Maintaining the standard: Challenges in adopting best practice when designing medical devices and systems (original) (raw)
Related papers
Applied Ergonomics, 2017
This paper focuses on the challenges of meeting agency requirements as it pertains to the application of human factors in the medical device development process. Individual case studies of the design and development process for 18 medical device manufacturers located in the US and EU were analyzed and compared using a multiple case study design. The results indicate that there are four main challenges in implementing international standards. These include a lack of direct access to users for the purposes of device development; a lack of understanding by users with regards to the impact of their feedback on the development process; contract formalities limiting user exchanges; and the perceived attitudes of clinical users which impact participation in human factors studies. The barriers presented in this research have the potential to be resolved but only with greater commitment by both medical device users and developers.
T he failure of medical devices to communicate with each other in the clinical environment has caused patient harm 1 and has impeded the implementation of solutions to prevent patient harm. For example, the problem of respiratory depression associated with the use of patient-controlled analgesia without the monitoring of respiratory status and use of a safety interlock is well known and well characterized. 2 Manually pausing lung ventilation for a radiograph procedure followed by diverted attention of the anesthesiologist has led to delays in the resumption of patient ventilation with adverse outcomes. 3 The failure of converting weight measured in pounds into kilograms has led to significant dosing errors. 4 Unintended documentation of a change due to the recording of an artifactual signal and missed documentation of a significant transient event in the electronic medical record (EMR) are more subtle and less dramatic examples of problems with potential negative consequences. These examples illustrate the clinical implications of the failure to capture important signals and device attributes, which can be addressed, in part, through standards. These standards and technology gaps have inhibited the commercialization of more effectively integrated medical devices and interoperable platformbased applications for data analysis. Medical device and health information technology (IT) systems are increasingly interdependent. Hence, related safety standards must be developed from these systems' perspective. This article describes the current development of medical device standards and the need for these standards to effectively address informatics aspects including medical device intercommunication and integration. Medical device information should be gathered from a broad range of clinical scenarios to lay the foundation for safe medical device interoperability. Medical devices are interoperable when they are intended by their manufacturer to exchange and use information through an electronic data interface (EDI) with another medical device, product, technology, or system. This article provides recommendations relating to the coordination between historically separate development groups, some of which focus on safety and effectiveness and others focus on health informatics. It identifies the need for a shared understanding among stakeholders and describes organizational structures to promote cooperation such that the device-to-device interactions and related safety information are considered during standards development.
Role of Standards in the Assessment of Medical Devices
Advances in the Standard & Applied Sciences, 2024
Medical devices play a pivotal role in modern healthcare, contributing to improved patient outcomes and enhanced quality of life. The integration of technology into medical devices has been a driving force behind the progress of modern healthcare. Every day thousands different kinds of medical devices are estimated to be used in health care facilities and elsewhere all over the world. The global medical device market is worth over US$ 150 billion, and the market is expected to grow steadily by 4% to 5% annually by implying that this technological revolution in health will continue in the foreseeable future. The assessment of medical devices based on standards plays a critical role not only in ensuring product safety, quality, and performance but also support regulatory compliance, innovation, and global market access. Through their role in harmonizing regulations, guiding device design, and ensuring ongoing safety through post-market surveillance, standards safeguard both patients and healthcare providers while fostering an environment for technological advancement in the medical device industry.
Impact of Design on Medical Device Safety
2019
The growing number of emerging medical technologies and sophistication of modern medical devices (MDs) that improve both survival and quality of life indexes are often challenged by alarming cases of vigilance data cover-up and lack of sufficient pre-and post-authorization controls. Combining Quality with Risk Management processes and implementing them as early as possible in the design of MDs has proven to be an effective strategy to minimize residual risk. This article aims to discuss how the design of MDs interacts with their safety profile and how this dipole of intended performance and safety may be supported by Human Factors Engineering (HFE) throughout the Total Product Life-Cycle (TPLC) of an MD in order to capitalize on medical technologies without exposing users and patients to unnecessary risks.
