Medical Device Categories, Characteristics and Developments

According to the recommendations of The International Medical Device Regulators Forum (IMDRF), software intended for medical purposes falls under the category of medical devices (MD). In recent years, in Russia, a great deal of systematic work has been carried out to establish normative regulations and processes for controlling the efficiency and safety ofsoftware as medical devices (SaMD) and its subsequent state registration. Objective. The analysis of current procedures and results of state registration of SaMD in the Russian Federation in 2007–2024. Materials and methods. A systematic search of information on the software registered in Russia as MD was carried out. For this, the state registry of MD of the Federal Service for Surveillance in Healthcare of Russia (Roszdravnadzor) was used. 157 records of marketing authorizations (MA) issued between 01. 01. 2007 and 30. 07. 2024 were found. Results. 25.5 % of MAs were issued for radiological information systems, including image archiving and communication systems (PACS-systems). For SaMD with artificial intelligence technologies – 24.2 % MAs. 13.4 % of MAs were issued for laboratory information systems and 4.5 % for medical information systems of medical organizations. The “Other software” group accounted for 32.5 %, it included telemedicine solutions, software for planning surgeries, etc. More than 50 % of Mas for SaMD was issued for Russian-based developers. Half of SaMD was registered as the 2nd class of potential risk application (50 %), 17 % as the class 2b, and 18 % as the lowest 1st class of potential risk. 15 % of SaMD were of the maximum 3rd class of the potential risk of application, and most of them were SaMD with artificial intelligence (AI) technologies. Conclusion. In Russia, a system of independent testing and state registration of SaMD has been built and has been working reliably for many years, allowing manufacturers to bring to the market the most diverse products, including innovative AI-based MD. Russian development companies are gradually increasing their market share compared to foreign producers.

Multisociety guideline on reprocessing flexible GI endoscopes: 2016 update

Moderate-risk medical devices constitute 99% of those that have been regulated by the U.S. Food and Drug Administration (FDA) since it gained authority to regulate medical technology nearly five decades ago. This article presents an analysis of the interaction between the 510(k) process —the historically dominant path to market for most medical devices— and the De Novo pathway, a more recent alternative that targets more novel devices, including those involving new technologies, diagnostics, hardware, and software. The De Novo pathway holds significant potential for innovators seeking to define new categories of medical devices, as it represents a less burdensome approach than would have otherwise been needed historically. Moreover, it supports the FDA in its effort to modernize the long-established 510(k) pathway by promoting the availability of up-to-date device “predicates” upon which subsequent device applications can be based, reflecting positive spillovers that are likely to encourage manufacturers to adopt current state-of-the-art technologies and modern standards of safety and effectiveness. We analyze the of characteristics all the De Novo classification requests to date, including the submission type, trends, FDA review times, and device types. After characterizing how the De Novo process has been used over time, we discuss its unique challenges and opportunities with respect to medical device software and AI-enabled devices, including considerations for intellectual property, innovation, and competition economics.

Proactively Investigating “Limits of use” with Medical Device Manufacturers – An Example Case: Robotic Surgery

