@mjc22 Hi there! I agree with you that filing for FDA approval of a misclassified device can cause major hinderances to the entire process. I can recount a personal experience with this. While I was interning in a small startup…   Read more»

@sn64 Hey sn64! Although empathy and comprehension are essential characteristics for a project manager, I would also like to make note that altering goals or reallocating tasks shouldn’t be the initial strategy in such scenarios. The main duty of a…   Read more»

@benjaminrofail Hi Ben! You make a good point about how conflicts can either strengthen or weaken a team, depending on how they are handled. I agree that overcoming disagreements through clear communication and discussion fosters camaraderie. I can personally attest…   Read more»

I find that collaborating in teams of varying sizes presents distinct benefits and challenges. During my time in the military, I noticed that small teams typically offer efficient communication and quicker decision-making, yet might lack a range of expertise, while…   Read more»

When presented with new technology during a project, a project manager should carefully evaluate their possible effects by considering their compatibility with project objectives. This evaluation includes performing a detailed cost-benefit analysis, taking into account aspects such as increased efficiency,…   Read more»

During the lecture, we explored different organizational structures, and I think the leadership style—whether it be hands-off or micro-managing—significantly impacts a project’s success. Based off my previous work experience, I personally favor collaborating with a leader who takes a hands-off…   Read more»

@ms3548 This is a thoughtful question! I think that Agile approaches are very efficient in handling changing project objectives since they prioritize flexibility and teamwork. By dividing the project into smaller, time-limited sprints, Agile enables teams to reevaluate priorities and…   Read more»

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»