This topic reminds me of a somewhat comical video that I had watched a while ago
Similar to what is being talked about, this video gives an overview of standardization and how it is something that is used globally (particularly this video talks about ISO. One of the main points that are made is the importance of standardization in terms of experiments impacting different questions(tea experiment example).
In terms of monetization, I think that this is a neccesary barrier to entry, as it keeps the amount of agencies having the standard lower, and increasing the quality (assuming that having more money to spend to obtain the standard correlates to more money to go towards quality). The other side of the coin is of course making money on the labor that goes into creating these standards. If something is made using effort, it draws a cost on the one making it which is sought to be compensated.
To find the video search The $40 Internationally Standard Cup of Tea
Why do you think these regulations cost money?
I think regulations cost money because at the end of the day, information cost. I do believe that the price of the document may be expensive to some startups but however, if a company knows that they have to have certain paperwork needed for regulatory actions, then I would assume that would be apart of their budget starting out. I do not know if there is a better way to handle this, I mean the agency must hire people to read the documents and ensure that companies are meeting the standards.
I actually questioned this myself this past weekend when creating the DID for the project Dr. Simon has assigned to us. Personally, I feel as though regulations should not cost since these regulations help ensure that devices are being designed and manufactured properly and within FDA guidelines. I feel its unfair to require that certain regulations are followed but the regulations are not provided to everyone without purchasing.
Standards in the medical device industry, such as ISO, FDA, and ASTM, incur costs due to their development, maintenance, and the need for quality and reliability. These costs cover the extensive efforts in research, drafting, and updating by expert groups. However, this financial barrier can hinder compliance, especially for startups and smaller companies. To address this, potential solutions include tiered pricing, offering summaries or previews, subsidies from governments or industry associations, or embracing an open standards movement. These approaches could balance maintaining high-quality standards with making them more accessible and affordable, thereby encouraging broader compliance.
Your observations about the costs associated with accessing various standards and regulations in the medical device market are indeed thought-provoking. The primary reason these regulations carry a significant cost is that regulatory compliance has evolved into a complex and specialized field. This evolution has, in part, been driven by the highly competitive nature of the process, where companies vie for the attention and approval of agencies like the FDA. As a result, the entire regulatory landscape has become more intricate and demanding, often exceeding the complexity and cost of legal requirements. This escalation in complexity and competition has led to a situation akin to the rise of college admissions consultants in recent years. Just as students seek specialized guidance to navigate the increasingly competitive and complex world of college admissions, medical device companies find themselves in need of regulatory consultants. These consultants offer expertise in understanding and interpreting the standards set by bodies such as ISO, FDA, USP, AATB, ASTM, and others. The analogy extends to the financial burden as well; just as hiring admissions consultants can be a costly affair, so too can seeking the services of regulatory consultants. For startups and smaller companies, this scenario poses a significant challenge. The high cost of accessing these regulations can be prohibitive, potentially stifling innovation and growth. It raises the question of whether there could be a more equitable way to ensure compliance without imposing such financial burdens. Ideally, a system that allows easier and more affordable access to these crucial standards could foster a more inclusive and dynamic market, enabling companies of all sizes to contribute to advancements in medical technology while adhering to essential safety and quality standards.
Hi Savannah! Those are great questions. Compliance with ISO, FDA, and ASTM standards can be expensive as it involves a good amount of resources, expert cooperation, and continuous updates. Based off my previous work experience, I understand that these are financed through the sales of standards by these organizations. Although this model allows for better functionality, it poses a financial obstacle, particularly for new businesses. This is not to ignore the fact that these standards indeed do benefit everyone and companies should be able to afford them without too much financial strain. The impedance in budget could hinder creativity and result in difficulties with meeting regulations. Ideally, increasing accessibility to standards, maybe through public funding, would aid in guaranteeing that all companies are able to afford compliance. This will be well worth it in my opinion because ultimately this leads to improved public safety and encouraging innovation within the industry.
Hi sdl3,
I feel as if regulations likely cost money because they are developed by organizations that invest significant resources in research and maintenance of up-to-date standards. Thus charging for access helps fund this work. However, it can be challenging, especially for startups, to afford these standards while trying to remain compliant. A better solution could be subsidized access for smaller companies or a tiered pricing model. We see that so common now days in almost every service with different levels getting different benefits, ensuring broader accessibility while still funding the development process.
First off, I totally agree with someone above that it would be better to have subscription mechanism for citing all these regulations. Honestly, I think that these organization should be supported by the government because it is for everybody's good and is applied on big scale, why can it not be government's? I feel like taxes we pay are used for ourselves' sake, why can this not be in such scope?
However, I do understand by just learning about these regulation and how complicated they are, there must have been thousands of hours put into developing these regulation and organizing it, which means that this cannot be free. This takes back to my point: why can't the government just take care of this because this is for the community's good?
