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Welcome back to Glow to today two. Thank you very much everyone for getting up in the morning, um especially to those who came and joined us at 730 for the walk. Um This is hopefully going to be a really interesting panel. I've got some really great speakers here. Um And so we're gonna get on with um asking them questions without too much further. A I think just to remind everybody because it is day two and we might have forgotten the theme of the conference is rising to the challenge. We're thinking about those intersecting global crises that are affecting women and newborns around the world. And this morning, we've got the opportunity to reflect on the role of innovation to address some of those big challenges we've heard from a DEA some brilliant work and that really touches as well on the use of big data in advocacy and driving policy that we heard about from Zaina and from Angela yesterday. So we're going to listen to some innovators now who are working in this space and ask them some questions. So please start asking the questions on Medal straight away. I'm going to kick off with a few questions to the panel. So first off, can I ask you to each introduce yourselves by name and role and tell us a little bit about what you're working on? Yes. Uh Good morning, everyone. Uh My name is Brian Mato, uh my medical engineer from uh Mackay University. Uh I'm a veta and also a researcher. But uh I in my career personally, currently I'm working on uh uh a number of projects and uh one of them is the uh diagnostic for. However, I have some other projects on the utilization of ultraviolent C OK, as alternative disinfection measure. And then also a number of uh uh innovations that uh we are trying to, to, to work on in the country for uh laparoscope, uh C A and, and so many others. So I'm so much into the, the translation uh a bit of medical devices in the U in Uganda. Thank you. Mhm. Hi, I'm Katie. I'm a clinical research fellow in and I'm currently doing my phd at Kings College London. So my phd is looking at point of care testing for detection of acute maternal complications, specifically working in Sierra Leone. So I've been looking at three different bedside tests. One which I spoke about yesterday is point of care, placental growth factor, which is novel in that it's a whole blood test. Secondly, is a point of care creatinine test. And the third is looking at shock index in its ability to predict adverse outcomes in septic and bleeding women. And the shock index is incorporated into the cradle, vital signs, alert BP device, which you'll hear more about in the cradle five presentation. Later today, I've also been involved in some community engagement work, organizing policy labs in Sierra Leone and Zambia. Thank you for having me today. Hello, everyone. My name is Jessica Walter. I am an obstetrician gynecologist. I work at Northwestern University in Chicago and I also work at Cyle Health. Um We are working to develop a comprehensive vital sign monitoring system uh using wireless devices to help improve safety during delivery uh in low and middle income settings. Morning, ladies and gentlemen, my name is Roberto. I head by medical engineering at Ma University. And uh I think for the last 11 years, I've been at the center of training and building uh both clinical engineering and research capacity in medical devices. And my area of interest is actually increasing access to health care technologies that are appropriate for uh LM I settings and uh mainly working in Uganda by trying to develop uh models that can be utilized in other settings. So, one of our flagship device that's uh navigating the translational pathway is uh anor laparoscope device using gasless um uh gasless uh um approach without the need for uh carbon dioxide and many others. And maybe I should also point out that II trained Brian and now we are working together. So, whatever Brian does, I also have a hand in it. Thank you. Um Thank you all for coming. Um You will happen to be people that I've come across in my life and been very impressed by. Um And so I'm really glad to get the chance to grill you on stage now in front of everybody. Um I'm going to start by asking you to tell me what you think about a concept that we talk about often. And it's been observed that when it comes to phone technology in LMIC, we've entirely bypassed the need for a wired telephone network. We moved to most people in an LMIC setting, having access to a mobile phone, either themselves or within the family unit and actually being able to do quite advanced telephone banking, even off very straightforward mobile devices in a way actually that came in advance of mobile banking in high income settings. And I think it's common in maybe innovation circles to talk about how that model can actually and be applied in healthcare innovation and how we actually can innovate and drive change in LM settings that actually can then be reversed, engineered and brought back into high income settings. And actually, you can be the drivers of change and the innovation that comes in the low resource setting actually can lead the way. And I'd just like to hear your thoughts on that one stops. You start Roberts. Thank you very much. Um Uh yes, II think the great thing about technology is uh it moves forward very, very quickly and by doing so it uh values you with an opportunity to be able to tap into things that maybe uh people who went before you were not able to tap into. And