usability engineering in medical devices

Several amendments to the text of the international standard IEC 62366-1: Application of usability engineering to medical devices have been published in June 2020. The risk of design defects in the user interface, the correction of which can be time-consuming and expensive, is lower. The evaluation plan should have a clear objective and the method of evaluation. This includes certification, Notified Body and consultancy services. Use specifications include the intended use of the medical device, intended patient population, type and site of interaction with the user, intended users [users could be medical staff or the patient and in some cases, both patient and medical staff], use environment and operating principle. Usability Engineering has always been an integral component of design, but the dynamic around the topic has changed significantly as a result of the implementation in 2007 of IEC 62366. lay user versus healthcare professional), age (e.g. Bionic prosthesis design concept set of four isolated compositions representing different lifetime situations with human characters vector illustration. User interface characteristics related to the safety should be identified considering the primary operating functions of the device which the user or patient is continuously using to interact with the medical device to achieve the intended use of the medical device. This usability engineering process assesses and mitigates risks caused by usability problems associated with correct use and use errors, that is, normal use. View All. The international standard IEC 62366 medical devices - Application of usability engineering to medical devices is a standard which specifies usability requirements for the development of medical devices. Usability Engineering Process. The formative evaluation plan should address the objective, evaluation method and the type of user interface that is being evaluated and the criteria of acceptability. The process for evaluation of human factors engineering is defined within the IEC 62366-1:2015/AMD 1:2020 – Medical devices — Part 1: Application of usability engineering to medical devices — Amendment 1 and can be summirezed in the scheme below. In the past years the IEC 62366 was replaced by the IEC 62366-1:2015 + COR1:2016 Medical devices - Part 1: Application of usability engineering to medical devices. Meet our MDR team and get free educational resources on the MDR. Explicitly state how the participants in the summative evaluation are representative of the intended user profiles. If the USABILITY ENGINEERING PROCESS detailed in this International Standard has been complied with, then the USABILITY of a MEDICAL DEVICE as it relates to SAFETY is presumed to be acceptable, unless there is OBJECTIVE EVIDENCE to the contrary. Medical devices must meet certain requirements to be marketed in Europe and the United States. The IEC 62366:2007 standard defines the process by which the manufacturer of the medical product must “analyze, specify, design, verify, and validate usability, as it relates to safety of a medical device. In the United States (through the FDA) it has been important for many years to apply the usability aspects during the product development; you should be able to provide documentation to prove that the usability aspects have been applied. Similar to the formative evaluations, summative evaluations can be performed in a single or multiple iterations. Specify the application of the medical device. The basics to include in a report are clearly defined on the FDA’s website. Usability Engineering and Human Factors Testing for Devices Posted by Rob Packard on February 5, 2016. What is Human Factors Engineering? We are based in the UK and Sweden and focus only on the world-class delivery of our services. Device manufacturers are responding by actively initiating human factors and usability engineering to many high priority devices. A usable medical device also has advantages outside of regulatory requirements. IEC 62366-1, 1.1 Edition, June 2020 - Medical devices – Part 1: Application of usability engineering to medical devices This part of IEC 62366 specifies a PROCESS for a MANUFACTURER to analyse, specify, develop and evaluate the USABILITY of a MEDICAL DEVICE as it relates to SAFETY. Medical devices must meet certain requirements to be marketed in Europe and the United States. Self-selection Studies: Guarding against contraindicated use of OTC medical products, Medical device usability testing in China: Key considerations for manufacturers, Understanding customers and their needs in human factors engineering, 2020 amendments to IEC 62366 – implications for medical device usability engineering, Reasonably foreseeable use – normal and abnormal. Summative evaluations are conducted in the simulated environment or in a real use case scenario with the subjects being the users and/or the patients as defined in the use specifications. Usability may be evaluated by understanding the characteristic of the USER INTERFACE that facilitates use and thereby establishes EFFECTIVENESS, EFFICIENCY and USER satisfaction in the intended USE ENVIRONMENT. The records and documents arising from the usability Engineering process could be completely separate from the design & development documents and the risk management documents or could be a part of the entire design & development documents. This standard drives much of the usability engineering work done by Emergo by UL’s Human Factors Research & Design (HFR&D) team. With the added requirement for defining correct use for each use scenario evaluated, this means that the ”success” or “failure’ of summative evaluation is directly measured by the extent to which use-related risk is avoided. Medical