Research, Publications, and Grants

To achieve our mission of advancing pediatric medical devices, CTIP supports and promotes high quality research related to medical device development, regulatory science, data integration, programmatic innovation, HealthTech finance, health equity, and diversity, equity and inclusion in HealthTech.

Research

CTIP research activities concentrate around 3 major domains which we believe are critical to support pediatric medical device innovators from concept to commercialization:

Regulatory Science

Availability of pediatric medical devices on the market is limited and adult devices are often used “off-label” as a substitute in pediatric patients. As one of the five, FDA-funded Pediatric Device Consortia in the US, we are interested in identifying and addressing gaps and barriers that hamper medical device development efforts. These can be broadly grouped into five categories: clinical, technical, regulatory, ethical, and financial. Our primary mission is to work with pediatric device innovators and our ecosystem partners to mitigate these challenges and find innovative approaches to supporting pediatric medical device development. We strive to leverage our expertise to improve the quality of clinical research by deconvoluting the regulatory landscape, which in turn will benefit medical device companies and ultimately the children whose medical needs remain unmet.

Medical Device Data and Informatics

As data and software become larger components of medical devices, there is a growing need to apply rigorous informatics principles and methods to medical devices.  We strive to bridge informatics and medical device development by leveraging key concepts in integration, interoperability, data standards, ontologies, and FAIR use data principles. Currently, our focus is on Integrating data from continuous glucose monitoring (CGM) systems into electronic health record (EHR) to improve clinical workflows and deliver high-quality patient care. We also work on UDI integration and implementation in order to help health systems better prepare to track medical devices through the UDI system.

Real world-evidence (RWE)

RWE is an increasingly important component of post-market surveillance and evaluation of medical devices. Aligned with the FDA’s positioning on prioritizing medical device safety, our group is currently working on the development and implementation of Pediatric Device Patient Database (PD2). PD2 is the first prospective database that contains clinical, device, and patient-generated health data. When completed, researchers, industry sponsors, and the FDA will be able to conduct retrospective and prospective clinical and regulatory research. Additionally, with the clinical updates every 24h, PD2 will enable active medical device surveillance and adverse events reporting, for example by auto generating MedWatch forms (FDA form3500).

Grants

Awards received by CTIP to advance our work.

Identifying Evidence-based Strategies to Increase Diversity Among Funded Health Tech Founders

Grant Number: G-31072

Funding Agency: California Health Care Foundation (CHCF)

Grant Period: July 2020 - October 2020

Principal Investigator: Juan Espinoza

Total Award: $64,835

Description: Increasing diversity among health technology companies is a critical component of advancing culturally competent care, increasing access to high-quality health care services for underserved communities, and reducing the overwhelming health disparities they face. The CHLA Innovation Studio and CTIP are uniquely positioned to support CHCF in this important work. We have a deep understanding of healthcare, innovation, safety net populations, investing and venture capital, and diversity, equity and inclusion. We apply the same rigorous 4-step methodology to all projects: Learn, Synthesize, Operationalize, Evaluate. Our framework will leverage our extensive and diverse network of entrepreneurs, investors, and healthcare providers to inform and guide our recommendations. We will be able to use our years of experience investing in pre/seed stage teams and connecting founders to resources to support CHCF in developing a new investment strategy for the Health Innovation Fund that will support more diverse founders. We are excited for the opportunity to contribute our knowledge, network, and expertise to CHCF, and look forward to supporting your mission well beyond the current RFP.