<p>Although great strides have been made to tackle hospital-acquired pressure ulcers (HAPUs), there is a need for greater recognition of device-related pressure ulcers (DRPUs), including their causes, management and prevention. This consensus statement, an updated second edition, aims to continue raising awareness of these largely preventable injuries and, crucially, to stimulate action. DRPUs are relatively common and account for a growing proportion of HAPUs. Updated information on the incidence of DRPUs is described in chapter 1. Although it is recognised that DRPUs increase the financial burden of healthcare, there is little formal analysis of their economic impact. This needs to be addressed; robust evidence on the burden of DRPUs and the value that can be released by adopting prevention strategies is needed to help drive action. Our understanding of the pathophysiology of DRPUs has improved significantly over the past few years; this is described in chapter 2. One crucial difference between PUs and DRPUs is that body-weight forces are less significant in DRPUs, with the force being exerted from a device that is typically strapped or taped onto the body. Devices and their securement may generate high stress concentrations in tissues, leading to cell and tissue-damage pathways associated with sustained deformation. As more evidence is published on DRPUs, recurring themes are emerging, as outlined in chapter 3: The most vulnerable patients are bearing the brunt of DRPUs; paediatric and neonatal patients, and all those needing critical care are particularly susceptible. During the COVID-19 pandemic, a new high-risk population (people with severe COVID-19 infection) emerged. They are at increased risk of DRPUs because of their need for prolonged ventilatory support, especially when 'proning' Devices associated with DRPUs are often used to perform essential, life-saving functions. They include continuous positive airway pressure (CPAP) masks or endotracheal tubes. Minimising their use is clearly not an option, so practice innovation is needed Although the most common locations for DRPUs are the face, ears, lower legs and heels, any location where a device comes into close contact with the skin can be at risk. In the same vein, any device, whether needed for a medical purpose or not, has the capacity to cause injury if its use is not properly managed. Vigilance is needed for all patients. What can be done? The importance of routine risk assessment is covered in chapter 4. Although use of a validated risk assessment tool is the vital first step, this will not be enough on its own. Several steps can be taken to ensure the safe use of devices. These are described in chapter 5 and include device repositioning, cushioning with prophylactic dressings and moisture control (only where possible and clinically appropriate). Of key importance is the development of an institutional protocol and champions to ensure all necessary steps are adopted. For any of these changes to be put into practice, awareness of DRPUs needs to increase. A number of proposals are outlined in chapter 6. A change of focus among health professionals and policy makers, along with more investment in education and training, are needed. All patients being managed with a medical device must be considered as at high risk. The pandemic introduced the world to the problem of DRPUs in health professionals caused by the extended wear of personal protective equipment. Health professionals also have a right to expect institutional protocols and provision of devices that protect them from DRPUs. Cutting-edge ideas and technologies that may be available in the future are described in chapter 7. When designing new products, manufacturers of medical devices have a duty of care to investigate the risks of DRPUs associated with their products and mitigate them, wherever possible. Our developing understanding of how the design, structure and materials used in medical devices contribute to DRPUs will help us develop new solutions for tomorrow. The first step is for everyone involved to ask themselves, 'what can I do to help?' There is work to be done-your journey to reduce DRPUs starts here!.</p>

Background: The integration of medical devices with artificial intelligence (AI) software is rapidly advancing as technology progresses. AI machine learning can be used in commercial medical services to generate practical data; there is evidence that it can be integrated into newly developed devices. However, such devices must undergo approval, regulation, and supervision. The Food and Drug Administration approves regulations for numerous machine-learning medical devices and shares open lists with the public. In this article, we examine recent medical AI devices in different fields, including the diagnosis of colorectal polyps.Current Concepts: Currently, in the field of gastroenterology, there has been a significant amount of research aimed at enhancing adenoma detection rates using tools powered by AI, such as the EndoScreener and GI Genius. Various such devices have also been developed for other fields; examples include the 23andMe Personal Genome Service for DNA detection, Spectral MD’s DeepView platform for wound imaging in surgery, Gili Pro BioSensor for monitoring vital signs, DreaMed Advisor Pro for diabetes, Minuteful for urinary analysis, BrainScope TBI for cerebral diagnosis, Compumedics Sleep Monitoring System for sleep disorders, Idx-DR v2.3 for ophthalmology, and EarliPoint system for pediatrics.Discussion and Conclusion: By the time this article is published, it is likely that even more AI medical devices will have been approved and commercialized. The development of such devices should be strongly encouraged. Additionally, we anticipate greater involvement from practitioners in the development and validation of diverse medical AI devices in Korea.

Comparison of the international regulations for medical devices–USA versus Europe

Regulatory science can be defined as the science aimed at the optimal introduction into society of new products of science, such as discovered substances and new scientific tools and technologies as well as knowledge and information. In addition to engineering researches that create novel medical devices, scientific methods for evaluating efficacy, safety and quality of medical devices are necessary to enable rational and scientific evaluation of the device in device approval process. Engineers and medical doctors involving research and development of novel medical devices are required to have basic knowledge on medical device safety standard, medical device regulation, and relevant methodologies. In Japan, several graduate schools in Japan have started educational programs on regulatory sciences in collaboration of Pharmaceuticals and Medical Devices Agency (PMDA), Japan. In 2012, program for researches for development of evaluation guidelines for novel medical device products started where personnel exchanges between academic researches institutes and PMDA. Example of these programs will be introduced in the presentation and its impact on improvement of medical device research and development process will be discussed.

