Cutting-Edge Maternal Health Technologies to Address Postpartum Hemorrhage & Preeclampsia/Eclampsia

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Good morning good afternoon and good evening to  all my name is Patricia Coffey and I work for   path path is an international ngo headquartered  in Seattle Washington in the united states with   a global team of more than 1500 innovators  working in more than 70 countries to eliminate   health inequities so people communities  and economies can thrive next slide I am pleased to be here today to moderate our  panel and introduce our product development   partnership called the devices diagnostics and  drugs to address women's needs pdp or dawn a pdp   is a collaborative partnership between public  private academic and philanthropic sectors with   the goal of developing new products for people  suffering from diseases and health threats   underserved by traditional markets a report that  came out in January of this year entitled keeping   the promise product development partnership's  role in the new age of health research and   product development looked at the role and  performance of pdps in the global health sector   and they found that pdps are global leaders  in developing new health technologies where   lack of traditional market incentives  have stalled progress pdps achieve impact   by developing products appropriate for the  people and contexts in which they will be used   pdps save money and are a cost effective way to  save lives and grow economies they build local   capacity to perform research and strengthen health  systems and the products that pdps develop are   essential to achieve universal health coverage  and the un-2030 sustainable development goals   next slide the dawn pdp focuses on two of  the major direct causes of maternal death   postpartum hemorrhage and preeclampsia eclampsia  or hypertension as you can see in the pie chart   postpartum hemorrhage and preeclampsia eclampsia  together make up almost half of all maternal death   although the maternal mortality ratio dropped  by about 38 worldwide between 2000 and 2017   still every day in 2017 approximately 810 women  died from preventable causes related to pregnancy   and childbirth and for this reason we are focusing  our pdp work on developing innovation to address   pph postpartum hemorrhage and preeclampsia  eclampsia next slide the dawn pdp supports   activities across the spectrum of product and  market development shown here on the slide another   way of saying this is that we do end-to-end  product and market development which enables both   a sustainable supply of product and the necessary  demand to support product sustainability on the   African market we developed these life-saving  technologies by using a human-centered design   approach and in partnership with ministries  of health research institutions manufacturers   and companies in Africa we accelerate them  through our path product development process and   work with public-private partnerships and  introduce them into key African markets   our products are in various stages of product  development ranging from early concept validation   on the left hand side of the slide to introduction  and scale on the right hand side of the slide next   slide the four products that are currently in our  dawn portfolio are shown on this slide of note is   that the two products on the left hand side of the  slide the lrv uterine balloon tamponade and the   protein-to-creatinine radiometric diagnostic strip  test are downstream in the product development   process under the dawn pdp these two products are  being introduced and scaled in Ghana and Kenya   the two products on the right side of the slide  the relied delivery system and heat stable   oxytocin in sublingual fast dissolving tablets  are more upstream in the concept validation phase   of product development next slide the agenda  for our presentation is shown on this slide   in the interest of time I will introduce all  of our presenters now Dr Sylvia Degenes is an   accomplished obstetrician gynecologist and public  health physician with over 25 years’ experience   in safe motherhood and reproductive health Dr  Deganus is currently consulting in maternal and   newborn health issues in Ghana and elsewhere Ms  Charlotte Tavia Ajman is a senior research fellow   with post-graduate training in public  health nutrition and social sciences   she has been working at the contampo health  research center in Ghana for the past 20 years   especially in the areas of nutrition and maternal  newborn and child health Mr. Dan Myers is a   product development engineer and has worked for  over five years in the path product development   and engineering laboratory his work at path is  split between drug delivery devices and vaccine   cold chain equipment Ms. Jacqueline de la Rosa is  a program officer at path she is a public health   scientist engineer and acts as a research project  manager to facilitate and implement the evaluation   development and introduction of product Ms Mitsumi  Metzler is a senior commercialization officer at   path where she handles the commercialization and  introduction of medical devices pharmaceuticals   and diagnostics products to improve maternal and  newborn health finally please type any questions   in the chat and we'll do our best to answer them  during the q a at the end of our session thank   you very much now I invite Dr Sylvia Degenes to  present on the llv ubt next slide thank you Sylvia Sylvia we are not hearing you right now Okay so hello everybody thank  you for the invitation to share   my presentation with you I’ll be sharing with   you the Ghana experience of introducing  the larvae and innovative environmental That’s right well in my presentation I will  tackle address three main issues   I’ll look at the facilitating and individual  factors to write producing the larvae uvp   I’ll then talk about how we set about training  and supporting our providers in using their logic   liberty and maybe to end it all I’ll share  what the next steps are for this company   Sylvia could you speak up just a little  bit it's really difficult to hear you um I was saying that in my presentation  I’m going to address three main areas   I will look at the facilitating and inhibiting  factors to introducing larvae into the country   our very touch on how we were able to train   and support our providers to provide care using  their loving ubc and to end my presentation and   fashion what the lessons for the country are  so when we start up and look at some of the   factors that facilitated the introduction of the  learning unit into this country the first and   most important factor was that we have partners  in countries and we're able to mobilize our key   stakeholders pub is a well-recognized national  partner in fight against pph indeed in the past   park have worked with the country nationally on  various fronts to address maternal death from pph   we have looked at ositosin safety as that  surveys in this country they have helped   the country develop policies and guidelines and  also have gone ahead to how the country's trained   in nutrient balance sometimes using condom  components which was then the most accessible   balance component and these have set the tone for  this program indeed this was seen as another step   in the fight against gph when our health service  was therefore very ready to lend its support   too fast to introduce this interventioning  country other things that were of benefit   to this country was that we have been able to  register their product in country and having   identified a country distributor who was already  engaged to provide in our community next slide there's to introduce this device as well we  set about using the implementation research   approach we're able to