Eli Lilly Co was involved in giving kickbacks to doctors for many years involving diabetes and osteoporosis drugs. They gave free nursing services to those doctors. The nurses were supposed to health the patients manage their disease but instead strong encouraged the patients and doctors to use Eli Lilly products. It eventually led to kickbacks to…[Read more]

I would ideally want to work with people who I like as well as people who are experts. When I worked at General Dynamics Electric Boat, I collaborated with people who worked at the Naval Research Laboratory, Lockheed Martin, small vendors and of course, representatives of the US gov. I didn’t choose who I worked with but I liked everyone who I…[Read more]

I think the best way to get rid of the negative competition is to develop a rapport within the company between employees. This is done through company events. At a nuclear plant I use to work at, every year they had a huge clam bake. At other companies, they have a family day at six flags. These strategies save the company money because it have…[Read more]

When I worked at General Dynamics Electric Boat, I feel it was more of a functional organization. The functional heads have a lot of power. I had a great rapport with my functional manager so I didn’t mind it but I could see where problems could occur. The functional manager typically wasn’t a technical expert or knew what was going on in…[Read more]

To run a risk management meeting, first I would identify the technical experts that are related to that topic. Then I would get everyone in a room and I would have a brain storming session. I would first start by identifying the stakeholders. Then for each stakeholder that we brain stormed, I we would think about their individual risk associated…[Read more]

As a nuclear engineer, risk assessment and management is very important. I wanted to highlight on one of the risk analysis tools used for risk management for nuclear power plants. When I worked at a nuclear power plant, I used Bayesian updating to predict if a system would fail in the plant or not. We would try to turn on the system and every time…[Read more]

For high severity risk, I would use avoidance. I want to get rid of the high severity risk. The best way to do this is by avoidance because mitigation just lowers the risk of it happening, acceptance is just accepting it and transference still lets it happen. Avoidance and getting rid of the problem is the best solution when you know the…[Read more]

To make a successful validation process you need to clearly state your inputs and make sure they match your user’s needs. You must think critically about what each input means so that you can design a test that covers that. You must also clearly define what is a pass or fail for each input. If you don’t clearly state this in the validation process…[Read more]

I choose a Band-Aid. The verification protocol makes sure the inputs matches the outputs. I believe the inputs would be that it sticks to the skin but can be removed without much force and that it doesn’t irritate the skin. A verification test would test for this. I think the verification protocol would call to first test the stickiness on the…[Read more]

Design review meetings are critical for the success of the product. At my old company whenever I held a design review meeting, I would send out all the materials a few weeks before the actual meeting. I would ask the recipients to review the material and give back comments within one week. Within 1.5 weeks, if I haven’t received any comments, I…[Read more]

Above, a lot of people listed all the requirements but I wanted to elaborate on one. I think the FDA looks to see that the design changes were implemented. This might seem trivial but its something to look for because people actually overlook this. They might have identified a problem earlier and there is documentation for that. They might have…[Read more]

Without sufficient design controls, a number of things can happen. Entire systems can fail due to the inputs not reflecting the standards of the industry. People can get fired after those entire systems fail. Without complete and accurate design controls there is nothing to ensure that people are getting a quality product that is safe. From the…[Read more]

As Adrian stated above, past projects are a source of design inputs. To expand on this, the Design History File (DHF) of other similar projects would be a source of design inputs. The key to choosing design inputs is to find something that satisfies the customer but is also practical. The customer doesn’t have the history of designs that failed or…[Read more]

I think the advantage of a clinical trial is being about to actually see the product of years and years worth of research. To get to a clinical trial means that there was a lot of data that got it there and this is the climax. This is where we actually get to see if that research paid off and if we are actually going to get to help people. The…[Read more]

I would be a clinical project manager. I am good at looking at the big picture and the main goal of the project but also break that down into small pieces and organize and motivate people. I learned this while managing projects for the government while working for the defense contractor General Dynamics Electric Boat. As I stated in another post,…[Read more]

I think they should put more emphasize on just making sure the person can think critically and actually has a background in research. If you read publications such as “Embracing failure: What the Phase III progesterone studies can teach about TBI clinical trials”, you will learn about a particular example of a Phase 3 clinical trial that fai…[Read more]

I think “participation marketing” can happen without the company even really trying. A lot of times companies go to college campuses for career fairs and “participation” market without them knowing it. They speak to students about their company and medical devices and then pass out the stress balls or pens or w.e. Those stress balls and pens get…[Read more]

GE Healthcare

“GE Healthcare provides transformational medical technologies and services that are shaping a new age of patient care.

Our broad expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, drug discovery, biopharmaceutical manufacturing technologies, performance improvement and…[Read more]

EI affects sales because people want to do business with people they like and trust. People don’t want to do business with someone who they don’t like because you don’t even want to talk to that person again. Also, I believe that people want to give money to and support people who they believe are “good” people. If someone fits your idea of a…[Read more]

Widgets, Inc. is an example of an S-Corp. An example of a C-Corp would be Amazon. I think that companies don’t get to really choose whether they are S or C. I think they just are. Ideally, I think all companies would choose to be C-Corp but they just simply are not big enough. I do agree that S or C can be an advantage or disadvantage depending on…[Read more]