(Edited Transcript – link to the full presentation)
How do you make the business case for MDR? You need to do a product portfolio rationalization.
For some of your products, right off the bat you’re going to know it’s not worth it. But for some of them, maybe it will make sense. In that case, how do you go about structuring that business case?
Do you have an existing product on the market? Yes. That’s going to be easy; you have some known numbers there. It’s going to be your typical five-year growth plan and projections.
If this is your initial entry, do you have competitors? If yes, then you need to map out what percentage of the market over what period of time do you think you can secure from that subset of competitors? If you don’t have competitors and you have a new and novel technology, then you’re going to need clinical data to show how you reduce risk, improve care, and reduce cost in the healthcare market – all of those things – and this is where it gets extremely hypothetical to project what your revenue could be.
If you have a new and novel technology, then you’re going to need clinical data to show how you reduce risk, improve care and reduce cost in the healthcare market
But there are a number of costs and hypotheses you have to keep in mind when building your business case for MDR. You will have QMS updates that you have to make on a regular basis, especially as the MDCG (Medical Device Coordination Group) comes out with clarifying guidance documents. You will have third party fees year over year – you’ve got your notified body, your European authorized representative, your UK authorized representative, your Swiss authorized representative, and who knows what else is coming with the changing political climate in Europe right now.
As technical standards get updated, you will have to update your engineering documents and your lab testing. You will have to make label updates, and you’re going to have ongoing maintenance of the documentation across all those sectors. And then you’ve got your hypothesis.
Year one, a best-case scenario, you need to anticipate no more than half a percentage of market share. Europe is on a tender-based market, and tender cycles usually last about three years. If it takes a year and a half to get through the certification process, when you are done, you’ll still have another year and a half before you can get into a particular system. And by that time, you’re up for re-certification without ever having gotten a single tender to sell your product.
Year one, a best-case scenario, you need to anticipate no more than half a percentage of market share
You need to understand the contrast in ways of communicating and budgeting between the FDA and the notified body.
The FDA has nearly a dozen of ways to communicate before your review – most of them are free. The (FDA) review fees are very small, no matter what kind of submission you have in the US, compared to the rounds of assessment fees that you are going to go through for a notified body.
For the notified bodies, right now, you’re going to be knocking on a lot of doors to get anybody who is taking new business at the moment. When you do, the only things that are free are the application form and getting a quote. Notified body and other MDR fees are so notoriously high that one company pulled the plug when they had spent over six figures in notified body review fees with no end and no certification in sight.
One company pulled the plug when they had spent over six figures in notified body review fees with no end in sight
So, take the time to validate your regulatory strategy and do a serious analysis of the business case for MDR. Only you can decide if MDR makes $en$e for your company – or whether it will be a complete bu$t.
Link to video of the full webinar: https://youtu.be/f4suuXDaNWA
Want more regulatory goodness? Check this out: https://leanraqa.com/choosing-the-right-predicate-device/