identify  in-country champions and recruit   them and these persons who are respected of  the facial cardiac ecologist and selected   leaders in the facilities that were going  to introduce their lobby to also offer to be   principal investigators in this  elaborate implementation research   and also most important was the fact that I  experienced the country's experiences from   using the condom component have contributed  to the development of the navy uvc let's slide first implementation research which we were going  to done won the confidence of most providers   because we had ethical approval from the Ghana  health service and what we were doing was not   testing the larvae uvp but to generate evidence  for its successful uptake and adoption into the   country so it was seen as a long-term process and  not just as a research of the product that's life there were a few inhibiting factors as you  can see and most important one was the knight country and it also required modification to  their study protocols and so we had to introduce   combinating guidelines into all our training plans  and activities for example the social dispensary   limitations meant that only small numbers of  participants could be trained at this time and   therefore we have to have several of more training  sessions to meet this image note that this was a   very practical cleaning approach so in the next  few slides I’ll share how we were then able to   proceed with the lovely training introducing it  to care providers and those facilities let's slide to start off what we did was to build on  the previous experiences we have gained from   in-country condom component training and  we adapted the training materials that we   have from these previous trainings for using  the elaborate training we had locally made   for more velvet models which we further adapted  for a larva training these models which were made   by ourselves were very available and we could even  leave some of it for some of the facilities to   use we also selected three health facilities with  high caseloads and who had familiarity with condom   component uses so we could get the numbers and we  had the supplies as I said a country in country   distributor was available and we had ordered  enough supplies for the participating facilities   so these preparatory activities were all important  and set the tone for the training next slide the training itself was very focused  and it focused on three areas   we focused on the diagnosis of management of  cbs and how elaborate ut could fit into this   into case management we also focus on how  to prepare and apply their lab and the third   component was to prepare them participants for  their role in the implementation basis next slide we had three facilities involved in the training  and this meant that we're doing an on-site   training over 90 percent of care providers  on these sites could therefore be trained   because we're moving to them within training of in  small batches of about 20 persons per day at each   facility because of the covid 19 registration and  onsite training mentor facility managers and even   my district managers could be could participate in  the training and see how this was going next slide our training was competency based and we use  a variety of interactive learning approaches   we use quizzes we use videos and of course we have  simulated female models for our practical sessions   the first few balls you can see in the picture  with the arrow pointing short how we're able to   demonstrate severe cpa we had colored water to  be able to because we recognized that diagnosing   severe cph was a challenge and we use quizzes  to elaborate this point next slide learn it was   daily by doing in the next few slides you see  how participating this learning was that's like So it was demonstrating everybody participated   and they could practice the recession  and the removal and they had several   models we have several stations for the  participants this was supported I also used   of the labview video which was demonstrated as  participants practicing their skills next slide this shows more videos of all  the participants in groups of   three and four working on their less life more training so it was hands-on training and  whereas we believed in the concept of what I do next slide these pictures are all showing everybody was  involved in this training we have the doctors   we have the nurses we have everybody  the managers we're on board next slide and so what were the accounts of these trainings  in total 237 persons including two managers from   the general health service headquarters  were trained in the three facilities   the participants included midwives doctors nurses  and these were drawn mostly from the labor walls   the postnatal the antenatal and maternity unit of  those trained about 90 percent were eager to use   the device and concentrate to participate in the  study we made sure that at the end of the training   we had supplied the three facilities with enough  ubc's to start up and also had enough for backup   and we made sure that these supplies were went  through the normal logistics supply channels   through the facility stall  and normal systems next slide our free and post-course assessment  shows that learning indeed has taken   place at the beginning the lowest  call was 6 over 25 as you can see   but at the end the average falls were all about  22 over 25 with a minimum score being 17 over 25   indeed 15 participants for the maximum score of 25  so learning in this took place overall next slide other point of note was that we have directors  in charge of family productive health and that's   dropped here standing there taking part  in the training and learning and seeing   these were important we also had the distributor  being in alongside with us making up to the   managers and the potential users and this was also  very important in strengthening his introduction   into the facility indeed we also had another  case actually while the training was going on   we were able to show how effectively love we went  because we had kids in case that okay that would   be used to demonstrate how  effective the program was next slide after training we continue to mentor our  clients and our sites we established a   24-hour phone-based contract for support and  discussions we set up a WhatsApp system and   we have also been able to visit these sites  on some occasions to talk to the users and   discuss any challenges they have there's been  a few very few challenges most of the time   this has been that sometimes doctors have used the  device but have not reported it to us next slide so what have been the post  training outcomes to date   the device is being used in all the three  facilities and today has been used for about 24   cases we had one unfortunate antenna that it  was due to hemorrhagic shock but generally   it's been very exciting it's being used by both  doctors and midwives directly in case management   and the users have often reported that it's  very easy to apply we've had very few challenges   and we've even recently been approached  by the collaboration hospital which is our   largest seeking hospital and they are very keen  on introducing the device on similar in a similar   fashion to their facilities they have initiated  steps to purchase the device for use next slide so this shows a breakdown of the use of  the device we have 265 persons spraying 210   agreed two other persons have consented to be  part of our implementation study after reference   and so far we've used it on 24 locations  this is after extensive pro next slide so what have the conclusions we have taken the  first step as a country and I must say Ghana has   successfully introduced the innovative Vietnamese  into three facilities in countries we've had   