Your Enemy, is not, Your Enemy!
PEST is your Enemy
At the same time that the European Economic Community (EEC) was becoming more integrated, the Medical Device industry was evolving from the first interventions by Ivan Seldinger in 1953, all the way through to the discoveries of Charles Dotter, Andreas Grüntzig and Melvin Judkins in the 1960s. Doctors of all clinical persuasions were finding that their procedures and treatments were becoming more dependent on Medical Devices. In a study conducted in France, between 1980 and 2007, the government found that the average French hospital used 2000 medical devices in 1980, and over 7000 by the turn of the century. For the French competent authorities, this raised the question of safety in their public health service, and alongside the UK they regulated these devices closely.
This explosion of medical device use in clinical practise, coincided with the vibrant integration of trade that was occurring in Europe between member states. A mixture of social and insurance driven healthcare systems, were trying to deliver common standards of care across all of its member states. The rising use of medical devices, came to the attention of the ministries of health across the European Economic Community (EEC), since these devices accounted for a greater and greater percentage of the national and healthcare spend. It was becoming fairly critical for health authorities to understand medical devices, and how critical their use had become in procedures, more so than pharmaceuticals. The status quo was, that each member state had jurisdiction over healthcare for their respective populations, but it was the European Economic Community (EEC), that had power over trade. At that point trade and Medical Devices and the provision of healthcare collided.
Member states were forced to consider that one set of rules was needed to govern Medical Devices, resulting in the Medical Device Directive 93/42/EEC (MDD), that was transposed into law in the early 1990s, resulting in the CE Mark, Conformité Européene that we all know today.
Medical Device organisations, had the freedom to sell their devices across borders to all member states, with no restrictions as long as they complied with the CE Mark. However, because each state had some latitude of how to transpose the medical device directives into law, each country tweaked the directive to protect industry locally. Therefore, inadvertently creating local and subtle barriers to trade, that frustrated medical device entrepreneurs the world over. In addition to growing local requirements, the use of language made the manufacturing, sale and distribution of Medical Devices less than optimal within the Community. This drove the need for greater use of symbology on product, labelling and packaging, to overcome the challenges raised by language so that products could continue to move across borders without friction.
Finally, the European Commission decided to take all that they had learnt to create a new law, this new law is called the Medical Device Regulation 2017/745/EC (MDR), that was intended to become statute on the 26th of May 2020. Many Medical Device organisations have struggled to meet the new requirements; the need for clinical investigations, the greater focus on effectiveness over function, the greater emphasis placed on patient outcomes, even for products with long standing commercial histories.
But still, as MedTech Leaders, we focus primarily on our competitors when we write our business and marketing plans. When will we realise that they are not the biggest threat, over the medium term of five to ten years? Your enemy, is not, your enemy!
Regulation, usability and the harmonisation of global ISO standards are the greatest threat. There is an ancient Hindu proverb that goes back to the 4th century BC, that state’s, ‘The enemy of my enemy is my friend’. As Medical Device leaders, let’s ask the question; who is our enemy? Is it the companies that sell similar products into the same clinical discipline as we do? Or is it the company, that uses alternative technologies to offer opposing patient outcomes to those we propose? I would argue no; these are not your enemies; these are your competitors!
Our real enemy is Politics, Environmental Awareness, Social understanding due to the greater dissemination of information via the internet, and finally, the constant drum beat of the advances in Technology, such as Artificial Intelligence, Robotics, Augmented Reality, Blockchain and Big Data.
Why are they enemies? Because if they take your business, you cannot respond; and most importantly, they may not be MedTech at all!
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