uh when we look at the mobile phone technology, for example, I'm, I'm quite uh interested in how the banking uh system in Africa is completely different because people do banking through their mobile phone. And when we look at medical devices, I'm intrigued by this point of care devices, rapid diagnostic tests. I think they are going to revolutionize the way diagnosis is probably done because we end up reaching closer to uh the person who needs it. Well as in uh maybe systems where everything is uh much more organized. Uh there will be room for going to centralized laboratories for testing and everything. But uh from the presentation made here, we know that traveling uh distance is really hard. So uh getting these uh units closer to the people who need it, I think is going to really make wonders in um in Africa. If I can speak for for that, we've seen this work well with malaria diagnostics where you know, almost uh down around the corner, there is somewhere where you can get a kit and you can easily tell that you have malaria or not and that dictates how um how you can move forward, there was a presentation around antimicrobial resistance. In Uganda, people can easily go down to the drug shop and buy most of the drugs they want. If the drug shop says no, they move to another. And in Uganda, when someone has a fever, they will first think it's malaria. And so they will start treating malaria. But now with the malaria diagnostic here, we can easily say it's malaria or not and that makes clinical decision making much, much, much easier. But then uh these days, we have access to data science to A I tools that were not there a few years back. And uh this is definitely going to be quite useful in augmenting clinical decision making. And also the care uh the device I was talking about earlier, which is the laparoscope unit is basically getting a tower that we probably know that is used in theater and shrinking that into a very easy uh led based uh light source and also getting rid of the need for carbon dioxide. I've worked a lot in gynecology theaters, looking at those, looking after those towers. And most times, the biggest problem is we do not have carbon dioxide and if we want to get it, we cannot. And the other day, I was speaking to someone who said that, oh, we can go to those companies that pay Coca Cola and Pepsi Cola. Yes, we have them. But II don't think they um they can easily just give you their carbon dioxide. So we, we are completely transforming and uh maybe benchmarking on what others are doing. But also trying to understand that we do not have the luxuries and the money that can um that can really be used to bring the the high, the need for high cost consumables with medical devices is something that goes unnoticed in high income countries. Whereas in Uganda really, uh we do not have the luxury to have consumables. So we, we have to rethink how it's going to be done. But in doing so, we think that we are going to basically just leapfrog some of these things that are being done elsewhere. Let me stop here. Thank you. OK, to go. So I completely agree with you about the potential of transcending access barriers with point of care. Could you just close to the point of care being a kind of way to transcend access barriers that we've obviously been speaking a lot about and just thinking about obviously most relevant to my work is the use of point of care plgf testing and its potential in a place like Sierra Leone. And if you think about, I think I mentioned in my presentation yesterday for a woman to come to a health care center for a check up on average will cost her more than a week of wages. And that's without any sort of inpatient stay and or other things, other interventions that she might need. So you can see kind of the potential transformation that point of care testing could provide. But I suppose I feel one caution is that you know, the point of care revolution may look like a kind of golden bullet. But you know, we've experienced challenges in you know, in the fact that lack of electricity means that you may not always be able to charge the point of care device, lack of refrigeration means that you may not be able to keep the test cartridges at the suitable temperature to store them and to rely on them to be consistently accurate. So I suppose my concern having worked a little bit and having some experience of point of care testing in a setting like Sierra Leone is that we don't want to rely too heavily on on this strategy and and kind of forsake the more established kind of laboratory infrastructure that you know in Sierra Leone since Ebola virus and everyone got very excited about care testing, understandably the kind of laboratory infrastructure and development that needs to go into maintaining laboratories has been somewhat neglected. And if you completely rely on point of care, you you kind of decentralize your system. So that means you decentralize your procurement pathways, you decentralize your training, you decentralize your supply chains. So things become a bit disparate and harder to sort of maintain quality and standards. So I guess whilst I think it is transformative and it and it must be the future. I think there are also important reasons to think that it's not the kind of golden bullet. I think that brings us back to what I said. When was telling us about the implementation yesterday, which is reality bites. I, I'm gonna ask you a bit more about implementation sites, but I just want to hear Jesse's thoughts on