It seems the company has a lot to worry about and updating the Gantt Chart may be the last of their worries. The balloon pops immediately instead of lasting for days could be a catastrophic issue and could result in…   Read more»

I think another great example of process group within medical device are product complaints and change control that fall under monitoring and controlling process group. This continuous monitoring provides the project team insight into the heath of the project and…   Read more»

As mentioned in today’s lecture, often companies disregard project management with design controls thinking they are one and the same. This leaves gaps that can implicate the success of the project. The PM would ensure the planning phase of a…   Read more»

The marketing team typically identifies the need based on market evaluation for a new product to be developed and often provides design inputs mostly from VOC (voice of customer). However from my experience if the project depends solely on marketing…   Read more»

Selection of the members of the project team is extremely important in several ways. Obviously you desire the project team to be composed of people a high level technical knowledge/ skills from all functional areas that will support the program…   Read more»

Based on the PMBOK, there are five phases of project management. Phase 1; Project Initiation – This is the start of the project, and the goal of this phase is to define the project at a broad level. This phase…   Read more»

In my opinion, it is very important that projects are properly prioritized and that every member of the team understands the details around priority that the project holds. Ultimately, successfully prioritizing tasks in each project will impact the success of…   Read more»

In agreement with some of what was described in previous posts, if the manufacturer is not the one claiming that the TJA total joint arthroplasty can be used while performing high intensity or extreme sports then it would not fall…   Read more»

I believe no matter how flawless a medical device design and manufacturing process is, there is still potential for users to be harmed (e.g. use error). That said, the manufacturer is responsible for understanding all risks related to the medical…   Read more»

Verification and validation are distinct, but related activities that combined demonstrate through objective evidence that the medical device meets the design requirements defined and the medical device meets user needs and intended use. Before talking about timing of V&V, it…   Read more»

I agree with what was said in previous posts about regulatory compliance challenges, but I also think these challenges will only increase at least for the next 10-20 years. Given the EU Medical Device Regulations (MDR) 2017/745 that will take…   Read more»

The beginning of a project can be the calm before the storm or an insane rush to get things sorted and ready for the main project team work to start. As per PMBOK, the project is composed of five process…   Read more»

Using a similar but different example, birth control implants are also combination products. The implant is a tiny, thin rod about the size of a matchstick. A doctor inserts the implant under the skin of the user’s upper arm. It…   Read more»

A project manager requires many skills in order to succeed. There is no one sole skill that will allow the project manager to be successful. As emphasized in the PMBOK, effective project managers require a balance of technical, interpersonal, and…   Read more»

The experience I have comes from working within a device development group in a big pharma company organized in a project based environment. The organization structure is based on teams with specific goals. Main business goals for big pharm companies…   Read more»

The beginning of a project is critical to the program as it is when objectives, scope, purpose, and deliverables to be produced are defined. Early in the program there can be a lot of unknowns especially if the project involves…   Read more»

The NDA is a great mechanism to protect the company during partner ventures, but not a substitute for a patent. For example, you find out that company ABC (to whom you never told your idea), has put out the same…   Read more»

The gift restrictions are established by the Sunshine Act that came into effect in 2010 and it required companies such as pharmaceutical and medical device, including durable medical equipment suppliers, to report gifts above $25. While I understand the perspective…   Read more»

I really enjoyed this course. The course is well structured and provides pretty good insight of the device development process and design controls. As a professional with multiple years in the pharma-med dev. industry I have learned from this course…   Read more»

In addition to the examples mentioned in previous posts, Olympus Corp. of Americas (OCA), the United States’s largest distributor of endoscopes and related medical equipment, will pay 623.2 million to resolve criminal charges and civil claims relating to a scheme…   Read more»