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Summary

This on-demand teaching session covers the development of technology designed for low resource settings with a focus on addressing global health challenges. It focuses on understanding the challenges faced in developing solutions and honing in on the real clinical need. Medical professionals are invited to join the session to learn from Professor P Coma and June Maudette who will discuss three case studies and three lessons to understand the importance of working closely with clinical experts and providing resource light solutions.

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Description

Module 3: Technology design for low-resource settings

o  Describe participatory and context-specific design principles

o  Understand how to develop sustainable technologies

o  Learn how to collaborate across disciplines

o  Technology transfer principles in global health

Learning objectives

Learning Objectives:

  1. Introduce medical audience to the concept of healthcare Metronics, and the application thereof to address global health and inequities
  2. Understand the importance of gathering broad consensus and insight when developing technology for low resource settings
  3. Explore case study of a device designed to retract tissue during laproscopic surgery
  4. Examine case study of producing CPAP solutions for patients in need of respiratory support during the COVID-19 pandemic
  5. Analyze the benefits of developing a system that is low cost and oxygen efficient while removing unnecessary functionality
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Computer generated transcript

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The following transcript was generated automatically from the content and has not been checked or corrected manually.

And move forward in a positive manner. Uh I'm going to move straight on to model three, which is about technology designed for low resource settings. And we're very, very pleased to have with us uh Professor P Coma and June Maudette who's joining us from Kenya believe uh to talk to us about uh this topic. So without further to, I'm going to introduce proper peak comma first, who's a professor of health engineering leading the healthcare Metronic research group at the University of needs. His research concerns the development of sensing an automation technology with application to address global health challenges with a particular focus on underrepresented groups and conditions. So, and I'm going to uh hand over to pigs first and put your slides on life now. Oh, perfect. Thank you very much Jeanne. Excellent. Can I advancing myself jean or do I need to ask you? You have to ask me to say no problem, no problem at all. Thank you for this. Well, thank you very much for the invitation to speak to you today and I'm really pleased to be joined by June. Hopefully, between the two of us, we'll get some nice kind of complimentary messages out to everyone. Uh So, yeah, thank you very much for the invitation. Um Just as a brief background um uh my backgrounds in Mecca Tronics, the subject which looks at the integration of electronic computing and mechanical engineering. And during my phd, I was involved in applying that to healthcare. So first of all, looking at rehabilitation and then I was interested in surgery. Um and more and more, I've kind of grown into the idea of applying these skills to look at the inequity and provision of surgery and surgical technology across the world. So that's the kind of the the angle A I'm coming from um my presentation today. I will um next slide please. Gene I will share with you three lessons I've learned and just draw on a couple of well, three case studies um hopefully to highlight the points um that I'd like to make. Um and then I'll be very interested to kind of hear from you about any questions. So here I've got this idealized representation of innovation um that can be applied particularly in the healthcare domain. So you start off with a particular challenge and you move through these two phases where you develop ideas, uh you refine them according to kind of user requirements. So this might be your clinical healthcare team, you clearly define the problem, you test it and then suddenly you find yourself with a solution. So we often see diagrams like this which kind of represent and portray this, this innovation process that we'd like to go through. Um I guess the message that I'm going to sort of talk to today is that that process is rarely as straightforward as we see here. Um And there's kind of lots of ups and downs. Um And it's important to understand where the challenges might lay uh next slide, please. So the first case study is actually some a project where I started off in surgery and surgical technologies. Uh And this involves the development of a device we called the IAP the intraabdominal platform. So, the concept came from a surgeon that we worked with. And the idea was to provide a structure that could be used in keyhole surgery in a particular laproscopic surgery where you inflate the abdominal cavity with gas and then you use instruments that are inserted through incisions in the abdominal wall to perform surgical operations, particularly things like the liver or the kidneys which lie in the abdominal cavity. So the idea was we could provide a structure with which the surgeons could use um to retract tissues to. So that enables them to kind of expose underlying tissues and and to conduct their operations. The idea was that it would help reduce the dependence on numbers of assistants who would typically kind of have to do this manually um and give more flexibility to the to the lead surgeon. So we thought it's a wonderful idea. And we set off on a on our way to develop a solution and engineer something next slide, please. And we assembled a good team. Um and we went through a whole range of prototypes. So we understood the kind of the size, we kind of looked at things like the anatomy and the typical size of the abdominal cavity, the kind of loads we might be having to lift. So how heavy is a liver, how we're going to retract tissues, how we're going to hook them and pin them on this device? And we went through lots of different iterations that you can see there, the design slowly changing over time. And we went all the way from a system that was designed to be reusable to something that was single use. Um We've got various bits of funding along the way. So we're very pleased with how the project was progressing. We had some uh good investment and then we started to have sort of commercial interest in the project, which ultimately is what we'd like as, as engineers, we'd like to design things that can go into the real world and actually have an impact. So next slide please, we were asked to kind of illustrate the uh the system and how it would be used in real life. So we uh leads have access to a really good anatomy department and we could do categoric simulation. So using cadavers, um in particular ones that