Device Usability Usability (or human factors) engineering’ has become a hot topic in the medical device industry. All the medical devices that were manufactured prior to the publication of the standard, IEC 62366-1:2015 can also comply to this standard by assessing the medical device considering the Use specifications and User interface specifications, Post-market data, applying risk controls if necessary and by maintaining an UEF having the document evidences of Use & User interface specifications, PMS data assessment, risk management and verification of the risk controls. Human Factors & Usability Engineering in Medical Devices. Share. Overall Human Factors Engineering and Usability Testing Services Market for Medical Devices, 2020-2030 10.4. Part 2: Guidance on the application of usability engineering to medical devices • To be more “usable”, easier to understand than original 62366 • Contains the “what” requirements in Part 1, the “how” is in 62366-2 • Closer ties to risk management, EN ISO 14971 • Closer to FDA guidance 35 . Following Brexit, medical device and IVD clinical study sponsors will face different sets of requirements... Resources and tools tailored to medical device professionals. The formative evaluations can be module by module, developed stage wise. A platform of digital products to improve, simplify and automate RA/QA activities, The latest industry news and insights from our global team. We have deep expertise with a range of product types, including combination and borderline products. Human Factors Engineering: application of knowledge about human behaviour, abilities, limitations, and other characteristics to the design of medical devices (including software), systems and tasks to achieve adequate usability. This is because the fundamentals of usability engineering (or human factors) do not recognise geography. Historically, manufacturers of active medical devices, including software should be familiar with the application of usability engineering during product development. In the United States (through the FDA) it has been important for many years to apply the usability aspects during the product development; you should be able to provide documentation to prove that the usability aspects have been applied. Yesterday, February 3, the FDA released a new guidance document on the subject of “ Applying Human Factors and Usability Engineering to Medical Devices. But, it is an important inclusion nonetheless. This standard drives much of the usability engineering work done by Emergo by … child versus adult), and disease type (e.g. Likewise, the international regulatory community has incorporated IEC 62366, Medical devices – Application of usability engineering to medical devices, as a part of the approval process outside the US. Figure 1: Human Factors Affect Outcomes of Using Medical Devices (Obtained from: FDA’s Applying Human Factors and Usability Engineering to Medical Devices, FDA 2016) Usability Engineering within Regulatory Frameworks The U.S. Food & Drug Administration (FDA) receives about 100,000 medical device incident reports every year. Part 2: Guidance on the application of usability engineering to medical devices • To be more “usable”, easier to understand than original 62366 • Contains the “what” requirements in Part 1, the “how” is in 62366-2 • Closer ties to risk management, EN ISO 14971 For some organizations, this can appear to be an overwhelming possibility, and particularly if the essential aptitude isn’t in-house. This is the application of information about human behavior, capabilities, shortcomings, and other features to the design of medical devices like software, systems, tasks to achieve adequate usability. Learn from our experts through live events. Recently with the new regulations, standards and guidance there is an emerging emphasis on the application of usability engineering to medical devices. THAY Medical are a specialist Human Factors and Usability Engineering consultancy who partner with clients to focus on medical device users. UE is a regulatory requirement and PDD can fully integrate UE throughout the medical device design and development Risk control measures (section 4.1.2): Training has been introduced as a third priority control measure, alongside information for safety. During the usability engineering process, engineers use human factors analysis to obtain design optimization. Abstract . Understanding how people interact with technology and studying how user interface design affects the interactions people have with technology is the focus of human factors engineering (HFE) and usability engineering (UE). In order to protect and prevent any conflict of interest, perception of conflict of interest and protection of both our brand and our customers brands, UL is unable to provide consultancy services to Notified Body or MDSAP customers. This guidance recommends that manufacturers follow human factors or usability engineering processes during the development of new medical devices, focusing specifically on the user interface, where the user interface includes all points of interaction between the product and the user(s) including elements such as displays, controls, packaging, product labels, instructions for use, etc. In summary, the 2020 amendment to IEC 62366 includes several changes that impact various UE activities, as well as an updated linkage to the newest version of ISO 14971. Although usability engineering is a requirement for the design of medical devices, most of people designing software are not familiar with this process. Usability Engineering for all medical devices. View All, Our global consulting team works from 20+ offices on six continents. The interactions among the three components and the possible results are depicted