A Product Managers Thoughts of the Medical Device Directive Part 1 of 3

Intended Use to Post Market Clinical Follow Up

If you are a Product Manager or Marketing Manager in a Medical Device company, you will know that on the 26th of May 2021, the Medical Device Regulation 2017/745 will become law. The transposition of the Medical Device Regulation (MDR) is absolute and immediate. The difference between this new law and the preceding regulation(s), is that the Directives were a ‘strong suggestions’, with the expectation that they would be transposed into local law as a whole or in part. Each member state had the right to transpose the Directives into local legislation, and to modify that law to best fit the needs of their markets, and existing practices. This caused mild and irritating commercial resistance, across the borders in the European Union, with some misalignment of interpretation of the Directives, which made it difficult for marketers to seamlessly launch products across the region as was intended by the commission.

Over the next three weeks, three articles will be published from the perspective of a product manager, with a grasp of the regulations, to help product executives within the industry be better prepared for what the Medical Device Regulations means for the dreamers! The marketer, the business development manager, the entrepreneur, the board member, the change manager, and all who set the strategy and decide on which products come to market and when, but very rarely get involved in understanding the true impact of that decision, on the regulatory affairs team, and or how their decision's create challenges of conformity with the law.

Where are we now?

The medical device directive is different because it is a Regulation, it is not, a Directive. It has been delayed for one year, because of the COVID-19 pandemic, and many product managers and the marketing managers, are still asking the question daily of their regulatory affairs colleagues, “What do you want me to do, I don’t understand?”

As a product manager in the Medical Device space, you have been told time and again in the last 18 months, that under MDR you will have to set up clinical studies for your products, to keep them on the market. We are used to setting up trials for new products when they are being launched for the first time, but MDR also requires us to set up studies that are ‘statistically significant’, that prove the safety and performance of the products we place on the market. Or more accurately, studies that prove, or refute the intended use of the products we place in the market. So where do we start? Where do we start to unravel this legal chameleon called the MDR?

Start with the Intended Use of the Manufacturer

Your primary focus must start with the ‘intended use’. We will look at what the MDR says and examine the purview, that a product manager or a marketing manager needs to do, and what they need to be aware of, in order to support their regulatory affairs colleagues, in delivering a technical file that conforms to the regulation. Before we get into ‘intended use’, we must first explain how we came to have the MDR.

Let's start with something we are all familiar with to explain, Microsoft. Over the years Microsoft has brought forward many different Office packages for us to use including MS Word, MS Excel and PowerPoint just to mention three, and there are many other applications that we use. Some of you may remember ‘Windows Vista’! If you tried to use Vista you will know that it was ‘C**p’ and OMG, so frustrating. NOTHING, was where you expected it to be! After the release of Windows Vista, Microsoft rapidly released a number of software patches, that corrected many of the mistakes and irritations that were found in Vista. As a result of those patches, and other iterations we have now ended up with something that is actually quite good; Microsoft Office 365.

©Jarrett MedTech Coultant MDR for Marketer Training

The medical device directive has had a similar journey. We started off with the MDD 93/42/EEC and the AIMDD 90/385/EEC. Both of these directives needed patches, and as a result, the European Union published many additional documents to fix and update them, as we used them overtime. These ‘Patches’ were called MEDDEV documents, and they gave us additional information that made the Directives relevant to the products that we were managing at the time. In 1993 and in 1990, when these laws were first drafted, such products as biodegradable stents, drug eluting balloons, AAA stenting, and many other devices were not yet on the market. So, when these products were released to the market, the regulations had no way of managing them and classifying them accurately. Many times, the expertise of the companies far exceeded that of the notified bodies, and that of the competent authorities who would award the CE mark. Therefore, the MEDDEV documents were the updates, the plasters, the patches that brought the Directives up to date and made them more applicable to the products that we were responsible for placing on the market.

MDR 2017/745, is the combination of the Medical Device Directive 93/42/EEC, and the Active Implantable Medical Device Directive 90/385/EEC, and all of the MEDDEV patches, plus a little more programming. These have all been brought together to form the MDR.

©Jarrett MedTech Coultant MDR for Marketer Training

How did we come to an intended Use?

Before we can look at the law and what it says about the intended use of the manufacturer, we must first look at how we arrived at the intended use? When did we arrive at the intended use? And who was involved?

In most medical device companies, the decision to bring a new product to market is one of the most expensive decisions a company can make; because the organisation has to commit the time of research and development, product management, business development, a customer user group, and somebody with a shed load of money to spend it on your product idea. After many hours of thought, discussions, brainstorming, and market research, we convinced the board this is the product that will change the trajectory of the company. In simple terms we the dreamers, create the intended use. It is not the Regulatory Affairs team that creates the use, we do! So, let me ask a question, why is it that we expect our Regulatory Affairs colleagues to understand what the product does? Who signed off on the product design? Who attended all of the stage gate or agile project reviews? Who decided on the product size range, the lengths and sizes? Who agreed on the materials after the animal studies? Yep, you guessed it, we did, the dreamers. The intended use starts with us!

So, what do the medical device regulations say about intended use?

The first thing we must accept is that the Dreamers, create the intended use. We created the ‘principal function’ of the device; and if we created it, we need to figure out how to measure what we intended. A medical device is an instrument or apparatus intended by the manufacturer to be used alone or in combination with other devices for human beings. So, whatever you intended it to be or achieve, as the manufacturer; that and only that is the function by which it can be legally used. The complication is, that sometimes we mix up the intended use of the device with marketing claims. Our marketing claims, are predominately the messaging we create to sell our device. We become confused about what the product was intended to do, and to whom, i.e the patient and by whom, the specialist physician. Who is the intended ‘patient population’ the device was created to serve? Which clinical physician’s practice was it designed to enhance? What disease state does it impact? This is the greatest complication for product and marketing managers under MDR. A clear and well-defined intended use will make the classification of the product straightforward. It will make the identification and documentation of risk or hazards easier to foresee. If we start to target interventional cardiology, with a product that was originally intended for radiology, and then we start targeting interventional oncology, we are swimming in the deep and murky waters of the MDR.

©Jarrett MedTech Coultant MDR for Marketer Training_ Medical Device Directive 2017/745

In simple terms, until the dreamers, clearly define ‘intended use’, it is difficult to figure out how to measure the safety and performance of the device, or any clinical outcomes that the product, may or may not have for the patient. And if we don’t know, and if we cannot define the intended use succinctly, without waffling, then regulatory don’t have a chance!

In Part 2 of this series of articles, we will spend a little more time looking at the classification of products, and how the use of the manufacturer’, impacts the classification. We will be examining how the intended use marshals the product, towards perceived and unexpected risks, which gives the product manager the opportunity, to study the safety and performance of a device as intended, or to study the ongoing failures of a medical device, with the resolve, to redesign it to be safer; and to deliver performance more consistently in line with its original principal intention.

#EUMDR #innovation #entrepreneurship

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