그런데 또 옥탄 of rose red outlet onl 늦을 수 있겠 ssr co-worker ooh tote 아무

민간 들었소만 note is damp ok lee hooker 2 drive test 입니다 이 번 맞을 생각을 해 볼게요 고구마 entered 개나 악수 준 스티커 m 뭘 powers on non 테스트 무 볼 체인 주머니에 넣을 수 4 그 lesen 아우디 s5 현성 이제 웽거 프레셔스 were 매스 개인 파울 supex used or even a radio sw owl 김도 학생 보호 wonderstone 4인 놀 수 있는 5초 링 바이 먼 eisen doors 2 to reside in our 서늘하고 소스와 메이슨 견디 스탁 등 지으려 뭔가 된거 x 225 lovers 스카 we 줄 4 덮어 힘은 빙 무 브라운 든 릭 dox 근데 그 사업 날이 코 4 50 호스가 쭉 론가 웃었을 조이 의사 결정 타이어 10 멀어 볼 4 카메라 floors po 배경 sows 2 로버 컴패니언 o 킹 라운드 하우스 오브 더 선 배 어려움 쏭 으 어 할테고 셔링 딸이 준 3 못한 수 또 레버는 우승할 생각해볼 exr 탐스 잉 낮추어 아이뮤즈 프로세스의 면 거미 도로 표준 아까 to la vida 디자 교회당 캠핑 사슴 릴리언 쏙 스토리 포 임스 자금 텐스 볼 말이 거로 사신 옷은 과잉 won to stores 에서 혹시 5 a i can't love 옥은 it operates over 들어 링 4인 타이어프로 sofitel 이쯤 ago the tread 프린팅이 ok and wide 앙크 spera oral 놈에게 미소 섹스로 남을지 배웠소 쏘서 버스 보드 포인트 otters 빅백 뿐 되는 이번에 기반 더 쉬울 dc 원조 놓인 예수님만을 중 때 품어줄 올 간호부 we 않고 마셔 보다 open to demand 드시오 네마 인해 용 리아 do us 바이옴 포인트인 리벌버 하지 못한 스폰 테이션 o 무것도 놓은 다이너스티 많이 써서 알 pex is later 메이킹 페이션트 보니까 어떻해요 to die and flow at seoul 4 we 그 일단 역할 거 같아요 woo 이거 쿨 괜히 flaws tesco 파일이 yerevan 섹스 오스월드 란 말이 곧 좋아할 것도 좀 쓰다가 쪼아요 do to six of and ios 디바이스 mc 일단 max rider 음란 이봐 해줬어요 썽 초 마이크 re text in lower total war 해킹 이빨이 그것마저 않은지 free icons were no 큐브 화이트 s louder louder 성화 이스 cooper & 유진 어디 구멍 학교 stent in did 오미 5p 가슴을 쓰다 1 샌델의 미오 다를 뿐이지 도 내놓을 수 쉔 버스비 감도 스트레스도 - 프라이멀 이렇게 펜션 지급될 치우 치아 노쓰 보러 뭐 이거 되게 졸인다 리 존스 리칭 금 허프 액션성을 이슈 소 맞게 시험만 하지 못함 4 그 of tool in hell on wheels or south on 보통 월 s 펜 스틱 많이 그런 oisoo 8원 2개 늬우스 to 80 x 놈이 먼저 써야 하고 하겠어 내 기사 얹어도 이딴 입상 또 덜한 상단이 뭐 벋은 마디 그렇게 좋지 않았어 액션 10 여기에 wax 뭐 mv 익사이팅 스태

all right greetings fellow clinicians dr g back again and if you're anything

like me then you find yourself oftentimes scrambling coming in early for your shifts leaving later and we're already working overtime and getting stressed out just to be able to pass on all that contextual knowledge or to capture it that may not be recorded within the emr and other things as you come onto shift or as you leave there's so many things that can take place it just sometimes takes up a lot of our time again handing that off and gathering that or passing it along so we have introduced something to help to lessen the stress and that's made available both through desktop so whether you're on your cart going around with the emr or shared workstation as well as more and most conveniently your phone right so in my case i have an iphone you may have a an android phone but whatever the case might be clinician sound bites is really something meant to ease your day and to make things just a little less stressful and to aid with that transition and handoff so today we're going to take a look at how that works within our emergency room team now one of the things we've instituted here at smarterhealth for our folks is for each of the different units be it the er be it the maternity ward be it radiology whatever the case might be we have introduced teams within microsoft teams so that you can pass along notes share files um pass along learning and other things you know we just did a video on just in time learning and here you can see we've brought some of that together for our er folks but we've also now introduced something called sound bytes and what sound bytes does is exactly what you think it might do it allows you to share a sound bite a quick and easy capture of what's taking place within the environment at a given time so that not only can you pass along that information that may not necessarily be captured within the emr but furthermore those folks coming in can listen to it just like a podcast in their car right they're driving in i'm driving in getting ready for my shift here in the er and rather than trying to scramble and get corner somebody hey bring me up to date what's going on we can capture all that information make it available and then as i'm driving in just like i would any other audio podcast listen to it via my phone using microsoft teams so i can hear it over my speaker so i'm going to do a couple of things here number one here we are we're in microsoft teams and there's my connections we looked at learning earlier but i'm going to go into teams and there you can see i've pinned the two teams i'm a part of i'm a part of both uh the general er one as well as pediatric care and so i'm going to go ahead though in this case so that everything's the same i'm going to bring up my er one and there i am i'm i'm in there and if i go to the more tab at the top let's go ahead and we'll select that there are sound bites so that's going to render and bring up the same ones you see there on my screen there we go so we have it both ways and this is how it's designed to work this is easy folks this is a great way again to capture that data be it around a visiting you know maybe it's in pediatrics and you have a client that came in one of your patients and you're attending to them and you're capturing that information and wanting to pass it along but in this case we're talking the er so let's say during my shift i'm the head of the er for that day i'm the lead clinician and we had just before you know maybe 40 minutes before my shift ends there was a pile up on a local highway and as a result we're seeing a lot of blunt force trauma uh and other injuries that are coming into the er on my shift and they continue to trickle in and i want to pass that along because folks coming in you know sometimes it's jarring we come in we're getting ready to start our shift and bam we're hit with this emergency we've got to quickly shift our brain and there's all that mental shift that takes place okay what do i need to do for triaging blah blah blah this enables me i'm on my drive to quickly see it and listen to it so let's go ahead and do that now i could do it right here on the computer you can see right here it says create a soundbyte and i can play them right here but again teams on the phone makes it all right there so right here whoops right there we have this icon i'm going to say record and then it's going to ask me for a couple of things i'm going to give it the title in the title we're going to call it shift because my shift is let's say shift 2 and the date today is oh 6 16 so 6 16. 20 whoops 20 22. there you go and then it gives me the option if i've already recorded something to just upload the audio file or to press record i'm going to hit record and oh it also asked me i'm sorry to pick an audience so in this case this is going to be for this particular group which is the er emergency room there we go now when i click record we're now recording so this is dr g i'm here on the second shift today's date of 616 2022 and we just had a pile up on local highway 9524 as a result of that we've been seeing an influx of patients brought in via ambulance for so emergency services bringing them in also self-transported with various blunt force trauma including breakage internal bleeding hemorrhaging etc all the things you might expect and we anticipate this to continue for the next 20 to 30 minutes so i just wanted to pass that along as you're coming in be prepared it is chaotic in here and there's going to be a lot of work to do so be ready we'll see you then and we're going to stop so i've now stopped my recording it then says click and then i have the option at the bottom here to click create so we're going to go ahead click that it's now creating that piece and it's going to have that all uploaded and boom look at that i got the alert here i got an alert on my phone and if i come in here let's just go ahead first we'll refresh the view here on our pc and we should see that new particular piece come up and i'm refreshing i did a pull down on my phone so we can refresh the view here as well and so there we go we have shift 2 216 right here i'm also seeing that at the top here with my latest and so i'm going to go ahead and let's turn up my volume so this is what we would anticipate yes you can play it here on the pc maybe you're at home and you're logged in but let's say you're that clinician and we you know many of us do podcasts today so it's just a simple just like you might do on you know one of the service streaming services for podcasts out there i'm just going to simply hit oops the play button up here and so and play we're now recording so this is dr g i'm here on the second shift today's date of 616 2022 and we just had a pile up on local highway 9524 as a result of the so i'll stop that and close it but as you can see it's quick it's easy it's mobile so as you're going about your duties and your team has a need for shift changing for that kind of a handoff you want to minimize the time that you have to have you don't want to come in you know a half hour to an hour earlier than you need to be in there or stay afterwards for all that time kind of sitting down you think about some of the huddles that take place we can now start to virtualize that and use sound bites to absolutely do those handoffs and minimize your time so that you can keep more time for yourself your loved ones and other activities that you need to attend to so lowering the stress clinician sound bites they're here at smarterhealth take advantage of them share them with your colleagues and show them how they can use them it's simple it's easy and it lets you get rocking with that this is dr g finding you have a great day take care and as always ciao and improve those patient outcomes Videolytics

