As stated in previous posts, I believe there are pros and cons to both in-person and online project management. While it is more convenient and cheaper to have an online project manager, communication is certainly not as effective in an…   Read more»

The PDCA cycle is an essential aspect of successful biomedical engineering projects. While each respective department may have its own PDCA cycle, the “check” aspect can involve members of different specialties. For instance, in a pharmaceutical company, clinical trial protocols…   Read more»

Sub plans are important in project management, especially in cases where specific details of a specific aspect of a project need to be expanded. For instance, a project management plan usually includes an executive summary, a Gantt Chart, a risk…   Read more»

Verification and validation are similar processes but with different goals. Verification relies on testing the design requirements/specifications to ensure that the product is built/functions as designed. Validation is testing to ensure that the customer’s requirements or needs are met. For…   Read more»

I do believe there is some ambiguity in the classification of medical devices, especially when considering combination products. However, I’d make the argument that it is better to “overclassify” than “underclassify” the device. For the example of mouthwash with fluorine,…   Read more»

Misclassifying a medical device will shift the project’s overall timeline as different testing or steps would be necessary. For instance, if a Class II device is reclassified as a Class III device, a PMA must be filed and a human…   Read more»

Reclassification can happen if there are changes made after undergoing testing. For instance, imagine that a traditional hip implant is being tested. During this testing, the researchers note that the implant is loose at the bone-implant interface. Thus, to improve…   Read more»

A lack of funding is not a positive sign when proposing a new project. While the project may have patent potential, you need to ask yourself why there has not been funding for the project. Is the project unrealistic? Is there…   Read more»

I think the size of a given project team is highly dependent on the scale of the project being worked on. However, in terms of medical devices and biomedical engineering products, I do believe that there should be at least…   Read more»

@afshinsadri Thank you for your explanation of both preventative maintenance and preserve maintenance, as I had never heard of these terms before. This aspect of project management seems especially important in biomedical engineering, where consumers have to balance cost with…   Read more»

I don’t believe giving lavish gifts like the “old days” is permissible or appropriate in the modern pharmaceutical industry. As stated above, these gifts result in bias where physicians recommend products based on gift-giving rather than what is best for…   Read more»

While these rules or regulations may seem like they are too restrictive, they are necessary for the integrity of the pharmaceutical/medical device industry. While it is appropriate to pay for a physician’s dinner when taking them out for dinner to…   Read more»

In most scenarios, verbal contracts are legally binding. However, it is often hard to prove these contracts without written documentation. This can lead to parties not abiding by the contracts. Several measures can be taken to prevent this from occurring…   Read more»

The most effective type of organizational structure depends on the type of project being worked on and the available assets. For instance, a Matrix or Functional organization may be better for a smaller company because the entire team is composed…   Read more»

For the project manager, it would definitely be easier to work in a project-based organization than a Matrix organization. In a project-based organization, the project manager only needs to work with their assigned project team and does not need to…   Read more»

As stated in other responses, I think communication and setting expectations are of utmost importance. When a new manager is assigned to a team, it is important that this manager gets to know every member of the team, their habits,…   Read more»

The pros of a risk assessment far outweigh the cons. On the surface level, the cons are that these plans may result in the project taking a longer time and greater expenses. However, in the long run, these plans actually…   Read more»

Risk assessment is an essential part of the planning phase. All potential risks must be discussed so a thorough, well-thought out plan can be constructed. By doing so, the plan will run more smoothly when enacted and the risks will…   Read more»

While it may seem that companies tend to outweigh reward more than risk (due to media headlines and such), I believe that most companies outweigh the risk more. First of all, liability is of utmost important in the biotechnology industry….   Read more»

I belive that both inputs and specifications have their intended purposes. In terms of actually constructing a device, it is impossible to do so based on solely inputs. Specifications are needed for the actual construction of the device and for…   Read more»