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.