excited that you um have have come to see our session today before we get

started just a couple of housekeeping items we encourage our attendees to ask questions so please be attentive and ask questions the more you ask questions the more our speakers have the opportunity to respond to what is top of mind for you and the questions that you might have we will moderate those questions um so they'll they will show up to the audience as we publish them however if they want if you want them answered privately you can just kind of denote that in your chat and we'll just respond to you one-on-one also this webcast will be recorded so we'll post it at the same blog link that you had for when you joined this session okay so now how to engage in the q a panel if you've been in a microsoft teams live event you've probably seen this before but if not just in case up in the top right hand corner there is a little box with a question mark on it for asking questions if you click that it will open up the q and a panel and this is where you can type your questions and see the responses that um my team and we have we have a couple of other folks back here josh and vasu who will be responding to these um so please go ahead and um ask questions in the meantime we'd love for you to give a shout out of either who you are what company you represent or what country you're joining us from today we um have had a denmark in germany before um also lots of different states around the us so please go ahead and start using the q a now we've got australia and italy so far so awesome sorry minnesota good representation there so on to the presentation today we have michael hobbs um one of our senior technology specialists from microsoft here to talk about healthcare device manufacturing and inventory management we're so excited to have you today michael oh my pleasure and thank you thank you for the uh the opportunity here to uh to share with the uh the folks of um our solution that we've created in terms of the focus on medical device suppliers and how they can manage their inventory so a little bit about me my name is michael hobbs i've been doing healthcare supply chain work for the last 30 years actually started off as a cath lab technologist so i'm a i'm a clinician by trade um you know spent the last seven years uh helping um a large erp launch their into the cloud and have been here at microsoft microsoft brought me on board really to help them build out and create supply chain uh business applications for both the provider and them and the medical device manufacturer so today we're just going to focus on the device manufacturer uh in terms of managing their inventory so we know uh from the medical device manufacturer there's a challenge today for them to manage their inventory once it's inside of the hospital or once it's in the trunk of their representatives as well so when we talk about these type of devices we're talking about things uh that could be like pacemakers defibrillators heart valves um so it's not only the single use devices but it also might be mobile devices so in this in this case study this use case uh this is an actual uh devices that the supplier was trying to manage and they lacked visibility it was all being done manually and they really didn't have a utilization of any of supply chain methodologies like fifo or fifo or even the ability to do min max planning or demand planning and so i won't say for all medical device manufacturers um but for the majority of the device manufacturers today once the product leaves their warehouse their challenge to see inside of what's inside of their rep's trunk or what's inside of the hospital or if the product has even been utilized right um and so they're challenged to see that and so what we focused on and we know there's a market demand uh there's there's competitors out in the marketplace that have solutions that actually require an outsourcing for the medical device manufacturers to do that we also know that there's an roi so these are the typical buckets in terms of the opportunities um in terms of the opportunities that we see within the marketplace that absolutely a lot of our medical device manufacturers have products that are expiring either in the trunk or in the hospital because they're not able to track by lot serial number and expiration or they may have excess inventory of what's in the sales rep trunk or what's in the hospital because they don't have the ability to do anything like demand planning or mid max planning and we absolutely know there's freight expedition that occurs uh with the medical device manufacturers are having to overnight products overnight to get them into their rep or into the hospital in time for that next day surgery so so there's a significant roi and an impact uh in terms of helping the medical device manufacturer uh minimize their their cost and so what we've created here with microsoft is a biz application that's really focused on helping medical device manufacturers manage that the front end of our application is a crm so absolutely you know microsoft has a crm and so we've built that as the front end of the biz application but we also know the medical device manufacturer might be using sales for so we absolutely have the ability to use the microsoft crm but we absolutely understand that we may also need to be able to interface into uh other crms that are out in the marketplace as well uh so that's the front end and then underneath that what we've created is a solution now this first use case is really just focused on those single item um devices like a pacemaker a defibrillator or a heart valve and so in this use case um we've used uh an rfid scanner now this biz application is built on our partnership with hcl and so hcl brings in a a plethora of hardware technology from rfid to computer vision uh to bluetooth so and i'll show you that a little bit later about all the different applications or hardware that they bring but it's with that hardware that we can track the devices but then we wrap the hardware with the supply chain methodology so with the hardware what's wrapped around it is our power uh automate our power platform our power applications our power bi is wrapped around that and then we wrap around that technology as well all of the different supply chain methodologies so that could be anywhere from doing fifo to fifo to min max to supply demand planning so in this use case the medical device manufacturer using rfid could put the tag on when when the product is manufactured they're going to be able to track that as it goes to their warehouse and then they can actually track it as it goes out to their sales rep and the sales rep can scan those items into their trunk they can scan those items on consignment into the hospital the hospital then utilizes the product scans it out and then whatever products aren't utilized can go back into the consignment room or go back into the sales rep trunk and so with this use case what the medical device manufacturer now have the capability to do is using rfid they can go in and they can start tracking their products in the hospital looking for products that are about to expire so they could use first expire first out they could do min max planning they can do supply demand planning of what's going on inside the hospital and with rfid they're going to have that same capability to do that with the trunk stock as well so that's just using rfid remember uh there's multiple types of devices that can be utilized in this use case we're just focused on using rfid from that perspective the second use case is helping the medical device manufacturer to track their mobile devices so that could be a ventilators it could be lasers it could be either systems so for example if you had a medical device manufacturer that had lasers at uh anova healthcare within within virginia they would be able to see hey i've got five lasers that's in the nova fairfax i've got three on the third floor in room a i've got two on the second floor in room b and i've got four lasers that's in uh anova arlington so they would be able to see the precise location of where those mobile devices are within the hospital and that would give them visibility to do that and then again based on the use case right if we needed to use cellular or nebott we could do that if we needed to use rfid or bluetooth we could do that and again the same biz app is focused on using the hcl technology and then what's built around that is the power platform and what's built around that is the supply chain methodology so it's all built into one single platform so earlier this year we actually launched a biz app focused on implant management just for the hospital because we know within the industry this is a challenge that both the medical device manufacturer face and it's also a challenge for the provider so in january we launched a very similar biz app for the hospital and then just in march we've launched this biz app for the medical device manufacturer the great thing that you see here is on one single platform of the medical device manufacturer and the hospital are both on the same platform so the hospital would be able to share um their or cases that are coming up and the medical device manufacturer can share back hey yes we're able to meet that demand so it really gets rid of the it really provides full transparency for both the medical device manufacturer and for the hospital in terms of managing what's a very costly item for both of these entities within the healthcare marketplace so that's the platform that we've created um and and and that we have out and that we've launched into the marketplace one of the components of the biz application this is just an example not all but an example of all of not all i should say some of the hardware that hco has built into the biz application so rfid bluetooth computer vision so based on the use case right we would apply the appropriate tag and hardware for those items whether it be a single use item or whether it be a mobile device and then all of this is built on the cloud so you can see whether you know as the devices get scanned as they get read it all goes into one cloud and then from there all of that information is pushed into microsoft so that you can do your power bi your power apps your power automate you can do intelligent order management and you can do all of those different supply chain methodologies that i mentioned to you before so it's an omni-channel solution it's all built into the cloud one single platform and then you've got the supply chain methodologies that you can apply as well and so let's take a look at some of the use cases because i think it's i wanted to make sure that everyone understand um we understand there's a multitude of different use cases but i want to show you some use cases that we've already looked at and have addressed so for example this is a use case um where the supplier came to us and said hey we'd actually like to try to use computer vision and can you show us how computer vision could be utilized and so in this case what you're going to see these are interocular lenses that are in a cabinet that has been computer vision have been installed and so you're going to see this individual actually is going to go ahead and turn on and you can see the computer is reading everything within that cabinet right so it's tracking and it's it's monitoring all of the um metadata that's on those tags and then you could go in and you could do a search by lot by serial number by first expired first out and the computer is actually going to tell you hey based on the lot of serial number here's the right item that you should pick or based on this item is going to expire first here's the item that you pick and it would also alert you if you pick the raw knife okay so this was a use case that we put together uh for device manufacturer they wanted to track computer vision uh and wanted to create cabinets and so i just wanted to show that as one use case um that we've addressed and that's using computer vision remember the initial use case i showed you was rfid but with our solution we've got a multitude of different use cases that's one is using computer vision the next use case is where we had a device manufacturer that