I definitely agree. Having a good grasp on business and strategy can also allow project managers to know which areas to prioritize. For example, if they know a competitor medical device company will also be laucnhing a similar product, they…   Read more»

This is a really great topic, and I do think that the answer to which types of risks are more predominant and the most impactful depend on the industry. I think that finanical risk and reosurce risks are not as…   Read more»

Another very useful tool is the Work Breakdown Structure. It essentially helps define the project scope better and breaks it down into the larger functions and their tasks. This can help with making sure that no task is overlooked. Forgetting…   Read more»

I agree with the posts above. Indentifying the critical path will aid in a seamless execution of the project. Another tool I find to be helpful is a prioritization matrix. It will allow the stakeholders and project managers to break…   Read more»

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 Gantt charts can be improved. For example,…   Read more»

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 informed of any changes that would…   Read more»

Hi everyone! My name is Priyanshi Luhar and I’m a student at NJIT in the BS/MS program studying biomedical engineering. Looking forward to connecting with everyone. I’ve included my linked in below:https://www.linkedin.com/in/priyanshiluhar/

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 would depend on if it…   Read more»

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, we listed ideas on which methods we…   Read more»

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 usability and profitability. For example,…   Read more»

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 that the entire device needs to…   Read more»

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…   Read more»

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 with all the stakeholders…   Read more»

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 determined to comply with pateint…   Read more»

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 primary mode of action to see if the CDRH,…   Read more»

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 customers (surgeons, patients, researchers, etc). Often, project members…   Read more»

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 what the aim of project is and exactly…   Read more»

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 can clear up any miscommunication. I…   Read more»