The West Coast Consortium for Technology and Innovation in Pediatrics

Grant Number: P50FD006425

Funding Agency: FDA

Grant Period: September 2018 - August 2023

Principal Investigators: Juan Espinoza, Yaniv Bar-Cohen

Total Award: $6,892,765

Description: The West Coast Consortium for Technology & Innovation in Pediatrics (CTIP) is a pediatric medical device consortium based at Children's Hospital Los Angeles (CHLA) and the University of Southern California (USC) established in 2011 and first funded by the FDA in 2013. CTIP promotes commercialization and clinical use of pediatric medical devices as encouraged by the U.S. Food and Drug Administration. CTIP facilitates the development of pediatric medical devices by coordinating resources within the existing translational and commercialization framework of CHLA and USC and the Southern California community to a stage where they can be transferred to a commercial partner and brought to market. Over the past year, CTIP has focused on developing partnerships across the West Coast, evolving into the West Coast CTIP Network. The new CTIP includes academic and industry partners from every major metropolitan area in California, Oregon, and Washington. CTIP’s over-arching goals are: 1) to build upon our network of multi-disciplinary stakeholders across the West Coast to identify and foster promising pediatric medical device projects; 2) to increase awareness around the need for novel pediatric medical device development; 3) to overcome current barriers to commercialization with a particular focus on establishing academia’s role in alleviating these barriers; and 4) to develop and implement strategies that will sustain a productive needs-driven pipeline of new pediatric medical devices. CTIP was established by uniting faculty and administrative leaders from schools, departments, programs, institutes, and centers at USC and CHLA that are focused on commercialization, translational and clinical research, pediatric care, and engineering. This core group is now joined by key leaders representing partner institutions across the West Coast Network. CTIP engages the business, investment, higher education, and philanthropic communities in the West Coast in order to provide CTIP portfolio companies with comprehensive pediatric medical device development services.

Southern California Consortium for Technology and Innovation in Pediatrics

Grant Number: P50FD004896

Funding Agency: FDA

Grant Period: September 2013 - August 2018

Principal Investigator: Yaniv Bar-Cohen

Total Award: $2,167,000

Description: The Southern California Center for Technology and Innovation Consortium (CTIP Consortium) is a pediatric medical device consortium based at CHLA and USC that promotes commercialization and clinical use of pediatric medical devices. The CTIP Consortium facilitates the development of pediatric medical devices by coordinating resources within the existing translational and commercialization framework of CHLA and USC and the Southern California community to a stage where they can be transferred to a commercial partner and brought to market. The Consortium's goals are: 1) to assemble a network of multi-disciplinary stakeholders at USC, CHLA, and other academic medical centers in Southern California, as well as within the business and investment communities, to identify and foster promising pediatric medical device projects; 2) to increase awareness around the need for novel pediatric medical device development; 3) to overcome current barriers to commercialization with a particular focus on establishing academia's role in alleviating these barriers, including through the engagement of students; and 4) to develop and implement strategies that will sustain a productive needs-driven pipeline of new pediatric medical devices. The CTIP Consortium was established by uniting faculty and administrative leaders from schools, departments, programs, institutes, and centers at USC and CHLA that are focused on commercialization, translational and clinical research, pediatric care, and engineering. These individuals constitute CTIP's steering committee and provide CTIP with guidance as well as access to business, financial, regulatory, reimbursement, engineering, scientific, clinical, intellectual property, and student resources. The CTIP Consortium networks these CHLA/USC stakeholders with the business, investment, higher education, and philanthropic communities in the entire Southern California region in order to provide CTIP investigators with pediatric medical device development services.

CTIP Publications

These manuscripts represent the work of CTIP team members that are directly related to CTIP’s mission to support pediatric medical device development, regulation, and real world evidence.

Proposing a Practical, Simplified Framework for Implementing Integrated Diabetes Data and Technology Solutions (2022)

Espinoza JC, Chin SW, Shah P, Tut M and Raymond JK. (2022) Proposing a Practical, Simplified Framework for Implementing Integrated Diabetes Data and Technology Solutions. Front. Clin. Diabetes Healthc. 3:867284. doi: 10.3389/fcdhc.2022.867284

Link: https://www.frontiersin.org/articles/10.3389/fcdhc.2022.867284/full 

The Launch of the iCoDE Standard Project (2022)

Xu NY, Nguyen KT, DuBord AY, Klonoff DC, Goldman JM, Shah SN, Spanakis EK, Madlock-Brown C, Sarlati S, Rafiq A, Wirth A, Kerr D, Khanna R, Weinstein S, Espinoza J. The Launch of the iCoDE Standard Project. J Diabetes Sci Technol. 2022 May 9:19322968221093662. doi: 10.1177/19322968221093662. Epub ahead of print. PMID: 35533135.

Link: https://pubmed.ncbi.nlm.nih.gov/35533135/ 

Pediatric Medical Device Development and Regulation: Current State, Barriers, and Opportunities (2022)

Espinoza J, Shah P, Nagendra G, Bar-Cohen Y, Richmond F. Pediatric Medical Device Development and Regulation: Current State, Barriers, and Opportunities. Pediatrics. 2022 Apr 15:e2021053390. doi: 10.1542/peds.2021-053390. Epub ahead of print. PMID: 35425971.

