[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 wo