Tag Archives: product development

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...

Medical Device Complaints Come From Product Design

Have you considered the relationship between medical device complaints and the product design? I mean, you know something about about complaints. And you know something about medical device product development. I'll confess. Until a few months ago, I had not spent much time thinking about how much an impact my product development efforts could have on downstream processes such as complaint handling. I think the concept has been recently drilled into my head as we spend quite a bit of time evaluating product issues. It definitely makes sense. You spend time and effort tirelessly as you go through product development. You understand and grasp the importance and purpose behind Design Control and embrace the process. You do a pretty decent...

Class I Medical Device Should have a DHF

If you are developing a class I medical device, you could make a solid argument for not documenting Design Controls and not maintaining a Design History File (DHF). In fact, your argument would be supported directly by FDA Design Control regulations. Very few class I devices even require Design Controls per FDA. However, if this is the approach you decided to take, I would advise against this. You might argue that documenting Design Controls will only slow you down on your process to bring your class I device to the market. Perhaps. So why do I recommend documenting Design Controls and maintaining a DHF for your class I medical device? Design Controls are documented, objective evidence that the product development process has been followed. Design Controls help ensure that User Needs are translated...

Why the Indications for Use of Your Medical Device is Important

The last post was about capturing User Needs for your medical device project. Related to User Needs is the indications for use. Another term that is often used is intended use. There are some debates about the difference between intended use and indications for use. For the sake of this post, I'm considering these two terms to be synonymous--or at least similar enough that debating the nuances and differences is trivial. Part of a FDA 510(k) submission is the Indications for Use statement. According to FDA:
The statement should include specific indications, clinical settings, define the target population, anatomical sites, etc. This statement must be consistent with your labeling, advertising and instructions for use. 
As you can see, the Indications for...