Project Management in Healthcare

Michael Sarachman

Project Management Fundamentals and the Consideration of the Dynamics of Digital

Fundamentally, project management is a structured methodology for planning and completing unique work in a repeatable fashion. Many approaches have been developed for structuring this work, often based on the type of product or industry in which work is being performed - manufacturing, information technology, finance, etc. Projects in healthcare, particularly those focused on medical devices and pharmaceuticals, present unique issues that need to be considered when planning and executing these projects.

When identifying projects that are applicable for formal project management, organizations must consider three main factors of business model transformations. These include projects that involve change of people, process, and technology. Enterprise-based projects including one or more of these factors generally introduces a strong requirement for project management. Given the ongoing implementations of new technologically based initiatives in the digital era, projects requiring project management are vast.

Digital technologies, often introduce disruptive elements to traditional processes that include speed of communication and transmission of information through the utilization of electronic devices. The dynamic attributes of these projects may require more flexibility in aspects of the project management process, and involve a more agile approach. Agile project management techniques involve situations where the scope of the project can change on an intermittent basis along with corresponding supportive resources. These types of projects often involve strategic change or the incorporation of innovative process [1]. Regardless of the project type, this chapter provides the structural process of achieving success in organizational initiatives through a project management approach.

Initiating the Project

Projects in most industries will often focus on cost effectiveness, profitability, and bringing new revenue. These are important in healthcare, but two dimensions need to be considered and emphasized when initiating a project - patient impact and regulatory compliance. Improving patient lives and healthcare outcomes is a universal healthcare organizational mission. Therefore, a project leader must consider how their projects help achieve this mission, especially considering competition for priority and resources.

Healthcare organizations are reluctant to take on regulatory risk, since adverse findings can limit market access, elevate compliance scrutiny through audits and inspections, and have numerous other effects. As a result, project leaders should consider regulatory compliance, and how their projects will account for regulatory requirements and limit or eliminate any existing compliance risk.

Developing Goals and Objectives

Organizations operating in healthcare are challenged with several unique issues, with an evolving international regulatory landscape being the most prominent and consequential. As a result, project managers need to establish consistent understanding across all the organizational functions in order to ensure these issues are understood and can be considered when developing a schedule and identifying the activities to be performed.

The best way to establish this consistent understanding is to document the project goals. Organizations may have standardized goal templates, but often these lack certain dimensions. An effective goal statement should include the following elements:

■ Problem Statement — a clear statement, describing the problem or challenge being addressed and the ways the problem is affecting the business. This statement should be limited to three or fewer sentences and should avoid the use of industry or technical terms, ensuring consistent understanding across all functional areas.

■ Goals — similar to the problem statement, focusing on the issue the project will address. The objective should describe the future state, or how the problem will be reduced or eliminated. This statement should specifically identify the process being affected, and how it is expected to operate once the project is complete.

In some cases, especially for product launches or introductions, the project goal should highlight when the goal is to be met. Establishing time expectations can help set expectations across all the stakeholder functions, ensuring they consider timing when considering their department resource plans and prioritize across competing projects.

■ Objectives — this should describe how the team intends to achieve the goal and the areas where the team will focus its effort.

Objectives are critical to the initiation stage, since they are the first opportunity a project leader has to make an impression on leadership stakeholders, ensuring both influential and practical support. Objectives should help each leader exposed to these statements to understand the benefits to be delivered, how the project will affect their department, and the role they will need to play in its successful completion.

Goals and objectives are an important step in starting or initiating a project, since these statements are often the way leaders across the organization will hear about a project as it is being proposed. Engaging these leaders is the next step in an effective initiation.

Selling the Project and Building Organizational Support

Once goals and objectives have been drafted and reviewed with the project sponsor, they must be shared with functional leaders that will influence your project. These project stakeholders will determine the appropriate teams within their organizations and allocate funding and resources to support the project. Therefore, clearly communicating project goals is a critical step that should be prioritized at this early stage.

Once goals have been drafted and individuals directly involved in its planning and execution agree, they should be reviewed with the project sponsor. The project sponsor, a leader that will champion the project throughout its life, should be a senior executive that leads a functional area directly affected by the proposed project. An effective and influential sponsor should be selected from a department that is close as possible to affected patients, or healthcare providers. Therefore, supply chain, commercial operations, sales, or similar functions should be targeted as sponsors.

Establishing leadership support is most effective when introductions are conducted in brief meetings, limited to the target leader, project sponsor, and project manager. The list of leaders to engage should be broad, engaging leaders in all functions that could be affected based on project objectives. The discussion should focus on establishing understanding and alignment to the problem statement, project goals, and support needed from that leader’s organization and the level of direct involvement expected. The discussion should end with action items and specific actions needed from the leader being engaged. Such actions could include assigning a project planning point of contact, resource assignment, or steering committee participation. Limiting these discussions to information sharing will limit their effectiveness, as leaders will interpret the lack of tangible actions to mean involvement will be limited and involvement will not be required.

Once functional leadership has been engaged, any feedback should be collected and incorporated into these foundational project descriptions. The revised goal statements should then be presented to regulatory affairs and compliance leaders, especially in cases where processes involving product design, manufacturing, or distribution may be affected. Ensuring these areas are aware will ensure project scope and plans include compliance-related steps and tasks. Not including this group up-front, and ensuring they are part of the planning process exposes the project team to unplanned tasks or documentation during more costly phases. These introduction sessions should result in the assignment of a regulatory subject matter expert to be a team member, especially through the planning phase.

 
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