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»

I agree with you, that trust is absolutely vital in a clinical study, not only to attract and retain participants, but to also ensure that the patients report honestly. I believe that the best way to build to maintain trust…   Read more»

I think marketing for medical devices should first and foremost focus on presenting positive patient outcomes. It should especially be emphasized for outcomes that beat out competitors to highlight the benefits. For new devices you will probably be restricted to…   Read more»

For dental tools, as someone else has already mentioned, dentists tend to be in small practices that they may own and run themselves as opposed to larger hospitals. This makes marketing to them more difficult compared to patients themselves and…   Read more»

@shreya  I think you bring up a really great point about how different audiences being important for narratives. I think that different narratives and storytelling styles should be used for different target audiences. For the examples you use, investors, healthcare…   Read more»

As many others have said, LLP is not the best choice to start a business, and definitely not a good choice at all for a medical device company. You would need full trust in your partners for a LLP for…   Read more»

I believe that being a private company does generally allow for far more freedom for the company as others have said. However, as you pointed out, when transitioning from public to private, the buyers will finance that buy with debt…   Read more»

For the Biomedical Industry and Medical devices especially, I feel like in a vacuum keeping the company private is the best thing. Being able to invest money from the company into long term projects, as well as provide the best…   Read more»

I think that directly comparing QA, and QC like this doesn’t really work well. As you said these groups have totally different roles. Like other have said, QC is testing batches to ensure that products aren’t defective, and ensure that…   Read more»

I would definitely focus on initiating a quality management system. I think that a good quality management system not only enhances the quality of the operations of whatever company you may be in, but it will also hopefully ensure that…   Read more»