Tag Archives: product development

Project Management Chaos

Project management is a key to successful medical device product development. Sounds cliche, I know. But it is true. When project management is good, you know it. And of course, when project management is bad, you know this too. The trouble is we all experience poor project management more often than good project management. When you hear the term "project management", what thoughts come to mind? I suspect you instantly think of things like work breakdown structuresGantt charts, and MS Project. You might also think of organizations like the Project Management Institute and the PMBOK. Yes, these are all pertinent references for project management. When I refer to "project management", I'm referring to something more basic. I'm referring to a process of getting things done.

Project Management Certification?

I think...

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...