Tag Archives: product development

Design Control Software Simplifies Medical Device Development

You may be aware that I have been involved with the design and development of a Design Control software solution. I'm happy to report that we have released this software and currently have a fantastic product ready and released. The product is greenlight.guru. [caption id="attachment_6563" align="alignnone" width="300"]greenlight.guru Design Control software simplifies greenlight.guru Design Control software simplifies[/caption] I have a really great deal for you right now too. But you need to contact me to learn more about the greenlight.guru Turkey Day Special deal. Read on below to discover why this matters to you.

Origins of a Design Control software solution

Why did I have the idea to create a Design Control software solution? I can't exactly pinpoint the day, but I can recount many of...

Medical device product development – take action!

Product development of any kind is definitely challenging and full of all kinds of unknowns, obstacles, and pivots. Medical device product development is certainly no different. To complicate matters with med device, throw in regulatory, such as FDA, to complicate matters. If you ask entrepreneurs and startups in the medical device space to define their single biggest challenge, the response will overwhelmingly be clear. Money. Not enough funding to get to market. money   Which kind of stinks. Especially if you have a fantastic idea for a medical device technology that can improve the quality of life. Seldom is having the idea good enough to secure all the funding necessary. So what do you do? I mean every thing  you need to do requires funding. Right? Well yes. And...

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...