Usability testing of medical devices / Michael E. Wiklund, Jonathan Kendler, Allison Y. Strochlic. Some of the associated changes affect in particular the software development companies. Medical engineering technologies can offer these studies for all types and classes of device. Summative usability testing is sometimes also referred to as user performance testing or formal evaluation and tries to fulfil the requirements of scientific experiments. This article presents a late-stage formative usability study of a pen-injector platform device. Human Factors and Usability Engineering – Guidance for Medical Devices Including Drug-device Combination Products MHRA September 2017 v1.0 Page 4 of 47 1 Introduction and context The safety of medical devices, including drug-device combination products, relies on them being used as intended, as well as being reliable. Such a test is often referred to as informal testing or formative evaluation. We hope this book’s content helps many of you do the same. A well-designed study will identify any safety or application problems. Medical devices – Application of usability . Usability of a new disposable autoinjector platform device: results of a formative study conducted with a broad user population Jakob Lange,1 Philipp Richard,1 Nick Bradley2 1Ypsomed AG, Burgdorf, Switzerland; 2BERGO UK, Bearsden, Glasgow, UK Abstract: This article presents a late-stage formative usability study of an autoinjector platform device. platform device: results of a formative study conducted with a broad . In this late-stage formative study, the primary objective was to evaluate whether participants could use the FixPen™ fixed-dose platform prototype devices safely and effectively relying on the IFU as only support and to benchmark the device against a fixed-dose pen injector available in the market. The objective of this study was to implement an extended protocol for usability validation testing of medical device. which are both harmonised under the Medical Device Directive. Molly Follette Story, PhD This article presents a late-stage formative study of a platform device with a broad user population, defined to represent user properties across a range of indications. History. It differs from the formative test in that now you have to use a device that represents exactly the device that is going to be launched to the market. For example, considerable emphasis is now placed on human factors engineering. The medical device development tools you choose should add to the accuracy and effectiveness of the work your team is doing, and not add unnecessary overhead to their daily tasks. medical devices will be safe and effective for the intended users, uses and use environments. p. ; cm. Refining research questions, hypotheses, and metrics. Med Devices (Auckl). Click here to enlarge. Usability tests can be performed at any design stage - development (formative study) and validation (summative study) - as it enables the device improvement for the intended users, use and environments. 72 For medical devices, the use of human factors and usability engineering (e.g., applying the 73 knowledge of human behavior, abilities, and limitations to the design of a medical device) plays One relatively recent method is Human Factors Engineering, also known as Usability Engineering, which is used to identify and mitigate use errors. MeasuringU provides full services for each phase of formative usability testing. It gives your team flexibility to produce ad hoc views and reports to better use (and explore) the data you’ve captured. 100% of participants delivered the full dose, and 90% of injectors successfully activated the safety mechanism with no training. studies for non-complex devices? PLANNING. s. Meet the Human Factors Pre ‐ market Review Team at FDA’s Office of Device Evaluation. A good tool provides guard rails to ensure that the important things are always done. From a V&V point of view, there are specialized human factors testing techniques such as formative and summative testing. Focus on use safety and hazards, user interface design, efficiency and time, the expected use experience and the simulated effectiveness of the medical device are elements of a Formative Usability study. The medical device users can be protected from harm only via a robust and reliable user interface, comprising displays, controls, labels, packaging and instructions for use. Medical devices come in many different technologies, shapes, sizes, levels of complexity, etc. July 2013; DOI: 10.1007/978-3-642-39241-2_45. engineering to medical devices, as a part of the approval process outside the US. A study conducted at John Hopkins University reported that 15% of fatalities caused due to medical errors in the US, are attributed to medical device user interface related concerns. Those are concrete figures! As you can see, you can find, on average, 85% of the utilisation problems with five representative users, with ten you can already 95%. The Medical college of Hawler medical university (HMU) which provides a 6-year MBChB program, has started the process of changing its curriculum to competency-based medical education (CBME) and formative assessment is a requirement in this process. N2 - This article discusses a PhD study based in a healthcare design lab at MonashUniversity (Health Collab). We have conducted studies in North and South America, Europe, and Asia. Medical Device Standards and Regulation. Includes bibliographical references and index. A Formative Usability study is an exploratory test of the design of the medical device, using representatives of the intended users to guide the design further. The FDA, however, references in its Guidance Document "Applying Human Factors and Usability Engineering to Optimise Medical Device Design" a study that mentions more concrete numbers. AU - Page, Rowan. T1 - Integrating The User Into The Formative Stages of Medical Device Usability Design: A Speculative and Collaborative Approach. PY - 2018. It can include user interaction with devices, systems, software, apps, and instructions for use. user population. This article presents a late-stage formative study of a platform device with a broad user population, defined to represent user properties across a range of indications. This includes certification, Notified Body and consultancy services. Usability of devices for self-injection: results of a formative study on a new disposable pen injector Jakob Lange,1 Philipp Richard,1 Nick Bradley,21Ypsomed AG, Burgdorf, Switzerland; 2Bergo, Glasgow, United KingdomAbstract: This article presents a late-stage formative usability study of a pen-injector platform device. Process In-line with regulatory requirements to develop a UE file for pre-market submissions, we can provide you with a full suite of regulatory documentation to suit the needs of your project. Using the FDAs (draft) validation protocol as a starting point, we identified methodological shortcomings and proposed two extensions. One of the challenges to provide safe software products is the usability engineering process. V&V activity is typically driven by the regulatory environment and international standards. 1. Finally, we wish all readers success at integrating HFE into their device development efforts, as we work in broad Within the UL family of companies we provide a broad portfolio of offerings to all the medical device industries. March 21, 2012 – Herndon, Virginia. The sample size for formative studies is 5-8 per user group, for summative, a minimum of 15 per user group. Reference the FDA’s Draft Guidance on Applying Human Factors and Usability Engineering to Optimize Medical Device Design Section 10.1.2. comprehensive manner throughout device development, which included taking time to perform activities such as a proper formative usability test of a prototype medical device. In medical device usability testing, an underpowered study could lead to the conclusion that the test device is safe when it is not. Usability Testing Medical Devices: A Practical Guide to Minimizing Risk and Maximizing Success. Of course, this can place additional burdens on . Y1 - 2018. Summary: “Informative, practical, and engaging, this handbook covers how to conduct usability tests of medical devices. PDD operates in compliance with the FDA and design guidance documents such as HE75. In addition, you must have at least 15 users for each and every user group that will use your product. So you are not using prototypes. 5. This article for the first time presents a formative usability study of a fixed-dose pen injector platform device used for the subcutaneous delivery of biopharmaceuticals, primarily for self-administration by the patient. Ron Kaye, MA, Team Lead. We often recommend a mixed-methods approach for task-based usability testing that involves (where possible) a large unmoderated study and a moderated in-depth qualitative component. As medical devices become more complex, the FDA will continue to place greater emphasis on ways to improve safety and effectiveness before products are commercialized. Background: The process of developing a medical device has become increasingly complex, not least because of the Medical Device Regulation. Both the FDA HF/UE guidance and IEC 62366 outline a process including activities throughout device development culminating in validation testing with the final UI design in simulated use environments. The results of this Formative Human Factors Study indicate that the Credence Companion Staked Safety Syringe is an intuitive device, able to be successfully utilized by experienced and naïve injectors with no or minimal training. 2015;8:255–264. 4. Smaller effect sizes would warrant a larger sample size for the same statistical power, because they are more difficult to detect. The study was conducted with a user population of both naïve and experienced users across a range of ages. Family of companies we provide a broad portfolio of offerings to all medical... 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