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»

If enough complaints or report of a single issue arise then that would mean there was either a deficiency in the inspection and testing process, or there was an issue with the shipping or storage of the device if that…   Read more»

As many others have said the physician will face a pretty hefty set of obstacles. The main one mentioned was, of course, money. Without money no development can take place, and developing a medical device is an expensive project. Others…   Read more»

While I do believe that FDA classification system using a classification system based on the risk to the patient, I do think that there are some outdated parts of the FDA classification system. The risk based system makes sense since…   Read more»

I think that compliance should at least be considered from the outset. I think that disregarding compliance at the start and attempting to simply get rid of parts that won’t get past the FDA could easily lead to huge problems….   Read more»

Stability testing is of utmost importance for medical devices. However, while not medical devices stability testing is also important for pharmaceutical products as well. Considering how many different pharmaceutical products from different providers to treat a large number of conditions,…   Read more»

Like many others in this thread, I also would personally prefer to be involved in research that would be used immediate future rather than far later into the future. I personally would like to see the work that I do…   Read more»

I think that what the tougher challenge is really depends on the on the complexity of the specific scientific questions that need to be solved, that will vary from study to study. The complexity of the organizational and approval process…   Read more»

I don’t think that having a detailed plan, and having a flexible plan are mutually exclusive. You can plan for details ahead time in a way that does harm the flexibility of your project. Actually, I believe that incorporating details…   Read more»

I don’t think that having a detailed plan, and having a flexible plan are mutually exclusive. 

As other have said, managing multiple projects is very difficult, and a schedule and timeline is absolutely critical in the planning process especially so for multiple projects. Planning will have a whole new dimension to it as now you will…   Read more»