I think that the best way to deal with an unresponsive team member is to schedule a meeting with them either in person or over the phone. In the meeting I would discuss their unresponsiveness with them and hear from them why they have been so unresponsive to clear up any potential misunderstandings. I would also encourage them to be more…[Read more]

I think that it is important that the project manager remains ethical while facing the pressure of a timeline with rapidly approaching deadlines. Any unethical behavior from a project manager could add a ton of risk to a device that may already be a high risk device. The added risk could result in potentially serious injury, or even death, if…[Read more]

I think that risk management successfully begins in the planning phase of the project. The more risks and roadblocks that can be identified before the project begins the better equipped the project team will be to handle risks as they come up. On that note, it is unlikely that all risks and roadblocks can be identified during the planning phase,…[Read more]

I think that the planing phase is one of the most important phases of the lifecycle of the project. In the planning phase, the entire remaining lifecycle of the project is mapped out. It is important that during the planning phase that proper time is allocated for each activities, that enough time is built in the schedule for any unforeseen…[Read more]

An engineering change order is an important part of a project and it begins when someone on the project team identifies an issue or problem that may require a change to be made. After an issue has been identified and before an ECO a document called the engineering change request is completed to initiate the change process by identifying the…[Read more]

I think that the phrase “everything is about risk” refers to the fact that any decision that is made on a project, that the first consideration will be the risk involved. From beginning to end all decision are made with the risk in mind. At the start of a project a company decides whether they should even take on the project, or if it just isn’t…[Read more]

I think that risk/benefit ratio is something that comes up throughout the entire lifecycle of the project. Risk is a major concern regarding medical devices because an issue could lead to serious injury or death if the device malfunctions. The greater the risk that comes up is the more difficult the decision becomes to make for the company.…[Read more]

I don’t think that an issue such as labels peeling off of the bottle when submerged underwater, would be enough to warrant a recall but the company would still likely respond if many customers were having complaints. Having a label peel off the bottle may be an inconvenience or annoyance, but it doesn’t have an affect on the safety of the drug…[Read more]

Medical devices classifications are broken down into class I, class II, and class III devices. How a device is classified depends on how much of a risk the device presents to the user and how novel the device is. It is up to the FDA to determine which class to classify a given device. Class I devices are the lowest risk devices and are…[Read more]

I think that the company should definitely explore ways that they could take on that project if they really believe in its potential even if they don’t have the funding. For a small new company there are many different avenues they could go down to end up with the funding that they need. Small start-up companies can try to take out a loan if…[Read more]

I think that using a different material can definitely cause a change in the product classification of a product. The overall impact of the material being used depends on what the material being used is and whether or not it has been safely used in similar applications in the past. Introducing a new material for a device that interacts with the…[Read more]

I don’t think there are any risks involved in performing validation and verification, rather performing validation and verification reduces the overall risk of the project by ensuring quality and that the product meets all requirements and specification and fulfills its intended uses. Verification and validation are both very critical aspects of…[Read more]

I think that the quality plan is important because the quality plan defines how quality can be achieved in a project. Quality plans determine a plan for meeting relevant quality standards and maintaining quality through the project with quality events. Planning these quality elements can be important in meeting the overall requirements and goals…[Read more]

In the case of an implant coated with antibiotics, I would guess that the FDA would designate the product as a device because its primary mode of action would be as an implant, not as a antibiotic. The reason being that the primary therapeutic aspect of this product would be to serve as an implant. It would be up to the FDA’s Office of…[Read more]

I think that Fitbit and other fitness wearables don’t fall under devices to be regulated by the FDA. The reason being that they aren’t truly medical devices as they don’t make any medical claims. As a general wellness product Fitbit is marketed towards improving a persons physical health and fitness rather than claiming to help treat or cure…[Read more]

I agree that it would be unethical for a company to embellish their product to try to get it classified as a type II device rather than a type III device because of the large risk associated with class III devices. The company runs the risk of negative affects from their device if it hasn’t been properly tested for its proper classification.…[Read more]

I think that a balance of the two skills is needed and agree with 85:15 ratio of interpersonal skills to technical skills. I think its important for biomedical engineering students to focus on technical skill rather than interpersonal skills for an undergraduate degree. The reason is because biomedical engineering is such a large field it is…[Read more]

I think that the primary mode of action of the digital Abilify pill makes it a drug, rather than a device. This digital pill is more of a pill that comes with a sensor than it is a sensor that comes with a pill because the pill most important therapeutic action is the biological action by the drug portion of the combination product. As a…[Read more]

I think that the priority of a project plays a huge role on the resources that are devoted to the project. The priority of the project will likely depend on how much the company can benefit from the success of the project which is the end goal of every organization. The overall success of a high priority project will have a much bigger effect on…[Read more]

When it comes to severance agreements a company would want your signature agreement on the separation, even in the case of at will contracts to limit the legal issues you can take. I believe most severance packages a company would offer would be standard for the amount of years that you worked there, but you may be able to negotiate a better…[Read more]