Training Decay Selection for Usability Validation

2016 ◽  
Vol 5 (1) ◽  
pp. 76-83
Author(s):  
Shannon E. Clark
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Validation Studies ◽  
Future Research ◽  
Medical Device Manufacturers ◽  
Selection For ◽  
The Moment ◽  
High Level ◽  
First Time ◽  
Validation Testing

When conducting usability validation testing, representative users must use the device in the expected conditions of use in the field. There is usually a period of time—days or weeks—between the point in time a user is trained, and the moment they use the device for the first time. For this reason, the FDA acknowledges the need for “training decay” as part of usability validation testing, but manufacturers face challenges simulating real-time decays. In response to challenges associated with lags of days or weeks between training and usability validation testing, medical device manufacturers typically simulate shortened training decay periods. This paper discusses the theory behind the shapes of various training decay curves and the variables that drive differences between training decay curves. The author proposes to use a task-based approach for defining training decay curves in usability validation studies and sets out generalized training decay curves at a high level. Future research could reveal detailed and generalizable training decay curves. Identifying generalizable training decay curves could standardize the usability testing required for medical devices, and ultimately improve use error identification while avoiding an undue toll on manufacturer resources.

Adopting Identification Standards in the Medical Device Supply Chain

2020 ◽  
Vol 13 (1) ◽  
pp. 1-14 ◽  
Author(s):  
Yousef Abdulsalam ◽  
Dari Alhuwail ◽  
Eugene S. Schneller
Keyword(s):  
Supply Chain ◽  
Medical Device ◽  
Medical Devices ◽  
Business Intelligence ◽  
Return On Investment ◽  
Survey Methods ◽  
Device Identification ◽  
Medical Device Manufacturers ◽  
High Level ◽  
The U.S

The U.S. Food and Drug Administration has recently mandated that medical device manufacturers adopt Unique Device Identification (UDI) standards on their medical devices. The benefits that UDI brings to hospitals and patients is relatively obvious, including inventory transparency, product safety, product equivalency, business intelligence. However, adoption by manufacturers, who face the mandate, has been slow in part because the benefit to them is not as readily perceived. This study focuses on the incentives, barriers, and benefits that medical device manufacturers perceive in UDI adoption. This study seeks to understand which adoption pressures are driving manufacturers to act, and attempts to gauge the benefits to manufacturers from UDI adoption. Through survey methods, the evidence suggests that medical device manufacturers implement UDI largely as a response to the coercive and normative pressures they face. There continues to be a high level of uncertainty regarding the return on investment for the medical device manufacturers, particularly from the late adopters.

Quality Assurance in Medical Devices

2021 ◽  
pp. 302-314
Author(s):  
Juliana Shaibun
Keyword(s):  
Quality Assurance ◽  
Medical Device ◽  
Medical Devices ◽  
High Performance ◽  
Quality Management System ◽  
Business Environment ◽  
Future Research ◽  
Medical Device Manufacturers ◽  
Device Manufacturer ◽  
Assurance Process

Quality management system (QMS) is acknowledged as the primary method for any manufacturer, especially medical device manufacturers, in order to sustain the product quality in the competitive advantage in business environment. QMS is an essential requirement for regulatory control in high risk medical devices. Globally, the number of medical device manufacturers certified by ISO 13485 is escalating. Ownership of this certification symbolizes the medical device manufacturer acquired high performance in their QMS. This bibliometric provides a brief review of the quality assurance and how safety plays an important role in medical devices. Bibliometric analysis guided user to summarize the essential part of quality assurance process in medical device. The insights presented in this research assist in building a firm theoretical base and direction for future research.

A Platform and Multi-sided Market for Translational, Software-defined Medical Research in the Operation Room: OP 4.1 (Preprint)

2021 ◽  
Author(s):  
Magdalena Görtz ◽  
Michael Byczkowski ◽  
Mathias Rath ◽  
Viktoria Schütz ◽  
Philipp Reimold ◽  
...  
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Heterogeneous Data ◽  
Healthcare Sector ◽  
Successful Development ◽  
Software Developers ◽  
Intelligent Support ◽  
Operation Room ◽  
Central Platform ◽  
Medical Device Manufacturers

BACKGROUND While digital and data-based technologies are widespread in various industries in the context of Industry 4.0, the use of smart, connected devices in healthcare is still in its beginnings. Innovative solutions for the medical environment suffer from difficult access to medical device data and high barriers for market entry due to proprietary systems. OBJECTIVE In the proof-of-concept project OP 4.1, we show the business viability of connecting and augmenting medical devices and data through software add-ons by giving companies a technical and commercial platform for the development, implementation, distribution, and billing of innovative software solutions. METHODS The creation of a central platform prototype requires the collaboration of several independent market contenders, amongst them medical users, software developers, medical device manufacturers, and platform providers. A dedicated consortium of clinical and scientific partners as well as industry partners was established. RESULTS We demonstrate the successful development of the prototype of a user-centric, open, and extensible platform for the intelligent support of processes starting with the operation room. By connecting heterogeneous data sources and medical devices from different manufacturers and making them accessible for software developers and medical users, the cloud-based platform OP 4.1 enables the augmentation of medical devices and procedures through software-based solutions. The platform also allows for the demand-oriented billing of applications and medical devices, thus permitting software-based solutions to fast-track their economic development and become commercially successful. CONCLUSIONS The technology and business platform OP 4.1 creates a multi-sided market for the successful development, implementation, distribution, and billing of new software solutions in the operation room and in the healthcare sector in general. Consequently, software-based medical innovation can be translated into clinical routine fast, efficiently, and cost-effectively, optimizing the treatment of patients through smartly assisted procedures.

