Discusses project management challenges and potential solutions to common obstacles faced by medical device companies developing new products, specifically the problems posed by regulatory restrictions, resource constraints, and timeline hitches.
During the course of the development of a new medical device, project managers inevitably come across three major obstacles to efficient project management: regulatory constraints, resource limitations, and on-time delivery. Prevailing over these challenges may have less to do with better planning and improved project execution and more to do with the management systems employed during the product development cycle.
Challenge: Regulatory Restrictions
Compliance with specific regulations like FDA requirements, ISO 13485 standards, CE marking, and other global regulatory requirements necessitates that a tremendous number of documents be generated and managed. 21 CFR Part 820.30 in particular has great impact on new product development (NPD). The Part 820 notation states that the design and development plan (DDP) should be updated and approved as design and development evolves. Project managers must be constantly diligent with timeline management and task assignments and can be easily overwhelmed with these duties as the project progresses. Unfortunately, documentation burdens can divert energy away from efforts that are more valuable to the enterprise and focus that energy into making sure documents are properly created, approved, tracked, and so forth. Not only do project managers have the responsibility to generate the necessary documentation but they must update the DDP as tasks are completed throughout the project lifecycle. Keeping up with the documentation demands of such regulatory requirements can cause project managers to spend more time managing documents than actually managing the project.
A tempting yet imprudent approach is to blaze forward with tasks and leaving documentation undone until long after the tasks have been completed. Project managers that wait to document after the fact run the risk of the following unfavourable consequences:
- Out of compliance – The likelihood of being found out of compliance is remarkably high if project managers get behind with documentation, especially if audits take place during the product development lifecycle.
- Documentation of lower value – The intrinsic value of the documentation being generated is low if it is not kept current. Project managers may unintentionally omit vital information or make generalities when working from memory.
- Missing information due to personnel turnover – If a key engineer or project leader leaves the company in the middle of a project, their knowledge may leave with them if it hasn’t been documented.
The regulatory submission is another wild card in the medical device development project lifecycle. The submission is a crucial component of the timeline but also an element over which project managers have very little control, especially if they don’t understand up front the regulatory path that the device is going to take. Project managers also must cope with the difficulties that stem from tasks—labeling, for instance—that cannot move forward until clearance or approval from the regulatory body has been granted.
The most straightforward means of overcoming regulatory challenges is the integration of the project management system with the document management system, which would most likely take place via the implementation of a GxP process automation tool. Integrating the systems with a proven software solution makes good business sense since a great number of the deliverables in a medical device new product development project are in fact documents generated directly from the design control process. By interfacing the project management and document management systems, a synergy is created that allows project teams to execute projects efficiently and bring products to market more quickly while facilitating compliance.
Comprehensive document management software solutions allow users to create and define document hierarchies and automatically populate related portions of the design history file (DHF). This provides a tremendous advantage in terms of compliance since the DHF is automatically completed in the background as project tasks are completed.
Challenge: Resource Constraints
Can you ever have too many resources? The common theme in project management is that there are never enough people to do all the work that needs to be done. This is especially true of the medical device development process. Further complicating the matter is that the project team structure in medical device companies typically involves shared resources. The cross-functional team model often employed by device companies entails that team members who are assigned quality, regulatory and manufacturing tasks are likely to be shared with other project teams. As a project manager, it is extremely difficult to determine completion timelines for tasks that have been assigned to a shared resource. For these reasons, resource limitations are often the most difficult component of a project to surmount.
Another resource constraint challenge for project managers is that the project lead is also often the technical lead on the project. In many device companies it is common for the development engineer to lead the project but also maintain responsibility for the project’s technical elements. This can result in conflicting priorities on the part of project manager, especially when one role is more enjoyable and fulfilling than the other. Most engineers would prefer to focus on the technical component than push papers for the administrative piece of the project. This conflict frequently results in managerial tasks being neglected.
A robust GxP process management software solution can ease the resource constraints faced by project managers in medical device companies. Effective GxP process management software systems incorporate phase gate implementation into project plans and automatically handle the legwork of task assignment and tracking. All-inclusive software systems automatically assign and track tasks in phases; beneath each phase are a number of tasks that must be completed before moving on to subsequent phases. Systems that integrate with e-mail can provide electronic notification of task assignments with links to tasks within the system. An effectual system will also make task assignment and tracking easier for project managers by providing the ability to electronically associate document collaboration and approval routes and assign tasks by project according to user names. When an efficient software system assumes the legwork of documentation and task tracking, project leads can focus on the technical aspects of the project they enjoy most rather than on managing documents and task assignments.
Challenge: On-time Delivery
Timely project completion is the obvious goal of any product development project. For this reason, efficient project execution continues to be one of the top concerns among business leaders today. From a business perspective, project delays can cause a medical device company to lose millions of dollars for every day a product is not on the market. The impact of those losses on smaller companies can force them to go out of business. Another oft overlooked result of project delays is that if projects are not running according to timelines, patients are not receiving the therapies that device can offer them in a timely manner. For these reasons, it is crucial for product development project managers to be able to predict timelines accurately and execute a project plan to meet those pre-established timelines.
Document and GxP process management software solutions can help overcome these challenges by automating project management. Efficient task assignment and robust reporting capabilities provided by proven software solutions can help project managers streamline project execution and identify and eliminate bottlenecks. Filtering and project baselining capabilities inherent in high quality software systems can allow project team members to view tasks by categories and see how projects are evolving and expanding. Project workflows are dramatically streamlined when project tasks are automatically updated and electronically managed.
Key Elements of Effective Software Solutions
When selecting software solutions that can help manage regulatory restrictions, resource limitations and facilitate on time delivery of a device, consider four key characteristics the system should include:
- Straightforward: GxP process and document management software solutions should be relatively easy to use, easy to deploy, easy to validate and easy to maintain.
- Sustained compliance: An effective software solution will help lower the cost of achieving compliance, alert users to deviations from compliance, and facilitate sustained compliance while offering ongoing solution improvements as regulations are updated.
- Rapid validation: The ultimate purpose of the software system is to enable a company to extend the investment across the enterprise and bring products to market sooner. A first-rate software solution will drive down the total cost of ownership by providing a continuum of risk-based software and validation products and services.
- Improved GxP Process and Document Management: Solution vendors should offer state of the art innovation, expertise, and industry best practices so the company utilizing the system can automate and connect every stage of the product development cycle.
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