Hi, my name is Joany Jackman, and I'm a member of the Center for Point of Care Research Network for STDs. I'm here today to talk to you about a resource that we built. Originally built this resource for ourselves, but then we realize that head utility for other people. I'd like to tell you about it, and we can all come in and use it. This resource is called the technology watch database. Before I get started going too far, I just want to tell you I'm not affiliated with any of the companies that are in this database. I don't receive any compensation from any commercial or private sources. It's all from an IBIB Grant. How we became involved in this project is, as I said, as a member of this center; in fact, I'm the technical lead for technical development within the center. We looked at this data that we had, and we realized that other people might want to be able to compare information on various technologies in that having such a database will be useful to do that. That's part of what we're going to tell you about today. We're going to familiarize with the database. At the end of this lecture, you'll hopefully be able to describe some of the benefits to developers and adopters of technology. I'm going to be able to conduct your own searches, looking at specific characteristics that you're interested in for each type of technology, and be able to recommend maybe additions of technologies to the database we're always expanding. The benefit of the tech watch database is it pulls together information on hundreds of technologies at this point and use to detect infectious diseases. We pull it together in a single site, so it's not information you can't find yourself, but you'll find it all in one place. That's what we've been able to do. The search engine that allows people to sort through the technologies based on specific characteristics, which I'll mention what they are a minute, and for adopters, people who are interested in acquiring technology for maybe their particular clinic or laboratory or office. This would be a good way for you to compare the features of different technology to see what you're most interested in, what would fit best in your particular office. For developers, we realize had utility for people who are looking for potential collaborators. They have part of a device, or they have maybe a sample prep system, and they want to pair it with something. Or also, if you're developing a device, you need to understand what other things are out there. What might you be making something similar to? Are you using something that's similar to somebody else's patent? In fact, one of the things that you need to file as a developer's [inaudible] call that Freedom to Operate document that shows that you've done your due diligence and that you have your licensing in place if needed, or that the things that you're inventing are truly your patents and your own work versus being something that somebody else has already patented and is using. All those things are particular outcomes that you can see from the database. What does that database contain? We looked at a number of different targets, and because our center initially focused on STDs, we selected this as a target for point of care tests that we are looking at in our center. That was one aspect of trying to find these devices. But there are still many devices out there that weren't quite on-call point of care, but bench-top systems that would be in a clinical lab, we thought at some point to include some of those in the database so people had a point of comparison in terms of times it takes to run samples and that type of throughput you can run for sample. Some of those are in the database too. You can also find out more information about what are the needs for point of care tests and what are the characteristics that people find most important by going to the website listed here for our center and going to the publications area and looking, taking a look at some of the articles that we've published about the needs assessment for point-of-care technologies. Initially, we started this out. As I mentioned to you, it was for STDs, and then SARS happened. Because we had this database started already, we were approached by an IBIB to expand this into a database that included current COVID diagnostic devices. As you can imagine, getting this database stuff quickly was quite a challenge because once we were tasked to do this, there are already around 80 or 90 devices that were EUA approved for SARS. Since then, there's over 300 devices that have been approved under EUA for diagnostic devices for SARS. We have pulled [inaudible] together. We did not include serological devices because our sponsor us is not to. I'll just warn you in the database if you're looking for those, those will be there. But they are the molecular tests, and the antigen paste direct viral tests. The things that we don't collect information on right now are for primary care applications or cancer detection. People are always asking us about those that's unfortunately not within our area. We wholly focus on infectious disease, and as I said, these two particular disease targets are primary what we have. But as you can imagine, if you can build a device for SARS, you can certainly build it for other infectious diseases, and those targets are also listed under the database. I mentioned to you that the information contained here contains information on different characteristics, and these characteristics are listed below here, and you can see what they are. These characteristics, their choices of them are based on a survey, a small survey that we did within Johns Hopkins School of Medicine and School of Public Health and what people felt were important to know about various devices. You'll notice one thing, for instance, in terms of time, we broke down time into multiple units. We have the total turnaround