Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Concept Videos

Drug Regulation01:25

Drug Regulation

2.6K
Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
2.6K
Drug Control Governance: Regulatory Bodies and Their Impact01:03

Drug Control Governance: Regulatory Bodies and Their Impact

423
Drug control governance involves the oversight and regulation of pharmaceuticals to ensure their safety and efficacy while preventing illegal drug use and trafficking. Regulatory bodies, including the US Food and Drug Administration (FDA) and the European Union's European Medicines Agency (EMA), play a central role in this process. These agencies evaluate the safety and efficacy of drugs before they can be marketed. They fund clinical trials and assess the benefits and risks associated with...
423
Global Regulatory Systems01:28

Global Regulatory Systems

494
Global regulatory systems in bacteria enable rapid and coordinated responses to environmental changes by integrating sensory inputs with gene expression, ensuring efficient adaptation to fluctuating conditions. Key global regulatory mechanisms include regulons, two-component systems, sigma factors, and secondary messengers.Regulons and Global RegulatorsA regulon is a collection of genes and operons controlled by a common global regulator. These regulators enable bacteria to prioritize resource...
494
Pharmacovigilance01:19

Pharmacovigilance

1.5K
Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
1.5K
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

336
Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
336
Drug Products: Biologics, Biosimilars and Interchangeables01:28

Drug Products: Biologics, Biosimilars and Interchangeables

179
Body:Biologics, derived from living sources such as humans, animals, or microorganisms, represent a significant category of pharmaceuticals. These complex molecules, developed through advanced biotechnological methods or purified from natural sources, include essential medical treatments like insulin and growth hormones. The complexity of biologics arises from their large molecular structures and the intricate processes required for their production, making them distinct from conventional...
179

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

Aerobic Exercise Activates S1PR1 Signaling in Tumor Endothelial Cells to Promote Vascular Function in Pancreatic Cancer.

Cancer research·2026
Same author

Toward developing a patient reported outcomes measure for children with heart failure: A qualitative study design.

American heart journal·2026
Same author

Leveraging remnant viral load samples for SARS-CoV-2 antibody seroprevalence trends among PLHIV in Kenya, February 2021-October 2022: a cross-sectional surveillance survey.

BMJ public health·2026
Same author

Medical device development and innovation for rare and pediatric populations: a global landscape overview.

Orphanet journal of rare diseases·2026
Same author

Can indocyanine green fluorescence aid operative decision making in neuroblastic tumour surgery? Early experience from a single centre.

Journal of pediatric surgery·2026
Same author

HIV-1 variants in population-based national surveys in sub-Saharan Africa, 2015-2022.

AIDS (London, England)·2026

Related Experiment Video

Updated: Dec 25, 2025

Evaluation of Cardiac Contractility Modulation Therapy in 2D Human Stem Cell-Derived Cardiomyocytes
08:47

Evaluation of Cardiac Contractility Modulation Therapy in 2D Human Stem Cell-Derived Cardiomyocytes

Published on: December 16, 2022

2.7K

Regulatory Science, and How Device Regulation Will Shape Our Future.

Nicole Ibrahim1,2, Nicole Gillette3, Hetal Patel3

  • 1Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD, USA. Nicole.Ibrahim@fda.hhs.gov.

Pediatric Cardiology
|March 22, 2020
PubMed
Summary

Pediatric medical device development faces regulatory hurdles. Innovations like early feasibility studies, 3D printing, and real-world evidence can accelerate pediatric device approvals.

Keywords:
3D printingDevice regulationInnovationPediatric device developmentPersonalized medicineReal world evidenceTechnology

More Related Videos

Electric and Magnetic Field Devices for Stimulation of Biological Tissues
13:29

Electric and Magnetic Field Devices for Stimulation of Biological Tissues

Published on: May 15, 2021

5.6K
Designing a Bioreactor to Improve Data Acquisition and Model Throughput of Engineered Cardiac Tissues
12:28

Designing a Bioreactor to Improve Data Acquisition and Model Throughput of Engineered Cardiac Tissues

Published on: June 2, 2023

2.9K

Related Experiment Videos

Last Updated: Dec 25, 2025

Evaluation of Cardiac Contractility Modulation Therapy in 2D Human Stem Cell-Derived Cardiomyocytes
08:47

Evaluation of Cardiac Contractility Modulation Therapy in 2D Human Stem Cell-Derived Cardiomyocytes

Published on: December 16, 2022

2.7K
Electric and Magnetic Field Devices for Stimulation of Biological Tissues
13:29

Electric and Magnetic Field Devices for Stimulation of Biological Tissues

Published on: May 15, 2021

5.6K
Designing a Bioreactor to Improve Data Acquisition and Model Throughput of Engineered Cardiac Tissues
12:28

Designing a Bioreactor to Improve Data Acquisition and Model Throughput of Engineered Cardiac Tissues

Published on: June 2, 2023

2.9K

Area of Science:

  • Biomedical Engineering
  • Regulatory Science
  • Pediatric Cardiology

Background:

  • Pediatric medical devices are often adapted from adult applications, leading to slower innovation.
  • Regulatory processes are a key factor influencing the development and commercialization of pediatric devices.
  • Existing challenges necessitate advancements to meet the unique needs of children.

Purpose of the Study:

  • To highlight key regulatory areas that can advance pediatric cardiology device development.
  • To identify innovations supporting pediatric device innovation from conception to commercialization.
  • To emphasize the importance of regulatory pathways for pediatric medical devices.

Main Methods:

  • Review of FDA's Center for Devices and Radiological Health (CDRH) initiatives.
  • Analysis of four key regulatory areas: Early Feasibility Study Program, 3D printing, computational modeling, and real-world evidence.
  • Discussion of the impact of these programs on the device development lifecycle.

Main Results:

  • The CDRH Early Feasibility Study Program can facilitate early-stage device testing.
  • Advancements in 3D printing offer new prototyping and customization possibilities.
  • Computational modeling and simulation can aid in design and predict device performance.
  • Real-world evidence provides valuable data for regulatory decision-making.

Conclusions:

  • These regulatory and technological advancements have the potential to significantly improve pediatric device development.
  • Collaboration among stakeholders is crucial for the successful implementation of these programs.
  • Addressing regulatory aspects is fundamental to improving the availability of innovative medical devices for children.