I think both the DID and DSD are important since they provide different information needed for the medical device. The DID gives the general idea of what the device needs to accomplish, while the DSD are the requirements the engineers…   Read more»

I agree that design controls do make things more complicated in the development process, as there is more documentation and testing that is needed. Documentation, at the end of the day, saves time and resources in the long run. At…   Read more»

I think any design change has to be documented. An example I can think of is when even changing the angle of one component can impact how many of that component can be accepted when it is manufactured. If the…   Read more»

I agree that the term “user” is a wide range of people; many of us first think it pertains to the patient only, but it applies to healthcare professionals who will be using the device. I think one way a…   Read more»

User needs are one of the major and important steps before developing a medical device. The device has to consider what the customer needs, as that is how they can sell their device. If there is no market, then the…   Read more»

I believe having multiple design reviews is more important throughout the development of a medical device than just having one. One factor in how many design reviews a device should have is based on the class I-III, complexity of the…   Read more»

Based on what we have learned and even reading other posts, double-blind studies are deemed more beneficial than single-blind studies because they help reduce bias. The double-blind studies reduce bias from the patient and investigators therefore there are no chances…   Read more»

Patients who participate in the clinical trials should receive some form of compensation. The patients are taking time out of their day and taking risks. As mentioned previously in other discussion posts, is that particpanting in these clincal trials can…   Read more»

AI can be useful in the clinical research field, but it can never replace human participants. The human body is so complex that we truly do not understand every single thing that happens plus every human body is so different…   Read more»

No, I don’t think the best medical device is always the best-selling product. It depends on the promotion of the product, customer needs, and how often it is really being used. A medical professional might still use a different product…   Read more»

Brand coloring is important and I have noticed many medical brands use blue and white or red and white. On the top of my head we have Medtronic, Abbott, Pfizer, Amgen, and Roche and for red we have Johnson &…   Read more»

Brand coloring is important and I have noticed many medical brands use blue and white or red and white. On the top of my head we have Medtronic, Abbott, Pfizer, Amgen, and Roche and for red we have Johnson &…   Read more»

I agree building trust is so important as a sales rep for a medical device or medication. Since these medical devices affect patients health and lives. Sales rep help inform medical professionals with new studies done with the medication, intended…   Read more»

I believe there is a difference between public and private but it does not stop innovation. At the end of the day, it is a company that needs to make profit. Therefore, any company whether it is private or public…   Read more»

I would not turn down a company based on their type of business structure they run. As someone who is graduating in a few weeks, getting experience is important but it is in someones best interest in researching about the…   Read more»

Based on my experince so far in the industry as an intern and co-op, I have preferred in being in a mid-larger size company. In a larger company, there is more often resources that allow to grow and learn new…   Read more»

To be able to keep up with the changes in technology, is by being knowledgeable about them. QC should be aware of technologies that could help them, and higher-ups are in charge of doing all the training or creating training…   Read more»

In my prior experience, quality and R&D would often work with one another. One way my company worked with one another was by having meetings set up to touch base every week on the progress of the device and documentation….   Read more»

Innovation would be slowed down by QC but it is necessary. I would also not say it slows down by so much since QC helps question the innovation itself. One could ask the innovator why use this material if you…   Read more»

I do not think the FDA is biased but it does raise concerns since money is involved. The money that the FDA gets from applications is there to help review the applications. However, I think it is difficult to discredit…   Read more»