time, some calls tat. We have the assay runtime, which is the time that when you put the material into the machine, we have the hands-on time, and sample prep time. The reason we did that is to give you an example. Some clinics may have a staffing and people to be dedicated to doing experiments, so if you have a device that runs in 20 minutes, and it has a hands-on time of 10 minutes, that is okay. But there's other places that people are doing other things, and they don't have time to stand next to a machine. But maybe it's a [inaudible] that works in less than that amount of time in 20 minutes, but in 15, but it only has a hands-on time that's short, that's great. But what if it works in 30 minutes, and it has a hands-on time that's only two minutes long. For some people, even though it's a longer runtime, the fact that it's a shorter hands-on time because they don't have the staff to stand next to a machine, makes it a better tests for them. That's what I'm going to make you aware of, that some things are broken down, cost is broken down to the cost of the assay the new one and the costs if there's a device to run it. Those are two different types of costs that people struggle with. If it's a device that can run a particular assay for a couple of dollars, that's great, but if you need a $100,000 machine to run it, that can be prohibitive for someone to acquire that. Look through the information that's in there once you get a chance to get into it and feel for what's important to you in terms of looking at devices that you're interested in and also what choice of devices were being developed out there. Now, the other thing to point out is that all of this is open source information. There's no proprietary information in this database, and that was for several reasons. One of which is, we can assemble this information based on open source material without having to go to a company and ask for permission. We do actually ask every company to review their page in the database to make sure the data is correct. Sometimes they choose to update it, and that's a choice. We do ask them not to provide us information that would be inside information within the company because it is going to be used by multiple people. Yes, if you're from a foreign site, you can still use this database. How can you find this database? First, this is the location on the web. It's at Johns Hopkins University Applied Physics Lab, and it's just called the pocket database for the pocket of point of care database. You can also find it on our centers webpage and I gave you that address before, but on the ribbon down below you can see the red circle. It's right on the landing page, so you can just click on that and get to the database. What's it cost? Well, I can tell you that I've been approached by several people trying to sell me databases in anywhere from the 2-5000 per year category, and luckily, this database is free. It's been funded by the NIBIB, the National Institute of Bio-molecular Imaging, Bio-engineering to develop this database, and so we offer it to you for free. You are required to register for the database and that's because we want to keep track of who's using it and who's not using it. If you have not used the database in over a year, you may find that your registration has been inactivated, you just have to call us again. To register for this, it's pretty easy. You send me an email with TW access and subject line, and usually less than a day can get you access to the database. Your computer features that you need, it does work on both a Mac or PC. It was built using SQLite software. It should not be necessary to download this software, you're looking at it through a browser with that software as operational. There are cases where people use some network systems or some operating systems on their computer that have not been tested and I've heard in one case where someone actually had to download SQLite browser to be able to use it. I don't think most of you will need that, but we want to make you aware of that. We also have not evaluated this on all search engines, and depending on how you update some of your software, may have some difficulty if you haven't updated in a while. We have been using Explorer, though Explorer is no longer supported. So if someone has trouble with using the new version of Explorer, which I guess is called Edge, please let us know. We have not seen a problem with it so far, but we haven't had a lot of users. Google Chrome works well, Firefox does work, although once again, if you haven't upgraded, it may not work as well as you may need to do an upgrade first. If you do find a search engine that interferes, please let us know, and we will investigate and see we can fix that problem. What does it look like? Here's the landing page. The idea is that you would be able to come here and you need to register. As I mentioned, you need to send me an email to do that. My name is on the bottom on the red circle. What's important to us is once you register you'll be sent a password, and you should probably change your password, or pretty quickly reset it yourself, so you can remember it, because there are some pretty narrowly password that they give you. If you do lose your password, you can reset it yourself, but I have no access to that information. So if that doesn't work, you'll need to give me a call and probably have to inactivate and reactivate your registration. The other thing on this page though is we have some links to some of the other centers. On the corner, you'll see that there's a link to surveys, and also our systems engineering tool that we developed for people to be able to do their assessments and have a group of subject matter experts review their material. That's the subject of another [inaudible] We'll get back to you about that. But once you log in. The next thing that you and me have done