A communications plan is important in a clinical trial because the project manager will engage with project members and stakeholders at other sites or organizations, and regulatory bodies. For example, obtaining FDA and IRB approval for the clinical trial will…   Read more»

Project management starts in the early stages of a project, but work is also done before project approval is obtained. Before the scope is developed, a feasibility study can be conducted to determine the scope and support project initiation. The feasibility…   Read more»

Procurement processes in the medical device industry are significant due to strict regulatory requirements along with expected quality and safety standards. If a team is trying to find a new vendor, then the project manager may be working on costs…   Read more»

Cost estimation tools can help grasp an unknown budget, and potential changes, such as new requirements or design changes, should be incorporated. Most importantly, having a well-defined project with detailed tasks will more accurately determine the required budget, rather than…   Read more»

When hiring, whether externally or internally, the PM should consider the project team’s size and the need for full-time or part-time availability. The project team’s location is also important, as there may be preferences for either external or internal hiring…   Read more»

The success of a medical device project depends on stakeholder involvement, among other factors, as their contributions to design, quality, and safety are valuable. Their industry experience and connections allow easier implementation when the product hits the market. However, when…   Read more»

Clinical trials, usability testing, and software validation are common methods used in the medical device industry. For example, software validation can ensure the system does not crash and includes preventive measures when a user makes mistakes, which replicates a real-world…   Read more»

I have found that the size of the organization or project team has a significant impact on change fatigue. A smaller team struggles to keep up with frequent changes while other tasks remain to be completed. Likewise, rotating or new…   Read more»

Relying too heavily on metrics like EV, PV, and AC can hurt the team when they cannot control the variables that affect them. If the project scope is not defined, the tasks in the work breakdown structure are less accurate…   Read more»

Incorporating review meetings throughout the project stages is highly recommended for monitoring, and auditors can request a review of the quality of this information. These meetings can be used to discuss or approve change drafts, or reveal changes that need…   Read more»

Estimation failures during the planning phase can threaten the project’s success, as the project is more likely to have a higher burn rate, increasing the risk of running out of budget before project milestones are completed. Actual resource costs are…   Read more»

Performing project quality assurance or monitoring & controlling the project execution are significant for its success. Preventive actions, such as obtaining the proper document signatures and retraining staff, support the process improvement and the quality management plan. Reviewed and approved…   Read more»

Verification includes testing to determine if the inputs match the outputs. Validation, on the other hand, assesses whether the inputs meet the user’s needs and whether the device does what it’s supposed to do. For design validation, the product must…   Read more»

Someone with a science degree can also become a project manager. If they have additional work experience, they can be attractive to a medical device organization, especially if they have product lines focused on biologics or combination products. I agree…   Read more»

Testing results should be communicated to stakeholders or senior management, and the project manager will need their approval to proceed with further action. Approaching a preliminary test includes identifying a clear purpose and, for many, choosing the testing solution that…   Read more»

Early-stage risk assessments are less expensive than addressing the risks as they arise. Taking risks should not come at the expense of safety, and their significance depends on their severity and probability. Realistically, certain risks may be accepted, but the…   Read more»

Including costs and resources in the risk management analysis can lower project estimates. Finding alternatives to different resources to mitigate risk can increase project success. Having a vendor when internal production issues arise, or training additional employees for coverage, are…   Read more»

I had a lab research project that followed a finish-to-start mode, where each task could not begin until the previous task was completed. A finish-to-start relationship is common, especially in the laboratory; for example, a sample cannot be analyzed until…   Read more»

An organization running multiple projects will have many tasks that should ideally be organized, and there are different methods for planning them. Depending on the organization’s level of project management sophistication, the task breakdown can range from using pen and…   Read more»

Poor execution and late regulatory integration are both common pitfalls for medical device developers. Startups are likely to design medical devices with a strong emphasis on innovation, and risk integrating regulatory compliance later than necessary. This can be an example…   Read more»