scholarly journals New medical device regulations: the regulator’s view

2019 ◽  
Vol 4 (6) ◽  
pp. 351-356 ◽  
Author(s):  
Tom Melvin ◽  
Marina Torre
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Clinical Investigation ◽  
Pool Data ◽  
Critical Function ◽  
Core Dataset ◽  
Medical Device Manufacturers ◽  
In Vitro Diagnostic ◽  
And Performance

Advances in medical device technology have been dramatic in recent years resulting in both an increased number of medical devices and an increase in the invasiveness and critical function which devices perform. Two new regulations entered into force in Europe in May 2017, the Medical Device Regulation (MDR) and the In Vitro Diagnostic Device Regulation (IVDR). These regulations will replace the current directives over the coming years. These regulations, for the first time introduce requirements relating to registries. Medical device manufacturers are required to have systematic methods for examining their devices once available on the market, by systematically gathering, recording and analysing data on safety and performance. Registries can assist public health protection in very practical ways, for example, to help urgently identify patients or devices. Registries can also be powerful tools for collecting and appraising real-world clinical evidence concerning medical devices. Clinical investigations are limited in terms of the sample size and the duration of follow-up which can reasonably be expected. Registries may also be the only available tool to examine rare adverse effects, sub-populations or for time durations which it is not possible or feasible to study in a clinical investigation. By ensuring that a core dataset is collected which can be compared to other registries or trial data, it is possible to pool data to better examine outcomes. There are a range of excellent initiatives which have aimed at ensuring the appropriate regulatory application of registry data. Cite this article: EFORT Open Rev 2019;4 DOI: 10.1302/2058-5241.4.180061

Software-as-a-Medical Device: demystifying Connected Health regulations

2016 ◽  
Vol 18 (2) ◽  
pp. 186-215 ◽  
Author(s):  
Noel Carroll ◽  
Ita Richardson
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Healthcare Service ◽  
Healthcare Sector ◽  
Future Research ◽  
Extensive Literature ◽  
Comprehensive Overview ◽  
Content Type ◽  
Connected Health ◽  
The Impact

Purpose Connected Health is an emerging and rapidly developing field never before witnessed across the healthcare sector. It has the potential to transform healthcare service systems by increasing its safety, quality and overall efficiency. However, as healthcare technologies or medical devices continuously rely more on software development, one of the core challenges is examining how Connected Health is regulated – often impacting Connected Health innovation. The purpose of this paper is to present an understanding of how Connected Health is regulated. Many of these regulatory developments fall under “medical devices”, giving rise to Software-as-a-Medical Device (SaaMD). Design/methodology/approach Through an extensive literature review, this paper demystifies Connected Health regulation. It presents the outcome of expert discussions which explore the key regulatory developments in the context of Connected Health to provide a practical guide to understanding how regulation can potentially shape healthcare innovation. Findings Several key issues are identified, and the authors present a comprehensive overview of regulatory developments relating to Connected Health with a view to support the continued growth of IT-enabled healthcare service models. The authors also identify the key challenges in Connected Health and identify areas for future research. Originality/value A key outcome of this research is a clearer understanding of the opportunities and challenges that regulation and standards present to Connected Health. Furthermore, this research is of critical importance in a first attempt towards recognising the impact of regulation and standards compliance in Connected Health.

scholarly journals Biocompatibility of Medical Devices - A Review

2021 ◽  
Vol 10 (36) ◽  
pp. 3152-3158
Author(s):  
Ramya Shree Gangadhar ◽  
Balamuralidhara V ◽  
Rajeshwari S.R.
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Human Body ◽  
The Body ◽  
Biological Responses ◽  
Medical Device Manufacturers ◽  
Biocompatibility Testing ◽  
Biological Environment ◽  
Key Words Biocompatibility

BACKGROUND Biomaterial is defined as "any substance or combination of medicine, artificial or natural origin, which can be used at any time, in whole or part by a system that controls, adds to, or restores any tissue, organ or function". ISO 10993-1: 2018 standard defines bio compliance law as "the ability of a medical device or tool to perform a selected program with the acceptable response of experts". Incompatible factors cause chemical reactions in patients, with little or no side effects. The body can respond in a sort of way after the installation of medical devices, so testing and improvement is important here. Therefore, testing and improvement in this field are important. Biocompatibility is required for any significant use of components or materials in medical devices. Inconsistent factors create negative biological responses in patients, which may have serious consequences. Biomaterials are substances utilized in medical devices, especially in applications where the device is touched, temporarily embedded, or permanently implanted within the body. Because of the significant impact of biocompatibility, many countries have imposed regulations on medical device manufacturers to meet biocompatibility specifications. Here is a brief explanation about the biocompatibility and incompatibility parameters of medical devices with a human body and its need for biocompatibility of medical devices with the human body. Medical devices have improved doctors' ability to diagnose and treat disease, which has led to significant improvements in health and quality of life. Thus, medical devices are prone to various incompatibility issues and procedures that affect the biological environment must be followed. KEY WORDS Biocompatibility, Material Interactions, Sterilization, Medical devices, Biocompatibility Testing, Incompatibility Factors.