Since 2010, two significant international regulations regarding medical device development have come into force, the amendment to the European Union (EU) Medical Device Directive (MDD) 2007/47/EC and the United States (US) Food and Drug Administration (FDA) final rule on Medical Device Data Systems (MDDS). Adherence to these regulations is mandatory to be able to market a medical device in the respective region. The ability to understand these regulations and apply them to a development project can be difficult. The MDDS final rule changes the safety classification of a number of devices from Class III-high risk to Class I-low risk. The aim of this regulation is to make the process of achieving regulatory approval for manufacturers easier. The MDD aims to provide guidance for the development of medical devices to be marketed for use within the EU. It also provides defined pathways which manufacturers can follow in order to achieve regulatory approval. However, changes made as part of an amendment to the directive have a direct impact on the development of medical devices. One of the most significant changes as part of this amendment is for software to be potentially considered as a medical device in its own right and potentially the only element in a medical device subject to regulatory conformance. These regulations have created confusion surrounding specific areas, such as the use of mobile device applications for healthcare purposes. This article describes the key points of these latest regulatory changes that medical device manufacturers need to be aware of.

The CADTH Horizon Scanning Service identifies and monitors new and emerging health technologies likely to have a significant impact on health care in Canada. This Watch List focuses on those categories of medical devices, clinical interventions, or other health technologies that are, or may become, important or disruptive to Canadian health care or decision-making in the next few years. Among others, the trends and technologies featured in this Watch List include: developments of artificial intelligence within imaging technologies greater integration and connectedness of wearables to improving patient monitoring systems proliferation of transcatheter valve devices driving innovations for interventional cardiology increasing interest and development of non-pharmacological solutions for pain management rapid growth in technologies and digital services enabling virtual care

Cybersecurity vulnerabilities of cardiac implantable electronic devices: Communication strategies for clinicians—Proceedings of the Heart Rhythm Society's Leadership Summit

Making sense of the Food and Drug Administration

The development of medical devices currently faces several challenges, like the urgent need for new products in a pandemic situation and the release of a new regulatory framework for medical devices in the European Union, which shall ensure the safety and effectiveness of newly developed medical devices. At the same time, the desire for smart, user-friendly products is growing. These can be realized through agile and flexible process models. Based on agile values and the integration of customer feedback, this need can be achieved in iterative development cycles. What at first sight does not seem to be combinable, however, be well integrated into the regulated area of medical technology through the targeted use of agile processes and the adaptation of individual steps. This paper presents a framework for the integration of Scrum into the regulated design control process for medical devices. This framework facilitates flexible product development of smart medical devices.

Software is now a crucial component of every product as technology continues to develop all elements of health care. It is widely integrated into digital platforms for both medical and non-medical uses. One of three forms of software connected to medical devices is software that, on its own, qualifies as a medical device. This article intends to provide an analysis and summary of recent research in the field of medical device development methodology, explore these investigations’ phases, and assess the risk and legal implications. The literature search was carried out to find peer-reviewed articles on content released between 2010 and 2021 in Scopus, Web of Science, and Science Direct. based on criteria for inclusion and exclusion. Given the distinctive characteristics of software as a medical device (SaMD) that go beyond those of conventional medical hardware or devices, regulators across the globe started to realize the need to consent to a framework and set of guiding principles for the industry. This will allow all stakeholders, including regulated entities, to advance safe innovation and safeguard patient safety. From the time a product is first conceptualized until it is launched onto the market, the development of software as a medical device is incredibly complicated and greatly relies on the use of good manufacturing practices. The key issues that must be addressed in the future are the transparency of regulatory processes throughout the globe.

In the United States, drugs and medical devices are regulated by different divisions of the U.S. Food and Drug Administration (FDA). While defined similarly, drugs and medical devices differ in their modes of action. Both are products that are labeled, promoted, or used in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease. A device, however, does not achieve its intended purpose through a chemical action within or on the body or by being metabolized by the body. 1 Although both drugs and medical devices must comply with federal regulations regarding labeling, advertising, production, and postmarketing surveillance, there are differences in the FDA premarket review and approval processes. FDA clearance and prescription status of a device do not necessarily mean that safety and efficacy have been shown for the product or that clinical trials have been conducted. We conducted a literature review to (a) examine the historical legislation and approval processes for drugs, medical devices, and combination products and (b) discuss implications of the differences in FDA review processes for clinicians and payers. ■■ Methods