Hi i think design controls is the primary driving force behind medical device productions. In our module we had learned that a design control is set to provide clear and concise information for how a company handles their device protocols…   Read more»

Both of these documents complement each other very well in the conception of medical device development. Its seems like approaching a design from two different angles to ensure the best of both worlds and provide customers with a device that…   Read more»

Hi based on this weeks module I gained a great appreciation for design controls and how vital it is for a successful medical device on market. I do agree that the consequences of poor design controls put users and companies…   Read more»

I also agree with your perspective as it would provide a holistic method to device development. In this weeks module we discussed how intricate the methods of design can be and how trials and other forms of evaluation play a…   Read more»

I do agree that from this weeks module that packaging and labeling play a pivotal role in the success of a medical device. Ensuring that a device doesn’t deteriorate or alter from the intended use these parameters are key. The…   Read more»

I think that laboratory testing is a vital role in the progression stages for device implementation. Although once a device enters clinical trials parameters and the intended effects can vary once tested with human trials they are still very important…   Read more»

For participation in human trials I think it would be nearly impossible to rely on AI for an accurate representation of a human let alone the human population a device would service. While AI is an amazing tool which can…   Read more»

When it comes to providing incentives for participants it definitely can be tricky for individuals to seek compensation other than of monetary value. I would say this just because it is a common practice to pay participants for their time…   Read more»

As provided in the module this week clinical studies are vital in the process for getting devices and drugs to the market for large scale distribution and treatment. I think there are both pros and cons to all studies. A…   Read more»

I believe that marketing should never oversell a device onto the public. It simply cannot be on the providers to justify a devices long term safety. Physicians are not trained to fully understand the FDA regulations and what tests and…   Read more»

The best selling product is surely not always the best product. I have worked in hospitals and in medical offices for years and have noticed physicians usually will go with companies that they are most familiar with rather than exploring…   Read more»

In present day many surgeons do serve as Key opinion leaders for medical devices and run clinical trials, so I do feel that having prominent physicians can be a huge asset to a company. While the physicians will be the…   Read more»

Hi I deeply agree that all STEM majors especially engineers should take more business related courses. While being an engineer and understanding the principles and skillsets to translate a concept to device are important, the skills to get said device…   Read more»

Hi I think this is a great question which ultimately depends on the companies trajectory and long term goals. While being either public or private comes with their pros and cons, knowing your brand and what would be the best…   Read more»

I also agree that an MBA would not be necessary for an engineer who has aspirations of going into business. While an MBA can be an amazing tool if used properly, many of the skills and content can be learned…   Read more»

Hi, yes it may seem that the cost of quality can be a hassle to deal but in the long run for companies that would like to continue to perform and survive they are absolutely vital. They serve as a…   Read more»

I can definitely understand the perspective that QC can slow down innovation, but I feel that with all of the pieces that work together. Without QC innovation would possibly be more chaotic in my opinion as there is no proper…   Read more»

I believe that the AI is a decent tool to use while performing QA, but I don’t feel that it should override Human judgement from actual experts. QA experts have experience in the real world and can properly and accurately…   Read more»

I feel that AI based devices may need to be approached differently than how regulations has handled medical devices traditionally. There just has been a surge in recent years with the applications towards device advancements that it definitely makes it…   Read more»

I too didn’t realize how important regulatory affairs were in the grand scheme of device progression and maintaining it beyond it being in the market! I recall from earlier modules with Dr.Simon stating that companies are eager to hire individuals…   Read more»