Posted by: @savery115 A small part of the lecture reviewed Upper Management vs Middle Management. Upper Management people are strategic and tend to set the groundwork and vision for what the company ...

Posted by: @amd29 Quite recently Dr. Simon organized us into project teams. And strangely, I became a part of one before I knew it. The approach of forming the team was weird.Personally, after experi...

Posted by: @fo3 As we know, forming a project team is partly making sure every member is working toward the same goal(s). Each member should be able to contribute something valuable to the project ac...

Posted by: @tulikadasp To make sure medical devices remain safe and effective once it’s on the market - medical post-market surveillance (PMS) is done. It a system that provides continuous feedback a...

Posted by: @traceymraw Based on the risk management tools mentioned in the lecture (Failure Mode Effects Analysis (FMEA), Brainstorming, and Fish Bone Diagram), which have you used on projects in the...

Posted by: @lmathis When dealing with risk, in what instances would it be okay to accept the risk in medical device development? Is it worth accepting? In the medical field from the developer side ...

Posted by: @la82 As mentioned in other discussions, design control is an integral part of any medical device design, and its benefits are clear. However, what are some of the issues that arise of the...

Posted by: @rgp29 Hello everyone, I have noticed how Dr. Simon keeps pointing out to importance of taking minutes in all the meeting of the team. I never really thought of how important they are. Bef...

Posted by: @smk45 While watching this week's lecture on design control, I tried to figure out the main difference between Design Verification and Design Validation. Both are used to make sure that th...

Posted by: @jr377 This year, the Right to Try act was signed into federal law. This law allows patients to request the use of investigational drugs (without FDA involvement or state law). There was a...

Posted by: @merzkrashed As Dr.Simon mentioned about placebo-controlled trials, which is A “dummy” device or drug is used on one group of patients and compared to patients with the real one, or someti...

Posted by: @alexandrabuga Background: Henrietta Lacks was a woman whose cancer cells were the source of the HeLa cell line, the first immortalized cell line and one of the most important cell lines i...

Posted by: @llefevre It is estimated that globally, the market for Clinical Trials is in upwards of $44 Billion as of 2020 and is expected to grow by approx 6% over the next 7 years, mostly fueled by...

Posted by: @manolo Dr. Simon touched upon Branding when going over the Facets of Marketing. The coloring is an important component to think about when branding a product/company. What kind of colorin...

Posted by: @amd29 Prof. Simon has made it simple; he seems to definei) Marketing: --- as being able to have the customer believe that what you - the marketing agent - areoffering is what they truly n...