the first question. Yeah. II completely agree with what you mentioned. I think um it's, you know, I love the analogy with cell phones, but it's a ubiquitous device. I think there it becomes more complicated when we're thinking about health care interventions because they're not as widespread, there's not as clear training and clear management or how we sort of sustain those devices. So I think those are added wrinkles and how we think about how this, you know, these technologies and everything can help to move care forward. But I think there are other sort of more basic lessons that we have from. Um you know, the sort of development of these technologies, whether it's interoperability, wireless technologies, all of these things that we have now A II think all of those things are gonna help this move much more rapidly in the future. And II think the opportunities are really exciting, but it's not gonna be a straightforward, I don't think is every, everyone having a cell phone, unfortunately, which I think brings me to my next question, which is around the implementation science around this. So you've all been involved in bringing devices into use and I'm sure you face some barriers and challenges around that. But I think the understanding of how devices are used by the people who are intended to be using them in the context, they're operating in the acceptability to the patients. The sustainability of the devices is such an important area in medical innovation in these spaces and perhaps something we're just starting to get to grips with. What are your thoughts on or what's your experience of doing the implementation kind of research around your devices? Let this Brian start. OK. Right. Uh Right up to the microphone, I might need to move. Yeah. Yeah. So uh my experience has been more of uh uh trying to uh to see that uh the end users, especially with the, with the local innovations. They, they are really challenges of uh you introducing a new product, a a new idea into the uh uh a new idea to the end users. And normally they are really uh a lot of challenges with them embracing and uh we have uh like a common saying, OK, in Uganda and I think will be the rest of Africa, not really trusting most of the products that actually are are are locally made and people really doubt OK. Will this work? OK. Will this work? I think it, it's Ugandan and made how OK, so winning the trust of end users really is a, is a challenge irrespective of what stage of your innovation that you you are at. But then also, uh there is uh there is a bit of respect. IP. OK. So you find that uh in terms of protection of your IP as local innova, OK. In our settings, not many people really understand OK, the issues around IP. So it becomes really a challenge. Tell them that OK. Here you are infringing on my IP. OK. Here probably you are doing this, OK? You shouldn't be doing uh such. And we have an example, I think a few weeks back, one of our students came back that there's this facility that actually has gone ahead to manufacture uh the, the, the, the, the, the their product because she was providing some terms of working and probably they say no, I think we can go about this. So there, there, there, there are a lot of, of, of, of, of, of such and such huddles that we actually as, as innovators as people are trying to bring uh a new, a new product or system into our settings that we actually need to uh to, to navigate. Yeah. Yeah, maybe what I can add is also um what, what is probably accepted in Kenya will not be accepted in Uganda, Tanzania, South Africa and so forth. And uh what we find is that uh in our settings, we tend to trust uh the already approved and tested uh systems such as the C EAC for a medical device or uh FDA. Uh we, we really lack harmonization of um uh harmonization and standardization of regulations. Where if I make in Uganda, I, we can have these maybe African or I see as um approved uh creation system where I can make a device and be able to uh send it across the world. I think that, that that is quite challenging for us. But also uh we've seen that most of the regulatory systems, we have to actually work with them as we are building. Uh So they are also building because uh medical devices definitely is a new thing. Um I don't think we routinely see medical devices made in Africa. So our regulators are having to build their capacity as we are moving through the channels. II see that as quite a challenging aspect as well. I think, I think just to follow on from that kind of concept of tailoring something to different contexts. I think it has to be sort of, there has to be a feeling that it's locally owned and, and locally needed. And um one of my colleagues yesterday MDA was talking about community engagement. Um and I think it's about sort of understanding what the community needs and why they want to and then then it being handed over because, you know, in Sierra Leone, there are in the hospital where I work, there's probably about 10 different trainings for the staff per week of different kind of innovative strategies and solutions and pathways from different ngos and different organizations. And everyone just ends up kind of having all their time taken up by these sort of different trainings. And actually I think it's about sort of saying, look here, this is and what do you think should be done with it and how are you going to do it? And we're happy to support if useful. And you know, for example, the cradle device, there's been work over some years going