While changing multiple steps in the verification process does seem more efficient a key aspect of regulated industries in general is finding the root cause of issues. Executing multiple changes to the verification test at once will make it difficult…   Read more»

Hypothetically, if I could change the DSD I would alter the part of the DSD that required that the label pass a submersion test. In the instructions for the simulation the simulation mentioned two products both the hydrophobic and hydrophilic…   Read more»

As said a change control process is essential in managing design changes in a project. A change control system will allow for a thorough analysis of a design change and its potential impacts. This is critical for ensuring that changes…   Read more»

When considering risks for in medical device project management, technical and regulatory risks usually also have financial implications to them. An issue with a regulatory filing, will almost definitely set the project behind schedule which will cost the company money….   Read more»

I think that while Design reviews and Design change requests are important to do during the check and act phases, I think it is just as important to do these during the “Do” phase. While doing a final review as…   Read more»

Personally, I find that when it comes to making final decisions, differing backgrounds does not have as much impact when there is minimal overlap in roles or responsibilities regarding the project. Of course, as teams get larger overlapping responsibilities becomes…   Read more»

While I do think that the PM should be ensuring that the team is keeping regulatory concerns in mind at all stages of the project, I am not sure if dealing with the FDA directly is the primary role of…   Read more»

While I believe that an online PM is possible, I think that usually an in person PM is generally better though it may depend on the specifics of the project. While obviously for entirely online teams an online PM would…   Read more»

I also believe that interpersonal skills are far more important to a PM than technical skills. Like someone else said, the exact technical skills needed will vary from project to project, while the interpersonal skills can easily transfer and most…   Read more»

There were a lot of good suggestions in this thread about methods and tools you can implement in a risk management plan. I saw FMEA, and the bowtie method already mentioned in this thread, which are both great options for…   Read more»

I agree that a more dynamic approach to each device would be the best way to handle risk management on any individual project. I do think that you are correct, that maybe there may not be enough emphasis on scenario…   Read more»

I do not think it is really possible to design a zero-risk device. While certain kinds of risks can be eliminated, some risk will always exist in some form. Unfortunately, I think that means that striving for zero-risk designs, while…   Read more»

I think you brought up a great point about validating alternative equipment, in case of equipment failure. I think that in addition to validating alternative equipment, alternative materials should also be validated. Otherwise, disruptions in the supply chains can result…   Read more»

Alot of great points were already brought up in this thread. Trying to keep balance between maintaining up-to-date documentation and balancing inefficiencies, has some challenges. I agree with the approach of using controlled versions and schedules updates rather than real-time…   Read more»

While it might be possible that not every real-world failure can be predicted or fixed with design controls, however in this case highlights how design controls are not effective unless there is a workplace culture willing to enforce integrity and…   Read more»

There are many issues and limitations involved with using contract manufacturers. Someone has already brought up ensuring good and consistent QC. Whether you rely on their internal QC or your QC to ensure product quality is also a very important…   Read more»

I generally do agree with the others that one design review is probably not likely to be enough, and while technically following the law is likely not the best idea. Not only will this raise uncomfortable regulatory questions, but also…   Read more»

Others have already mentioned specifics of using documents like the DID, and DSD to turn broad user needs into specific device specifications. However, I believe that more generally speaking, anything that ensures the robustness of the feedback loop is the…   Read more»

While virtual trials can help with reaching as many patients as possible, this approach has drawbacks to it as well. The main benefit of virtual trials is of course, the ability to reach the maximum number of possible participants across…   Read more»

GCP is absolutely necessary because innovation is useless, if the methods used to essentially prove the device are not sound. While GCP does involve much more extra paperwork, that causes things to take much longer and also cost more money,…   Read more»