effective key stakeholder engagement we have  committed champions and these have facilitated our   competency-based trading today 23 lives have been  saved and I think this is a good beginning thank   you all and I wish to end my presentation thank  you for your attention yes I just missed the next   slide let me go on yes what are the next steps the  next steps are that we will continue to find ways   to scale up 11 in country we hope to be able to  disseminate the information about Belarus to our   national and regional key stakeholders  and work through the associations like the   society of sufficient gynecologists and regional  associations that midwives association we hope to   cross the use of larvae and make sure it's  integrated into pph management costs under   the national health insurance system and we want  to plan for progressively expanding training   nationally to all emergency of capital  units in countries thank you all very much thank you so much Dr Degenes we really appreciate  that next slide please and now we'll move   to charlotte ajimon we'll talk a little bit  about our proteinuria creatinine test charlotte   thank you very much Patricia for giving  me the opportunity so I would like to   talk about understanding uses their needs  and wants and as a critical approach to   increase adoption of protein creatinine tests  by anc healthcare providers next slide please so as part of them as a background pre-eclampsia  it's among the leading causes of maternal death in   worldwide and as Sylvia mentioned it is  a a challenge also for us in Ghana so   and preeclampsia is responsible  for about 10 to 15 percent   of maternal deaths worldwide and in Ghana I’m a  maternal mortality ratio it's about m3 per 100 000   live bits of which about 10 percent is attributed  to pph or eclampsia and preeclampsia so as part of   this study that we conducted in kintampu north  and south in the central and belt of Ghana   we understudied some midwives and community  health nurses who are mainly responsible for   attending to pregnant women at the community  level when they attend and antenatal pay so our   location we are based in now no east it used to  be the bronze half region now the region has been   divided into three so we we are now based in the  puno east region and preeclampsia and eclampsia   and other hypertensive disorders in pregnancy  account for about 20 percent of maternal mortality   in this region where I currently work  and midwives like I mentioned earlier   are the primary care providers who provide  anc services to pregnant women as at the time   that we are conducting the study we had  about five community health nurses to one   midwife so it was really a challenge we had  most community health nurses providing anc   services with few midwives and also providing the  services at the community level next slide please so who recommends that at every  anc contact every woman is craned   for preeclampsia and what they are to look out  for is elevated blood pressure and proteinuria   in the urine and protein in the urine so these are  the key indicators that we were looking out for   so for the life assay diagnostics that  we were testing in our study area we   set out there to test the protein creatinine  dipsticks which is a simple tool to use it   has two parameters first to read within one minute  your result is ready sorry and then it also helped   increase accuracy over protein only dipsticks as  an account of the level of urine dilution and then   in terms of course it was comparable to protein  only dipsticks and what we see on the screen is   a graphical presentation of what's the protein  creatinine lipstick that we used let's like please so sample health research center where  I work and pass we collaborated to   do a usability usability tests on the protein  creatinine test using the life acid diagnostics   this was in 2016 and our aim was to evaluate  the usability and acceptability of the test   with focus on test interpretation and then getting  feedback from the end users because at the end of   the day is the anc workers who are going to  use the device so we wanted to find out from   them get their feedback in product development  and for our results for the usability tests we   the anc providers agreed that it's acceptable  and easy to use and they also identified some   common challenges which was to do with timing and  then interpretation of the results in 2019 2020 we   went ahead to test the results in a real sample of  1482 pregnant women in six facilities health and   facilities across our study area so our aim was  also to assess the accuracy of the prcr tests   for detection of proteinuria in the study area  and our results showed that there has been a   10 to 15 percent improvement over what's the  protein dipstick that is already in the system   this was our expectation was lower than  normal because we're expecting between   75 percent sensitivity but at the end of  it we had between 50 and 65 sensitivity   which also was not bad it had an improvement over  what was already in the system let's like please so as part of that we also wanted to find out  to understand and how the users would also come   up with a digital tool or we coming up with a  digital to how are these also going to help with   the screening processes of pre-eclampsia in our  anc settings so as part of that user research we   set out three objectives one to understand the  process of preeclampsia screening and care in asc   settings in our study area and also to identify  challenges and opportunities for improvement   our second objective was to understand the typical  day in the life of an anc provider that is once   they are working from morning to evening what are  the challenges how are they able to screen women   for pre-eclampsia we wanted to find out that and  then also to evaluate the usability of a digital   application if it's in use for automatic  interpretation of the urine dipsticks among   our staff that we or the healthcare providers  that we did the study with let's slide please so for our first objectives um sorry yes for our first objective the method that  we used was a focus group day discussion with the   midwives and then the community health nurses that  we used we used 20 of in all for them to come out   with their challenges that they face in their work  and also probably to also introduce a screening   process where midwives are supposed to go through  this that's from first to last or from a to z I   mean there's a strict projection that they need  to go through so for this one we gave it to our   community health nurses and our midwives to go  through it and then they revised this screening   process based on the work that they do in their  facilities and for the findings urine screening   in decay tests of plus two shows that you really  end coupled with elevated blood pressure you need   to refer to the district hospitals I mentioned  that these health workers are coming from   a lower level facilities so it's not the  district hospital but it's from the community   level facilities and for the chips compounders  the community health plan based planning services   that's the lowest of the health services they have  different referral practices due to availability   of the dipsticks or sometimes they don't even  have the logistics to test for preeclampsia or   to screen for pre-eclampsia so the urine  intestine was also conducted at first anc   and when the bp is elevated area in the district  hospitals they always do these testing anytime   the pregnant woman comes in contact with  the health care provider next slide please so for our second objective and we also wanted  to define the key challenges of anc providers   to better inform the product development so we  gave them the opportunity and they came up with   