on with the cradle device in Sierra Leone. But now when it's sort of training ceremonies, training is done in communities, one community recently had a naming ceremony where they took the device and they initiated it into their community and it was entirely led by that community. And then the training is organized by the community so that sustainable in a way that if it relies on, you know, the King's College London turn team turning up to do the training, it's just not sustainable and it's never going to work and, and they're never going to really feel ownership and autonomy. So I think that's a really kind of key part of implementation in a sustainable way I II would add to medical devices are so different. You know, whether it's a point of care tool point of care, ultrasound or a system that's meant to be worn on a patient during inpatient stay or a laparoscopy unit. And so implementation, I think becomes even more critical with medical devices compared to a medication that we might administer for some sort of specific illness. And so you sort of have to think about what are the stakeholders across that whole lifespan of the device when it's being integrated into that patient's care? Um you know, that's training in some cases for the staff to teach them how to use it, teach them how to clean the device. How is it going, you know, what's the life cycle of the device? How does the patient feel wearing it? So, um and and what's the battery life, how how does it contain, you know, privacy information, how does it have fidelity between a patient and the information it's giving you? So I think really thinking about it the from the moment a patient interacts with it or staff interacts with it, understanding that whole life cycle of the device on a patient and in the system to ensure sustainability is, is really critical and much more complex than other types of medical interventions and it's really device specific. So having a good understanding of that or building that into early clinical um trials and understanding what implementation really looks like for the um specific context of use it, it's really essential. Yeah, thank you. We've got an interesting question from CEFA, which I think touches on an issue that is very live in medical device innovation, which is the sort of balance of profit and impact, you know, we know that to get devices out to have the maximum impact they are going to need to be delivered commercially. And that is going to require us to interact with capitalism, which we are a community of academics and clinicians and that's not necessarily our natural home. Um And I think actually in the panel, we've got quite a wide representation, we've got Katie who's a clinical academic, you're interacting with a number of industry partners to test different types of point of care device. But you're, you know, company agnostic, um Robert and Brian, you lead an academic department that is developing new technologies and you've successfully spun out some companies from that department so that they can proceed with the commercialization of those technologies, but you still reside yourself within the academic space. And then Jesse, you're here representing a company, but a company that is heavily involved in implementation research around understanding how your device works and has has its best impact. So I just wonder from each of you, from those different perspectives, how do you find the balance between profit and impact because profit needs to happen so the impact can be achieved and how do we do that in this space when we're dealing with very vulnerable women and babies? Yeah. Thank you. That's a very nice question because uh uh I've always thought that my role is to create a technology and leave it there for someone else to worry about that. Uh Clearly we know that uh that will not work. I've had an opportunity to interact with uh lots of uh companies that make medical devices, um you know, huge companies. And usually the response is we don't really have the buying power in Uganda in Africa to really be able to really support what you need. Maybe you bought a few 100 devices and to you, that's really plenty. But compared to what else we are doing, that's close to nothing really. So um recently we've gotten interested in figuring out what, what's the f what financial model should we really look at in uh ensuring that uh you know, the company or the entity that's making these devices continues to thrive because without bringing in money, then we will not be able to move forward. But at the same time, trying to keep to our objectives of increasing access to these technologies to people who need them most. Uh And to be quite honest with you, I don't think there is a, a straightforward answer to, to this. And I think maybe uh I II love that question because it, to me, II think I would say we need to figure it out together. There are some ways of, you know, maybe people placing a device and then you buy, you pay for consumables or reagents and those have been tested. And we have hugely expensive equipment sitting in laboratories in Uganda and they are never used. And the companies really can't do much because initially they thought, oh, there's this contract that people honor. And then the road, the people who are using these expensive devices realize that actually the reagents are so expensive, we cannot keep running. So we, we need to figure out really some of these models and to be honest, uh because I've been concentrating on the