Med Device Online

We're Heading Toward A Bottleneck For EU MDR Approvals; How To Get Ahead The deadline for medical devices compliance to the new medical devices regulation 2017/745 (EU MDR) was originally May 2020 for class l non-sterile devices and May 2024 for all other devices. During those first years, the accreditation of notified bodies to EU MDR was a lengthy process, which was further slowed down by the pandemic. There was the fear that there wouldn’t be enough notified bodies to deal with all the certificate renewals. The EU Commission therefore issued the regulation 2020/561 to postpone the compliance date for class l devices to May 2021, while maintaining the May 2024 date. However, accreditation of notified bodies continued to be a slow process. Manufacturers of medical devices were also slow in submitting their applications. This resulted in most of the technical files being submitted in 2023. Notified bodies alerted the EU Commission that it would be impossible to handle all the applications in one year with their current resources. In this article, ?Hilde Viroux and Chris Illman discuss the challenges facing manufacturers in the transition to EU MDR. https://lnkd.in/ed6WJeyu #eumdr #medicaldevicemanufacturer

How Does Robotics Aid Occlusion Testing For Drug Delivery Devices? Robotic automation testing helps the engineers confirm the fix during reliability testing and improves the accuracy of identifying the occlusion. Occlusion testing is critical for confirming the safety and efficacy of medical devices, particularly infusion pumps, catheters, and other drug delivery systems. In recent years, FDA recalls have occurred more due to the safety and reliability of infusion systems used in medical treatments, primarily due to occlusion issues. In this article, Stephen Prabu from Baxter International Inc. discusses the benefits of robotic automation for occlusion testing. https://lnkd.in/eD4bDQRb #drugdeliverydevice #medicaldevice #occlusiontesting

Navigating the ??Neurotech Valley of Death ? Neurotech startups face a unique set of challenges as they transition from lab to market. Don't let these hurdles derail your innovation! Key considerations for success: - Regulatory Landscape: Understand the complex regulatory pathways and plan accordingly. - IP Protection: Safeguard your intellectual property to maintain a competitive edge. - Market Access: Identify your target market and develop a robust commercialization strategy. - Reimbursement: Ensure your technology is covered by insurance and other payment models. In this article, Liron Nunez Weissman and JoJo Platt from Corundum Neuroscience examine the key components that neurotech startups must address to traverse the Valley of Death and scale the “Mountain of Opportunity” to commercial success. Read the full article: https://lnkd.in/etKN7uDw

We are all aware of the technical complexity of medical device design and development. This article discusses why you may choose to select a contract development organization (#CDO) to meet your organization's needs and highlights key considerations for how to evaluate CDOs in order to find the best fit for your project. Read the full article: https://lnkd.in/eDMyMJrf

Adaptive AI-Driven Medical Devices In The U.S.: Ethical Considerations In the United States, the FDA has addressed the recent boom in AI technologies. The immense power of adaptive AI comes with profound accountability. Through proactive efforts, we can promote responsible innovation and allow adaptive AI to enhance our lives and the public sector safely and ethically. In this article, Jessica Chen and Thuha Tran, focus on the ethical concerns regarding patient health data, safety, and privacy, which adds an additional layer of complexity to the design and development of these devices. Read more: https://lnkd.in/e9rD-tnP #AI #llm #medicaldevice #medicaldevices

Considerations In Selecting A Biomaterial For Implantable Smart Devices Smart implants are innovative devices that signify the beginning of a new era in medicine. Smart implants offer significant advancements in patient monitoring and treatment, providing real-time data and improved therapeutic outcomes. However, the integration of electronic components into implantable devices presents unique challenges, particularly in the selection of suitable biomaterials. When developing an implantable device with electronic components, several critical requirements must be addressed to ensure safe and long-term functionality. Learn more: https://lnkd.in/eXhUnAz6 #smartimplants #implantablesmartdevice #biomaterial

Life Sciences Cybersecurity Incident Management: The End-to-End Approach Cybercrime is big business and even the smallest malicious attack can seriously damage an organization’s reputation, productivity, and intellectual property (IP) rights. No life sciences organization should think it is safe from cybercrime. Cybercriminals do not just target large finance or banking organizations. On the contrary, a life sciences, medical device, or healthcare organization may be a more lucrative victim because of the information it processes or even the partners it works with. In this article, John Giantsidis discusses what a good cybersecurity incident response plan?looks like, along with several basic principles to keep in mind. Learn more: https://lnkd.in/eKj78YTR CyberActa #cybersecurity #lifescience

ISO 14971 is one of the most referenced and quoted risk analysis guidance documents in the medical device industry. In this article, expert Mark F. Witcher, Ph.D., reinterprets the risk model in Annex C of ISO 14971 using relational risk analysis (ReRA) to describe a better approach for understanding, analyzing, and managing not only medical device risks but all risks. Read the full article: https://lnkd.in/eh2w9Bar #medicaldevice #meddevice

The Regulatory Affairs Function Is Evolving. Are You Evolving With It? Regulatory affairs are typically seen as a cost center and innovation stifler across horizontal functions and executive leadership, but RA enables revenue creation and prevents unnecessary expenditures (i.e., recalls, legal fees, and reputational damage). The talk around AI has caused many in the space to wonder what its impact will be on their role. What will the future regulatory affairs role look like? What types of tools and skills will determine individual and team success? In this article, Maggie Chan, Nora Hernández García, and Hilde Viroux, offer insights on what the future of regulatory affairs may entail and how to succeed in that role. PA Consulting https://lnkd.in/e2bHYV4z

The ABCs Of PCCPs (Predetermined Change Control Plans) This regulatory burden facing medical device software and software as a medical device (#SaMD) manufacturers is further exacerbated by the speeds at which artificial intelligence (AI) and machine learning (ML) algorithms can learn and improve. Enter the FDA’s Predetermined Change Control Plans (#PCCPs). This regulatory tool aims to ease the regulatory burden of updating AI/ML algorithms and has potential applications across software-enabled medical devices. Companies that master this tool will be able to more rapidly improve their device products – and potentially patient outcomes – faster than their competitors. In this article, Randy Horton, Orthogonal breaks break down the ABCs of PCCP to help professionals across medtech understand this tool and its nascent potential... Read the full article: https://lnkd.in/emDRb_ac #medicaldevices #meddevice