have what we call like a soft fix. You can simulate a, a surgical procedure. So that's what you can see here. Some images and stills from videos where we use the device uh to retract issues. So we were increasingly pleased with the way it was panning out. We thought, right. We have a system, we've designed it, we think we have some I P here, some intellectual property and we have commercial interests. So it all seems to be going very nicely. And then next slide, please, we produced this final system. Um and you can see here, I've kind of represented um what they sometimes call kind of the hype cycle. So as you go through this period of innovation, you come up with concepts, you rapidly develop kind of prototypes, you test them. And then we found ourselves with the views of feedback, redesign. So we went through this iterative process, produce the final design. And then at the point where we thought it was all done, actually, the companies that were involved asked lots more feedback and they asked in particular from a range of surgeons. So we had our key surgeon that had been informing the design. But as we got a broader set of opinions coming through, we found that there was a real diversity in surgical opinion. So we designed a system that very well met the needs of perhaps one or two surgeons. Actually, if you looked at, if you took a step back and took that more holistic view. We found that the surgeons in this area tended to do things quite differently in style. And a lot of them didn't really see the same need for a device like this as perhaps our lead champion surgeon are advocate. So we were left in an awkward position where we designed a system that we were very pleased with it worked. But actually, we should have taken this step right at the start to get this broad kind of consensus, a greater understanding of what the clinical need was. We thought we understood it and we had a good viewpoint, but that was limited and it was very focused on one or two, two individuals. So my lesson here is that it's very important not to design a solution that doesn't have a real clinical need. It's an easy thing to do for us as engineers. If we think we have a particular understanding of a clinical view point, we're not trained as medics, we're not trained as surgeons. So we may think we understand it and go off and do our thing. Um But is it very important for us to kind of keep working closely with clinical uh experts to guide the process and not to rely on just one or two individuals, but to try and get a broad view of uh the clinical case. So that's my first lesson to make sure that you work with a broad range of people and you really understand the clinical need. Okay. Um The second, sorry, the next slide um brings up the second case study. Um So the last one you'll notice is essentially a failure. Um I guess we have to accept our failures and, you know, learn from them. And that's absolutely what I did in that project. It was a really good learning opportunity despite the fact that it didn't come to an outcome that we might have anticipated at the start. This is a slightly different narrative, a situation that we nobody in the world wanted to find themselves in. But with the advent of COVID, um we were faced with shortages of respiratory equipment all around the world. So in the UK, um there was a real need for oxygen efficient respiratory support devices. Um We were running out of oxygen in hospitals, in particular when, when they described as those waves, uh the capacity just wasn't within our hospital infrastructure to supply the numbers of patient's that we anticipated. So we worked with the teaching hospitals locally at Leeds. Uh And they were particularly interested in looking at provisions for, for patient's who weren't critically ill but could become. So if they didn't receive some um some support earlier on, and in particular, they were looking at a form of um respiratory support called CPAP. So a continuous positive airway pressure. So uh systems which can uh not act like a ventilator but just provide enough positive pressure to open the lungs and then supplementary oxygen is introduced uh to help that person's health. Next slide, please. So we were interested in developing a system um working closely with the teaching hospitals during the COVID pandemic. Um they had uh identified that there was this a sleep apnea machine which could produced, could be using the CPAP device and it was fairly low cost. So we were looking to see what we could do, what we could engineer. You can see a mapping there where we've kind of worked with. The healthcare professionals are teaching hospitals to understand the range of different solutions that are out there. We've mapped how efficient they are in terms of the use of oxygen and how complex they are. And we saw that there was a real gap there. So the sleep apnea machines that you can see one is called the Nippy, the Nippy three plus um a relatively oxygen efficient, but they are fairly complex. They have a lot of extraneous functionality that they don't really need. So if we need to produce them quickly or at volume, they weren't particularly useful. So what we were trying to address is that bottom quadrant there that you can see uh the resource light section. So again, this is a real case in point that we had to work very, very closely with a range of disciplines. So healthcare professionals, but also a range of technical staff from our teaching hospitals. Uh And we rapidly kind of came to the conclusion that what we could do is develop a system specifically to deliver CPAP and to remove a lot of the unnecessary functionality that was in something like the nippy three, the CPAP sleep apnea machines. And in doing so, we could make this efficient and also low cost so we could hopefully react quickly and deliver these system was where they needed to be. Uh next slide, please. And we were really pleased, we kind of produced this system. Um We were, I guess just behind the curve in the UK because it turns out that the the anticipated kind of peak demand never quite hit the peak that we anticipated. So uh there wasn't a need for these systems in the UK, but we demonstrated in safety tests and working with our clinical partners that these systems could produce equivalent care, uh equivalent performance to CPAP machines like the nippy that I showed you in the previous slide, but a fraction of the cost and they were very, very easy to use. Um So this could have been the end of the story, but actually, we felt that there was really kind of virtue here and we didn't want to just look inwardly. We like to kind of look globally and think, well, how else can this be of use? We can't be the only people who have kind of the need for this kind of system. Um And through some of the links we have at the teaching hospitals were introduced to a fantastic group uh of researchers and clinicians at Mango Hospital in Uganda. Next slide please. And they happen to be interested in looking at respiratory support uh and testing new systems. And we had