Strategy most people get. It’s part of business DNA. If you don’t know where you are going then you’re lost – literally and businesswise. The same pretty much goes for “law”. You have to comply. No more, no less. Everybody knows that. But what happens when you put these two together? And then as an extra spice you add the EU, yes the European “red-tape-monster“ Union, to the game? Well, if you play your cards well, what you get is competitive advantage – and who wouldn’t want that?
So how do you make that happen?
The EU’s only effective tool to work with is regulation, and with regulation it aims at achieving two things really. The first is to have one unified internal market instead of 28 national markets. For that to work, EU-regulations protect the free movement of products and services through harmonized rules that apply in all member states. If you can sell your product legally in one member state, you can sell it in all 28 member states. Brilliant! The second objective is to make sure that the products are safe to use. This is especially relevant in the health and wellbeing sector, which means you have to demonstrate that this is actually the case. But again, in principle, the same rules apply for all 28 member states.
Of course, it is not quite that simple. Since we are talking about products relevant to people’s health, the safety requirements are going to be rather challenging to meet. The good news is that they are different for different products. So if you are planning to launch a new kind of connected adhesive plaster telling the patient when it is time to change it, you might get away with a quicker and simpler process than if you are developing a hip joint using a new revolutionary composite material – just to take two purely fictive examples.
So where does strategy fit into the equation?
The strategic issues is this: If you design a product, get contracts for production, get a couple of first orders, and then find out that you need to go through a formal certification process to even have the right to sell it – how much time and money do you think you are going to lose? Or, if you have a basic understanding of the requirements you need to fill for your product, the manufacturing process and the entire value chain involved, and can calculate how much time and money you need to reserve and make the implementation part of your normal operations – how much money do you think you can save (or avoid losing)? Which alternative do you think would be better for your business?
I said something about competitive advantage, didn’t I? So, what do I mean by that? Well, most companies have no idea where to start finding out about regulatory requirements, or that these binding legal requirements even exist. They end up applying ad hoc and learning along the way, making costly mistakes, having to back track and losing both time and money. If you can avoid this by being informed, prepared, and organized both in terms of time, money and knowledge/skill, then you will have a substantial competitive advantage in relation to most of your competitors.
… go together like a horse and carriage, goes the song. Well, for strategy and regulation you may have to look for the connection a little harder, but they do go together. In a heavily regulated sector like health, identifying that connection may even be one of the keys to your success.