Link: https://pubmed.ncbi.nlm.nih.gov/35425971/

The Need for Data Standards and Implementation Policies to Integrate CGM Data into the Electronic Health Record (2021)

Espinoza J, Xu NY, Nguyen KT, Klonoff DC. The Need for Data Standards and Implementation Policies to Integrate CGM Data into the Electronic Health Record. J Diabetes Sci Technol. 2021 Nov 20:19322968211058148. doi: 10.1177/19322968211058148. Epub ahead of print. PMID: 34802286.

Link: https://pubmed.ncbi.nlm.nih.gov/34802286/ 

Diabetes Technology Meeting 2020 (2021)

Shang T, Zhang JY, Bequette BW, Raymond JK, Coté G, Sherr JL, Castle J, Pickup J, Pavlovic Y, Espinoza J, Messer LH, Heise T, Mendez CE, Kim S, Ginsberg BH, Masharani U, Galindo RJ, Klonoff DC. Diabetes Technology Meeting 2020. J Diabetes Sci Technol. 2021 Jul;15(4):916-960. doi: 10.1177/19322968211016480. PMID: 34196228; PMCID: PMC8258529

Link: https://pubmed.ncbi.nlm.nih.gov/34196228/ 

The Scarcity of Approved Pediatric High-Risk Medical Devices (2021)

Espinoza JC. The Scarcity of Approved Pediatric High-Risk Medical Devices. JAMA Netw Open. 2021 Jun 1;4(6):e2112760. doi: 10.1001/jamanetworkopen.2021.12760. PMID: 34156458

Link: https://pubmed.ncbi.nlm.nih.gov/34156458/ 

Kathryne Cooper and CTIP: Accelerating Diversity in Medtech (2021)

Yin, P.L., & Rostoker, B. (2021). Kathryne Cooper and CTIP: Accelerating Diversity in Medtech.

Link: https://store.hbr.org/product/kathryne-cooper-and-ctip-accelerating-diversity-in-medtech/SCG583 

Underinvested: Strategies for Supporting Diversity, Equity, and Inclusion in Health Care Venture Investment [White paper] (2020)

Cooper, K., Cramer C., Tibebu, S., O’Malley, M., & Espinoza, J. (2020). Underinvested: Strategies for Supporting Diversity, Equity, and Inclusion in Health Care Venture Investment [White paper]. The California Health Care Foundation, Oakland, California.

Link: https://www.chcf.org/wp-content/uploads/2020/12/UnderinvestedDiversityEquityInclusionHealthCareVenture.pdf  

Continuous Glucose Monitors and Automated Insulin Dosing Systems in the Hospital Consensus Guideline (2020)

Galindo RJ, Umpierrez GE, Rushakoff RJ, Basu A, Lohnes S, Nichols JH, Spanakis EK, Espinoza J, Palermo NE, Awadjie DG, Bak L, Buckingham B, Cook CB, Freckmann G, Heinemann L, Hovorka R, Mathioudakis N, Newman T, O'Neal DN, Rickert M, Sacks DB, Seley JJ, Wallia A, Shang T, Zhang JY, Han J, Klonoff DC. Continuous Glucose Monitors and Automated Insulin Dosing Systems in the Hospital Consensus Guideline. J Diabetes Sci Technol. 2020 Nov;14(6):1035-1064. doi: 10.1177/1932296820954163. Epub 2020 Sep 28. PMID: 32985262; PMCID: PMC7645140.

Link: https://pubmed.ncbi.nlm.nih.gov/32985262/ 

Integrating Continuous Glucose Monitor Data Directly into the Electronic Health Record: Proof of Concept (2020)

Espinoza J, Shah P, Raymond J. Integrating Continuous Glucose Monitor Data Directly into the Electronic Health Record: Proof of Concept. Diabetes Technol Ther. 2020 Aug;22(8):570-576. doi: 10.1089/dia.2019.0377. Epub 2020 Jul 10. PMID: 31904260.

Link: https://pubmed.ncbi.nlm.nih.gov/31904260/

Identifying Evidence-based Strategies to Increase Diversity Among Funded Health Tech Founders: 2020 Landscape  Analysis [White paper] (2020)

Cooper, K., Cramer C., O’Malley, M., & Espinoza, J.  (2020). Identifying Evidence-based Strategies to Increase Diversity Among Funded Health Tech Founders: 2020 Landscape  Analysis [White paper]. The  West  Coast  Consortium for Technology & Innovation in Pediatrics, Los Angeles, California.

