The planning phase is very important because it will set the foundation of how you’re going to tackle this project. If poorly planned out then the project could face delays, cancellation, or might not be profitable in the end for the company because the development process was poorly executed. A well planned out project can have impacts m…[Read more]

During the development process, identified potential risks can come from a variety of sources. In my experience, most of the risks identified were from our engineering teams working on the project and from previous experiences on past projects. Some risks were identified by mechanical, some by electrical, quality, and so on. During development we…[Read more]

For my company, to initiate a design change request, the CAD model and drawings must be updated with any changes that are being proposed. It is then reviewed and hopefully approved. If approved, our PM team creates a change request document that will list all the changes done and all product SKUs that will be affected by this change, they will…[Read more]

Similarly like srg36, if I was a PM running risk management meetings, I would schedule major and minor checkpoint meetings throughout the entire development process. Major meetings for when we complete a step in the development cycle, such switching from initial planning to conceptual design. Minor meetings to study any risks for when we want to…[Read more]

Initiating a project idea is the hardest part of project development because it can have a lot of consequences on what happens to the company if the project was worth pursuing or not. Marketing research plays a massive role because with the data they provide we can see if the product market sector, depending on what the product, will be growing…[Read more]

Picking the right members of a project team is very important in many ways. Obviously you want people with the proper technical knowledge depending on their department (engineering, marketing, etc.) but also people that are compatible with each other and can work off each other. What I mean is creating a respectable and efficient team, with…[Read more]

Not for medical devices, but I’ve been involved with testing shipping containers that would be used to ship out my company’s products. Tests were done with accordance to ASTM D4196-16 specs. These tests involved rotational flat drops of around 3 inches using a quick release mechanism, and vibration for a set amount of hours. The vibration pro…[Read more]

I think these 9 design controls are necessary as a good checklist to ensure the project proceeds smoothly. While I don’t work in a medical device company, we follow a similar structure where I work. I’m part of the design and review aspect of the 9 design controls. Once the part is designed and reviewed, we order a sample in order to do fit…[Read more]

Personally I prefer the Project-Based organization. Being able to be transparent with other departments working on the project would be greatly beneficial. Information would flow more easily between each department versus everyone being on their own and you having to beg procurement or manufacturing for info that you need to do your part in the…[Read more]

The FDA’s Office of Combination Products would develop regulations and guidance for any combination products that are presented by a company. The Office of Combination Products would review and assign responsibility for combination products to one of the branches of the FDA, which are CDRH, CDER, and CBER. Its assignment to which branch of the F…[Read more]

A combination product’s primary mode of action establishes its regulatory and product development framework as well as how it is viewed in the eyes of a regulator depending on which agency it’s assigned to within the FDA, as we learned from the mini-sim this week. Looking at this digital pill, I would argue the pills primary function is to act as…[Read more]

I would say the squeezable stress reliever ball can be considered a general wellness product. There are different kinds of them but in general they round soft objects with some kind liquid inside. We squeeze them to help alleviate stress or just get our minds off things bothering us. If you think outside the box they can also be used for hand…[Read more]

At my current job, I would say that my company is still growing in terms of project management awareness at least in my department. At my company we do have Project Managers or PJMs as we call them that oversee the project budget, deadlines, customer communication, and also dictate information to all different teams involved, teams such as…[Read more]

I believe the skills necessary for an ideal properly functioning project team are: communication, good leadership, and knowledge of the problem. Everyone in this thread has already gone into great details about these skills, so I want to talk about how the team needs to be able to respect and understand each other as well. Respect isn’t a t…[Read more]