some challenges which we ranked they  came up with several of them and each   health care worker was given three votes to come  up with the challenges so after ranking them these   five came up as stops communicating with patients  because in our study area it is a multilingual   area and we there are about 21 languages so  the midwives have challenges speaking with   directly with their healthcare and their  pregnant women and sometimes finding an   interpreter at the point of care was  very difficult and which also makes   in healthcare a bit challenging to provide quality  of care shortage of staff was one thing that was   mentioned fortunately Ghana health service is  providing more midwives into our facilities now   availability of essential supplies does the drugs  the diagnostics to even test for or screen for   pre-eclampsia late a nck seeking which is also a  very big challenge it cuts across all not only for   pre-eclampsia but women attending anc fights  leads and then shortages of the anc booklets   for record-skipping in terms of their death takes  they also came up with some challenges which they   mentioned about the color not matching what is on  the bottle that is if you are able to do the the   testing matching it on there but colors on the  bottle really doesn't match so most of the time   they lose confidence in the interpretation  and then reading the results at the correct   time this was also another thing when clinics  are busy was another challenge that they talked   about and then availability of the urine  strips sometimes they are not there and   trying to attend to most of the women the some  of the healthcare providers were cutting their   strips into two just to make sure that the women  that they are saving at that particular time   would also be getting to get  to be tested next slide please so out of the challenges that they came up with  we developed a persona for the local providers to   inform the design of the new interventions and  our main aim was to communicate user needs and   then inform products development and also build  understanding within the multi-disciplinary teams   and keep the users at the forefront of the design  efforts because at the end of the day they will be   the end users so we thought that we should engage  them at every stage on the way so we developed two   personas one for the community health nurses and  one for the midwives and the results and also we   validated and refined through secondary research  we did another follow on interviews with another   15 and 20 healthcare providers coming from 19  facilities all within our study area and this   was by focus group discussions and interviews  with the healthcare providers next slide please so in terms of understanding the  considerations for new digestive   supports for pre-eclampsia screening based on the  challenges that they've mentioned if we introduce   something that will help interpret  the results how do you take it so we   use an existing digital solution this can well  dipstick test which this one was for uti but we   thought that if something like this is developed  for pre-eclampsia screening how are you going   to do that so for this one we gave this this  scan well test for them to try their hands on   and also to feedback to us so we did observational  interviews as well as individual interviews and   after trying their hands on we also interviewed  them on ease of use priority features for digital   applications in terms of key findings  and there were priority features that   the end users also informed as timeless  they needed clinical decision making support   paper and digital instructions and optional  training videos these are some of the things that   the way requiring to be features of the digital  application another key considerations were   reduction in time to run the test compatibility  with android phones which of course most of them   have and connectivity both internet and  electricity was something that they also mentioned   will be of key interest and compatibility with  different multi-parameter lipsticks so in case   you are doing the protein-only lipstick of protein  and creatinine will it be possible for us to also   add glucose and hemoglobin to it as well so that  at the end of the day they can also interpret   all these things using the digital  tools application next slide please   so in summary shortages of their supply kits  was limited they were abandoned staff and   communication barrier was also another challenge  that was informed that was communicated to us   precise windows and color metric interpretation  poses a challenge for the healthcare workers   with analyzing their urinative states and  the guitar tools they really supported it   and the health workers supported the  digital use in interpreting these   information but they required the adaptations  environmental content contextualization to   solve the challenge in our anc setting and also  in pre-eclampsia screening next slide please so in terms of next steps there is future considerations to optimize  anc for preeclampsia and eclampsia screening   so what we intend to do is that the potential  value of bundling innovations to provide more   comprehensive solutions to end user users  including new diagnostics like that protein   creatinine with emerging m health tools will  be of immense help to our health care providers   and under the dawn pdp that's Patricia mentioned  two implementation research in the planning phase   to evaluate introduction track strategies to the  protein peritoneum test within anc settings in   Ghana and also potentially self monitoring  in Ghana and then in Kenya next life please thank you very much charlotte we really appreciate  thank you very much for the opportunity and I   will be on standby for any questions that might  come up thank you excellent thank you so much   and now we'll move to Dan Myers who  will talk about the rely delivery system   Dan thank you Trish good morning everyone yes  I’ll be talking about the windy light delivery   system a hybrid pneumatic electric syringe driver  for magnesium sulfate infusions next slide please so to get everyone thinking about  infusion pumps this morning I wanted   to start off with a survey question and I  understand from our technical support that   the audience will need to refresh their browsers  in order for the poll question to show up   so I’ll give everyone a few seconds to do that okay so hopefully everyone's refreshed now  so there was a survey that was completed   in December 2016 where surgeons were asked about  the availability of essential medical equipment   at an annual meeting of the college of surgeons of  east central and south Africa and 42 Africa-based   surgeons participated in the survey and of these  10 of the surgeons identified as working in public   district hospitals so my question is of these 10  surgeons how many had access to an infusion pump   at their hospital so I’ll give everyone a half a  minute or so to respond to the poll question there Okay let's see I’m not seeing  any of the results just yet doesn't seem like we had any responses   so in the interest of time I’ll go  ahead and move on next slide please so of those 10 respondents at public district  hospitals it actually turns out that only two   of them had access to an infusion pump there  were a couple other categories of hospitals   that were included in the in the study as well   at the public referral hospitals 7 out of 16  respondents had access to an infusion pump   and then at the other category which were the  private ngo and mission hospitals 13 out of 16   respondents had access to an infusion club so  even at the best equipped hospitals there still   not all of them have access to this very important  life-saving piece of equipment next slide please   so as was