The rapid development of COVID-19 vaccines did appear to defy the traditional “fast, good, cheap — pick two” paradigm, largely due to unprecedented global collaboration, government subsidies, and existing research infrastructure. Emergency Use Authorizations (EUAs), overlapping clinical trial phases, and…   Read more»

The Covid vaccine was shown to be good, cheap, and fast due to several reasons. Under normal circumstances, it would be nearly impossible to fulfill all three. During the pandemic, the government passed an emergency use authorization which took a…   Read more»

In the case of a recall, Medical Device Manufacturers should take the following steps on what to do. First, a letter should be sent to clinics, doctors, patients, and all stakeholders of the recalled device describing the reason for recall,…   Read more»

After landing a job that I’m passionate about, I’d be very excited to begin by journey learning from new experiences, and continue growing my skills. In the situation where there’s no long term growth or opportunities in the company, I’d…   Read more»

As mentioned previously, there are different stages to recalls; each one being more severe than the other. The FDA can inform the company on a strategy on how to proceed with the recall, either through public announcements or coordinating return…   Read more»

Career satisfaction in clinical trial project management, or really any field, isn’t just about checking tasks off a list or hitting deliverables. Over time, if there’s no room to grow, no new challenges, or if the day-to-day starts to feel…   Read more»

Totally agree that communication plans don’t always get the attention they deserve, even though they’re such a big part of what keeps a clinical trial running smoothly. Once a trial moves into the execution phase, things start moving fast. Without…   Read more»

Balancing cost, time, and quality in clinical trials is definitely a tough equation, especially since quality really isn’t something that can be compromised. Between regulatory requirements and the responsibility to ensure patient safety, cutting corners on quality just isn’t an…   Read more»

This might be a scenario where you could swap career paths if you were truly passionate about the subject. There might still be long term growth if you’re willing to do change career goals. However, this is something each person…   Read more»

I learned how to work with a variety of people who each have differing backgrounds and type of work flow. This allowed me to develop my skill to bring project team members together in order to strategize how to approach…   Read more»

I personally believed that compensation was a larger part of why people work. It was both comforting and motivating to see that people work to make a difference, to help others, and to feel fulfilled. This is the exact cause…   Read more»

The cheap aspect of fast-good-cheap is one topic that may be up for discussion. More specifically, much of the financial aspects of developing a vaccine was subsidized by the government and FDA instead of the pharmaceutical companies. The financial planning…   Read more»

If scope, resources, or risks aren’t properly managed from the start, even small projects in medical device development can quickly spiral out of hand. Originally a little design update or limited feasibility study, what begins as a time-consuming, resource-draining project…   Read more»

Certain jurisdictions allow for streamlined product approval by using clinical data obtained from other jurisdictions. This is called a data-reliance pathway. For example, Canada and the US have a mutual agreement which essentially help approve new medical devices in both…   Read more»

Through outsourcing clinical trials, Contract Research Organizations (CROs) have been somewhat well-known in the medical device industry helping to reduce expenses, timeframes, and regulatory complexity. Outsourcing can increase production, worldwide reach, and access to specialist knowledge—that which might not be…   Read more»

In the development of medical devices, contingency planning is quite important when supplier issues, regulatory changes, testing failures, or clinical delays quickly throw budgets and schedules off. A well-developed contingency plan helps teams to overcome unforeseen challenges without sacrificing the…   Read more»

Cost and quality are both great indicators for success when selecting a vendor, but transparency should also be considered. Companies that obscure information that they don’t want others to notice should be approached with caution. This is especially the case…   Read more»

Like many others, one of the things that motivates me is the desire to create something meaningful. I want to be a part of something that has a true positive impact on the lives and well-beings of people every day….   Read more»

There are absolutely more factors to consider when selecting a vendor. For example, delivery timelines and reliability is essential to avoid delays, especially when working on time-sensitive projects. Another one is regulatory compliance and any associated certifications. When working on…   Read more»

One important thing I know I have learned in this class is the project management is much more than just planning. Beforehand, I did not really know what project management was. I had assumed that the majority of the work…   Read more»