For a project we were working on it was a smaller part of a whole, which was analyzing viral clearance for a legacy product process. At first we did the initial research and looked through historical information within the company processes to see the logic and rationale behind the current process. We then created a rationale based on the research…[Read more]

I have had several instances where I’ve had to deal with vendors and our project team has had to work on choosing the appropriate vendor. The initial steps in dealing with the situation are setting up meetings with different vendors. One key aspect of larger companies is that they usually have approved vendors, therefore you must meet with them…[Read more]

Similar to Davids’s situation I was in the same class and our final project was a novel prosthetic arm. Our proposal was the development of new types of soft robotic structures, especially materials/methods for the fabrication of such robots, involving biomaterial science and robotics. The goal was to increase current standards in limited range of…[Read more]

An example of a combination product would be Stryker’s Vitagel Hemostat (http://www.stryker.com/en-us/products/Orthobiologicals/SoftTissue/Vitagel/index.htm). The delivery system for this product is a syringe and the primary mode of providing a therapeutic effect comes from the contents of the syringe which is the combination of microbibrillar…[Read more]

An example of a combination product would be Stryker’s Vitagel Hemostat (http://www.stryker.com/en-us/products/Orthobiologicals/SoftTissue/Vitagel/index.htm). The delivery system for this product is a syringe and the primary mode of providing a therapeutic effect comes from the contents of the syringe which is the combination of microbibrillar…[Read more]

An example of a combination product would be Stryker’s Vitagel Hemostat (http://www.stryker.com/en-us/products/Orthobiologicals/SoftTissue/Vitagel/index.htm). The delivery system for this product is a syringe and the primary mode of providing a therapeutic effect comes from the contents of the syringe which is the combination of microbibrillar…[Read more]

An example that I dealt with on a team at work was on a hemostatic agent that we were releasing. The testing that we conducted with the contract lab suggested that there would be potential risk associated with the endotoxin levels in the hemostatic mesh that was in the process of being launched. The teams initial thought was to accept the risk as…[Read more]

Although I do not have personal experience with FDA audits. We are always reminded to adhere to the protocols set forth because they are in place as safeguards for if/when audits do occur. Employees at our company are constantly trained on proper documentation and record keeping of all data and communications so that there is full transparency…[Read more]

Although I do not have personal experience with FDA audits. We are always reminded that to adhere to the protocols set forth because they are in place as safeguards for if/when audits do occur. Employees at our company are constantly trained on proper documentation and record keeping of all data and communications so that there is full…[Read more]

For a animal trial study I worked on we had a cost variance associated with the study, and did end up going over budget as our cost variance was negative. Our earned value on the project was estimated at about $30,000 and the actual cost came out to around $55,000. This negative gap was a result of delays in the animal study which led to rising…[Read more]

Logging work is definitely an important aspect of research and development for any company. When I started working for my current company about 2 years ago logged research was essential in helping me understand how the research progressed and the key experiments that lead to certain thought processes on how to move forward with the research.…[Read more]

To extend on tn58’s response, a project manager also faces a similar issue with information, not only for budgets but also for product information. It has been a repeated theme in Dr. Simon’s lectures that a PM, especially for the medical device industry, may not have all the necessary safeguards and information for a product. This is because…[Read more]

To extend on tn58’s response, a project manager also faces a similar issue with information, not only for budgets but also for product information. It has been a repeated theme in Dr. Simon’s lectures that a PM, especially for the medical device industry, may not have all the necessary safeguards and information for a product. This is because…[Read more]

The best course of action for all those questions is establishing proper communication with all team members. While acquiring team members it is the project manager’s responsibility to organize a rough schedule of team members planned vacations/absences. If you preemptively plan around the absences there should be no issues. However, this is a…[Read more]

This is my first course with Dr. Simon and since I work in industry I had experience in most of the topics that we are learning. The greatest benefit this course provides for me is the thought process on management. This course along with the book give good fundamentals on organizing and managing projects that can be applied to all any industry…[Read more]

Currently at my company we are working on a project that is international, as we must communicate with Brazil, India, and Austria. The key hurdle with project management is the time difference within the countries and the communication gaps. With the project the burden of following as would be expected falls on us and it is the U.S. divisions job…[Read more]

Missing a milestone is usually more than a minor hurdle within industry. For a project missing milestones as indicated in your post would waste company financial resources. However, this is not the extent of the damage, along with financial resources being strained missed milestones can delay a project and take away employee resources as well. For…[Read more]

During a project that I was working on our team missed a milestone for our execution of animal trials. We had gone through the protocols for conducting the trial, however there was an error in the paper work required for approval of the animal trial and the testing facility. This error delayed us in our trial by about two weeks and increased our…[Read more]

During a project that I was working on our team missed a milestone for our execution of animal trials. We had gone through the protocols for conducting the trial, however there was an error in the paper work required for approval of the animal trial and the testing facility. This error delayed us in our trial by about two weeks and increased our…[Read more]