Tag Archives: product development

Design Inputs Take Time

If you ask me the most important aspect of a medical device product development project, the answer most definitely is Design Inputs. Design Inputs are the foundation for your project and ultimately the medical device you plan to launch to save and improve lives. And this is the essence and intent behind Design Controls. Establish a framework for medical device product development to ensure products are safe and effective. I read a statement in the FDA Design Controls Guidance that defining Design Inputs should take 30% of a project. I know from my experience, I always felt like I could have spent just a little more time defining the Design Inputs. And extra time was rarely a luxury. Schedules and due dates were discussed way more often than...

Medical Device Startup – 3 Things To Do

Imagine for a moment that you are a medical device startup. There are probably thousands of things you are concerned about and have to do before you can go to market. Where do you begin? It's easy to get bogged down realizing all the stuff you have to do. But you have to make progress. And in order to do so, you need some structure. You need to focus. It requires discipline. Before you start every day, you need to ask yourself this simple question: What do I need to accomplish for my medical device startup today? If "today" is too big, break it up into smaller chunks. Yes, you need to have some idea of where you are going--the end goal. So figuring out the smaller chunks should be based on that. Once you...

Medical Device Engineers Are Special

Medical device engineers are definitely special people. Yes, of course, I have a very strong bias since I am (or at least used to be) a medical device engineer. It's funny, though, for me to think about this for a few minutes. When I entered college to pursue my Rose-Hulman chemical engineering degree, I didn't for one minute ever consider the medical device industry as a place I might call home. I really was unaware that the medical device industry existed. I first became aware of the medical device industry my junior year, and somewhat by accident. I had to take some engineering elective courses and heard from classmates that Dr. Sam Hulbert (then president at Rose-Hulman) taught biomedical engineering courses. Samuel F. Hulbert

Incubating Medical Device Talent

I've been working in the medical device industry for my entire career. I'm so thankful for the experiences I've had. The first stop in my career was with Cook Medical, a relatively large, private medical device company. Although large, it never felt large. In fact, based on all the startup  / entrepreneurial experiences I've had since, I would say my first job felt very much like that kind of environment. I had the title of "product development engineer" and had the opportunity to work on many exciting medical device technologies. In fact, I just learned that one of the projects I had a small part in just sold it's one millionth unit (and that's a HUGE deal for this type of product). As a newbie engineer, I was given so many...