said hey we'd actually like to track our surgical devices firm which provides specialized medical kits to hospitals worldwide a major part of conor's job is to track and monitor these kits which are being lent to various hospitals and institutions however due to misaligned prioritization and erroneous manual processes it becomes extremely hard to track the kids once they leave the warehouse leading up to reduced productivity and unnecessary losses thus creating a need for a simple affordable solution which could save valuable resources for conor sperm hcl's iot works as specialized asset track and trace solution is an iot backed solution that streamlines the inventory management process and maintains complete round-the-clock visibility of assets amalgamates things data processes and people by providing services that deliver measurable outcomes for better analyses and forecasting hence realizing the potential to optimize about 30 to 40 percent in poorly utilized working capital for device manufacturers it leverages multiple sensors such as a gps sensor a gsm connectivity module a bed of infrared sensors a magnetic door sensor and 24 7 cloud connectivity to locate monitor and assess the kit from anywhere all data can be monitored via web-based dashboard which helps connor monitor every movement of the kit once it is taken off the shelf this solution records and analyzes the quantity category demand and so that's the use case that's a particular use case that we were presented with where they actually wanted us to create uh the the medical device tray itself but we absolutely have the ability to take an existing trade that you have and and again based on the use case determine what's the appropriate technology so i wanted to show you again just the flexibility of the solution that given the particular use case uh the solution itself will be able to adapt it's just understanding what the use case is and and then working to create the solution and wrapping the solution around that and so what we've done in in doing this we absolutely see moving forward what we'd like to be able to do and working with the medical device manufacturers is absolutely let's do a proof of concept right let's let's identify one product line you know they've got you've got various product lines let's take one product line and then do a proof of concept to demonstrate that based on that product line here's the appropriate use case and and show you how the solution would work so absolutely we would like to do a proof of concept uh as we work with the medical device manufacturers around this and so that's everything that i wanted to show you um i'll stop now and see if you have any questions so um one question mike that came through is talking about you know managing the asset if you're able to schedule it um as well uh it says if you can manage the asset can you schedule it as well for better asset scheduling or lab scheduling yeah so that so that's that next phase of the use case right is not only can you track the so in this case you know it could be a implantable or it could be a mobile device so not only can we track the location that next level is is about the readiness of that device as well so absolutely if that device has the capability to send a signal to the cloud then yes you you could go to that next level of monitoring uh the device as well and so that's something that we believe um within the healthcare industry that that's a need as well this initial use case is just burst on on tracking it the location but absolutely with the same application uh we would be able to say now if that's if that device can send a signal then we can absolutely monitor it uh and capture those signals as well awesome thank you i know we had uh just looking at the attendee account we had a number of people join you know once you got into the presentation and so i'm just wondering mike if you can speak a little bit to you know for those who join a little bit late like where do you recommend organizations start when they're being you know interested in a solution like this yeah certainly um and i'll and i'll actually go back just a little bit here um and and uh just to show from the beginning of the presentation so this is you know when we talk about for the medical device manufacturers you know especially around this um it may be the vp of operations it might be the vp of i.t might even be the vp of sales uh because when we're talking about the inventory it impacts all of those right all of those so uh that's where i would say you you start initially i i always like to say you know let's let's start with uh who you know best uh and and kind of build our way from there because at the end of the day we're going to need to be able to touch a multitude of um entities within the medical device manufacturer it won't just be one person making that decision and i'll just for those who joined late what we're talking about is helping and what we've created is a biz application um around helping the medical device manufacturer track their inventory within the hospital whether that would be in the trunk of their reps or in the hospital itself and we have the ability to do that for both the single use items whether it be pacemakers or defibrillators in this initial use case we're using rfid but as i showed you just here recently uh we could use bluetooth we could use computer vision um and and in partnership with hcl we've got a multitude of different types of tracking tags and devices that we could utilize uh so it's not only the technology but then we've wrapped the technology with the power platform power automate power bi robotics process automation and then we've wrapped it as well with our supply chain methodology so we can do that for single use items and give that a medical device manufacturer visibility into the hospital into the trunk and we could do it as well for the mobile devices that a medical device manufacturer might have as well and this is this is that this is that piece joshua that you you know in terms of not only tracking where the ventilators are but if those ventilators are giving off signals uh we could also connect those ventilators to the cloud and we can track the monitoring and the readiness of whether it's a ventilator or a laser or something like that that would be that next use case that we could extend into awesome that's perfect we've gotten a number of other questions here as well mike while you were responding to that one so um let me just start tackling them i guess in we'll do them in order um so the first one was uh does this solution produce reports like uh such as demand planning organizations to save money and time yeah absolutely so early on i kind of showed you that roi that exists where the roi in terms of ex products expiring in terms of excess inventory even in terms of the freight expedition that occurs with medical device manufacturers so absolutely there's an roi around that and then the key piece is what we've created in the in the solution itself is it's again it's not just you can track it but then the solution provides you that supply chain methodology so now the medical device manufacturer and the rep can start doing supply and demand forecast demand planning uh they can do min max planning uh they can do first expired first out so it brings them that supply chain methodology as well and that's and that's really part of the solution that's going to help them drive and reduce their overall supply costs that they're seeing their day so yes demand planning that's just built in it's part of the overall application awesome so the next question is um so talking about tracking systems in the field like how do you track uh systems in the field globally and understand what is being utilized out of the implant bank that you showed earlier i'm sorry josh what's the last part of your question how do you track systems in the field globally and understand what's utilized out of the implant bank yeah so so that's the beautiful piece of the overall so globally yes you have the ability again based on on the technology that we're using so cellular technology you could track uh if you're a medical device manufacturer you'd have the ability to track that device in if it was here in the us or if it was overseas in europe right so the technology excels expands globally there is no barrier or limitation in terms of where and in terms of how the technology works or where the technology can track from so it's absolutely globally i kind of gave the example within the hospital but you could track it across the united states um or you could track it even if uh the medical device manufacturer was over in europe and they had entities in europe and the united states is going to give you that global visibility and joshua what was the last part of that question um and understand what's utilized out of the implant bank so not yeah yeah so absolutely part of the solution itself and this and this is a valuable piece not only for the device manufacturer but for the hospital as well so part of that part of that is as that product gets utilized the nurse is just going to scan that product out and as the nurse scans that product out you now have visualization to say hey yes my product was utilized um so that's so that's that piece of the visibility of not only visibility is it in the hospital um is it in my rep's trunk but when the nurse scans it out you're gonna get visibility at least to see hey yes this product was used and this was the date that it was used at so so you will get that visibility i think personally uh the opportunity here for for both the medical device manufacturer and for the provider right is is the sharing and the transparency of that information so now that you know your product is getting utilized uh the hospital is going to take it and they're going to record it in their emr and things like that and so i think there's a possibility here where you can get a hospital and a medical device manufacturer utilizing our platform and sharing that level of information that the hospital could say hey you're working with me to manage my implants better as part of that you know i'll share with you some didactic information at least to show you hey the product was utilized and it was utilized in a patient that had this disease state right i think that's just an opportunity a partnership that our platform and the overall solution can help drive across the medical industry yeah thanks for that um switching gears a little bit you know another question that came through was how have you seen organizations address physical challenges like battery life and connectivity you know within a hospital for example yeah and and and and that's and i think i've got my friends on from hcl they're probably more of that's more of a technology question that they're available i'd like uh wade are you one is there someone else from hcl that could address that from a technology perspective um i can address it generally but i i would it's more of a detailed question that i'd like my partner to address with their own i don't i don't believe they're they're okay wait joined michael so if you're able to answer it generally um that would be great yeah so that's that's part of the and i'll take that question as a follow-up as well um but certainly part of understanding um the ability to track these devices is the battery life um and and and that's that's that piece as well where um if you're if you've got it connected to the cloud and that you know say it's a ventilator or it's a it's a laser system uh and you've got and you've got a battery there if that device can send signals right that's a signal that you can that you can capture from the cloud to see you know where is the battery life on that but it's key that that device has the ability the device the mobile device would have the ability to send the signal and it's got the internet capability to send the signal and then we have the ability to be able to read that signal to see hey the battery on this device is at half-life or it's at the quarter of a life but it's dependent on can that medical device send a signal that we would be able to capture in terms of the battery life and things like that gotcha okay um we still have a number of questions