Although there’s not a substantial difference between verbal and oral agreements, there are some notable differences to note. Verbal agreements are classified as those that are through any form of communication, whether it be email, phone calls, etc. However, oral…   Read more»

No, an NDA is not a substitute for a patent. An NDA is an agreement that protects confidential information between business when collaborating. It is a temporary agreement that requires resigning every certain duration (typically 2-5 years) to reinstate it….   Read more»

When finalizing a consulting agreement, it is important to clearly outline the expectations of the services provided by the firm, a timeline of when the service will be completed, and the payment details. It is also required that prior to…   Read more»

I am currently interning at a biomedical equipment manufacturer, and we use PFMEAs I am currently interning at a biomedical equipment manufacturer, and we use PFMEAs for all of our products, as per ISO 13485. The PFMEA of each of…   Read more»

A risk assessment consists of a risk analysis, which identifies potential hazards, and a risk evaluation, in which each hazard is evaluated in terms of its probability and severity. Risk assessments are critical in medical device development, as they serve…   Read more»

The entire medical device development process, including the planning phase, has been carefully and strategically structured to minimize any unnecessary time or finances spent. If anything, risk management saves money and time for companies, as a lack of risk management…   Read more»

In the development phase of product development, the process of verification occurs. This process verifies that the product aligns sufficiently with the requirements in place. The process includes a variety of inspecitions and testing that serve to answer the question…   Read more»

Insufficient design controls can have negative repercussions on many aspects of the medical device industry, such as creating unnecessary costs, high defect rates, and in extreme cases, a company can be banned from producing insufficient products. However, the most prominent…   Read more»

Meeting minutes are essential for staying on track with a project and being able to recollect information. I have used meeting minutes for numerous courses and clubs I have been involved in on campus. Without the use of meeting minutes,…   Read more»

I think it is a great idea and highly beneficial that students spend time in a clinical setting to learn about the field’s needs and shortcomings. Getting actual experience in a clinical setting would help students get such useful first-hand…   Read more»

Inclusivity in clinical trials is such an important concept, as it benefits not only the research, but also a diverse pool of participants. It’s unfortunate that previous research trials have been more geared towards the inclusivity of white males. As…   Read more»

Clinical trials often offer its participants benefits of some sort, whether it be monetary compensation or some sort of personal health benefit with access to experimental therapies that may treat the participant’s condition. Also, for those that have a personal…   Read more»

A lot of medical device companies seem to use blue for the coloring of their logos, which is supposed to signify trust and strength within the brand. Of course, other medical device companies use different colors, such as Johnson &…   Read more»

During this course we have been introduced to different aspects of medical device development including business. Although this is a BME course how beneficial do you think a business minor/major/certification to an aspiring engineer?  For an aspiring engineer with little…   Read more»

Maintaining a diverse demographic across clinical trials is beneficial not only for collecting efficient data, but it is also advantageous in the sense that people across all backgrounds are given opportunities to experience and likely benefit from their participation in…   Read more»

Two businesses currently supplying medical devices on the market include Medtronic and Getinge. Medtronic is a publicly traded company with about 95,000 employees across the globe. In 2023, Medtronic’s reported revenue was $31.227 billion. Similarly, Getinge is also a global,…   Read more»

I, too, would prefer working for a large and publicly owned company due to the benefits relating to salary and stock options. Also, compared to a smaller company, there are more opportunities in most cases to hold different positions within…   Read more»

While not all engineering students are interested or plan on perusing a career in industry, I feel that taking an additional business course should not be required. However, in the event that engineering students are planning to take the industry…   Read more»

QA is a proactive process that seeks to prevent defects from occurring within the product development process. QA designs the processes and improves upon them to maintain quality. On the other hand, QC is a reactive process that identifies and…   Read more»

In my professional work experience at a biomedical equipment manufacturer, I have gotten insight into the issues that are commonly encountered within the Quality Department. The main issue being a lack of communication between the department and upper management. It’s…   Read more»