For my capstone project, many of the delays we ran into were communication-based. We needed to order chemicals, but since we had an external sponsor (and therefore external payment), we had to go through numerous additional steps to order the…   Read more»

I don’t know if there’s a good reason to keep the PM out of the loop financially. Everything in a company relates to finances. “Time is money,” and when it comes to the development of a medical device, it can…   Read more»

I think what is useful about the FDA regulatory aspects of medical devices is that once your device class and required documents/steps are determined, there is a relatively clear pathway that your team must follow for FDA approval. Of course,…   Read more»

If members of your team are working on multiple projects, it may be useful to speak to the other PMs to get a sense of the project timeline to ensure that the project has people available to work on it…   Read more»

As Dev said, there should be multiple design review meetings and controls such that there is no need to return to a completed phase. If a PM and their team are thorough, and the proper design documents have been maintained…   Read more»

I think that certifications without the degree to back them up don’t really mean anything in an industry setting, whereas someone with a degree (say a Bachelor’s in Biomedical Engineering) would likely be encouraged to seek a certification such as…   Read more»

I agree with Krish that the PM’s role combines task management with the objective of completing the DHF and compliance assurance. While the PM shouldn’t be the only one focused on compliance, when trying to get a medical device to…   Read more»

I agree with Ehab that changing the DSD may not be necessary in this case due to the nature of its stipulations not including that the water bath had to be 37C. Additionally, if the DSD is changed any time…   Read more»

If the stents fail during in-vivo testing, the team as an entirety would need to re-assess the design. It would be critical to understand why the stents are failing and possible avenues to rectify that. It is also possible that…   Read more»

Products like smartphones or less-strictly-regulated medical devices, such as Class I devices, can have a very fast product life cycle. I have seen that Class II and III products tend to have a longer life cycle due to the amount…   Read more»

I agree with Sami that collaboration is a big component in ensuring a full completion of the DHF, especially when the design controls and project management processes are separated. If the two are completely separated and there is a lack…   Read more»

In order to make sure important information isn’t overlooked in the DHF creation process, it is important to be constantly working on the document rather than waiting for the end. It also would likely be a team effort, of a…   Read more»

I think that a crucial part of a PM’s job post-market release is ensuring that all the proper documentation has been collected and organized, and the PM should, as Sami mentioned, either prepare for post-market activities or help facilitate a…   Read more»

I also agree with Vansh that it would be more under the purview of a regulatory control team member than the PM to ensure that FDA regulations are being upheld, but I believe that a close relationship between the PM…   Read more»

I think to be a successful project manager relies heavily on the interpersonal skills. If you have established respect and a rapport with your team, you would, in theory, be able to rely on them when your own technical skills…   Read more»

I think that the answer to this is very situational. If, as a PM, you anticipate being in charge of a very niche biomedical product, and future projects you manage will also remain in that niche, it would very much…   Read more»