The cost of regulation I believe is just. Companies pay millions of dollars in applications and fees in the process of releasing their product. These expenses pay for testing and regulations processed done on the product,and also to the subscription of forms and services. As the FDA's job is to make sure the processes are done properly and safe for the public which involves a reasonable fee which need to pay. I understand the concern that start up companies might not have the resources needed for the monetary aspect of the regulation processes, therefore the FDA should take it case by case depending on the size of the company. Each company hires employees that take care of regulations associated with ISO, FDA, USP to make sure the it done properly on the side of the company. This job is a paid one and money is a good way to make sure corners are not cut, therefore the cost of regulations processes are just.
On one hand, it is easy to see how the burdensome costs of regulatory controls may deter businesses from pursuing medical device development. But there are reasons to believe that this is not as large a downside as it initially seems. First, it must be noted that these regulations are essential for patient safety and product success. Further, developing appropriate standards and controls is not a cost-free process. Recouping these costs through charging companies helps the associations and departments involved remain free of political disturbances in the government by preventing their funding from ever being made hostage.
While small companies are at a definite disadvantage since these are fixed costs that larger companies can easily pay, it is better to have loan or grant programs available for them than rather than simply make these controls free and lose out on an important source of revenue.
This is a pretty good topic for discussion, sdl3. You see, these regulations are developed by other companies to help others be compliant. They are basically doing a service to others companies by ensuring that they remain compliant. This is a point that has been brought forth by Katlin and jnm22. The companies that develop these regulations spend a lot of time and resources in them, so they would want to recover their costs and make some profits. The penalties that come with non-compliance are heavy, and this is why companies, including start-ups, have no other option than to view and use regulations. They would better pay for these regulations and remain compliant than be penalized heavily for non-compliance. However, I believe that these prices should not be too exorbitant. I, therefore, support cef3’s idea that companies should be granted access to such regulations through subscriptions that they would pay for regularly.
It helps if a similar product is already approved in whatever country the company is trying to release their product. If it is a whole new product that is being brought to market most of the cost are going to be exorbitant. If it is a high risk PMA expect to pay millions of dollars. Part of this is due to the FDA process of reviewing in which delays occur and there is turnover within the company and regulators. Labeling issues with products add to cost. Also, regulations is a way to "weed-out" companies to see if they are truly serious about bringing a device to market. If you want to compare, the European Union process for cost of regulation is controlled mostly by physicians.
The companies that I have worked for that operate under any sort of regulation either purchase the standards or opt to use a subscription service. There are many regulations, and as has been mentioned, they are very expensive to purchase. However, these regulations are a necessary part of the cost of business as they provide guidance for the regulatory and quality measures a company needs. It should also be noted that standards also exit for other markets (europe, asia). The availability of international standards, in my experience, is significantly less expensive than many of the standards provided by the FDA and other NGO's.
Strict regulations allow for enforcement agencies such as the FDA to filter out companies that are dedicated in meeting regulatory standards along with creating an effective product. Purchasing these standards shows how committed companies are in advancing their agenda. It also helps companies to maintain their safety standards throughout all their products. In the end this can prevent any major lawsuits. I do agree that for smaller companies, purchasing such material may be too expensive. It could be ideal to create a way to rent this material for companies that are under a certain net value.
I was not aware that you have to pay to view the regulations. I am sure that it does help in the upkeep of the companies that are writing the regulations but I do think this favors innovations from current companies rather than a start up. A startup company facing a charge of a couple thousand dollars for instance is going to be hurting much more than some of the multi-billion dollar companies having to pay the same amount. I feel like since most of these are federal regulations they should be federally funded entities. A company should not have to pay to make sure that it is using its products correctly. A federal agency should allow their information to be public knowledge to ensure that companies have the ability to exercise correctly.
Calibration, maintenance, safety inspections, regulations and standards all cost money but they are necessary to do it. Subscribing to these databases are simply an indispensability. If they are not charged then corners will be cut and for standards of this magnitude, cutting corners can’t be a possibility.
I believe these regulations costs money is because of how useful it is which means there will be people who need it, making it a business. The company has to purchase them to make sure all the companies’ regulations are correct for future. One person starts the regulation for everyone else to use. With all that hard work and money the person put into creating the original regulation should be compensated for, which is why they also cost money. They could be more cost efficient if the was a specific database to just find all these regulations to use. Or let those that are using the regulations have to pay a specific fee while those just viewing it for general knowledge pay a lower fee. These costs also make it harder for startup companies to build their business if they’re not within regulation but this might be a good thing because if they are not willing to make sure their product is within regulation, then they could have major issues in the future. Just anyone being a lot to afford the costs would mean many more businesses starting up and having more competition for companies. The startup companies get the short end of the stick when it comes to paying for the regulations but they must be necessary.