a long discussion with them about what we could do and how we could collaborate together. And the interesting thing here is that we were able to um run a safety study at Mingo Hospital. So Mingo worked with us and they ran a study with healthy volunteers that Mango Hospital and they were interested to see how this technology might work in their context. Obviously, the context, the environment is very different from the UK, the set of resources, they have a different uh even things like the physical environment. So they reported lots of ingress of sort of fine dust that we wouldn't really get in the UK far to dump here. But they would often get kind of dust, things that would be pulled into the fans. So we work with them and their biomedical engineers as well as their clinical teams to understand how this technology might be of use uh in their context. And um then the COVID wave hit uh the Ugandan um sort of nation and it went across and we were um in this position where actually the team at Mingo had a range of these CPAP devices that we call levy. Um and they were forced to use them in emergency use cases uh with real patient's. So it was a really strange position to be in. But the wonderful thing here is that they're biomedical engineering team um innovated themselves and use these systems. You can see some of them. They're so Rachel was one of the lead engineers, biomedical engineers who really helped kind of innovate, took the, the unit system that we had the levee system uh and hooked it up in such a way with their, with their infrastructure, they could actually support and care for people with COVID. And they did, they did so successfully throughout their kind of their peak wave until things stabilized again. And this was something that we could never have foreseen. So my message here is that firstly, that understanding the local clinical needs of very important, there's no way that we could have had any idea about those local clinical needs unless we'd worked with Mango. And they were the experts in their particular area in their particular context. So they were able to take a piece of technology and use it in a way that we haven't anticipated because they were flexible uh and they could react to local conditions uh and their local kind of challenges. So it shows you that sometimes you have to be kind of, you have to show ingenuity. But having that understanding of the local environment is absolutely crucial in doing so. So that's why we need to work not just across disciplines but across national borders as well. Because as an engineer from the UK, there's no way I could appreciate the kind of demands and the challenges that they were facing in Uganda. Um So working across those borders is absolutely fundamental. Okay, next slide please. And my last case study. Uh So this looks at a system we've been developing um for gas interplay shin list laproscopic surgery, which is a bit of a mouthful. So Gill's is the shortening there. And basically uh Gilles is a technique that's used to allow the use of laproscopic surgery. So again, this idea of using keyhole surgery techniques in the abdominal cavity. So where you lift the abdominal abdominal wall up to expose the underlying organs. Um and this kind of surgery has a lot of benefits or brings a lot of benefits. Um in general, for patient's uh in contrast to open surgery, which is the alternative, you remove the need for this large incision that would go all the way across the abdominal war. A large incision like that means that you're kind of, your recovery time is quite long because you've got to wait for this large incision to heal. Uh you risk hernia, you risk infections as well. So using a laparoscopic technique with just small incisions, means that the patient can recover much more quickly. You reduce the risk of them having an infection and you enable them to get back out of the hospital uh and into their kind of daily life much more quickly. So that's very relevant for low resource settings, particularly when people need to get home, maybe they have caring responsibilities for their family, maybe they're, you know, earning money and they need to support their family. So they don't want to be laid up in a hospital for a long time. Uh It can also reduce the expense associated with having to stay in hospital for a long time. So there's a number of advantages to the laparoscopic technique in general. Unfortunately, it's quite difficult in terms of the level of resources it requires to deliver in low resource settings. So one of the things it uses is carbon dioxide gas to lift the abdominal cavity. Now, that can be difficult to uh to either obtain or to ensure that you have a regular supply of that in these low resource settings. It also demands the need for general anesthesia and anaesthetist team to administer that. Again, these are difficult to obtain in some low resource settings or neural areas which are remote from say big hospital centers. So the gas lis approach innovates by um changing a couple of those scenarios. Instead of using gas to lift the abdominal wall, we use a small, um I suppose it's like a ring that's inserted through the umbilicus and that mechanically lifts the abdominal wall. So you can imagine it's sort of a ring that's inserted through, it's like a spiral through a small incision in the umbilicus. And then it mechanically lifts the abdominal wall. Uh So because it mechanically lifts it, we don't need the gas. So there's no resource requirement for gas. Because of this, it also enables you to use a spinal block rather than general anesthesia. So you don't need that. You don't have the cost and the complexity of the general anesthesia. You have the relatively far more simple spinal block, which can be administered by a lead surgeon. So as a whole is a technique which lends itself to low resource or neural environments very, very well. So our involvement came next slide, please. In that the equipment used to perform this surgery, we need a lift device. So essentially a bit like a retractor, so it can hold this um this disk, this coil that's inserted through the umbilicus, uh and then it can be anchored onto the surgical bed and then used to physically lift the abdominal wall. The challenge was that um the existing equipment used to deliver that had a number of limitations. It evolved over time. So it could do its job, but it was very heavy, it was difficult to clean and sterilize to modern standards. Um And it's quite complex to keep it, it was very vulnerable. Um in case of any damage, it was difficult to maintain. So we stepped in here working with a team um of product designers, engineers, surgeons from the UK and from Northeast India, uh identifying the need for a kind of a modern fit for purpose piece of equipment um that met modern standards. Um And we went, we went away and we went to engineer a new device for GUSTA surgery. Uh And so the first part you can see here is that we took a long time, given the lessons I've explained before to really get a deep understanding of the need and