Software asset management and domain engineering

Human factors in the design of medical devices – Approaches to meeting international standards in the European Union and USA

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.

Medical device development involves user safety, and it is governed by specific regulations. The failure of medical device developers to consider the influence of users, the environment, and related organizations on product development during the design and development process can result in added risks to the use of medical technologies. Although many studies have examined the medical device development process, there has been no systematic and comprehensive assessment of the key factors affecting medical device development. This research synthesized the value of medical device industry stakeholders' experiences through a literature review and interviews with industry experts. Then, it establishes an FIA-NRM model to identify the key factors affecting medical device development and suggests appropriate pathways for improvement. Results indicate that the development of medical devices should begin with stabilizing organizational characteristics, followed by strengthening technical capability and use environment, and finally, consideration should be given to the user action of medical devices. The results provide medical device developers with optimal development pathways and resource allocation recommendations to support developers in developing medical device development strategies as well as ensuring the safety and effectiveness of the products for end users.

This chapter focuses on emerging opportunities and related challenges associated with medical device development. In a rapidly changing healthcare environment and related support structure, it has become essential to develop products and technologies that are not only innovative and affordable, but at the same time, safe and reliable for long-term performance stability. With the advancement of efficient computational platforms and artificial intelligence, newer opportunities in the form of software-driven medical devices and robotic minimally invasive surgical systems have emerged as key thrust areas in medical device manufacturing sector. A lot of research outcomes are being reported worldwide for development of haptic feedback-based robotic manipulators for complex surgical procedures. Leading industry manufacturers are focusing on transdisciplinary synergetic research for faster product development and subsequent market deployment. However, such medical cyber-physical systems have also brought out the need for ensuring product safety and data security for uncompromised privacy and process integrity. There are other challenges related to validation, certification and regulations of healthcare-related mobile applications and software-driven diagnostic and therapeutic tools which need to be handled with highest priority for patient safety. The chapter focuses on the AI-powered and software-driven medical devices as well as various technologies of robotic surgery and the associated research opportunities and challenges in these domains.KeywordsSoftware-driven medical devicesRoboticsMedical regulationsMedical cyber-physical systemsValidation

Demand for health products in Indonesia is increasing, with an estimated annual growth of 11.9% until 2024. This is driven by population growth and public awareness of the importance of health. Indonesian government believes developing medical devices industry is essential in supporting health resilience in Indonesia. The development and marketing of medical devices does not only focus on the benefits of a product but requires planning and control so that the product can be safe and effective for users, such as by paying attention to quality standardization, patient safety, regulation, and market licensing. This exploratory qualitative research approach yields results in the form of patterns that can increase the availability of safe and quality medical devices, namely 1) research and development of medical devices, 2) regulation of medical devices, 3) assessment of medical devices (health technology evaluation), and 4) management of medical devices (health technology management). The results of this trial will provide valuable information on the process of developing medical device products to choose an approach that suits your needs and conditions.

We propose a method for managing software assets in the automotive industry to enhance software competitiveness and to reduce development costs. The ownership of software assets in the automotive industry is held by automotive parts companies, making it challenging to exchange these technologies. Moreover, the criteria for determining software assets are often unclear, resulting in difficulties in integrating automotive software and implementing over-the-air updates. To address these issues, we suggest breaking down black-boxed software assets into tradable components, valuating them, and introducing the concept of exchanging software technology assets. Additionally, we provide a structured approach for recycling used software assets and establish a software asset management system for registration and tracking. Our proposed approach can help traditional automotive OEMs narrow the technology gap with automakers such as Tesla and improve their software competitiveness in the automotive industry. This paper contributes to the advancement of software asset management practices in the automotive industry, and provides insights into the integration of automotive software and over-the-air updates.

Background: Deaths from drug overdose have reached a crisis level, with more than 100,000 reported from April 2020 to April 2021. Novel approaches to address it are urgently needed. Objectives: National Institute on Drug Abuse (NIDA) is leading novel comprehensive efforts to develop safe and effective products that address the needs of the citizens affected by SUD. NIDA aims to support research and development of medical devices intended to monitor, diagnose, or treat substance use disorders. Results: NIDA participates in Blueprint MedTech program is part of the large NIH Blueprint for Neurological Research Initiative. It supports the research and development of new medical devices through product optimization, pre-clinical testing, and human subject studies, including clinical trials. The program is structured in two main components - Blueprint MedTech Incubator and Blueprint MedTech Translator. It offers free to the researcher services that are typically unavailable in academic environment - business expertise facilities and staffing to successfully develop minimum viable devices, pre-clinical bench testing, clinical studies, planning and executing in manufacturing, as well as regulatory expertise. Conclusions: Through Blueprint MedTech, NIDA provides innovators with expanded resources to ensure the success of the research.