I think that these regulations cost money because they provide a platform that companies can use, where if they follow these guidelines, they will be recognized as a company who abides by these set out standards and who provides safe and exceptional products. For start up companies I think they should pay to use these regulations because it helps them learn about how to safely make products, it will teach them certain regulations, procedures and test standards that they may not have known, and it ensures buyers that even though they are a new company they follow the same procedures and guidelines as the larger companies. I think the only way to decrease the expense is to decrease the cost of the regulation standards documents. In order for everyone to be compliant they must all follow the same standards and regulations, and that is only done through everyone receiving these same set of regulations. The regulations can not be free because people must work to create and enforce these regulations, keeping them constantly updated and relevant to the changing environment.
I think that using these regulations costs money simply because it's a service that businesses and companies can use to show that they are complying with regulations and not trying to take the easy way out when it comes to making medical devices. Writing these regulations and standards were the result of effort and hard work and I think that the money is just a way for people to be compensated for their work. I think that it makes sense for companies to use these regulations but not start-ups simply because start-ups are at the early stage and may not have enough funding to even consider buying these regulations. It makes sense for companies to purchase these standards because it gives them an advantage of choosing what to comply with. the business knows its product or service better than anyone so having the choice to purchase the standard to comply with gives businesses and advantage. I think that the expense involved with purchasing these standards can be dealt with by having more businesses purchase them. Due to the Supply and Demand principle, if more businesses purchase a particular standard from the medical device market, the value of it can go down dramatically.
I believe that "There is no such thing as a free lunch" is a really applicable quote for this situation. As stated previously stated, there are costs to hiring people to create and maintain this standard. All of the work put into the standard, including the test that the standards exemplify, require money. There are also basic costs that, for example, the FDA has to consider such as website maintenance and general budgetary needs. Those costs would go directly to taxpayers, most of whom don't actually use these standards. Having these standards cost money allows them to recoup some money while allowing people to buy individual standards. For smaller companies and startups, I believe that a good alternative would be charging either a smaller price per standard until they produce a product or doing a "buy x get x free" system. They could have to pay the rest of the money owed when they start making money. I don't believe they should get stuff for free, especially if they succeed. Although big companies can afford it, it's not fair to them to charge only them.
The regulations are written by people who do this for their career. That means they need a form of compensation. The fee(s) are used to compensate the employees who help write these regulations. These regulations show the quality of product that company is willing to pay for to have excellent quality for their medical devices. The saying goes “you get what you pay for”. To want a hip stem implant to last you 20 years as opposed to 10 years requires more effort to enhance the quality of the product. The company that you know has more certifications means they take what they do more seriously, especially in regards to medical devices. The company I intern for is only ISO 9001 certified for quality management system. For a medical device company just to have this ISO certification isn’t enough for the FDA. The company will be willing to spend the money on the various certifications because they want to ensure safe and effective products are being used on people.
The organizations that create these regulations are offering a product. As such, they aren't going to just give that product away for free. The organizations are These regulations aren't mandatory either. Due to the history and reputation of the regulatory organizations, by adhering to these standards you create a more reputable product. It also proves that the product is safe and will survive as needed.
For example, for joint implants there is a standard ISO 21534 Non-Active Surgical Implants - Joint Replacement Implants - Particular Requirements. This specific standard specifies the intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information to be supplied by the manufacturer. Tons of knowledge, iterations, and studies have been put into developing the standard to get it to where it is today. By claiming compliance you tell your consumers that your product is safe and that the implant will survive for it's intended life.
Sadly I think access to these regulations costs because they can. They know companies will need access and that they will be willing to pay as they will see it as a cost of doing business. Is it shady? Yes. But it is something that companies have to deal with. It is one of the many things that can hamper the growth of biotech startups.
One possible solution could be a database that a company would pay for access to. Something like the way you can pay for access to a journal and get all the papers published in it. A company could pay a flat monthly or yearly fee to get access to any document regulations related to whatever the specific company is interested in. That way companies can still make money and the companies that need the information are not priced out of getting that information.
