It is important for the framework to evolve for AI integrated medical devices, and companies shouldn’t need a full reapproval for every update because it can become redundant. However, when it comes to changes that affect safety, performance, or clinical…   Read more»

It is also important to consider how each environment from academia to industry is when it comes to helping individuals in smaller populations and how that can impact a project, especially when it comes to profit. Industry may provide more…   Read more»

Personally, it really depends on the project but an essential factor that should be taken into account for a project is the sensitivity or confidentiality of the brand new instruments or technology. In-house testing would be most preferred because the…   Read more»

An important factor in determining clinical readiness is by looking at whether lab and animal studies showcase enough evidence of safety and efficacy. At the same time, one should identify the major risks that could affect human trials. The goal…   Read more»

Contributing to everyone’s perspective, an important part that comes from project planning may not be planning every individual task, but it can be identifying every major decision point. A team might not know what will happen during the development stage,…   Read more»

From personal experience, another major conflict point that can be seen with teamwork is competing personalities. At times there can be certain members or subject matter experts that can be very straightforward or close-minded about how something can be done….   Read more»

Prioritization and judgement is an additional quality a project manager must showcase, especially when there are competing demands coming from stakeholders, engineers, or others. A project can have an organized timeline and a motivated team, but situations when there are…   Read more»

Another component that comes with dealing with teamwork that is challenging is the possibility of there being unclear ownership for certain tasks. Even when people want to contribute, the project can still face challenging issues if no one in the…   Read more»

It is essential to be a well-rounded student as described in the conversation; many students take on more than they can chew, and it can ultimately affect their performance in certain aspects. I think it is important to see how…   Read more»

It is essential to have experience in industry, especially if you want to break into top companies; however, the experience matters less compared to how you explain your accomplishments. It’s important to keep in mind that one can be successful…   Read more»

For non-PMs, the understanding of project management concepts strengthens one’s risk ownership, even without formal authorization. In engineering roles, small decisions such as selecting certain materials or sizes, adjusting tolerances, or delaying tests can create downstream risks that aren’t immediately…   Read more»

System-level accountability is essential, and it covers aspects that involve a larger group of individuals who are underperforming along with individuals. At times, underperformance is less about the individual and more about how success is measured or supported in the…   Read more»

The decision is usually driven by the overall risk and the long-term cost instead of the unit price. Although it may seem reasonable to spend time investigating and finding a solution to a defect with a low-cost supplier, the effort…   Read more»

Agreed, blaming a specific person isn’t productive; instead, looking for a direct solution or remediation is most suitable. In many cases, elements such as site selection and early-stage predictions can keep problems from arising. In clinical trials, underperformance can be…   Read more»

Companies usually rely on the informal leverage systems when legal protection is not effective. Even though there aren’t any explicit quality clauses, vendors are usually part of a larger network where reputation, contracts, and long-term partnerships are a priority. Companies…   Read more»

COVID-19 is a special case where vaccines were able to achieve that “fast, good, cheap,” result compared to how it works traditionally. One difference is that instead of resolving all uncertainty before the approval, there was risk that was acknowledged,…   Read more»

A way PMs can make an informed decision between utilizing crashing and fast-tracking is by questioning which decision is more reversible if something goes wrong. For example, since crashing means adding resources or supplemental support, then it can be scaled…   Read more»

Similar to Sami, in my time working as an intern at a medical device company, I was onboarded into a team at a later stage of a project, before FDA submission. One part that I believe is overlooked is when…   Read more»

One way a PM is able to navigate an unknown budget is by integrating changes that are centered on structured prioritization, phased decision-making and proactive escalation instead of waiting for a full budget before executing. If new regulatory requirements or…   Read more»

One of the most difficult parts when it comes to working on a team project is maintaining team alignment as the project evolves. This also includes all stages of product development, from planning to production. As other commenters have stated,…   Read more»