As stated by previous responses R&D would be a factor that extends the Gantt Chart and timeline of the project. However, another important aspect of the balloon system popping immediately may cause upper management to re-evaluate the project entirely. This would be a major setback to a project of this magnitude and something that would have been…[Read more]

A critical path I identified occurred during the R&D phase of a project I was working on before it became a formal project. We were working on creating a surgical lavage and had found a substance that after multiple iterations and testing was optimized in performing it’s intended function, or so we thought. It turns out that the physical form the…[Read more]

Within our company a project we started last year needed a good amount of information before we introduced the idea for a formal project. First off we had an R&D phase for the product in which we tested it’s effectiveness and after about 5-6 months of testing against various conditions we developed an animal trial. During the time of R&D we also…[Read more]

A budget cut as stated by the previous posts is a critical factor in project management. While planning under budget is a good idea for any project it is more difficult to achieve in a medical device project. I believe that it is harder to have a realistic budget because of the lack of data and the innovative factor in medical device projects. For…[Read more]

For the specific scenario that was given by Dr. Simon I think that working face to face would’ve solved the problem with one or two conference meetings that lasted 60-90 minutes maximum. Through industry experience a problem similar to this one we usually do our own individual research and the project manager will advise us that we will meet in a…[Read more]

For the specific scenario that was given by Dr. Simon I think that working face to face would’ve solved the problem with one or two conference meetings that lasted 60-90 minutes maximum. Through industry experience a problem similar to this one we usually do our own individual research and the project manager will advise us that we will meet in a…[Read more]

One basic example of a general wellness product would be the recently released amazon echo dot. The echo dot has many functionalities and can be considered a low risk general wellness product because it provides ambient sounds such as white noise and other relaxing sounds for promoting sleep and relaxation. Moreover it has features called “skills”…[Read more]

I agree with the posts above that fitbit should not be classified as a medical grade device because it’s purpose is not to be used as a replacement for an EKG. The purpose of fitbit and similar activity bands is to give a general guidance on your daily activity and not exact measurement. If it were to be considered a medical grade device it would…[Read more]

Initiating the project is a crucial part of the project and the hardest step in initiating the project is the business and market research. I think that these two factors are the hardest because you need to make sure that you have solid research in both areas for your project to receive the go head. These two factors of business opportunity and…[Read more]

Validation and verification as stated in the lectures are both independent procedures used to establish that the product meets specifications/requirements. Validation can be described as an external process because it is associated with the needs of the customer, while verification is necessary for compliance with regulations it can be viewed as…[Read more]

Validation and verification as stated in the lectures are both independent procedures used to establish that the product meets specifications/requirements. Validation can be described as an external process because it is associated with the needs of the customer, while verification is necessary for compliance with regulations it can be viewed as…[Read more]

I agree with what everyone else has said, that the thalidomide crisis played a pivotal role in shaping the regulatory authority of the FDA and creating more awareness to remain vigilant. Without the thalidomide crisis the FDA may have had a more lax environment in approving drugs that were already approved in other international markets, unless…[Read more]

Although both have similar end goals, mainly that of ensuring successful completion of a project. I agree with Shachi in that there is a significant difference between the two. Project manager is more of a broad term which can refer to any industry and not specifically medical devices. A clinical project manager on the other hand deals with…[Read more]

This is an interesting topic and one that goes through considerable research when launching medical products. Personally I have some experience with the human factor research during my time working as a clinical research coordinator for a pain management clinic. The main factor that attributes to errors/misuse of the product is unclear language on…[Read more]

A brief history of this loophole begins with the creation of a regulatory agency for the benefit of the United States Populace.

-Medical devices came under FDA regulation in 1938 when the FD&C Act was passed, however this only allowed regulation after devices were placed on market.
-After the Drug Amendments in 1962 pre-market approval…[Read more]

I work for Ethicon Biosurgery and they are a subsidiary of Johnson and Johnson. The company’s project management awareness is advanced, however it is not without it’s flaws. The company provides many resources from conferences, seminars, and online tutorials on topics pertaining to project management and the importance behind successful team work.…[Read more]

Currently I work at Ethicon Biosurgery in Somerville, NJ. The organizational project management base is a funcational organizational structure. My work focuses on quality and regulatory performance of surgical devices mainly suture, surgical mesh, and hemostatic agents. Our division also deals with smaller side projects for devices in the R&D…[Read more]