02 May The Lifecycle of a Medical Device: From Concept to Clinical Use
Photo By: Kaboompics.com[/caption]
Medical devices play a vital role in modern healthcare, enhancing the ability of clinicians to diagnose, monitor, and treat a wide range of health conditions. From simple tools like thermometers to complex implants like pacemakers, each medical device follows a structured lifecycle that ensures its safety, efficacy, and compliance with regulatory standards. Understanding this lifecycle is crucial for manufacturers, regulatory bodies, and healthcare providers alike.
- Concept and Feasibility
The lifecycle of a medical device begins with the identification of a medical need. This could be a new method to monitor chronic disease, an improvement over existing tools, or a completely novel approach to treatment. During the concept phase, inventors, engineers, and medical experts collaborate to develop a clear understanding of the problem, explore potential solutions, and evaluate the feasibility of developing a device that addresses the identified need.
Feasibility studies often include technical assessments, market analysis, and an initial regulatory pathway review. At this stage, prototyping begins, often relying on rapid iteration techniques such as SLS 3D printing services, which allow engineers to create functional prototypes quickly and cost-effectively. Selective Laser Sintering (SLS) is particularly valuable for producing durable and precise components that can mimic final product functionality.
Shani Vaknine[/caption]
Shani Vaknine, Ph.D. candidate
Brain and Behavioral Sciences
The Hebrew University
MedicalResearch.com: What is the background for this study?
Response: We’ve long known that maternal stress during pregnancy can affect her baby’s development, but the molecular mechanisms behind this remained unclear. In our study, we explored how psychosocial stress experienced by the mother in late pregnancy influences tiny molecular fragments in the newborn’s blood. These fragments, called transfer RNA fragments or tRFs, were considered for many years to be disposable, but have recently been shown to have important biological functions.
Dr. Moyland[/caption]
Cynthia Moylan, MD
Associate Professor of Medicine,
Division of Gastroenterology
Duke University Health System
MedicalResearch.com: What is the background for this study?
Response: Metabolic dysfunction can lead to several health problems including metabolic dysfunction associated steatotic liver disease (MASLD), is driven by different factors, including: a person’s behavioral or lifestyle factors, environmental factors, and genetics. Limited research exists regarding genetic , epigenetic, or other factors that might impact development of metabolic dysfunction and MASLD. Our group has previously shown that alterations in DNA methylation (a type of epigenetic change), identifiable both in liver tissue and in blood, associate with MASLD and its progression to more severe liver disease. Whether DNA methylation that impacts imprinted gene expression also associates with metabolic dysfunction and MASLD risk remains largely unknown.
In this project, we explored imprinted genes: imprinting is a normal process that regulates genes by silencing one parental copy (either the maternal or the paternal) so that only one copy is expressed. Imprinting is an important biological process for development and has a disproportionate impact on disease - in fact, imprinted genes are hypothesized to affect 1-6% of the human genome. We sought to explore how altered DNA methylation of imprint control regions (ICRs) that help ‘control’ these imprinted genes might impact development of metabolic dysfunction in children (and hence potentially even in adults).
Summerlin is known for its clean streets, scenic walking trails, master-planned neighborhoods, and an overall reputation for being one of the safest, most peaceful areas in the Las Vegas Valley.
Unfortunately, that safety doesn’t mean pedestrians are always protected.
Even in a well-designed suburb like Summerlin, where people take pride in the planned beauty of the community, pedestrian accidents happen, and when they do, the effects go way beyond the physical. A 
Luke Cavanah B.S.[/caption]
Luke Cavanah, BS
Department of Medical Education
Geisinger College of Health Sciences
Scranton, PA, 18509
MedicalResearch.com: What is the background for this study?
Response: Almost a third of patients with medication-treated major depressive disorder will fail at least two depressants—many patients failing more.1 Esketamine is an intranasal medication that was FDA-approved in 2019 for such patients when used in conjunction with an oral antidepressant.2 Esketamine also is unique from the more traditional oral antidepressants in its mechanism of action, quick onset, and evidence for treatment of acute suicidality.3 While esketamine has been of much interest for these last few years, a recent study found low and geographically variable use of this medication within the Medicaid population.4 We were interested in investigating esketamine treatment utilization among Medicare patients in 2019 and 2020.
