I do believe these columns are enough as they allow for the entire design process to be visualized without overly complicating it. I think the most useful aspect of a Design Matrix is that it tends to be easy to…   Read more»

In general, clinical trials for both medical devices and drugs have the same end goal, to prove the safety and efficacy of these products for their given purposes. However, as many indicated above, the process of proving the safety and…   Read more»

In terms of validation, I believe that the key is to always go back to the customer. By definition, validation is the process of ensuring that the device meets all of the customer’s needs. If the device fails in a certain…   Read more»

Why seemingly similar and first-glance, validation and verification are quite different terms. Validation is the process of ensuring that a device meets the predetermined customer needs while verification is the process of ensuring that the physical aspects of the device…   Read more»

The most important part of meeting minutes is that they lay out deliverables for each team member and when those deliverables are supposed to be accomplished. Especially in a project with a lot of moving parts, it is important to…   Read more»

If I were to work in clinical trials, I’d like the role of working patient advocacy. I think one of the most overlooked aspects of clinical trials is the individual patients involved. Patient advocacy is being the “voice” of the…   Read more»

I never realized that for rare diseases, sometimes clinical trials are the only means of getting treatment. Some of these diseases are very niche and do not have approved drugs, so the only drugs available are experimental products. Are patients…   Read more»

Clinical Trials (in all of the different stages) require a lot of data to display two aspects of the drug: safety and efficacy. If the “drug” has no adverse effects and the data displays positive symptom relief, then it would…   Read more»

I believe the method of marketing and advertising depends on the medical device being marketed. Some devices/drugs have a much broader demographic, so selective marketing may not be needed in order to reach the target consumers. For instance, diabetes affects…   Read more»

If possible and it does not delay graduation, I believe getting a minor in business or marketing is beneficial. This minor will expose you to topics and skills needed in a biomedical engineering career, such as customer satisfaction, cost minimization,…   Read more»

As you indicated, I think it depends on the type of individual you are. If you an extrovert and good at pitching ideas/devices as customers, you may be suited for a sales job. Although an engineering background does not directly…   Read more»

I believe basic business classes should be required electives for all students, not just biomedical engineering students. For almost all careers, a basic understanding of financials and business development is needed. As an engineer, it is important to understand the…   Read more»

I believe it all depends on what you are looking for. If you are looking for a stable, reliable job with the potential to remain in the same company for decades, you should look at larger, more reliable companies. However,…   Read more»

In terms of stakeholder interest and general outsider perspective on a company, larger more well-known companies can afford to have a year with a poor ratio for numerous reasons. First, they often have a long-standing history of being a reliable…   Read more»

In my opinion, 99% of the time companies do not violate FDA regulations on purpose. The companies are aware that violating these regulations can lead to both poor reputation and failure to get approval. However, abiding by all the regulations…   Read more»

From my experiences working in pharma, when the FDA comes to audit a clinical trial, the most important aspect the company focuses on is organization. All the required documents need to be filed correctly and organized in a manner that…   Read more»

Quality Assurance and Quality Control are similar processes, but both are needed to ensure medical devices meet quality and regulatory standards. Quality Assurance (QA) is a more proactive process that focuses on the method of device production and works to…   Read more»

When working as a team on a project, it is very important to have diversity because this diversity leads to different perspectives on the project. Different individuals have different experiences which allow them to approach problems in a different manner….   Read more»

All humans are inherently biased, so any organization run by humans will have some level of corruption. Small biotech companies definitely struggle in this regard because they do not have as many connections in the FDA and do not have…   Read more»

The FDA is most definitely strict when it comes to its rules and regulations but it NEEDS to be strict. According to their mission statement, the “FDA is responsible for protecting the public health by assuring the safety, efficacy and…   Read more»