Manolo you didn’t really address my point of even if there were no regulations, the cGMP violations would eventually cause some problem. Probably people getting sicker/dying. That would cause lawsuits and the loss of reputation I talked about above. That would lose them much more money than the amount they’re losing now due to not being able to…[Read more]

Anthony, I’m not sure that employee and contract payments are the issue in that. Full time employees get salary, so they usually would be working on another project/aspect if they finish early. Contractors get paid hourly (for the most part) and if they finish they either stop getting paid, or they get moved to another aspect/project. I don’t know…[Read more]

From what I’ve seen there’s a few things that happen. When making a timeline, if the task seems similar to previous tasks, they will use the previous task’s timeline as an indicator of how long it will take. There is always opportunities for extensions depending on importance, and finishing earlier than previously thought is never an issue. Entire…[Read more]

I’m not why you have a question about this, it seems pretty straightforward to me, even if you look at this through a purely financial lens as opposed to a morality lens. I assume that you believe that it’s the right thing to do so I’ll argue my financial lens point. If something went wrong because you haven’t implemented the safety features you…[Read more]

Building in delays is a good idea, but one thing no one has talked about is how long that buffer should be. You can’t make it too long or else you may give the impression that the project shouldn’t be done by an earlier date of nothing goes wrong. That extra time may make people complacent, which is the wrong result of what this is intended for.…[Read more]

I’m not 100 percent sure on what your point is but I’ll try to answer to the best of my ability. The only situation I can see when that might be an issue is when a project leader gets promoted to a higher position which may have the ability to choose the continuation or end of a project. It’s probably too rare to talk about though.I agree with…[Read more]

If you look at every person that works their way up in the company, there’s one thing they always have: strong interpersonal skills (or are at least improving those skills constantly). There’s a saying at Merck: “When you think of the patients first, the profits follow, and when done so they have never failed to follow”. It also applies to those…[Read more]

ajm73 I agree with your sentiment that some countries will not recognize it. They will definitely have some of their own specified regulations. For example, most regulatory agencies as I said before have de facto standards because it’s a basic requirement for all countries. I know that your sentiment is true because it’s happening already! Most…[Read more]

This is an interesting question and I haven’t heard of such a thing before. The short answer is: they have to worry about it. The FDA is a national regulatory agency, but states have the right to pass their own regulations. They usually end up being more strict (I can’t say I’ve heard of the reverse). If states will refuse to let a company…[Read more]

I mostly agree with what what said above. I believe there is a hierarchy of importance. First, the device needs to be within tolerance of it’s designed use. You can’t have an implant that is too big or small from it’s designed size. Next, you need to have the correct tolerances in the parts. If the pieces won’t fit together properly, it’s not a…[Read more]

For most companies in the BME industry, they operate globally. This means that they have to adhere to all of those nation’s regulatory agencies. There are agencies such as EMEA, CFDA, ANVISA, etc. that come to the US to ensure regulatory compliance. Not all companies that try to sell to the US have such regulations. For the US, companies follow a…[Read more]

I feel like the point that verification/validation will not always pass needs to be brought up more. Companies need to keep in mind that the verification and validation steps will not pass, so that if they fail the timeline is not drastically affected. Failing either can set a project back months if not longer. As to the specific when should…[Read more]

Most companies invest in potential projects until there are serious signs of non-viability. They spend millions on R&D for that purpose. Every project has the potential to become the next breakthrough in the field. As said above, if they can’t internally fund, they will usually look for grants or venture capitalists. However, these are usually for…[Read more]

I agree with both zbw2 and alexandra. The FDA establishes minimum requirements in terms of safety and testing. Many companies choose to hold themselves to a higher standard. If something goes wrong, they can lose millions in terms of recall or settlements. The hits to their public image also affect their sales and stocks. I’m not sure the FDA can…[Read more]

Well this is an interesting point. Acupuncture has been done for centuries, so safety doesn’t seem to be a concern. However, the needles have been known if migrate if left in the body. Whether or not it is effective is also still in doubt. There would need to be more studies for the FDA to decide whether or not to allow it’s continued practice or…[Read more]

May 2018 saw the signing of the “right to try” bill into federal law. It allows terminally ill patients to try experimental drugs, biologics, and devices that have completed phase I testing but hasn’t been FDA approved. Whether or not it is ethical is a different argument, but according to your question there are systems in place for “emergencies”.

A missing or erraneous label means that the product can not and should not be used. FDA regulation is strict for a reason. If anything is wrong with the product people can become very sick or die. The amount of money lost due to a recall is nothing in comparison to the worth of the patient. For most drug companies, those that put people first…[Read more]

I’m not a fan of giving either percentages of importance. It may differ from situation to situation. Of course, both are important. You need a have a good handle on both in order to be effective. Knowing what needs doing isn’t helpful if you can’t convey it. Then you might as well have no technical knowledge at all. Interpersonal skills are great,…[Read more]

It is a tricky subject. On one hand kickbacks are an obviously bad thing. However small gifts are good ways to start/improve relationships. I think that $100 is a good cap, and limiting it to the physician only seems to be a good idea. I’d want to learn more about what people actually do in terms of business relationship-building but a small cap…[Read more]

This course has been really useful, and I know I’ll be looking back at these forums and documents in the future. The information is well rounded. I wish we could have gone a little more in-depth but with the amount of time and the knowledge of an advanced class that does so I can’t complain. I’m still not entirely sure which aspect of BME I’d like…[Read more]