Going off of what srg36 said in response to moniquet07, I think the project scheduling would need a “Clarification” or a “Agreement” step. This way all parties know what they are up against, and if something is not correct (either…   Read more»

This is a very interesting case to me. I honestly wouldn’t know what to do. In my life though I have always found that honesty is a better policy. Releasing a product and banking on a placebo test is probably…   Read more»

The planning phase sets the foundation of how to complete the project. When this phase is not executed properly, then project could be terminated or not worth the money for funding. It’s a pain to go back and re evaluate…   Read more»

I volunteered in a tissue engineering lab and we were working on trying to make a bio-ink with a decellularized pig heart. We had researched previous inks and composition models and did what we had to do. At the end…   Read more»

I think it depends on the device in question. While I think engineers are a key aspect of the building part and setting limitations on what can and cannot be done, when it comes to designing something like a prosthetic…   Read more»

Scope management is an important part of the company to inform the public and potential investors the projects description and heading. Its helpful for the company to have this timeline because they can use it to meet deadlines and allow…   Read more»

This topic brings to mind the end of any commercial and how there is a long list of things that may happen based on their statistical analysis. For devices, their risks seem to incorporate an entire warning’s page (or something…   Read more»

I think we can all agree that the classification comes from the risk and novelty of the device. However when preparing my response for another forum post, I learned that this classification system was made back in 1976. And according…   Read more»

I think she is making a great point. Though I haven’t read the book, from the sound of it I can see it has value. While funding and business needs the “easy” class system to report new devices, I think…   Read more»

I think this is interesting because I want to say that companies should go for it. For established companies, they would have ann easier time looking to the future and establishing new ideas than a company more involved with competition…   Read more»

As a scout we had a very functional organization. We worked in patrols, we had an assistant Patrol leader and a patrol leader. They got together with other leaders and executed decisions made be the senior patrol leader. I did…   Read more»

As a kid I was in the Boy Scouts. We had 4 different patrols, each with a Patrol Leader and his assistant, and then there was the Senior Patrol leader with his two assistances. Even though there was no “skill”…   Read more»

I think there are pieces from every post before mine that are critical in what should be included. I agree, to an extent, with what all of you have had to say. I think it needs to be improved by…   Read more»

I would still say no, the fitbit does not need to be regulated. The CDRH defines a general wellness product as “Products that are intended for only general wellness use and present a low risk to the safety of the…   Read more»

Going in line with the example in the question, there are different coating on implants used to stimulate specific responses. For example the Hydroxyapatite coating on a titanium implant to convert fibrous tissue to bone around loaded implant. The implant…   Read more»

The Lifevest would have to be a Class III because it has the potential to save a life, though is a great risk to the wearer. Because the response of the mechanism is based off the persons heartrate, there is…   Read more»

I am a little torn on this. On one hand, I believe they are different and yet on the other I say not. Project managers are in charge of obtaining the end, desired result. This is alike for both professions…   Read more»

I may be going out on a limb here, but I think board games could be considered something of a general wellness product. It would be of the first category because games don’t reference diseases or conditions (other than operation?…   Read more»

I agree with what has been stated before me. I do not think the Fitbit should be considered for FDA approval; as it does not make any medical claim. This function of the watch is merely there for convenience and…   Read more»