[background noises] welcome back ladies and gentlemen. If you like to take your seats we are going to start with the next session. Thank you so much. Julia will turn it on to you. Hi everyone. Welcome back. My name is julie i am chair of advocacy for the American Diabetes association and the arizona chapter. Also on the Arizona Diabetes Coalition counsel one of my collies was eight data population innovation expert so please see her after. Im also cochair of the arizona Bio Industry Association take a lot of personal pride in the voice of the patient. We advocate so well for arizona. I also the newest members the University ArizonaHealth SciencesCommunity Advisory board in phoenix. And my daughter has type one diabetes she is just finishing her first year of med school at u of a phoenix. I am so proud to see a lifetime of someone who is diagnosed at age one now in her mid 20s becoming a physician and right along with her having the same experience that she did, but as a caregiver, mom and now at advocacy professionals very exciting for me. Id like to introduce our panel and welcome it to enhancing Patient Engagement and medical Device Development and sure going to add deployment of those devices onto the panel. Today we welcome catherine who served as Deputy Division director with the office of Strategic Partnerships and Technology Innovation and the division of all hazard response science and strategic partnership. The food and drug administration. With nearly 20 years of experience the medical Device Development and regulation shes dedicated to building productive partnerships and programs to drive more Patient Center medical product innovation, evaluation, accessing care and to advance health equity. Previous roles at the fda have included Senior Advisor in the office of the Center Director and in the division of cardiovascular devices. She has worked and led various initiatives rent Clinical Trial innovation, realworld experience and reducing disparities cardiovascular device evaluation. She is a biomedical engineer by training and spent some time in the industry as well as Academic Research prior to thats our time also charisse who worked in the diagnostic Company Founder of the Foundation Diabetes social media advocacy creator and women of color diabetes. She serves on the board of directors childrens diabetes was the nexgen mentor for the College Diabetes network. She has 14 plus Years Experience in Digital Communications for healthcare and frequently invited panelists and speaker for the government, media online committees and. Support for citizen researcher Baylor College of medicine as well as being a patient wife, mother, veteran. Last but certainly not least we have doctor Chris Gibbons who is the interim director of the National Health it collaborative for the underserved. Previously was the associate director at the Johns Hopkins urban health institute. He is a published author with over 75 peerreviewed manuscripts, books, book chapters, monograph. His work focuses on the role of Digital Technology in a Perfect Health the underserved and disadvantaged population. He is a frequent speaker and visionary Digital Health entrepreneur and innovator in the health sector. Hes a start up advisor at microsoft for startups and a special faculty member. Doctor gibbons is also an adjunct professor at Johns Hopkins school of medicine and visiting Professor University schools of medicine. And before we get into our thoughtful conversation we would like to hear from katy. I will try to have the file off the stage here. [laughter] good morning everybody but is wonderful to see you all. I for one think theres so wonderful to be back in person for these types of events. What a wonderful conversation we have been hearing. This panel, youll hear from a lot of different perspectives bearlike to get a little glimpse of who is in the audience. How many of you work in policy and advocacy . Science and research . In the patient focused activity . Patient safety . And communication Information Knowledge is power. Yes fda works at the intersection of all these areas. At the center for devices and Radiological Health we have a very broad scope. Very briefly at my goal for the next 10 minutes is to give you all a broad landscape of what medical device innovation includes. Touch on three areas of work at the agency particularly relevant to todays conversation, device innovation, digital help in advancing health equity. So, with all the activities we do patients are at the heart of all of that work. We oversee over 200 30,000 different types of medical devices. Which includes home use devices like glucose meters, Life Sustaining and supporting technologies like insulin pumps or dialysis systems, and plans ranging from heart pumps to pacemakers limb implants and electrical stimulators in the brain. Overthecounter devices medical equipment like pulse oxen cpac machines and a wide range of Digital Health technologies. Our activities range from Covid Response to advancing innovations that benefit patients may be authorized 84 novel devices last year alone in france over 135 breakthrough devices which reflects the pipeline of breakthrough innovation coming to the agency. Our mission has twin aims at advancing innovation as well as protecting patient safety. We do all the work to advance innovation while balancing rigorous oversight to ensure safety. We collectively as a community are always learning more about these technologies and how they work, once they are in the market for