I agree with the two post above. There are set guidelines when it comes to the ownership of the intellectual property. However, documentation is always key when it comes to this issue. I believe that the ownership falls directly to the sponsor of the project. However, if there are any other combinations of ownership. then that should be signed off…[Read more]

I do think that having placebo-controlled trials are ethically sound and necessary. There are guidelines place with a huge emphasize on when a person should be placed in a trial. The well-being of participants should be considered, and whether or not it is worth having the patient take part in this study when they are already receiving adequate…[Read more]

A double-blind experiment is an experimental method used to ensure impartiality. When both the researcher and the patient are ignorant to the actual ingredients, therefore the trial is completely unbiased. I believe this method is a better way to carry out a trial because the researcher can subconsciously influence the experimental outcome.…[Read more]

This video was indeed very entertaining and connected very well to the comic strip. Each department in a company has people with different backgrounds. An R and D engineer might interpret a customer need and tackle a problem in a different manner than a marketing professional. Therefore a simple and standard way of communication between departs…[Read more]

This product and marketing method might not connect too well with the topic, however education can be seen as a product and search engines as a platform to market on. Google makes a lot of money by AdWords and many companies pay to have their products be seen for these specific words. The most expensive groups of AdWords are financially based and…[Read more]

Two strategies that work well for medical device companies are direct marketing, and coordinated content streaming. Marketing directly to clients and other corporations is one of the best methods for medical device companies. Most products developed by these companies are not meant for the average consumer. Therefore, there is no need for an over…[Read more]

This question can have vastly varying, subjective answers. For example, a person in my demographic might not have the luxury to turn down a job offer. The first demographic being a recent grad. Many recent graduates have a dream job they would love to have and usually have an action plan to get there. However, for many graduates, the first couple…[Read more]

Courts have the right to pierce a company’s veil when there is something illegal or any form of wrongdoing that occurs that the corporation is a part of. In total, I think there are three big reasons why courts may need to do this. The first big reason might be because there isn’t a real separation between a company and its owners. A court can…[Read more]

With the perspective of starting or owning a medical device startup, I would prefer an LLC. The inventor can assign their patents to their LLC. You can do the registration without an attorney, the filing fee for an LLC is only $100. “Once you’ve registered your LLC with the state, you can get an Employer ID Number (EIN) from the IRS, and get…[Read more]

Improving the Quality departments is always an important decision. The biggest would be to track mistakes, keeping a paper trail and enhanced data transparency. This will help with not repeating mistakes and if there is any form of auditing occurring, then accurate and thorough records will be in the favor of the company. Another great improvement…[Read more]

The dynamic between the research and development and quality department is understandable. They are almost an oxymoron, one is a more creative entity using scientific skills for innovation and discovery, where the other department is in place to follow procedures and guidelines and play with the legal aspects that can somewhat hinder the…[Read more]

Srg36 I agree with your statement “However, no matter how robust a design is, there is always the potential for unforeseeable risks that were not visible to the manufacturer or the FDA at the time of approval.” Granted its the job of the FDA and the company to extensively test these products but there are also technological limitations to testing.…[Read more]

To take a tangent off what you said, it is exciting to see Wireless medical devices, mobile medical apps
and health IT becoming more and more prominent. It’s also reassuring to see that the FDA is taking steps to have regulation set on that part of health technologies. With the advancing of wearables and their ability to track health, it can…[Read more]

I understand where you are coming from when it comes to restrictions. I can see how the FDA can cause unnecessary hindrance. But I’d rather have a strict agency then even if it may cost the industrial companies some time. One aspect of the FDA I do wish was more involved is strict is the dietary supplement sector. “The terms of the Dietary…[Read more]

Working in a TBI lab means countless animal testing. What are your opinions on the issue? I believe it is very needed however I can’t stop asking myself if using artificially created organic materials can do the trick. It can be a lot more expensive but closer to human specifications. Then again mice are ‘worthless’ (because as humans we are at…[Read more]

One of the biggest differences between industry research and academic is revenue. Industry end goal is to make the most money by having the best products and in academia, it is to find new approaches/solutions to a problem (whether relevant or not to the end goal) to receive more funding. I think a more effective model would be to tie in industry…[Read more]

I agree with your point that as the technology exponentials grow the power of simulations and computer added testing will be very close to reality. But in my opinion animal testing, even in the future, you speak of will still exist. It does not matter how close one gets to realistic result, the computer can be 99.9% accurate but it is still not…[Read more]

Having multiple Project managers can possibly hurt the project, two capable people having the same command on a project can hit a wall in progress. “One person is the Project Manager and underneath the project manager are a bunch of Project Leads from different departments.” The structure you mentioned is ideal I think. Having sub-teams with…[Read more]