@dbonanno1 exactly, agreed with what you stated here! I think its also important to note that the question of “What could go wrong with this product” should be applied to the SME’s. The SME’s are the subject matter experts of…   Read more»

Several others have made very valid points already in that using an Acceptance approach doesn’t necessarily increase risk. However, I think its very important to distinguish that using the Acceptance method generally implies there is very low risk to begin with…   Read more»

As many others have said, it is important to conduct the human factor study if the device is to be used in the human body. Although the guidelines may be general regarding what’d needed for these studies, conducting these would…   Read more»

As others have mentioned here, meeting minutes are useful for keeping the team in the loop as to what was discussed in every meeting. This is true, however, typically the project manager would send out tasks and dates associated with…   Read more»

Verification vs validation can be tricky to understand sometimes. Sometimes its helpful to view it as a ‘what makes sense’ in that moment when it comes up to verifying or validating a device. One example I can think of that…   Read more»

@krp67 To add onto this and emphasize you’re point; yes these drugs do need to go through animal trials first, but they then must be confirmed with human trials. As you mentioned, the human body is not exactly one to one…   Read more»

A double blind study greatly improves the authenticity of the study results and removes bias from both and patient and Investigator involved. To give an example, if you provide a swatch of color to a person and ask what color…   Read more»

Having a clinical background seems to be used as a filter by many companies to recruit talent with a certain background and make it so those who do apply without that experience and get in-are exemplary. From that perspective, I…   Read more»

As mentioned, several companies use different methods for advertising rather than traditional ‘tv’ or simple video advertising. Many companies used word-of-mouth, targeted mail-in offers, or offer discounts and benefits to their members when referring others to join.  Some companies like…   Read more»

Reading through the replies, there are several good points brought up like: the internet has changed to allow a higher range of products to be advertised, the easier expansion of your consumer base, the cutting of overhead costs as some…   Read more»

@dag56 , agree using a celebrity is definitely an effective tool that’s used in todays marketing to further connect with the intended audience. Another example of a celebrity very well used in Marketing is Ryan Reynolds in Mint Mobile ads….   Read more»

@reginabarias Yes! Thank you for bringing up the points that its difficult to land a ‘dream job’ right after college, and that you may end up staying in the job that you land longer than you’d like. I feel these…   Read more»

Reading through several of the comments here, I noticed many were of the opinion of choosing an LLC; justly so since there are many advantages like limited liability and the potential for dividends. The kind of business I would want…   Read more»

@as934 , reading through the other posts, agree this point is not mentioned and is a good one to consider. Tying into this point, the type of corporation chosen also depends on the future intent of the individuals attempting to start this…   Read more»

The biggest issue I’ve seen that people dislike when working in a manufacturing company is change. No one likes change or having to do things differently than what was deemed ‘acceptable’ in the past. This applies across any department in…   Read more»

Working in R&D in a medical device manufacturer, in the past I’ve noticed that the main issue with quality is that each QE may have a different interpretation for how something should be done. I.e. you’re filling out an operational…   Read more»

Ensuring a medical device is safe and acceptable per todays regulatory standards is a difficult task to tackle already; many companies and industries take different, but often times similar approaches to doing this. While many others have mentioned regular inspections…   Read more»

Like they say, hindsight is always 20/20. The FDA could’ve handled the rollout of the vaccine much more effectively. But didn’t at the time as a pandemic of that scale and severity hadn’t been seen since the 1918 Influenza Pandemic-with…   Read more»

Reading through the comments on here, I’m going to go against the grain here and say…post-market management is equally, if not even more important than the product development stage. Both are critical. However, in the product development stage, the ‘safety…   Read more»

To add onto this, precision and accuracy starts from the ‘ground-up’ on a medical device. By this I mean that each and every single component that make up the medical device is evaluated separately to ensure the overall assembled device…   Read more»