader by 2000 and the first randomized trial by 2002, just slightly after the 400,000 operation was done. And before there were results, there was no significant difference between this and the old one incontinence and they appeared to be and last as well. So if we wired forward, sadly, none of all these new operations had any data. And if you look at history, you'll see that there was an operation in the 19 sixties called the go He Sling operation um done in Oxford. And this was for incontinence. And this created all sorts of complications with pain and discharge and erosion. And if you look carefully at on the left, the TVT operation and on the right, the 19 sixties operation, you see they're pretty much identical. So all the concepts around mesh being potentially dangerous were known as way back as 1968. And the society chose not to read the literature and listen to the marketing ahead of the science en pro materials. They all claimed they were the same made for polypropylene. But of course, you can see how different they are, one from the other in the way they look. Now we put these in rats and studied them and they showed differences according to their architecture and how they responded in the body. And we were able to reclassify them into six types of mesh only type one of which being safe for human implantation. And yet they were all on the market. And of course, soon after that came the first big medical case um where this patient then the growth sold J Sue J and J successfully for a couple of million. And the whole mesh story started which you're all as familiar with as I am. And one of the problems is that they interfered with the rate of adoption of a new surgical technique. Normally it follows an s curve. But if you hypermarket something and you hyper sell it, then that curve moves to the left. So at the point where you would have just been coming to the early majority, you're up to the late majority. And so um you affect many thousands more people before you've had an opportunity to get the results. And this lady sold a Su um, Boston scientific and for 100 million and won it blood going back to blood. You all have seen the blood problem. We need justice. People have been contaminated. Nobody knows quite how many billions are gonna have to be set aside to pay for the blood um, transfusion scandal and um, an international Consensus conference on transfusion in 2021. So the blood transfusion is appropriate in about 11% of cases, is uncertainty in about 25% of cases. And it's almost certainly inappropriate transfusion in the vast majority of patients that receive it. If you're too fond of new remedies, first, you'll not cure your patient. And secondly, you won't have any patients to cure. It usually requires a considerable time to determine with certainty, the virtues of a new method of treatment and still longer to ascertain the harmful effects. And what's incredibly important here is that people who are innovators don't forget about the science that comes behind it. The ideas are great. But for successful innovation, you have to never forget your surgical principles, your medical principles, evidence and the generation um of that as well. So for successful innovation, you really need to understand the subject. Don't think you can rush around in a Ferrari as an innovator and it's an easy job. Successful innovation is 100s of hours of work. It requires you to read research and to absolutely know what's going on in the subject to do the history, to do the background, to work hard. And um also be able to get up and pick yourself up from failure because if you want to move into the innovation, world failure is never more than a few inches away. So, thank you so much for letting me join you today. I hope that it's giving you some ideas into what it's like to have done a career with innovation and with quite a lot of original research and um we've got a few minutes left for any questions that you may want to ask me. Thank you very much. Thank you very much doctor for the presentation. Um I'll start with a question, um which is what advice would you offer to trainees who are passionate about innovation? But in the current climate, um they have kind of limited resources and they're limited by their current schedule. I mean, that's one of the biggest problems, um you know, is, is, is affordability and I was this question, I was gonna ask Jane earlier as well. You know, the, you know, it's expensive to do um innovation with products and with surgery and there's no quick fix around it. And that's why we have to think very carefully about how we introduce and we create mechanisms to introduce, you know, the top 20 drugs in the world make between 2030 billion per annum. The biggest um surgical company in the world has Medtronic, they make 20 billion in, but they have 880 products. So if you put the same cost behind farmer trials, behind surgical trials, that's the end of the MedTech industry in one. we just can't afford it. And also the some of the um methodologies don't give you the right answers in surgery. So we do have to think about ways of nurturing it so that young people can get that exposure. So I think companies like mine, we have to think about ways of having interns and I've got quite a few interns in the company already. Um So people can take a year out. The university in Cambridge has got a fantastic new course where they do an integrated engineering degree with their medical degree. Um and that is producing some very good people. And we have to support the much as we consider supporting the association of surgeons in training. We have to consider the young innovators. We have to find ways of getting them into programs. And then the other thing, we have to listen to them when you, when you're a youngster and you come up with funny ideas. Believe me, you don't always get a positive response. Um Someone on the chat says that um you know, innovation across many sectors favors a make fast break, fast approach. But um in medicine, we should have kind of less tolerance of this as patient safety is paramount. But you've given us some great example of how, you know, there's that has not always happened. So what do you think for young innovators? What are the main pitfalls? How do you avoid uh going into shortcuts that could cause kind of patient safety issues but still make your ideas successful? Yeah, I mean, we've got to think about other ways of, of demonstrating innovations and that's with lab based work and with simulations as well. And with Mannequins, there's so many modern ways of doing it. I mean, you know, if you think about the the vaginal mesh story, there were prospective randomized controlled trials that are just totally inadequate. Um And they were never going to pick up the problem because they were too small and too short for, for picking up the complications that occurred. So, you know, it's this openness to, you know, it's a much more affordable thing to keep a database. People can just about write it themselves. Um And, and, and have other ways of doing it. But one of the things that I think are really exciting are going forward are things like mannequins simulation virtual reality, um which is gonna open up all sorts of spaces to get that proof of principle done and then, and then come back on it. But, but it's difficult. Yeah, I have a blood transfusion cause I wouldn't transfuse patients. And um when I'd come from South Africa. People said, I said, I'm not transfusing because you don't test for HIV and Hepatitis C. And, um, we had an argument one day and we went to the blood bank and about 80% of the products stored in the blood bank weren't, weren't tested. Um, and, and, and, you know, the, the drivers behind these industries and that unfortunately also happens, you know, from, from making money, certainly in America, blood transfusion is very profitable. But in research, these drives to make money as well. And my anxiety is that a lot of the proposals for increased um what surveillance and, and um increased. Um um what's the word I'm looking for? Um sort of governance around research is not necessarily motivated by patient safety. It's motivated by making money for the companies that are running that are doing those. And, and likewise with regulatory approval, we have a real problem with regulation and, and regulation is aimed at the big scandals. There are often criminality and regulation or in catch criminality, we have to be smarter than that. So I don't have an answer. II love it when I see what people like Jane and have done, I love the concept of ideal of been, we've done our entire robotic program um based on the ideal principles which makes us the only one that have done it. But, but um it's not an easy answer. It really isn't and it's gonna require some very inventive thought and we're gonna be pushing uphill against strong vested interests. I mean, even the notified bodies are making money out of it and, and there's no motivation for them to speed up or make it more affordable or anything else. So, we've got to be very careful that regulation and research is done for the right reasons and not to lie in the pockets of, of, um certain sectors. Thank you very much, um to all the speakers and I think it's time for a break now. Thank you so much for your time.