Balancing communication methods is very important practice to be able to keep projects running smoothly without wasting valuable time. Some good strategies are to tailor communication to the type of information being shared. For simple updates or information that doesn’t…   Read more»

Organizations are able to maintain balance between control and flexibility through setting clear guidelines and actually structuring how to make project changes. Defining the scope of creativity and encouraging cross-functional collaboration helps teams approach problems with innovative solutions while staying…   Read more»

Project execution is rarely static, especially in fields like medical device development where shifting regulations, sudden roadblocks, and changing priorities are the norm. Adaptability isn’t just a nice to have it’s essential. Teams need the flexibility to shift roles, rebalance…   Read more»

Effective planning can be very essential for the managing of various complex demands in medical device development. This can include but not be limited to including meeting deadlines, staying within budget of the project, as well as tending to regulatory…   Read more»

From my experience project risks come in various forms which include financial, schedule, resource, and quality risks which can all impact a projects success differently in their own way. One common form of risk is the schedule risk in which…   Read more»

Balancing rigorous design controls with the flexibility that is needed for innovation is crucial in various regulated industries like medical devices. While strict design controls ensure safety, accountability, and regulatory compliance, as well as proper documentation and formal review processes,…   Read more»

If you were to start a project without a clear proposal and a feasibility study in can lead to scope creep, resource misallocation and unexpected challenges. A well-structured proposal will align stakeholders on objectives, timelines, and other expected outcomes, while…   Read more»

Slack is a very crucial element in project planning because it helps accommodate for the unexpected, like delays, vacations, holidays or various emergency closures. Including slack in your schedule also allows for increased flexibility which will prevent the project from…   Read more»

As far as I know PMA and 510K’s are two pathways to get FDA approval to sell their product to the US. For a 510K the company is saying that their device is similar to a device that is already…   Read more»

A drug is a treatment that works through a chemical or biological interaction with the body which can impact various cellular pathways or physiological functions to treat, prevent or diagnose diseases. Though a medical device is different because it achieves…   Read more»

Personally in my field, team size depends on the types of projects you’re working on. Since I work in the development of In-vitro models the kind of research we do can really only be done by one person at a…   Read more»

In my opinion, good leaders are born with emotional intelligence, and learn how to manage projects logistically in the company. A good leader takes into account both the logistics of the team, their skills, their work, and what they need…   Read more»

When someone signs an NDA it is  very crucial to review and understand the agreement as best as possible, some key considerations is the definition of confidential information, the level of confidentiality as well as the duration of the agreement…   Read more»

I found that this course ended up focusing on the practical aspects of the medical device industry rather just the theoretical knowledge which was very interesting, there were a lot of insights into the real world application and processes. I…   Read more»

In my field written agreement is a very important aspect of our work. When we share research outside of the company we have to come up with agreement documents to outline what information is to be shared or not, who…   Read more»

Since i mainly have worked in many lab setting there are a lot of hazards we come into in the biological sense, where at times we need to work with harsh chemical like paraformaldehyde or even other cases where we…   Read more»

In medical device companies there are a lot of ways to implement risk avoidance, mitigation and acceptance from what I learned in the field there are design changes in the medical device as a way to use biocompatible materials as…   Read more»

I believe risk management is an important aspect of risk management because it ensures patient safety because any malfunction or failure can lead to significant harm. There is also requirements in the FDA and other health bodies that require risk…   Read more»

As someone who works in a research field the project proposals created in my field may be different as our work tends to also focus on  publications and research based goals. Overall they tend to formulate in similar ways. Background…   Read more»

At work I have implemented the use of meeting minutes as a way to highlight project progress and highlight team member achievements. In the minute  meetings we all highlight the main progress in our projects which can then be easily…   Read more»