is, this is now inside the database. Here you have two different databases. As I mentioned, you have a choice of doing STD database and the COVID database. We didn't combine them because some of the features, the characteristics are a little different between them. To make it that we can get this database up quickly, we decided it was easier just to do them as two separate databases, but you can easily switch back and forth between them as you'll see in a minute. Right now there's a total of 467 devices in the database. We're expanding it all the time. The STD database as you'll see has 202 active devices you can look at and right now, COVID has 126 active but we have about 56 devices still to upload. We particularly mentioned the active sites that's because, first before we activate so that you can see these we go through a rigorous process of verifying the data that's in the database and making sure that we haven't made any gross errors. We also as I mentioned, send it to companies but they don't always send this back. If an error is small they may not let us know. We still want to do a data check on that, make sure it's good data. We have hidden the serological assays. As I said, our sponsor after we'd started doing this we found out that they didn't want the assays for anything but direct viral tests shown so they're in there and when we get a chance or if our sponsor gives us permission we'll uncover those. The reason we hide some devices too is that there are some devices in there that companies have either ignored to find them. They have asked us to take down the site. They can offer permission to do that. We don't like to do it, we like to convince them because it really doesn't harm anything but they have their own reasons if they don't want something put up there. Like I said, all the information is available to you on the Internet, so it's not what you can't get it if you go and look for it, but I think it's something that we want to give companies the option of participating versus forcing them to do it. We also see here on the bottom there's some other boxes and we'll into those in a minute in terms of what they mean, but there's some FAQs to help you if you're having some issues and also there's just another primer of how to use the database, essentially what you're going to see here. I want to once again emphasize that not everything in the database is the point of care tests, but they're things that are sometimes called near point of care and there's also bench-top systems which are usually the gold standard assays that you might want to compare to when you're searching for devices. We are actively putting up more things. Our next steps is to add more of the radix devices, we'll probably have another 50 or 60 devices that have been approved since our last list was updated in August, and our annual verification occurs every single device in the database every year, customer verification. We look at all the information that's listed because sometimes there's improvements or sometimes they've made a new device to replace something that was in their system and they're no longer offering. We do update all the entries every year and those are going on starting in the summer with the updates. Let's click on the first database and take a look what you get when you actually go into this database. As I mentioned there's 202 devices in here if we look at. It's not exhaustive. Not every device out there, imaginable is in this database, but it's a pretty good representation. We think in particular that we have a very good representation of the different types of technologies that are used. LAMP versus RT-PCR versus PCR versus qPCR. All those are different versions and so all of those, there's usually representatives for every one of those different types of molecular tests for nucleic acids in this database and the same thing goes for immunoassays. If you look on the left side, you'll see a list of pre-package searches. We'll talk about those in a minute, but you can do your own search if you are looking over this list and you just for instance here and you see, one called Alere, it's circled in red. If you click on that, the next information you get is this. Here's all the detailed information we talked about. Up in the top left corner, it describes company information how they're getting contact with them, where they're located. Do they have any data sheets on their device that you want to pull up and look at and those are in there. Then on the right side, upper corner, we have a short list of some of the key characteristics that people seem to be most interested in. They're interested in the targets that device can detect, how easy it is to use, whether it's an enabling technology or detection technology or both as in the case of this. What we mean by enabling technology, is something that's maybe just a sample prep technology. Maybe it concentrates in urine or strips material off a swab sample to be able to get it into a liquid matrix so that you can develop it for something like PCR or even some of the other immunoassays. Then as you go down farther into this list, you'll see there's a short description that's technology. Then in our notes section, we will actually post papers, product guides, and other information that you may want to look over, that the people use the device or get more information. As I mentioned, some of the key things that we were interested in is in time, the time it takes to run the tests but also, here's what I mentioned before about the breakdown in time to hands-on time, runtime, turnaround time. Also, what type of power it takes. This one is a lateral flow strip so it doesn't require any power but whether it's battery operated and this is AC and DC power, that's all part of it. If there's specific storage conditions, especially since some clinical centers don't have storage conditions