Effective medical device project management requires a thorough understanding of regulatory requirements to avoid compliance issues. Teams should stay updated on FDA, ISO, and other relevant regulations throughout the development lifecycle. Proactive risk management, proper documentation, and early engagement with…   Read more»

One regulatory challenge in developing medical technologies with AI is exploring real-world data in clinical practice. As technology is evolving quickly, regulatory agencies have an urgency to be proactive with guiding principles to promote safety and efficacy in the development…   Read more»

The most significant regulatory challenge in developing emerging medical technologies is balancing innovation with patient safety and user acceptance. FDA has evolved and has regulatory rules for  AI/ML-based software.1)As AI-based devices are constantly emerging, getting FDA approval every time for…   Read more»

From my work experience, project management is an essential part of any successful working experience. Project management skills of cooperation, team work, conflict resolution, and being approachable are skills everyone should have. For project managers, they are skills they must…   Read more»

I believe leadership qualities are a combination of innate characteristics and learned characteristics. However, the greater portion belongs to learned behavior. If we are speaking with regards to children, a child may learn from anyone they have met how to…   Read more»

There are several differences and similarities between medical devices and pharmaceutical drugs. Now, whether a pharmaceutical product is a medical device (drug delivery systems) is a separate conversation. Medical devices are usually closely associated with implants and materials that are…   Read more»

I agree that AI-driven medical devices should be even more highly regulated than other devices because of their potential to evolve over time. I think certain guidelines must be put in place to ensure that the device is still FDA…   Read more»

Drugs and medical devices are quite different and their general regulatory pathways reflect those differences. A medical device is some sort of mechanical instrument that’s purpose is not dependent on chemical action or being metabolized. Drugs, on the other hand,…   Read more»

I’d also agree that inadequate risk management is the most common regulatory pitfall in medical device development. Classification of the device can be a difficulty in the project management process as mentioned above. I’d like to add that submitting an…   Read more»

I personally believe that much of leadership is nurtured with experience and mentorship rather than something one is born with.  A project manager refines his leadership by overcoming obstacles, learning from mentors, and accepting changing dynamics from team members. Skills such as communication, problem-solving, and resilience do not…[Read more]

I think drugs and medical devices differ not only in their mechanism but also in their level of patient dependence. Drugs depend on biochemical processes of the body to produce their effect, while most medical devices act either independently or…   Read more»

I believe large teams are more effective however, an effective strategy has to be there for involvement in terms of productivity. Large teams have the advantage in experience and broad views that might lead to a better decision. At the…   Read more»

I agree with the previous claims of underestimating regulatory requirements from the start. To add to that, picking the wrong classification of your medical creation will certainly create problems. Your potential product will fall under a single or a combination…   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»

A project manager can keep project goals dynamic while avoiding scope creep by establishing a clear framework that integrates flexibility with control. At the start of the project, clear, measurable objectives should be set, both in financial terms (such as…   Read more»

Understanding Project Management: Why It’s Beneficial for Non-PM Roles While project management is often associated with a specific career path, the principles and techniques can be incredibly valuable for anyone working within a project, even if they do not have…   Read more»