discussed earlier in the presentations  today preeclampsia and eclampsia are the second   leading cause of maternal mortality and morbidity  and there is an effective treatment magnesium   sulfate it's safe it's low cost but unfortunately  it's underutilized and there are a couple of   reasons for this one relates around the complex  intravenous and intramuscular dosing regimens   but then there's also concern around risks  related to over infusion if magnesium   sulfate is over infused it can lead to depression  respiratory depression and even respiratory arrest   however if so clearly there's a need for  very controlled infusion of magnesium sulfate   when it's used and fusion pumps provide a safe  controlled method for iv infusion of magnesium   sulfate but unfortunately they see limited use in  low and middle income countries next slide please so the slow you spin from several issues so  the existing electronic infusion pumps and   syringe drivers that are on the market have a few  shortcomings first of all they're fairly expensive   most of them range in the 500 to  several thousand dollars in in price   the interfaces on these infusion pumps  can be rather complicated they may require   programming and extensive training to learn to use   they require electricity and of course electricity  isn't always available in health facilities in   low and middle income countries and if it  is available it may not always be reliable many of the electronic infusion pumps come with  a battery backup for when the power goes out   however the battery life typically ranges  from 5 to 12 hours and that may not be long   enough during a prolonged outage similarly  generators may not be reliable enough to   ensure that there is power to run infusion  pumps during an outage next slide please there are existing non-electric options one option  are our spring driven syringe drivers you can see   an example of that on the on the right in the  picture and they work however one issue with   them is that to control the flow rate you they  rely on a small diameter flow control tubing   which you can see in this image it's the it's the  tubing coming off of the syringe going towards the   towards the needle and this flow control  tubing is proprietary and it's disposable   which means it has to be replaced after every  infusion and of course over time that that cost   adds up the other big disadvantages are if you  need to change the flow rate during an infusion   it's very difficult because that requires you to  actually change the flow rate swap out the flow   rate tubing during the infusion and furthermore  the syringe these spring driven syringe pumps are   less accurate than electronic pumps typically  their accuracies are in the range of 15   whereas electronic pumps are have accuracies flow  rate accuracies of 5 or better next slide please so clearly there's a need for a low low-cost   robust simple to use infusion pump that  has a has a long battery life next slide so the rely delivery system is a pneumatic hybrid  pneumatic electric syringe driver that's meant to   address a lot of these issues so this is  a system that is in development right now   so the we've done a lot of work on the pneumatic  side of it and are only just getting to the   to the electronics at this point but the target  specifications are that will have a very low power   consumption which means it will use have a very  long battery life it will be inexpensive relative   to existing electronic confusion pumps people  have a simple user interface so that not it will   not require extensive training to learn to use the  rely there will not be any proprietary consumables   the flow rate will be adjustable during infusion  and it will be compatible with a range of   5 milliliter to 60 milliliter syringes it will  be robust easy to maintain and serviceable in   the field and we have a target flow rate range  of 0.1 to 200 milliliters per hour with a target   flow rate accuracy of 3 and over here on the right  you can see a picture of the pneumatic subsystems   this this is the these are the subsystems that are  actually responsible for driving the syringe and   go to the next slide please explain a little bit  about how this pneumatic subsystem works so the   rely has an air pressure air reservoir that's  pressurized using a hand pump then a pressure   regulator adjusts how much of that pressure  is applied to a drive piston and that drive   piston is what pushes the syringe plunger and of  course infuses the medication into the patient   on the part of the drive piston opposite of the  air side there is oil and that oil is forced   through a narrow tubing a flow restricting tubing  and this is what helps control the flow rate   so then when you go to reset the device you switch  to a larger diameter reset tubing that has low   flow resistance and it makes it easy to reset the  piston for the next infusion next slide please   so just to show a little bit of data on how  the rely is has both steady flow rates and   is adjustable during infusion we have a graph here  of the two minute average flow rate in milliliters   per hour over time and we did a test that ran over  three hours and you can see how we start off it   takes a little a few minutes for the for the rely  to get up to the target infusion rate and that   infusion rate and on this left side of the graph  is about 0.7 milliliters per hour and then it   proceeds at a very steady rate until we  adjust it up at around the hour one hour mark   there's a brief spike at the beginning of that  but then it settles down very quickly to a steady   rate of 8.8 milliliters per hour and then  around the two hour mark we adjust it back down   to a steady flow rate of 0.5  milliliters per hour next slide please

so how might this be used in treatment  of preeclampsia with magnesium sulfate   so over on the right is one of  the existing protocols for using   magnesium sulfate to treat preeclampsia and  eclampsia this is from the managing complications   in pregnancy and childbirth published by the world  health organization and we can take these dosages   and using some recommended dilutions  and infusion rates from a publication by   hull and rucklage we can determine that  a loading dose of eight milliliters of 15   magnesium sulfate which corresponds  to four grams of magnesium sulfate   diluted in 22 milliliters of five percent  glucose for total volume of 30 milliliters   could be infused at 60 milliliters per hour and  then to achieve a maintenance dose you could use   four milliliters of 50 magnesium sulfate which  corresponds to two grams of magnesium sulfate   diluted in 56 milliliters of 5 glucose and infused  at 30 milliliters per hour to achieve a 1 gram per   hour infusion rate of magnesium sulfate so  you can see that these infusion rates of 60   milliliters per hour and 30 milliliters per hour  fall within the range of what rely is capable of   again its range is 0.1 milliliters per hour  to 200 milliliters per hour and the volumes of   30 milliliters and 60 milliliters  of diluted magnesium sulfate   can be handled by syringes in the 5 milliliter  to 16 milliliter range next slide please so what are the next steps in the real  eye development well since we have the   pneumatic side the system worked out pretty well  at this point we are moving on to the electronic   interface and the electronic interface that we're  developing will have a number of benefits to it   and it'll give real-time flow rate information  back to the user we'll have a full suite of   alarms and safety features including alarms for  occlusion and over infusion or under infusion   the electronic interface is going to increase  syringe compatibility so that we can use syringes   from a range of different manufacturers and it  will greatly simplify the process of setting   the flow