that are refrigerated, it's important to know if you need refrigeration or a freeze ring that would be in this database and I see a lateral flow strip like that. One that's shown up here at the top that clarifying committee assay is easily portable. We do have definitions of highly portable, merely portable, man-portable which is something you would carry around. Then whether the test is disposable or if it needs any cleaning protocol like a larger device might need. On the other side of the screen, you'll see the cost is listed and whether it's a manual operation or automated. As I mentioned, some of these devices are fully able to do all the sample prep you need and other than putting in the swab or apportion the urine sample into a tube or a port, there's really not much else that you need to do. What type of controls are on the device is also listed. What sample types it's able to do. If it gives you results in real time, we're talking about using PCR in that case, where as the reaction is running versus an endpoint essay like in a lateral flow strip where the material has to reach the end of the strip, all of it reaches and then you can read the test. Whether it's commercially available, it's in development whether has an EUA, for instance, the COVID devices, whether it has FDA approval, EUA approval, that's all listed. How large the device is. We didn't put down exact dimensions because some people don't have a good idea of that, but we did dimensions that could compare it to things that you know what they were, what common to find in the house. Then honestly, the very important limit of detection and sensitivity information. If it's listed as percentage, that means those are the clinical sensitivity and specificity measurements, meaning it's been compared on clinical samples. If it's listed as PFUs for viruses, CFUs for bacteria, that usually means that it's only been tested with analytical samples or set contrive samples where known amount of material has been doped into a matrix. Those devices, they may have been approved for use for other things, but they may not be FDA approved. That's something to pay attention to depending on what you're looking for in use, whether it's in research project or you're looking to adopt it for a particular medical need. If you go back to the site, the terms in there, they have categories that may not be familiar to you, click on this site and you can get into the specifics of how we defined certain things, especially about our measurements for analytical and clinical sensitivity, what we meant by enabling technology. You can get into all that information before you go into the database or you can come back out easily and take a look at this and go back in. The other thing is that even though we have almost 500 and devices in there at this point, we are always looking to expand. There's always more devices out there and there's new ones coming down the pike. As I mentioned, there's about 15 new COVID devices that we're looking at putting into the database. If you know the device, and it's your favorite device, and it's not in the database, you can add it with the "Add Device" button. It's important that you add the company information too. If it's not in the database and you don't want to do it, you might let the person know from the company that you're interested in looking at their technology, that there's this database and they might want to consider entering it. Before the entry is posted we will verify any data that's put into there and make sure that it's accurate and that if we can get additional data from other sites that we searched to what you ventured, we certainly would do it. This is where you'd find the information. It's our recommend device. When you open up that page, you'll see that there is quite a few boxes to fill in. The red boxes are information that is required for us to be able to move forward as we need the contact information on the company is really important. Then there is some basic information, not a lot, but there's some additional information that we would want you to identify. You certainly should be able to tell whether the device is portable or not, have an idea of why you like it and whether it's easy to use or not. All of this information, once we get it, we review it, and then we have enough information if it's far enough developed, we would put it into the database. Just to tell you that there are a few rules that are important to remember when you are using the database. This is something that calls on frequently. I don't know why it is, but definitely it's a little harder to develop the registration page. It'll accept upper and lower characters, so it's important that you only use lower characters in your email name when you're registering. Please don't share this access information with other people. It's really meant for you. If other people want to use it, just tell them to go and register. It's free. It's part of our justification of why we exist to show that people are using it. If everyone uses one access code it defeats that purpose. It makes it a little harder to justify keeping this going and maintaining it. As I mentioned before, I don't have access to your password, so I can't reset it for you. If the reset doesn't work, which occasionally happens, it's usually sometimes people have a change in their email address or some other thing that I have to re-register them or sometimes whatever gets corrupted and I have to go back in and modify that. It can take a couple of weeks to do the modification because it requires an upload of the entire database to do it. I know, but that's the way it is right now and so that was the easiest thing to get up. But we do want you to use it and we do everything we can do to help you get access to it. If you do find something that's broken, e.g isn't working right, please let us know. We