widespread use we monitor for safety signals and provide essential information taught patients and providers determine the best course of action for the particular circumstance. We leverage patient partnerships at innovation and safety work we do, to keep programs i will highlight for you include caregiver connection on Patient EngagementAdvisory Committee. The Patient EngagementAdvisory Committee is a formal federal Advisory Committee comprised entirely of patients and caregivers patient advocates. We go to this group with key questions about innovative emerging technologies as well as safety issues and tackle those issues through the lens of the patient and see the things that emerge and bear focus. To examine challenges and heard a loud and clear patients are often unaware or confused about recall information. How does impact them . How urgently do they need to act . Work and they turn for help . We turn too. Give her Connection Network which is a collection of Patient Advocacy organizations that work within a bidirectional manner to help us here about Patient Experience with the common questions and concerns and help get information back up to the patient community. We are conducting a robust study to help us identify how to work with industry and the Healthcare Community as well as Patient Advocacy groups get more informative information about recall participation. T28 we launched a Digital Health center of excellence. This is obviously an ink beverly active sectorf innovatn. The cenrf excellence has been a major enable it works across t agency and extensively with external partners. At overseas regulation for wearables, Patient Generated Health Data at over 500 devices that are currently enabled with ai capabilities. That list is always growing. We use a collaborative approach to address safety and effectiveness of ai and all enabled devices includes collaborations including ost p. We focus on realworld evidence of performance of devices to softer transparency managed by algorithms. Next slide please. No person should be left behind and healthcare. Technology can help bridge the divide while advancing better healthcare quality of life and wellness for all. We are focused on four objectives in this space but how we can empower patients to make more informed decisions about their healthcare. Reduce barriers to participation by diverse audiences and support innovation changing Healthcare Delivery moving more into the home. Next few slides a big Key Resources key guidances as well as a quick glimpse of Scientific Research that we have been advancing. Patient perspective as part of the decisionmaking framework and the guidances that lay out the way regulatory evaluation is conducted at the agency. We also have issued three patient focused device guidances lang collaborate to include Patient Engagement and study conduct, Patient Preference information throughout the total cycle and approach for patient reported outcomes in device evaluation. They are to draft guidances that are out right now that may be of interest to this audience. Additional Health Technology for remote Data Acquisition clinical investigations and updates are Breakthrough Devices Program to reduce disparities in healthcare. These guidances aim to clarify how these tools can be used in clinical investigations and how healthcare disparities of eligibility impact to the Breakthrough Devices Program. We have conducted Patient Preference studies across a wide range of clinical conditions in areas to help advance innovation by helping to articulate and elicit Patient Perspective and prces and conditions were device innovation can advance Patient Health and wellbeing. We have also conducted a range of studies in diverse populations and patient reported outcomes. Patient generated health data is an area of Research Interest for the Agency Working in collaboration with the folks across the ecosystem here are listed near and longterm reese while research areas. Ultimately there has been Significant Impact in terms of the Patient Preference studies conducted dozens of industries regulatory studies have been completed during the pipeline and the device sector, and all of the submissions for novel technologies we see over half of them containing patient reported outcomes. Points of the pump. She jumped in the pool and we quickly found out the waterproof pump wasnt that waterproof and quickly the fda was alerted and we went through a series of interviews with the product developer and it was great but we were a little sad it wasnt waterproof but there were other things we had to do to tether her so she could still swim but i do have to commend the fda on the quick action it took and with the Device Manufacturers that was a phenomenal response. The fda does work with patients to increase the Patient Centeredness of medical product design. Can you tell us a little bit more about the Patient Preference information and how you work with of the members in this audience to interview the patients and hear what they have to say . Absolutely. So, about ten years ago we kicked off the tip asking the question how can we elevate this anecdotal patient information because the decisionmaking requires us to rely on valid scientific science so how can we get the aggregate information to look at the heterogeneity of preferences and how patients look at benefits and risks with of the technologies and alternative actions so we did that Exploratory Research study and issue the guidance that i referred to and we began to work