Verbal contracts can be followed through ensuring that the agreement is as clearly defined as possible to attempt to prevent the opposite party from identifying and exploiting loopholes. When these verbal contracts are not specific, it can result in both…   Read more»

Although a scenario like this may appear to be too restrictive, I believe that it is best to maintain these strict practices to ensure that ethics are not being compromised. As mentioned by others, the Sunshine Act was established to…   Read more»

The days of giving gifts like the “old days” are in the past for most companies today. The company that I am currently working at actually assigns a specific training relating to this exact topic and gives different instructions on…   Read more»

Currently, I work within a matrix organization in which I work within a certain department and am involved within different project groups. This style of organization is a good fit for me as it allows for me to work with…   Read more»

Upper management typically includes executives whereas middle management can be managers over particular departments or teams. In upper management, the executives typically evaluate decisions from a business perspective and are more focused on the big picture. In middle management, the…   Read more»

My team has had two meetings so far virtually since it is difficult to meet in-person due to each person having different class schedules as well as working during the day. As of now, we have completed the DDP, a…   Read more»

Risk management should be a team effort and should thus be equally as important across all functional areas. Although Quality may be the department that actually develops the documentation pertaining to risk management, such as an FMEA, every department should…   Read more»

It is important to understand both. In order for a device to be successful, the rewards have to be evident to appeal to the market. Although it can be tempting for companies to be solely focused on the rewards, it…   Read more»

Risk assessments are crucial for medical devices as they lay out potential risks that can occur in the device. A risk assessment allows a team to see the different risks possible and find a way to mitigate or eliminate those…   Read more»

Companies should have a high sense of corporate responsibility, particularly within the medical device and pharmaceutical industry due to their products having a direct impact on patient health. The implications that can result from not valuing corporate responsibility could be…   Read more»

Within a design review meeting, it is important to ensure that each department involved in the project should be represented at the meeting. This may include the project lead as well as the quality lead, regulatory lead, research and development…   Read more»

Minutes for meetings are crucial as they allow for team members to be aligned on what was discussed throughout the meeting. This can be helpful in ensuring that team members are aware of what tasks need to be completed as…   Read more»

Different departments within a medical device company have a hand in working with design controls. A quality assurance department may be focused on developing the inputs and outputs for the device, the regulatory department may be focused on ensuring that…   Read more»

When revising design controls it would be important to observe whether they follow the desired inputs and outputs for the device. From there, the first and most important step to implement to keep operations moving smoothly would be to ensure…   Read more»

A factor to consider when developing a test method and protocol is repeatability. It is essential that the test can be performed at a different instance with a different operator. For example, in my current role, I do some mechanical…   Read more»

In order to eliminate the placebo effect, researchers have to ensure that both products look as close to identical as possible. For example, if a clinical trial is being conducted using auto-injectors and syringes, with the placebo being water-filled syringes…   Read more»

During undergrad, I had a course called FDA Regulations of Medical Devices which served as a good precursor to how medical devices are developed in accordance with FDA regulations. In that course, we were tasked with developing a semester-long mock…   Read more»

A way that companies could incentivize participation in a clinical trial is through having benefits that could improve their health. For example, if a company is conducting a clinical trial on a specific drug, it could offer free medical screenings…   Read more»

Participation has become a huge factor in marketing due to the popularity of social media. Social media has provided companies with the opportunity to turn their marketing into a two-way conversation, whereas other marketing avenues, such as television commercials, are…   Read more»

Transitioning from engineering into sales or marketing would be an interesting potential future opportunity, but personally, I would currently prefer working in engineering. Sales and marketing have a lot of positives such as more direct interactions with prospective patients and…   Read more»