really want to know. Have feedback because that's how we make it better. We're happy to take any comments that you have. Just send them to me, Joany.Jackman@jhuapl.edu. As I mentioned, if you haven't accessed the database and you're trying to go in and it doesn't work, we may have deleted your account just because we have only so many slots for registration. We haven't maxed them out, but we feel someone's not going to use it within a year they're probably not going to be coming back to it frequently enough to maintain the slot. We'll just make you a new one. It's not a problem. Plus, we do actually hope that you use it more frequently than once a year because things do change in devices. We've had many devices that have improved by many categories in terms of the total turn round and have the amount of time it takes to run the samples or their detection limit has increased dramatically or they've dropped the cost because now they're making more units. If those are the things you're interested in, it's good if you can come back to the database multiple times. Same thing, if you're developing something, there's new devices always coming onto the market. You try to keep track of the market, but you may not be able to, but this will be an easy way for you to see what else is new out there. How do you search the tech watch database? As I mentioned on the left side of the screen, there's a lot of these pre key-in in searches, but also we have the ability for you to do your own searches with keywords, if you know the tartan you're going after. Let's say you just want to know what's going on with some company. I'll show you now here. Here's an example is let's say for BioRad. I have no affiliation with them they were just a convenient one to pick. Interesting advice you knew is that BioRad and typing the name in updates. Turns out there's four devices in there for BioRad's. You can compare those devices within a company. Lets say you want to search on a characteristic like the cost of a device and you want to search on something that will not cost over a $100. This is an important point. If you look at the first slide and you check the box and you pick 25-100 because 100 is your maximum, you only get three devices that come up. Here's what you have to do, you actually have to check both boxes, which is the box for 25-100 and under 25. Now you get many more boxes coming up here. I think it's 10 boxes come up with this particular search. You want to make sure that you look at all the categories and choices and understand that sometimes it'll go up to a certain number and sometimes you have to check multiple boxes to get all the combinations. You can also stack your search or if you want to look for devices costing less than $100, you have ten devices there, then you want also look for devices that cost less than $100 and take less than 30 minutes. Now you have five devices showing, and then you want to know if the device costs less than a $100 and takes less than 30 minutes and detects Trichomonas, and you end up with one device. If that's what you want, you can also just put them all together. But sometimes it's useful to see the way that you get to that point because sometimes it pulls up devices that you may not have known existed. Even though I've detected Trichomonas, there may be other STDs you be interested in, or maybe that feature isn't as important to you as one of the other features. You may consider more of these devices and how they operate. One of the reasons that searches sometimes fail is because people forget to click the Update button. This is not a dynamic search engine, such that when you click the boxes it automatically starts giving you the information you need, you have to click the "Update" button between each set of additions that you add that you're looking at. Plus, as I mentioned before, by checking the boxes sequentially, you can actually get some useful information about a path to get to some of these devices and how many devices are in each category that you're looking at. What if a device doesn't appear and you know, it should be in the database or should be there. There is a place to add your device and it's in a drop-down menu. You can use this attention button. We've actually may have changed the name from attention to new device, but I still believe it's in there's as an intention button. You can go to the administration tab over here and pull this down and add a device. There's also, as I mentioned before, another button or item in the pull-down menu called Add a Company. You need to add both of those when you're talking about looking for a device and trying to add information in there. If you only add the device information without the company information, it will not upgrade into the database. We tried to get this review with under five days and get it online into the database and that you have that device in here if that's something you want to search against and compare to other devices that are like them out there. We're happy to get that information up to you and let you know when it's been added if you send us an email, if that's what you're really interested in. That's the tech watch database, how you can access it. We hope you find some useful information in there. Makes it easier for you to follow what sort of diagnostic devices are coming online and what ones are already on the market that you could choose from. Also for developers that you can find potential collaborators. We mentioned more by comparison of your device with the other things that are out there that you can get a good idea of what the market is and where your device fits in the current market. This is people that helped us. Can't thank them enough. If you have any questions, contact, my information is at the bottom of this slide. I hope you give me a call and ask to get entry into the database. Thank you very much.
