You bring up a great point - medical device regulation standards do not translate uniformly on a global scale. What may be deemed as a "safe" medical device in Europe for example may not pass US FDA regulations. When working for a company with global competitors, it's hard to level up to one another because each country has their own regulation standards either enabling/prohibiting them from bringing a device out to the market. For instance, say that there is a competitor company based in Asia that creates a pacemaker out of a specific material that reduces it's weight tremendously and this minor change proves to increase the revenue significantly. Now, your company is based in the US and try to also create a product with the same material but change up something in the design so that it is not exactly copied to avoid patent complications. As you do more research on the material, you see that it is not FDA approved and you cannot find the material in medical grade - this is a major issue that you cannot pursue easily. This therefore impacts the project timeline and may not even be viable to carry on since it will not pass under current FDA regulations.

A few possible solutions if it were ideal situations. First, there should be a regulatory affairs individual from the company that is assisting or consulting with 30%- 50% of the project. This allows for technical input of what regulatory organization should be used for the medical device. Then this individual asks regulatory affairs at the FDA which organization it falls under. Then write the required documentation. In terms of global regulations, a meeting should be proposed to write a generic form for medical devices that can be universal. Also, the materials being used should be allowed for everyone to use if we are indeed working together to make the quality of life better.

In response to krp67: Is there "generic form" that you proposed a suggestion that the regulating body for medical devices should be a global organization? Or is your suggestion that a company's documentation should be formatted in such a way that it is compliant for all major regulating bodies throughout the world?

I do not think that a global regulating body for medical devices would be realistic for various political reasons, however I think that the second situation that I described could save a lot of time for a company when they try to enter new markets. However, sometimes a company does not have time to redesign their entire infrastructure. For example, I am currently working on a multiple phase project that is focused on updating documentation from a legacy product to ensure that it is compliant with today's standards. Since the majority of the market for this product is located in Europe, the project plan's first priority is to make sure that the product is compliant with all of the EU's standards for medical devices. Once that is complete, we will be doing the same thing for the US market and the FDA. This means that a lot of the work that we already did will need to be transferred to different documentation. If we had standardized documentation that could work for both, then we would have been able to avoid doing the same thing twice. However in the interest of completing the project without any unnecessary delays, existing documentation forms were used.

I took Dr Collins class "Biomaterials" last spring, and this discussion took me back to a discussion we had in class about the Global Regulatory Environment.
The FDA has very stringent rules, that they are adamant into applying. Whereas other countries in the world do not have such strict guidelines for drug/medical device distributions. So companies that we're able to receive FDA approval on their drugs/devices would out source them to countries that lack strict policies.
I think that every country should have a unanimous policy where as, if the drug/medical has not received approval from their respective countries they shouldn't be allowed to be distributed.

Proper planing and deciding release schedules for different regions should be considered, but the major goal in developing a commercial product is to have it available in the primary market first and then expand into other regions. Having a simultaneous release of a product into every market would take too much time and resources. If an issue was found with the product after its commercial release, the costs incurred would be much greater if the product was released for global distribution rather than a primary region.

Reply to: ap962
Its interesting that the FDA is so much more stringent with medical devices in comparison with other countries. However, there are aspects to these fields in which other countries were more stringent. For instance, no cosmetic brands used to be able to sell things in China unless animal testing had been done on them, something which is vastly unfavored in the US.

However, the world is moving towards globalization. China, in order to keep up, is beginning to adapt to Western standards. As you guys discussed above, it would be beneficial for devices to have standards across the board, to keep up with other parts of the industry.

I have recently come across another example of a challenge in the global regulatory involvement and that involves continuous improvement. When a product is launched, often times the manufacturing process or product quality or cost are not as efficient and cost effective as it could be. So we go through the process of improving the product over years by evaluating where we can improve quality, process and cost. This is done on a continuous basis through the lifecycle of the project. The problem we have encountered recently is that the global regulatory submissions required as a result of the product or process change will be so cost prohibitive that it prevents us from implementing product improvements. This prevents us from lowering the cost of products. This is a really interesting problem. How can companies improve products considering the cost of all the regulatory submissions? We often will try bundling changes to maximize the benefit, but on older products even this is rarely enough. Anyone have any other thoughts?

The basic objective in developing a commercial product is to have it available in the primary market first and then extend into other countries. Appropriate planning and establishing release schedules for different locations should be taken into consideration. It would take too much time and money to release a product into every market at once. If the product was issued for global distribution as opposed to a primary region, the expenditures spent would be substantially higher in the event that a problem was discovered with it after its commercial release. Globalization is taking place in the world. It would be advantageous for gadgets to have universal standards, in order to keep up with other areas of the industry.

This is an interesting concern as it sounds obvious that manufacturers have to conform to different regulatory bodies and practices in different countries, though it hides the complexity of the issue. As others have stated, the primary regulatory body that should be focused on is the main country/area of product issue. If the United States is the primary country of distribution for a product, the documentation and regulatory process of the FDA must be followed. Only in a perfect world can we expect the documentation standards to be similar or the same across different nations. In Europe, the European Medicines Agency (EMA) uses a centralized process in which the agency itself conducts scientific assessments of products for their safety, efficacy, and quality. This allows for a more streamlined and consistent approach. The FDA on the other hand has several different departments that handle different aspects of products, all of which have slightly different regulatory practices. As Dr. Simon stated in his recent lecture, CDER, CBER, and CDRH all have slightly different practices, and the application for a product into one department is different than applying to another one, which is why it is imperative to correctly classify your product. The decentralized aspect of the FDA allows it to be more flexible and adapt to local needs and regulations.

In the post, you state that it would take the company 2+ years to invest into a new set of practices that allow the products to be distributed in India. While this may seem like a lot of time at first, all of the hoops you may have to jump through to correctly meet their standards and regulations, it makes sense. It is imperative that the standards are met for the product to be continually distributed in that country, and I expect that standards for different countries cannot all be met at once. It is more likely that a country or a couple of similar countries of interest are selected first, and in the meantime, regulatory standards for other countries are analyzed to market the product there.