When finalizing a consulting agreement, several key elements must be meticulously addressed to ensure clarity, safeguard the company’s interests, and establish mutual expectations. Defining the scope of work is essential, as it outlines the specific tasks, deliverables, and timelines the…   Read more»

While I don’t have personal experience with consulting, I believe it’s a strong option for recent graduates, especially in industries where full-time positions are highly competitive and difficult to secure. It’s interesting to note that consulting isn’t particularly common among…   Read more»

The discussion on verbal contracts is indeed fascinating, especially in the medical device industry, where precise documentation and regulatory compliance are critical for success. While written contracts are generally preferred for their clarity and enforceability, verbal agreements can be valuable…   Read more»

Given the structure that was presented to us during class, I would say that my group originally started off as a functional organization. As organized by Dr. Simon, each student was grouped into an area of expertise of their choosing,…   Read more»

A functional organization is hierarchal structure in which employees are grouped in departments based on their specialized functions or area of expertise. In this type of organization, authority and decision making are centralized within the functional department. For medical device…   Read more»

When it comes to the appropriateness of a matrix type (strong, weak, or balanced) for a medical device project team, it is important to consider several factors, including the complexity and regulatory requirements of the project. To start with a…   Read more»

As someone who lacks industry experience it is very interesting to see everyone’s experience with risk management and which circumstances they encountered with each method (risk avoidance, mitigation, and acceptance). While each method has similarities to each other, they can…   Read more»

Just as many have said above, it is clear that risk management is a crucial process conducted throughout each stage and area of the project, but I would argue that the product design stage requires the most attention and awareness….   Read more»

Risk acceptance is a risk management strategy in which an organization consciously decides to accept a risk without taking proactive steps to avoid or mitigate it. Therefore, to answer the question above, risk acceptance can technically lead to a higher…   Read more»

The responses seen above do a great job in explaining and describing the steps/process a team must take to define success criteria, but it is also important to highlight the disadvantages that come with moving target success criteria. To start,…   Read more»

This an interesting topic because there are so many medical devices that the 3 categories of design input requirements can be very different. The device that I will be mentioning is a pacemaker, which is a small, battery-powered device that’s…   Read more»

As many of the previous responses have stated, a project proposal is crucial because it establishes the foundation and direction of the project within a company. Not only does a project proposal clearly identify a business need and present a…   Read more»

When it comes to medical device companies and “corporate responsibility”, they tend to the take the matter very serious due to ethical obligations and regulatory requirements. To start with regulatory accountability, medical device companies need to follow the stringent safety…   Read more»

While it is certainly worth arguing that a Design Matrix with the four columns listed above (inputs, specifications, validation, and verification) can provide enough critical information to complete a matrix, I believe that adding additional columns could enhance the matrix’s…   Read more»

For my capstone project, my team and I designed and developed a mechano-myography (MMG) armband that was able to track the mechanical vibrations of the upper arm while also measuring the changes in circumference during a muscle contraction. The armband…   Read more»

This is a very interesting topic because controlling the placebo effect in clinical research is critical to the success and accuracy of a trial, especially in studies in which the patient’s perception of pain can heavily influence the results. While…   Read more»

People decide to participate in clinical trials for a variety of personal and medical reasons. To start from a medical perspective, one of the main reasons individuals volunteer in clinical trials is because it gives them early access to new,…   Read more»

As a graduate student-athlete who is pursing their Master’s in Biomedical Engineering at NJIT, I definitely think that students would greatly benefit from spending time in a clinical setting. Throughout my past four years at NJIT, I have found it…   Read more»

Although currently, with my aspirations and desires, I do not really see myself transitioning into either marketing or sales after completing my biomedical engineering degree, if it truly came down to it and I were to transition into one of…   Read more»

In today’s world, social media has certainly proven its effectiveness in reaching vast and diverse audiences. With various different social media platforms like TikTok, Instagram, Twitter, Facebook, and YouTube it is practically inevitable to come across an advertisement that will…   Read more»