PMDedu: Assessing the educational needs of startups and academic investigators focused on pediatric medical device development
Abstract Background: The pediatric medical device development (PMDD) process is highly complex, beset by a variety of financial, technical, medical, and regulatory barriers. Startup company innovators and academic investigators often struggle with accessing specialized knowledge relating to regula...
| Main Authors: | , , , , , |
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| Format: | Article |
| Language: | English |
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Cambridge University Press
2023-01-01
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| Series: | Journal of Clinical and Translational Science |
| Subjects: | |
| Online Access: | https://www.cambridge.org/core/product/identifier/S2059866123006337/type/journal_article |
| _version_ | 1797615854023606272 |
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| author | Payal Shah Alexis Snitman Jennifer McCaney Lynn M. Rose David Sheridan Juan Espinoza Salomon |
| author_facet | Payal Shah Alexis Snitman Jennifer McCaney Lynn M. Rose David Sheridan Juan Espinoza Salomon |
| author_sort | Payal Shah |
| collection | DOAJ |
| description |
Abstract
Background:
The pediatric medical device development (PMDD) process is highly complex, beset by a variety of financial, technical, medical, and regulatory barriers. Startup company innovators and academic investigators often struggle with accessing specialized knowledge relating to regulatory requirements, product development, research, and marketing strategies.
Objectives:
The West Coast Consortium for Technology & Innovation in Pediatrics (CTIP) conducted an educational needs assessment to understand knowledge gaps and inform our educational strategy.
Methods:
We surveyed a total of 49 medical device startups and 52 academic investigators. Electronic surveys were developed for each group on Qualtrics and focused on manufacturing, regulatory, research, commercialization, and funding. Descriptive statistics were used.
Results:
A larger proportion of academic investigator respondents had a clinical background compared to the startup respondents (45% vs. 22%). The biggest barriers for academic investigators were understanding regulatory and safety requirements testing (52%) and finding and obtaining non-dilutive funding was the most difficult (54%). Among startups, understanding clinical research methods and requirements was the biggest barrier (79%).
Conclusion:
Startup companies and academic investigators have similar, but not identical, educational needs to better understand the PMD development process. Investigators need more support in identifying funding sources, while startup companies identified an increased need for education on research regulatory topics. These findings can help guide curriculum development as well as opportunities for partnerships between academia and startups.
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| first_indexed | 2024-03-11T07:32:52Z |
| format | Article |
| id | doaj.art-5e3b808df0ad41c2ae61581dd166311d |
| institution | Directory Open Access Journal |
| issn | 2059-8661 |
| language | English |
| last_indexed | 2024-03-11T07:32:52Z |
| publishDate | 2023-01-01 |
| publisher | Cambridge University Press |
| record_format | Article |
| series | Journal of Clinical and Translational Science |
| spelling | doaj.art-5e3b808df0ad41c2ae61581dd166311d2023-11-17T06:35:02ZengCambridge University PressJournal of Clinical and Translational Science2059-86612023-01-01710.1017/cts.2023.633PMDedu: Assessing the educational needs of startups and academic investigators focused on pediatric medical device developmentPayal Shah0https://orcid.org/0000-0001-5211-6169Alexis Snitman1Jennifer McCaney2Lynn M. Rose3David Sheridan4Juan Espinoza Salomon5https://orcid.org/0000-0003-0513-588XDepartment of Pediatrics, Children’s Hospital Los Angeles, Los Angeles, CA, USAUniversity of Southern California, Los Angeles, CA, USADepartment of Decisions, Operations and Technology Management, University of California Los Angeles, Los Angeles, CA, USADepartment of Pharmacy, University of Washington, Seattle, WA, USADepartment of Emergency medicine, Oregon Health & Science University, Portland, OR, USAStanley Manne Children’s Research Institute, Ann & Robert H. Lurie Children’s Hospital of Chicago. Chicago, IL, USA Northwestern University Feinberg School of Medicine, Chicago, IL, USA Abstract Background: The pediatric medical device development (PMDD) process is highly complex, beset by a variety of financial, technical, medical, and regulatory barriers. Startup company innovators and academic investigators often struggle with accessing specialized knowledge relating to regulatory requirements, product development, research, and marketing strategies. Objectives: The West Coast Consortium for Technology & Innovation in Pediatrics (CTIP) conducted an educational needs assessment to understand knowledge gaps and inform our educational strategy. Methods: We surveyed a total of 49 medical device startups and 52 academic investigators. Electronic surveys were developed for each group on Qualtrics and focused on manufacturing, regulatory, research, commercialization, and funding. Descriptive statistics were used. Results: A larger proportion of academic investigator respondents had a clinical background compared to the startup respondents (45% vs. 22%). The biggest barriers for academic investigators were understanding regulatory and safety requirements testing (52%) and finding and obtaining non-dilutive funding was the most difficult (54%). Among startups, understanding clinical research methods and requirements was the biggest barrier (79%). Conclusion: Startup companies and academic investigators have similar, but not identical, educational needs to better understand the PMD development process. Investigators need more support in identifying funding sources, while startup companies identified an increased need for education on research regulatory topics. These findings can help guide curriculum development as well as opportunities for partnerships between academia and startups. https://www.cambridge.org/core/product/identifier/S2059866123006337/type/journal_articlePediatric medical deviceInnovatorsstartupsinvestigatorsFDA regulationeducation assessment |
| spellingShingle | Payal Shah Alexis Snitman Jennifer McCaney Lynn M. Rose David Sheridan Juan Espinoza Salomon PMDedu: Assessing the educational needs of startups and academic investigators focused on pediatric medical device development Journal of Clinical and Translational Science Pediatric medical device Innovators startups investigators FDA regulation education assessment |
| title | PMDedu: Assessing the educational needs of startups and academic investigators focused on pediatric medical device development |
| title_full | PMDedu: Assessing the educational needs of startups and academic investigators focused on pediatric medical device development |
| title_fullStr | PMDedu: Assessing the educational needs of startups and academic investigators focused on pediatric medical device development |
| title_full_unstemmed | PMDedu: Assessing the educational needs of startups and academic investigators focused on pediatric medical device development |
| title_short | PMDedu: Assessing the educational needs of startups and academic investigators focused on pediatric medical device development |
| title_sort | pmdedu assessing the educational needs of startups and academic investigators focused on pediatric medical device development |
| topic | Pediatric medical device Innovators startups investigators FDA regulation education assessment |
| url | https://www.cambridge.org/core/product/identifier/S2059866123006337/type/journal_article |
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