I think a reasonable location has to be somewhere where the main purpose is the meeting itself, with no other unrelated benefits. So places like meeting halls, restaurants or a hospital would be considered reasonable places to discuss a contract…   Read more»

While there are a few things I would want to know before signing an NDA, I agree with other posters that they are not something to be avoided at all cost. I would be ok with signing as long as…   Read more»

The obvious reason for choosing a written contract over a verbal one is that verbal contracts are more challenging to defend or enforce in court, but another key advantage of written contracts is setting clear expectations. It is a long…   Read more»

I think going above your management to senior management is usually a bad idea, and can engender negative work environments. If you believe as a manager you can implement certain techniques and processes to increase productivity and results, then you…   Read more»

I think keeping everyone talking and in communication can be a great benefit to a project team. Having a once a week meeting, even just for 30 minutes, where a rotating team member can give a short presentation on their…   Read more»

I think one person having decision making powers can be a bonus when kept to specific, time-limited scenarios. When the person making decisions has lots of experience and a clear idea of what needs to be accomplished, the freedom to…   Read more»

I think the greatest tool you have in this case is historical data. In most cases, unless your product is truly revolutionary, there should be at least a few devices that have gone through the entire development cycle and have…   Read more»

I don’t think acceptance changes the probability of risk in a situation. I believe it just means that you are ok with that probability combined with the severity of a situation. This process was mentioned in the lecture as not…   Read more»

Learning about all the different fields in medical device development so far, I have seen a large overlap in responsibilities between the different teams like Design Control, Risk Management and Quality Assurance. This leads to a lot of similarities and…   Read more»

Literature research can be a big help in designing success criteria for a study. Looking at similar successfully released products can provide a great roadmap on defining what success means. This is important to do well the first time, because…   Read more»

The Design Transfer Document is the answer to the first question. As long as all inputs/outputs are exhaustively documented, production errors should be kept to a minimum. Keeping a member or two of production in the loop during creation of…   Read more»

Design minutes, while often ignored, I think are a very valuable tool. For one, they help to ensure accountability. If minutes are kept, they can always be referred back to if someone was given a responsibility or a decision was…   Read more»

Software validation is a great feature that can help in many ways. One big help is in customer satisfaction, if the software for a product works as expected and outputs the required information, less time will have to be spent…   Read more»

As mentioned in the lecture, some companies do not take Design Control seriously, and instead create these documents as an afterthought, and just fit the already created methods into the required formats. This can lead to major problems downstream. For…   Read more»

While it is certainly possible to overdue it, I think logging more inputs then you think you will need is a smarter way to go then just logging the bare minimum. If failures start to occur in the device and…   Read more»

From my understanding, if a study is properly designed with an actual placebo control group and a treatment group, and the treatment provided to the treatment group was also a placebo drug it should be pretty much impossible for that…   Read more»

Environmental factors can play a huge role in clinical trials, creating effects that wouldn’t be seen until a larger role out happens and post market research is done. For instance, if a pain study is done in a small country…   Read more»

Placebo must be controlled at the group level in order to ensure results are not biased because of it. One group should be set aside and receive placebo treatment for their pain, while the other group should receive actual medication….   Read more»

One of the best marketing methods I have seen in the past few years has been on a weekly comedy podcast I listen to, Bill Burr’s Monday Morning Podcast. Ad reads, scripts sent by companies for the podcaster or radio…   Read more»

I have been working as an engineer in neuroimaging research for the past 5 years, and having a good relationship with sales rep has been a great boon to our research. The equipment we buy has a large ticket price($50000-$200000),…   Read more»