I am definitely feeling the pressures of scope creep as I near closer to my Master’s defense. I made the mistake of waiting until the last month to run my most important and intricate experiment, not giving myself enough time to repeat it if something were to go wrong. Also, best case became finishing the experiment, collecting and analyzing data…[Read more]

Simply, the rate of return is profit, it could be a dollar amount or percentage of how much was invested. It is impossible to know exactly what the rate of return is just as it is impossible to predict the future; the best that can be done is to make an educated guess. Factors that can influence this guess and subsequently the rate of return are:…[Read more]

I don’t have any med-tech industry experience but I imagine the design review experience being tense for the product developing team. Passing a design review means completing a major milestone in the project development process and shows that the product is ready to be launched therefore it can be distressful for any engineer/developer. The…[Read more]

A product risk can be a faulty release mechanism on a drug delivering device. Under FMEA this would be a Concept Design / Hardware risk where we could monitor its probability of failure throughout its development process. Specifically, risk can be monitored with modeling software; designs would be imputed into the software then the software can…[Read more]

Recalls are a very interesting topic, nice post. Recalls are done, not by the company that designs and develops the product, but by the manufacturer or distributor. When these parties find that the medical device violates an FDA law (e.g. efficacy or failure to perform what it was designed for) they initiate a recall. How did this device slip…[Read more]

ECOs admit that no design is ever completely perfect, infallible. They are neither a positive or negative event, ECOs are an eventuality. The cause could be: a design error evident only during the testing phases of the product; change in customer needs, market demands, and/or governmental regulations or policies; manufacturer problems such as not…[Read more]

I was lucky enough to choose a Capstone project where we did not have to pay for anything, all of our parts were given to us from previous attempts at the project. However we later found out that the sensors we got were faulty and we had to buy new ones ourselves. This was a major set back to the project, we kept modifying our code thinking we…[Read more]

There are many reasons why tracking time is an important practice for any company or organization. Some include: 1) Following the progress of the project, how much time is needed to complete a certain task, is this time spent wisely, any unnecessary time wasted, can time management be improved? 2) Determining cost of the project, how much should…[Read more]

A lot has already been said in this post, but teamwork and a PM’s handling of team management is a very important prevalent topic. I think the best approach is to set the rules right from the start. Explain what is expected from the employee, how those expectations are to be met, what constitutes deviation from these expectations, what is the…[Read more]

I agree here. The suppliers you want to be dealing with are well-established and are known for their high quality materials. In fact build a relationship with these suppliers and do not burden the planning phase. Additionally, a good relationship might help you get your materials faster and at better prices and latest qualities. A good…[Read more]

Some tools/techniques that can be used to assess quality assurance include:

Fishbone Diagram. In this cause-and-effect type diagram factors causing a defect are listed as inputs and their combined efforts may output the possible defect. For example, inputs such as suspicious, unchecked glue suppliers, high humidity in the factory, and an…[Read more]

When creating my group’s Gantt Chart I would organize our tasks considering the following (in order of importance):

1. What tasks must be completed before this task can begin?

2. What is an ideal time to complete this task? A realistic time? A worse-case-scenario/behind-schedule time? (based on task history and work force)

3. How many members…[Read more]

The most impactful lesson I have learned from this class so far is how applied research/basic science (that is, what we learn in our core classes) is just a small percentage of research and development and R&D is just a small percentage of actual product development. As several of the posts above have mentioned, knowledge in project management,…[Read more]

Some enterprise environmental factors might include a sudden market niche for a particular product or a governmental decrease in sales tax for a particular resource. I would then argue that the proposed project should be initiated because there is a need for it in the current market and/or the material for its production can be bought on the…[Read more]

My capstone project involved programming a 3-DOF admittance control hand exoskeleton for robotically facilitated training of the hemiparetic hand and an interactive, virtual 3D environment for its platform. We broke the project down by task and order of completion because the next task of the project could not imagine fruition without the…[Read more]

Missing a milestone might be the worst thing that can happen to a project. A milestone defines the completion of an important step in a project’s development process and task times are often dictated by it. If a milestone is missed, the first step for the project manager is to identify why. In terms of the Gantt chart: Was the milestone deadline…[Read more]

Absolutely! One of the aspects of my thesis project was to develop an in vitro blood-brain barrier; primary cortical neuronal cells would be attached to the bottom of a well while endothelial cells and astrocytes would be suspended on either side of a transwell above the neurons. I thought the first task, culturing the neurons, would be very…[Read more]

Absolutely! One of the aspects of my thesis project was to develop an in vitro blood-brain barrier; primary cortical neuronal cells would be attached to the bottom of a well while endothelial cells and astrocytes would be suspended on either side of a transwell above the neurons. I thought the first task, culturing the neurons, would be very…[Read more]

To answer how much information is needed to begin a formal project it is important to outline what information is needed. You sort of answered this in your question, enough preliminary details to plan or propose. These preliminary details (most already explained in previous posts) would include . . .

1. Description of the project. What will the…[Read more]