Process of designing robust, dependable, safe and secure software for medical devices: Point of care testing device as a case study

This article has been made available through the Brunel Open Access Publishing Fund.Copyright © 2013 Sivanesan Tulasidas et al. This paper presents a holistic methodology for the design of medical device software, which encompasses of a new way of eliciting requirements, system design process, security design guideline, cloud architecture design, combinatorial testing process and agile project management. The paper uses point of care diagnostics as a case study where the software and hardware must be robust, reliable to provide accurate diagnosis of diseases. As software and software intensive systems are becoming increasingly complex, the impact of failures can lead to significant property damage, or damage to the environment. Within the medical diagnostic device software domain such failures can result in misdiagnosis leading to clinical complications and in some cases death. Software faults can arise due to the interaction among the software, the hardware, third party software and the operating environment. Unanticipated environmental changes and latent coding errors lead to operation faults despite of the fact that usually a significant effort has been expended in the design, verification and validation of the software system. It is becoming increasingly more apparent that one needs to adopt different approaches, which will guarantee that a complex software system meets all safety, security, and reliability requirements, in addition to complying with standards such as IEC 62304. There are many initiatives taken to develop safety and security critical systems, at different development phases and in different contexts, ranging from infrastructure design to device design. Different approaches are implemented to design error free software for safety critical systems. By adopting the strategies and processes presented in this paper one can overcome the challenges in developing error free software for medical devices (or safety critical systems).Brunel Open Access Publishing Fund

A Knowledge Transfer Partnership - the development of a Bespoke Enterprise Resource Planning System in the UK

Abstract. A Knowledge Transfer Partnerships (KTP) is a UK-wide programme designed to enable businesses to improve their competitiveness, productivity and performance. A KTP achieves this through the forming of a Partnership between a business and an academic institution. The aim is to enable businesses to access skills and expertise from academics and embed this knowledge in their businesses in order to develop the business. The knowledge sought is embedded into the business through a project, or projects, undertaken by a recently qualified person (known as the Associate). Part funding is provided by the government towards the Associate’s salary and towards the release of an Academic supervisor who works a half a day a week at the company. KTPs can vary in length from 6 months to three years, depending on the needs of the business and the desired outcomes. Therefore a KTP enables new capability to be embedded into the business and has benefited and continues to benefit a wide range of businesses across many sectors in the UK, including micro sized, small and large businesses across many sectors. This paper describes a Knowledge Transfer Partnership project between the University of Hertfordshire and a small and medium sized enterprise (SME) based in Cambridgeshire, UK.Final Accepted Versio

The Design and Implementation of a bespoke Enterprise Resource Planning System (ERP) for an acoustical engineering company

This paper will describe the tasks completed so far as part of a Knowledge Transfer Partnership between the University of Hertfordshire and Acoustical Control Engineers (ACE) a ‘small and medium sized enterprise’ (SME) based in Cambridgeshire, UK. ACE’s 25 personnel design, manufacture and install noise and vibration control systems to solve a wide range of acoustic problems. The projects undertaken include acoustic enclosures for supermarket refrigeration plant and for generators used in many situations, together with other more diverse applications such as controlling noise in the workplace and even on a luxury boat. Before the current KTP project the company used some partially computerised systems consisting of spreadsheets to perform acoustic analyses, pricing and project management functions supplemented with a paper based system to ‘fill the gaps’. Enterprise Resource Planning (ERP) systems provide an integrated database for all parts of the organisation allowing decisions to be based on a complete understanding of the organisation’s information, avoiding the problems due to duplication of data and ensuring that the consequences of decisions in one part of the organisation are reflected in the planning and control systems of the rest of the organisation. ERP systems became popular from the 1990’s mainly in relatively large organisations due to the complexity and cost of these systems. This project is unusual in that rather than adapting an off-the-shelf ERP solution to ACE’s very specific and specialised requirements we are taking an ERP development approach in an SME whose legacy systems are made up of spreadsheet and paper based systems. For the software development an Agile approach has been used. Agile involves software development methods based on iterative and incremental development. The initial attempt was to start developing the ERP from an Open Source ERP Source Code; however this effort was futile as a result of the bespoke nature of ACE’s business and product lines. Mapping ACE’s data model to the database which any existing ERP system could be adapted to, proved to be a very difficult problem. Therefore, developing the ERP from first principles was inevitable. Several of the ERP modules have been developed, user training has taken place and the core modules have been signed off. The project is due to complete in September 2014 and by this time we will have further information on how the ERP system has increased the competitiveness of the company, as well as experience of introducing an ERP into an SME. However, as would be expected the work undertaken developing the system so far has had several significant effects on ACE and acted as a catalyst for change in various parts of ACE’s business.Non peer reviewe

