Abstract:Even though software can be found everywhere, software development has encountered many problems, resulting in the emergence of new alternative development paradigms. Among them, agile approaches are the most popular. While much research has been published about agile software development (ASD) in general, there is a lack of documented knowledge about its use in healthcare. Consequently, it is not clear how ASD is used in healthcare, how it performs, and what the reasons are for not using it. To fill this gap,… Show more
“…The other articles mentioned refer exclusively to agile methods used in the health sector, which was our first research question (RQ1) for this article's solution. Despite this, some articles describe the barriers to implementing a combination of agile methods [56][57][58][59][60][61].…”
Section: Related Workmentioning
confidence: 99%
“…Also, a gradual software development process focused on changes, where customer collaboration is considered. The adoption of agile software development in the healthcare sector has encountered several obstacles, such as lack of documentation, insufficient advance planning, regulatory compliance, low traceability of process and system maintenance, and management of non-functional or insufficient requirements [60].…”
The development of medical technology devices leads to the introduction and use of agile methods, which enable the delivery of increasingly complex software with the fastest possible innovations. Delivery of the highest quality software must be considered during development, as medical products are important elements in saving human lives. Their development begins with determining a set of product requirements that exactly correspond to it. The development of specified medical products is finally delivered to the customer, who participates in the development. In this article, we present the use and combination of agile methods in software development, which correct and facilitate timely and continuous delivery of products. They also know how to smooth out a quick reaction to the customer’s changing needs and mainly focus on team management and communication. Specific agile methods make it possible to implement development through gradual improvements by integrating customer requirements towards the product. This article identifies three interconnected approaches to integrating agile methods and principles: SCRUM, SAFe, and Kanban combined with the V-model. The methods are gradually analysed based on the literature review, and the article presents a practical application in Siemens Healthcare Slovakia.
“…The other articles mentioned refer exclusively to agile methods used in the health sector, which was our first research question (RQ1) for this article's solution. Despite this, some articles describe the barriers to implementing a combination of agile methods [56][57][58][59][60][61].…”
Section: Related Workmentioning
confidence: 99%
“…Also, a gradual software development process focused on changes, where customer collaboration is considered. The adoption of agile software development in the healthcare sector has encountered several obstacles, such as lack of documentation, insufficient advance planning, regulatory compliance, low traceability of process and system maintenance, and management of non-functional or insufficient requirements [60].…”
The development of medical technology devices leads to the introduction and use of agile methods, which enable the delivery of increasingly complex software with the fastest possible innovations. Delivery of the highest quality software must be considered during development, as medical products are important elements in saving human lives. Their development begins with determining a set of product requirements that exactly correspond to it. The development of specified medical products is finally delivered to the customer, who participates in the development. In this article, we present the use and combination of agile methods in software development, which correct and facilitate timely and continuous delivery of products. They also know how to smooth out a quick reaction to the customer’s changing needs and mainly focus on team management and communication. Specific agile methods make it possible to implement development through gradual improvements by integrating customer requirements towards the product. This article identifies three interconnected approaches to integrating agile methods and principles: SCRUM, SAFe, and Kanban combined with the V-model. The methods are gradually analysed based on the literature review, and the article presents a practical application in Siemens Healthcare Slovakia.
“…Difficult and rare expertise that can be met, but remain in the capacity of thought or competence, so that appropriate action can be immediately implemented. The following is an overview of the Development of software one type of development used is thematic analysis, from theory to software creation, and the benefits obtained [4,5].…”
Background: The coastal situation in Indonesia with thousands of islands and its area, the use of Ultra Sono Graph (USG) as a tool for general practitioners will be useful to facilitate examinations, consult with experts, and make referrals easily and quickly. Objective: For ultrasound readings that require decisions, using the Decision Support System makes it easier and there are friends to discuss, indirectly with experts, even machines. Theoretical Basis: DSS is very important to clarify and speed up decision-making with the help of software and computers. Use Process: The ultrasound software will guide and direct the appropriate diagnosis so that decisions can be made or referred and handled quickly and precisely. DSS will be very useful in preventing accidents among diving fishermen, by using the P02 benchmark which is easy to use. Conclusion: The use of the Decision Support System for normal and abnormal pregnancy ultrasound is beneficial for coastal area support for early diagnosis and implementation of a referral system. By looking at examples of use like this, it is recommended to create a Decision Support System for Diving Fishermen.
“…The second overarching issue a new framework must address relates to regulatory issues. To date, regulation of DTx typically follows one of three approaches: (1) providing relatively limited guidance on evidence production, biasing toward the trustworthiness of DTx companies, as used in the FDA Precertification (Pre-Cert) Program [ 13 ]; (2) using emerging standards relevant to real-world data (RWD) and real-world evidence (RWE), such as reliance on data quality standards, use of RWD to efficiently run simulated clinical trials [ 14 - 17 ], and open science practices [ 18 , 19 ]; or (3) simply following variations of the 4-phase model [ 12 ] originally created for pharmaceuticals [ 20 - 22 ]. Payors are not providing adequate reimbursement systems, likely in part because of these issues, causing some DTx companies to declare bankruptcy [ 23 ].…”
Digital therapeutics (DTx) are a promising way to provide safe, effective, accessible, sustainable, scalable, and equitable approaches to advance individual and population health. However, developing and deploying DTx is inherently complex in that DTx includes multiple interacting components, such as tools to support activities like medication adherence, health behavior goal-setting or self-monitoring, and algorithms that adapt the provision of these according to individual needs that may change over time. While myriad frameworks exist for different phases of DTx development, no single framework exists to guide evidence production for DTx across its full life cycle, from initial DTx development to long-term use. To fill this gap, we propose the DTx real-world evidence (RWE) framework as a pragmatic, iterative, milestone-driven approach for developing DTx. The DTx RWE framework is derived from the 4-phase development model used for behavioral interventions, but it includes key adaptations that are specific to the unique characteristics of DTx. To ensure the highest level of fidelity to the needs of users, the framework also incorporates real-world data (RWD) across the entire life cycle of DTx development and use. The DTx RWE framework is intended for any group interested in developing and deploying DTx in real-world contexts, including those in industry, health care, public health, and academia. Moreover, entities that fund research that supports the development of DTx and agencies that regulate DTx might find the DTx RWE framework useful as they endeavor to improve how DTxcan advance individual and population health.
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