I believe project based is ideal for smaller companies because each team can focus without being distracted by details of other projects. however, larger companies or companies with multiple integrated projects would benefit from matrix structure. as some have mentioned previously, matrix enables more access to project details, limiting errors…[Read more]

In agreement with ashley, it is not the responsibility of the company to retest their device, especially since they are not making any claims about extreme sports. Also, according to the FDA Mission statement, “The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human…[Read more]

to follow up on what was posted above, for software updates, which may seem trivial, device approval is based on if the update “could significantly affect the safety or effectiveness of the device”. an excerpt of this FDA guidance publication states

“If a manufacturer modifies their device with the intent to significantly affect the safety…[Read more]

considering the immediate risks of both acupuncture and transcutaneous electrical nerve stimulation are well documented and are minimal when performed by an experienced practitioner, and electroacupuncture is a combination of the two practices, i don’t believe it should be banned. many drugs and devices on the market do not have documentation of…[Read more]

Often times with group projects information is delayed because everyone works on a different schedule. at my current job, our in person meetings are organized, however are not given a time limit to ensure all avenues of thinking/troubleshooting are exhausted. while this requires patience, it ensures everyone is able to get immediate feedback on…[Read more]

In my experience, NDAs have been sufficient in protecting ideas during development. patents, even provisional ones must include every detail of the device. if the device is still in development, you don’t necessarily want to patent a feature that will likely change in the next prototype. therefore, if you do not have access to the necessary…[Read more]

In many CDAs or NDAs it will be stated that the information belongs to the disclosing party, therefore any version or permutation of the information is still covered by the agreement. I believe in this situation specifically, the disclosing party can pursue legal action against the receiving party, and would likely have to prove that the…[Read more]

@rachel, I do not believe a guardians medical decision counts as a verbal agreement as the doctor/hospital is seeking consent to perform an emergency procedure rather than exchange goods. in the case that the procedure is not an emergency, a written informed consent form is signed. How i do agree with you and many others who have mentioned…[Read more]

I believe risks should be handled differently depending on how critical the part of the device the risk is associated with. the most critical parts will likely be handled with acceptance or transference regardless of the risk level, unless the risk is too high, in which case the device probably too risky to make in the first place. for less…[Read more]

I mentioned in the Risk management meeting thread of a system to follow when brainstorming for potential risks

During the brainstorming process identifying risks, priority should be placed on the risk of the most critical parts of the device that cannot be avoided, followed by the risk on that can be mitigated or transferred, then lastly risks…[Read more]

while many have mentioned FMECA as the main tool for identifying risk, I believe during the brainstorming process identifying risks, priority should be placed on the risk of the most critical parts of the device that cannot be avoided, followed by the risk on that can be mitigated or transferred, then lastly risks that can be accepted. this same…[Read more]

China is one country with a comprehensive design control system regulated by the Chinese Food an Drug Administration(CFDA). since 2013 the CFDA has been revamping their medical device controls. in march of 2015 the CFDA “revised [their] Good Manufacturing Practice for Medical Devices compris[ing] [of] 84 articles in 13 chapters, which requires…[Read more]

I did my Bachelors at Long Island University, Brooklyn where I did subject based research. while devices were used, the purpose was to test the effects of the activity on the subjects rather than the efficacy of a device. many, if not all, of the steps covered in the lecture will be apart of any academic subject based research. The protocols…[Read more]

With any clinical trial, the ownership of the intellectual property will be established in the contracts between both employer and employee and between the sponsor and any contracted assistance. I think the IP should belong to which ever party owns the device/drug being researched. typically, as many have stated above, the party providing the…[Read more]

I can understand clinical experience being desired for an investigator, however research experience and good communication/people skills seem to be more important. While clinical experience icludes patient interactions and the administration various treatments, unless completion of the trials requires some specialized knowledge of a treatment or…[Read more]

Fresenius Medical Care

Vision Statement: “Creating a future worth living. For patients. Worldwide. Every Day.”
“About four decades of experience in dialysis, innovative research, the global leader in dialysis services and products – that is Fresenius Medical Care.

Patients with kidney disease can now look ahead with much more confidence t…[Read more]

Music videos are the prime location for many tobacco and alcohol brands that do not typically run television advertisements. While these music videos are showed on cable and satellite video channels, most of its views occur on youtube. this is not only in the US either. A research study published in the Journal of Epidemiology and Community…[Read more]

Another way companies utilize participation is with crowdfunding. Companies like Kickstarter have allowed companies, usually startups, to run a ‘campaign’ to fund a product. the ‘backers’ are treated as ground floor contributors and are encouraged to feel some kinship with the company in launching the project. the backers are given early…[Read more]

to elaborate further on what Ibraheem stated, the biggest difference between s-corps and c-corps is that unlike c corps, s corps income is passed through so taxes are only applied directly to the owners, rather than c corps taxation both on the company level and on the owners personal taxes. Ibraheem’s mention of a s corps’ ‘inability to…[Read more]