In my personal experience, I have found manufacturability and manpower(affecting timelines) to be the main factors I had to take into consideration with contract manufacturers. Make sure you are not making tolerances overly strict, and try to be within realistic…   Read more»

I believe that in the initial design requirements meeting, it is important to make a clear scope of who is using the product and how it is being used, This can help lead to understanding clarification of usage case and…   Read more»

Once future updates are not projected to make a worthy profit, the company is unlikely to push a new product. For example, if you are creating an additional feature on an already available product, if sales does not predict that…   Read more»

Meeting Minutes are extremely important. They are not common practice in my past experience, but I have found them to be extremely helpful in the past whenever they were available. They give you a history and your next steps forward…   Read more»

I do believe that packaging and labeling should be treated just as importantly as the actual medical device for product safety. Without proper labeling, it is possible that a device would be used incorrectly and become ineffective, or even worse,…   Read more»

 I agree that developers should put a nearly as much importance to usability testing as to mechanical testing. A product is only as good and as valuable as its use. If it is a difficult tool to use, no one…   Read more»

I believe that biomedical engineers are moving more towards the applications and design side of clinical research. They would be focused in design of experiments and modeling end. They can pull data and make decisions on how effective the studies…   Read more»

I do not believe that the placebo effect can have a negative effect on a clinical trial, as it is one of the necessary parts and helps to see the actual efficacy of the test drug. If somehow the placebo…   Read more»

I believe double blind is better due to its exclusion of bias. Pretend that you are a researcher for a new drug formulation, and you are checking the patients to see if their symptoms have improved. You might find yourself…   Read more»

I have some small experience in branding due to past events I have run and because I am an artsy person at heart. I have done research on cohesive brand image and other considerations that are important for marketing. However,…   Read more»

I feel like it depends on the type of product. If you are marketing a tool with a new ergonomic grip that helps with hand muscle fatigue, you probably want to reach out to the physicians who would want your…   Read more»

I do believe that the quality of the product is more important when it comes to medical devices and most products in general. However, bigger companies have a long history of successful products; this makes customers feel more comfortable with…   Read more»

I feel like it would be beneficial for engineers to take atleast one more buisness related class. Industry is nowhere near what I expected it to be or how I expected it to be run. In college you get a…   Read more»

I feel like I could argue this point both ways. The first example I can think of is company policies. Say a factor of safety for a company is 2x, but industry standard is 4x, and something breaks, I would…   Read more»

I feel like in corporate, you are pushed to fit within your job title’s restrictions a lot more. Like, if you are in manufacturing, you should not be trying to push ideas for R&D, and vice versa. Or if your…   Read more»

I feel as though it should still be considered a class three device. It is going internally into the body; there is huge risk involved. I do not believe it would be characterized as a drug. It does the same…   Read more»

Precision is very important in the creation of devices to ensure that they come out accurately. You need precise machines and measurements to ensure that a device or implant comes out perfectly. Being off by a couple of thousandths can…   Read more»

I believe that as things continue to advance, there is a change that some devices may be able to be reclassified as lower classes. Complexity and impact are huge factors that factor into the classification of devices, but as things…   Read more»

It is important to use all tools at your disposal to keep things in check. New technologies are allowing for parts to be checked more accurately and better than ever before. For example, 3D scanners allow for much more precise…   Read more»

I think it is best to keep quality independent. To have a specialized team of eyes on a product design, I believe, is very important. However, I believe that the design engineer should still be more hands-on in the quality…   Read more»