At this moment it is estimated that globally 1 in 7 people are in need of some form of medical device in order to carry out their daily activities. In light of the fact that the global population is increasingly living longer, more sedentary lives, this number will most likely increase.
This would lead most people to expect that the medical devices industry would be held to the highest standard, as these devices may often be expected to stay with a patient for the duration of their life. Recently however, this has appeared not to be the case with failures in devices such as spinal rods, pacemakers and hip implants, with these appearing to be at least partially caused by lack of regulation. It is important therefore to consider whether or not an increase in regulation of these devices would be a benefit.
Your Pain, Their Profit
In order to consider whether greater regulation is needed, it is first of all important to consider if the lack of regulation itself is ethically right. By using the Categorical Imperatives laid out by Kant, we can evaluate whether the action is just. Firstly, is lacks regulation capable of being universalised? This is unlikely, as the vast majority of mass produced products in our lives are regulated for our safety, and reducing this would only lead to greater issues for humanity. Secondly, does the use of lacks regulation to push through a medical device quickly to improve profits treat humans as ends in of themselves, or simply means to an end? Again, this appears to show that lacks regulation cannot be considered as ethical, as it does not consider the persons affected by poor quality devices, only caring for the profit margin. And finally, would the act of universalising lacks regulation be agreed upon by all. This again is unlikely, as those affected by the devices would likely not want others hurt by this, and many would likely agree it wrong to not stringently regulate other products in our lives. This therefore shows that on all three imperatives lacks regulation fails, and therefore even the action of using this to produce medical devices cannot be considered ethical, leading to the conclusion that regulation should be increased.
The Golden Rule is the principle of treating others, as one’s self would wish to be treated and simply defined as a simple and clear default position for moral decision-making. The golden rule being associated with christianity also overlaps in many religions and a vast majority of people aim to live by it. With the problem being, that many medical devices rush through the testing stage or even bypass totally under the grandfather law which exempts the medical device from meeting new legislation, due to the fact a similar device has already been approved. Therefore would the engineers and employees at these companies behind these medical devices want the product developed to be used on them? The extent of this cowboy rule is simply inconceivable, with a stent in the US being administered 7,632 times; there were 2,628 reports of problems – 1 in 3 stents implanted. Would you go under the knife at these odds? It is clear that the engineers would adopt more in-depth tests on the stent rather than risking their life, so expecting others to take the risk of injury and in many cases death clearly conflicts this golden rule of moral decision-making.
The Cost of Regulation
Whilst medical devices do fail, these instances are rare compared to the number of lives saved by medical devices. Considering this, reduced regulation may help the largest number of people by increasing the rate of development of medical devices. As an example, MAGEC rods have received negative attention for failures in children with early onset scoliosis (EOS) because its use had not been approved in the US at the time it was first used in patients. However studies into the effectiveness of magnetic controlled growing rods (MCGR) compared to traditional growing rod (TGR) treatment shows that statistically, MCGR treatment was superior in terms of economic burden and overall satisfaction. Therefore the Utilitarian ethical theory would favour the lack of regulation that allowed many patients to benefit from this product, which reduced the amount of invasive surgery required.
Increasing the level of regulations inevitably will lead to an increase in cost due to the increase in testing and amount of time taken to get the product to market. A study run by Stanford University found that, in the US, the average cost related to getting premarket approval (PMA) for a class 3 device is $75 million, approximately 80% of total concept to market cost. As a result, businesses are either forced to reduce profit margins, leading to less funds available to be diverted towards R&D, or increase the price of their product. Furthermore, a less profitable industry will discourage investors from entering the market and make it almost impossible for new innovative startup companies to stay afloat. This reduction of funds being directed towards research could slow down development, causing potentially worse products to be developed in the long run. As the majority of patients benefit from these advances in technology, the increase in regulation cannot surely be in the favour of the many, therefore disagreeing with the theory of Utilitarianism. Time to market is an important consideration for medical devices. Medical device regulation by the FDA in the US is much more stringent than in the EU. As a result, EU patients were able to receive transcatheter aortic valve replacements (TAVR) four years earlier than in the US. Its success in the EU reducing mortality by 20% led to its approval in the US. In the study conducted by Stanford University, it was found that the majority (approximately 60%) of time taken to get a medical product to market was FDA dependant and that overall satisfaction in medtech industry executives was much lower in the more tightly regulated US than in the EU.
We support greater regulation