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 requires project managers to bear more responsibilities within a project…[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 be perceived as positive due to the level of cohesion required among…[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, bone marrow aspirate, and white blood cells (WBCs) for immunotherapy.…[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 risk is handled in my company is to categorize the most common types of errors throughout the…[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 be addressed and managed. According to lecture, there are four methods for managing risk: avoidance, mitigation,…[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 a project, which also applies to ISO 14791. These areas mainly apply to safety aspects regarding…[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 to analyze how a demographic of patients respond to the applied medical device. An…[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 batch record. The verification step therefore requires one sample to be taken for each day…[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 to be done, what deviations need to be addressed from prior processing, and the implementation…[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 one another. Normally, tasks are connected on a Gantt chart under a Finish-to-Start relationship, which…[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. Essentially, design transfer begins with R&D extending out to a production department while…[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 device history file (DHF) when developing a medical device in the US, but the same does not go…[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 several ill/dead patients. It’s true that there’s only so much that laws and controls…[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, then a biopsy would still have been taken if it was known what would come about them. John’s Hopkins Hospital at…[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 is being put through clinical trials, then clinical experience should definitely be a must for any CRAs that are interested.…[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 more towards the company’s occupants and investors. Both are important to a company because of the motivation and…[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 becoming aware that they can simply skip or ignore ads that they feel do not apply to them. An…[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 if they have EI based on their ability to influence others, however, as mentioned in the Kidwell paper (1),…[Read more]

The key differences between public and private companies mainly revolve around how exclusive both are and how each succeeds with respect to their public disclosure. A public company has full access to the public market in that any entity can invest in the company’s stocks, thereby enhancing the company’s liquidity and making it easier to sell…[Read more]

A medical device company with only 50 employees and $10 million in revenue would classify as a small business (less than 100 people) and therefore should consider which aspects of either an LLC or a Corp. appeal to the company’s current health. Initially, an LLC seems to be the way to go for a few reasons: The owners of an LLC are expected to…[Read more]