Pub Date : 2024-09-01DOI: 10.1109/MPULS.2024.3443548
Jim Banks
This article is an in-depth examination of the role of pediatric device consortia (PDC) in the development of innovative devices. Looking at the funding model, and at how the challenges that arise in the development of medical devices differ from the development of drug therapies, the article looks at how PDCs can help OEMs with not only funding, but also expertise, regulatory guidance, and more. There is also an examination of some successful devices that have been backed by PDCs, and a comparison with how pediatric devices are funded in Europe to who how the true value of the FDA's PDC grant program.
本文深入探讨了儿科器械联盟（PDC）在创新器械开发中的作用。文章探讨了资助模式以及医疗器械开发过程中出现的挑战与药物疗法开发过程中出现的挑战有何不同，并探讨了儿科器械联盟如何不仅在资金方面，而且在专业知识、监管指导等方面帮助原始设备制造商。文章还研究了一些获得 PDC 支持的成功器械，并与欧洲儿科器械的资助方式进行了比较，以说明 FDA PDC 资助计划的真正价值。
{"title":"PDCs: A Vital Drop in the Ocean of Funding for Pediatric Devices.","authors":"Jim Banks","doi":"10.1109/MPULS.2024.3443548","DOIUrl":"https://doi.org/10.1109/MPULS.2024.3443548","url":null,"abstract":"<p><p>This article is an in-depth examination of the role of pediatric device consortia (PDC) in the development of innovative devices. Looking at the funding model, and at how the challenges that arise in the development of medical devices differ from the development of drug therapies, the article looks at how PDCs can help OEMs with not only funding, but also expertise, regulatory guidance, and more. There is also an examination of some successful devices that have been backed by PDCs, and a comparison with how pediatric devices are funded in Europe to who how the true value of the FDA's PDC grant program.</p>","PeriodicalId":49065,"journal":{"name":"IEEE Pulse","volume":"15 3","pages":"20-24"},"PeriodicalIF":0.3,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142299349","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-01DOI: 10.1109/MPULS.2024.3443489
Leslie Mertz
Autism spectrum disorder is a condition that showcases the potential usefulness of artificial intelligence (AI) and machine learning (ML). This is an area of great need, according to Dennis Wall, Ph.D., professor of pediatrics and biomedical data science at Stanford University in California. "ASD diagnostics is crying out for a solution that's faster, more equitable, and more quantitative. This is where biomedical data science can really help,"he said.
{"title":"Using AI and ML to Predict Autism Spectrum Disorder.","authors":"Leslie Mertz","doi":"10.1109/MPULS.2024.3443489","DOIUrl":"https://doi.org/10.1109/MPULS.2024.3443489","url":null,"abstract":"<p><p>Autism spectrum disorder is a condition that showcases the potential usefulness of artificial intelligence (AI) and machine learning (ML). This is an area of great need, according to Dennis Wall, Ph.D., professor of pediatrics and biomedical data science at Stanford University in California. \"ASD diagnostics is crying out for a solution that's faster, more equitable, and more quantitative. This is where biomedical data science can really help,\"he said.</p>","PeriodicalId":49065,"journal":{"name":"IEEE Pulse","volume":"15 3","pages":"11-15"},"PeriodicalIF":0.3,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142299350","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-01DOI: 10.1109/MPULS.2024.3443492
Jeffrey LaRose
Designing a pediatric circulatory support system has several unique challenges related to the small and growing body size. In addition, there is an extra burden on caregivers as these patients can be very active though not yet capable of managing the life sustaining system. This article describes some of the design challenges and offers hope from existing commercial systems being applied to larger pediatric patients.
