A hybrid assessment approach for medical device software development companies

Download
2018-07-01
Medical device software development organizations are bound by regulatory requirements and constraints to ensure that developed medical devices will not harm patients. Medical devices have to be treated as complete systems and be evaluated in this manner. Instead of manufacturers having to ensure compliance to various regulatory standards individually, the authors previously developed a medical device software process assessment framework called MDevSPICE((R)) that integrates the regulatory requirements from all the relevant medical device software standards. The MDevSPICE((R)) was developed in a manner that suits plan-driven software development. To improve the usability of MDevSPICE((R)) in agile settings, we extended the assessment approach. The hybrid assessment approach described here combines the MDevSPICE((R))-based process assessment method with steps for prioritization of improvement needs through value stream mapping and enabling process improvement through the use of KATA technique. This approach integrates agile methods into the medical device software development process while adhering to the requirements of the regulatory standards. This paper describes the implementation of the approach within 4 organizations that develop software in line with medical device regulations.
JOURNAL OF SOFTWARE-EVOLUTION AND PROCESS

Suggestions

A Lightweight Software Process Assessment Approach Based on MDevSPICE((R)) for Medical Device Development Domain
Özcan Top, Özden (2017-09-04)
Software process improvement is challenging in the medical device development domain, as significant constraints exist such as ensuring conformance to regulations while improving software quality. The regulations that medical products are subject to may be overwhelming for organisations as a variety of international standards have to be implemented in order to address regulatory compliance. MDevSPICE® is a framework developed to overcome this challenge by integrating different international regulatory stand...
How Does Scrum Conform to the Regulatory Requirements Defined in MDevSPICE
Özcan Top, Özden (2017-10-02)
Medical device software development is subject to high regulations due to the potential risk of harming patients with unsafe medical devices. These regulations require software development to be performed with high discipline and evidence to be provided for auditory purposes. It’s not easy to manage both conformance to regulations and efficiency in medical device development. Therefore, there is a transition towards agility in safety critical systems development, to build high quality systems, shorten time ...
An Agile business process software development methodology
Çulha, Davut; Doğru, Ali Hikmet; Department of Computer Engineering (2014)
An agile business process software development methodology is proposed, developed and tested in this research. To speed up the business process software development practices in the organization and to address the requirements more efficiently, an agile approach was adapted. Two new processes were developed using the new methodology. The improvement was assessed by utilizing nine older developments: A formula was developed in this research that estimates the development efforts for old business process soft...
To what extent the medical device software regulations can be achieved with agile software development methods? XP-DSDM-Scrum
Özcan Top, Özden (2019-08-01)
For medical device software development organizations, it is very challenging to maintain both conformance to the strict regulatory requirements enforced by the safety-critical nature of the domain and achieve efficiency in software development. Agile software development methods provide promising solutions to overcome the efficiency issues and the challenges of traditional software development approaches in the domain. Previously, we investigated to what extent the regulatory requirements defined in MDevSP...
A Semantically Enriched Clinical Guideline Model Enabling Deployment in Heterogeneous Healthcare Environments
Laleci, Gokce B.; Doğaç, Asuman (Institute of Electrical and Electronics Engineers (IEEE), 2009-03-01)
Clinical guidelines are developed to assist healthcare practitioners to make decisions on patient's medical problems, and as such they communicate with external applications to retrieve patient data to initiate medical actions through clinical workflows, and transmit information to alert/reminder systems. The interoperability problems in the healthcare information technology domain prevent wider deployment of clinical guidelines because each deployment requires a tedious custom adaptation phase. In this pap...
Citation Formats
Ö. Özcan Top, “A hybrid assessment approach for medical device software development companies,” JOURNAL OF SOFTWARE-EVOLUTION AND PROCESS, pp. 0–0, 2018, Accessed: 00, 2020. [Online]. Available: https://hdl.handle.net/11511/31917.