EU MDR: A journey from change to opportunity
The transition period from MDD to MDR is almost over. Yet still many companies and manufacturers are facing numerous questions or even doubts whether or not their particular product is subject to the new requirements demanded by the Medical Device Regulation. Changes in the way we used to approach and handle things often induce critical thoughts or even a state of anxiety, as we are facing something new, something unknown and something of what we can not quiet grasp the entire outcome and impact just yet.
“Humans are creatures of habit” or “Never change a running system” We like to refer to these quotes when it comes to changes in our routine. But what if we shift our perspective towards the term of “change”? If we start to perceive change as a challenge, a journey, a possibility to make something that is already good even better?
Having exactly this frame of mind, let´s continue our chat about the new MDR requirements. So do the adjustments for the MDR implementation sound like a lot of work? Yes they do, but like all new beginnings the first step is to figure out how to start. So take a big breath, roll up your sleeves and hop on to the train of MDR readiness.
A bullet proof transition plan
The antidote to “change paralysis” is a plan. A plan is recomforting as is gives you an outlook on how things should turn out in an ideal case. There is a beginning and an end and the end is defined by a successful accomplishment. Hence in an initial step the establishment of a detailed MDR Transition Plan will help you to assess the current gaps and define the necessary steps to achieve and maintain compliance to MDR2017/745.
Looking at the facts and discovering the potential of change & transformation
Once the gaps are identified, the action items are determined and a goal is set, it´s time to take a step back and take a look at the bigger picture. Having a timeline with milestones that lead to a final result is a great start but the master´s discipline is to achieve this goal in the most efficient and streamlined way. So ask yourself:
Are your processes and approaches the most suitable ways to reach this goal? Do you have the resources, the manpower and the appropriate knowledge to reach each of your milestones in the most competent, qualified and optimal fashion?
The German Software Company Climedo Health addressed this type of key questions to European based companies, amongst which 77% operate in the production of medical devices. The results speak for themselves:
55% invest more than (5) additional hours per week to comply with the MDR requirements
67% have already / or are planning to hire a new employee in order to cope with the MDR
Asked about their main challenges, 68% mentioned the amount of time necessary to have a full understanding of the new requirements whereas 63% cited “clinical evaluations and studies”
From a financial point of view 75% revealed that most of their budget goes into “clinical evaluations and studies” followed by “PMS- and PMCF activities” (52%)
Furthermore, 48% stated that they anticipate the costs to implement the EU MDR to be higher than 5% of their annual revenue
When it comes to the processes of post-marked clinical data collection and evaluation, 69% use Excel, 47% use paper based solutions and only 11% use an electronic data capturing (EDC) system. In many cases the process is a combination of different solutions.
83% specified that they spent more than a tenth of their time allocated to clinical studies and post-market clinical follow-up (PMCF) for documentation and data management
51% have not implemented automated PMCF processes yet and only 5% of participants have more than 10% of these processes automated.
Looking at these numbers and reminiscing that we earlier defined the way to attain MDR readiness as being an essential part of the ultimate goal, it appears that there is a lot of potential here to reinvent Konfuzius famous phrase “the way is (part of) the goal”.
The way is (part of) the goal
What does this mean in our particular case? To some extend it means that time is money. It also means that in the long run, digitalization will provide your company with more time and will eventually lead to higher cost savings. How? Digitalized processes will enable your team to focus on other tasks, since part of their current scope of work will be taken care of in an automated way. They will also leverage the productivity & speed as well as diminish the potential error rate in your process flow and quality management.
Right here, at this point, we can loop back into our initial conversation about “change” and the emotions and thoughts these changes can trigger: “Why should we change the paper based process we have developed and used for years,- after all it works fine? I am not the most tech-savvy person and feel out of my comfort zone when it comes to digitalization.” Fully understandable trains of thoughts and part of human nature. But let me ask you: Do you extract your own tooth when it hurts? You would probably rather go the dentist as he has the appropriate skillset to perform this rather unpleasant operation in a professional and less painful way. Or what about these incredibly good looking 4 layered cakes in the window of this bakery that you pass by each day. With a little bit of effort, the right recipe and lots of time you would certainly be able to bake a similar cake, but would it look and taste as good as if it would be made by the pastry chef itself? By now, you can probably guess where these examples are heading to. It is absolutely normal to reach out to experts whenever we feel the need for support or the resources
available to achieve a certain goal are spare.
Quality Revolution® as part of your solution
Our mission at Digital Chameleon is to function as a line up of experts in the field of Digital Healthcare that act as an extension of your team in order to support with challenges you and your team are might facing when it comes to digitalization. We are constantly reviewing and adapting our products and solutions based on our clients needs. When it comes to MDR we have been consulted at various occasions with questions like
<< We are unsure whether our current processes are MDR compliant >>
<< We are uncertain if our MDR-strategy has gaps or is sufficient / efficient?
<< Is our future product considered a Medical Device
and / or
is our current product now considered MDR- class IIa or higher? >>
The saying “walking in somebodies shoes” is there for a reason, listening carefully to these issues and apprehensions, the EU MDR set into motion, inspired and empowered us to create a solution that is geared towards and focused on the individual needs of different target groups being confronted with the new requirements. In response to the exchange we had with our clients and other target groups, we came up with (4) distinct solutions when it comes to MDR challenges.
Our MDR solutions portfolio include Training, Coaching & Mentoring packages as well as complimentary assessments at preferred pricing offers for StartUp companies which will displayed on our website soon, - so make sure to stay tuned!
Ultimately our mission is to transform the term of “change” into the term of “quality revolution”. A revolution that adds value, is contemporary and reaches the next level. A revolution that defines the journey from something good to something even better. Reading this article may have already altered your perspective in regards to changes, at least to some extend - and you might have even shifted your perception more towards seeing this MDR journey as a great opportunity to implement a sustainable change (or revolution) within your company. Whatever way you choose to reach your goal,- if you need a partner in crime to make the walk easier – We are here.