{"title":"Design Issues With Pediatric Mechanical Circulatory Support Systems.","authors":"Jeffrey LaRose","doi":"10.1109/MPULS.2024.3443492","DOIUrl":"https://doi.org/10.1109/MPULS.2024.3443492","url":null,"abstract":"<p><p>Designing a pediatric circulatory support system has several unique challenges related to the small and growing body size. In addition, there is an extra burden on caregivers as these patients can be very active though not yet capable of managing the life sustaining system. This article describes some of the design challenges and offers hope from existing commercial systems being applied to larger pediatric patients.</p>","PeriodicalId":49065,"journal":{"name":"IEEE Pulse","volume":"15 3","pages":"16-19"},"PeriodicalIF":0.3,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142299347","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-01DOI: 10.1109/MPULS.2024.3443488
Eric Benjamin
Living with type 1 diabetes is challenging, especially for children and their caregivers. This article describes how Insulet, the global leader in tubeless insulin technology, has continuously innovated Omnipod, a discreet, wearable, waterproof insulin delivery system that simplifies life for people with diabetes.
{"title":"Designing a Closed-Loop Automated Insulin Delivery System: Simplifying Life for People, Including Children, Living With Type 1 Diabetes.","authors":"Eric Benjamin","doi":"10.1109/MPULS.2024.3443488","DOIUrl":"https://doi.org/10.1109/MPULS.2024.3443488","url":null,"abstract":"<p><p>Living with type 1 diabetes is challenging, especially for children and their caregivers. This article describes how Insulet, the global leader in tubeless insulin technology, has continuously innovated Omnipod, a discreet, wearable, waterproof insulin delivery system that simplifies life for people with diabetes.</p>","PeriodicalId":49065,"journal":{"name":"IEEE Pulse","volume":"15 3","pages":"5-10"},"PeriodicalIF":0.3,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142299348","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-07-18DOI: 10.1109/mpuls.2024.3405745
Victoria S. Marks, Rory J. Piper, Joram J. Van Rheede, Moaad Benjaber, Alexander L. Green, Martin T. Tisdall, Timothy J. Denison
Brain Stimulation Technology for the treatment of neurological disorders is rapidly evolving. With the advent of “bidirectional” systems, such as the Medtronic Percept, which are able to sense from and stimulate the brain simultaneously, there is opportunity to modify stimulation based on changes in brain activity. The utility of such a bidirectional application is exemplified by the success of the NeuroPace responsive neuro stimulation (RNS) device in the reduction of seizures [1] and pivotal trials of spinal cord stimulation for chronic leg pain using evoked compound action potentials to facilitate a homeostatic feedback system [2] .
{"title":"Challenges and Opportunities for Physiologically Controlled Therapy in Neural Systems","authors":"Victoria S. Marks, Rory J. Piper, Joram J. Van Rheede, Moaad Benjaber, Alexander L. Green, Martin T. Tisdall, Timothy J. Denison","doi":"10.1109/mpuls.2024.3405745","DOIUrl":"https://doi.org/10.1109/mpuls.2024.3405745","url":null,"abstract":"Brain Stimulation Technology for the treatment of neurological disorders is rapidly evolving. With the advent of “bidirectional” systems, such as the Medtronic Percept, which are able to sense from and stimulate the brain simultaneously, there is opportunity to modify stimulation based on changes in brain activity. The utility of such a bidirectional application is exemplified by the success of the NeuroPace responsive neuro stimulation (RNS) device in the reduction of seizures <xref ref-type=\"bibr\" r xmlns:mml=\"http://www.w3.org/1998/Math/MathML\" xmlns:xlink=\"http://www.w3.org/1999/xlink\">[1]</xref> and pivotal trials of spinal cord stimulation for chronic leg pain using evoked compound action potentials to facilitate a homeostatic feedback system <xref ref-type=\"bibr\" r xmlns:mml=\"http://www.w3.org/1998/Math/MathML\" xmlns:xlink=\"http://www.w3.org/1999/xlink\">[2]</xref>\u0000.","PeriodicalId":49065,"journal":{"name":"IEEE Pulse","volume":"16 1","pages":""},"PeriodicalIF":0.6,"publicationDate":"2024-07-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141739931","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-07-18DOI: 10.1109/mpuls.2024.3409110
Nancey Trevanian Tsai
For this issue, we feature Josh Niesen. He is 31/2 years into his position with Medtronic, after spending two summers as an intern during college. Josh earned the B.S. degree in biomedical engineering (BME) from the University of Wisconsin-Madison.
