New medical devices offer fresh opportunities for your company to improve health outcomes, push the boundaries of medical innovation, and grow your business. But medical devices also carry varying levels of risk that must be carefully managed. As the product…   Read more»

In the medical device industry, there is a large push to be first-to-market and minimize project timelines in order to capture/increase market share, increase revenue, and reduce costs. Sometimes, businesses will push the ethical envelope in order to do this….   Read more»

From working in a testing group, one common strategy I see for developing fast and low cost testing is by taking advantage of compendial test methods. Compendial test methods are test methods that have been used in the past and…   Read more»

I agree Kellye, nice post. It was well thought out.

@nr473 I agree, nice explanation and mapping out the process. 

I don’t have any experience working with medical devices, at least not yet. But from what I’ve gathered here at Morehouse School of Medicine, a project manager can be very vital to a medical device start up.

I think meeting minutes are very underrated. They are taken for granted and passed over quite often. Meeting minutes can be crucial to you if you happened to zone out or take your attention off of the meeting, even for…   Read more»

I believe the most important part of design control is the design verification phase. I chose this part of the process because the verification of the design is crucial to being a “good” product in my opinion. I think it…   Read more»

Regulation of medical devices is different across the world. Some places have very complex requirements while others have none at all. In the U.S., we have established Design Controls. Design controls designate the application of a formal methodology to the conduct…   Read more»

As a Project Manager, the key to helping underperforming employees is to act as soon as you start noticing signs of underperformance. Upon noticing changes in their work behavior, you should schedule time for a one-on-one meeting. During this time…   Read more»

Verification and validation are both elements of the medical device testing process, they serve two very different but equally essential functions. In simple terms, verification determines whether the product was built right, while validation determines whether the right product was…   Read more»

There is no set way for a company to decide on its project management. There are advantages to both methods. When having members of the same company be part of the project management team, the team will contain members that…   Read more»

Remote employees are working longer, spending time in more meetings, and having to keep up with more communication channels. Instant messaging platforms are best for short messages that need a fairly immediate response. Email is usually better for longer messages…   Read more»

My team’s approach to the simulation was to first list all the possible roots of the problem. Then, we would list them in decreasing order of how probable they would to occur. After that, we would conduct some research on…   Read more»

It is important to have check points to constantly monitor the activity and project level. I believe that it is more likely to go under the planned value because there are usually some obstacles that occur that would inhibit the…   Read more»

Hi all, I am a PhD student in the BME department at NJIT. 
Here is my linked in profile 
 
https://www.linkedin.com/in/alexandros-tzalavras-aa9000170/

@jbarbee I agree, I think there is value in having an internal PM and also having fresh eyes from a third party service come in to evaluate and assist in the implementation as well. 

In my most recent role, the company was fairly large and there was a PM but there was no PM team. The project manager would enlist the input/services of an individual from the internal team the project focused on, to…   Read more»