I think it’s always good to validate. I agree with @bb254 about engineers being trained per the SOP’s of the company and validating equipment. I think every employee, not just engineers should be made aware and trained in the validation process. To answer @tn58 original question about how to understand the validation process, I found flowcharts…[Read more]

I agree with @alexandrabuga and @bb254 about the importance of Participation. I want to further emphasize the importance of participation, especially now in this era, participation is required to keep up with the market and maintain brand relevancy. Thanks to social media and social networks, brands and companies can get feedback on where they…[Read more]

Participation, the fifth P of marketing, is crucial when marketing a product. You need to engage your potential client(s). At Sloan we actively market are medical devices and we will meet with companies and have the surgeon explain the unmet need that the medical device solves present a pitch deck and, show the company how the medical device…[Read more]

I support @bb254‘s description of the process of design review meetings. While I am not yet an engineer, as a co-op I am often tasked with preparing the data and materials before an engineer’s design review meeting. For example I was responsible for testing samples for a protocol that they would be presenting for the design review meeting. The…[Read more]

I agree with @bb254 and @asimbana about the INC choice over LLC and would like to add more on the CONS. The biggest drawback is the double taxation (C Corp). Also, shareholders that control and own a significant amount, or majority, of the corporation’s voting stock have a dominant voice in the management of the business in comparison to s…[Read more]

I agree with @bb254, if a mid-sized company is making $10 million in revenue per year, the company would generate a larger net worth if the company became an Inc corporation. As discussed in the previous discussion above, the long-run gain would be to attract shareholders to buy stock in the company and increased the overall net worth of the…[Read more]

I echo the sentiments of others like @asimbana and @bb254 that QA/QC is necessary and is crucial to the success of products. Spending extra time and money and going through QA/QC processes/methods isn’t ideal, but it is necessary to lower risk. For example in 2010 Johnson and Johnson underwent a quality control reorganization after both the House…[Read more]

As many have mentioned like @bb254 and @dag56 before testing in clinical trials many tests need to be preformed. The biocompatibility testing needs to be performed in accordance with ISO 10993 including Cytotoxicity, Genotoxicity, Irritation, Systemic Tox, Hemocompatibility, Implantation, Toxikokinetics. A urinary catheter is an example of a…[Read more]