Challenges of Communication in Global Teams

In project managements and especially, the management of software projects, there have been a change from the traditional project planning to agile project planning. Agile project management for a while has been viewed as new transformations that will help in revolutionizing the software industry.

It is evident that agile project management is arising as an emerging way for development software projects. The idea of agile is something that has been existence for some decades, and even though information and utilization are improving, agile project management is not the automatic remedy. Comprehending the right time to utilize agile and the type of success factor to consider, it is significant to accomplish goals and objectives.

Agile project management is perceived as a modern and new methodology that keeps rising. It advocates that the application of agile practices that is not adequate. Indeed, to effectively and efficiently start a new business enterprise, projects or products, there is need to strengthen emphasis on the customers. Even if the word agile had been existence for some years, a new agile methodology is still in the process of formation with the urge of doing agile even to higher level.

The main aim of this particular research paper is to change the mindset of project managers for using agile methodologies for projects in FDA regulated industries. More specifically, there is a need for checking the agile practices that are essential for the project to be success. In essence, to figure this out, there is a case of considering some previous researches about the agile projects.

This research paper continues to explore how agile development method, prevalent in several industries and currently recognized as the standard guideline by the FDA industries. It addresses shortcomings in the waterfall development and how it can be used for the sake of meeting the safety, reliability, and regulation demands of the medical devices and diagnostic industries.

Agile practices, project management, FDA industries, Kanban, Scrum, Project Management Life Cycle, agile methodologies.

Table of Contents Abstract 2 Key Words 3 Introduction 5 Problem Statement and Justification 6 Problem Statement 6 Research Questions 7 Justification 7 Hypothesis 9 Literature Review 10 Incorporation of Agile Methodology in FDA Regulated Industry 24 Conclusion and Summary 28 References 31

Introduction

The theme of the research paper is about changing the mindset of project managers for applying agile project management for projects in FDA regulated industries. The emphasis lies on the agile methodologies and agile practices. Intrinsically, agile project management is something new in the development of some projects. More and more organizations are applying agile methodologies in delivering projects in a faster and smarter way (Stettina & Hörz, 2015). Indeed, Agile methodologies were initially designed for projects that deal with software, but since it is beneficial, it is now utilized in a variety of projects (Larson & Chang, 2016).

Agile software development was systematically reviewed in 2008 (Diebold et al., 2015). It was concluded that a lot of studies need to be done through the development of the agile methodologies as well as several benefits and limitations that are identifiable; its effectiveness may be low. Based on the review, quality studies about agile methodologies need to be developed. As such, the research paper is thus relevant for the purpose of achieving the effectiveness of the agile methodologies in the FDA industry.

Many projects have failed or contested every year. Through the CHAOS Manifesto, it was noted that only 37% of all projects are termed successful, 44% of the projects were contested (there are either late or having missing features), and 19% of projects were termed failed (there were either canceled or forwarded but not utilized). Indeed, there have been gradual improvements on the rates of success, up from 30% in 2005 (Torrecilla-Salinas et al., 2015).

The paper continues to indicate the size of the project is more crucial than whether or the methodologies applied are agile or traditional. It is argued that the reasons for the use of an agile methodology that make more accessible in the creation of both small and large. However, large projects are ten times more likely to fail, unlike small projects.

Agile knowledge, as well as the usage of agile, is increasing. According to the 9th State of Agile Survey shows that 46% of the participants are applying agile methodologies in most of the projects (Stettina & Hörz, 2015). Besides, at least 92% of the organizations as reported by the survey have some usage of the agile development (Larson & Chang, 2016). Eventually, scrum is given highest preference as the agile methodology, which is utilized by 55% of the agile team members (Torrecilla-Salinas et al., 2015). Therefore, the usage will possibly increase in most of the projects regardless of the industry.

The research paper is hence organized into other parts which consist of (1) Problem Statement and Justification, (2) relevant literature review regarding the agile methodologies, (3) Incorporation of Agile Methodology in FDA Regulated Industry and (4) conclusion and summary.

Problem Statement and Justification

The research question guiding this research comprises of the following:

1. How to change the mindset of project managers for using agile methodologies for projects in FDA regulated industries?

2. What should managers do in order to incorporate agile in FDA Regulated Industry?

3. How can agile project management-based practices result in the improvements of project success in the upcoming FDA Regulated Industry?

Project management is a normal phenomenon in various organizations. In essence, several companies encounter many challenges while dealing with multiple projects simultaneously; therefore, they are not capable of finishing it at the right time. Further to wastage of time, projects are becoming quite expensive in terms of usage of resources as well as failure to achieve the projected objectives. Hence, there is a need to incorporate agile in the management of companies to assist in proper planning, management as well as the implementation of projects in the FDA regulated industry. Usman, Mendes & Börstler, (2015) explains agile project managements as methods that help in assigning various tasks associated with the intended projects to be used in the accomplishing goals of the company regardless of the strict deadlines.

Despite the existing traditional methodology, agile methodology implementation is still tricky particularly during a situation when standard needs to be maintained. Since agile has been seen to help in the definition and to secure the project success factors, any problem can shift the whole project. As a result, companies may end up experiencing problems such as delays when the right methodology is not used. Besides, the quality of the project can also be changed and finally affect the reputation and the whole image of an organization (Torrecilla-Salinas et al., 2015). In most cases, problems are caused due to poor implementation of the right methodology while attempting to get the right way of achieving the project's objectives. According to Usman, Mendes & Börstler, (2015), an appropriate methodology lies agile methodologies is an effective way of getting solutions to the problems affecting the accomplishment of the issues. In most scenarios, issues are created due to inadequate focus on the priorities of the project's goals and objectives. Activities and tasks are supposed to be done in a way that will allow the project to succeed (Usman, Mendes & Börstler, 2015). Therefore, project managers need to change their mindset in the application of the agile methodologies for projects in FDA regulated industries for the sake of accomplishment of the project goals and objectives with the scheduled timeframe.

The world is becoming more advanced in technology; thus business enterprises must focus on the relevant issues to be competitive in the corporate world. Ideally, some of the things that make a company outstanding in the market are how it manages and conducts its projects (Stettina & Hörz, 2015; Kostalova, Tetrevova & Svedik, 2015). Often, many companies are struggling to be more innovative as well as being technologically advanced. Hence, such companies are faced with a lot of complicated issues. As such, agile project management is perceived as a viable remedy to assist in dealing with the activities within the project. Unfortunately, there are several factors to consider in the incorporation of the agile project management methodology to achieve projects’ objectives. Organizations that adopt agile project management methodology should expect positive improvements in the project success. Nonetheless, without appropriate redress of the factors, the expected gains can be an unachievable dream.

The significance of this study is based on the main objective, "to change the mindset of project managers for using agile methodologies for projects in FDA regulated industries." The application of agile project management is inevitable, particularly, in this period of technological advancement, whereby organizations are confronted with sophisticated and multiple projects that may need appropriate initiation and planning (Stettina & Hörz, 2015; Kostalova, Tetrevova & Svedik, 2015). Agile project management is critical in the organization and preparation of the projects. It is vital in the clarification of the performance metrics as well as the accounting and oversight of the project activities. Consequently, project managers have to be competent enough in the identification and finding of remedy to any problems that can hinder the successful adoption of the agile project manager in the projects. It is crucial in the utilization of resources effectively whereas conducting any project. Intrinsically, this research assists in understanding how project managers can use agile in project management.

The study targets to test the following hypothesis anchored on the analysis of a variety of existing literature on agile project management:

1. Effects of using agile methodologies for projects in FDA regulated industries by project managers.

2. Actions of managers in incorporating agile methodologies in FDA Regulated Industry

3. Contribution of agile practices in the improvements of project success in the upcoming FDA Regulated Industry.

In this chapter, begins by describing the project management in general and specifically in the United States Food and Drug Administration. Moreover, there is a provision of the review of essential agile methodologies and practices and discuss some existing studies that are performed on the agile project management parameters. Eventually, there will be summarized links between the literature review and the research questions.

Definition of Software Project Success

There are many means of defining the projects’ success. Inherently, the traditional methodology is the application of the project management paradigm in which the scope of cost and time ends in forming a triangle (Rigby, Sutherland & Takeuchi, 2016). Quality is always included as an element that is separate in the triangle.

The scope is described as a set of functional features that should be delivered during the lifetime of a project. Time refers to the actual duration that is needed for the completion of projects within their scope. On the other hand, the costs are the number of resources necessary for the projects to be completed. Ideally, making any change to one of the features in the triangle affects other elements in the triangle (Serrador & Pinto, 2015; Papadopoulos, 2015; Dingsøyr & Lassenius, 2016).

Quality is crucial in the development of software products. Indeed, the quality is described in many approaches, however, for the products that use software; there are always some forms of quality such as functional, process, and structural quality (Pope-Ruark, 2015).

Structural quality can be defined as the source of quality code of products. It comprises of the maintainability, efficiency, and robustness among others as well as how it conforms to the definition of coding practices (Kupiainen, Mäntylä, & Itkonen, 2015).

Functional quality refers to ways in which the products work for the targeted users, mainly, the manner in which the software is conforming to the described necessities and designs, the number of bugs, the level of the excellent performance and its easiness to use and learn (Mergel, 2016).

Process quality is described as the means at which systems are formed with the existing processes. The main elements of the process quality comprise achieving the rates of delivery, attaining the required budgets, and repetitive development processes that reliable in the delivery of quality software (Kupiainen, Mäntylä, & Itkonen, 2015).

For the projects to be termed as successful when they are completed on time, in the prescribed budget plus all the necessary elements and functions. Nevertheless, it is challenging for determination whether specific projects are successful or not. A variety of people most likely stakeholders are involved in the project may have different perceptions of what consists of success (Silva et al., 2015; Dingsøyr & Lassenius, 2016). Whereas external stakeholders typically consider time and cost, internal stakeholders always utilize quality and scope as the best ways of determining success (Torrecilla-Salinas et al., 2015; Mergel, 2016). Alzoubi, Gill & Al-Ani, (2016) describes quality as effective evaluation by customers of respective behavoral objects that create customers' satisfactions. As a vital component of the functional quality, customers' satisfaction is considered as the essential component of quality (Vijayasarathy & Butler, 2016). It has support from the 9th Annual State of Agile Survey (Mergel, 2016) in which customers/users' satisfactions were positioned number three notably depending on the measurement of success (Sommer et al., 2015). Product quality and on-time delivery ranked first and second in the order. Besides, the product score and business values ranked positions four and five respectively.

Project Management

Projects are defined as temporary activities that lead to unique products, services or results. Indeed, projects have a planned beginning and the end. In reality, the end of the project is reached when the goals and objectives of the project have been met, or the project is stopped due to some reasons. Therefore, project management is seen as a way of utilizing skills, information, and approaches in various project tasks for the sake of meeting the project requirements (Perkusich et al., 2015; Saltz & Crowston, 2017; Diebold et al., 2015). According to Flora, (2018), the project management comprises of five processes such as initiation, planning, executing, monitoring and controlling, and closing (Sommer et al., 2015). In the traditional project management (TPM) most of these processes are performed linearly and incrementally (Vijayasarathy & Butler, 2016). In Agile Project Management, these processes are delivered in a more iterative and adaptive means (Perkusich et al., 2015).

Based on these processes, Flora, (2018) describes various project management life cycle processes. Intuitively, processes include iterative, incremental, and extreme among other processes. The decision about the project management life cycle model to opt for solely depends on the goal uncertainty and the solution level (Kupiainen, Mäntylä, & Itkonen, 2015). The linear and incremental project management life cycle lies under the traditional project management. Indeed, they have levels of the solution that are low, and the objective of the project is specific (Saltz & Crowston, 2017), while the adaptive and iterative project management life cycle lies under the Agile project managements. They have high levels of solutions and the objective of the projects still specific (Vijayasarathy & Butler, 2016). Finally, the extreme project management life cycle is lying under the extreme project management. They have high levels of the solution with goals of project uncertain (Sommer et al., 2015). Figure 1 is giving all the illustration.

Figure 1: Project Management Life Cycle

Traditional Project Management Life Cycle

In the linear process, each project management model is done in the necessary sequence. Indeed, the model is not encouraging changes in the scope. Products are completed as described by the scopes that are formed at the beginning of the projects.

The incremental process is somehow same as the linear process, but the scopes are done in the form of increment. It offers the provision of the best customer feedback as well as changes in the scope as encouraged in the model. The benefits are different from the linear model because the end products are closer to the demands of the customers.

Agile Project Management

Situations where the goals are clear but solutions and how to find them becomes unclear then an agile project management model is utilized (Stettina & Hörz, 2015; Kostalova, Tetrevova & Svedik, 2015; Vijayasarathy & Butler, 2016). In essence, these forms of project are described as complicated and need a method that is non-traditional for the successful execution of the project (Saltz & Crowston, 2017).

In the traditional project management, every action is planned out into upfront details. It is known as the plan-driven approach. On the other hand, the agile project management project is a change driven (Rigby, Sutherland & Takeuchi, 2016). It implies that rather than avoiding changes in the projects, changes should be welcomed. It results in more dynamic relationships between the teams that create products and the external stakeholders (Kupiainen, Mäntylä, & Itkonen, 2015). In essence, stakeholders must be involved in the process, but the results of the project need to be close to their demands. Since the end solutions are uncertain at the start, they are described during projects as feedback according to the customers and various stakeholders.

Agile Project Management Life Cycle

The iterative process is used improving the incremental model through inclusion of the planning in the loop of implementation. Indeed, every circuit generates potentially shippable codes that stakeholders can provide feedback on them (Kostalova, Tetrevova & Svedik, 2015). Often feedback is welcome and considered as a vital component of the process. According to the input as well as the general mission of the products, another iteration is always organized, managed, and employed (Silva et al., 2015). In this case, solutions are not adequately noted at the start, but it is described through the lifecycle of the project. In figure 2 designed by Yamato et al., (2015) depicts an iterative model and how most of the processes such as planning tends to be repeated in the loop.

Agile methods can be categorized as both iterative and incremental. It is incremental since the work undergoes pre-division into small batches and iterative since the scopes of all batches are described just prior to the beginning of loops. Intrinsically, the iterative natures make the whole processes to be quite flexible.

Figure 2: Iterative Project Management Life Cycle Model

Agile Project management can also be defined as the adaptive process that is quite same as the iterative processes though they have short loop periods, making it much easy in responding to the shifting necessities (Kostalova, Tetrevova & Svedik, 2015). The primary difference between the iterative and adaptive models are most of the solutions are uncertain in the adaptive models. Indeed, the fewer that are determined, the higher the risks and complicated it would be. Whenever complication becomes too high, the adaptive models becoming a bit favorable (Saltz & Crowston, 2017).

Agile Methods

A variety of approaches has various practices. When opting for techniques for provided projects, these practices need to be factored in making sure they are suitable precisely in the projects (Kostalova, Tetrevova & Svedik, 2015). In reality, not all methods describe to all the practices, but instead they focus on other aspects. Scrum has the capability of explaining practices in terms of events and artifacts (Silva et al., 2015). Extreme programming can describe more than 24 practices in words of engineering practices.

On the other hand, Kanban comprises of the description of the five principles that at times are viewed as the practices. Methods are considered as a group of best practices, values, and laws that have proved to work for certain forms of projects (Bilgaiyan, Mishra & Das, 2016). This chapter discusses some of the commonly applied agile methods.

Kanban

Kanban inclines to mindset instead of methodology. It implies that it offers little specific rules in the manner which process is followed, but instead it focuses on possessing the exact attitude (Sohi et al., 2016). Kanban does not have many principles, and Khmelevsky Li & Madnick, (2017) identify at least five principles for the sake of creating of a lean behavior in projects: limiting work-in-progress, managing flow, visualizing workflow, making the process to be explicit, and improving collaboration (Dingsøyr & Lassenius, 2016).

Every item chosen for the development originates from the prioritized backlog described as a Kanban board. Kanban boards have several columns where every column is depicted to represent status. Every item comes from the column and always moves from one point to another point when they are being worked on (Bilgaiyan, Mishra & Das, 2016). The work-in-progress limit sets every column by showing the number of items that can be held by a column at any given time. In case, there are too many items appearing to be clustered in one column, and the whole is responsible for solving those problems in order to ensure that the flow is working again (Perkusich et al., 2015).

Figure 3: An Example of Kanban Board

In figure 3, items are placed in a column and appeared to be higher, and they have higher priorities. They make Kanban an excellent option for maintaining activities where priorities always change.

Scrum

Scrum is a framework that is both incremental and iterative, mainly formed for the management of software in some projects in the agile ways. Intrinsically, scrum was described around the mid-1990s, but its popularity increased from 2001 after founding the Agile Alliance (Sohi et al., 2016). The Scrum framework has a definition that revolves around roles, events, and artifacts (Usman, Mendes & Börstler, 2015). Besides, the Scrum framework is depicted to define only three roles including product owners, team members, and scrum meters (Bilgaiyan, Mishra & Das, 2016). The product owner is involved in controlling the product backlog as well as defining the requirement. The Scrum masters are ensuring that processes are duly followed and resolving the impediment. Lastly, team comprises of other persons such as developer, designer, and testers among others.

Scrum consists of some events including sprint plan, day to day standups, sprint retrospectives, and sprint reviews. Every event has been time-boxed and must facilitate the fast response as well as a constant flow of information that exist between stakeholders and team members (Usman, Mendes & Börstler, 2015). A sprint ordinarily is a two-four weekly cycles in which team members work on an agreed activities (Sohi et al., 2016). The most significant artifacts comprise of the product backlogs, sprint backlogs, and product increments (Khmelevsky Li & Madnick, 2017). The product backlogs contain requirements that should be developed in the future sprints. The sprint backlogs include requirements that are recently being operated on as the active component of the sprints that are ongoing. Eventually, the products’ increments are the results of the duties which were performed during sprints.

Figure 4: Scrum Process Flow

In the figure 4 above, the scrum model flow is illustrated. In every sprint, during the plan, the product owners and the team members decide on the sets of items that come from the products’ backlogs for the sake of putting them into the sprint backlogs (Sohi et al., 2016). The team members work during the sprint to form shippable products that are potential increments according to the goods found in the sprints’ backlogs (Diebold et al., 2015). Daily, there is a scrum meeting to share information and find solutions to the problems.

Extreme Programming

Extreme programming is referred bas software centered on the agile methods. Objectively, Usman, Mendes & Börstler who are one of the first initiators of the agile manifestos and participated in the creation of extreme programming in 1999 (Usman, Mendes & Börstler, 2015). Currently, extreme programming has defined about five core values, fifteen principles, thirteen leading practices, and eleven corollary practices (Perkusich et al., 2015). Ideally, these aspects are to be used in the improvement of code quality as well as product value, and creation of the best development practices (Sommer et al., 2015; Flora, 2018). Besides, extreme programming advocates for the short development iterations and emphasizes on transforming several practices into appropriate action. The leading practices are quickly adopted and should provide instant results (Khmelevsky Li & Madnick, 2017). On the other hand, the corollary practices are somehow sophisticated and demand more experience in the implementation in the projects (Torrecilla-Salinas et al., 2015).

The FDA and Agile

Whereas various professionals in the industry believe that FDA regulations need waterfall, neither quality system regulation nor other regulations are based on the prescribed development methodology. There is a sense of confusion that comes up in various standards that FDA does not consider though written in a manner to elucidate waterfall (Sohi et al., 2016). Ideally, the FDA completely cautions against applying the waterfall for sophisticated devices: the model of the waterfall is useful in activities that are limited while for advanced devices, another model is preferred (Diebold et al., 2015). Despite the challenges in the adoption of agile, several firms in the industry such as Pathfinder give recognition to the agile value and the adopted methodology for the sake of complying with the applicable standards and guidelines. Indeed, they have to apply them in developing and launching FDA products that are cleared and approved (Layton & Ostermiller, 2017). For the sake of providing clarity as well as the guidance on aligning the agile at both concept and practical levels.

Incorporation of Agile in FDA Regulated Industry by Project Managers

The Agile can be incorporated in the industry by the project managers through three major principles that can be used in promoting safety for medical tool software: risk management, quality management, and software engineering (Diebold et al., 2015). Indeed, agile can be used in addressing all these principles in a manner that is superior to the traditional waterfall (Torrecilla-Salinas et al., 2015).

It can start by comparing risk management with Agile. Like other perspectives of the software development processes, not all risks are detected at the start of the project and at the same time majority of the hazards are discovered as the system is evolving (Layton & Ostermiller, 2017). As acknowledged in the ISO 14971, the international standards for the risk management system for the medical devices: risk is always introduced in the product lifecycle and fact, risk becomes apparent in the product life cycle that can be managed through activities that can take an entirely different occasion in the product life cycle (Larson & Chang, 2016). The application of the agile can be depicted in the risk management at every level of the product life cycle, with output and output from every task within a particular level — besides, risk analysis, evaluation, and risk controls that are done in the sprints or iterations. There are aspects of maintaining backlogs of requirements with related risk scores for each task (Layton & Ostermiller, 2017). For any problem, increment, risk assessment forms part of the definition done. The new hazards have been introduced; the DFMEA needs to be updated (Stettina & Hörz, 2015). Customers' stories are used in the implementation of mitigations as well as reviewing the results in the demonstration of iteration. Early embedment of risk management in the process, there is discovery and elimination or mitigation of more risks and doing much earlier in the phase of change. The approach is thoroughly illustrated in the modified of AAMI TIR45: 2012 version in figure 5.

Figure 5: Modified version of AAMI TIR45: 2012

Attaining Quality at Speed with Agile

Quality is one of the primary objectives of the agile methodology, and a variety of central core agile practices that are designed for the sake of improving software quality at the same time maintaining the speed of the project (Larson & Chang, 2016). Intuitively, traditional software development members always spend a third or half of their time on defecting the troubleshooting and reworking, and agile practices have a design to be used in catching and fixing early defects when they are comfortable and cheap to catch and fix (Torrecilla-Salinas et al., 2015).

Incorporation of the human factors in agile to improve effectiveness and risk mitigation. Intrinsically, human factors in the software become more significant. With more complication, excellent access and availability and mostly the user types that come with the richness of opportunity for the users' error (Stettina & Hörz, 2015). Majority of the risks for sophisticated medical devices are directly associated with human factors such as permitted misuses, user interface design, user interface confusions, and user complacency which are not adapted to the users' workflow (Larson & Chang, 2016).

Conclusion

In this chapter, several topics are created in the theoretical foundation for the research. There is a description of the identified in the project success for the software projects through considering four components; quality, time, scope, and cost. There is background information about traditional project management and agile project management. Besides, there are many ways of using agile. Various agile methodologies have several practices, devices, and ways. Indeed, there are several practices and not equivalently essential in attaining success. Most of the agile practices used in the identification of the State of Agile Survey. Ideally, the combination of all these identified practices from the topics covered and finally describing practices mostly significant for agile projects.

The Agile can be incorporated in the industry by the project managers through three major principles that can be used in promoting safety for medical tool software: risk management, quality management, and software engineering. The combination of agile practices and methodologies can be used to change the mindset of project managers in conducting projects in FDA regulated industries.

When agile methodology was initially introduced, there were some comprehendible resistances because it had not been proved as a new approach. While some organizations were adopting agile in different industries, a variety of researches were performed for the sake of analyzing the effectiveness of agile (Saltz & Crowston, 2017). The Standish group did a report known as CHAOS report which is published yearly since 1994; it is one of the studies that are respected among the software projects (Kostalova, Tetrevova & Svedik, 2015; Vijayasarathy & Butler, 2016). Indeed, it has continuously depicted a high correlation between the agile and the success of several organizations since its adoption in the mid-2000s.

By 2012, the Standish Group applied one of the best languages to explain the significance of agile: "an agile process is universally a solution for the software development project failures. In fact, the software applications that are developed through the process have higher success rates than traditional project management and with much lower cost as well as time-saving (Vijayasarathy & Butler, 2016). Other researches comprise of the medical service industry, which has depicted continuous improvements in the project quality and success (Mergel, 2016).

Agile project management is suitable for the FDA regulated environment. Over the last two decades, agile has been used and depicted better results in several industries such as the FDA regulated industries in terms of reliability and safety. Since the agile methodologies have proved to produce better results, therefore they can be used in the medical service and diagnostic industry despite being adopted in the slow pace (Stettina & Hörz, 2015; Kostalova, Tetrevova & Svedik, 2015; Vijayasarathy & Butler, 2016). The objections to the adoption of agile in the medical device industry have focused on the following issues:

Medical devices should be reliable, effective and preferable safe, as well as they cannot pose some added risks to the patients. Agile methodologies do not have enough rigor and complexity to be applied in safety critical systems (Vijayasarathy & Butler, 2016). Agile methodologies eschew planning, processes that are controlled, and documentation, most of which are needed by the Quality System and Regulation of FDA (Torrecilla-Salinas et al., 2015).

Even if agile methodologies had proper processes to comply with the FDA regulations, it would not matter since the FDA is not prescribing to the waterfall processes (Saltz & Crowston, 2017).

As can be seen all these concerns are based on the misconception. In reality, agile methodologies applied appropriately leads to the improvement of reliability, effectiveness, and safety if it is compatible with the Quality System and Regulation of FDA, and indeed, recognized as part of the standard by the FDA (Rigby, Sutherland & Takeuchi, 2016).

Whereas various professionals in the industry believe that regulations of FDA need waterfall, neither of the Quality System and Regulation of FDA nor other regulations can be formed to prescribe to the specific development of the methodology. There is confusion that arises since most of the standards do not recognize several ways elucidated by the traditional project management (Kostalova, Tetrevova & Svedik, 2015). Intrinsically, the FDA completely cautions against the usage of the traditional project management for the sophisticated devices: the practice of the waterfall's model is useful though limited for complicated devices same as the engineering models which are more representatives (Saltz & Crowston, 2017).

Even though there are barriers in the adoption of agile, several companies in the industry such as Pathfinder, indeed have recognized the usefulness of agile methodologies and have adopted the methodology in all its standards and guidelines (Mergel, 2016); therefore, it has used it in the development and launching of products that are cleared and approved by the FDA.

Agile methodologies through the promotion of safety of medical device software are addressed through the following principles; risk management, quality management, and software engineering. All these principles help in showing how the agile methodologies are seen to be superior to the traditional project management methods.

Risk management with agile methodology is crucial since it helps in the integration of the risk with agile practices. In reality, the combination helps in the embedment of risk management at stages of the project’s lifecycle with input and output from every task with that stage (Silva et al., 2015; Dingsøyr & Lassenius, 2016). Besides, the risk analysis, risk control, and risk evaluation are done in particular iteration for the sake of maintaining the backlog of requirements which are related to the risks identified in each stage of the project lifecycle. Through embedment, risk management is discovered early in the project lifecycle, and it is immediately eliminated or mitigated followed by reviewing the results during the iteration demonstration as well as the release of the reviews.

In the traditional project management in the product development, release dates are always fixed since most of the dangers are discovered late thus leading to high cost and consumption of more time to eliminate or mitigate, making the projects to either being extended or inadequately worked with or tested (Kostalova, Tetrevova & Svedik, 2015). Intrinsically, the hazard response is quite challenging unless it is performed at early stages in the project lifecycle. Intuitively, agile methodologies allow exceptional and targeted prioritization of characteristics after every iteration. Ideally, the application of the risk-based prioritization of attributes and consistent risk assessment; there is a high possibility of spending the right effort on the most critical risk sections at a low cost. It can be related to the incorporation of human factors in the improvement of effectiveness and risk mitigation.

Human factors are essential in the development of software used in projects. With complications, excellent access and availability provide a great opportunity in the industry. Most of the risks for complicated medical devices that are connected to the human factors such as user interface confusions and user interface designs that cannot be adapted to user workflow (Silva et al., 2015; Dingsøyr & Lassenius, 2016). The expectations of the FDA on user errors that get much rigorous and higher focus on being placed on comparative safety as well as effectiveness (Silva et al., 2015) and conducting formative usability tests as well as dealing with the best usability issues by training and labeling that are no longer acceptable. Insufficient focus on the user experiences can have significant business influences: systems that are difficult to apply and do not offer what users need, when it is required, in actionable ways, do not get used. Besides, systems that do not get utilized do not lead to future sales (Vijayasarathy & Butler, 2016). Inherently, human factors, experience, and methodologies to the team assigned to develop products contribute to the dramatic improvements of the project quality and speed, and user satisfaction (Kostalova, Tetrevova & Svedik, 2015).

Agile methodologies can be adapted in the direct incorporation of human factors into the process of development. User experience and human factors create task flow, storyboard, and wireframe, as well as, creating detailed designs with the binding acceptance to help product developers to have clear guidelines. Product developers have the capability of getting usability feedback from the product end users as improvements are made by the software development team (Rigby, Sutherland & Takeuchi, 2016). Therefore, hazards associated with the human factors are mitigated at early stages to help in quick designing and testing. It is significant in achieving project quality at the right speed with agile methodologies.

Quality is one of the primary targets of the agile methodologies, and several of the agile practices that are designed for the sake of improving the project quality at the same time maintaining the projected velocity (Stettina & Hörz, 2015). Whereas traditional project management makes the development team spend at least half of their time for defecting troubleshooting and rework, agile methodologies are designed in a way that they have capability of catching and fixing defects early enough, when they are needed at the most comfortable time and cheapest cost to fix such errors (Silva et al., 2015; Dingsøyr & Lassenius, 2016). Eventually, the agile practices that include users' stories, tests, and tests based on the development, consistent integration and tolerance on the zero bugs that are designed for the sake of improving and maintaining the project quality. It allows the team to move much faster with fewer defects than in the traditional project management methodologies (Bilgaiyan, Mishra & Das, 2016). Therefore, agile methodologies are supported by several practices that result in the improvement of quality, reduction of risks, and improvement of project speed.

Conclusion and Summary

The goal of this research was to get the changing the mindset of project managers for application of the agile management for projects in FDA regulated industries. Besides, it extended to looking at how agile practices are contributing to the success of projects. Most of the studies reviewed depicted significant relevance of the agile methodologies; however, their perceptions about importance are entirely different.

At least five agile practices were discovered to be extremely significant. The most crucial aspect for the application of the iterative development as well as the sprint reviews was noted to the earliest feedback from the customers. Intrinsically, iterative development is applied to deal with the changing priorities as well as uncertainty in solution and accomplishing a shorter time to get to the market. Incremental sprint planning, stories, and designs were utilized while responding to the changing priorities and needs of the customers.

The main reason for the application of the sprint retrospective and collaborative improvement was meant to enhance the process for improving the effectiveness of the product development teams. The objective of which was to attain a change in the mindset of project managers for using agile methodologies for projects in FDA regulated industries in terms of improving the working environment as well as working pace. Probably they were depicted as the most significant practices that product development team can utilize.

All the practices perceived to be significant were associated with quality and scope. It is not amazing since all the participants were treated as the internal stakeholders and most of the stakeholders always utilize quality and scope as the best criteria for the determination of success. In summary, agile practices and other practices such as incremental designs, sprint retrospective are considered as the most crucial in the research. It was reported that results are indicating that practices can improve customer feedback and the processes used by the product development team, as well as assisting the team in comprehending the essential needs of customers as very important with a lot of significance.

Agile methodology if duly incorporated to the quality system regulations of FDA, it has the capability of providing superior outcomes to the current traditional project management methods, particularly for the complicated system with significant software elements.

Agile methodologies are designed for the sake of getting more feedback early and even during the product design process as well as applying this feedback to improve products consistently. Consequently, it is suitable for the development of sophisticated systems that have new requirements. Ideally, the loop of feedback is adaptable in the incorporation of risk management, human factors, and validation. The agile methodologies are critically through making organizations adapt quickly to changes, rapid reduction of uncertain requirements, development of project speed and reduction of waste, and reduction of risks and defects. Therefore, organizations should incorporate agile methodology to have better opportunities in the rise of challenges posed by the dynamic changes in regulations, reimbursements, and technological landscape and converting them to competitive market success and advantage.

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