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 what is most often done but I would hope not to be done otherwise. I would ask for an extension, or make an appeal to the FDA hoping to come…[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 what needs to be done, I think it needs to be done at times to make sure the project can come to fruition. Thus I think that y…[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 of it all, we were ready to put it through the printer and then we had realized that the printer heats up during the printing…[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 you would want someone focused on the biomechanics spearheading the project. This would ensure the design of the device meets all…[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 others to expect a certain outcome at any given time.
I would plan the scope management to be agreed upon by…[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 of the sort). I can think that the only reason why the product is on the market is because the warnings, or risks, s…[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 to the link – https://www.fda.gov/MedicalDevices/NewsEvents/News/default.htm – there have been very little updates…[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 it should be adjusted so the devices are updated on their public records. I get that just because you make a slight modification to an already…[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 and needing to consider the risk more over reward. That being said, I want all companies to invest in the…[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 like this method as a growing teen, I thought it was helpful to have such a clear cut way of “who’s my boss?; who’s his…[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” separation, this reminds me very much of a functional organizational system. I do like this system for organizing the rascals we were, but…[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 management, and to give the company reasons to fund your idea. The proposal should not only include what ks629 and ial4 said, but also a realistic factor.…[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 user.” The fitbit is a good estimate and accurate to an extent but there’s a reason a doctor will still take their own reading inste…[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 itself would have to go through the CDRH and probably be a class 1 device as there are…[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 concern for what conditions would warrant a defibrillator, so I would recommend talking to the physician to make sure an ICD wouldn’t be b…[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 but differs when considering the end result. Clinical project manager is typically only involved with medical settings. This includes ensuring…[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? – kidding). In general though a board game stimulates our brain. Take pictionary for example. You have to be…[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 for those trying to get a general idea of what their current lifestyle is, and how they can change it to reach a goal. One should not…[Read more]