A Framework for Agile Development of Component-Based Applications

Agile development processes and component-based software architectures are two software engineering approaches that contribute to enable the rapid building and evolution of applications. Nevertheless, few approaches have proposed a framework to combine agile and component-based development, allowing an application to be tested throughout the entire development cycle. To address this problematic, we have built CALICO, a model-based framework that allows applications to be safely developed in an iterative and incremental manner. The CALICO approach relies on the synchronization of a model view, which specifies the application properties, and a runtime view, which contains the application in its execution context. Tests on the application specifications that require values only known at runtime, are automatically integrated by CALICO into the running application, and the captured needed values are reified at execution time to resume the tests and inform the architect of potential problems. Any modification at the model level that does not introduce new errors is automatically propagated to the running system, allowing the safe evolution of the application. In this paper, we illustrate the CALICO development process with a concrete example and provide information on the current implementation of our framework

Some Findings Concerning Requirements in Agile Methodologies

gile methods have appeared as an attractive alternative to conventional methodologies. These methods try to reduce the time to market and, indirectly, the cost of the product through flexible development and deep customer involvement. The processes related to requirements have been extensively studied in literature, in most cases in the frame of conventional methods. However, conclusions of conventional methodologies could not be necessarily valid for Agile; in some issues, conventional and Agile processes are radically different. As recent surveys report, inadequate project requirements is one of the most conflictive issues in agile approaches and better understanding about this is needed. This paper describes some findings concerning requirements activities in a project developed under an agile methodology. The project intended to evolve an existing product and, therefore, some background information was available. The major difficulties encountered were related to non-functional needs and management of requirements dependencies

A review and future direction of agile, business intelligence, analytics and data science

Agile methodologies were introduced in 2001. Since this time, practitioners have applied Agile methodologies to many delivery disciplines. This article explores the application of Agile methodologies and principles to business intelligence delivery and how Agile has changed with the evolution of business intelligence. Business intelligence has evolved because the amount of data generated through the internet and smart devices has grown exponentially altering how organizations and individuals use information. The practice of business intelligence delivery with an Agile methodology has matured; however, business intelligence has evolved altering the use of Agile principles and practices. The Big Data phenomenon, the volume, variety, and velocity of data, has impacted business intelligence and the use of information. New trends such as fast analytics and data science have emerged as part of business intelligence. This paper addresses how Agile principles and practices have evolved with business intelligence, as well as its challenges and future directions

Cyber physical systems implementation for asset management improvement: A framework for the transition

Libro en Open AccessThe transformation of the industry due to recent technologies introduction is an evolving process whose engines are competitiveness and sustainability, understood in its broadest sense (environmental, economic and social). This process is facing, due to the current state of scientific and technological development, a new challenge yet even more important: the transition from discrete technological solutions that respond to isolated problems, to a global conception where the assets, plant, processes and engineering systems are conceived, designed and operated as an integrated complex unit. This vision is evolving besides a set of concepts that are, in some way, to guide this development: Smart Factories, Cyber-Physical Systems, Factory of the Future or Industry 4.0, are examples. The full integration of the operation and maintenance (O&M) processes in the production systems is a key topic within this new paradigm. Not only that, this evolution necessarily results in the emergence of new processes and needs of O&M, i.e. also, the O&M will undergo a profound transformation. The transition from actual isolated production assets to such Industry 4.0 with CPS is far from easy. This document presents a proposal to develop such transition adapting one iteration of the Model of Maintenance Management (MMM) integrated into ISO 55000 to the complexity of incorporating “System of Systems” CPSs maintenance. It involves several stages: identification, prioritization, risk management, planning, scheduling, execution, control, and improvement supported by system engineering techniques and agile/concurrent project managemen

Software Engineering Timeline: major areas of interest and multidisciplinary trends

Ingeniería del software. EvolucionSociety today cannot run without software and by extension, without Software Engineering. Since this discipline emerged in 1968, practitioners have learned valuable lessons that have contributed to current practices. Some have become outdated but many are still relevant and widely used. From the personal and incomplete perspective of the authors, this paper not only reviews the major milestones and areas of interest in the Software Engineering timeline helping software engineers to appreciate the state of things, but also tries to give some insights into the trends that this complex engineering will see in the near future

