As previous posts have stated, packaging and labeling are just as important as the medical device itself. One aspect I would add is that packaging should also be considered throughout the entire lifecycle of a device and not just during…   Read more»

I think one of the biggest challenges is that engineers can sometimes focus too much on meeting the technical requirements that they overlook how the device will actually be used in a real-world environment. From speaking to engineers in the…   Read more»

I agree with both responses that safety and reliability should remain the priority, especially because even minor design changes can introduce risks that were not present in the original device. I also think that another important factor to consider is…   Read more»

One of the best ways to attract participants besides money is to make the study more convenient and provide them with benefits. For example, offering transportation reimbursement, flexible appointment times, or even virtual follow-up visits could encourage more people to…   Read more»

AI assisted virtual trials could be useful during the early stages of medical device development but I would not feel comfortable using a device in a hospital if it has only been tested virtually. One thing I think AI could…   Read more»

I understand the argument that a single blind study should be enough, especially if the investigator has no intention of influencing the results. However, I think double blind studies are important because bias can happen unintentionally. For example, in an…   Read more»

I think medical device companies can make sure they are meeting actual needs by focusing on three things. First, they should communicate directly with physicians and patients to understand the challenges they face and what improvements they would like to…   Read more»

I think price has the greatest influence on whether a hospital adopts a new medical device because hospitals have to consider their budgets and whether the benefits justify the cost. Even if a device is more effective than existing options,…   Read more»

Advertising is a crucial component of marketing, however memorable ads are subjective and highly depends on each persons interests. The most memorable ads are those that increase the value of a company or brand. Nike’s “Just Do It” ad campaign…   Read more»

I was also surprised after hearing the 80% statistic in this weeks lecture. There are a lot of great points in this discussion thread regarding the ethics behind shelving a medical device just cause it won’t generate the necessary profit….   Read more»

The aspect of limited liability is something that has always bothered me about corporations, especially those whose leaders and/or decision makers get no punishment after harming the public. Corporations with limited liability set a dangerous ethical environment for the company’s…   Read more»

I was intrigued by this discussion thread because I know very little about the business side of medical device companies and this weeks lecture helped me better understand it. From what I learned, it comes down to saving money on…   Read more»

Like most other posts, I believe that the final decision should be made by the QA professional. From what I have learned, AI tools are increasingly being used in medical device companies, specifically in quality related activities but mostly as…   Read more»

I think the original post is phrased in a way where we have to pick which option is better and dcapera does a great job of breaking down the differences between each role and their contribution to the medical device…   Read more»

I agree that companies may be more likely to focus on QC because catching defective parts gives an immediate measurable result while the benefits of QA are harder to see since they involve problems that never happen in the first…   Read more»

As other have mentioned before, I would most likely start with a smaller set of core claims first to secure a faster, lower risk path to market. Afterward, I would expand claims down the road as real world data accumulates….   Read more»

This is a very interesting discussion post, especially in the direction we are heading into with innovations in AI integrated in medical devices. I personally think that existing regulatory frameworks are not sufficient for the regulation of AI powered medical…   Read more»

Great points were made in previous responses to the original post about the balance between protecting patients and fostering new ideas. I agree with the original post and Areemoshe that the high costs and long timelines can feel like a…   Read more»

Finances and industry pressure can certainly affect the timing of the clinical readiness of a project. When competitors are fighting within the same market, the pressure to fast-track a product is massive. A previous post mentioned how we can never…   Read more»

After undergrad I aim to finish my masters degree while working in the industry. That being said, I expect that the research topic may not necessarily be up to me but rather my employer or manager. However, I would like…   Read more»