The Date of Application for MDR is May 27th 2020. Will your company be ready when the date rolls around?
This is the third year I visit MEDICA, a global event held in Düsseldorf every mid-November, where more than 5,000 Medical Device companies exhibit their products. To give you an idea of the size, the exhibition covers 1.2 Million sq. feet, attracts more than 5,000 exhibiting customers and over 120,000 visitors.
Like earlier years, finding lodging is a challenge. This year, I found a place more than 20+ miles away. It’s very quiet and has a nice view. A good place to come back to after a busy day.
This year I got to the show at 10 am (opening hour) Monday. By the time I left, around noontime on Thursday, I listened and spoke to quite a few people. Many of them fellow consultants like me, existing or future customers.
I love going to MEDICA because of all the positive energy. Everyone is showing their best side: established companies show off, small companies hustle, innovators try and dazzle. Consultants like me walk the show and make presentations at the invitation of one or another industry organization. Several countries rent space where they invite their countries’ companies to promote their products. Of course, the US has its own area (three areas actually: one in a Medical Device Hall, another in the IVD Hall and a last one in a Suppliers Hall – COMPAMED).
But MDR looms heavily.
This year, with MDR around the corner, there is still much talk about how to get ready. A bit late in my opinion. If a company is not well on the way to being ready for MDR, chances are they will not make the deadline. But it is clear that many companies are not ready.
The general relief following the postponement of EUDAMED is a tangible symptom of the unpreparedness. I notice that many direct their frustration with MDR to the EU Commission; they overreached, its the wrong kind of intrusive regulation that will not help the problem, etc… But, while that may all be true, fact is the MDR is in place and will apply from May 26th, 2020 onwards. You’re either with it or you plan to leave the market.
Unfortunately, for a company making more than 20% of its revenue in Europe, loosing that revenue is very painful.
Strategy and Tactics, and desperation
Smart owners and CEO’s mention that the costs involved in staying on the market are high, and that these costs may not weigh up to the revenues currently make with their product in the EU market. But they know that same argument counts for their competitors. They realize that everyone needs to jump the same hurdle.
These smart companies have carefully selected the products they intend to keep and the one they want to jettison. And then, they stepped up and ensured that jumping hurdles became part of their competitive advantage: this is a time when the one best at jumping has the best shot at winning the race.
Complaining about the rules of the race does not help a company get a place in the top.
Unfortunately, some companies will lose out. They will not have taken the time to strategically review their portfolios, decide which projects to pull, which business units to sell, which to keep, what strategic acquisitions to pursue, etc….
With MDR only 6 months away it is too late to think strategy. From here on tactics and execution is all that can still be done.
IVD Companies beware
IVD companies have 2 more years, but higher hurdles. Do NOT make the same mistake.