Great question Talha,

The FDA’s intervention to prevent the release of Thalidomide into the US market is critical to how important drug trials and long term effects should be considered. If had the drug been released,the US market would have experienced the same tragedies as the European Union. If thalidomide had been released, I believe that the…[Read more]

Hi Roberto,

it really depends on how invasive the device may be, which will categorize the medical device. For example, the implantation of coronary stent is more invasive and is a “riskier” device when compared to band-aids for example. Essentially the classification of devices depend on the potential risk it has to the patients’s health.

Chris

Hi All,
Great comments, and I do agree repeatability and traceability are vital for a clinical study, and it really comes down to is how many patients can be monitored and evaluated, because as Luisa mentioned, if there are not staff members to evaluate a clinical study, then the quality of the trail may diminish. Patient evaluation is very vital…[Read more]

From my experience, i feel that I work within a matrix organization, my team operates by function and product, which overall exposes me to different teams and projects. I’ve had the pleasure to closely work with Quality, R&D and manufacturing during my team at Ethicon. In addition, I feel that a matrix organization is best suited for me due to the…[Read more]

Based on my experience with GMP, it is a vital practice that ensures companies in the eyes of regulatory agencies that there products are traceable, they meet all quality standards, meet regulatory agency standards, and are safe.I know with respect the manufacturing of microneedles, each needle is hand inspected by a technician for defects,…[Read more]

Design validation means that the right device was designed for its intended use, such as users requirements.

1) A diagnostic microscope slide that determines the presence of certain stem cell markers.
With Respect to the diagnostic microscope, it would not need a clinical trial because the microscope itself can not determine the presence of stem…[Read more]

Hi All,
I haven’t particularly dealt with contract, but I have dealt with the contractors that have done work within the facility through the contracts and from my experience it has to be very detailed, because often times these contracts may be vague and interpreted differently, as a result delays may happens and multiple parties have to be…[Read more]

Hi All,

I am currently working at Ethicon within Operations. As some of you may know or if you don’t know Ethicon is known for developing surgical devices or materials. One such device that they are widely known are there sutures and microneedles. Fortunately for me, I deal with the validation aspect for the manufacturing of sutures and…[Read more]

As a lot of people mentioned before, the biggest different is mainly documentation. A written contract is easier to dispute in court when compared to an oral contract. Often times, what is said can be interpreted indirectly or may imply something else. As a result, oral contracts tend to be harder to dispute within court. One should rely on…[Read more]

Hi Roberto,

In my opinion, I don’t think its too restrictive, you want to keep business within business, particularly with physicians, you don’t want to introduce bias to what your selling or attempt to bribe the physician. As Dr. Simon mentioned in his lecture and Fady as well, it should be kept modest and to the immediate team only. I’ve notic…[Read more]

As everyone above mentioned, this course really showed me how the medical device industry works, especially since I just started working within the medical device industry; this course proved to be a guide for me and a reference during work. Essentially, it provided me a basic framework to my ongoing real world experience.

Chris

Hi Lamiaa,
In my opinion working for in a matrix organization is more difficult for the project manager, due to the fact that cross functional team situation, such as sharing resources and staff. Often times multiple team members are involved in multiple projects with different project managers, thus coordinating meetings and deadlines may be…[Read more]

I have worked within both divisional: product-based and matrix organization. I would still consider the matrix to be organization structure of choice.In my experience within product-based, there were always issues regarding statuses or approvals from other team, communication was often lost, and as a result this hindered meeting timeline…[Read more]

Based on my current work environment, I would say my work organization is a matrix organization. I work within the operations division as manufacture engineer, so I closely work with multiple groups and I report to multiple managers. So far, I have closely worked with the quality operations and operations department. Since the medical device that…[Read more]

I do agree with the comment above, how severe a failure is by looking at the nature of the harm is a very important aspect. In addition, other factors that may potentially determine risk would be:
1) Vulnerability- which relates to the impact and likely hood of failure to occur, the more vulnerable the entity is to risk, the higher the impact it…[Read more]

With respect to medical devices that are used during surgery, lab technicians should be properly trained in aseptic technique, and both surgeons and lab technicians should be aware of how there devices function. I know for one product in the company that I worked in, there were complaints on how to use a particular surgical staple device… s…[Read more]

I haven’t had formal experience with risk analysis, but from what I understand of the risk methodology is that it incorporate all cross functional teams within the products development. Whether if it’s marketing or R&D Engineering, the concept of Risk insures that uncertainty will not impact business goals. All potential risks should be add…[Read more]

I have never actually been involved in a design review meeting, but I know from my experience within R&D and now in manufacturing. To me meeting minutes are essential with regards to project deadlines or even addressing potential issues or concerns with respect to certain products.I guess the only type of meeting that is similar to the design…[Read more]

Hi Lamiaa,

If design controls are not adequately used often time the concluding result would be the termination of the project if it’s in early phases or if it’s an approved project this could lead to lower quality product. Design controls ensure all phases in the product development lifecycle will reach an acceptable level of efficacy and saf…[Read more]

Hi Roberto,

Meeting notes are important with respect to relaying critical information on projects to creating timelines for projects. I know in my experience, during these meeting we update the team on statuses of projects, revise timelines with deliverables. Lastly, it is during these meeting were concerns are addressed and future projects are…[Read more]