engineering side, I haven't thought clearly, well, we haven't thought clear about which what will work and what won't work and I'll be open some suggestions myself. Thank you. Yeah, maybe what I can supplement to that is uh so as, as as as I said, we've been concentrating more on uh on the engineering. OK? But then later because we have a dream of seeing that OK, can these devices actually end up on the, on the, on the bed side then currently. So the team has been growing. So initially our biomedical engineers now, OK. We have now software engineers. So most recently we now have uh uh like whom we are calling regal officers, like people who are now trying to understand more of these regulations, they are now really part of us on day to day or a basis because we are on the journey to see that actually goes there. And, and most recently, I think in, in, in, in a couple of months back, we are now starting to discuss the the like business. OK. Now how best we are trying we are almost there to get the regulations but how can we make this sustainable business wise? So we are seeing ourselves actually bring on more people, ok, business people who have a business mindset who can give us the election in terms of sustainability to actually be part of the team. Ok. So my take would be there is need to involve a lot of stakeholders, especially in the team building. OK? So maybe as innovators not to just concentrate on the, on the technology and the product because at the end of the day, your dream is structurally see this product, whether it's a software, whether it's a medical device or whatever to see that actually ends up onto, on, onto the market. And there is a lot and uh currently we have like uh one, one or two devices that have locally been manufactured uh OK, locally designed and manufactured, not in Uganda somewhere else. OK? But all the concept and everything is actually from Uganda and then they just import this device. So currently these people are trying to look for. So what model they actually what model works for them? They are trying to test different models or renting model or whatever. OK? Can you maybe take it? And every month you pay small amount of money until when, OK, you finish. So there are different in our settings, there's not much one from as far as this device translation on the business side. So there is a lot of we are like among the first people that are trying to figure out, OK, how best can we make the medical device industry in Uganda profitable, especially for local innovations? OK. All in questions that have come from elsewhere and we are trying to translate them, having them manufactured into the country. So it is really uh it involves a lot and really we are taking in a lot of advice and, and work from different people that actually have experience all across the world to see that we are actually able to make this a success. Um This is a great question and I think as somebody who wears two hats, both as a academician and also sort of with, you know, a foot on the business side, I think it doesn't necessarily have to be mutually exclusive, but I'm gonna answer it from both hats. So as the from the academician side, just as um I think implementation science is, is having a moment and we're, we're understanding that that's a huge part of understanding medical interventions. I think similarly, there's um great opportunity to think of about really methodologically rigorous cost effectiveness and economic analyses that can go alongside implementation science, uh you know, introduction of new devices. It's something that we do in Chicago and can be just as relevant in other areas because cost is kind of a universal concern when we're dealing with health care. So I think there's huge opportunities to demonstrate value in a scientific way um that can speak to sort of the more clinically research minded folks. And then I think it's um you, you know, it's about partnerships and some of those partnerships are gonna come in the commercial and industry and philanthropic groups um working together and leveraging other folks' experience because as you know, physicians or clinicians, we don't necessarily, or even as engineers, we don't necessarily have that background to think about how do I decrease costs through different manufacture, measuring mechanisms? Thinking about what consumables can we use that are more sustainable? And so really getting a multidisciplinary group together, I think can be really powerful and, and leveraging those those different communities, whether it's from a commercial side or a philanthropic side or university side. I think there's great opportunities for um collaboration to kind of move things forward. I think from the from the academic side, I definitely feel this is not my, it's not my comfort zone. It always feels like the ultimate tension. But ultimately, I do think for, you know, an ultimate piece of the sustainability puzzle is a commercial aspect. And it's the part of the grant application that I dread writing the most is like, what is your kind of plan for the commercial sustainability of this device? But I do think that just kind of based on my own. I guess relatively limited experience from the devices that we're evaluating. There are are examples of partnerships. So for example, with Microlife who manufactures the cradle device, they've pledged to manufacture and sell the devices to low income settings at cost which is subsidized by their prices that they charge to higher income settings. And I