Project management and systems requirements in medical device development

¶ … Project Management in Medical Devices and Hospital Procedures

Uses and Advantages of Project Management in Medical Devices and Hospital Procedures

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.

Change Management Benefits From Project Management

Changing of how people work in conjunction with one another and with the processes they rely on to do their jobs is crucial for any project to be successful. The ability of a project managers to bring together project teams and create a collaborative workgroup is a major benefit of project manager as well.

This aspect of the Gathering System Requirements Process is the most critical of all in defining new medical devices and hospital procedures in that it focuses on how the everyday processes people work on are re-ordered and changed. This is the most costly aspect of any new product development process and accompanying implementation: changing how people work and think about the tasks that comprise their jobs.

Typically a requirements analyst will coordinate with project managers to handle the gathering, analysis, and synthesis of the customers' needs during this phase of the SDLC. In smaller medical devices companies product managers and software engineers also specifically handle this task, working either directly with users and customers, or through marketing managers and sales managers who have responsibility for customers' accounts that need to contribute their specific needs. The requirements analyst and project manager coordinates with these other departments to gain access to the users or customers the applications or solutions they are building are intended to serve. In the most successful approaches to Gathering Systems Requirements Phase, a collaborative approach to developing and completing requirements eventually begins to form between the requirements analysts, project managers, and process experts for hospital procedures on the one hand and the users or customers on the other. This collaboration extends into the prioritization of features and the eventual development of the end application or solution. Clearly the focus on minimizing "scope creep" is critical. Scope creep is defined as when the scope and definition of a project continually changes as the needs of the user or customer change. (Hatler, 20) an expert on SDLC and specifically the gathering of user requirements states that when requirements are volatile consider an incremental development approach. This sequences the development of the application or solution to the highest priority needs of the customer or user, and alleviates the need for scope creep.

Critical to the role of the project manager fulfilling the role of requirements analyst, whether they are from marketing, engineering, development or even service, is that the following key functional areas surrounding the Gathering System Requirements Process need to specifically be addressed:

Aligning the project vision and scope relative to user requirements - Intermediating the needs across several different user constituencies, user groups, and customer groups while keeping the development aligned with the vision and scope of the original project is a critical step in the final definition of an initial release of a product. The person(s) fulfilling the requirement analysis role need to focus on how the evolving needs of the customer base can stay aligned with the original visions of the original project. This takes tact, diplomacy, and a clear sense of what the original product concept entailed, and a strong sense of direction on the part of the requirements analyst to stay focused on "on message" with the original vision and scope. Too many projects are compromised in this area when requirements analysts capitulate and give in to the many requirements of others and lose sight of or worse, compromise project vision and scope.

Finding and growing product champions is critical to change management - This is a critical step also in the Gathering System Requirements Process, and is also essential for the entire change management process defined earlier in this paper. In specific hospital procedures development (Russell, Tippett, 36, 37) discusses the need to have a product champion lead the development of new change management initiatives and change management projects. The more significant the change required from the systems development and process definition, the greater the need for a product champion. In fact for the largest changes need the highest levels of management to be included in them. Is an adjunct part of the Gathering System Requirements Process, and includes the buy-in and endorsement of senior management. This focus on making change permanent through the support of senior management also supports the fact that those affected by the change of processes need to also feel ownership for the changes be recommended as well. (Brynjolfsson, Renshaw, Austin, Van Alstyne, 43, 44) "Theories of ownership, for example, suggest that decentralizing data management can boost quality levels in systems users control themselves." The ability of requirements analysts to inspire product champions at the highest levels of their organizations is critical for change to be lasting.

Requirements Specification, Validation and Management is also critical in the Gathering System Requirements Process - This is also a very critical task in that the feasibility of the project and its vision must be rigorously and thoroughly defined into product and solution concepts that can be transformed into specific application features and solution sets. The progression of turning requirements into specifications, validating them, and managing the requirements in the context of an overall product line strategy is also very critical. The database or repository of requirements must be continually managed and updated to reflect current user and customer unmet needs, with a strong focus on how to translate them into future product directions.

Creating test cases and validation test points is critical in the overall development of the final application or solution. Another aspect of Gathering System Requirements Process is the strong focus on creating test cases to validate not only the overall design and functioning of the medical devices or hospital procedures align to technical performance including scalability, responsiveness, fault recovery and fault tolerance, ability to recover from both fatal and non-fatal errors, and the ability to integrate directly with other devices and processes as well the development of test cases is clearly the collaborative aspect of the Gathering System Requirements Process phase, and underscores the need to have the Voice of the Customer (VoC) be very clear and specific in the overall development of medical devices and hospital procedures.