rate once we've got the electronic  interface developed we'll be integrating   the electronic and mechanical systems and  followed by benchtop verification testing   and some usability studies and that concludes  my presentation thank you for your attention   thank you very much Dan next slide please we  really appreciate your presentation and now   we're going to be moving to Jacqueline  de la Rosa we'll be talking a bit about   our heat stable oxytocin and sublingual  fast dissolving tablets Jacqueline   thank you very much today I’ll be presenting on  an innovative technology that's currently under   development underneath the don product development  partnership and that's the heat stable fast   dissolving tablet formulation of oxytocin that  is delivered underneath the tongue for the use   and the prevention and management of postpartum  hemorrhage you may refer you may hear me refer to   these as oxytocin fdts for fast dissolving tablet  throughout the presentation next slide please so excessive bleeding or postpartum hemorrhage  after birth is the single most common cause of   maternal mortality and oxytocin is a drug used to  stimulate uterine contractions and is the first   line treatment but there are three main challenges  to ensuring its utilization for women giving birth   in low and middle income countries the first major  obstacle is that oxytocin is a protein that is   very susceptible to high temperatures and current  products for oxytocin degrade more rapidly and   lose its potency when exposed to heat therefore it  must be stored at either controlled temperatures   to ensure its quality however refrigerated  storage is not always available or reliable   in some settings the second challenge is  the affordability of a heat stable product   although there may be other heat stable products  for postpartum hemorrhage management it is   very expensive lastly oxytocin in its current  violent needle parental format for intravenous   or intramuscular administration requires  training in skilled health workers however   an easy to use sublingual tablet format could  potentially make it possible to administer   oxytocin in more remote settings these  challenges together are resulting in a   gap in ensuring global coverage of oxytocin  for all women giving birth next slide please   so path's solution was to develop a very  simple fast dissolving tablet fdt dosage   format of oxytocin that is heat stable easy to  administer under the tongue and affordable for   women everywhere there are many advantages of our  fdt technology because it addresses several of the   challenges I just mentioned with the current  products for postpartum hemorrhage management   I’ll mention just a few of these reasons that are  listed here in no particular order most obviously   it removes the complications of needle injections  making it more convenient to administer in wider   settings in reducing the training burden on health  workers our oxytocin in an fdt format is not only   heat stable and does not require refrigeration  as I’ve mentioned already but it is robust   and has compact packaging making it easier to  distribute and store compared to other products   the oxytocin and the sublingual  fdt completely disintegrates very   quickly in less than 30 seconds under the  tongue to achieve an immediate response   the product is made with ingredients that are  generally regarded as safe and are low cost   making the fdt's affordable it also uses  a well-established process to make it easy   to transfer to manufacturers in low and middle  income countries in the future next slide please another unique feature to highlight  about our oxytocin in a heat stable fdt   is that it can be made into any  size or shape making it available   in multiple different packaging options  for improved distribution and storage   shown on this slide are just a few examples of  a couple of different options on the top row of   images you can see the fdt's are in bulk packaging  in bottles and if you look closely inside these   bottles you can see that the fdt's are shown  in different geometries as one alternative   option on the bottom row of images you can see the  fdt's individually packaged in blister packaging next please next I want to show you a couple  of different video demonstrations of the fdt's   so it'll give you a better sense of what they  look like how they're made and how they dissolve so the first video shows how flexible the fdt's  are and how they can be produced in our path lab   using an off-the-shelf reusable silicon tray  the fdt's can be made into any type of tray   and into any different size their shape  depending on the trade that you use   in addition this reusable tray could potentially  further reduce the manufacturing costs   lastly the fdt's you can see are being placed  into a bottle just to show how robust they are the second video is just a five  second clip of the fdt on a spoon   just to show how quickly it disintegrates  even with very little fluid they're using   a micropipette to deliver just a tenth of a  millimeter of fluid and the third and last   video will show the complete transformation  oh sorry next slide please so this last video   shows the complete transformation of the fdt  from a tablet to a viscous muco adhesive gel   in less than 20 seconds we show decreasing amounts  of fluid being added to the fdt starting with half   a milliliter down to a tenth of a milliliter and  the fdt disintegrating rapidly within each one and you can see the fdt's is completely dissolved   into this gel to make it easy for it to be  delivered and absorbed underneath the tongue some paths formulation contains low-cost very safe  non-toxic ingredients the full ingredient list is   shown here and it is with this combination  of both the unique formulation composition   and the manufacturing process together that  achieves a very heat stable product at relevant   elevated temperature and humidity conditions  at path we have three formulation candidates   for oxytocin in an fdt format that after a  two year stability study that we conducted   in our lab it shows really promising  results with no loss in oxytocin potency   at 30 degrees Celsius and 65 degrees relative  humidity after two years next slide please we have also completed a pk and toxicology  study in rabbits and have demonstrated we   were able to achieve uptake and absorption by  sublingual delivery of the fdts the results   confirmed the formulation is safe there was  no inflammation toxicity or adverse events   and the sublingual groups showed rapid  uptake within five minutes of administration   similar to the intramuscular control next slide please so path is continuing to develop our heat stable  oxytocin in a sublingual fdt and to summarize a   few of our key next steps are to establish the  plasma bio equivalence using sublingual route   of delivery in healthy volunteers investigate  leveraging the abbreviated usfda505b2 regulatory   pathway which has the potential to accelerate  approval in lower middle income countries   and we are also working on obtaining  clinical guidance on the relevance of low bio   availability of sublingual oxytocin in  the management of postpartum hemorrhage   and that concludes my presentation  thank you all for listening   thanks so much Jacqueline we  appreciate your presentation very much   next slide and now we will move to Mitsumi Metzler  who will be talking a bit about commercialization   strategies for introduction and scale of  this new innovation Mitsumi thank you Chris   so I will be talking about how dawn pdp  project working with the various partners   to accelerate the technology uptake for pph and  also pre-eclampsia glands their package of care so   in my presentation I will focus mostly on ubt and  also prcl tests because those two technologies are   