Avoidance is more easily incorporated and possible in the product design phase of the product, product design, and manufacturing process. This is because the product design phase is in the earlier developmental stage of the product lifecycle. This means changes…   Read more»

To ensure appropriate approvals during the design review meetings, project managers need to incorporate careful planning with appropriate preparation and effective communication. Project managers should clearly and precisely define goals and objectives for the team to follow. These expectations should…   Read more»

In a matrix organization, effective communication and negotiation are essential for proper resource allocation between the project manager and the functional manager. One way to do this is by clearly stating the project’s objectives and deliverables and what the impact…   Read more»

Having a basic understanding of project management can always come in handy, even if one does not plan on going into that particular field. It can help one understand the various roles seen within a project and by doing so,…   Read more»

As you mentioned, class I devices such as tongue depressors or masks would have an extended maturity phase due to the consistent demand for these products and the limited room for significant improvement. In addition to many class I devices,…   Read more»

For successful management of a project that the manager has little expertise in, there are multiple steps that the manager can take to ensure the success of the project. The first step could be to assemble a team of experts…   Read more»

To put it simply, functional organizations have centralized authority, whereas weak matrix organizations have shared authority between functional managers and project managers. Additionally, for functional organizations, projects are managed within functional departments while for weak matrix organizations, projects have dedicated…   Read…[Read more]

Team members must be appropriately motivated to report their tasks which can become a tedious task at some points. Here are a few ways the team members can be motivated: 1. Recognizing and showcasing the individual contributions of the team…   Read more»

I agree with the notion that culture plays a crucial role in project management and although I am not personally aware of any company or organization that is in dire need of culture upgrade, I can talk about some points…   Read more»

Both medical devices and drugs are essential parts of healthcare and medicine. Although both have quite a few similarities, they also have quite a few differences. They’re similar in that they can be used to diagnose, prevent, and treat diseases…   Read more»

Emotional intelligence is quite crucial to the path to success. However, schools and training facilities focus more on cognitive abilities and academic access due to the traditional path implemented for the longest time. Emotional intelligence is also quite subjective and…   Read more»

Employees with different specialties are involved at each stage of the PDCA cycle. The plan and the do stage often consists of engineers, scientists, and regulatory affairs specialists who create and implement the technical aspects of the projects. The check…   Read more»

Some topics that are unique to the biomedical industry are risk management in clinical trials and regulatory compliance. Biomedical industries often involve clinical trials that require managing the risks associated with it. Such as integrity issues and handling experiment subjects…   Read more»

I have not experienced gift-giving in the corporate world; however, there should be some set rules and expectations when it comes to giving gifts. When giving gifts, the company should keep the gifts at a small and nominal level such…   Read more»

International contract law should provide uniformity and consistency across all countries so that there is an even playing field. Moreover, the contract should have a standardized dispute-resolution mechanism so that there is less uncertainty across the multiple legal systems across…   Read more»

To add to the comments made earlier, a confidential agreement (in addition to the basic components of the contract) should first clearly define what constitutes the document to be confidential and it should also underscore the duration of the confidential…   Read more»

Given that the groups had already been assigned their specialty, such as marketing, pre-clinical research, clinical research, etc., the groups have taken on the structure of a functional organization where there is a clear hierarchy among team members and the…   Read more»

The shift from an in-person environment to a virtual environment definitely had a huge impact on the workforce. For functional organizations, the shift may have impacted maintaining that traditional hierarchy that is often seen in functional organizations. This could have…   Read more»

The choice of matrix type depends not only on the nature of the medical device being developed but also on various other factors such as organizational structures. A strong matrix type would work well with medical devices that are complex…   Read more»

Here is a SWOT analysis for the case mentioned above:  Strength: The proposed lithium pump is a novel solution to the problem mentioned and the device could have a significant medical impact and improve the lives of patients with traumatic…   Read more»