Great topic, and I read an article with regards to shifting clinicial trials to third world countries because of the cost and the not as stringent regulations in other countries.
http://theconversation.com/ethics-vs-economics-the-cost-of-outsourcing-clinical-trials-to-developing-countries-43246

My biggest motivation at work is the impact that the product that I work see manufacture has on the patients. In addition, my ambitions come from my family and friends that inspire me to go a step further than what I should. My overall goal would be to innovate and design devices that will enhance healthcare.

Chris

The best method to motivate my team members, if i was a project manager, would be to show the influence the product being produced has on the users. For example, show the logistics on how the product is growing and its impact to the applicable patient population. As the comments mentioned above, this motivation is heavily depended on…[Read more]

As someone who works within the medical device industry, I am kind of surprised how “meaningful work/ make a difference” is listed so low. I know the engineers that I have spoken mostly stated that they want to make a difference or introduce innovation that can improve mankind, but that was only speaking with R&D engineers so it may be slightly…[Read more]

I don’t have direct experience within procurement, but I know that procurement is very contract oriented and once these suppliers are approved into the company, the company essentially has rights to be purchased from the company. In addition, approved vendor may have the ability to be qualified for inspection incentives and aid in the…[Read more]

During summer internship, my main task was to reform out of a particular raw material. My internship consisted of several parts, which also incorporated a potential introduction to a new process change, if given enough time to complete the reform. During the conclusion of my internship, my second project i.e. the process change was a potential…[Read more]

From my experience, I am split between two departments, but I directly report to one. When the department that I am hired doesn’t have a major project in the works, I am sent to the quality department to help them with their projects. I do not deal with project managers in particular, but I have two managers that i report to. There is a lot of…[Read more]

As Viraj mentioned, the CAPA itself is used to find the route cause of non-conformity and a method to address the NC, while creating a way to prevent it from happening again. During the CAPA execution, documentation may change such as SOP’s and process specs, which leads to the correction action itself.

We are actually doing an internal Audit either next week or the following. The biggest advantage about the internal audit is that potential issues can be addressed early before the outside auditor arrives. A corrective action can be initiated to address these problems early, thus when the external auditor arrives they are aware that actions are…[Read more]

I have personally dealt with a non-conformity, on a material that we manufacture, the material failed one of the critical inspection areas within Quality assurance, which opened an investigation to find the route cause of what caused the failure within the manufacturing aspect. A CAPA was opened to address the problem and correct it.

Ambiguity of GMPs for start up companies are completing understandable, I believe that is is a learning curve for these types of companies, because their product is being initialized in production and there are no pre-existing GMPs nor standards. As these GMPs are created, the standards will improve. So essentially vagueness of GMPs in the…[Read more]

In a No GMP aspect, I use to work for a company that did not utilize GMPs, and the process to upscale a potential product from lab to production became difficult at times, because methods that could replicate the lab scale were not utilized and it was very inconsistent in the amount of raw materials used to make these batches. At time it became…[Read more]

As technology improved, so has the ability to manufacture goods. I know from my experience, this improvement has constituted to an increase in areas of inspection or in other words inspection techniques have become more strict and controlled. All aspects of manufacturing at checked to ensure that the product meets/exceeds all company standards.…[Read more]

Based on the provided information, I agree with the assessments above, I believe that a change order would be needed and this change should be addressed with R&D and Quality. In addition, a risk assessment on the device should be conducted for different variable of risk to the patient. Since the change is on a finished product, there could be a…[Read more]

I have never personally done a design change from an initial design standpoint, but I have made Engineering Change Orders on documentations post the design change. Essentially these change orders have to be approved by R&D, Quality, and the effected area. Prior to initiating the change order, I would set a meeting with these team groups and…[Read more]

An example of risk that I have personally worked with was the creating of SOP’s for in process checking, the SOP that was created ensured proper inspection of the manufactured product. We had to ensure that all operators were trained properly on the SOP so that our product would be manufactured to company standards. As part of the team, I have to…[Read more]

In my opinion, I feel that Research and Development is probably your highest investment, you want to ensure that the product you are developing meets specific standards and criteria’s, a project after designed can undergo trials, where they fail or pass. If lets say they do pass clinical trials, the ultimate question would be how much money would…[Read more]

As you mentioned, recalls may be detrimental to the reputation of a company. Particularly the possibility of litigation. Below I attached a link to an article about a lawsuit that is currently happening with Merck.

http://www.investopedia.com/news/mercks-zostavax-drug-hit-lawsuits-mrk-gsk/

I completely agree, to be in business you have to have an the knowledge of industry and most importantly the ability to speak and negotiate with potential buyers. I know I personally deal with a particular vendor and he goes to great lengths to show us that he sells the best products, it goes to the point where he would give us a piece of…[Read more]

I agree with the comments above, it is difficult to point at which role would be the most critical for a project manager. If I were to take a guess, I assume that creating the story behind the product line. As Andrew mentioned earlier, their are great and innovative products out there but don’t have a story. In addition, from my experience, the…[Read more]