Based on my experience, I disagree with those that say corporate culture can change in the blink of an eye. This is usually the hardest to change, and what some mistake for culture change is simply a change in moral. Moral can easily increase or decrease with some changes such as, hiring or firing of management or employees, stock price increasing…[Read more]

I have worked on several projects like this before with some good and bad outcomes. From an engineering point of view, this can be a pain if the work culture and engineering processes are different in both companies. Also, if there are intellectual properties that one or more companies are trying to protect during this collaboration, this can make…[Read more]

Hi,
In one my past job, I worked in a “Self directed cross functional team”, which I enjoyed and saw as having many advantages.This included creativity, such as each member offering an alternative perspective to the problem and potential solution to the task. However, without a good coach or leader, these team can easily fail if consensus is not…[Read more]

Hi,
In one my past job, I worked in a “Self directed cross functional team”, which I enjoyed see has many advantages and creativity, such as each member offering an alternative perspective to the problem and potential solution to the task. However, without a good coach or leader, these team can easily fail if consensus is not reached on any…[Read more]

I agree that sample size is critical to any project. I don’t have any industry experience with sample size related to risk analysis, however, I was able to find an article that talks able sample size estimation which was a good read.

http://www.sciencedirect.com/science/article/pii/S1532046414000501

Another method: Event Tree Analysis (ETA)
It is an inductive failure analysis performed to determine the consequences of a single failure for the overall system risk or reliability. Event Tree Analysis uses similar logic and mathematics as Fault Tree Analysis, but the approach is different – FTA uses deductive approach (from a system failure to…[Read more]

I had the experience of sitting in on a couple of risk analysis meeting, and this is early in the process when the team are trying to determine if the project is a go or no go. This prevent the company from spending too much time and money on a device or project to then deem it too dangerous or risky. As some of you have mentioned, these meetings…[Read more]

There are always pros and cons with outsourcing, however, this is not really dependent on the size of a company, but more so to do with time, cost or if you have the expertize and setup to do the job in-house. Additional when company decides that it’s going to outsource a product in development, a lot of time the manufacturer are involved in the…[Read more]

Meeting minutes are an extremely important part of any project, without this your project will easily failure. The bigger the project to the more important the meeting minutes are. Based on experience and as several you of you have already mentioned, most time test are quickly glanced over when sent out in emails. The issue here is, often time…[Read more]

I agree with most of that the FDA doesn’t demand specific test and to me this would be too much of an overhead and additional unwanted burden for them. I have some experience outside of BME with verification and validation, however, there is not much difference here. For each input requirement a test has to be created, and how to create the test…[Read more]

Design inputs can and will come from various sources. Depending of the type of design, input can come from the customer, market research, feasibility study, medical standards, past projects, FDA, ISO, etc. Also, design input can change based on needs of the end user, schedule or any of the above source.

I agree that all the parts are very important, however, I have to disagree with you on this point, that the communication management plan is the most important part of the DDP. Not that there is more important part, but my reasoning is that without any of the other parts, the project will fail, and I can’t see the communication being more…[Read more]

Fady,
This is a very interesting and also important subject matter. To answer your question, even products that were designed and built pre 21 CFR, has to have some sort of design and technical documentation somewhere, and especially so if these products were patented. They won’t be as completes as the DHF, however, we now have a starting point.…[Read more]