Link: osf.io/4xkpu 

Innovation in Pediatric Medical Devices: Proceedings From The West Coast Consortium for Technology & Innovation in Pediatrics 2019 Annual Stakeholder Summit (2020)

Espinoza J, Cooper K, Shah P, Afari N, Batchu S, Bar-Cohen Y. Innovation in Pediatric Medical Devices: Proceedings From The West Coast Consortium for Technology & Innovation in Pediatrics 2019 Annual Stakeholder Summit. JMIR Biomed Eng 2020;5(1):e17467 DOI: 10.2196/17467

Link: https://biomedeng.jmir.org/2020/1/e17467 

Pediatric Device Consortia (PDC) Publications

Publications from our colleagues at the other PDCs and about the PDC program in general:

High-risk medical devices, children and the FDA: regulatory challenges facing pediatric mechanical circulatory support devices (2007)

Almond CS, Chen EA, Berman MR, Less JR, Baldwin JT, Linde-Feucht SR, Hoke TR, Pearson GD, Jenkins K, Duncan BW, Zuckerman BD. High-risk medical devices, children and the FDA: regulatory challenges facing pediatric mechanical circulatory support devices. ASAIO J. 2007 Jan-Feb;53(1):4-7. doi: 10.1097/01.mat.0000247958.84788.3a. PMID: 17237642.

Link: https://journals.lww.com/asaiojournal/Fulltext/2007/01000/High_Risk_Medical_Devices,_Children_and_the_FDA_.2.aspx

FDA's pediatric device consortia: national program fosters pediatric medical device development (2013)

Ulrich LC, Joseph FD, Lewis DY, Koenig RL. FDA's pediatric device consortia: national program fosters pediatric medical device development. Pediatrics. 2013 May;131(5):981-5. doi: 10.1542/peds.2012-1534. Epub 2013 Apr 8. PMID: 23569100.

Link: https://publications.aap.org/pediatrics/article-abstract/131/5/981/31220/FDA-s-Pediatric-Device-Consortia-National-Program?redirectedFrom=fulltext

Lessons From Drugs to Devices: A Pediatric Perspective (2015)

Eskandanian K, Klein M, Kim PC. Lessons From Drugs to Devices: A Pediatric Perspective. JAMA Pediatr. 2015 Nov;169(11):989-90. doi: 10.1001/jamapediatrics.2015.1932. PMID: 26348365.

Link: https://jamanetwork.com/journals/jamapediatrics/article-abstract/2436540

Off-Label Use of Medical Devices in Children (2017)

SECTION ON CARDIOLOGY AND CARDIAC SURGERY; SECTION ON ORTHOPAEDICS. Off-Label Use of Medical Devices in Children. Pediatrics. 2017 Jan;139(1):e20163439. doi: 10.1542/peds.2016-3439. PMID: 28025239.

Link: https://publications.aap.org/pediatrics/article/139/1/e20163439/52002/Off-Label-Use-of-Medical-Devices-in-Children

Incentivizing Orphan Product Development: United States Food and Drug Administration Orphan Incentive Programs (2017)

Le TT. Incentivizing Orphan Product Development: United States Food and Drug Administration Orphan Incentive Programs. Adv Exp Med Biol. 2017;1031:183-196. doi: 10.1007/978-3-319-67144-4_10. PMID: 29214572.

Link: https://link.springer.com/chapter/10.1007/978-3-319-67144-4_10

Pediatric medical device development by surgeons via capstone engineering design programs (2018)

Sack BS, Elizondo RA, Huang GO, Janzen N, Espinoza J, Sanz-Cortes M, Dietrich JE, Hakim J, Richardson ES, Oden M, Hanks J, Haridas B, Hury JF, Koh CJ. Pediatric medical device development by surgeons via capstone engineering design programs. J Pediatr Surg. 2018 Mar;53(3):493-498. doi: 10.1016/j.jpedsurg.2017.01.067. Epub 2017 Feb 6. PMID: 28196661; PMCID: PMC5545169.

Link: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5545169/

Children and Adults With Rare Diseases Need Innovative Medical Devices (2018)

Peiris V, Xu K, Agler HL, Chen EA, Gopal-Srivastava R, Lappin BM, Lewis DY, Rao GR. Children and Adults With Rare Diseases Need Innovative Medical Devices. J Med Device. 2018 Sep;12(3):0347011-347018. doi: 10.1115/1.4040489. Epub 2018 Jul 13. PMID: 30397422; PMCID: PMC6123063.