think through kind of working with those manufacturers right from the outset. So we currently work with Lepsis who manufactures a different point of care PLGF test and also the manufacturers of the device. And that we are working towards similar partnerships with them, whereby they pledge that to low income settings, they'll charge a lower amount. So I do think that there are ways to kind of, as you say, partner and create a sort of arrangement that feels mutually beneficial ultimately to the beneficiaries of the device itself. OK. One more, Robert very, very quickly. II just uh got this point from you that uh in, in Africa, we have the numbers, the numbers are big. Um maybe in IC, we have the numbers but you the numbers are not buying the equipment. Uh Maybe we need to, to again look into the this business Eva evaluation from a scientist, scientific perspective and say, well, why are people needing laparoscope surgeries, given the clinical benefits? And at the same time, they are not buying or using the high the expensive complicated devices that they are, they are making elsewhere? Thank you. Thank you. Guys, I think strongly that there is a strong ethical imperative for delivering innovation to the people who need it most and taking the highest quality technology where the burden is greatest. And that is why I think medical device innovation in those settings is really important. But we're also talking about very vulnerable populations. We've talked several times about how these people can often be the least empowered, least able to speak up for themselves. And so we're talking about conducting research in a setting with the population that historically is, is disenfranchised. And so in doing that, um how do we do really high quality ethical research where it's most needed? Um What's your examples of best practice in that area? What's your sort of aspirations for us as a field? I will pick it random. Robert can go first. Yeah. Uh Ethics is always an uh an interesting uh topic because we uh clearly have to look out for everyone. And um uh I think uh what I look out to is uh if it's not good enough for me, then it shouldn't really be good enough for anyone. And uh we know that people who are vulnerable will probably sign on to what you tell them much, much easily. Um In Uganda, we have um we have a policy by the National Ethics Body that we have to compensate uh participants using money, money terms. And in a constant, you have to actually read and say we shall compensate for your time and expenses uh to the tune of this amount. And you can see easily that this can bring in people who are vulnerable. And uh II think what, what, what, what's happening and helping out uh with this is uh we have a different uh ethics uh committees that we have to navigate. So the uh it's a two tiered system where you have to have the institutional review. But then at the national uh uh level, there's also a review to try to ensure that these people are uh any anyone who is going to be recruited uh is uh the ethic, ethical patients are really taken care of. Um I think uh we as researchers, you want to get, you know, the device as quickly as possible. But then we also appreciate that what, what it means that if it's not good enough for me, it shouldn't be good enough for anyone else is we have things such as good manufacturing practices. Um And uh this, this actually gets you to have facilities set up that we have um at least uh the minimum viable product for making sure that you, you, you have a device that's going to be safe before it's used into. Uh anyone. I think that's all um Jessie this, it's challenging, I think because medical devices um I I RBS or these kind of ethical consortiums that review our clinical protocols don't always have um a great literacy around them. Uh and understanding about how devices might be implemented, what they're, what they're providing, that's new, what they're providing, that's sort of standard clinical clinical care. So I think educating around that can sometimes be a challenge. And then I think there is also a tension when we're, you know, it's essential that when we're making medical devices that the innovations that we have, we're, we're proving that they work in the context of use where they're needed most. So i it's necessary that we do research, you know, in areas where the devices are needed. Um But it's challenging if the device isn't necessarily FDA cleared or ce marked to get it approved by the f to by the um ethical boards that it can be introduced. So sometimes I find it's a chicken or an egg situation that you need a certain level of regulatory security and safety. But some of that evidence might be generated from that study itself. Um So, so I think there is a bit of tension there because the cost to get something FDA cleared or ce mark is so extraordinary sometimes that can be a barrier to getting these medical devices to the places that need the most. I also think just in our experience of consent. Um So we found that when we were training the midwives uh to do consent, um they, they said, you know, we got, we, we did some role plays and they said Well, the woman won't consent without her husband there or her mother in law or, and it will often be that the woman herself will not give consent. She'll say, well, I can't, II don't know, II need to ask my husband and it might be that she's under financial duress. It might be that the person who's paying for the care gets to make the decision, but it's often not the woman