more closely with the organizations and industry to develop more case examples included in the regulatory submission or by the fda in an area so we continue to look to partner with Patient Organizations interested in doing the research studies. Weve seen them come to the agency and the biologic space looking at the condition area that crosses those Different Technology ties but they play an essential role because they are the voices of the patient and they understand all of these perspectives and can be a key partner in bringing that information into the evidence framework for the regulatory evaluation to support advancing the nation in these areas. Thank you. So what would be the next step for people sitting at the tables right now looking at their neighbors saying i want to do that, i didnt know that we could do that . I believe that it will be made available. There are resources there that you can reach out to and i would be happy to chat with of those afterwards. In particular if theres an area where innovation is happening but there are opportunities for more Patient Centered conversations to happen where understanding what matters most to patients is something the Patient Organization can help bring to the table these are areas we are actively looking for a collaborator. So feel free to chat with me afterwards or reach out to one of our social mailboxes and we can have a conversation about that. Speaking of collaborators, charisse is legendary in the Diabetes Community and is a fantastic advocate and innovator in online communities. I would love for you to tell the audience about how youve inspired an entire nation, and, i mean, that. Youve inspired an entire nation and so Many Organizations that have done such a great work for so many years, and i applaud you. It is an honor for me. Youre making me blush. Thank you so much. But i want to go back a little bit. I am not the ceo. Everything else she said about me is true. Theres so much difference. Your daughter was diagnosed with type one. I was diagnosed late as an adult at the age of 24 so it was after i got out of the reserve and my husband was actually stationed in iraq when i was diagnosed. I have always had access to the best doctors and the technology the Service Provided for me. What i did notice at the time i was diagnosed i started medications because i had antibodies like type one is so the cells were attacked and my own would increase so that was in 2004. Around 2007 i started noticing that my blood sugar was going crazy. Even salad dressing, the blood sugar just skyrocketed after. What i did didnt work so i went to the nurse practitioner. Remember i told you my diabetes was a little different i think its time for me to see an endocrinologist so the endocrinologist said theres no way you could have it because thats more common in white women. So here we go again and low and behold i did. But then it put me in a different journey. At the time they didnt really recognize people like me who were diagnosed later in life, who kind of functioned in both perspectives and i went into this Online Community and the guy that created it actually had a box for me. Like my gosh someone finally gets it. So i joined this community and i found my voice. My husband luckily was in the military and i have something to occupy my time. [laughter] when you get diagnosed with something you get so involved in this space because after living with it i didnt know anybody so i found this community and i lived in it and slept in it and then i started to notice that there wasnt a lot of people that looks like me in this space. It was more white people or parents who were advocating for their child. So one day i was invited to participate in a diabetes summit. I called my husband and walked in the room like im the only black person in here. Hes like what did you expect . I said i dont know. You see more people that are black with diabetes so he was like okay well have fun. [laughter] after that that kind of put me on this track i think that sometimes when people are diagnosed with chronic conditions like diabetes they get into this rot where i didnt give myself enough time to become a victim instead i made my diagnosis my blessing and i started learning and it was intended to help one person because i didnt think anybody would show up because not only did people show up from canada, australia, craving support participating what i realized in this space is that once again theres always even one black person which is me and there may be two hispanic and a parent. Every time somebody invited me i would be the person that raised my hand and said if you are supposed to be creating devices for people with diabetes, what about the people with type two, why arent there more people of color in this space where it affects more people. They said we arent going down that route yet. I said yeah but if the majority of the people with type two and those that use insulin and the other 80 something million on insulin why arent we thinking about those people . They are like you have a form of type one so why are you advocating for so much with people with type two. I said if people in this space were not showing up for everybody with diabetes then we have a problem. I dont like to talk about myself so before i came, i wanted to talk about a couple of friends that i know. These people are reasons why besides the color of our skin should have a table when it comes to designing medical devices. The first is an extraordinary woman. She used to