Comparing Business vs. Technical Needs in the Context of the Gathering Systems Requirements Phase

Pervading the area Business Process Management (BPM) and Business Process Re-engineering (BPR) initiatives that are in turn driving the development of SDLC projects and the need for gathering customer requirements are the many unmet business needs of hospital procedures users and internal "customers" of healthcare facilities. These service needs are in fact dominating the SDLC cycles of many healthcare providers who strive to better serve both their internal and external customers. Business needs are as diverse as the companies initiating and completing systems design projects, yet the broader and more strategic goals are focused first on the financial performance of one business unit or division relative to its own goals, followed by the operational performance of one division relative to another and its own goals. There are also line-of-business objectives that pervade the Gathering Systems Requirements Phase that focus on the payback of taking one operational strategy over another, including the selection of hospital procedures across each key functional area of healthcare providers. The single largest factor in the context of the Gathering Systems Requirements Phase that pervades many business needs however is pricing, and its many aspects and its implications on a project being successfully completed.

The technical requirements of the Gathering System Requirements Process phase are organized into a product functional specification that is transformed into a technical products specification that is used to manage the overall development process. This specific step in the Gathering Systems Requirements process applies to both medical devices and hospital procedures as well. The intent of using this document is to address the technical requirements of the customers for a new medical device or new hospital procedures as captured during the Gathering System Requirements Process phase and specifically include the following:

Performance - a series of performance benchmarks need to be defined and used from the engineering specification stage of n medical devices through development to the finalized design to ensure the delivered application or solution adequately meets users' needs. This also applies to the redefining of hospital procedures as well.

Scalability - Can the medical device or hospital procedure fulfill the original intended requirements and support the number of users without failing or becoming unresponsive.

Customizable and Adaptable to User Needs - How flexible and scalable the application or solution is needs to be defined as a technical requirement and managed throughout the entire project completion by the project manager. This is where the critical need is for a cross-functional team that can execute quickly and in close contact with each other.

Integration Capabilities - Defining how easily the medical device or hospital procedure can integrate with other devices and processes is also a critical area that specifically needs definition during this phase.

Robustness - How easily or difficult a medical device or hospital procedure or process can plan for any potential malfunction is another critical component in the overall definition of technical requirements.

Project Management Benefit of Understanding User Requirements

There is an abundance of research on methodologies specifically focused on collecting user requirements. (Dirlam, 61) defines a series of them in his analysis of the SDLC at Northrop Grumman Corporation. Building a methodology to capture user requirements is comparable to creating a market survey methodology that an auto manufacturer would use in the development of a new vehicle for example.

Dirlam advocates the use of interviews, document analysis, brainstorming, requirements workshops, and the development of prototypes. These are all specific techniques for gathering user's inputs, yet need to be selected based on the over-arching information need. The focus on use cases as defined in other parts of this paper also hold true as an approach to capturing new user requirements as well. The bottom line is that the approach to design methodology must match the need at hand; there needs to be a strategy behind finding the best possible information to fulfill the products' vision and requirements first and foremost.

Conclusion

The many benefits of project management as a discipline used for managing the development processes required for creating medical devices or defining and executing hospital procedures have been shown in this analysis., the phase of the SDLC on gathering user requirements has been highlighted as the catalyst of any successful project, regardless of whether the end result is a new medical product or a new process or procedure in a healthcare provider. The SDLC process is also critical to consider as the foundation for long-term project management as it can quickly encapsulate unmet needs and translate them into schedules that triangulate between cost and time constraints to attain project goals. The anchoring of projects in the unmet needs of customers is what saves many projects from getting too lost in the myriad of distractions and "scope creep" that can pervade any project over time.

The need for a stable framework on conjunction with project managers able to create ownership overcoming resistance to change in the process is also critical. This is one of the greatest benefits of managing a project with a focus on overcoming resistance to change is that in the steps required to ensure a projects end result stay entirely focused on the unmet needs of those the products or processes are being designed to fulfill. Project management also needs to create a forum for continually keeping in touch with the needs of those that projects were designed to fulfill. This includes the need for managing Customer Advisory Councils that stay in place even after projects are completed. This ensures the lifecycle of a project continues on and stays relevant to those they were created to fulfill. This full-cycle approach to project management is one of the more powerful aspects of a lifecycle based approach to managing development. The SDLC model specifically concentrates on this aspect of the project management strategies of companies using this approach, ensuring the iterative approach to creating medical devices or hospital procedures is responsive to the changing needs of the customers they are intended to serve.