and it's rarely wholly the woman. So we tried to do a lot of work around kind of talking to the midwives who were consenting the women to get them, to advocate a little bit for the women, to empower the women and to talk directly to the women to try and encourage her more to be involved in the decision making process at the very least, so that we could be confident that actually she understood that it was her that was participating in the research study and it wasn't a necessary component of her care etc. And I think the other thing is, which is a bit of a sort of tension is that, you know, we have to submit our, our ethics applications and consent forms and materials, patient information, materials to the local Ethics Board and also to the University Ethics Board. So Kings, Kings want you to include all sorts of data protection information, which in creo when you translate it, there are no words in Creo for the Data Protection Act et cetera. And of course, you need to convey this information. But unfortunately, the wording that is insisted on is entirely unsuitable. So we need to change this process and we're doing some work around at the moment trying to kind of understand how we can create better patient information materials and consent materials so that the women have a better chance of understanding and being able to have the relevant information that they're signing up to. Very briefly, Brian. So I think uh uh for there is uh there, there is a paper that is uh that we are going to put uh that's soon going to be published by BMC trials. And uh we are looking at uh uh it's like a comprehensive analysis of the medical device can trials that have happened on the African continent. And actually the results are so shocking that almost every African country has had a pharmaceutical trial going on. But when it comes to medical devices, we we actually some countries, I think only 32 countries have had like one medical device can trial happening in their country. But we have some countries that actually don't have any registered medical device can trial happening. So that shows the gap that is actually that we have in the African continent compared to, compared to maybe the West. And this shows the gap that is actually there even in our ethics bodies. OK. So since they don't have this experience of of handling medical device, clinical trials. So chances are also very high. We don't actually have capacity for them to be able to provide the regulation. Ok. Many countries are now, I think they've wo enough, for example, like in Uganda, the the the National Council of Technology has now set up joint reviews where made for medical devices can called trials. Ok. They bring together all these different ethics committees and regu bodies in one room. OK? They, they review your protocol, they give you commerce and then, and then they tell you this is the person or this is the body should now follow up with to have. Ok. So there is capacity that is, that is being built up around medical devices and we feel a lot is going to change, ok? And we've seen a lot of medical device trials are really happening in Egypt, Egypt is leading and then South Africa and who is coming next? There is actually Uganda and then we see Nigeria, we we see, we see Kenya there, this is also representative of, of how different regulatory bodies actually are putting effort to see that. They they they there's enough regulations around these medical device clinical trials. And I believe uh for example, like in cases of of of emergency, there's a trial that happened during COVID-19, I didn't participate in it but were interacting with one clinician and said so, so there's this device, OK. It was for uh uh for for pediatrics but it happened at the hospital didn't have any technological intervention. Ok. And this child comes in ok. Severely ill shouldn't be put on this medical device but the clinician said I didn't have any alternative. Ok. I had to try out ok, on this medical device, I didn't have anything else. I was just going to leave the baby there to see. Ok, what's going to be so and, and, and there were discussions with the National class of Science and technology. Hey, why did you intervene? Why did this happen? But it was an emergency. There is no technology. OK. There, there is no alternative at that point and it was really back and forth to see. Ok, now what, what would be the best alternative in terms of handling this? So there is a lot of, of, of building capacity that is going on and uh we are hoping to learn, ok, so we haven't had much of participation in most of these trials, but we're also really learning and seeing, OK, what's the best practice that we could actually have? Thank you. Um We are going to, I've got so many questions online but I've not got enough time to ask all of them, but you'll all be available at the coffee break. I'm going to ask one last one, which I think is probably the most important anyway, and relates to two points that have been made in the chat. Um And it's really, how do we engage and what is the role of patients and the people who are going to experience the medical devices in their design development and translation. Um And so Katie, you've told us about that naming ceremony for the cradle device and how the village welcomed it in your colleague, Bindu Carbo, who unfortunately due to the home office, can't be with us today. And hi, I'm really glad that you're engaging online and we really miss you here, but has pointed out that the creator