PharmaShots Magazine-July 2024 Edition
In June, PharmaShots was busy covering the heavy influx of life science updates.
Our most-read Top 20 reports covered Nutraceutical and Innovative Digital Therapeutics companies.
For the Disease of the Month report, we covered Fabry Disease. The Know Your Investor report featured a condensed report on Google Ventures.
Like every Month, we published reports on Biosimilars, Designations, FDA and EMA approvals.
About the Theme: Understanding Class III Medical Devices
Last month, PharmaShots Magazine focused on Class I & Class II medical devices. The July Edition of our magazine is dedicated to Class III medical devices. Medical devices classified as Class III are high-risk due to the magnitude of their risks.
This month, we are navigating the nuanced aspects of Class III medical devices with engaging articles, illustrative infographics, illuminating regulatory updates, and a few interesting facts to keep our readers hooked throughout the magazine.
In August, PharmaShots will be exploring Animal Health Part 1: Companion Animal & In September, PharmaShots will be exploring Animal Health Part 2: Livestock
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The Evolution & Impact of Class III Medical Devices
High-paced technological transformations and continuous innovations are shaping the future of the healthcare sector now and then. By infusing innovations in healthcare, regulatory bodies must ensure the medical devices being used are safe and conducive to human health. In this article, we will explore the systems of tracking adverse events in High-Risk Medical Devices used by two regulatory bodies the US FDA, and the EMA.
The evolution of Class III medical devices has been marked by significant technological advancements. Initially, these devices were relatively simple, like early heart valves, but have since evolved into sophisticated systems integrating advanced materials, miniaturization, and software enhancements. This progress has been driven by continuous research, clinical trials, and improvements in manufacturing processes.
Class III devices have a profound impact on public health. They enable the management of complex medical conditions that would otherwise be life-threatening. For instance, modern pacemakers and defibrillators effectively treat arrhythmias, significantly reducing the risk of sudden cardiac death. Similarly, advancements in implantable devices have improved outcomes for patients with chronic conditions, enhancing their quality of life.
The stringent regulatory requirements for Class III devices ensure that only the most rigorously tested and proven technologies reach patients. This regulatory oversight is crucial for maintaining public trust and ensuring that these high-risk devices provide the intended therapeutic benefits without compromising safety.
Overall, Class III medical devices play a vital role in contemporary healthcare, offering solutions for conditions that are otherwise challenging to manage. As technology continues to advance, these devices are likely to become even more effective, further improving patient outcomes and overall public health.
Tracking Adverse Events in Class III Medical Devices
High-paced technological transformations and continuous innovations are shaping the future of the healthcare sector now and then. By infusing innovations in healthcare, regulatory bodies must ensure the medical devices being used are safe and conducive to human health. In this article, we will explore the systems of tracking adverse events in High-Risk Medical Devices used by two regulatory bodies the US FDA, and the EMA.
FDA Surveillance via MDR
Medical Device Reporting (MDR) is one of the post-market surveillance tools that the US FDA uses to track the performance of devices, device-related safety issues, and risk-benefit analysis of devices. Using MDR, the FDA monitors device malfunctions, device-associated injuries, and deaths. FDA’s mandatory reporters are manufacturers, device user facilities & importers. The US FDA encourages HCPS, patients, and consumers to share voluntary reports on medical device adverse events about quality and therapeutic failures.
EU Medical Device Vigilance System
Medical Device Regulation took over the Medical Device Directive (MDR) with Regulation (EU) 2017/745, expanding the scope of MDR and setting new parameters for regulations of medical devices. The European Database on Medical Devices (EUDAMED) is instrumental in ensuring vigilance and Medical Device Post Market Surveillance. The database allows adverse events reporting across Europe
Augmenting Surveillance through Technology
When it comes to post-market surveillance and adverse event reporting, it is necessary for regulatory bodies to gather information from credible sources. Using the right database to collect resources, data, and information helps build trust among consumers and companies. By leveraging new-age technologies, regulatory bodies can ensure tracking of the malfunctions in medical devices at the time of event, safety-related concerns, and deaths associated with high-risk medical devices.
Web-based reporting systems like the FDA’s MedWatch play an instrumental role in voluntary adverse event submissions by consumers and healthcare professionals. Regulatory bodies across the globe must ensure seamless adverse event
reporting when dealing with high-risk medical devices.
Insights & Infographics
Regulatory Updates
Final Rule Amending the Quality Management System Regulation
CDRH plans to commence the reclassification process for most high-risk IVDs
Did You Know?
Bio-Trends
Our Bio Trends section is thoughtfully designed to keep our readers acquainted with the trailblazing practices in the Healthcare industry.
With this month’s theme on "Class III- Medical Devices", we bring a curated analysis of the trends of approval in Medical Devices because in an era marked by rapid advancements in medical technology, Class III medical devices are at the forefront of medical device trends, shaping the future of healthcare.
Objective:
To assess and compare Medical Devices approval trends by FDA based on various aspects. As per our analysis, we understand that the FDA-approved Class III category of medical devices is under PMA (Pre-Market Approval).
Methodology:
PharmaShots carried out an extensive keyword analysis on Google Trends for the selected five keywords under two categories; web search and video search and tried to draw some insights that could be helpful for future research, understanding unmet needs, and shifting focus areas among other things.
Web and Video Search
Web and Video Search
Insights:
Future developments in cardiac health focus on pacemakers with leadless designs, MRI compatibility, wireless monitoring, and adaptive algorithms, aiming to enhance safety and quality of life. Concurrently, cardiac stents are aiming to be bioresorbable and of newer materials to reduce long-term risks and promote improved artery healing compared to traditional stents.
US FDA Approvals Overview
All Class III medical devices are subject to Premarket approval as part of their regulatory controls. Submission of PMA application and approval from the FDA is required before marketing this class of medical devices in the US as they act as life-supporting and life-sustaining devices and are important in preventing impairment of human health. Just 10% of the devices regulated by the US FDA fall into Class III. ng their substantial contributions to medical device innovation
Premarket (PMA) Approvals: It is the FDA’s evaluation process for assessing the safety and effectiveness of?Class III medical devices or those not substantially equivalent to lower-risk classes through the 510(k) process.
There are four types of PMA applications: Traditional PMA, Modular PMA, Product Development Protocol (PDP), and Humanitarian Device Exemption.
Insights:
Focused Therapy Area
Insight:
Designations to Medical Devices
The FDA grants designation to medical devices, such as Breakthrough Device Designation (BDD) and Humanitarian Device Exemption (HDE) to expedite access to novel devices that can save lives and treat debilitating and orphan diseases.
Insights:
According to our understanding, the FDA grants Breakthrough Device Designation (BDD) to only a small number of Class III devices because it is challenging to meet the FDA's specified criteria. Firstly, the device must provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating human diseases or conditions. Secondly, it must represent breakthrough technology, have no approved alternatives, offer significant advantages over existing approved alternatives, and its availability must be in the best interest of patients.
Conclusion
The trends observed in FDA approvals for Class III medical devices in 2023 reflect a dynamic landscape characterized by innovation, rigorous regulatory scrutiny, and a commitment to addressing critical medical needs. The steady stream of FDA approvals, coupled with innovative and supplemental approvals with designations in various therapy areas. This data highlights the global trends in cardiovascular class III devices such as “Stent”, Pacemaker", “Heart Valve”, “Defibrillator” and “Balloon Catheter". These insights are invaluable for stakeholders in the healthcare industry, guiding future research, development efforts, and strategic investments in medical technology.
Discussion:
There were several limitations and shortcomings to the analysis:
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