graphic… Introduction  India’s medical device market is the fourth largest in Asia-after Japan, China and South Korea. The MDR specifies that conformity with standards that are published in the ‘Official Journal of the European Union’ will provide evidence of conformity with the requirements of the MDR. Describe how data will be collected during the test. Part 2, IEC 62366-2:2016, “Guidance on the application of usability engineering to medical devices”, contains tutorial information to assist manufacturers in complying with Part 1 and provides lots of examples and guidance on how to deal with generating the required deliverables. There could be multiple iterations in the formative evaluations until the desired safety level is achieved to conclude that the usability of the device meets the criteria of the acceptability as defined in the Risk management process or the usability Engineering process. Usability Engineering is one of the important processes, part of the design and development of the medical devices. Normal use is further divided into correct use and use error, whilst abnormal use is depicted as “outside of scope” for 62366. Collateral standard: Usability BS EN 60601-1-6:2010+A1:2015 Medical electrical equipment. Sterling incorporates medical device human factors & engineering services throughout our design process which helps to mitigate risks and save time in other phases of your development. The amount of usability work required for a medical device can vary widely, since some user interfaces comprise a single button and others are more complex than a desktop PC. Comprehensive service offerings at every point in the product life cycle. Therefore, our recommendation is to follow the methods described in IEC 62366-1:2015 and provide this as evidence that you have adopted a “state-of-the-art” process. This usability engineering process assesses and mitigates risks caused by usability problems associated with correct use and use errors, i.e. Action errors: The previous version of IEC 62366 used the term “action error” to describe a use error caused by some aspect of the physical limitations involved in performing a task; in the new version the term has been replaced by “physical mismatch.” Note that this is slightly different from FDA’s term “physical actions,” and encourages us to think about any mismatch between the capabilities required to perform a task and the physical capabilities of the user. Larger medical device organizations have been gradually incorporating the guidelines into their processes since the draft of the FDA guidelines was first released in 2011, but many small companies involved in medical device design are struggling in applying human factors and usability engineering into their development process. The standard describes a Usability Engineering Process with 9 stages: 1. Human Factors Engineering and Usability Testing Services Market: Distribution by … 0 Likes. The key changes that will affect usability engineering (UE) methods are as follows: Reference to risk management: Updating of the reference to ISO 14971 with the standard’s 2019 version. Having said that, IEC 62366-1:2015 is the standard recognized by the European Union, USFDA and the other major countries where the medical device regulations are stringent and difficult to comply. Likewise, the international regulatory community has incorporated IEC 62366, Medical devices – Application of usability engineering to medical devices, as a part of the approval process outside the US. The international standard IEC 62366 medical devices - Application of usability engineering to medical devices is a standard which specifies usability requirements for the development of medical devices.It is harmonized by the European Union (EU) and the United States (US), and therefore can be used as a benchmark to comply with regulatory requirements from both these markets The choice is left to the manufacturer, the documents could be maintained however that is feasible and practical based on the complexity of the medical device. The smallest details count when designing a medical device: colour, shape, feel, and language – the list goes on. This standard has been revised by IEC 62366-1:2015. IEC 62366:2007was harmonised to the Medical Device Directive (MDD), which means performing usability engineering has been recognised as one of the processes used to manage risk. The FDA guidance — the 2015 “Applying Human Factors and Usability Engineering to Medical Devices” — lays out the needs and expectations for your Human Factors/Usability Engineering Report. Three major elements of Usability Engineering are User, User Interface, and Use Environment. Usability Engineering process during and/or when the device is placed in the market, involves the following tasks:-. For example, the need to clearly define intended users and design the medical device … Human Factors Engineering and Usability Testing Services Market: Distribution by … In addition… The story begins with a plan, as usual in the quality world.The usability engineering plan shall describe the process and provisions put in place. This USABILITY ENGINEERING (HUMAN FACTORS ENGINEERING) PROCESS permits the MANUFACTURER to assess and mitigate RISKS associated with CORRECT USE and USE ERRORS, i.e., NORMAL USE. The usability engineering plan can be a section of the software development plan, or a separated document.The usability engineering plan describes the following to… General requirements for basic safety and essential performance. HFE/UE considerations in the development of medical devices involve the three major components of the device-user system: (1) device users, (2) device use environments and (3) device user interfaces. 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