there uh definitely quite a few that have come through so you know another one is a little bit more general but can you speak a little bit to some of the challenges that you've had implementing this system you know we've talked a lot about what it can do but what are what are some of the gotchas challenges that type of thing well the exciting piece for us is this is new this is a new uh solution that we have just launched uh we launched it in for the provider uh for the hospital provider whether it be a hospital or an ambulatory surgical center we just launched it in january for the from the provider side and we've just launched this for the medical device manufacturer in march so it's it's a new application that we've created uh so we haven't gotten to the point where we've done implementations but we're just trying to get it out and make sure that everyone understands the new capability and the new solution that we've brought to the marketplace so haven't done implementations yet um so i can't speak to any you know lessons learned and things like that okay and that probably feeds into the next question which was asking you know how popular the computer vision solution is you know and they commented that the devices seem to be the same dimensions and so um and yeah and that now computer vision depends on who you know from a healthcare perspective um that's that's a new technology that that typically what we've seen it's used outside of healthcare um used in the automotive industry or in the retail industry so if you go into any retail store today they're using computer vision and that's part of the innovation that we brought into the solution is we're looking to say what can be utilized what can we bring in uh that's different that exists in healthcare today so for the most part for example um the rfid applications that exist today in healthcare require you to have a cabinet right you've got to buy their capital equipment but you can see what we've identified and what we've launched doesn't require you to buy a cabinet now the one use case that i showed you that device manufacturer wanted it in a cabinet and so we built computer vision into the cabinet because that was what they wanted was they wanted to have it in a cabinet so you don't have to have computer vision in the cabinet but for that one particular use case that i demonstrated to you that was what they wanted and so we built it into a cabinet uh we are finding absolutely across healthcare more and more organizations from both the device manufacturer and the provider are are interested in computer vision because it is an innovation and it's something that a lot of healthcare organizations uh have not had the opportunity to understand how that could be applicable in healthcare as well awesome okay so let's see i'm just working through some of these other questions here um this next one so another one so asking if there are any use cases with the led rfid tags um so so the one use case that i did show was just rfid i think i've got raj on raj can you speak to so so absolutely with rfid raj can you speak to any use cases that that that hcl has worked with in reference to rfid led tags as well um can can you hear me uh michael yes ross i can hear you yes yeah yeah i'll request lalit uh speak on this i don't know if he he's okay to speak he's on the technical team okay that's fine um but yeah but there are and and i think what we are open to understanding is again based on the use case what's the appropriate technology to utilize um with our hcl business partners we absolutely have rfid we absolutely have led and bluetooth there's a multitude of different uh hardware technologies that they bring as part of the solution it's just a matter of understanding what's the use case and then identifying what's the appropriate hardware technology that we would apply to that whether it be bluetooth or led or something like that okay yeah thanks mike thanks raj um so the next question so you mentioned inventory management and reordering logic the question is where is this logic defined and are there standard modules on the platform that handle various uh inventory management methodologies yeah absolutely so it's going to be defined as part of the supply chain module that's in the business application itself so that's where you can define uh your min max levels if you want to create min max levels uh so within the business application itself there is a supply chain module uh that you can define your min max levels there or you can also go in within that supply chain module and do demand planning demand forecasting and then you can also establish if you wanted to do a fifo first in first out or fifo first expired first out so the application itself has a supply chain module and that's where you would go in and and set up those types of methodologies and define the appropriate uh supply chain methodologies inside the platform cool okay yeah thanks for that mike so another question says with the reduction in nwc mentioned was this done by optimizing terms of systems or was it done by eliminating systems in the field that had dead stock that were unable to be utilized yeah so it was all it was it was absolutely all of that right so it was a combination of expired products of uh excess inventory inventory that just uh where they had excess inventory uh it was a combination of obsolete products so products that were just sitting on the shelf that weren't moving so when you looked at those buckets uh it was a combination of all of those different buckets along with um reducing uh expedition or having to overnight freight uh to the hospitals themselves so yeah the the roi comes in a multitude of different areas uh in the and the opportunities that we see exist go across all of those so there'll be some expired products there'll be some obsolete products uh and there'll be uh also excess inventory that's out there that you could move around and that excess inventory could be whether it's a single device a single-use device or it could be a mobile device where for example you now have visibility to see hey i've got 15 iv solutions i've got 15 ventilators in one hospital um but they're only utilizing 10 of them so now i can take the five that they're not utilizing and i can allocate those to other hospitals as well very helpful okay um getting towards the end of these questions but uh you know one came up asking if this could also be used for other devices such as infusion pumps or laptops or you know some of those other scenarios absolutely yes yes and and that's and that's especially on the mobile devices right so if you think about the mobile devices uh that are within our hospitals today uh we're talking ventilators we're talking iv pumps we're talking wound pumps right so the use cases just expand um beyond just this kind of initially but absolutely um from the mobile device perspective the ability to track items um can go across you know even if you're talking about wheelchairs and beds and things like that yes absolutely uh that's that's that's an expansion of the use case that's very simple and very easy to do and that's why the platform is built the way it is is to say hey depending on the use case we'll identify what's the appropriate hardware but everything else all of the supply chain methodologies and all of that is applicable so yes you can you could go beyond this simple use case that i showed you and track a multitude of mobile devices within a hospital yeah very helpful um the last question that i have and if others have questions feel free to keep them coming but um they they were just asking hey you keep referring to this this platform using kind of quotes um but what what is the name for it like what do we call it i don't know if that's so they can do research on their own or talk to their account team but is there is there a particular i guess name or something that uh that we refer to this inventory management solution yeah it's it's it's it's just simply the microsoft uh busy application uh for implant management right uh so you know we haven't you know we don't have a fancy marketing name but but you can certainly talk to any of your microsoft um executives account executives a sales executive and just mention to them you'd like to learn more about the microsoft biz application uh for implant and inventory management and whether you're a hospital provider or whether you're a device manufacturer uh that's what we call it the microsoft biz application uh for implant and inventory management okay awesome um and with that we have come to the end of all of the questions that i see so um i don't know if uh anybody else has any additional questions um shelly i don't know if you want to to wrap or wind it down and talk about kind of where we go from here yeah sure so michael um and raj thanks so much for joining us today i mean any kind of last minute comments on um on your part if not we would love to take a minute to promote our next sessions and thank all of our attendees for coming yeah i i would just want to say uh shelley and to those who are attending um you know this is new innovation um that microsoft has focused in on for healthcare supply chain and a lot of organizations know us for other things that we have done we have looked at uh where we've had success outside of healthcare and things like the automotive industry the retail industry the manufacturing industry and have really you know the creation of this has really come about with some of our existing customers both hospitals and manufacturers in the medical device industry that has come to microsoft and said hey can you tell us what you're doing in other industries right what what innovations does microsoft is utilizing in other industries to help them resolve their supply chain challenges and and that's what we've done is we we've we've been asked to help other organizations that are current microsoft customers and and and with that we've created these business applications that are focused on helping both the hospital and the device manufacturer to better manage their inventory their implantable inventory or their mobile devices and so we we see this as kind of our first exciting step in healthcare supply chain uh and we're excited about the innovation that we're bringing into healthcare supply chain and and really look forward to uh continue to build and continue to help both the healthcare provider and the device manufacturer in this challenging time of supply chain disruptions that occur today so that's all i have shelly awesome michael we're so excited about these innovations and look forward to them maturing and as they start solving problems it's going to be really exciting for the industry so thank you so much for that so for the rest of you who have um stuck on with us to the end we're so excited that you're here um just a little shout out um on april 27th that will be our next session i want to say that is in two weeks um or possibly yes two weeks um from today we are going to have um some guest speakers from intermountain healthcare and from nuance um talking around optimization documentation in the ehr with ambient ai we're really really excited for this session i have posted two links in the chat uh the first link is if you would like to receive invites for the april 27th or may 11th session that we are going to talk about using ai to reduce and prevent collaborate in the hospital um please go ahead and fill out that form it's just putting in your email there so we can send you the invites for these upcoming sessions and then the final link that i posted is actually the blog post and announcement for the optimizing documentation in the ehr with ambient ai and i will just give you a little teaser of that here we have some really great speakers you can see here um jared um craig tyler and michael i'm different cmio cio and chief health information officer from intermountain healthcare and from some of their new acquired entities so we're really excited to have them on our knox session and hope that you will join us so with that um be sure to check our blog posts for the recording and um deck from the session today and we hope to see you again in two weeks thanks so much thanks all thank you Videolytics Tools Compare SUMMARY

welcome to this short course on clinical investigations for medical devices

and the iso 14155 standard my name is maria niakar and i'm a clinical research professional and i've worked in the medical device industry for 15 years now and i'm very passionate to share my knowledge about clinical research and medical device technology and i hope you will enjoy this course as a consultant entrepreneur and founder of a medical device cro i have an excellent perspective of the current challenges that medical device manufacturers are facing when setting up clinical investigations in this video i will share my knowledge and understanding and help you set up clinical investigations of medical devices let's get started the goal of this short course is that you should get a basic understanding of what the clinical investigation for medical device is and why you should care about this and based on that you should be able to figure out if the full course on clinical investigations of medical devices and the iso 14155 standard that we offer medical device hq could help you in your job or career the full course is similar to this course but much more comprehensive and with more in-depth information and quizzes at the end of each topic to test your knowledge and understanding the full course also gives you an iso 141 gcp certificate at the end of the course which many auditors and employers will be looking for so what is the iso 14155 about well the first edition of this iso standard was published in 2003 and the second revision of the standard was released in 2011 and the third and current version of the standard was released in july 2020 this course is based on the 2020 version of the standard the iso 14155 standard is an excellent guidance document and i encourage you to carefully read it and understand it it will almost guarantee that you will set up and conduct clinical studies with high regulatory compliance and high scientific credibility so let's look at what clinical research is and why it's important clinical research is necessary to develop new treatments for different diseases and conditions that occur in humans to develop these new treatments we have to perform clinical studies to get proof that the new treatment works and that it's safe in humans clinical trials and studies using medical devices are called clinical investigations in the iso 14155 standard the term clinical trial or clinical study are synonymous with clinical investigation so clinical investigations are carried out to assess what works and does not work as treatment in humans and more elegantly this is described in the iso 14155 as clinical investigations is defined as any systematic investigation involving one or more human subjects undertaken to assess the clinical performance effectiveness or safety of a medical device so the purpose of the clinical investigation is to establish and verify clinical safety or establish and verify performance or establish and verify clinical benefits or detect any undesirable side effects i want to emphasize that clinical investigation should not be confused with the term clinical evaluation it is easy to misuse or use the terms interchangeably but it's important to know the difference so we know if we speak about one thing or the other so in other words a clinical investigation is when you're using a medical device on real patients to demonstrate the safety and performance of that medical device whereas the clinical evaluation is a theoretical and scientific assessment of existing data from many different clinical investigations and other sources of clinical data furthermore the clinical evaluation is about answering two important questions such as is there sufficient clinical evidence to confirm compliance with relevant requirements for safety and performance when using the device according to the instructions for use very few and is the clinical investigation needed now let's look a bit more in detail at clinical investigations so do all medical devices need a clinical investigation well here it's important to make a distinction between clinical research of drugs and clinical research of the devices so when studying new drugs a clinical trial is always required however when studying medical devices a clinical investigation may be required and this decision is based on the novelty of the device the risk classification of the device the outcome of the clinical evaluation and the conclusion from the risk analysis of the device you may think that why wouldn't all new medical devices need a clinical investigation how can you know that they're safe well if you are manufacturing a syringe or scalpel it might be possible to say that the device is safe and performs well by using results from relevant pre-clinical testing of that device including bench test in vitro test ex ex-vivo test animal tests and so on together with an evaluation of published literature on that device nevertheless in the united states all high-risk medical devices such as class 3 devices and some class 2 require a clinical investigation in the eu the european union all high risk devices such as class 3 devices and implantable medical devices require a clinical investigation some class 2 devices require clinical investigation too there may be some exceptions to this and in our course on scene marking on medical devices you can learn more about how to classify the risk of a medical device now that you know more about what clinical research is and what clinical investigations are let me bring you up to speed on what good clinical practice is so good clinical practice also known as gcp is an international quality standard that describes how to manage clinical trials involving human subjects governments can use this standard to transpose it into regulations for how to set up and manage clinical studies the gcp standard is an ethical and scientific quality standard for designing conducting recording and reporting clinical trials that involve human subjects it provides public assurance that the rights safety and well-being of subjects are protected and that clinical data is credible the gcp standard also established what is required in terms of how to prepare gcp required documentation such as a clinical study protocol how to maintain important records how to train study staff how to qualify the clinical sites and its facilities how to maintain quality assurance and perform monitoring and auditing you may have seen the acronym ich in the context of gcp the ich stands for the international council for harmonization of technical requirements for pharmaceuticals for human use wow i almost wasted my time there anyway the mission of ich is to promote public health by achieving a greater harmonization of global drug development the ich does this by developing technical guidelines and and requirements that can be used by the regulatory authorities and the pharmaceutical industry harmonization leads to more rational use of humans and animals and other resources it aims to eliminate unnecessary delays in the development of new therapies and that's really great isn't it so the gcp follows ich and enforces tight guidelines on the ethical aspects of clinical research the ich gcp document therefore provides a unified standard for the european union switzerland canada japan and the united states on how to generate clinical data now let's switch gears to one of my favorite standards the iso 14155 this standard was specifically developed for clinical investigations of medical devices it's an excellent tool to help you implement gcp when conducting clinical investigations for medical advices similarly to ica's gcp the iso 14155 is an international quality standard which governments also can use to transpose into regulations for how to manage clinical investigations with medical devices in human just like ich gcp this standard includes protection of human rights for the subjects in the clinical investigation the iso 14155 standard provides a detailed instruction on how to set up and perform a scientifically credible clinical study the standard also helps you understand how to properly document the clinical outcomes and everything else related to the study to meet the requirements of the iso standard you have to create the well-structured and complete clinical investigation plan the cip there's even a specific index to help you with this and xa of the iso 14155 you also have to keep a good organization of important study documents called records the standard also describes how important it is to train the study staff and how to qualify the clinical sites and the facilities and finally how to maintain quality assurance performing monitoring visits and auditing so it's clear that gcp and iso 14155 the standards are important and that remaining compliant with these standards is essential but who is responsible to ensure compliance let's look at this now who are the stakeholders that will ensure good clinical practice and make sure that it's implemented and followed we will look at the main part is now involved in clinical research the stakeholders that share responsibilities to ensure gcp compliance are the sponsor the principal investigator the research nurses and clinical research coordinators the ethics committees and the regulatory competent authorities the contract research organizations cros and monitors the medical monitor all these stakeholders are bound by three basic concepts and duties their ethical scientific and administrative responsibilities to summarize the sponsor is ultimately responsible for the clinical investigation the quality planning conduct as well as ensuring appropriate communication with the regulatory authorities such as the competent authority the investigator is responsible for the day-to-day conduct of the clinical investigation and the investigator must be qualified by education training and experience the ethics committee is the independent body that should give opinions on the ethical and scientific matters of the clinical investigation and the competent authority is the regulatory body that acts on behalf of the government to ensure that the legal requirements are applied any of the stakeholders can unfortunately and often without knowing it breach the requirements i outlined in the gcp and the iso 14155 standard much of our work as clinical research professional is to know that the gcp and the iso standards so well that we can anticipate and avoid making these mistakes in the full course we talk more about the breach of gcp serious protocol deviations and how to make sure that you can avoid this now that you understand the importance of the iso 14155 let's look at some of the specific sections and its requirements the standard released in 2020 has 10 clauses and 10 in excess three normative and access and seven informative it's almost twice as long as the previous standard version it starts by providing an overview of terms and definitions and there are quite a few of them actually 55. i can really recommend to carefully read them since it's very useful that you use the correct term that is widely accepted and well defined what is new in the 2020 version is a summary of the gcp principles which have been aligned with with the ica's gcp principles and this is presented in clause 4. this is an excellent summary the 13 gcp principles are summarized and start with that a clinical investigation must be conducted in accordance with the ethical principles that have their origin in the declaration of helsinki you also have to ensure that the foreseeable risks are weighed against anticipated benefits for the individual subject as well as the society the rights safety and well-being of human subjects are the most important consideration and should prevail over interest of science and of society the available preclinical and clinical information on the investigational device should be adequate to support the proposed clinical investigation and the clinical investigations must be scientifically sound and we described in a clearly detailed clinical investigation plan the cip the clinical investigation must receive prior ethics committee approval and approval from the regulatory authorities where needed the medical care given to the subjects and the medical decisions made is the responsibility of a qualified healthcare professional each person involved in designing conducting recording and reporting a clinical investigation must also be qualified by education training and experience to perform their task each subject should freely give an informed consent prior to the participation in the clinical investigation all clinical investigation related information should be recorded handled and securely stored the confidentiality of records that could identify subjects must be protected and respect the privacy and confidentiality rules investigational devices must be designed manufactured handled and stored correctly and they must be used in accordance with the approved clinical investigation plan and the ib and manufacturer's instructions for use and finally there should be a quality system in place with procedures that ensures the quality of every aspect of the clinical investigation i also want to show you that while clinical investigations of medical devices have many similarities to clinical trials for pharmaceuticals the regulatory evaluation of devices is distinct to that of drugs and there are critical differences in the way that device studies are designed and executed let's look at this so clinical research is broken up into series of phases each with a distinct purpose phase one to phase four pharmaceuticals must undergo the full clinical trial phase sequence before market release for medical devices the sequence is similar however most medical devices will go through clinical investigation stages instead of faces this table provides a side-to-side comparison of pharmaceutical trial phases versus medical device stages it also shows the main differences between the different phases and stages for drugs versus devices i know it contains a lot of information and in the full course we review this stage by stage and finally i would like to end this short course by speaking a bit about the clinical development process and the importance of carefully preparing a clinical research budget and to monitor costs and timelines i have prepared this flow chart outlining critical steps that you need to adequately plan and execute towards this is of course simplified and there could be many more pitfalls during this journey we will review all of these steps in the full course and you will learn how to anticipate some of these challenges and avoid some of the pitfalls clinical investigations are notorious for the complexity they typically take many years to reach completion and are often very costly but in this course you will see that there are several actions that you can take to optimize the process and make sure that you set up a successful study and even save money we have now come to the last part and with all that you have learned you have probably realized that you need to build a solid clinical budget to convince your manager the sponsor and possibly investors about the project's feasibility you will need to identify the key cost parameters for your clinical research project it is also important to make sure that you keep an eye on the differences in costs related to assessment specified in the clinical investigation plan and these costs are sometimes country specific in the full course we will review all the cost drivers and how to carefully craft a clinical research budget the better you plan your study from the beginning the more you can optimize your budget and control the costs remember if you're failing to plan you're planning to fail thank you for watching this short course i hope you found it interesting and valuable if you need templates to give you inspiration on how to write these clinical documents or if you require more knowledge on clinical investigations of medical devices on medical device hq you can find some free templates of essential documents that are required in clinical investigations or you can purchase the full course introduction to clinical investigations for medical devices and iso 14155 you can find that on medical device hq we offer online courses public classroom courses as well as in-house trainings on clinical investigations clinical evaluations cm marking risk management design control and project management for medical devices drop us a line on support at medicaldevicehq if you want to learn more about your options or receive a proposal you can also email us on the same email address if you have a question related to clinical investigations and clinical evaluation or share what you think are the most challenging topic in the clinical evaluation process i hope to see you soon again

subjects using medical devices i will be showing you the key provisions of the medical device specific gcp standard the iso 14155 and describe its role in the

welcome to this short course on clinical investigations for medical devices and the iso 14155 standard my name is maria niakar and i'm a clinical research professional and i've worked in the medical device industry for 15 years now and i'm very passionate to share my knowledge about clinical research and medical device technology and i hope you will enjoy this course as a consultant entrepreneur and founder of a medical device cro i have an excellent perspective of the current challenges that medical device manufacturers are facing when setting up clinical investigations in this video i will share my knowledge and understanding and help you set up clinical investigations of medical devices let's get started the goal of this short course is that you should get a basic understanding of what the clinical investigation for medical device is and why you should care about this and based on that you should be able to figure out if the full course on clinical investigations of medical devices and the iso 14155 standard that we offer medical device hq could help you in your job or career the full course is similar to this course but much more comprehensive and with more in-depth information and quizzes at the end of each topic to test your knowledge and understanding the full course also gives you an iso 141 gcp certificate at the end of the course which many auditors and employers will be looking for so what is the iso 14155 about well the first edition of this iso standard was published in 2003 and the second revision of the standard was released in 2011 and the third and current version of the standard was released in july 2020 this course is based on the 2020 version of the standard the iso 14155 standard is an excellent guidance document and i encourage you to carefully read it and understand it it will almost guarantee that you will set up and conduct clinical studies with high regulatory compliance and high scientific credibility so let's look at what clinical research is and why it's important clinical research is necessary to develop new treatments for different diseases and conditions that occur in humans to develop these new treatments we have to perform clinical studies to get proof that the new treatment works and that it's safe in humans clinical trials and studies using medical devices are called clinical investigations in the iso 14155 standard the term clinical trial or clinical study are synonymous with clinical investigation so clinical investigations are carried out to assess what works and does not work as treatment in humans and more elegantly this is described in the iso 14155 as clinical investigations is defined as any systematic investigation involving one or more human subjects undertaken to assess the clinical performance effectiveness or safety of a medical device so the purpose of the clinical investigation is to establish and verify clinical safety or establish and verify performance or establish and verify clinical benefits or detect any undesirable side effects i want to emphasize that clinical investigation should not be confused with the term clinical evaluation it is easy to misuse or use the terms interchangeably but it's important to know the difference so we know if we speak about one thing or the other so in other words a clinical investigation is when you're using a medical device on real patients to demonstrate the safety and performance of that medical device whereas the clinical evaluation is a theoretical and scientific assessment of existing data from many different clinical investigations and other sources of clinical data furthermore the clinical evaluation is about answering two important questions such as is there sufficient clinical evidence to confirm compliance with relevant requirements for safety and performance when using the device according to the instructions for use very few and is the clinical investigation needed now let's look a bit more in detail at clinical investigations so do all medical devices need a clinical investigation well here it's important to make a distinction between clinical research of drugs and clinical research of the devices so when studying new drugs a clinical trial is always required however when studying medical devices a clinical investigation may be required and this decision is based on the novelty of the device the risk classification of the device the outcome of the clinical evaluation and the conclusion from the risk analysis of the device you may think that why wouldn't all new medical devices need a clinical investigation how can you know that they're safe well if you are manufacturing a syringe or scalpel it might be possible to say that the device is safe and performs well by using results from relevant pre-clinical testing of that device including bench test in vitro test ex ex-vivo test animal tests and so on together with an evaluation of published literature on that device nevertheless in the united states all high-risk medical devices such as class 3 devices and some class 2 require a clinical investigation in the eu the european union all high risk devices such as class 3 devices and implantable medical devices require a clinical investigation some class 2 devices require clinical investigation too there may be some exceptions to this and in our course on scene marking on medical devices you can learn more about how to classify the risk of a medical device now that you know more about what clinical research is and what clinical investigations are let me bring you up to speed on what good clinical practice is so good clinical practice also known as gcp is an international quality standard that describes how to manage clinical trials involving human subjects governments can use this standard to transpose it into regulations for how to set up and manage clinical studies the gcp standard is an ethical and scientific quality standard for designing conducting recording and reporting clinical trials that involve human subjects it provides public assurance that the rights safety and well-being of subjects are protected and that clinical data is credible the gcp standard also established what is required in terms of how to prepare gcp required documentation such as a clinical study protocol how to maintain important records how to train study staff how to qualify the clinical sites and its facilities how to maintain quality assurance and perform monitoring and auditing you may have seen the acronym ich in the context of gcp the ich stands for the international council for harmonization of technical requirements for pharmaceuticals for human use wow i almost wasted my time there anyway the mission of ich is to promote public health by achieving a greater harmonization of global drug development the ich does this by developing technical guidelines and and requirements that can be used by the regulatory authorities and the pharmaceutical industry harmonization leads to more rational use of humans and animals and other resources it aims to eliminate unnecessary delays in the development of new therapies and that's really great isn't it so the gcp follows ich and enforces tight guidelines on the ethical aspects of clinical research the ich gcp document therefore provides a unified standard for the european union switzerland canada japan and the united states on how to generate clinical data now let's switch gears to one of my favorite standards the iso 14155 this standard was specifically developed for clinical investigations of medical devices it's an excellent tool to help you implement gcp when conducting clinical investigations for medical advices similarly to ica's gcp the iso 14155 is an international quality standard which governments also can use to transpose into regulations for how to manage clinical investigations with medical devices in human just like ich gcp this standard includes protection of human rights for the subjects in the clinical investigation the iso 14155 standard provides a detailed instruction on how to set up and perform a scientifically credible clinical study the standard also helps you understand how to properly document the clinical outcomes and everything else related to the study to meet the requirements of the iso standard you have to create the well-structured and complete clinical investigation plan the cip there's even a specific index to help you with this and xa of the iso 14155 you also have to keep a good organization of important study documents called records the standard also describes how important it is to train the study staff and how to qualify the clinical sites and the facilities and finally how to maintain quality assurance performing monitoring visits and auditing so it's clear that gcp and iso 14155 the standards are important and that remaining compliant with these standards is essential but who is responsible to ensure compliance let's look at this now who are the stakeholders that will ensure good clinical practice and make sure that it's implemented and followed we will look at the main part is now involved in clinical research the stakeholders that share responsibilities to ensure gcp compliance are the sponsor the principal investigator the research nurses and clinical research coordinators the ethics committees and the regulatory competent authorities the contract research organizations cros and monitors the medical monitor all these stakeholders are bound by three basic concepts and duties their ethical scientific and administrative responsibilities to summarize the sponsor is ultimately responsible for the clinical investigation the quality planning conduct as well as ensuring appropriate communication with the regulatory authorities such as the competent authority the investigator is responsible for the day-to-day conduct of the clinical investigation and the investigator must be qualified by education training and experience the ethics committee is the independent body that should give opinions on the ethical and scientific matters of the clinical investigation and the competent authority is the regulatory body that acts on behalf of the government to ensure that the legal requirements are applied any of the stakeholders can unfortunately and often without knowing it breach the requirements i outlined in the gcp and the iso 14155 standard much of our work as clinical research professional is to know that the gcp and the iso standards so well that we can anticipate and avoid making these mistakes in the full course we talk more about the breach of gcp serious protocol deviations and how to make sure that you can avoid this now that you understand the importance of the iso 14155 let's look at some of the specific sections and its requirements the standard released in 2020 has 10 clauses and 10 in excess three normative and access and seven informative it's almost twice as long as the previous standard version it starts by providing an overview of terms and definitions and there are quite a few of them actually 55. i can really recommend to carefully read them since it's very useful that you use the correct term that is widely accepted and well defined what is new in the 2020 version is a summary of the gcp principles which have been aligned with with the ica's gcp principles and this is presented in clause 4. this is an excellent summary the 13 gcp principles are summarized and start with that a clinical investigation must be conducted in accordance with the ethical principles that have their origin in the declaration of helsinki you also have to ensure that the foreseeable risks are weighed against anticipated benefits for the individual subject as well as the society the rights safety and well-being of human subjects are the most important consideration and should prevail over interest of science and of society the available preclinical and clinical information on the investigational device should be adequate to support the proposed clinical investigation and the clinical investigations must be scientifically sound and we described in a clearly detailed clinical investigation plan the cip the clinical investigation must receive prior ethics committee approval and approval from the regulatory authorities where needed the medical care given to the subjects and the medical decisions made is the responsibility of a qualified healthcare professional each person involved in designing conducting recording and reporting a clinical investigation must also be qualified by education training and experience to perform their task each subject should freely give an informed consent prior to the participation in the clinical investigation all clinical investigation related information should be recorded handled and securely stored the confidentiality of records that could identify subjects must be protected and respect the privacy and confidentiality rules investigational devices must be designed manufactured handled and stored correctly and they must be used in accordance with the approved clinical investigation plan and the ib and manufacturer's instructions for use and finally there should be a quality system in place with procedures that ensures the quality of every aspect of the clinical investigation i also want to show you that while clinical investigations of medical devices have many similarities to clinical trials for pharmaceuticals the regulatory evaluation of devices is distinct to that of drugs and there are critical differences in the way that device studies are designed and executed let's look at this so clinical research is broken up into series of phases each with a distinct purpose phase one to phase four pharmaceuticals must undergo the full clinical trial phase sequence before market release for medical devices the sequence is similar however most medical devices will go through clinical investigation stages instead of faces this table provides a side-to-side comparison of pharmaceutical trial phases versus medical device stages it also shows the main differences between the different phases and stages for drugs versus devices i know it contains a lot of information and in the full course we review this stage by stage and finally i would like to end this short course by speaking a bit about the clinical development process and the importance of carefully preparing a clinical research budget and to monitor costs and timelines i have prepared this flow chart outlining critical steps that you need to adequately plan and execute towards this is of course simplified and there could be many more pitfalls during this journey we will review all of these steps in the full course and you will learn how to anticipate some of these challenges and avoid some of the pitfalls clinical investigations are notorious for the complexity they typically take many years to reach completion and are often very costly but in this course you will see that there are several actions that you can take to optimize the process and make sure that you set up a successful study and even save money we have now come to the last part and with all that you have learned you have probably realized that you need to build a solid clinical budget to convince your manager the sponsor and possibly investors about the project's feasibility you will need to identify the key cost parameters for your clinical research project it is also important to make sure that you keep an eye on the differences in costs related to assessment specified in the clinical investigation plan and these costs are sometimes country specific in the full course we will review all the cost drivers and how to carefully craft a clinical research budget the better you plan your study from the beginning the more you can optimize your budget and control the costs remember if you're failing to plan you're planning to fail thank you for watching this short course i hope you found it interesting and valuable if you need templates to give you inspiration on how to write these clinical documents or if you require more knowledge on clinical investigations of medical devices on medical device hq you can find some free templates of essential documents that are required in clinical investigations or you can purchase the full course introduction to clinical investigations for medical devices and iso 14155 you can find that on medical device hq we offer online courses public classroom courses as well as in-house trainings on clinical investigations clinical evaluations cm marking risk management design control and project management for medical devices drop us a line on support at medicaldevicehq if you want to learn more about your options or receive a proposal you can also email us on the same email address if you have a question related to clinical investigations and clinical evaluation or share what you think are the most challenging topic in the clinical evaluation process i hope to see you soon again

device and if that is not possible it shall be placed on the packaging

so i am pontus yada i have worked as the technical planning manager for an mdr notified body for several years and this video is part of my course introduction to mdr the medicaid device regulation and are you interested in the full course on the mdr check out the course by visiting the course page that is linked below and if you need a record of your training in this area the full course will result in you receiving a course certificate before we start ensure that you are subscribed to our channel to make sure you're always on top of content then click the notification button too let's dig right into it now let's look at the requirements related to the unique device identifier or just short udi udi is applicable to all manufacturer of medica devices in europe and before we dig into the udi requirements in europe i would just like to clarify once and for all that the udi requirements in europe are not identical to the udi requirements of other markets like the u.s market a colleague of mine once said during a training session we had on medicare devices that should be a slogan for udi i think okay i said and what would that be he answered udi more than just the barcode and i actually have to admit that he was quite right at the time it is a lot more than just the barcode even though i never heard this slogan again after that meeting sorry i know it's a bit nerdy but what more can we do to bring more attention to this important subject but jokes aside this udi thingy is actually a whole world of its own so let's start to introduce you to this world let's start with an overview of the udi concept we can picture it as three pillars starting from the left and i will then further elaborate the pillars first we have the basic udidi or sometimes called beauty the purpose of the basic udidi is to act as the main key in udemy and relevant documentation like certificates declaration of conformity technical documentation periodic safety update reports and sscps but also certificates of free sales worth noting for those of you taking this course outside europe is that the basic udidi is unique to the european union and therefore there is no corresponding codes available in for example us which has already and will probably continue to cause some confusion the basic udidi is kind of a collective code used to cover devices with the same intended purpose risk class and essential design and manufacturing characteristics the basic udidi shall not be on any device or packaging it is only to be used as a collective term for grouping devices and for reporting into udemed moving down in this blue pillar now one basic udidi can then cover several udis as i just explained but a udi cannot be included in several basic udidis the actual udi is then split into two parts the udidi and the udi pi di stands for device identifier and pi stands for production identifier the udi part is mandatory for all medicaid devices whereas the udi pi part is only applicable where production related information is required to be included in the labeling like lot number serial number software release or when expiry date is essential to communicate so please understand that if expiry date or manufacturing date is essential for your device independent on class a udi pi is required so basically we can say that any essential information on the label that is defined during the production will require a udi pi the udi shall be placed on the product by the manufacturer and no one else and thereby it is also a requirement that the manufacturer has integrated the assignment and application of the udi in their qms below this video you'll find an mdcg endos document explaining the udi requirements in relation to the manufacturer's qms it is really quite a good guidance so i recommend you to read it and i expect or actually i know that notified bodies will follow this guideline both the beauties and the duties shall be unique to the manufacturer and must be obtained from a designated issuing entity in accordance to that issuing entities nomenclature there is a list of currently available issuing entities below this video the basic udidi is an alphanumeric code that shall be readable for humans a human readable interface or short hri so no need for barcodes on the basic udidi but the udi including then the udidi and pi shall both be readable to humans and to machines and machine readable interface is abbreviated aidc which stands for automatic identification and data capture examples of aidcs are 2d barcodes dot matric codes biometric codes or rfid as i just mentioned the basic udidi is for example used for certificate but also needed when registering the actual device in udemad together with the udidi and those two are the so-called static parts of the udi system meaning as long as you don't change your device or add or remove devices they remain the same there is an mdcg endorsed document mdcg 2018-1 published that explains when you need to change gud idi and also the relationship to the basic udidi for those you find the link under the video focusing on the udi di a bit then the udidi must be unique to a manufacturer and a device and it shall be both human and machine readable so to put it in normal words the ud idi is kind of corresponding to the order number that you will use for selling your devices this is also known as the ref number but please note that this doesn't mean that you need to replace your order number ref number with the actual udidi code but they must be linked internally and also in udemed this also means if you offer your product in different quantities for example a five pack of a product or a twenty pack and they have different order numbers you need to have different udi idis for those levels of packaging meaning one ud idi for the actual device and another udidi for the sales package if so if in anything else than a single pack but please note that shipping containers are excluded from the udi requirements that was a summary of the udi setup now let's continue with the udi carrier which is basically the label then first of all let's just make it clear again the udi carrier shall not include the basic udidi only the udidi and if applicable to udi pi and once again the udai carrier shall be readable both to humans and machines the udi shall be placed on the actual let'sdevice and if that is not possible it shall be placed on the packaging

then focus a bit on the udi pi part the pi production identifier part of the udi code is the code that is dynamic and used to identify the specific data related to the production of that specific device such as serial number lot number software identification manufacturing or expiry date or both of those dates and for devices exclusively intended for retail sales for example band aids the udi pi is not required to appear on the sales packaging as aidc meaning machine readable so that is excluded for those retail devices and at the other end of the risk scale there are active implantable medical devices and for them the serial number on unit level is mandatory to be included in the udi pi so what could one of those machine readable codes look like well here is an example of a 2d barcode udi including the udidi and the udi pi and as you hopefully understand if the pi part needs more data then we need a longer code and if your product doesn't have a really big label it could become a challenge to fit this barcode onto the existing one but there are dot matrix codes available to use also if a 2d barcode will be too long but still the data must be able to be read by humans also so when do you need to comply with this marking of the udi on your device here you see the dates when the udi carrier must be on your device the upper row is for normal devices and the bottom row is for devices that are intended to be reduced like surgical instruments and the dates for those reusable devices shown here is the date when the actual device needs to be the udi carrier themselves so basically meaning marking the device itself with the full udi not just on the label as you can see now udi is more than just a barcode so the majority of the mdr requirements are collected in article 27 and annex 6 but i have to admit that this annex is quite messy and not the best part of the mdr actually and since there are quite many things in the mdr that needs to be clarified in relation to udi the mdcg has been busy in issuing guidance documents on this subject so i strongly recommend you to frequently check the mdcg web to see if when new or updated guidelines are published related to udi and be aware that there are some specific requirements for software and procedure packs plus some other devices that have specific guidelines published by the mdcg for the udi feel free to drop a comment or question below i'd love to talk to you are you on linkedin make sure you follow medicaldevicehq there and do tell our friends from the medical device industry to connect with us too that's all for now thanks for watching once again and see you next time

just screen and buttons when talking about a medical device all kinds

introduction to usability engineering and iec 62366-1 you'll find it on medicaldevicehq.com usability engineering if you want more premium medical device content don't forget to click the subscriber notifications button so you don't miss out usability engineering is about understanding who uses the device the tasks of the users the environment in which they will use it and designing a great user interface there are directly two terms i would like to introduce to you the first and probably the most important one in the whole usability engineering work is user a user is simply the person who is interacting with the medical device and the second term when talking about a great user interface is of course user interface and in the medical world the user interface actually includes more than you might think the user interface means so much more than

accompanying documentation and basically everything that the user can interact with needs to be considered a user interface it even includes auditory signals and the instructions for use so where does the usability engineering process start it starts with the preparation of a used specification the use specification is a document that includes all the information about your users you can imagine it as an extended form of the intended use and getting information right is really crucial for the success of your product that becomes really clear if you have a look at this example imagine you are talking about a glucose measuring device if it is used in a home use environment by a young child you will need to prepare a different device compared to a device that will be used by a professional caregiver in a hospital environment even more the same could be true if you're looking only at home use environment imagine you're comparing a device that will be used only by kids with one that is used only by elderly people they will most probably be designed completely differently to make sure that your device will be good and safe you have to take great care of identifying the right user profiles and writing down all the information that makes this user so special and please remember this not only includes characteristics of the person but also characteristics of the tasks and the use environment and this is the starting point for the usability engineering process based on what the use and the users are like you should analyze what could go wrong with regards to the safety of the user interface this is similar to identifying hazards or answering questions relating to the safety of the device that many would be doing as part of risk management process according to the iso 14971 standard let's have a look at the graphic from the standard again as you can see safety plays a major role in usability engineering for medical devices in the original process looking at things that could go wrong makes a total of three steps i just group them together for the sake of simplicity and when speaking about things that could go wrong one term that comes up is the term use error the term use error has a very broad definition because you could say that a use error happens every time a human and the machine misunderstands each other not every use error will lead to hazardous situation far from but some use errors may and those are the ones usability engineering is focusing on the formal definition of use error is a use error is defined as a user action or lack of such an action while using a medical device that leads to different results as intended by the manufacturer or expected by the user of the device typical examples of a use error could be a nurse who accidentally pulls out the cable of the sensor of a monitoring device without noticing it or it could be a healthcare professional who touches a sterile tissue with his or her bare fingers before applying it to wound but it could also mean that someone accidentally connects a cable to the wrong part of a medical device and the signal is not transduced correctly as you can see there are a lot of different potential use errors and please note it's not called the user error if you think so you won't pass the final exam of this course because user error implies it's the user's fault but it's most definitely not always the user's fault when there's a use error another important term that is highly relevant when talking about things that could go wrong is the term hazard-related use scenarios the term can be a bit challenging for those that were not always working with risk management therefore i'd like to introduce you to it a hazard-related use scenario is a hazardous situation that you occurred as a result of a use error and we already discussed what use errors and the hazard related use scenarios are the things you need to identify and document because you will need them in the next step because then based on the identified use error and on what could go wrong you decide which things you should evaluate in the very end of your product development that is to identify hazard-related use scenarios that will be included in your summative evaluation in the end to ensure that your medical device is safe providing or verifying that the device is safe is a must because it is a general principle in both risk management and design control so you have to check whether your risk control attempts were successful and the success is checked by the summative evaluation but don't worry i will explain what a summative evaluation is in a few moments now that we've gone through the first analysis it's time to specify requirements on the user interface when implemented those requirements should reduce the risk that we previously identified to make sure that when we do the final evaluation of the device the user will not end up in a situation where the risk is unacceptable from a risk management point of view you could say that these requirements are risk control measures and that is the great thing about starting with the risk in mind you now know which user interface requirements you need to include to be able to reduce those risks nevertheless i would like to encourage you to not only include requirements that make a safe device but also think about the requirements that come to mind when thinking about the user environment and the task of your users so those requirements that would really make a great device that everybody is delighted to use next you need to implement the requirements you decided on in the previous step by designing the device and its user interface while you do you should check that you are on the right track that is really important because from my experience you won't get the design right on the first try especially when you're designing a new product there's a term for making tests along the way and that is called formative evaluation let's look at the term formative evaluation it's a quite challenging term to remember this term is actually not only used in usability engineering but also in teaching and it means almost the same thing in both contexts remember i say that we are checking that we're on the right track which is also what you would do in teaching when you're doing formative evaluation in fact when you take this course and you go through the checkpoint quizzes this is also kind of formative evaluation having said that i hope i've created a few memory hooks for you to remember the term formative evaluation so what could a formative evaluation be like it could be that you show early wireframes to users to see where they would click you could be making tests with prototypes to see how people interact with your device or you could do focus groups or surveys a formative evaluation is basically any method you can come up with that would solicit feedback on your user interface in its simplest form it's just to ask if someone understands it or what the symbol should be like on the device more advanced formative evaluations include testing in an environment that is as real as possible with multiple users and a product that is similar to the final one the amount of work you do in this field depends on whether the product is brand new or not and the severity of the harm that could occur as a result of failure in the user interface if you are for example making a new iteration of an already existing product you are likely to do very little formative evaluation or even little usability engineering at all whereas if you are developing a brand new high risk product that trusts humans to operate it correctly you are going to invest a lot more time and resources into this field what if you find that you're not on track well then you need to iterate on the design and approve this is how you proceed with the development until you find in your last formative test that just nothing to improve anymore after having implemented a user interface according to the requirements you have defined and evaluating it along the way it's time to do the final summative evaluation the summative evaluation should demonstrate that the user does not end up in a situation with an unacceptable risk as a result of poor usability before explaining the summative evaluation please note it is not the same thing as design validation the design validation will focus on showing that the user needs have been met while the summative evaluation is about showing that the user interface is safe there might be a small overlap in terms of how you do the testing but they do have different purposes so summative evaluation is testing the usability under conditions of simulated use it should also be done using production units or equivalent devices from the point of view once again it's similar to design validation but remember that the purpose is different lastly all the documentation and records you have created throughout the usability engineering process will be referred to as the usability engineering file that was the usability engineering process in a nutshell if you want to learn more about usability engineering you can sign up for my online course introduction to usability engineering and iec 62366-1 on medicaldevicehq.com thanks for watching and stay tuned for the next