There are many types of ISO requirements. ISO is an acronym for International Organization for Standardization. The one that Dr. Simon discussed in this weeks lecture refers directly to the application of risk management to medical devices. There are many of these to pick from that I feel are necessary in creating a successful product. ISO 13485 is a document published in 1996 that details the regulatory, and quality requirement for medical devices. Quality of a device is far most one of the key aspects of a successfully selling device. Therefore, a document such as this should be followed whether mandatory, or not. ISO.org has a catalogue in which you can search for specified requirements of certain devices.

I'm not why you have a question about this, it seems pretty straightforward to me, even if you look at this through a purely financial lens as opposed to a morality lens. I assume that you believe that it's the right thing to do so I'll argue my financial lens point. If something went wrong because you haven't implemented the safety features you would first lose money in any potential lawsuits/payouts and second through the hit in your reputation. Not being able to sell your product because you don't have the public good-will that your competitors have will lose you your money and possibly your company. Investing even millions in safety features is a small price to pay in a billion dollar industry (a little more than half a trillion at this point).

It may seem straightforward to you, however, there are cases where companies are not following regulations. A recent example would be Philips Healthcare. They were forced to cease operations at both their Massachusetts and Washington facilities pending corrective actions due to CGMP violations. So obviously there are some things that Philips wouldn't do if they were not required to because they aren't doing it even though it is required right now.

The company being told to cease operations goes to show that not following these requirements are more than proof of the consequences, are they not? You're right in that a company can decide to not follow requirements in attempt to save and money, but eventually they are allows going to get caught. The worst case scenarios for a company not following specific requirements would result in, as jr377 was speaking about, lawsuits and payouts. In the end the question is always, is it worth it? Personally, taking an illegal shortcut in attempt to save some money is not worth the consequences; especially when it comes to medical devices.

Manolo you didn't really address my point of even if there were no regulations, the cGMP violations would eventually cause some problem. Probably people getting sicker/dying. That would cause lawsuits and the loss of reputation I talked about above. That would lose them much more money than the amount they're losing now due to not being able to manufacture and sell anything, and the money they would have saved through any shortcuts. I agree, some companies would make the foolish decision to cut costs short term without thinking long term consequence. Most wouldn't though, because they'd know that the investment in doing things right will pay off in the end.

There are many types of ISO. I'll focus on ISO:13845 which is desgined to be used by the organization involved in the design, production, installation and servicing in the medical devices and has been revised every 5 years for the better quality of the devices. I will rather the ISO protocol for the medical devices because there are certain safety protocol for the patient health care which has to be carefully taken care.

I would follow ISO:9001, the standards that specify quality management. Quality is an important part of the entire project and these guidelines help make sure that industry standards are met while meeting the demands of the customer. These processes can help with organization and efficiency of the project as well as to detect possible areas of improvement in company procedures.ISO:9001 outlines the required documentation, planning, responsibilities of management, steps from design to delivery, and improvement procedures such as internal audits and corrective and preventive actions. Currently if a company is ISO:9001 certified it gives them more credibility.

There are many devices that exists where they do not have ISO standards but still maybe in use. I believe that ISO are mandatory because any device that can endanger a person's life must not be used. Tgey are just a matter of safety. As of many people may invent or innovate a use of medical device and if there are drawbacks to it, people may ignore them to reduce any further complications or failure. This harms the patient at the end if anything goes wrong. To ensure this safety ISO are made. The devices that are actually made by aiming a good deed it would be made safe even without ISO standards.

Maybe I worded the original post poorly. Yes, violating the current standards can be dangerous to the end user & costly to the company.

As more regulations are developed, making medical devices become more cumbersome. Because of this, medical device companies may neglect a certain area of research due to the heavy financial or time burden. Or (and this may be the case with Philips) they cut corners in places that they feel are redundant in hopes of not being caught. So in that case, they would alter the regulation (if they could) to avoid the redundancy.

Let's look at a separate company, Thanos Inc. This company is working on Power Glove Deluxe and the head of the company is adamant that everyone quadruple check each step in the development process. This just so happens to align with the regulation that Philips does not like due to them feeling it is redundant.

Say Philips was able to change the regulation that they felt caused redundancy, Thanos, Inc would still quadruple check each step anyway because to them it's the right thing to do.

What I am asking is if there is a standard that, although it could be perceived as not needed to another company, you would make sure your company follows if it was decided today that it was no longer needed? If so, what standard is it?

I don't know what company you're talking about and I'm not sure if I'm looking in the right place (all I can find is avengers stuff). That's good that they're checking each step. There's a lot of aspects of cGMP but I'm not sure you can narrow it down to just one. Maintaining data integrity and ensuring only certain people get access to certain things are some aspects. These ISOs are fine as well. I think a good question is what else would you like to see? There may be gaps that you think need to be filled, what are they?

I would also follow the ISO requirements and guidelines regardless of enforcement. I feel that developing a medical device that causes users harm during testing and execution defeats the purpose of developing the device in the first place. Users put their trust into the claims made by the medical device companies and it is their responsibility to uphold it. Even if we disregard morality, there will be a rise in lawsuits and compensation that the company will have to pay for in the event of causing damaging side effects. Eventually, the company will have to file for bankruptcy, which will put a stop to future projects and opportunities for success. The risk of harming users coupled with the company going under, overrides the cuts in cost and time from taking illegal shortcuts.

manolo the issue with what you are asking is that ISO are regulations that must be required. Different devices need these regulations or else they will run into issues with the FDA. The FDA could then stop these companies from selling the product. If for example Philips made an electric toothbrush that needed to have insulation regulations checked, but decides to skip these regulation tests the product could be taken off the shelves of a store due to its possibility of shocking someone. This week we did a mini-sim where you were given an option to skip weeks 8 and 16 of animal testing. Cutting corners is wrong, especially for a billion dollar company like philips. Sure they may save money by cutting down on resources such as "man-power",etc. However, when the FDA catches on it will come back to bite the company in the butt as they will have to recall their unregulated device. Which would mean all the research, and time they saved would have gone to waste due to the product not even being able to be sold, and customers returning it due to its recall. In the end cutting corners may be effective, but it definitely is not worth it; especially with medical devices.

One ISO standard I think would always be followed  if ISO requirements did not exist is: ISO 10993, the standards for biocompatibility. This standard calls for evaluation of all data from materials, prior use, clinical data, and testing performed. Its eight principles require careful assessment of the device by laying out the approach for consistent biocompatibility testing. Following this standard ensures biological risk is managed properly as seen in this international standard being essentially applied globally. Careful evaluation of the body and device interaction is extremely necessary to ensure safe devices are entering the market.