Poorly designed regulations may cause more harm than good; stifle innovation, growth, and job creation; waste limited resources; undermine sustainable development; inadvertently harm the people they are supposed to protect; and erode the public's confidence in our government. Regulations are indispensable to the proper function of economies and societies. They create the “rules of the game” for citizens, business, government and civil society. They underpin markets, protect the rights and safety of citizens and ensure the delivery of public goods and services. 

I do believe it could cause an hindrance in the improvement of quality products because of the system it'll have to go through, in order to be approved. 

@zbw2 Certain regulations are in place to standardize practices among all medical device companies, not necessarily because these regulations will impact the effectivity of the product. For example, there are strict compendia regulations for how to test certain medical devices before their release for sale. A company may be implementing a non-compliant testing system, however their product is proven to be safe and effective when used in patients. However, due to a requirement to be compliant, the company may have to make changes to their product to meet the testing requirements and therefore reduce the quality of their product. While the intention of such standards is to ensure doctors are confident in the products they are purchasing to sue in their patients, it may have unintended consequences to the quality of those products. How important do you believe standardization is amongst medical device companies testing procedures?

I believe that the purpose of the FDA is to ensure that the product that is being sold will not cause any adverse reactions or cause more harm than good. When determining the quality in terms of how well it functions I believe that is the function of the company itself to make sure they are selling the best product that they can. One that is made with the best parts that they can source from or that their budget can encompass. This allows for market competition between companies as one company can give a better quality product at a higher price whereas another company can offer a cheaper product but have to cut back on their quality of the product. But both will meet the FDA safety considerations. And also I believe that shouldn't be the FDA's responsibility to regulate where companies cut corners or spend the extra money as long as the product is safe and effective for the general public. If the company takes the chances at reducing their costs of producing, then there's a higher chance of failure and that would be on the company itself.

Government involvement in regulation is crucial for ensuring public safety, particularly in industries like medical devices, pharmaceuticals, and biotechnology. Regulatory frameworks set minimum standards for safety, efficacy, and manufacturing practices, ensuring that products entering the market do not pose significant risks to consumers. However, when the regulatory focus becomes too centered on compliance, it can inadvertently create barriers to innovation and continuous improvement in product quality. Here's why this happens:

1. Regulatory Rigidity Stifles Flexibility

2. Regulatory Burden Diverts Resources Away from Quality Improvement

3. Misalignment Between Regulatory Requirements and Product Quality

4. De-Incentivizing Continuous Improvement

Regulation and Quality are 2 separate, but equally important processes of the medical device field. Government regulation is more concerned with devices being safe for human use and implantation, and ensuring that they will not cause harm. By the time Quality get involved, all of the regulation issues should be figured out. Qualities job is to ensure that whatever end product is coming out of the manufacturing process is what is actually expected, and that any differences are documented and addressed.