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Role of increased regulatory costs in increasing risk

#1
:notme:
Now here's a "fun" discussion topic that came up in our office. I was explaining to our staff how our company is responsible to track the entire lifespan of our product from design to contract manufacturing, shipping, distribution to final disposal - all in the name of patient protection and risk management/mitigation. The idea being that any one of these stages could affect the risk to the patient (at the end of the day, its patient safety that is the end goal).

Therefore, if any one of these steps negatively impacts our product from reaching the patient, does this count as an increased risk to the system and are we responsible? If there are multiple substitutions on the market, then one can say that this doesn't in fact impact patient safety and therefore the risk is minimal (how those substitutes reach the patient would not be our responsibility)? Do we just do a quick risk assessment and say, "Well that's too bad for the patient that they can't get our product anymore but that's as far as we are willing to go"?

Then it came up that the increased regulatory commitments are causing changes to notifying bodies as well as global distribution as companies assess whether to stay in certain markets, all based on cost and value. Therefore the question is this: What is the role of changing regulatory commitments to increasing risk to a patient if said changes cause a retreat from the market? Do we just note it as part of a management decision and assess the risk to the company itself or in reference to the patient population that will no longer have access to the product?

Sorry for the long post but I just had to ask my esteemed colleagues.
 

Statistical Steven

Statistician
Staff member
Super Moderator
#2
I am unclear if you are saying the risk to the patient if you stop selling your product, making them have to find an alternative. That is not an issue for your risk management system, that is a business risk.

Of course the class of device and the interchangeability of the products are documented. If you are a disposable, single use device then the risk is lower to the patient for switching out. But if you make an implantable device then removing from the market might have a bigger impact on people currently with the device implanted on the ability to have a replacement.
 
#4
No. I apologize for the confusion but we are the designer and owner of the patent. We manufacture our product using a third party, who is our critical supplier.
 
#5
I am unclear if you are saying the risk to the patient if you stop selling your product, making them have to find an alternative. That is not an issue for your risk management system, that is a business risk.
If I'm reading into the OP correctly, I think the OP is simply pointing out that regulatory burden, if applied to stringently, ultimately can put patients at risk.

When this happens, it is actually a case of regulatory authorities not conducting adequate impact assessments of their policies. It's not far-fetched to imagine (relatively) sudden regulatory shifts burdening companies to the point where they simply leave the markets, hence depriving patients of their services.
 

yodon

Staff member
Super Moderator
#6
I think it's a very valid discussion. Look at Canada and their requirement for MDSAP. That will no doubt drive some product out of their market. In the end, a device manufacturer is a business and has to make decisions based on the viability of the business. Another case is India where they put a cap on the cost of some devices and the manufacturers said they'd pull out because they couldn't afford to operate under the cap.

Neither of these is "best" for the patients but I don't see this as part of the risk file.
 

Statistical Steven

Statistician
Staff member
Super Moderator
#7
If I'm reading into the OP correctly, I think the OP is simply pointing out that regulatory burden, if applied to stringently, ultimately can put patients at risk.

When this happens, it is actually a case of regulatory authorities not conducting adequate impact assessments of their policies. It's not far-fetched to imagine (relatively) sudden regulatory shifts burdening companies to the point where they simply leave the markets, hence depriving patients of their services.
Mark, if we take the tact you propose, then no individual company has any risk to the patient because the regulatory burden is too high for them to operate efficiently, that risk is squarely on how the government chooses to regulate and the economic impact. Look at the US tariff on solar panels as an example. If that causes solar panels not to be installed in the US, there is a risk that we will depend more on fossil fuels and cause environmental damage. The solar companies don't have a risk. Replace solar panels with a medical device.
 
#8
Mark,

That's exactly what I was trying to get across. I know of several Canadian distributors that may have lost several foreign product lines because of MDSAP and one Canadian manufacturer that withdrew from Europe. If any oneof those products were "best in class"I have also read European Authority assessments that stated that they recognize that NB's and companies will withdraw as a result of Rev 4.

Years ago I heard of a new implant/stent in Europe that was quite revolutionary. During the Q&A at the release, the US availability date was requested. The response was that due to regulatory costs of repeating the studies to satisfy the FDA, there were no plans to make the product available in the US.

There are probably several examples of this and I think it would lead to an evolution of regional healthcare strategies based on whats available and how its applied (another thread perhaps).
 

Statistical Steven

Statistician
Staff member
Super Moderator
#9
I will still stand by my opinion that pulling a product off the market or not introducing a product to a market because of regulatory or reimbursement concerns of a company is not part of the risk file for that device.


Mark,

That's exactly what I was trying to get across. I know of several Canadian distributors that may have lost several foreign product lines because of MDSAP and one Canadian manufacturer that withdrew from Europe. If any oneof those products were "best in class"I have also read European Authority assessments that stated that they recognize that NB's and companies will withdraw as a result of Rev 4.

Years ago I heard of a new implant/stent in Europe that was quite revolutionary. During the Q&A at the release, the US availability date was requested. The response was that due to regulatory costs of repeating the studies to satisfy the FDA, there were no plans to make the product available in the US.

There are probably several examples of this and I think it would lead to an evolution of regional healthcare strategies based on whats available and how its applied (another thread perhaps).
 
#10
...There are probably several examples of this and I think it would lead to an evolution of regional healthcare strategies based on whats available and how its applied (another thread perhaps)...
Not only cases like you mention where companies pull out of markets outright, but imagine how regulatory burden affects consumer costs which, indirectly, affects patient access. Similarly, one could consider lost opportunity: how many device/drug development is simply not pursued due to the the costs involved?

It's pretty hard to evaluate (though I've no doubt many have tried to make estimates), but there's no doubt that there's a cost-benefit that must be assessed when proposing new/expanded regulations.

To what degree governments are effectively making these assessments is an open question....

On a related note, I notice that Hong Kong presently has "no specific legislative control over the importation and sale of medical devices". It is, at present, voluntary, and customer driven - i.e. customers may request to see MDCO registration before purchasing, but otherwise there is no strict requirement to go through the MDCO evaluation/registration process. I'd be curious to know how this is affecting the industry there... is the market thriving, and innovation booming? Are patients suffering?

...be really curious to know (if anyone can link to any stats), as this represents a case of government siding (for now) on one extreme of the regulatory cost-benefit assessment we are discussing.
 
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