Roberto,
Fady provides a great example. In my case, whenever dealing with business meetings, it is only the person that is part of the project itself would be eligible to receive the set gifts. Within the industry, these are aspects that are part of the employee training in order to understand the difference from holding an event for educational…[Read more]

My current work environment is a matrix organization. Within the procurement department, I have had the opportunity to be involved in different projects and collaborate with different SME’s throughout J&J in the medical device and pharma sector. It is an ideal environment due to being able involve in different projects that gain skills that can f…[Read more]

It is interesting that in my line of work, there are times that teams are formed due to what projects the team members were involved. And using that experience that can be leveraged for another style of projects. And that has occurred to me within my position. Since I was working on a project initially, my manager liked how I delivered that when…[Read more]

That is an interesting question Lamiaa. I believe that for a Matrix Organization, even though it is ideal, could pose more challenges to a project manager. One of the main reasons is due to sharing resources that sometimes need to be negotiated and possibly conflict with other schedules. So it is tough for the project manager to coordinate with…[Read more]

Risk cannot always be eliminated by design solutions. This is why medical devices use protective measures (i.e., – alarms) and inform users of residual risks (i.e., – warnings and contraindications in an Instructions For Use (IFU). The “ALARP” concept has a legal interpretation which implies financial considerations. Instead of claiming that th…[Read more]

I agree with the comments above. The acceptance leads to a high severity of risk due to the company not any additional steps to deal with the risk. As Dr. Simon has mentioned, sometimes it is cheaper for the company to allocate certain money for the risk of the product rather than dealing with reducing the risk. The mitigation and transference…[Read more]

This is an interesting discussion. The main one that I believe is overlooked is the lifecycle process of risk management. Most companies, as expressed by article, only work with this portion during product development. But is it important to also look at the risk during post market evaluation and see that the product is functioning. And taking…[Read more]

Good discussion topic. I found this interesting link that provides a helpful visual on page 3 to understand where Phase I Clinical Studies would occur. As per the source, it shows that as part of the design validation, the clinical trials would be done after the validation tests and reports are completed. Also, the DDP, DID, DSD and design output…[Read more]

Good discussion topic. I found this interesting link that provides a helpful visual to understand where Phase I Clinical Studies would occur. As per the source, it shows that as part of the design validation, the clinical trials would be done after the validation tests and reports are completed. Also, the DDP, DID, DSD and design output (including…[Read more]

Good discussion topic. I found this interesting link that provides a helpful visual to understand where Phase I Clinical Studies would occur. As per the source, it shows that as part of the design validation, the clinical trials would be done after the validation tests and reports are completed. Also, the DDP, DID, DSD and design output (including…[Read more]

The benefits to outsourcing the design transfer into manufacturing process are leveraging multidisciplinary expertise have breakthrough ideas from other industries and technologies and be able to expand without needing to maintain the technology in-house. Expand internal engineering capabilities helps to use the other company’s full time staff t…[Read more]

In general, validation is an important part of getting a product to market because it verifies that the user needs are met. Even though it may take up to a few years to complete, it can improve the launch success and reduce the chances of product recalls. Also, other benefits can include the reduction of scrap, increase in outputs, eliminate…[Read more]

I agree with the responses so far. One of the aspects that I think design controls help to bring out in the product development process is risk management. This is a way to take the policies, procedures, and practices to the responsibilities of identifying, analyzing, controlling and monitoring risk. Also, with framework is helpful to managing…[Read more]

I agree with what has been said so far. The design input is the document that provides the basic requirements of the product. It takes the input from different sources like marketing, sales, direct team, customers in order to obtain the general idea for what is in demand within the market. The customers provide the input due to needing the…[Read more]

I agree with what has been said so far. The design input is the document that provides the basic requirements of the product. It takes the input from different sources like marketing, sales, direct team, customers in order to obtain the general idea for what is in demand within the market. The customers provide the input due to needing the…[Read more]

Fady,

That is an interesting point to bring up. With combination products, if I understand correctly, the company must identify first the necessary center for the primary use of the product. Once it is designated into CDER, CBER, or CDRH then that would specify how the approval process would be for the product. Usually the pre-amendment device…[Read more]