Gantt charts are a great tool especially for sticking to the project timeline in a visual manner. However, sometimes these charts do not offer flexibility in terms of deadlines. There are many ways Ga...

Some other things to keep in mind are ensuring that you are up-to-date with all the regulations and standards/qualifications that must be met. The FDA is constantly updating so it is important to be i...

Hi everyone! My name is Priyanshi Luhar and I'm a student at NJIT in the BS/MS program studying biomedical engineering. I'm also currently doing a co-op at Ethicon in GTO/engineering. Looking forward ...

I agree with the points above. Changing the DSD is a more difficult process compared to the test veriffication plan. However, my decision on whether or not it would be appropriate to change the DSD wo...

My group performed similarly. We took a more collaborative approach. We first did a root cause analysis and identified the areas of error that could have contributed to the testing failure. From that,...

You bring up a really good point that I think is highly debated in this high stakes industry. Medical device developers will try to increase the scope and range the devices are usable to maximize usab...

From my experience in the med tech field, I've learned that companies take measures so that devices don't have to be redesigned. The device is made taking everything in consideration. It is very rare ...

Design changes can occur due to wanteding to improve the medical device or wanting to fix any issues it may have. In wach case, it is good to have a list of risks to be proactive on as mentioned in th...

Having design reviews regularly shows the progression of the project and ensures that it is on the right track. Something that I think would be beneficial in a design review is to meet and review it w...

While the long and challenging process for a PMA make it so that companies are discouraged at innovating new medical devices, it is necessary for a PMA to be rigourous so that the effectiveness is det...

The FDA created the Human Device Exemption (HDE) in 1990 to help streamline medical device approval for devices intended to help treat or diagnose rare diseases. There are more than 7,000 rare disease...

I agree that sometimes it is difficult to classify a medical device, especially if it is a combination product. Having a combination product brings in the additional challenge of determining the prima...

A project's scope is based on customer needs and stakeholder values. Stakeholders are most invested in the financial situation with the project, while customer values focus on what is needed by the cu...

Something that is told very frequently at medical device (or anything healthcare or biotech related) companies is to focus on the "why". Before jumping onto a project, it is important to understand wh...

I think the previous posts bring up great points in having transparency to maintain a clear line of communication. I agree that messages may become unclear through email chains so having a 1:1 talk ca...