Development in medical technology has played a crucial role in increasing disease survival rate and life expectancy. And the development of medical devices has led to the development of portable medical devices that can be conveniently used in homes to accommodate modern people’s busy lives. Infrared therapy devices, portable physical therapy devices, and electric massage machines are now commonly used in homes. An acoustic vibration health care device is now one such device. The device was developed based on research that showed when micro acoustic and vibration signals were applied to the damaged body parts, the resulting microscopic stimulation healed wounded cells, shortened the recovery time, and promoted cell division. We conducted this study to understand acoustic vibration health care device’s electromagnetic field characteristics and improve their performance. Using the ANSYS Workbench, we analyzed the magnetic flux density of the device’s permanent magnets. To increase the device’s vibration force, we stacked the magnets of equal size and identical material properties, ran a simulation, and compared the results. We aim to use the data collected from analyzing the magnetic field characteristics and the permanent magnets’ characteristics to improve the designs of acoustic vibration health care devices.

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.

<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>

This study innovatively employs transcutaneous auricular vagus nerve stimulation (taVNS), a non-invasive physical therapy, to intervene in elderly patients with chronic insomnia (CI) comorbid with functional dyspepsia (FD). Through systematic investigation of the molecular mechanisms underlying vagus nerve pathway regulation in ameliorating intestinal inflammatory microenvironment and modulating central neurotransmitter homeostasis, this research aims to provide a novel, neuromodulation-based precision therapeutic approach characterized by favorable safety and tolerability for integrated management of geriatric comorbidities. This double-blind randomized controlled trial will enroll 60 elderly patients (60-85 years) meeting ICSD-3 criteria for CI and Rome IV criteria for FD. Using block randomization with computer-generated sequences, eligible participants will be allocated 1:1 to either active taVNS group (n = 30) or sham control group (n = 30). The CFDA-certified transcutaneous vagus nerve stimulator (Model tVNS501, Reach Medical, China; Registration No. SuXieZhun20212090050) will be positioned at standardized anatomical sites: the concha cymba (the inferior margin of the intersection between the superior and inferior crura of the antihelix within the cymba conchae), electrical stimulation will deliver with fixed parameters (frequency: 80 Hz, pulse width: 100 μs, pulse 40-60s). The active group will receive validated taVNS parameters, while the sham group will undergo identical procedures without electrical output. Interventions will be administered 30 min per session, 5 sessions weekly for 3 consecutive weeks. Primary endpoints include changes in Pittsburgh Sleep Quality Index (PSQI) and Nepean Dyspepsia Symptom Index (NDSI) at week 3. Secondary outcomes encompass Insomnia Severity Index (ISI), 36-Item Short Form Survey (SF-36), and serum biomarkers (pro-inflammatory cytokines IL-1β, IL-4, IL-6, TNF-α, hs-CRP, TGF-β; neurotransmitters Dopamine (DA), serotonin (5-hydroxytryptamine, 5-HT), norepinephrine (NE), Glutamate (Glu), γ-aminobutyric acid (GABA)). Safety profiles will be systematically evaluated using CTCAE v5.0 criteria, with all adverse events documented throughout the study. This study mitigate the adverse effects associated with the significant side effects of oral medications in elderly patients with CI comorbid with FD. It seeks to scientifically validate the clinical efficacy of taVNS therapy, elucidate its underlying anti-inflammatory and neuromodulatory mechanisms, and establish a multimodal evidence chain integrating "efficacy-inflammation-neuromodulation." By doing so, this research provides a novel, convenient, scientifically validated, effective, and safe non-pharmacological therapeutic approach for elderly patients with CI and FD, it offers innovative insights and methodologies for the development of pharmaceuticals, medical devices, and related products.

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.

For medical devices, there might have clinical differences in medical device efficacy and safety among different racial and ethnic subgroups. The acceptability of various data generated during the design and development stage of medical devices between different regions and national regulatory agencies faces huge challenges. This study discusses the considerations of racial and ethnic factors in the design and development of medical devices, with a view to improve the quality and availability of safety and effectiveness data under one framework.

A targeted development of safe medical products can be supported by design methods. This paper analyses which design methods are applied in the development of medical devices and whether they are adapted for considering medical devices’ special features (legal, human and technical issues). In particular, variety management, risk assessment and user-centered design for medical devices are examined. Typically, interdisciplinary risk assessment is methodically supported. Additionally, user-centered design methods for requirements assessment, design verification and design validation are applied.

Firms in many industries increasingly are considering platform‐based approaches to reduce complexity and to better leverage investments in new product development, manufacturing, and marketing. However, a clear gap in literature still exists when it comes to discussing the problems and risks related to implementing and managing product families and their underlying platforms. Using a multiple‐case approach, we compare three technology‐driven companies in their definition of platform‐based product families, investigate their reasons for changing to platform‐driven development, and analyze how they implemented platform thinking in their development process and which risks they encountered in the process of creating and managing platform‐based product families. The field study shows that the companies involved in the study use a homogeneous concept of platform‐based product families and that they have similar reasons to turn to platform thinking and to encounter comparable risks. However, the companies analyzed use mainly product architecture as a basis for their platforms (and ignore many of the platform types advocated in literature), while on the other hand they show divergent applications of the platform concept regarding the combinations of product families and market applications. Through this exploratory study, some important white spots in literature became evident as well. In the discussion part of this article these white spots are discussed and directions for future platform research are proposed. The article concludes that given its importance, platform‐driven development of product families clearly deserves further research to provide more insight into strategic planning for new products.