As many others have said the physician will face a pretty hefty set of obstacles. The main one mentioned was, of course, money. Without money no development can take place, and developing a medical device is an expensive project. Others…   Read more»

While I do believe that FDA classification system using a classification system based on the risk to the patient, I do think that there are some outdated parts of the FDA classification system. The risk based system makes sense since…   Read more»

I think that compliance should at least be considered from the outset. I think that disregarding compliance at the start and attempting to simply get rid of parts that won’t get past the FDA could easily lead to huge problems….   Read more»

Stability testing is of utmost importance for medical devices. However, while not medical devices stability testing is also important for pharmaceutical products as well. Considering how many different pharmaceutical products from different providers to treat a large number of conditions,…   Read more»

Like many others in this thread, I also would personally prefer to be involved in research that would be used immediate future rather than far later into the future. I personally would like to see the work that I do…   Read more»

I think that what the tougher challenge is really depends on the on the complexity of the specific scientific questions that need to be solved, that will vary from study to study. The complexity of the organizational and approval process…   Read more»

I don’t think that having a detailed plan, and having a flexible plan are mutually exclusive. You can plan for details ahead time in a way that does harm the flexibility of your project. Actually, I believe that incorporating details…   Read more»

I don’t think that having a detailed plan, and having a flexible plan are mutually exclusive. 

As other have said, managing multiple projects is very difficult, and a schedule and timeline is absolutely critical in the planning process especially so for multiple projects. Planning will have a whole new dimension to it as now you will…   Read more»

As others have said, I also think planning is holds the most weight in ensuring a project close out. As others have already said, the planning phase provides the foundation for which the project execution is based on. Good planning…   Read more»

@pz98 I agree with you that AI is one of the biggest improvements in industry. While you have brought up its use directly in medical devices and in pattern recognition in AI based software, I think AI may also have…   Read more»

I agree with the those who have said that BME as a degree feels a bit too broad compared to other degrees, at least as an undergraduate degree here at NJIT. One of the first things in noticed as an…   Read more»

I do believe that it is useful to pursue certification in medical device development even if medical devices are not their main focus. I do agree with points that other have brought up in how it is useful because of…   Read more»