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»

Regulatory authorities, third-party organizations, or internal auditors will issue their findings, including identified non-compliances or non-conformances. Not having a written procedure is a failure to meet an internal requirement or an established standard. However, it does happen, and it is…   Read more»

Fair treatment and engagement with team members are part of stewardship, which embodies a broader commitment to the organization and its stakeholders. Project managers should use lessons learned from previous projects to identify members’ strengths and weaknesses, including their behaviors….   Read more»

Another regulatory strategy is the “De Novo” pathway for a 510(k), under which a low- or moderate-risk medical device that lacks a substantially equivalent predicate device can still be classified as a class I or class II device. This is…   Read more»

Different organizational structures have both pros and cons. While these structures affect projects and their outcomes, they are also influenced by other organizational factors, as others have shared. Managers who are unsure about which projects and responsibilities are theirs, or…   Read more»

Soft skills can be used to align business needs with customer satisfaction. Empathy and active listening help when dealing with customers, especially since the project manager is trying to maintain a stable relationship in every interaction. However, the project manager…   Read more»

Users benefit from training in information systems, including software tools, which help them use it more effectively and efficiently. I do not have experience with Jira; however, the platform is popular for its usability and support. Further training may be…   Read more»

Project management varies across companies, reflecting differences in organizational behavior, value delivery systems, and infrastructure. Incorporating project management into design controls while maintaining distinctions, such as design risk vs. project risk, may not be fully implemented across the organization. Project management…   Read…[Read more]

The company’s organizational structure can affect the project manager’s responsibilities. The project manager has more power than a functional manager in a strong matrix organization, which can give them control over post-market surveillance or projects related to regulatory or quality….   Read more»

A project manager can evaluate the project outcomes and monitor its products. Results of the project can be assessed for their benefits or value, especially as they continue to be used or produced in the post-market phase. Monitoring the products…   Read more»

A company may or may not pursue a pathway based on its capabilities or motives. Challenges can arise during the process of submitting a 510(k) or PMA. However, depending on the company, the project can be scrapped entirely because it…   Read more»

A project manager who understands value will help them navigate the stakeholder expectations and stay within scope. Value delivery can improve the team and company environment, where the work produced is about quality and not primarily about quantity. Having a…   Read more»

I agree with Jacob that regulatory or quality engineering are appropriate fields for a project manager to have experience in. Furthermore, a background in quality assurance greatly benefits a project manager. Understanding quality management systems (QMS) and how a company…   Read more»

There is emphasis on interpersonal skills for project managers. As cra24 explained, a well-rounded project team has members with diverse backgrounds and experiences who contribute to the outcomes or products. A project manager in the biomedical field should have the…   Read more»

Risk management can be applied to supply chain efforts, considering that supply chain disruptions are usual in manufacturing at any time. The likelihood of supply chain disruption is higher, and the severity may be significant or severe depending on the…   Read more»