{"title":"Early Career Spotlight","authors":"Nancey Trevanian Tsai","doi":"10.1109/mpuls.2024.3409110","DOIUrl":"https://doi.org/10.1109/mpuls.2024.3409110","url":null,"abstract":"For this issue, we feature Josh Niesen. He is 31/2 years into his position with Medtronic, after spending two summers as an intern during college. Josh earned the B.S. degree in biomedical engineering (BME) from the University of Wisconsin-Madison.","PeriodicalId":49065,"journal":{"name":"IEEE Pulse","volume":"95 1","pages":""},"PeriodicalIF":0.6,"publicationDate":"2024-07-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141746092","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-07-18DOI: 10.1109/mpuls.2024.3405688
Mike Hess
Fifty years ago, one of the most popular American television shows debuted this famous phrase: “We can rebuild him. We have the technology. We can make him better than he was. Better, stronger, faster.” Children and adults alike tuned in to see the latest adventures of Steve Austin, the Six Million Dollar Man, crime-fighting astronaut turned international spy who featured advanced implants that seamlessly blended cyberonic technology through neural interfaces to give him super speed, super strength, super vision, and more.
{"title":"From the Editor","authors":"Mike Hess","doi":"10.1109/mpuls.2024.3405688","DOIUrl":"https://doi.org/10.1109/mpuls.2024.3405688","url":null,"abstract":"Fifty years ago, one of the most popular American television shows debuted this famous phrase: “We can rebuild him. We have the technology. We can make him better than he was. Better, stronger, faster.” Children and adults alike tuned in to see the latest adventures of Steve Austin, the Six Million Dollar Man, crime-fighting astronaut turned international spy who featured advanced implants that seamlessly blended cyberonic technology through neural interfaces to give him super speed, super strength, super vision, and more.","PeriodicalId":49065,"journal":{"name":"IEEE Pulse","volume":"10 1","pages":""},"PeriodicalIF":0.6,"publicationDate":"2024-07-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141739929","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-07-18DOI: 10.1109/mpuls.2024.3405744
Bin He
Neuroengineering, also known as neural engineering, is a rapidly expanding interdisciplinary field that bridges neuroscience and engineering. It encompasses research at the cellular, tissue, and systems levels, and has become a core discipline within biomedical engineering and beyond. By applying engineering principles and methods, neuroengineering studies the nervous system and develops techniques for diagnosing, treating, and rehabilitating neurological disorders. This field includes neural sensing, signal processing, interfacing, modulation, computation, imaging, and device development, among others. Over the past decade, significant progress has been made in neuroengineering, or neurotechnology, which focuses more on neural devices or tools. This progress is partly attributable to initiatives such as the Brain Research through Advancing Innovative Neurotechnologies 1 (BRAIN) Initiative in the U.S. and similar efforts worldwide.