work at the apple chapel and was diagnosed with diabetes late in life. She struggled for many years to find an insulin pump. Every week she would get on and complain but she wasnt complaining she was sharing this is supposed to work for me and i cant see it. My Insurance Company is paying for this for me and i cant use every feature because i can see the menus to dial in or find the setting. The next person im going to talk about because i cannot talk about designing when the devices are on the market and this lady she lives down south and has type two and once a week on twitter every day she is fighting with her insurance for the right to utilize an insulin pump and continues but her primary care physician deemed medically necessary for her to have but her Insurance Company wont pay for it. Im encouraged by the reforms of medicare and medicaid implemented for people with type two recently to have access to continue. Thats a start but we still have a long way to go. The next person is from florida. She travels around the country, actually around the world. Shes a black woman and she has a seat at every table and shares her experience. But shes never been asked to participate in the design of an insulin pump. She says i would like to comment afterwards. They never took the groups recommendations and i want to highlight something here. Shes also a good friend who lived in dubai everywhere but shes freaked out because the color of her insulin pump is black and her main concern is im a black woman and if i was in a situation with the police and how to reach for my insulin pump, what could happen because my pump is black. They could assume im reaching for a weapon. Why do people only make insulin pumps and black. The next person a huge researcher in utah now working on several projects and one of her features was at the Film Festival in utah. Shes working to try to help the Deaf Community to help them find ways to connect. She still has had many ties where they have the technology they need so they can hear but she said [inaudible] its crucial to us. The Device Manufacturers can have hundreds of thousands of people involved in the nonprofits however if it allows for ten people, there should be a mixture of consumers. Consider the needs of older populations because they are required but please give them a seat with equity because just having a seat doesnt mean a thing. We would have technology that is fit for use for all. Keep us engaged and most importantly, nothing about us without us. Thank you. [applause] what a segue to what i was going to ask you. How can innovation and medical devices help to address the social determinants of health and these disparities that are so real and living in the western u. S. I can tell you its not enough to publish a pamphlet in a Spanish Language to address all the needs of our communities. Thank you. That is a great question. Let me say first there were a lot of examples of what happens when you dont do it. I dont need to tell you. The disparities and inequalities are not only in america in europe and other places and every continent quite frankly around the world. These things have been noted for a long time and a lot of people have done a lot of things to try to fix them having the same result, failure. Theyve had National Programs at the government level implemented and funded particularly in britain and then came back to measure the response of those interventions and britain did it twice. So they are complicated but its one of the things that gives me excitement about technology is i believe its not just about layering technology on top of what we already do because what we already do we have disparities so that cant be the answer. I think technology has the potential to help us do things differently in a way to achieve goals closing gaps weve not been able to do in the past however if we dont do it right it will make those gaps bigger and faster. We have the impetus not just to do it but to do it right. It goes far beyond the preferences to real needs and when you have people designing you have no credible expertise. This is one of the key parts that makes it so important because designing is one thing but implementing is another thing. Literacy is a nonissue. Its the beginning call for poor design. If you design it properly you dont need to be taught how to use it. How many of you its ridiculous that we as the professionals, as the academics we can teach people stuff and then of course the study shows that is needed. Its designed right it works and it works properly and all the time. Think about it, Shopping Stores now have a little automatic doors. You dont open a door anymore. It works. We are moving towards a voice first environment. You dont know how to program to do these things. If you do know how to do these things there is a benefit for you. But the whole idea that we design it for somebody by people who are not in the community and we have to teach them to use it thats poor design so many of the problems that i see in technology as the ones youve heard about really come down to poor design and its because of not having all the target users, only some of them. Thats why theres increasing interest now in the socalled user centered Design Technologies where you design for your users limitations and if it includes the environment in which they live so if you dont know about those things you cant design for them. I will stop there. My question to you is how do physicians get people because people are more concerned about