Category Archives: greenlight.guru

Enterprise Software for Medical Device Industry

Many of you likely know about my current venture with greenlight.guru. For those of you who don't, we are developing a software solution to help medical device companies to better manage Design Controls. greenlight.guru is a targeted solution designed specifically for the medical device industry. We are maintaining laser focus to solve real issues and struggles the medical device industry has with specific tools designed for a specific purpose. As part of market research for our new venture, and just for general education purposes, I have been paying attention to all the "medical device" software solutions already on the market. But interestingly, as you dive a little deeper and start to understand the software options available, very few of the solutions have truly been designed for the medical device industry. In fact, it...

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...

How Do You Capture User Needs for a Medical Device?

Why do you engage in medical device product development? The ultimate purpose is to solve unmet clinical needs. To develop products, technologies, and services which sustain and improve quality of life. If your experience as a medical device product developer has been anything like mine, starting a new project is often very fuzzy and raises more questions than answers. How you start a project is very important. And this is something that took me many attempts before I truly understood. What do you need to start a new medical device product development project? If your company is anything like those I've worked with, chances are the reason to start a project is often times very vague. Basically, it boils down to someone making a financial commitment to begin the endeavor. But as a product developer, you...

greenlight.guru Helps Ensure Medical Device Design Control Compliance

You might have read about some of our adventures with greenlight.guru. Today, I'd like to share another chapter in this startup journey. We had a call with a potential investor / resource. The guy had 20+ years experience in the medical device industry. The purpose of the call was to share a little more about greenlight.guru and do a brief product walk through. As we did so, the guy had strong energy about him. Every time we would offer an opinion, comment, or share details about the software, it felt as though he was bringing bad juju and negativity. Going into the call, I had good energy and an open mind. Right after the call, I felt like someone ran over my dog and slashed my tires. Now that there has...