Development of Secure Software : Rationale, Standards and Practices

The society is run by software. Electronic processing of personal and financial data forms the core of nearly all societal and economic activities, and concerns every aspect of life. Software systems are used to store, transfer and process this vital data. The systems are further interfaced by other systems, forming complex networks of data stores and processing entities.This data requires protection from misuse, whether accidental or intentional. Elaborate and extensive security mechanisms are built around the protected information assets. These mechanisms cover every aspect of security, from physical surroundings and people to data classification schemes, access control, identity management, and various forms of encryption. Despite the extensive information security effort, repeated security incidents keep compromising our financial assets, intellectual property, and privacy. In addition to the direct and indirect cost, they erode the trust in the very foundation of information security: availability, integrity, and confidentiality of our data. Lawmakers at various national and international levels have reacted by creating a growing body of regulation to establish a baseline for information security. Increased awareness of information security issues has led to extend this regulation to one of the core issues in secure data processing: security of the software itself. Information security contains many aspects. It is generally classified into organizational security, infrastructure security, and application security. Within application security, the various security engineering processes and techniques utilized at development time form the discipline of software security engineering. The aim of these security activities is to address the software-induced risk toward the organization, reduce the security incidents and thereby lower the lifetime cost of the software. Software security engineering manages the software risk by implementing various security controls right into the software, and by providing security assurance for the existence of these controls by verification and validation. A software development process has typically several objectives, of which security may form only a part. When security is not expressly prioritized, the development organizations have a tendency to direct their resources to the primary requirements. While producing short-term cost and time savings, the increased software risk, induced by a lack of security and assurance engineering, will have to be mitigated by other means. In addition to increasing the lifetime cost of software, unmitigated or even unidentified risk has an increased chance of being exploited and cause other software issues. This dissertation concerns security engineering in agile software development. The aim of the research is to find ways to produce secure software through the introduction of security engineering into the agile software development processes. Security engineering processes are derived from extant literature, industry practices, and several national and international standards. The standardized requirements for software security are traced to their origins in the late 1960s, and the alignment of the software engineering and security engineering objectives followed from their original challenges to the current agile software development methods. The research provides direct solutions to the formation of security objectives in software development, and to the methods used to achieve them. It also identifies and addresses several issues and challenges found in the integration of these activities into the development processes, providing directly applicable and clearly stated solutions for practical security engineering problems. The research found the practices and principles promoted by agile and lean software development methods to be compatible with many security engineering activities. Automated, tool-based processes and the drive for efficiency and improved software quality were found to directly support the security engineering techniques and objectives. Several new ways to integrate software engineering into agile software development processes were identified. Ways to integrate security assurance into the development process were also found, in the form of security documentation, analyses, and reviews. Assurance artifacts can be used to improve software design and enhance quality assurance. In contrast, detached security engineering processes may create security assurance that serves only purposes external to the software processes. The results provide direct benefits to all software stakeholders, from the developers and customers to the end users. Security awareness is the key to more secure software. Awareness creates a demand for security, and the demand gives software developers the concrete objectives and the rationale for the security work. This also creates a demand for new security tools, processes and controls to improve the efficiency and effectiveness of software security engineering. At first, this demand is created by increased security regulation. The main pressure for change will emanate