more downstream in terms of product development  and introduction process next study please so I want to start my presentation with this quote  that I found in the in idea to impact published by   USAID the center for accelerating innovation  and impact and this code is really relevant   to our work establishing a partnership and  collaborating with the local players is important   but also that's important with collaborating  with our global and regional stakeholders are   also critical and at the same time we  needed to collaborate not only public sector   but also private sector partners in order to  achieve access to innovations next slide please so as pdp we collaborate with the various partners  so we work with some partners from the beginning   to the end and we work with some partners more  closely at the beginning or early stage of product   development introduction process or more closely  work with them at the later stage so for example   we work with global regional and national  policy makers and users and influencers from   the beginning understanding their voice is really  critical to understand the needs and also identify   gaps and create target product profiles that will  meet the need of low and indoor income countries   and they will continue to be important  the partnership for us until very end   to implement innovations in the  package of care or in existing programs   on the other hand at the research in the design  phase we start working with the product developers   but when we move it to a validated developed phase  we start working with a commercialization partner   that has the capacity to actually produce  products get regulatory airflow about and   also distribute the product to low in the  middle incoming countries so in case of   lwg we are partnering with synaptic biomedical  located in south Africa and as for our prco test   we are working with like acid diagnostics  which is also located in south Africa and   we also collaborate with research organizations  regulatory agencies and also procurement agencies   and then however type of types of organizations  we work with really changes depending on the   stage we are at and also activities we  conduct at that time next slide please so how we are part learning with various  organizations before introducing the racl test   and then scaling up the dust so as a charlotte  I explained in her presentation earlier   we are working with the king temple health  research center to conduct the various research   and also currently we are working with university  of Utrecht to conduct implementation research   later this year to assess clinical utility  and also operational effect of the prcr test   in Ghana in Kenya we engaged with county with  management teams and worked with various levels   of health facilities to understand what's the  current practice around the protein unit testing   and access opportunities for a  new prcr test and we are currently planning to do implementation research both in  Kenya and Ghana and in Kenya as a preparation we   will convene workshop with various stakeholders  including ministerial health county health   management teams and professional associations  and the medical practitioners to really identify   research questions for implementation research  and by doing so we are hoping that the result   we will generate through implementation research  will be relevant and then also useful for those   partners when they are thinking about  nationally rolling out cl test in the future   let's just start with you please so here is the partnership for lwbt introduction  and scale up so we have been engaging with the   ministry of health professional organizations and  other key opinion leaders to incorporate the ubts   into a pbh package of care and we started to work  with those partners to really incorporate the uvg   training into emomp training program together with  other interventions necessary for pbh management   and also we are currently collaborating with the  ministry of health and research organizations   and also public and private sector facilities  to conduct implementation research and then   in Kenya in particular we have opportunity to  receive additional funding from another donor   and using that opportunity we will soon conduct  pirate introductions in two counties in Kenya so   when health systems are devolved it's really  important to ensure coordination between   national level and also of national level  governments and therefore we are making sure that   all the information or data we are generating  through throughout the project are available   for those partners so that they can have  the same information at the same time   and have a collaboration in a timely manner and  as for users as disability explained we provided   a very interactive and hands-on training to users  and the training is a really great opportunity   to make sure that users have adequate skill set  and knowledge not only for product to use but   also a pbh artist management and  also training is a great opportunity   to raise awareness and a generic demand for our  product and finally I want to make a point about   commercialization partners in this case synaptic  biomedical and then also are there distributors   we are in a very close collaboration with them  and close communication with them constantly to   ensure that their introduction strategy and our  mission and their strategies are in well aligned   and including a pricing Australia so that products  will continue to be available at affordable   pricing in the lower and the middle income  countries and also for the training for example   we involved snappy biomedical and also  their distributors when provided training   to users so by doing this so we can ensure that  commercialization partners will listen about the   product issues and the questions directly from  users and if necessary they can address those in   by modifying information on rejection for use or  training materials in the future next slide please so as we continue to work with the various  partners on how we are doing in terms of   calendar status while the prcl product is a little  bit more in introduction here is the mark showing   you that the current status of our introduction  effort for energy so lmubg received cd marking   in re 2020 and as of march 2021 snappy already  received the market authorization for the product   in 13 countries and then still a number of  countries are is accounting next slide please so what are key lessons we learned  through this dawn project as the court   I introduced in the beginning of my presentation  establishing a partnership with various national   and global organizations in public and the  private sector is really important to accelerate   introduction and scale up of innovations  and secondly product introduction is   really a program implementation so therefore it's  critically important to incorporate products as a   participle care and leveraging existing systems  and also pdp can categorize collaborative effort   of all partners to scale innovations but pdp  involvement cannot be infinite and the partners   must play leading roles to scale  innovations eventually therefore we believe   pdp must share evidence information  with all relevant partners to enable   transparent and timely communications and also  effective collaboration among those parties and   also developing maintaining healthy partnership  with commercialization partners is critical   because they are the ones who will continue  to produce any distributed products and ensure   sustainable availability of products in low and  middle income countries and finally fostering   direct interactions between commercialization  partners and also user policy makers is really   important to do at right appropriate times so that  they can