I work at a clinical research company that is involved with recent breakthroughs in immunotherapy. This includes treating conditions such as cancer, HIV, hepatitis, or pro-inflammatory diseases by processesing cell-based products that are intended for patients in Europe (EU) and…   Read more»

As a master’s student approaching my last semester, I can say that this course is unlike any other course I have taken in that it provides an alternative and even a more practical perspective on the medical device field. We…   Read more»

The role and responsibilities of a project manager easily varies depending on which organizational type they are placed in along with their preferred working environment. In terms of which organization is more challenging for a project manager, a project-based organization…   Read more»

According to lecture, information silos are most prominent in functional organizations, meaning that the departments and project teams within the organization keep to themselves to the point that they establish their own exclusive culture. Initially, the formation of silos may…   Read more»

The company that I currently work at would be considered a project-based organization considering that we conduct research on cell therapy-based products and techniques. For example the projects that we conduct focus on the processing and transplantation of stem cells,…   Read more»

My company manufactures a blood-based infusion product that is currently undergoing its clinical phase in trials, so it is common for errors to occur along the process which are then handled under a risk-based approach. One such approach in which…   Read more»

The first part of risk management, as mentioned, is to assess all the potential threats of a device by formulating a list of risks associated with its use. Each risk is then individually analyzed so that all potential hazards can…   Read more»

The major ISO for risk management is ISO 14971, which is enforced onto medical device companies as a means of preventing or mitigating the hazards associated with the devices. As mentioned in lecture, risk management occurs within multiple areas of…   Read more»

A proper validation process should revolve around the patient by ensuring that the medical device under development meets the user’s needs. An important aspect of design validation, as mentioned in lecture, is the application of clinical human studies in order…   Read more»

The clinical research company I work for carries out cell therapy in that T-cells are taken from a patient’s blood, which are then amplified via additives (viral vectors), and then expanded/proliferated until they reach the specified quantity stated in the…   Read more»

The company that I work for carries out clinical research involving the processing of auto/allogeneic cell-based products for therapeutic purposes. Each project team is required to hold meetings at the start of each shift to go over what processing has…   Read more»

I have not worked with Gantt charts in industry, though I have during my senior design project in developing a neuro-prosthetic arm. The first factor to understand is to know the relationships between tasks in terms of their dependencies on…   Read more»

The design transfer process aims to translate the design of a medical device into a production procedure in which the manufactured device can fully manifest its safety and efficacy in a way that complies with its essential requirements and standards….   Read more»

Design controls are certainly enforced throughout the development process of medical devices in the EU, the real question is whether or not they are sufficient enough to yield safe and effective medical devices to market. Design controls fall under the…   Read more»

An advantage to clinical testing is being able to come up with a breakthrough medical device/technique that treats many patients to unique illnesses while of course, being lucrative. A disadvantage is risking a high-cost study that yields adverse results with…   Read more»

The debate as to whether or not informed-consent should remain a law or be defunct really comes down to the pros and cons. If Henrietta Lacks had the option of selecting “No” on the informed-consent form regarding her medical visits,…   Read more»

When analyzing the qualifications for a CRA position, the first factor that comes to mind is what type of clinical product is being put through trial? If a Class III product such as a new pacemaker or a cell-based infusion…   Read more»

A vision statement is a company’s envisionment of the future regarding where they hope to stand and what they hope to have accomplished while a mission statement states how its vision is going to come to fruition and is directed…   Read more»

The participation aspect of marketing (the fifth “P”) seems to have gained recognition over the past two decades due to the excessive tactic of “push marketing”, which as explained in lecture is in decline. This results from the customer population…   Read more»

Emotional Intelligence (EI) is the level of intelligence one possesses when analyzing the emotional state or condition that another individual is in so that they can be engaged in a way that is beneficial to both parties. One can determine…   Read more»