The frequency, types and causes of medical device-related errors reported in the literature: a Rapid Review (Preprint)

2020 ◽  
Author(s):  
Emilia Anderson ◽  
Simon Poon ◽  
Jonathan Penm
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Improve Patient Safety ◽  
Near Miss ◽  
Rapid Review ◽  
Future Research ◽  
Surgical Equipment ◽  
Cardiovascular Devices ◽  
Automated External Defibrillators ◽  
Design Error

BACKGROUND The use of medical devices is rapidly expanding. Despite this, there is a huge gap in the literature surrounding the use of devices in healthcare and the adverse events occurring. Given that these errors can be life-threatening, it is imperative to have a thorough understanding of the problem in order to improve patient safety. OBJECTIVE To conduct a Rapid Review to identify the frequency, types and causes of medical device-related errors which are reported in published peer-reviewed literature. METHODS Following PRISMA guidelines, a literature search strategy was developed. Databases searched until 23 February 2018 included Pubmed, International Pharmaceutical Abstracts and Cinahl. Articles were included if they: defined medical devices, reported the frequency, causes and types of errors, were published in peer-reviewed literature. Articles were screened and discussed by two authors. RESULTS Database searching yielded 7,559 unduplicated articles. After two rounds of screening, 24 articles were included in the Review. Device types included cochlear implants, defibrillator leads, anaesthetic & intensive care devices, surgical equipment, automated external defibrillators, radiation oncology devices, ambulance stretchers, breast pumps, cardiovascular devices, orthopaedic devices, and patient controlled analgesia devices. The frequency of errors was 3.83-33.0%. The most common causes were user error, malfunction and design error. CONCLUSIONS This Review identified a range of device types associated with errors. The frequency of errors was lower than published literature. User error was confirmed as a leading cause, alongside malfunction and design error. Future research should examine near-miss events and expand the device types studied.

The What and how of Medical Device Design Validation: A Human Factors Methodology

2007 ◽  
Vol 51 (11) ◽  
pp. 750-755
Author(s):  
Merrick F. Kossack ◽  
Andrew W. Gellatly
Keyword(s):  
Human Factors ◽  
Medical Device ◽  
Quality System ◽  
Testing Methods ◽  
Validation Process ◽  
Design Validation ◽  
Medical Device Design ◽  
Medical Device Manufacturers ◽  
Proper Design ◽  
Validation Testing

To meet the FDA's Quality System Regulation, medical device manufacturers must include design validation as part of their design and development activities. However, the regulation does not specify which product requirements must be validated or what methods satisfy a proper design validation process. This paper outlines an approach that device manufacturers can follow to determine which product requirements should undergo design validation testing and what types of testing methods should be used.

Evaluation of success factors for medical device development using grey DEMATEL approach

2017 ◽  
Vol 12 (2) ◽  
pp. 204-223 ◽  
Author(s):  
Milind Shrikant Kirkire ◽  
Santosh B. Rane
Keyword(s):  
Sensitivity Analysis ◽  
Medical Device ◽  
Success Factors ◽  
Future Research ◽  
Content Type ◽  
Medical Device Development ◽  
Active Involvement ◽  
Device Development ◽  
Medical Device Manufacturers

Purpose Successful device development brings substantial revenues to medical device manufacturing industries. This paper aims to evaluate factors contributing to the success of medical device development (MDD) using grey DEMATEL (decision-making trial and evaluation laboratory) methodology through an empirical case study. Design/methodology/approach The factors are identified through literature review and industry experts’ opinions. Grey-based DEMATEL methodology is used to establish the cause-effect relationship among the factors and develop a structured model. Most significant factors contributing to the success of MDD are identified. An empirical case study of an MDD and manufacturing organisation is presented to demonstrate the use of the grey DEMATEL method. Sensitivity analysis is carried out to check robustness of results. Findings The results of applying the grey DEMATEL methodology to evaluate success factors of MDD show that availability of experts and their experience (SF4) is the most prominent cause factor, and active involvement of stakeholders during all stages of MDD (SF3) and complete elicitation of end-user requirements (SF1) are the most prominent effect factors for successful MDD. A sensitivity analysis confirms the reliability of the initial solution. Practical implications The findings will greatly help medical device manufacturers to understand the success factors and develop strategies to conduct successful MDD processes. Originality/value In the past, few success factors to MDD have been identified by some researchers, but complex inter-relationships among factors are not analysed. Finding direct and indirect effects of these factors on the success of MDD can be a good future research proposition.

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