Well, Dr. Simon, when I first signed enrolled in this class, I was expecting it to be really more about medical devices and theory that goes into that. I was kind of caught of guard with how it is really more about how the medical device industry works. That being said, the class is very useful, even for someone like me who has seen some of these…[Read more]

It’s been my experience that project teams are simply made by allocating personnel from each function that have less responsibilities with other projects. Sometimes, people with some expertise or knowledge necessary for the project are pulled in, regardless of their schedules/responsibilities, but generally I have never seen teams being formed…[Read more]

My work setting seems to fit best as a matrix-type of organization. There are functional departments as well as project teams and project managers. However, while there are projects that involve various departments, there are also projects within departments. There are also projects within department sub-groups. Because of this complexity, project…[Read more]

The way it was done in my previous job was to use a quality by design matrix. Critical quality attributes (CQAs) were determined based on the design input and then critical development parameters were selected. A risk ranking was then assigned to each parameter based on the theoretical knowledge of how the parameter could affect each of the CQAs.…[Read more]

Two other methods are:

Hazard Operability Analysis (HAZOP) – Based on a theory that assumes that risk events are caused by deviations from the design or operating intentions. It is a systematic brainstorming technique for identifying hazards using so-called guide words. Guide words (e.g., No, More, Other Than, Part of) are applied to relevant…[Read more]

Two other methods are:
Hazard Operability Analysis (HAZOP) – Based on a theory that assumes that risk events are caused by deviations from the design or operating intentions. It is a systematic brainstorming technique for identifying hazards using so-called guide words. Guide words (e.g., No, More, Other Than, Part of) are applied to relevant…[Read more]

I’ve wondered about this as well, especially because in academic research I’ve needed to look at ISO standards and I wasn’t going to pay for them. I found this information given by ANSI: https://ansi.org/help/charge_standards.aspx. It seems it is really just about the costs associated for the organizations to write, administer, and supply the…[Read more]

This is an interesting question, which brings another question to mind: would design transfer activities even have begun at phase I clinical studies? I ask because typically for drugs and biologics, transfer to manufacturing is not done during phase I, since low volumes are needed. Phase I studies are run with very small number of patients, which…[Read more]

I can only speak to my experience, but generally it’s been as Roberto pointed out. Nobody really pays much attention to the minutes and they are more just for documentation purposes. The team or project leader always sends out revised timelines with deliverables after every meeting, followed by the minutes. Since we always operate based on what…[Read more]

If quality by design is used in the development of the product, a simple way to come up with tests for verification/validation is to just use characterization techniques that have been used to measure the critical quality attributes all through development. As long as the testing technique is reproducible, scientifically sound, and not complicated…[Read more]

I disagree. For a smaller company, it is usually more cost effective to outsource manufacturing because they rarely have the infrastructure required for production. It is usually larger companies that are producing many products that can justify and afford the facilities, equipment, personnel, expertise, etc. for in-house manufacturing.

However,…[Read more]

Many things can go wrong during transfer. For example, if the design specs heretofore have all been for a product made through a different process and/or scale than what will be used in manufacturing, the release specs may have to be modified. Testing protocols for specs have to be properly documented and quality control personnel must be properly…[Read more]

It seems that the DHF is superior to the Design Dossier or Tech File in it’s thoroughness and documentation and that is why there seems to be a move in the EU toward the use of a DHF instead.
From the same link that pt58 posted: “Newer EU regulatory guidance documents are moving the TF/DD more in the direction of the DHF. However, a review of both…[Read more]

I found a presentation that was put together by BioTechLogic to address this issue (http://c.ymcdn.com/sites/www.casss.org/resource/resmgr/2016_CMCS_TreDenickTracy.pdf). It seems like it is a very involved process and I’ve just listed the major steps below:
1. Quality System Gap Assessment
2. CAPA
3. Form Cross Functional Team
4. Develop “Device F…[Read more]

It’s important to add that when revisions are made to the design controls, change control procedures must be followed and documented. The FDA is very strict on this, since good documentation practices require that everything be documented or else it didn’t happen. Furthermore, change controls require valid justification and cannot just be executed…[Read more]

I assume that sources of design input would be marketing studies on what type of product is needed, key opinion leaders, and scientific experts. In the lecture, Dr. Simon commented that marketing puts this together through customer opinions and development team input. Design inputs can be such things as how the device should function, how long it…[Read more]