Hi Roberto, I agree with you that these situations can feel awkward especially when the intent is simply to show professional gratitude. One way to address this awkwardness might be to have clear communication up front. I would have had…   Read more»

@cef3 You make a valid point however, I would argue that even legal action seems unlikely, having a contract is still strongly beneficial. A contract ensures that all parties are on the same page regarding stated terms, reducing any misinterpretations…   Read more»

@cef3 You make a good point! An NDA is surely an important piece in the early stages of development especially when engaging with collaborators to collect necessary data. Without an NDA, it is true that there is significant risk that…   Read more»

It is clear from our class lectures that organizational development (OD) is very important in assisting medical device manufacturing companies to integrate cutting-edge technologies. In fields regarding AI and IoT, OD helps in ensuring these advancements are in line with…   Read more»

Based off my experience in industry, I believe that the ideal organizational layout varies based on the company’s objectives. A flexible approach such as “everyone does all tasks” is suitable for small businesses as it promotes agility and multitasking, and…   Read more»

I believe I have the potential to succeed in both positions in the long run, but I envision myself beginning in middle management. Middle management is primarily responsible for task execution and ensuring the effective implementation of the company’s vision,…   Read more»

That’s an awesome question! In order to build a successful project team, I feel that I must prioritize selecting members with the required knowledge and abilities for their respective positions, in addition to their ability to work together effectively and…   Read more»

Hi Savannah! Those are great questions. Compliance with ISO, FDA, and ASTM standards can be expensive as it involves a good amount of resources, expert cooperation, and continuous updates. Based off my previous work experience, I understand that these are…   Read more»

Risk management is certainly a crucial aspect of the planning stage, particularly in the area of medical device development. I worked in medical device development for quite some time and what I noticed was incorporating risk management early enables teams…   Read more»

Based off my experience working in a medical device company for dental implants, conducting a risk management evaluation for a medical device offers many important advantages! One of the most commonly observed is the increase of safety for patients and…   Read more»

@jt63njit-edu I absolutely agree with you. Verification focuses on making sure that the software meets the specified requirements through activities like inspections or even reviews. It is often referred to as static testing in my workplace because it does not…   Read more»

Hi Saad,  You make a great point that design control is crucial for any medical device development as it ensures that the item is safe, efficient, and compliant with regulations. There are definitely challenges however, if the process is not…   Read more»

Hello Roberto, While I understand where Dr. Simon and many of these posts are coming from, I would like to play devil’s advocate and also recount a more negative aspect of meeting minutes. I have found in the past that…   Read more»

In the world of medical devices, I would imagine that companies take corporate responsibilities pretty seriously because patient safety and following FDA regulations are highly crucial. How companies actually commit however, depends on the company itself. Some factors are the…   Read more»

My capstone project focuses on creating a chitosan based sulfated polysaccharide hydrogel for wound healing, specifically aimed at larger cutaneous wounds, including the potential for diabetic foot ulcers. There is a gap in the market regarding diabetic wound care, as…   Read more»

I agree with you that design controls are very important for ensuring the safety and efficacy in medical device development. They help in maintaining the structural approach that aligns with FDA requirements, especially for class II and III devices which…   Read more»

As I worked in research with a Veterans Affairs Hospital, one major incentive outside monetary compensation that was used was access to free medical care or treatments. The offer of free medical evaluations, diagnostic tests, and healthcare services during the…   Read more»

@atk27njit-edu I would disagree that the placebo effect is “all in the mind.” While the placebo effect does rely on expectation, it’s not simply a mental trick played by the mind. This is rather a real phenomenon that is exploited…   Read more»

Coordination during unexpected adverse events in clinical trials is absolutely essential for patient safety and maintaining the integrity of the trial. A standardized, predefined process for assigning responsibility is ideal because it really ensures clarity and rapid response. Each key…   Read more»

@an83 I would have to disagree on your perspective because a business minor can offer valuable skills that actually benefit a student beyond an MBA or entry level role. An undergraduate education does often focus on immediate next steps, but…   Read more»