collaborate and communicate in a timely   manner to ensure introduction and scalable  innovations in in a timely manner so this is   the end of my presentation thank you so much for  listening and I would like to turn over to Trish thank you so much Mitsumi for that  interesting presentation next slide please so at this point we've come to the end of our  presentations and we are happy to engage in a   dialogue with the audience answer any questions I  think we have a specific question around rely Dan   and the approximate cost person was wondering  about that so perhaps we could start off there   if you don't mind sure yeah so since the rely  is still in development we don't have an exact   cost figure for it yet but what we're targeting  is a a cost of 500 or preferably less than that great thank you so I encourage everybody  to put any questions or comments that you   might have into the chat and while  we're waiting for you to do that   I thought I would just reach out to all the  panelists today and ask you a very broad question   which is around introduction and scale of maternal  health innovation so what do you all see as the   biggest challenge for introducing and scale lean  maternal health innovations like this so perhaps   you could turn on your videos except charlotte and  Sylvia I know you have bandwidth issues so maybe   you can just respond without your video on if  possible so anybody have any thoughts around that   so maybe I can start while other people are  thinking about challenges so in the beginning I   think that Theresa said that pvp works to idealize  the need of low-income countries or markets which   are not usually advised by a you know traditional  market so that's actually a challenge so the   growing government are low in the middle income  countries market may not be really a so-called   lucrative market for commercialization partners so  that means that you know volume of sales they are   expecting maybe very small or could be total  profit margin they can't expect could it be   a sling compared to other traditional markets  so for challenge for me as a commercialization   officer how to find the right partner  which can share a mission with us and   also continue to address the need of low-income  incoming countries perhaps martini you also might   speak a little bit to the different ways that  path addresses that issue yeah so yeah yeah thank   you for that and I think there are a couple of  ways to address that and then from that get go I   think we will do a very ambiguous due diligence to  really understand the corporate culture and also   technical capability and commercialization  capability like a distribution network so   that's the way to find the right partner so very  big residual divisions and then another way to do   is that I think that pdp is a perfect to do this  but you know working with the partners we can   reduce entry barriers to markets for example  like we can do much research and also articulate   healthy systems and also like the demand  regenerations or understanding regulatory systems   and those are usually needed to be carried out by  commercialization partners using their investment   so we can work with the partners to carry out  those activities by doing this so that the market   entry values can be reduced so even though that  may be the income or revenues commercialization   partners can generate from a low in the middle  income markets still it might make sense for   them to enter the market because of course to do  so can be lower thank you charlotte or Sylvia I   was wondering if you have faced any barriers in  your work in Ghana that you might be able to share   this is so weird what I want to think is that the  first and most important thing is dressing stitch   holder by ink people must recognize the need for  the device and be willing to use it and another   thing especially for pth is to have the device as  a point of check because when you have a device   for some time you don't have much time so it's  a logistic management system in addition to the   cost of the device because that tends to be a  big disincentive when it's expensive people are   reluctant to use it and the third thing is to  find a sustainable system of building it into   pre-qualification training and also on  the job training there must be a system   criteria to ensure that as new persons  enter the profession there is a system   for continuing training so  that it can become integrated thank you Sylvia it was a  little difficult to hear you   but I think your main points were definitely well  taken that you needed to make sure that you had   innovation that was able to be  delivered at the point of care   and that it needed to be integrated into the  existing system including the package of care   I think was your last point and do you want to  just reiterate your first point because I didn't   catch that very well the first  point was to get stakeholder buy right okay so that's great thank  you charlotte I don't know did you   have anything you wanted to add in  terms of your experiences in Ghana yeah add to the points that  Sylvia just mentioned about the   policy makers you know buying into whatever  yeah we want to introduce into the country   and I would also talk about another thing that  we also need to talk about is the food and drugs   authority in whether the product is registered  because that's also another big step that's   all header that we need to jump over otherwise  you know it might really cause a whole lot of   issues for us so I mean for us policy or advocacy  in the first place sorry is very important and   also getting the product registered in  country that's what I’ll add thank you thank you charlotte anybody else  on the panel want to respond at all sure I can say just a little bit and this really  comes back to the question we got earlier they so   it's interesting that the study that that I cited  for the you know where the surgeons were entered   were surveyed for availability of various medical  devices they were also asked about what some of   the reasons were why their facilities lack these  devices and by far the most common response was   cost so that's clearly a big driver and I  mean as far as rely goes we're in a good   situation right now because we're you  know since we're in the development phase   we can do a lot to try to control cost just  by right-sizing the features to what's really   essential for the device and not including a  lot of extraneous bells and whistles and we can make sure that we're using affordable but quality   components in the device and  then also partnering early with   manufacturers to work on the design in such a  way that it's really designed for manufacturer   there's a lot you know there's obviously those  cost of components but then there's the cost of   doing all the assembly and packaging so on so  anything we can do ahead of time in the design   to make it easy to manufacture the device is going  to help bring down bring down costs thank you Dan um well we have just five minutes left in our  presentation today so I’m wondering if maybe   do any of the panelists have any final thing you'd  like to share or any thoughts around your specific   product that you're working on or what you see  as the future for this particular innovation   in your country I think you did touch on  that already a bit in the next steps but   any final words from the from the panelists I guess everybody has said everything they need  to say for the moment so with that I think what   we'll do is we just have a couple of minutes left  in our session so I think what we'll do is we can   just close now and give everybody a couple of extra minutes to  get to your next session so thank you so much   for being

2021-09-04

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