Frustrations in Healthcare Innovations – the 4 Regulation Hick-ups

As I visited a friend some weeks ago in the hospital I was astonished when I saw these buttons next to her bed. This is a perfect example of frustration in Healthcare. But also a nice metaphor for creating successful innovative business (in Healthcare). The buttons in her room to call the nurse were clearly color-coded, but still they put a small piece of paper with three options (read; Rules)next to it.  To make sure you don’t make any mistakes and most importantly…follow the rules.
You have to push the right button to make it happen and always feel the pressure of these rules.

The second part of my presentation during the Conference in Vilnius was about the regulation hick-ups. I already spoke about the management challenges, see my last blog..

What we see in todays ‘jungle of regulations’ is that the pressure of rules & regulations results in 3 disturbing developments:

1.       The regulations form a huge barrier for start-ups to actually start a business. While it sometimes takes about 3 till 5 years for a Med-tech start-up to survive before even create some real turnover.

2.       The complexity of the regulations results in delay, postponement or even stopping innovation projects. Due to the delay it’s often very hard to oversee the whole project and keep on track.

3.       It result also in companies not starting real radical innovation. They prefer to improve existing ideas the reduce the risks.

So let’s see what kind of regulations do we have….

It’s a Jungle
I already spoke about the jungle….in this case I mean the CE-certification-Jungle. The regulations for filling a medical product for a CE certification can be so complex, hard and time consuming. It’s so important to really pinpoint from the start what kind of product you are going to develop. Only that way you can make sure you do all the rights steps, fill all the right information without having to redo certain steps during your innovation project.

It’s all about the Money
As we work in an innovation driven ecosystem within the EU, we are ‘lucky’ we can apply for Innovation grants. Governments are stimulating start-ups and SME’s to innovate and create more value for our society. There are different programs to file for and in the EU already there is 3 billion euro available for innovation until 2020. But there comes the “problem’’. The complexity, time consuming process, crazy request and sometimes impossible requirement, make it a real struggle to find your way to this mess of grant-application-process.  We want to focus on innovating and development not on filling in forms.

It’s a Stamp
Just like we said with the CE certification, also for getting the right quality mark you need to know very early in de development process what kind of product are going position in the market. Which market, or country, what are the common Q-marks for these kind of products, what are the critical scenarios for the end-users?
It’s an enormous melting pot of logo’s and regulations and institutes who all have their own guidelines Quality is key for patients and caregivers, but don’t overdo it!
Sometimes just be the rebel we need to really innovate!

It’s Connected
We know we live in almost completely digitised world. Everything is connected, lots of products record and share data. Internet of things is evolving into Internet of everything and even of everybody, if we place in the perspective of the Healthcare market. This brings new challenges and regulations. Privacy is just like patient safety of utmost importance. We really need to be informed about the rules, regulations and also the requirements for handling the data the right & secure way.   

I’m not an expert on the 4 regulations hick-up I mentioned, actually I hate it. But I’ve learned to not spoil too much time on finding my way through these ‘jungles’ all by myself. I want to focus on creating new innovative business models and successful innovations in healthcare. So I ask for help, there are these ‘regulations-Tarzans’ who can really help you! In that way you can focus on the innovation and be the rebel to disrupt!!

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