device has been very welcomed and is even called a magic machine locally. And that sort of really demonstrates a really warm hearted adoption of a novel medical device because obviously the community is seeing the benefit of that and that testifies. I would imagine quite a lot of engagement work from your team over many, many years. But also one of our audience members in India is pointing out a lot of people have had negative experiences of research being conducted, particularly from global North. Researchers working in resource constrained settings and they might well be rightly suspicious of novel devices and researchers coming to test them out. And do you have experience of that as well? And how do you see that community engagement as an important role, having an important role in bringing medical devices to market? Um I think it's, we've had people decline to participate because they feel that, you know, we're doing research on them and that it's purely for the benefit of others, all for commercial gain, et cetera. So I think that's a really critical barrier and understandable, hugely understandable as well. So I think again, sorry to bang on. But I do think community engagement is the key because as soon as you know, we've had discussion sessions with the village chiefs and elders in the community. And when you understand some of the kind of cultural and spiritual beliefs around medical, Western medical technology, there's still a huge dichotomy between Western medicine and the fact that they have much, sometimes much greater trust in going to the traditional healer in the community, which is far more familiar and closer and knows their family etc. So I think it is about saying, well, this could be kind of, this could complement and support care that you may receive and become a sort of acceptable component rather than something that is being done to you by someone who is a white person from, you know, halfway across the world, Jessie. Yeah, I mean, I just to echo everything you said, it's a hugely important to understand what's the experience of patients using the devices. What's their perception and acceptability and thinking about all the individuals who are involved in their care and not just the patient themselves, but you know, in the context of delivery, a birthing partner, a mother, an aunt, um the husband, whoever might be there is, is really essential I mean, that's you can't start if they don't accept it. Yeah. Um Brian, and then I'm going to give up the last word. I promise. Um So I know that you've done some engagement with women with preeclampsia in Uganda around the use of the device. So, um yeah, tell us how that went and how that's informed the plans for use of the device and development of your devices. All right. Uh Thank you. So, with uh with uh so the, the experience I have is, is mainly more on the side of uh times. Uh the, the, the the patients might expect a lot from you and then uh managing those expectations really. Uh you, you sometimes really, they are uh like so vulnerable, they've come into this public hospital, ok, hoping to get the best. So at times you, there is really uh adequate uh sensitization and giving them more information on what the study is about. So that really, uh although sometimes what normally happens is that after you giving them like consent and everything, they give you whatever sample that they actually need, at times there is a lot of, of follow up that uh more phone calls keep following unrelated. OK? To, to, to what you are uh study or you are trying to do and, and, and they actually want to, they want to either to get help on something else. Maybe they are feeling some pain, they can't reach their doctor. So there is a lot of that but the current experience that is that is ongoing is basically with uh I think we got this from the, the joint uh ethics reviews where we are supposed to have AAA C A community advisory board to actually be uh part of the clinical trial to try to see uh what uh uh to, to try to create that linkage. And there was an example of uh of uh a circumcision device that was, that was taken to Eastern Uganda. So they have their culture uh ways of circumcision and then introducing a technology OK into their healthcare facilities. So the community advisory body was actually able to give uh water device and was the best way. So they are really so important. OK? And there need to yeah, get them. Thank you. OK. Um One sentence to finish. Yes, I was going to say that uh uh we find that every device is different for the laparoscope device. We felt we couldn't really engage with the actual patients until when we get uh trial approval. But uh the community advisory board has people who speak out for patients. We have uh also another device with which is an artificial hand and there we've worked with uh people from the what go from conceptualizing and we are making and now we we are giving them to them to test out for us. So I think the difference of device also helps to dictate how well you can engage with the actual users. Yeah, because the patient is not going to see their laparoscopic stack in the same way that they see their wireless monitor or their test strip, isn't it? So it's, it's different types of engagement. Um Thank you to our lovely panel um that has been a really engaging discussion, lots of engagement online and I hope lots of more discussion over coffee, which is where we're going next. Um So thank you and please join me in a round of applause for the panel.