{"title":"Neuroengineering—Engineering the Nervous System","authors":"Bin He","doi":"10.1109/mpuls.2024.3405744","DOIUrl":"https://doi.org/10.1109/mpuls.2024.3405744","url":null,"abstract":"Neuroengineering, also known as neural engineering, is a rapidly expanding interdisciplinary field that bridges neuroscience and engineering. It encompasses research at the cellular, tissue, and systems levels, and has become a core discipline within biomedical engineering and beyond. By applying engineering principles and methods, neuroengineering studies the nervous system and develops techniques for diagnosing, treating, and rehabilitating neurological disorders. This field includes neural sensing, signal processing, interfacing, modulation, computation, imaging, and device development, among others. Over the past decade, significant progress has been made in neuroengineering, or neurotechnology, which focuses more on neural devices or tools. This progress is partly attributable to initiatives such as the Brain Research through Advancing Innovative Neurotechnologies\u0000<xref ref-type=\"fn\" r xmlns:mml=\"http://www.w3.org/1998/Math/MathML\" xmlns:xlink=\"http://www.w3.org/1999/xlink\">1</xref> (BRAIN) Initiative in the U.S. and similar efforts worldwide.","PeriodicalId":49065,"journal":{"name":"IEEE Pulse","volume":"43 1","pages":""},"PeriodicalIF":0.6,"publicationDate":"2024-07-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141746036","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-07-18DOI: 10.1109/mpuls.2024.3405749
Jim Banks
Back in 2021, a paper recently published in The Lancet [1] defined the impact on human life of disorders affecting the nervous system. Neurodevelopmental disorders, late-life neurodegeneration, and newly emergent conditions, such as cognitive impairment, were among 37 conditions reviewed. The results were chilling.
{"title":"Mapping the Impossible: Europe’s Human Brain Project Comes of Age","authors":"Jim Banks","doi":"10.1109/mpuls.2024.3405749","DOIUrl":"https://doi.org/10.1109/mpuls.2024.3405749","url":null,"abstract":"Back in 2021, a paper recently published in The Lancet <xref ref-type=\"bibr\" r xmlns:mml=\"http://www.w3.org/1998/Math/MathML\" xmlns:xlink=\"http://www.w3.org/1999/xlink\">[1]</xref> defined the impact on human life of disorders affecting the nervous system. Neurodevelopmental disorders, late-life neurodegeneration, and newly emergent conditions, such as cognitive impairment, were among 37 conditions reviewed. The results were chilling.","PeriodicalId":49065,"journal":{"name":"IEEE Pulse","volume":"44 1","pages":""},"PeriodicalIF":0.6,"publicationDate":"2024-07-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141739930","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-07-18DOI: 10.1109/mpuls.2024.3405748
Nancey Trevanian Tsai
In the 1999 movie The Matrix, Neo emerges from a vat of jelly shortly after taking the Red Pill. It suggested that there is a separation between the mind and the body and that the brain as the master driver of experiences could be hijacked to keep the body subjugated until its useful life—under the control of an outside force—had terminated. Likewise, students taking philosophy are often introduced to Rene Descartes’ “Cogito ergo sum,” which translates as, “I think, therefore I am.” The central idea of the discourse is that the mind is proof of existence, even if the body cannot be verified. Indeed, many of us seem to live one life inside our heads while our body moves through a different, physical world. By way of introducing the mind-body dichotomy, it also suggested an unintended hierarchy. Do any of us really believe we are mere “brain in a vat”?
{"title":"Dismantling Descartes","authors":"Nancey Trevanian Tsai","doi":"10.1109/mpuls.2024.3405748","DOIUrl":"https://doi.org/10.1109/mpuls.2024.3405748","url":null,"abstract":"In the 1999 movie The Matrix, Neo emerges from a vat of jelly shortly after taking the Red Pill. It suggested that there is a separation between the mind and the body and that the brain as the master driver of experiences could be hijacked to keep the body subjugated until its useful life—under the control of an outside force—had terminated. Likewise, students taking philosophy are often introduced to Rene Descartes’ “Cogito ergo sum,” which translates as, “I think, therefore I am.” The central idea of the discourse is that the mind is proof of existence, even if the body cannot be verified. Indeed, many of us seem to live one life inside our heads while our body moves through a different, physical world. By way of introducing the mind-body dichotomy, it also suggested an unintended hierarchy. Do any of us really believe we are mere “brain in a vat”?","PeriodicalId":49065,"journal":{"name":"IEEE Pulse","volume":"19 1","pages":""},"PeriodicalIF":0.6,"publicationDate":"2024-07-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141739932","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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