Med Device Online

Due to the potential for serious illness or death, it's crucial that all injectable pharmaceutical products and #implantable #medicaldevices that come into contact with the bloodstream or spinal fluid are rigorously tested for #endotoxins to ensure patient safety. This testing, known as bacterial endotoxin testing (BET), ensures that sterile pharmaceutical products are safe for human use. Endotoxins are toxic bacterial structural components released upon cell lysis. When administered to humans or animals, they can cause severe pyrogenic responses. That's why it's essential that all injectable or implantable drugs and medical devices undergo thorough endotoxin testing. In this article, Yadnyesh Patel provides an insightful overview of endotoxins and the tests used to detect them in drug products and medical devices. https://lnkd.in/dwqUnSS5

In the ever-evolving landscape of medical device regulations, the Predetermined Change Control Plan (PCCP) represents a significant advancement in how the U.S. FDA manages postmarket changes to medical devices. In this article, Yu Zhao from Bridging Consulting LLC will provide an update on the status of the #PCCP, examine regulatory developments, analyze authorized PCCPs, and explore emerging trends and future directions. Read the full article ⤵ https://lnkd.in/dUSYaBVP #medicaldevice #meddevice #medicaldevices #fdaregulation

Understanding The Potential Of AI Med Devices Amid Regulatory Challenges Regulatory bodies, such as the #FDA and #MHRA, are making strides in defining and regulating AI/ML-enabled #medicaldevices, with a focus on ensuring safety and efficacy. In this article, Timothy Bubb, technical director at IMed Consultancy Ltd gives some insights into the evolving regulatory landscape and challenges, especially as digital health solutions can blur the lines between medical devices and non-medical tools. Read the full article: https://lnkd.in/eAfukXXg #euai #medicaldevice #meddevice

Adaptive AI-Driven Medical Devices In The US: Regulatory Guidelines In this two-part article series, Jessica Chen and Thuha Tran, San Jose University, delve into the evolving landscape of AI-assisted devices in healthcare, focusing particularly on the emergence of Adaptive AI. This article discusses the proposed regulatory considerations surrounding these technologies. Stay tuned for part 2, where they will discuss ethical concerns with patient health data, safety, and privacy. Read the full article: https://lnkd.in/eZJNRU53 #medicaldevice #meddevice #medicaldevices #ai #cad #samd

Researching for the best location to implement medical device clinical trials? After recent government initiatives to promote #clinicalresearch, Mexico has emerged as an attractive destination for medtech companies looking to conduct #clinicaltrials. While challenges like bureaucracy, finding the right local partners, and addressing cultural barriers exist, Mexico's favorable landscape has made it an appealing destination for clinical trial outsourcing for U.S.-based #medtech companies seeking cost savings and value creation during early-stage development. Several medtech companies like FastWave Medical, NUVIEW, Rivermark Medical, Inc., NeuroCytonix Inc., Todos Medical (OTCQB: TOMDF), and AEGEA Medical, Inc. have successfully conducted clinical trials in Mexico, leveraging these advantages. Julio G. Martinez-Clark, co-founder and CEO of bioaccess™ LATAM CRO EXPERTS provides a detailed overview of Mexico's healthcare system, hospital infrastructure, FDA requirements, the current state of clinical research, and Medtech success cases. Learn more about Mexico's advantages - read the full article: https://lnkd.in/ehYhCiip #medicaldevice #meddevice

#SFMEA: An Alternative Approach For Analyzing Risks Some companies are required by internal procedures to use risk matrices and #FMEA for prioritizing and analyzing risks. In this article, industry veteran, Mark F. Witcher, Ph.D., describes an alternative approach based on relational risk analysis (#ReRA) for conducting a system failure mode & effects analysis (SFMEA). He also gives insights on why SFMEA is an easy-to-use, intuitively obvious method of identifying, analyzing, understanding, evaluating, managing, and communicating a wide variety of risks. Learn more - read the full article: https://lnkd.in/eHy-w5zp #medicaldevice #medicaldevicemanufacturing #riskanalysis

Unfortunately, there have been several diagnostic company collapses over the last decade, which have cast an immovable shadow of uncertainty over the entire sector. Underinvestment in diagnostics hinders the potential for better health outcomes since many conditions are harder to treat and manage when diagnosed later. The subsequent increase in treatment and downstream healthcare costs places a greater financial strain on the healthcare system, insurance providers, and patients. The lack of diagnostic tools also can increase the workload and stress for physicians and, in some cases, lead to burnout. In this article, Nathalya Mamane, MBA, founder and CEO of RT MicroDx provides some best practices for medtech/diganostic to attract and secure investments and a variety of strategies #medtech and #diagnostic companies can adopt to highlight their value and potential for growth Read the full article: https://lnkd.in/eGPti_gs

Gastrointestinal (#GI) #endoscopes, play a crucial role in diagnosing conditions and conducting less invasive surgeries. The GI endoscope market in the U.S. currently holds a value of around 💲1.2 billion, and it is projected to reach close to 💲1.5 billion by the end of the forecast period (2030) In this article, Hadi Salempoor and Kamran Zamanian, Ph.D. from iData Research provide an overview of the dynamic market landscape, explore the latest trends in the market, and the influence of COVID-19. Read the full article: https://lnkd.in/eVriEDiU

Getting a medical device through concept development, prototyping, design, and the regulatory process is hard enough for any developer. It’s no wonder that assembly and packaging are often afterthoughts. Yet these decisions are critical ones that impact a device’s safety, protection, and marketing. In this article, Jim Kasic at Boulder iQ and Boulder Sterilization provides six factors developers should consider to make the right decision for their device and their company. Jim also dives into the options of outsourcing your assembly and packaging with a 5-step strategy to identify and choose a contracting firm. https://lnkd.in/e3iFRRfC #medicaldevicemanufacturer #medicaldevice #medicaldevicepackaging #medicaldevicedeveloper

Forensic medical device engineering is a high-stakes discipline in which experts investigate and analyze medical devices that have malfunctioned, failed, or caused adverse events. In this article, Thom Wyatt, principal engineer at Springboard Pro Ltd. provides six essential steps for resolving #forensic medical device engineering problems. Read the full article: https://lnkd.in/eUEhfEai #medicaldevice #medicaldevices #medicaldeviceengineer