the context. Um So really understanding the process of gas list surgery, the context in which it's used. So what kind of hospital environments would this be deployed in? And what were the needs of the surgeons and the patient's in these type of scenarios? Next slide, please. So that took quite a long time, but it was really, really valuable. And what we gained from that was a close group of uh surgeons and not just one surgeon as I explained before, but actually a team of surgeons who we work with, we went through this innovation process. We often sort of say it's quite an iterative process. So formally, we might call this participatory design, but basically, we worked closely together with those experts, surgeons. Uh not just at the start, but actually all the way through that process. So we produced a series of prototypes which got increasingly more complex, increasingly more realistic until we got to the point where as you can see in the top right, we produced a system that could be used in cat of Eric studies and we did that in India. So we rapidly went through this process. We used a process called frugal innovation. So we tried to keep the system as simple as possible. Uh removing this sort of complexity that might kind of make it more complex, uh more expensive or more challenging to design or to commercialize. We kept things simple as they could be once we had that understanding. But the participatory design aspect meant that those surgeons kept us on track when we tried to make things too simple or missed this sort of the right functionality. They brought us back on track and that was a really important part of the process. Uh Next slide, please, you can see there that we went through a series of iterations, five main kind of loops, five main iterations until we got to the point where we had a really nice candidate system. Uh And at that point, we had to work with another set of partners. So we've had uh sort of designers and engineers, we've had clinicians and surgeons and healthcare practitioners. And now it's really important to work with industry experts because we felt we had a system that could be commercialized. So we worked with a manufacturing partner for the X L0 based in India. They make orthopedics orthopedic equipment and they have lots of expertise in this sort of domain in terms of commercializing equipment. Um So we worked really closely with them to get from the prototype that we had to a commercial version, which had regulatory support. Next slide please. And that enabled us to produce a system in a commercial way which could be used by surgeons. So we could only produce a single prototype somewhere like the University of Leeds. And we couldn't produce that in a way that would be possible for surgeons to use. Uh We wouldn't be able to get the regulatory approval. A commercial company has all the right standards and can go through the regulatory process uh and is able to do that. So it's that bridge that's really important in making our work more accessible. Uh and lots of expertise fed into that process. So there was clinical and surgical know how as well as the engineering kind of testing that goes into that. So all of those aspects kind of combined. Uh And we tested this uh and then the surgeons went uh and you can see a number of snapshots here of them using it inr oral uh parts of India in the northeast of India. And from that point, I'm just conscious of time. Next slide, please. We've been working with that same team to translate the work and translate the use of the system from parts of India to Sub Saharan Africa and through some of our network through our contacts. Uh We've heard increasingly that Sub Saharan Africa, uh in particular Uganda and Kenya, there was real opportunity for this kind of a surgical approach and the need for this kind of technology to support advances in the provision of surgery. In actual fact, the map that you can see there is color coded is shaded according to um the provision of surgery around the world. So lighter pink is higher levels of provision, darker areas, sort of darker reds are where there is less provision or less access to surgery. So you can see it's really kind of fundamental important to work in these areas. Uh Next slide, please. So the nice message here is that we then have been working with those same uh surgeons uh kind of clinical champions if you like. Um And they've run workshops in different parts of the world in Kenya. And you can see shops here from Uganda in Kabbalah. So it's in the south west of Uganda. Uh They've been running workshops to showcase the technology and the approach of gas list surgery. Um two people from different hospitals uh and to to kind of highlight how innovation can then be translated to these different regions. Next slide, please. So I think the important message here is that it's really important to work together. Uh and the virtues of doing that are that your, you build a team which enables you to kind of go through this long journey. Uh and there's lots of kind of challenges along the way, but you need these different skill sets and those same people that have helped us understand the problem. Initially, you can see in the top left, there's uh Doctor Bijou who practices in Northeast India. Um He has now gone on to be an advocate for training in gas list surgery and help people from different parts of the world to gain those skills and to gain the benefits of that innovation. So working with those communities, you actually build skills and expertise that translate as well as the actual technical operators itself. So uh I can't underest, I can't emphasize enough the importance of that kind of collegiate collaborative working together. Um And I think that's probably just brings me to the last slide, a series of kind of thoughts there just in conclusion, but those three lessons to kind of underline um that we need to work together, that initiatives like this, actually, the fact that you're still here listening to this is fantastic because we need to work across disciplines uh as teams and we need to work internationally as well. So not just within one country, but we want to see innovation across different international borders because that's the only way we can kind of really fully understand the challenges of the healthcare challenges and address them in ways which are appropriate to the local context. Um I think it also empowers people as you've seen their people working in healthcare um can and should get involved in innovation because their knowledge is absolutely fundamental to doing so. Uh So I won't go on too long. Um Just to say many, many thanks and I look forward to your questions. Thank you so much, Pete. And that was really, really inspiring talk. And thank you so much also for share ing with so much honesty about the learning points that you've gained from really all, all the many projects that we've taken on and we'll have questions for you uh later uh straighten to introduce in June now. So we have June May data with us. June is an enthusi fantastic and dynamic engineer researcher and senior lecturer with over 16 years of experience in biomedical engineering training and research. Doctor moderate's specialty is in biomechanics and she's the current coordinator of biomedical engineering at the School of Engineering and Technology in Kenya to university. So over to you uh June on gambling a slide up in two tickets. Thank you so much in um Are they on? So as you've introduced, I'm June Maudette. I am uh biomedical engineering uh engineer who's very enthusiastic, I'm trying to see my slides. I think I'm still on a different view. Perfect. Um And I'm very passionate about combining engineering and health sense is just as Peter's just said, because that's a gap we noticed. And yes, I started with biomechanics and biomechanics. It's looking at the body as a machine and you can't do that without involving the people who treat the body and the people who can fix the body. So it's very key. So uh we have several case studies that I wanted to look at. But I thought a new people come with all his innovations. So I thought I'd do context based in Kenya. I'll highlight some innovations next light. So biomedical engineering, it's very new in the Kenyan context. We started it as a as a degree course in 2013. Uh so far, we there are 23 universities in the whole of Kenya who offer it. And we are, as we go on, we're learning and I would like to just give you a path we took, we developed a ventilator during the COVID 19 period. Instead of me talking about the ventilator, I want to tell you about the lessons we learned because we reiterated so many times because we do not understand our own context when it comes to medical devices. So I'm going to give you a snippet of the lessons we learned. And some of the examples from the lessons with London says how to overcome some of the challenges next slide, please. So we cannot talk about designing those states starting on the regulations and standards. If you want to describe that context, if you don't understand how to develop sustainable technologies, we have to understand how it is. So in the beginning of 2020 most of the systems in the area sub Saharan Africa were using the AU process because it was already established, did not require any specification for ventilators. We did not have any. So we had to develop them for our context. We had to understand what the the device was to do. For example, for the ventilator, we we drew upon the medical device directive which is in the eu but there are things that they had specifically, for example, they were not specific about power and some of our ventilators sometimes can't work with the with our power fluctuations. So Kenya developed specifications for our contexts, how it can be classified, how it can be applied so that it can understand withstand the dust in the power uh fluctuations and for the market and different manufacturers in the area. Do we have manufacturers in the region at that time? We were not importing? So how are we going to regulate how a manufacturing center for medical device looks like? Uh next slide, please. Sorry, I'm looking at two slaves. Um The aspect it must demonstrate to operate effectively and safely. It has a checklist that has to be fulfilled with all medical devices, but our checklists could not be the same as other contexts. The responsibility must be determined. Is it the manufacturer or is it the user or is it the designer? We have to think about how this device is going to be reviewed and remember we've never actually had a medical device that has gone to market in the country, designed, made, manufactured in country. So we're learning these compliance had to be important from the time the product specification is done to the time it goes to market next slide. So yes, we did use standards. We we're not going to reinvent the will. Of course, we had ice a standards that we looked at to think about the quality of the systems, risk management and other various guidelines for clinical investigations. We also thought about uh the electrical components, the sterility of the components. And of course, the it was a device that is going to be important in the body. So we were like, okay, it's not only one uh standard, we're not only going to look at what the Kenya context is, we're going to look at how safe it is for the body. So we were learning as engineers as I said, we came, we made a ventilator in less than a week, but we do not look at standards. We did not look at regulated Buddhists and we do not look at the user which is very, very key. So we had to start the process again because we had uh the uh Bureau of Standards next slide, please. Uh huh. Coming for certification, they started asking us the question that the ISIS standards want. So they were like, where are the boys? The conformity matrix? They're like, oh we have to do that. We went back to the drain book, always the risk management plan. We're like, we didn't think of that. We had to go back to the drain both. So we had all these doses that we had not thought about and it was important for us to do it in the beginning. And this also informed the Bureau of Standards how they can address when a medical device goes to market. Next slide, please. So as I informed, we used the common international standard. I so when it comes to medical devices and it was interesting to start and dig into that rather than just teach it, but actually use it on a device that we have designed. Next slide, please. We had specifications that as I said, the Kenya, our Kenya Bureau of Standards used all the information, the land from our findings to come up with a critical care uh specification which we advised and they also learned from us, which was actually quite brilliant because it brought about quality specialists. It brought about standard and regulatory bodies. It put about all the engineers, all the users, the anesthesiologist come together in a room and actually start discussion of how we can get a medical device to market in our region. Next slide please. This is just showing that we have uh another board which is called the Pharmacy and Poisons Board and it has guidelines on conducting critical clinical trials, but they have only conducted trials on drugs, never on devices. So this is also knew we in we helped inform as academia, what are the steps that need to be taken? For example, for drugs, they have to have a placebo for a device, you cannot have a placebo over ventilator. For example, how do you advise that? And how do you go ahead, how do you enter different phases because they have strict guidelines on different phases. So we helped inform that we are different visits. I want to go into details with this to the next slide and all the visits were informed by different aspects that they've seen in other devices, but never from medical devices. So we're learning together, for example, as I said, we had to use uh standards for the sterilization. We had to have manuals in place, we had to have protocols in place. We had to have good manufacturing in place. Next slide, we have to look at the electrical safety and this was one of the toughest stages because as I said, we just invented and we thought we'd just go to market, but it had to pass certain safety guidelines and this was informed by the standards as well. Next slide please. And finally, this ventilator had to be operational. We have to look at calibration, we have to look at different confirmations that it had to go through. Not because we're thinking about the safety of this patient have to think about labeling different interfaces that are going to be used. And this really informed us as academia, as a nation, as a country and all the all the regulations and standards bodies on how we can approach the the learnings of a medical device development. Next slide, this is just reiterating the different uh device to see how we needed. We needed technical features like the drawing and the composition. We need the risk management. We needed bench testing, we needed to get clinical data. So it was not just about making uh something in the lab and taking it to market had to go through different processes. Next slide please. As I said, we have to look at clinical trial. This is going to be an invasive device. What is needed for this protocol to be discovered when you get to do the protocol and learn how a protocol for devices conducted. We need to submit this to an ethical review committee. We need to submit this to the poison pharmacy and poisons board in the country for a review and we need to get clear clarification to that and to the hospital to approve. So we learned through this process and by the time we got to this process, we had so many reiterations. We wish we started this from the beginning. So this is the journey we took as Kenya to understand the medical device landscape. And we got to a point where we had um an idea of what steps you can take. And we developed different groups, different multidiscipline in groups. So we can, we knew how to do the documentation from the beginning, we knew how to understand what standards to purchase or to access from the beginning. So from this information, when we started any device development, we knew what steps to follow. So I can give you an example of some of the devices that we've gone through next slide, please. So we have the uh and a need that was provided to us. We need an affordable alternative to the whole laparoscopy procedure. Pete has shown you how you can have gas lis procedure. So we were asked, okay, can we do we have to have the whole light system that is very expensive to be used? Can we simplify it, use the Gas Tlhis kit and also use the a simple one. So we had this discussion with the users from the beginning. We put a team together from the beginning. What is needed. We started documentation from the beginning even when we still had the drawings. So the components that were chosen were specific for medical devices. The imaging that was received was what we needed. So it did not take as long for us to actually go to the point of having a prototype that is working next slide, please. So I want, I want to go through all this, but we developed a device that can actually be showcased and um you know, given to the users not exactly used on the patient, but we have a device that can actually presented and demonstrated and we get reiteration from them. So that process people saying where you're okay, they'll tell you to address, remove this, you change the iteration to to fit what the user needs. Next slide, please. That's just my team working in the lab. It's not a medical device, certified lab, but it's a start next slide, please. You can go to the next innovation and it's nothing time. Um Next. Yes. So we have another device that I can. I'm very proud of. It's a phototherapy box. It's not surgical, but it's used in the newborn unit next lead. So we had a team from the uh from the lab put together a design that okay. The problem they are solving is we have very big phototherapy units that are made abroad. And when they come here, we have very many babies that need to use and most of the hospitals can only afford one or two and maybe you have 60 babies. So he came up with a design where you have the same, the um phototherapy lysed occupies the same space but can take up to three babies without passing infection across each other. So this is a problem that was found by the user. The user said we have this problem. I don't want all my babies to be in one unit. But I have to, should I ignore one baby and put the other one, how do I choose? So this was a design that actually came from the user next slide. So we managed to prototype it and we, we took it to the user and the way they said it's something that can work because actually the light was not coming from above, it was from, from the side. So each component, each uh each of the three was getting the enough flights that are needed. So our next step is to see how we can get this done. And all the out out outputs that we use the properties of the material, all the frequency that we needed. The wavelength of the lives that is needed was was able to be achieved. Next slide, please. So another one is a suction machine. Next slide. So one of the students went to the hospital as well and they discovered that most suction machines in the lab are not uh have a backlog backlash. So when the section happens that the liquid goes back and spoils the mechanics within the machine and there was not affordable unit that was in the market. So they developed a device, it's still in early stages. So this is just showing one that has been put together in the lab. So the the simulations that done this was put in the lab and it was able to stop the process if there's fluid passing through a, a certain place, then it stops the process and the fluid does not go back to the uh secretary and uh damage the machine. So this is another thing that the user came to us and said we have this issue. How can we mend it? Next slide almost done. Another one is the medical gases monitor with the remote alerts. Again, the student went to the hospital and found that some of this the gas is finished before uh the the information reaches what whatever it is, the gases are normally placed outside sometimes a distance from where they're being used and these manifolds that go through the whole hospital. So how can we know that the cylinder is almost halfway or almost done or damaged? So he came up with an I O T based um up and device that is attached to the manifold that can be able to real time monitor how much gas is in the cylinders when it's time to change. And if there's any fluctuation in pressure, which is a problem that was discovered. Again, we got this problem from the users and return it to the user and we're trying to retreat it to fit what they suggested. So the next slide we can skip this one. Um Same time I want to emphasize on the challenges and limitations. So next slide, this thank you uh for us, we found that calibration equipment was very hard to get and sometimes very expensive. And that is something that would be nice if it was easier to get because we are doing the testing before it goes to the market. Um sometimes getting parts in country to complete a prototype was quite difficult. And sometimes the manufacturers are, you know, if you, they don't want, you can't buy one piece, they want you to buy 30 pieces. And sometimes for a medical device, prototyping, that's not possible approvals for regulatory bodies sometimes are in silos and they take too long because there's a learning process, especially when it comes to devices. It was important to have a dedicated team to test and go through the process. And sometimes you either get the team starting the beginning and they drop out because the process takes too long or sometimes that you get a new team member coming in and changes the whole process. So it takes you back. It's very important to have that from the beginning. It's good to have space and capacity to prototype. And of course, this means funding next slide you can go to next uh next idea again, reiterating what it says. Multidisciplinary team is very key. Um document documentation from the beginning is very key. Sometimes it may take you back and approvals, take a long time to be patient and not quick to go to market. Also uh saying what you said, you don't think you're going to go on the whole thing and that enabling space is very important. Uh Sorry, it was the end, I've gone fast. But I think my most important key message is the context, the challenges we have and how we've come to overcome them and learn some of the lessons. And I would love to collaborate with anyone to get insights from the uh from uh everyone out there and to understand how we can improve or even how we can add to what we have. Thank you so much. Then go to the final slide. It has made contact details. Thank you. Thank you so much. Thank you. Thank you June and thank you people for really inspiring uh talks on tech technology in biomedical engineering and how it really affects our clinical work. So to our audience, keep the questions coming, I'm just gonna uh start off our kill any. I have a question uh really to Pete and doom. Uh You talked a lot about uh collaborations working across a multidisciplinary team and really for peace, you have even highlighted. So multinational team's working together. I just wondered if you had any challenges or any uh insight that you, you uh any problems that you experience with, with sort sustaining these relationships because oftentimes, you know, clinical demands can get in the way of things and you know, affect these partnerships. What, what's your experience with that? Um I can go quickly June and then passed to you if you. Um so maybe Um So one interesting point here is, is the, the last project I mentioned um with the gas less surgery, we were fortunate to be able to, to travel in person to India uh and to meet a group of surgeons. Um there was some funding that enabled us to do that. And so we all got together and met face to face and I think where possible, there is nothing better because you, you just, you start to understand people on a, you know, you make those kind of personal connections. And that meant that subsequently, when we had to do things remotely, actually, the pandemic meant that we did a lot of the development work during some of the lockdown periods. But because we established that good rapport, that good working relationship previously that really helped. So we kind of had that good working relationship to build on and to uh and to use, I guess that's not always the, you know, that's not always possible. And actually the, the project we did in Mango uh with in Uganda, in, with Mango Hospital, I've never been and we as a team couldn't travel because of COVID and that just relied on being flexible. And I think there is perhaps one of the things that I've taken from this, that as an academic, I'm often set up my computer, typing away, marking reports or whatever. And that's not the reality for a lot of people, particularly working in healthcare where they might be very busy day today. So email might not be the best communication or setting up multiple teams meetings might not be best. And actually some of the the most useful communication we've had there is via say whatsapp or sort of much more agile communication platform. So I think it, it's kind of responding to the needs of the overall team and being reactive to that. So you can't impose, this is the way we do it. You have to sort of work as a team to find methods that work for you. So that that would be some of my kind of um yeah, where possible meet in person but otherwise be flexible and be reactive. Uh Thank you Jean for me. I think Peter's mentioned most things. Um And for me, I think one thing that I found is you need champions, champions that are actually passionate about what you're doing and sometimes the champions come from uh in person meetings or even just responding to an email or inviting them to a seminar, they feel like they're part of the journey, part of the process. And yeah, communication is also very key. Um I think if 11 person communicate on the other one doesn't and vice versa. So you have to find a way that you can both communicate. Um not only uh stick in your lane but try and find out how best to communicate with them and that move things along. And also just to bring people up that, uh you know, our students or the interested in research and are interested in innovation and, you know, just trying to get them to um uh stay in your dream or focus on your dream and then they'll bring more people on and they also have friends in other different discipline, the different countries and that also helps some of us are stuck in our ways, but they come with a, with a nice picture. Thank you. Um That's a great talk for both of you. Thank you so much. Um I was just monitoring the chat box um around very good feedback. Um Actually Anele me and Jean were both were all actually in Kabbalah. So next door to us when we were seeing what was happening in the Gills workshop and we had some joint playing and hearing from Profit now Garage. So it's, it's really hum to see how things are going. So, thank you so much, uh Emmanuel um made a comment and I think that was directed June and all round compliments again is that uh saying the first steps are always the hardest. Thank you for breaking the ground and setting the pace in Sub Saharan Africa. We seldom think about our uh innovation of our own technologies but happy, overly dependent on developed countries so well done for setting the pace and setting the ground. Um That's wonderful and I must say, um I haven't seen what you guys have been doing. I don't know where you find your tenacity and your pash in for your job. I was just like all hats off to you all in uh pursuing and pushing and keep sending those envelopes out and that's, that's all around humbling experience. Um Any other questions on the audience one minute left? Um And we really take it. Sorry, go on there. Oh, I was about to be cheeky as well because um any steep peaks about what your current projects are and how we can help is basically um my, my question um as we have got an international multi disciplinary audience and that was the strength of gas on. So anything, any anything you're working on that you need someone at Ward's the term again, participatory engagement. Uh We're more than happy to give you uh whatever we think about things. So, yeah, any peaks of what's happening? Uh interestingly. So we, I met June recently, we went to the uh Isaac's conference in Kenya. Uh um And that was really fantastic to get some good discussion's going. Um And one of the areas that I think a few people have been working on is around the area of surgery, um visualization, light sources. Um So camera systems for laproscopy, uh I guess not limited to laproscopy, but typically they're kind of expensive and um difficult to maintain. Um So I know June um some of her students presented some fantastic work at the conference. And a group from Delph that we've worked with are also interested in this area and we have also had interest in this area because it kind of goes is quite complimentary to the lift device. Um So we had some I think broad discussion between us all that it would be nice to collaborate. So hopefully looking ahead, we can all kind of get together. Um I guess the space is kind of there for us to hopefully work together and see what we can do in this area. Mhm Yes. Um The laparoscopy one is something that's key for me. And because the thing is we've got students who are interested, mixed with stuff, mixed with like it wasn't all a project that the student will abandon. So it's something that will go on. They met with Pete, they met with the team from Delft and they met a team from India whose also trying to do the same thing. So this whole surgical area, I think it's something that we can definitely collaborate. Um as, as I sure do, we have different student projects where we can definitely collaborate. Um We have to do it, we just do projects abandon them because they've graduated. So they don't need to make money or anything. So that collaboration would, would be very key like I try and get them to present their work, try to see if we can get some funds. Okay. Let's go for conference. So they feel like they're, they're someone is listening to their work and um something like that, a collaboration even just, you know, publishing or even a shelter from Peter. Uh It always works. Um And yes, so just ideas on getting our students motivated because they are very smart, but they, they're all silent. I don't know why uh the move that along would be amazing. Amazing. You're giving them the less. So hopefully we'll see more and more of them. Um That's wonderful. Gene, your cheapy question. Uh I'm just raising one more question, have given the opportunity to the audience. I'm gonna get my question and it's a question, uh two piece really about the guest list, laproscopy. Um I think we have a lot to learn, you know, in terms of building uh low costs, uh equipment and, and, and uh sort of in the context of conservation. I just wonder, you know, um in, in, in the UK context, what, what is the take up of guess less laproscopy as uh it's a really interesting point and I think um here often it's seen as maybe a bridge. So I think if, if full gas laproscopy could be offered, um people probably wouldn't adopt gas lists because although it can produce kind of comparable surgical views in a single quadrant, um if you want to do some more complex procedures, um then I think there are some challenges. So it's, it's particularly suited to, I suppose more routine procedures like removing the gallbladder. So luck Kohli's and things like diagnostic laproscopy as well. So it's very good for those kind of core um procedures. Um I think there is sort of more broadly something to learn though about that kind of, it shows that you can kind of take something which is a, a routine procedure. And so the U K A gas uh laparoscope, uh laproscopic operation and the resource uses huge. Um We did a green surgery challenge and looked at all of the, the resources that are used and often now we use single use instruments in the UK and it's incredibly wasteful. So from an environmental uh and a cost perspective, moving away from that and looking critically at the kind of the equipment that we use, I think is really important. So there's lots of initiatives, I think there's lots of overlap here to think about global health or better provision of surgical instrumentation worldwide and also environmental sustainability because the to kind of go hand in hand if you're designing responsible reusable equipment, uh it should also be inherently uh you know, environmentally sustainable as well. So I think there is some good sort of lessons and ways that we can maybe harness some of the, obviously the trend certainly in the UK is to fund lots of areas of sustainability. Um So if we can kind of piggyback off that, hopefully we might be able to benefit um for the global community. So I, I don't know if I really answered your question. Actually, I think I went off on a tangent but really answered it. I, I think there's so much by direction or learning really and things that we can pick up in terms of reducing weight stage, you know, keeping an eye out on environmental sustainability. Because when we're not, we're not just looking after the patient's in front of us. We are looking after the patient's in the future as well. Yes, absolutely. Thank you so much. Is there anything else you would like to add Julian Pete? I'm just thankful that I've come, I've got to meet, I feel like I know you, but I'm happy that uh this has happened and I'm waiting for more collaborations and uh contacts from anyone that is interested. I'm available. Thank you. Yeah, just to echo that. So I think it's a great message that as a um it's a really good uh gas stock is great and just that's the place where ideas and new innovations come from. So, um engineers gonna do things if we understand new challenges. So, yeah, keep the ideas and communication open. Thank you so much to June and we thank you so much for your precious time and giving us uh very great talk. Um So to close this session, I just like to thank everyone again and thank you, put that on speakers, Lember E G. Uh And hopefully you'll see Maria in a catch up content. Uh We'll recall later on. Uh just have to along all our audience that could be a certificate of attendance. You can fill out our feedback and we'll be able to get certificate attendance. And all of this talk that we've done today will be recorded and again, uploaded has catch up content. Hope you've all enjoyed very inspiring two hours. Hopefully, lots of new ideas to come in the uh upcoming through your Innovation Schools, of course. And uh do you have any questions people in touch, uh guess off and we can put you in touch with us because so thank you everyone again, let's say goodbye now. We'll see you at our next event. Thank you. All right.