Link: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6123063/

Strengthening the Evidence Base for Pediatric Medical Devices Using Real-World Data (2019)

Fleurence RL, Forrest CB, Shuren J. Strengthening the Evidence Base for Pediatric Medical Devices Using Real-World Data. J Pediatr. 2019 Nov;214:209-211. doi: 10.1016/j.jpeds.2019.06.060. Epub 2019 Aug 1. PMID: 31378521.

Link: https://linkinghub.elsevier.com/retrieve/pii/S0022-3476(19)30824-8

Partnership Between Japan and the United States for Early Development of Pediatric Medical Devices - Harmonization By Doing for Children (2020)

Takahashi S, Ibrahim N, Yasukochi S, Ringel R, Ing F, Tomita H, Sugiyama H, Yamagishi M, Forbes TJ, Kim SH, Ho M, Gillette N, Nakamura Y, Mineta K, Fearnot N, Dineen D, Vang E, Haskin R, Becker LAM, Sekiguchi K, Sakamoto K, Ruiz CE; Harmonization by Doing for Children Working Group. Partnership Between Japan and the United States for Early Development of Pediatric Medical Devices - Harmonization By Doing for Children. Circ J. 2020 Apr 24;84(5):786-791. doi: 10.1253/circj.CJ-19-1092. Epub 2020 Apr 1. PMID: 32238666.

Link: https://www.jstage.jst.go.jp/article/circj/84/5/84_CJ-19-1092/_article

Advances in extracorporeal membrane oxygenator design for artificial placenta technology (2020)

Blauvelt DG, Abada EN, Oishi P, Roy S. Advances in extracorporeal membrane oxygenator design for artificial placenta technology. Artif Organs. 2021 Mar;45(3):205-221. doi: 10.1111/aor.13827. Epub 2020 Nov 4. PMID: 32979857; PMCID: PMC8513573.

Link: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8513573/

Quantification of US Food and Drug Administration Premarket Approval Statements for High-Risk Medical Devices With Pediatric Age Indications (2021)

Lee SJ, Cho L, Klang E, Wall J, Rensi S, Glicksberg BS. Quantification of US Food and Drug Administration Premarket Approval Statements for High-Risk Medical Devices With Pediatric Age Indications. JAMA Netw Open. 2021 Jun 1;4(6):e2112562. doi: 10.1001/jamanetworkopen.2021.12562. PMID: 34156454; PMCID: PMC8220494.

Link: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8220494/

Opportunities for Regulatory Changes to Promote Pediatric Device Innovation in the United States: Joint Recommendations From Pediatric Innovator Roundtables (2021)

Sanger, Terence; Chang, Anthony; Feaster, William; Taraman, Shrief; Afari, Nadine; Bearegard, Debra; Dethlefs, Brent; Chere, Tiffani; Kabeer, Mustafa; Tolomiczenko, George; Billig, Michael; Brophy, Jon; Eskandanian, Kolaleh; Espinoza, Juan; Farrugia, Sherry; Harrison, Michael; Horvat, Michael; Hoyen, Claudia; Koh, Chester; Komiyama, Allison; Krista, Nelson; Kulkarni, Omkar; Levy, Robert; Maher, Kevin; O'Donnell, Michael; Ponsky, Todd; Richmond, Frances; Richter, Jessica; Roy, Shuvo; Shreim, Samir; Srinivasan, Suresh; Stallworth, Charlette; Thekkedath, Usha; Toman, Kara; Wall, James; West, Leanne; Wolff, Dawn. "Opportunities for Regulatory Changes to Promote Pediatric Device Innovation in the United States: Joint Recommendations from Pediatric Innovator Roundtables, August 5, 2020 & January 6, 2021," in IEEE Journal of Translational Engineering in Health and Medicine, doi: 10.1109/JTEHM.2021.3092559.

Link: https://ieeexplore.ieee.org/document/9465164

Advancing pediatric medical device development via non-dilutive NIH SBIR/STTR grant funding (2021)

Sun RC, Kamat I, Byju AG, Wettergreen M, Heffernan MJ, Willson R, Haridas B, Koh CJ. Advancing pediatric medical device development via non-dilutive NIH SBIR/STTR grant funding. J Pediatr Surg. 2021 Nov;56(11):2118-2123. doi: 10.1016/j.jpedsurg.2021.01.025. Epub 2021 Jan 25. PMID: 33558071.

Link: https://www.jpedsurg.org/article/S0022-3468(21)00070-1/fulltext

CTIP Portfolio Members Publications

Publications supporting the science behind the powerful technologies developed by CTIP portfolio members: