Uses of Project Management in Medical Devices Thesis

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¶ … Project Management in Medical Devices and Hospital Procedures

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Thesis on Uses of Project Management in Medical Devices Assignment

The intent of this paper is to provide a thorough analysis of the use of project management concepts in the design and manufacture of medical devices, and the streamlining of procedures in hospitals as well. The use of project management concepts in the development of medical products is heavily dependent on the use of the System Development Lifecycle (SDLC) framework and concepts. The use of the SDLC in the context of project management for hospital procedures parallels Business Process Management (BPM) and Six Sigma approaches for streamlining process-based projects. The reliance on Six Sigma techniques including the process steps of Define, Measure, Analyze, Improve, and Control (DMAIC) are often used for managing hospital procedure projects as well (Mukherjee, 44-51). Project management techniques used for the development of medical devices and for creating, re-engineering and streamlining hospital procedures share a common attribute in having to align to the unmet needs of customers or patients. The most effective approach found in project management for staying aligned with the unmet needs of users is the SDLC process step of gaining systems requirements. This is often called the Gathering Systems Requirements process. Both the manufacturing processes and the service-oriented processes of creating new hospital procedures both must stay aligned with the unmet needs of those they serve in order to be effective as possible. That is the crux of best practices or the optimal level of performance of project management. An assessment of the use of project management as a means of translating the unmet needs of customers into finished medical products, and in the case of hospitals, the development and refinement of hospital procedures, is discussed in detail within this paper. Taking this focus keeps project management more focused on those customers and patients they are meant to serve.

Making Project Management Accountable to Customers and Patients

It is essential for project managers to have a very clear, succinct view of the requirements of those that the medical devices they are building are being developed for. For the business analysts who work with project managers, the redefining of business processes that form the foundation of business procedures also requires this same level of needs-based focus. As a result, one of the greatest benefits of project management for both medical products manufacturing and the defining of hospital procedures is the ability to deliver products or procedures on time, on or under budget, specifically aligned to the needs of whom they are built for.

One of the most critical aspects of project management that is used for staying aligned to customer needs is the Gathering Systems Requirements Process. This is the most essential step in project management and delivers the greatest potential benefit in terms of alignment with customers' needs (Caccia-Bava, Guimaraes, Guimaraes, 552, 553). Key to this specific stage of project management is the analysis of the two basic types of system requirements, both technical and business related. Implicit in this analysis is an overview of both the technical and business-related unmet needs of external and internal customers. In the case of hospital procedures the use of the Gathering System Requirements Process is seen as a means for keeping medically-based hospital procedures aligned to the unmet needs of patients (Anderson, 43, 45).

Overview of the Benefits of the Gathering Systems Requirements Process

In the context of the System Development Lifecycle (SDLC) the Gathering Systems Requirements Phase is the most critical in that it centers on getting the needs of the customers included in the design of the application or product or the development of a hospital procedure or service. The functional specification of any product, software or service must be first based on the Voice of the Customer (VoC) and specifically focus on their unmet needs. Specifically in the case of creating procedures to serve patients, the ability to have transparency throughout all service transactions is critical. The Gathering Systems Requirements Phase is the most critical phase of the SDLC as it also sets the foundation for the product's and services' structure and approach to resolving customer unmet needs, and defines the future product roadmap of the entire product series for the next three to five years.

Why the Gathering Systems Requirements Phase Is Most Critical

In the context of medical devices or hospital procedures the Gathering System Requirements Process is the most critical step in the total SDLC as this specific phase defines the many use cases of the applications being created. Use cases are the definition of the process workflows, information and process dependencies, and exceptions medical device engineers and hospital system analysts face in the context of completing their jobs. Key to use cases is also the definition of how the overall processes interact and support interlinked and interrelated processes as well. The center of use cases however is in delivering greater levels of efficiency, accuracy, cost and times savings relative to the previous, and often manually-centric approaches undertaken. The use case methodology medical devices companies use varies significantly across the many approaches, yet the majority relies on for completing steps of the SDLC. These common areas or benefits include the following key areas. First, the integration aspects of product and service use cases must be deal with, planned for, and specifically built into the product and service structure. Next, the aspects of changing the processes that employees rely on to do their daily jobs and their re-definition need to next to re-align within both the manufacturing organizations developing and producing medical devices. In the case of hospital procedures the aspect of gaining buy-in to make change permanent is critical as well. This is one of the most important advantages of benefits of project management as well.

Project Management and Overcoming Resistance to Change

The critical aspects of making change lasting center more on ownership and the internalizing of goals over simply defining and working through a series of steps or activities. This is one of the innate skills of effective project managers, specifically being able to overcome resistance to change to any new project or defining of a new hospital procedures.

Being able to overcome resistance to change is another aspect of effective project management as well. Implicit in this skill set for project management is the ability to create a high level of ownership throughout the entire development phase of a new medical device, or creating a more effective hospital procedure as well. This concept of ownership throughout the entire process is well highlighted in the many research efforts of (Brynjolfsson, Renshaw, Austin, Van Alstyne, 37, 38) from MIT who in several research papers and results report the importance of having ownership. In their study of the correlation of ownership with business process change success, (Brynjolfsson, Renshaw, Austin, Van Alstyne, 44, 45) comment that "The very act of decentralizing decision-making - asking workers for their values and then taking them seriously - can have a positive effect on the change process by giving employees a sense of ownership and responsibility," and from previous work show the impact of theories of ownership on change management with this insight from their work (Brynjolfsson, Renshaw, Austin, Van Alstyne, 42, 43) "Theories of ownership, for example, suggest that decentralizing data management can boost quality levels in systems users control themselves."

These insights point to a change management plan that begins with gathering the voice of the user and basing the following series of steps of the development program as the standing agenda for a User Advisory Council.

Creating an effective project management plan must include the creation and continual support of a User Advisory Council as well. This User Advisory Council must be comprised of the main users or internal customers for hospital procedures for example, or the customers for medical devices as well. Once the composition of the User Advisory Council is created, then the agenda needs to be executed as follows. The execution of advisory councils is one of the greatest benefits of having a project manager dedicated full-time to any development or process creation and redevelopment effort. These are the most critical steps in creating a project plan that incorporates the Voice of the Customer (VoC) through the use of the advisory council. These are the steps that medical devices manufacturers and medical services providers use for understanding the needs of those they serve:

Origination of Project - in this phase the User Advisory Council is created and the necessary steps to creating a workgroup is defined in addition to the schedule of product or services development. As hospital procedures require a high degree of cross-functional coordination, there will be specific advisory meetings held just for the stakeholders and suppliers whose content originating outside the company is critical. This is the critical sessions where user champions are hopefully found and ownership of the project is begun. Throughout this section user requirements also captured, clarified and turned into functional… [END OF PREVIEW] . . . READ MORE

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