Hey so what did you end up filing it as? This is interesting as I didn’t know you chose the notified body unless you work in regulatory then that makes sense. Even still I believe there are checklist involved and guidance to see where your product fits best, no?

So shouldn’t the EU also have systems in place to prevent tragedies? Shouldn’t they learn from the FDA and take precaution? I personally think that the FDA might prohibit research and great products to coming to market quickly but at least they will be safe. If always been weary about the EU device agencies.

Hey I agree that this is true but it also makes me worry about products coming from the EU. Due to the fact that the process is quicker and easier are product equally safe? I can’t imagine shortened/non-existent clinical trials for devices and drugs.

Hey gh56,
There is a graduate course on BioMEMs with Perez and it is very interesting where we read plenty of articles about the current practices. Yes I have been fascinated by 3D printing for a long time and I hope one day I can be a player in the field. Also Anthony Atala in Wakeforest has one of the leading institute in 3D bioprinting in the…[Read more]

Hi Andrew,
Yes this is a very common trend, that depends on company size but. My company is fortunate enough to have comparative medicine onsite so they do a lot of our pre-clinical animal studies but we do use CR as well. However I think there is a little bit of a push back going, I know for us upper management has decided to just expand our…[Read more]

Hi Andrew,
Yes this is a very common trend, that depends on company size but. My company is fortunate enough to have comparative medicine onsite so they do a lot of our pre-clinical animal studies but we do use CR as well. However I think there is a little bit of a push back going, I know for us upper management has decided to just expand our…[Read more]

Hey,
I also work in the pharmaceutical industry but I try to keep my self up to date with 3D printing for regenerative medicine along with BioMEMS. These two trends are huge and I personally think really are the future. BioMEMs is being used for therapies right now and being looked into for mini organs for diagnostic, testing and hopefully…[Read more]

My company also has rules against gift giving for protection against lawsuits. Personally I think instead of restricting the process they should just ban it. Doctors shouldn’t have to be bought and should just go off of the science or have patients chose products between companies. I recently learned that certain doctors office only stock drugs…[Read more]

I find that to be very surprising as I did not know verbal agreements were something that is acknowledged by the law. The quote above says “as long as there is enough evidence” but what is enough evidence? An email discussing the topics that were discussed in person? I don’t see why anyone would have an oral agreement in a business setting.

I thought this course was very useful as well and I am already working in industry. I liked that you showed us every division within medical devices and their importance. Honestly I wish I took it before I started working as my job search would of been different. Thank you for all the information!

As a lot of people have mentioned choosing your team members is not that realistic in the real world. People are just assigned projects based on their role. It would be best and helpful if the person is also knowledgeable and hopefully they are. The best thing one can do when working in teams is to stay open minded and constantly communicate. Most…[Read more]

Hey,
Thanks for the link. If I were to start my own company I would go for a matrix organiation as it makes the most sense to me. I think the combination of functional organziation and project base divison is very common in our industry. Departments whould be structured by function and there should be cross talk between departments. Not only…[Read more]

I am not sure what type of organization my job is. It seems to be a mixture of functional and matrix. Project managers are assigned to a project from their manager and the project can expand to different departments/groups depending on the stage of the project. My current project involves R&D, robotics, sample management and high throughput. Yet…[Read more]

Wow, that is very interesting. I didn’t know that you had to pay to view standards but it makes sense. As Kaitlin said they are essentially doing you a service by helping you stay in compliance. It is comparable to hiring a consultant for something (really expensive as well) or doing hours of research on your own? I am not sure how expensive they…[Read more]

In pharma risk analysis deals with biologics so all suggestions and concerns from the team are used to create the animal study. For example we recently were working on a drug and we feared it would have a certain side affect so during the animal study we paid closed attention to check for the side effect and it did appear so formulation had to go…[Read more]

I think mistakes should be taken into consideration when making a gantt chart.There should be room for error for materials and even in the lab. There should be a soft deadline and a hard one with weeks in between in case things go wrong that you cannot plan for such as equipment failure or etc.

I think there are pros and cons to outsourcing and it is dependent on your device and companies. Some companies lack infrastructure, or manpower and have to outsrouce others don’t and keep it inhouse. Other companies outsource so they can use their people to move on to other projects. Yet outsourcing itself is difficult. Even after visit have been…[Read more]

While these are all good points no one has mentioned simply scale up. Everything on the design sale or in R&Dis on a smaller scale and transfer to manufacturing is just difficult. If parts are being machined machines have to be found that can create small parts in duplicates, they need to be well maintained. If the product requires a chemical…[Read more]

That is interesting, before I red Dr. Simons comment I also thought it was needed as a lot of the things in the deism control seem to be standard steps in device development. In terms of which one is better I also think that the continuity of a DHF makes more sense instead of the snapshot. Snapshots do not tell the whole story and can be…[Read more]