from the people and organizations utilizing the software: security is a mandatory requirement, and software must provide it. This dissertation addresses these new challenges. Software security continues to gain importance, prompting for new solutions and research.Ohjelmistot ovat keskeinen osa yhteiskuntamme perusinfrastruktuuria. Merkittävä osa sosiaalisesta ja taloudellisesta toiminnastamme perustuu tiedon sähköiseen käsittelyyn, varastointiin ja siirtoon. Näitä tehtäviä suorittamaan on kehitetty merkittävä joukko ohjelmistoja, jotka muodostavat mutkikkaita tiedon yhteiskäytön mahdollistavia verkostoja. Tiedon suojaamiseksi sen ympärille on kehitetty lukuisia suojamekanismeja, joiden tarkoituksena on estää tiedon väärinkäyttö, oli se sitten tahatonta tai tahallista. Suojausmekanismit koskevat paitsi ohjelmistoja, myös niiden käyttöympäristöjä ja käyttäjiä sekä itse käsiteltävää tietoa: näitä mekanismeja ovat esimerkiksi tietoluokittelut, tietoon pääsyn rajaaminen, käyttäjäidentiteettien hallinta sekä salaustekniikat. Suojaustoimista huolimatta tietoturvaloukkaukset vaarantavat sekä liiketoiminnan ja yhteiskunnan strategisia tietovarantoj että henkilökohtaisia tietojamme. Taloudellisten menetysten lisäksi hyökkäykset murentavat luottamusta tietoturvan kulmakiviin: tiedon luottamuksellisuuteen, luotettavuuteen ja sen saatavuuteen. Näiden tietoturvan perustusten suojaamiseksi on laadittu kasvava määrä tietoturvaa koskevia säädöksiä, jotka määrittävät tietoturvan perustason. Lisääntyneen tietoturvatietoisuuden ansiosta uusi säännöstö on ulotettu koskemaan myös turvatun tietojenkäsittelyn ydintä,ohjelmistokehitystä. Tietoturva koostuu useista osa-alueista. Näitä ovat organisaatiotason tietoturvakäytännöt, tietojenkäsittelyinfrastruktuurin tietoturva, sekä tämän tutkimuksen kannalta keskeisenä osana ohjelmistojen tietoturva. Tähän osaalueeseen sisältyvät ohjelmistojen kehittämisen aikana käytettävät tietoturvatekniikat ja -prosessit. Tarkoituksena on vähentää ohjelmistojen organisaatioille aiheuttamia riskejä, tai poistaa ne kokonaan. Ohjelmistokehityksen tietoturva pyrkii pienentämään ohjelmistojen elinkaarikustannuksia määrittämällä ja toteuttamalla tietoturvakontrolleja suoraan ohjelmistoon itseensä. Lisäksi kontrollien toimivuus ja tehokkuus osoitetaan erillisten verifiointija validointimenetelmien avulla. Tämä väitöskirjatutkimus keskittyy tietoturvatyöhön osana iteratiivista ja inkrementaalista ns. ketterää (agile) ohjelmistokehitystä. Tutkimuksen tavoitteena on löytää uusia tapoja tuottaa tietoturvallisia ohjelmistoja liittämällä tietoturvatyö kiinteäksi osaksi ohjelmistokehityksen prosesseja. Tietoturvatyön prosessit on johdettu alan tieteellisestä ja teknillisestä kirjallisuudesta, ohjelmistokehitystyön vallitsevista käytännöistä sekä kansallisista ja kansainvälisistä tietoturvastandardeista. Standardoitujen tietoturvavaatimusten kehitystä on seurattu aina niiden alkuajoilta 1960-luvulta lähtien, liittäen ne ohjelmistokehityksen tavoitteiden ja haasteiden kehitykseen: nykyaikaan ja ketterien menetelmien valtakauteen saakka. Tutkimuksessa esitetään konkreettisia ratkaisuja ohjelmistokehityksen tietoturvatyön tavoitteiden asettamiseen ja niiden saavuttamiseen. Tutkimuksessa myös tunnistetaan ongelmia ja haasteita tietoturvatyön ja ohjelmistokehityksen menetelmien yhdistämisessä, joiden ratkaisemiseksi tarjotaan toimintaohjeita ja -vaihtoehtoja. Tutkimuksen perusteella iteratiivisen ja inkrementaalisen ohjelmistokehityksen käytäntöjen ja periaatteiden yhteensovittaminen tietoturvatyön toimintojen kanssa parantaa ohjelmistojen laatua ja tietoturvaa, alentaen täten kustannuksia koko ohjelmiston ylläpitoelinkaaren aikana. Ohjelmistokehitystyön automatisointi, työkaluihin pohjautuvat prosessit ja pyrkimys tehokkuuteen sekä korkeaan laatuun ovat suoraan yhtenevät tietoturvatyön menetelmien ja tavoitteiden kanssa. Tutkimuksessa tunnistettiin useita uusia tapoja yhdistää ohjelmistokehitys ja tietoturvatyö. Lisäksi on löydetty tapoja käyttää dokumentointiin, analyyseihin ja katselmointeihin perustuvaa tietoturvan todentamiseen tuotettavaa materiaalia osana ohjelmistojen suunnittelua ja laadunvarmistusta. Erillisinä nämä prosessit johtavat tilanteeseen, jossa tietoturvamateriaalia hyödynnetään pelkästään ohjelmistokehityksen ulkopuolisiin tarpeisiin. Tutkimustulokset hyödyttävät kaikkia sidosryhmiä ohjelmistojen kehittäjistä niiden tilaajiin ja loppukäyttäjiin. Ohjelmistojen tietoturvatyö perustuu tietoon ja koulutukseen. Tieto puolestaan lisää kysyntää, joka luo tietoturvatyölle konkreettiset tavoitteet ja perustelut jo ohjelmistokehitysvaiheessa. Tietoturvatyön painopiste siirtyy torjunnasta ja vahinkojen korjauksesta kohti vahinkojen rakenteellista ehkäisyä. Kysyntä luo tarpeen myös uusille työkaluille, prosesseille ja tekniikoille, joilla lisätään tietoturvatyön tehokkuutta ja vaikuttavuutta. Tällä hetkellä kysyntää luovat lähinnä lisääntyneet tietoturvaa koskevat säädökset. Pääosa muutostarpeesta syntyy kuitenkin ohjelmistojen tilaajien ja käyttäjien vaatimuksista: ohjelmistojen tietoturvakyvykkyyden taloudellinen merkitys kasvaa. Tietoturvan tärkeys tulee korostumaan entisestään, lisäten tarvetta tietoturvatyölle ja tutkimukselle myös tulevaisuudessa