If the company is looking to grow, it should be an Inc instead of an LLC. In an Inc, you can hire Officers to compartmentalize your company. This spreads the task of growth out onto more people. In an LLC, there are fewer owners. Between running the company, maintaining contacts, and driving expansion, they could get overwhelmed. Also, Inc company…[Read more]

For me, different aspects of the company would sway my decision more based on where I am in my career. Just starting out, I am not going for anything managerial related. I am more concerned with the company’s profit/debt ratios. The worst thing would be to accept a position from a company that will go under in a year. Later on, when I might be…[Read more]

Documentation control can be catalyzed with the proper use of online systems. Online folders allow you to organize by section almost indefinitely and access it from any computer in the office. If that is combined with fillable pdf’s of standard documents (like shipment documents) all the worker would have to do is go to the folder labeled…[Read more]

Quality in business always battles with ethics due to the increasing cost associated with ethical devices. Oftentimes, when you hear about an ethical scandal, such as the famous Ford Pinto, it comes down to cost analysis. Many managers already dislike the cost associated wit ha QA department and are not inclined to allocate more money to…[Read more]

Having a Quality department in your business is like having a plunger in your bathroom. For the longest time it will just sit there and remind you that you spent money to buy it. But if something happens and you need it, by god you are thankful its there. A quality department is a higher risk/reward than a plunger but the principle of the…[Read more]

One drug that was huge in the early development of modern FDA medicinal regulations was Thalidomide. This drug was popular in the 1960’s and was marketed for morning sickness in pregnant women. Unbeknownst at the time, the enantiomer of the drug was extremely teratogenetic. The FDA refused this drug even though it was approved by countries in…[Read more]

The blood glucose meter is an existing product and as such is class 2. It is a medical device and falls under CDRH. The interesting component is that is transmits data to an android app. The thing in question here I feel is the sending device, not the receiving device. The part of the glucose meter that sends the data might be subject to safety…[Read more]

The path of an antibiotic releasing hip stem would certainly start out with an RFD. Although the primary function of this device is the physical hip stem, the antibiotic releasing portion is the aspect of the device that would make it class 3. If it were just a hip stem, it would be class 2. If found that it falls under CDER, the pathway would…[Read more]

While they are both important, an we all agree that they are, I think, from a logical standpoint, research for the current generation is and should continue to be the bulk of completed research. There are two types of research, basic and applied. Most research is applied research, because it is used to solve a problem or explain a phenomena aka…[Read more]

My biggest concern in that scenario, like many others, would be the quality of the work done at the outsourced lab. While outsourcing always poses a quality issue, the most dubious aspect of this scenario is the reason for outsourcing to that particular lab. It was chosen based on a coworker having connections rather than research and reading…[Read more]

As technology progresses, animal studies will be phased out more and more in favor of computer simulations. Currently however, animal studies are needed because there is no alternative. There are steps humans can take to reduce the ethical issues presented by using animals, but I do not believe an animal study can truly be ethically clean. For…[Read more]

When a milestone is missed, it means that something pertaining to the project was misplaced. This could be resources, foresight, proper documentation, or failure to plan for setbacks. If the missed milestone points out a deficit in the product that would not otherwise have been known, it is a project success. If a missed milestone was made up in…[Read more]

I see a lot of posts on here citing the FDA as a huge difference between a medical device project and a construction project. However, this is just one of many huge differences. The FDA makes life hard for BME’s yes, but there is one huge elephant in the room when comparing projects… Medical devices are used to go inside someone. There are so…[Read more]

To revive this discussion, I believe the roles of managers and engineers in a project fit a Venn Diagram. One circle is strictly managerial/business tasks and the other is purely design and build tasks. In the overlap are the skills that both managers and engineers should be versed in. The overlapping skills are technical knowledge of the task,…[Read more]

Learn connect and learn again. As a student, your job is to learn. Not just your discipline but everything possible. From biomedical engineering to design to cooking to networking. The more you know the better off you’ll be and the more opportunities you can grab. As a soon-to-be adult in the “real world” your job is to find and secure a job. A…[Read more]

While the idea of a ratio of professional to theoretical classes is a possible solution for making sure all students have industry read skills, I disagree with the ratio idea completely. When deciding what the content of education should be, it should not be something as topical as an availability ratio. The ideal ratio of industry knowledge to…[Read more]

My advisor used to tell me “biomedical engineering is a third mechanical, a third chemical, a third electrical, and a third biology”. And from what I have seen of the major, it is true. We may not go into very deep detail of many things, but we have the foundations of everything. Graduating with a BME degree means that you can, on your own, learn…[Read more]