The clinical research path I know would not be something for me. But I do see it to be a good learning experience and provide a great base knowledge in regards to clinical studies and how the whole documentation process…   Read more»

I agree with the statement above that the clinical trials may be conducted depending on partially where the disease may be more prominent but the secondary is also the cost. This cost can be whether the company is directly managing…   Read more»

Both of the cases provided above are great representation of a clinical trial going wrong. Companies before reaching the clinical trial stage, they make sure the pre-clinical trials are successful and the device is effective. Also, the company makes sure…   Read more»

That is an interesting point to bring up. Within my current company, I have seen how teams are not allowed bring in more individuals even though the workload has increased. And it is unfortunate because it puts more burden on…   Read more»

From my experience, I am actually working on a project that currently deals with both. Due to regulation change in Asia on how the packaging is labeled, we were able to create the new product to reflect the change. However,…   Read more»

I agree that is a change in the quality system occurs, the projects would have to be evaluated and see if the change will completely change the parameters of the project or allow them to be grandfathered in. If a…   Read more»

With the way the GMP requirements are set up, it seems that it is trying to make any start-up companies fail. But as mentioned above, the GMP have general requirements to allow any style of company whether it is in…   Read more»

That is great input to this discussion so far. To add to the idea, the GMP is definitely required to also ensure that the product being sold is consistent. If the documentation used to make the product didn’t provide the…   Read more»

For the product life cycle, I do think that the introduction around the launch time frame can be very costly. At this point, the company places all the effort into the marketing and preparing for launch to have the adequate…   Read more»

Gp232, I agree with your call out since sometimes people do use those roles interchangeably and they are actually different. Product Manager is keeping track of the product as it evolved from the development phase to launch. I do believe…   Read more»

I do agree that both of the interpersonal skill and business knowledge are important during negotiation. However, interpersonal skill should definitely weight more since that is the drive that provides the trust to the customer of the product you are…   Read more»

I agree with the statements above. I have seen, similar to Michelle, how a product is placed in the development stages and had the approval of the company based on the market but towards the middle of the project it…   Read more»

I personally do not have a direct experience to link a product failure but there are some common reasons for the failure to occur. The device can experience some form of contamination whether it is from a chemical attack or…   Read more»

I agree with the key aspect of the post-launch product management being having the correct sales team to help push the product into the market and be a helpful resource to better understanding the nature of the product. Another key…   Read more»

For my experience, this is the fourth class I have taken with Dr. Simon and the content itself has been very helpful to relate to the industry. For instance, the two series of medical device development definitely helped me understand…   Read more»

I agree with the posts above. The investigation is definitely a key parts that should occur first to be able to find the answer. Even though sometimes it is a long process to find the issue, there are times that…   Read more»

It is a good point brought up that the setbacks are definitely crucial to be taken into account during any product planning process. And with my experience, I have been in companies that make sure to have a six-month supply…   Read more»

I agree with the posts above. The ISO standard provides the flexibility needed to accommodate the needs of the companies but still providing the necessary regulation to process output. But from the FDA side, it provides the monitoring through the…   Read more»

When encountering the movement of equipment in production, I believe that a re-validation is a necessary step. However, as some have mentioned above, it must be identified if a full Validation process is required in order to utilize equipment. This…   Read more»

Chris, This is a type of qualification that I have not encountered within my daily work but it is interesting to read about it. I found a few details that show how it can expedite the process a product to…   Read more»