how the iphone works or how much charge can you get any tesla then there medical conditions so how do you get patients more actively involved in this care because like now its not, but then you can make it right into design it right the problem is theres a lot of people that continue to use glucose monitors and their outcomes are not any better than those that dont. I think its an issue still. Youve got to get physicians on board. Weve been resisting technology and still resisting Technology Far too much. Number two, how many of you have to struggle to get your kids to use technology . You dont have to struggle because it is in a way that is designed to encourage them to do it. Weve designed our whole Healthcare System for the experts to do something to those people. Thats why for me it cannot be about layering technology on what we are already doing. That wouldnt change a thing. Weve got to use the power, the potential of technology to do things we could never have done before in ways that we couldnt even have imagined before. And if you look back at when technologies were introduced in society that is exactly what happened with those truly transformative technologies. Everybodys using the word disruptive or transformative. I would say its still and when designed right with the patient codesign process, you will see the problem is not the patient. I have a question about the data that is generated by all these devices. How does the fda partner with patients to make sure that data which we all know is used for outcomes, measurements and increasingly for reimbursements and valuebased care as both outcomes that are using the data from technology and devices it makes patients winners and losers on the other side of the visit and back offices. So, katie can you maybe talk to us a little bit about what the fda does with the data privacy . I will try to be brief. Its a big question that involves research with patients and the Healthcare Community and other entities to be part of the conversation. Its one of the areas that i highlighted is better understanding the need for privacy security, cybersecurity et cetera, ownership of data, how do you actually operationalize those principles. We have from the perspective taken a couple of concrete steps and issued the guidance in 2017 around manufacturers sharing patient specific information back to patients articulating that we support this principle and we understand from the specific cases there are certain technological challenges so again something that multiples have come together to figure out how to address but weve also issued a letter of support with the Safety Movement foundation in support of these principles. I think where it gets tricky is when the data is integrated into the Healthcare System into the manufacturer specific Monitoring Systems is generated in a format thats designed for another purpose actually how can we do this is where the issues come in. This is a primary that really needs to be redesigned. Back in 2016 i wish i could credit myself. But its a very wellknown Computer Scientist and researcher at a medical meeting that i was attending and made a comment that most people just walk straight over. 2016 long before the pandemic, long before telehealth was a big thing, it was all here but he said in the future, in the near future, most of the data that a doctor is going to use in the clinical visit to manage the patient, most of that data will come from outside and hes absolutely right. If we are having conversations about data and not just about blood drills in the hospital, youre not even getting 70 to 80 of all the data thats important that you might get in your fitbit or apple watch. So we are not even really having the real conversations yet we are just talking about that little bit of the data that is owned or collected by the Healthcare System and if that is all we have we are missing the bulk of it so we have to have that conversation and then the conversation on top of that. Talking about the transparency, it is a transparency issue for patients. Nothing could be worse. We know that there have been historical injustices with the misuse and trials and data exploitation. So what does that mean to you to have all transparency like we are going to have to do some regulation whether people like that word or not. For me if i am paying, insurance is paying like 4,000 for insulin not including the price of the device and i have skin in the game its my data i should be able to when i go in and read the terms and conditions i should be able to opt out at any time and to say i want to go to the university of virginia so that way i know where my data is going. Right now i dont know. I know its giving me all the data that i need to know to make decisions but as far as who owns it i dont know and thats scary. Its very scary. For all of us in the room an entire new conversation. Nonetheless very important and i appreciated what chris said about Health Literacy and how weve moved beyond that but we are at a point where its severely lacking in many of the Patient Advocacy endeavors. Thank you everyone on the panel for the great discussion and i apologize to the audience we didnt get any q and a but i hope you found the discussion robust and certainly inspiring. Lunch will now be served [inaudible] i havent even heard it. I am believing that its out there. Please talk among yourselves, shake some hands, make some new friends, get out those business cards while youre waiting in line. [inaudible] [applause]