{"id":4377,"date":"2019-08-08T17:12:30","date_gmt":"2019-08-08T21:12:30","guid":{"rendered":"https:\/\/advmedtechconf.wpengine.com\/?p=4377"},"modified":"2019-08-12T15:09:45","modified_gmt":"2019-08-12T19:09:45","slug":"pediatric-device-innovation-symposium","status":"publish","type":"post","link":"https:\/\/themedtechconference.com\/pediatric-device-innovation-symposium\/","title":{"rendered":"Explore Innovative Solutions to Pediatric Device Trials Methodologies at the 7th Annual Pediatric Device Innovation Symposium"},"content":{"rendered":"\n<p><em>By Kolaleh Eskandanian, Ph.D., MBA, PMP, vice president and chief innovation officer at Children\u2019s National Health System<\/em><\/p>\n\n\n\n<p>Are you\ninterested in advancing device clinical trials in general, but also learning\nabout potential innovative pathways for pediatrics? If yes, then make plans to\nattend <a href=\"https:\/\/advmedtechconf.wpengine.com\/\">The MedTech Conference<\/a> one day early to participate in the <a href=\"http:\/\/pediatric-device-symposium.org\/register\/\">7<sup>th<\/sup> Annual Pediatric Device Innovation\nSymposium<\/a>, Sunday,\nSept. 22. In addition to the much anticipated $150K <a href=\"https:\/\/medtechinnovator.org\/pediatricapply\/\">\u201cMake Your Medical Device Pitch for Kids!\u201d competition<\/a> that focuses on neonatal and NICU\ndevices, we\u2019re assembling a lineup of industry-leading keynote speakers and\npanelists who will address the program theme \u201cPediatric Device Clinical Trials:\nForging a Better Path.\u201d <\/p>\n\n\n\n<p>It\u2019s widely\nknown that pediatric medical device development profoundly lags behind device\ndevelopment for adults. At the <a href=\"https:\/\/childrensnational.org\/research-and-education\/sheikh-zayed\">Sheikh Zayed Institute for Pediatric\nSurgical Innovation at Children\u2019s National Health System<\/a>, we\u2019re focused on finding solutions\nthat will bring medical device innovations to market faster to benefit children.\nWe recognize that one of the major barriers to accomplishing this is the\nchallenges inherent in the pediatric device clinical trial process, which is why\nwe\u2019ve chosen this as the symposium focal point for 2019. To boost innovation in\npediatric device field, there needs to be more cost-effective and novel\nclinical trial study designs and regulatory pathways to assess safety and efficacy\nof devices in small populations. On September 22<sup>nd<\/sup>, we\u2019ll discuss\nways to optimize and improve current approaches.<\/p>\n\n\n\n<p>In\ncontrast with drug trials, device trials are generally less understood in\nacademic medical centers at clinical sites. Adding to this complexity is the\nnature of the pediatric population. Designing devices for children requires\nconsiderations such as growth and development, anatomical and physiological\ndifferences, hormonal influences, and activity level. Unlike the process for\ndrug trials, the safety and efficacy testing of medical devices for\nfirst-in-human use is not conducted in a Phase I through Phase IV clinical\ntrials approach. Device testing is stratified based on the class of device and\nlevel of risk. Minimal risk devices do not require clinical trials, whereas\ndrug studies always require clinical trials conducted in phases. Devices have\nno Phase I equivalent to drugs. It would be unethical and unnecessary, for\nexample, to implant a pacemaker or a coronary stent into a healthy subject\nunder the auspices of a Phase I trial. Sadly, safety review boards (IRBs) and\ncertain stakeholders are not always trained to appreciate these nuances. We\nwant to bring awareness for more efficient and innovative ways to validate\npediatric medical devices and bring these products to market safely and in an\naccelerated fashion. <\/p>\n\n\n\n<p>Join us at this action-oriented symposium to dig deeper into innovative concepts and fresh ideas to close the device gap in pediatric health care. Hear from the spectrum of stakeholder voices including biohealth innovators, clinicians, device sponsors, institutional review board members and children\u2019s hospital executives. These voices provide a much-needed 360 degree-view of the critical issues that impede pediatric device clinical trials and explore practical solutions to stimulate innovation and commercialization. <\/p>\n\n\n\n<p>Register today\nand stay tuned to <a href=\"http:\/\/pediatric-device-symposium.org\/\">http:\/\/pediatric-device-symposium.org\/<\/a> for keynote speaker announcements,\npanel themes and updates about the $150K NICU pitch competition. We look\nforward to seeing you in Boston in September! &nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>By Kolaleh Eskandanian, Ph.D., MBA, PMP, vice president and chief innovation officer at Children\u2019s National Health System Are you interested in advancing device clinical trials in general, but also learning about potential innovative pathways for pediatrics? If yes, then make &#8230; <\/p>\n<p class=\"read-more-container\"><a title=\"Explore Innovative Solutions to Pediatric Device Trials Methodologies at the 7th Annual Pediatric Device Innovation Symposium\" class=\"read-more button\" href=\"https:\/\/themedtechconference.com\/pediatric-device-innovation-symposium\/#more-4377\">Keep Reading<span class=\"screen-reader-text\">Explore Innovative Solutions to Pediatric Device Trials Methodologies at the 7th Annual Pediatric Device Innovation Symposium<\/span><\/a><\/p>\n","protected":false},"author":32,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"content-type":"","footnotes":""},"categories":[1],"tags":[],"class_list":["post-4377","post","type-post","status-publish","format-standard","hentry","category-uncategorized"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.4 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Explore Innovative Solutions to Pediatric Device Trials Methodologies at the 7th Annual Pediatric Device Innovation Symposium - The MedTech Conference<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/themedtechconference.com\/pediatric-device-innovation-symposium\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Explore Innovative Solutions to Pediatric Device Trials Methodologies at the 7th Annual Pediatric Device Innovation Symposium - The MedTech Conference\" \/>\n<meta property=\"og:description\" content=\"By Kolaleh Eskandanian, Ph.D., MBA, PMP, vice president and chief innovation officer at Children\u2019s National Health System Are you interested in advancing device clinical trials in general, but also learning about potential innovative pathways for pediatrics? 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