The goal of Creo Quality is to help you with your medical device product development project needs. Before I get too in depth on terminology and details, it is important to build a foundation. I want to be sure we start from as close to common ground as possible. In this post, I want to focus on one concept first. I want to define and briefly discuss the term “project”. After doing a quick search, I discover thefreedictionary.com has several definitions. Of these, my personal favorites are:
- A plan or proposal; a scheme.
- An undertaking requiring concerted effort.
While these definitions get us closer to understanding the term “project”, I want to share what this means to me based on the advise and wisdom of several mentors, colleagues, and my own experiences.
- A project has a defined scope or boundaries.
- A project has a beginning, middle, and end.
I think this last point is important. Perhaps you’ve had or are working on a never-ending project. I know I have. But in my opinion, these never-ending endeavours are not projects. These ongoing efforts usually result due to a couple reasons:
- Poor or lack of planning.
- Ill-defined scope; scope creep.
- Lack of support.
With the blog, I plan to tackle many issues I’ve experienced during medical device product development. Of course, your feedback and comments are certainly welcome and will help all of us learn about some of the finer points of product development. Topics I will be covering over the coming weeks include:
- Product Development Project Phases.
- Product Risk Management.
- Project Planning.
- Project Management.
- Design Controls.
- Phase Reviews versus Design Reviews.
- Research versus Development.
- Concurrent Engineering.
If you have other topics ideas or are interested in contributing, please contact me at jspeer@creoquality.com.