Placebo affects do not negatively impact a clinical trial. The Placebo group if compared with itself before comparing with the treatment group. Over many subjects, placebos results generally show insi...

I believe that in some cases it's ok, where in other cases it's not. In the case of a drug that required an IDE, it might be a good incentive just in case the patient may require additional treatments...

In a double-blind study, both the Investigator and Patient don't know whether they're being given the placebo or actual results. In a single-blind study, only the patient doesn't know what's being giv...

I agree that providing clear evidence based data on safety and effectiveness is important for doctor's and patients. I think that patients want to feel that the product is safe and effective regardles...

Product development is mainly responsible for research and development of devices. They are preoccupied with testing prototypes and designs for either improving current devices, or designing a new one...

I agree that Sales and Marketing are important for Medical Device companies to meet the needs of costumers and deliver their final product to them. Marketing is responsible for delivering the company'...

In public companies, shareholders and investors motivate a large portion of the direction that Engineering goes to. In private companies, the management is the main motivation of Engineering and resea...

If I were to start a business, I would first consider how my business would make an impact in the industry, who are the consumers, and how who would invest in my company. There may be a market gap to ...

I agree that structure in corporations can lead to restrictions in their research goals. For example, corporations are meant to make money, and run by board members and Officers that might not be moti...

QA and QC often work together, even in the same departments. QA established the baseline requirements, and even makes a lot of the SOP's. QC does many of the stability tests, and statistical analysis ...

In my experience, document control can always improve. For example, companies that still use a paper-based system should switch to completely electronic system. This way, documents wouldn't get lost, ...

I believe that emerging technologies would be very valuable in the field of QA. With the use of AI, quality management systems could improve by more easily detecting problems with the systems to preve...

As a Quality Engineer, I had to the opportunity to perform tasks within Quality Management such as approving and modifying SOPs that adhere to GDP, and making CAD specification drawings for all their ...

For higher class devices, more extensive clinical trials are needed to investigate the risk and effectiveness of a new device. For class 1 and 2 devices, they must go through clinical trials to demons...

I think that newer technology facilitates more efficient Regulatory practices, while also raising more questions. Documents and meetings could be submitted and held virtually, which saves time and cos...