Today we have the pleasure of interviewing Eider Fortea, Manager and co-founder of deviCE Sistemas, a consulting firm specialized in CE Marking of Medical Devices, Medical Devices for In Vitro Diagnostics and Machines.

To begin with, Eider, could you tell us a little about what led to the creation of deviCE Sistemas and how was your first contact with this sector?

Yes, of course. My first contact with this sector was while I was a professor at the engineering school of Mondragon University. I was on their staff for 20 years, which I am particularly proud of. I was teaching labor and product legislation, management systems and similar topics, and they offered me the opportunity to teach about medical device legislation in the new degree in biomedical engineering that they wanted to approve in a few years (back in 2013-2014). I was very interested and I started to study, to do projects in companies and so on. It was precisely in these projects that manufacturers of medical devices know a lot about manufacturing processes, materials, assembly and so on, but not so much about the legal and regulatory requirements that the product has to meet to be marketed in the European Union. And in 2018 deviCE Sistemas was born as a consulting firm specialized in the commercialization of medical devices, in vitro, machines and related products.

What obstacles did you face when starting out and how did you overcome them?

The main obstacles I faced were diverse and of different complexity: once I was clear that I wanted to set up my own company, one obstacle was to decide which company to create: to be self-employed, to create a cooperative, a limited company, which one. I contacted the Basque cooperative association Konfekoop and was quickly able to clarify my doubts. I created a small cooperative deviCE Sistemas. The following obstacles were more depth: how to make a budget, how much to charge, how to charge, but the market itself and the first blunders are forging you and are putting you in the market and in your place. The come situations such as how to pay an invoice, how to collect a salary, how to pass the VAT and things like that. We solved it by hiring an accounting consultant to take care of all the financial issues.

Tell us about your company. What problems or needs is your company trying to solve in the marketplace?

Our company is deviCE Sistemas, a consulting firm specialized in CE marking of medical devices, in vitro and machine and related products. The main problem or need that we try to solve is the fulfillment of the requirements of the legislation that applies to the product in question to be able to give in the CE Marking and, therefore, to be able to sell it in the European Union. As I said, we are specialists in the CE Marking of certain products, which means the knowledge of the relevant legislation for medical devices, in vitro machines and the whole process related to obtaining the CE Marking, form more bureaucratic aspects (licenses or authorizations and registrations) to the elaboration of technical documentation and development of related quality mangement systems.

How has the process of growth and development of your company been since its foundation?

The growth of deviCE is progressive, year after year. It is not an exponential growth and we are causing it. Think that our differentiation is based on the continuous and updated knowledge of legislation and regulations in relation to the product, and also on the knowledge of technologies, quality tools and management systems appropriate to the company and the product. Our work and continuous knowledge is essential to advise our clients on the most interesting strategies to market these products in the European Union. Our work is not attractive to young people, but is a springboard for companies manufacturing medical devices, in vitro and machine products.

What is the most valuable advice you have received as an entrepreneur? What advice would you give to someone who is just starting out?

When I was going to start with deviCE, leaving a good, steady, prestigious job that I loved, someone told me, “it’s a risk, but you create something yourself and for you. If it goes wrong, it’s not a failure, but a learning experience, then, go for another one”. And we really think so. Something very common around here is that if a company or a business goes wrong you are a failure, but nothing could be further from the truth. You have learned aspects of life that otherwise you would not have learned and now you have more knowledge to keep trying.

A humble piece of advice I would give to someone who wants to start a business is “be honest, but assert yourself”.

Round of quick questions

• A movie about entrepreneurship that you recommend? I don’t know if it’s about entrepreneurship exactly, but Armas de mujer, I like it. There is another movie that I love and talks about the need for all professions and how important they all are (and I won’t reveal more in case anyone wants to see it) called The philosophers. 
• Brand/company that inspires you: There is no one in particular. I am inspired by those companies that started from the bottom, with few resources and people and now they are able to live with dignity and give work to other people. 
• Phrase that most motivates you in your work: There are really two: “perfect is the enemy of the good” and “the sun rises every day”. 
• If you could have a meeting with any character in history, who would it be? Ugh, I would say almost anyone. You can learn a lot from all of them. 
• If you were to go back to the past, would you go back to entrepreneurship? Yes, without a doubt.