MATCH: A NEW INDUSTRY-FOCUSED APPROACH TO MEDICAL DEVICE DEVELOPMENT
2000
MATCH (Multidisciplinary Assessment of Technology Centre for Healthcare) is a new collaboration in the UK that aims to support the healthcare sector by creating methods to assess the value of medical devices from concept through to mature product. A major aim of MATCH is to encourage the inclusion of the user throughout the prod- uct lifecycle in order to achieve
Exploring the role of Design in the context of Medical Device Innovation
Conference Proceedings of the Academy for Design Innovation Management, 2019
Technology is the leading driving force in healthcare and medical device design, however, innovations which emerge from these practices are often driven by clinical requirements. Such innovations are focused on developing products that addresses current health issues, diseases or medical problems – often lacking consideration of the end users’ needs. Design innovation advocates that user-centred design happens much earlier in the product development process so that the patient needs are prioritised. However, this emerging field is yet to be defined and explored in a medical context. This paper therefore proposes a framework of Medical Device Design Innovation to explore the role of design in medical device innovation through two medical device case studies. The proposed framework suggests a way to navigate the nuances and complexities of the medical device industry in order to put the patient first while ensuring commercial viability.
The design evolution of medical devices: moving from object to user
J. of Design Research, 2008
This article embarks on the design evolution of some medical devices and identifies some characterisations that could not be isolated at each point. The evolution begins from a problem to solution (functional); to the need for safety and comfort with an ergonomic approach; to include technology that replaces many mechanically operated functional aspects; enabling design to integrate new materials or forms to be aesthetically appealing, understandable and user-friendly; and eventually trying to solve the 'failure' of design through universal design. Sensory and symbolic attributes that are successful in enhancing interaction, experience, and emotions can be identified as key variables for shaping the future of medical devices. These characterisations are unique and challenging in what is a relatively new domain for healthcare, and the designer who can define them can use them to 'get a grip' on the commercial success and viability of his or her future healthcare product.
Medical Devices : Evidence and Research, 2020
Purpose: A medical device may be of any type such as appliance, in vitro usable reagents, apparatus, instrument, machine, implement, material, software or other related articles. Either as a single entity or in combination, these devices are used by the skilled persons as per the manufacturer's instructions to prevent, diagnose, treat, monitor, alleviate the disease, compensate for an injury, investigate, replace, modify or support the anatomy in human beings. Methods: Using standards is a voluntary process unless and until it is identified as a mandatory one by the regulatory authority. The manufacturers must demonstrate that the medical devices they manufacture meet the relevant Essential Principles of Safety and Performance and are freely accessible to public. Results: Various national and international standards (not recognized by the regulatory authority), industrial standards, manufacturer-developed Standard Operating Procedures (not related to international standards), non-recognized standards, and state-of-the-art techniques are in process in terms of performance, material, design, methods, process or practices. Conclusion: The regulatory authority needs to ensure whether the manufacturer has implemented the risk management processes and met the regulatory requirements set. The responsibility towards medical devices safety and performance lies with both manufacturer and the regulatory authority.
The Essential Principles of Safety and Effectiveness for Medical Devices and the Role of Standards
Medical Devices: Evidence and Research
Purpose: A medical device may be of any type such as appliance, in vitro usable reagents, apparatus, instrument, machine, implement, material, software or other related articles. Either as a single entity or in combination, these devices are used by the skilled persons as per the manufacturer's instructions to prevent, diagnose, treat, monitor, alleviate the disease, compensate for an injury, investigate, replace, modify or support the anatomy in human beings. Methods: Using standards is a voluntary process unless and until it is identified as a mandatory one by the regulatory authority. The manufacturers must demonstrate that the medical devices they manufacture meet the relevant Essential Principles of Safety and Performance and are freely accessible to public. Results: Various national and international standards (not recognized by the regulatory authority), industrial standards, manufacturer-developed Standard Operating Procedures (not related to international standards), non-recognized standards, and state-of-the-art techniques are in process in terms of performance, material, design, methods, process or practices. Conclusion: The regulatory authority needs to ensure whether the manufacturer has implemented the risk management processes and met the regulatory requirements set. The responsibility towards medical devices safety and performance lies with both manufacturer and the regulatory authority.
Designing for safety and usability: user-centered techniques in medical device design practice
In Proceedings of the Human Factors and Ergonomics Society Annual Meeting Sage Publications, 2011
Abstract The design of systems affects the likelihood and nature of errors that people might make with them, and the ease of error recovery. If developers are to design systems that are less prone to errors propagating, they need to consider the users and user contexts. There are many techniques and resources available to support developers in this. In this paper we report on an interview study involving professionals from major manufacturers of medical devices, to better understand their development practices and the external forces that ...