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 potential customer’s being aware of the product. It is tough because at this point the company is still not sure how the p…[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 that the most critical is understanding factors that affect the product sales. This portion definitely provides…[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 selling. Also, providing the technical details is important but with the mix of the interpersonal…[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 was put on hold. Also, the resources that were heavily invested on the project were all re-allocated to higher priority projects to…[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 foreign substance. Poor molding of the device is another reason that can lead to a deform before the device reaches final…[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 aspect within this part of the cycle is having the correct project team to track of metrics, dealing with regulatory…[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 the process of the product design process. Also, all the training I had to go through like SOP’s and processes t…[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 time and money can be saved due to the thorough analysis. I have seen in my previous experience that any movement of the equipment may…[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 of the items required on the shelf just in case a supplier runs into issues with providing the adequate items. In addition,…[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 whole lifecycle of the product to provide a consistent quality. Although they are both similar, they…[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 is important because the company needs to ensure that the equipment is still able to produce 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 is important because the company needs to ensure that the equipment is still able to produce the…[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 market. An example is two companies coming together in a single contract partner to product quickly their minimally invasive laparoscopic…[Read more]

This link definitely provides a great representation of the difference between the two. Some key aspects of the DHF that are mentioned are that all the activities during the design and development process should be properly collected and should be compiled as you go. Also, how is it important to have the design outputs along with design…[Read more]

I agree with the comments above that an SOP is a step by step process that provides guidance to the person reading the procedures. In addition, the type of detail that goes into the SOP is crucial to accommodate any worker so if for instance you bring a person from outside the company with no prior knowledge, they can read through the SOP and be…[Read more]

I definitely agree with the QMS system in a small company can start off with various obstacles. But in a sense, it is a necessary rite of passage to get the base standards in place. The tough part is beginning the process and getting the team trained to understand the requirements for the quality manual, quality procedures and records.
Within the…[Read more]

I definitely agree with the QMS system in a small company can start off with various obstacles. But in a sense, it is a necessary rite of passage to get the base standards in place. The tough part is beginning the process and getting the team trained to understand the requirements for the quality manual, quality procedures and records.
Within the…[Read more]

I definitely agree with the QMS system in a small company can start off with various obstacles. But in a sense, it is a necessary rite of passage to get the base standards in place. The tough part is beginning the process and getting the team trained to understand the requirements for the quality manual, quality procedures and records.
Within the…[Read more]

As mentioned above and within Dr. Simon’s video, the ECO is required when the design controls are finished and the device needs a change. With this, it may create more modifications within the regulatory aspect such as SOP changes, additional work in verification, risk analysis, and even animal studies. And requiring those changes to be added i…[Read more]