Let’s get to know you a bit more. Can you tell us about your background and studies?
I started my career in the mid 80’s with an apprenticeship as plastic technologist at Hoechst, where I developed ultra-high molecular polyethylene for artificial hip implants. This was my first contact with medical devices, and I learned what it is like to work in regulated environments. Afterwards, I worked in Manufacturing and R&D for about five years (ground studies). That experience led me to study chemical engineering and plastic technologies at the University of Münster, Germany. There I joined my first courses in Quality Management, which was a brand-new field at the time.
As a recent graduate, did you have any preferred fields you wanted to work in?
The combination of working in a regulated environment and Quality Management was fascinating to me, and that is the reason why I stepped into the field straight after graduating from university. I worked as a consultant for QMS (Quality Management Systems) within the healthcare sector. Two of my biggest projects were to implement a quality management system into a huge hospital – the first ever ISO 9001 certification of a hospital – followed by the implementation of a quality management system at a major medical device manufacturer.
For many young people, breaking into the MedTech industry is quite challenging. How did you manage to enter the job market at the time?
Due to my apprenticeship and first experiences, I gained some visibility in the industry. As the first ISO 13485 for medical devices was on the horizon, I got hired by 3M to implement that standard at the Healthcare Division of 3M across Europe. This position gave me fantastic opportunities to learn and grow on the job. Later on, I led the QM system within the Healthcare Division for Medical Device & Pharma, and I implemented an audit system for medical devices.
What was it like back then to work in the industry, and how it has developed over time?
The Medical Device Health Authorities and Regulators – especially the US FDA – became much more active by the end of the 1990s. People with experience in the field of Quality and Regulatory of Devices – especially with knowledge in the areas of Medical Devices AND Pharmaceuticals – were clearly needed by the industry. The main areas of responsibility at the time were compliance with the FDA and to build internal audit systems. I was then hired by a global company in the space of Medical Devices & Pharmaceuticals, which was under a consent decree by the US FDA. As global Head Audit & Compliance, my areas of responsibility were primarily to drive the company back into compliance with the FDA and to build an internal audit system to avoid recurrence of this situation.
When Novartis acquired ALCON (a medical device and eye care company) in 2010, I had the opportunity to join the company to support the integration and implementation of the quality requirements for medical devices. In 2013, the US FDA announced the first requirements for Drug-Device Combination products. Then the EU MDR was enforced in 2017. The industry has evolved a lot. My personal development has been closely accompanied by these changes and by my involvement in trade associations like DIA, PDA, EFPiA and MPP.
During the MDR Symposium 2021, you spoke about the “journey and the lessons learnt” by the first company (Novartis) to achieve a certification of their QMS and product against the EU MDR.
It is difficult to summarize a 30 min. presentation into a few sentences, but for me the important message to take home is to be agile. Work with the unexpected and allow yourself to take a certain level of risk. When we started the implementation of the EU MDR in Novartis, many fields of the MDR were new, unknown, and unclear. We made our interpretations of the regulation knowing that not everything could be perfect at that point in time. Relying on internal experts, approaching the work as a team, as well as being completely transparent with the notified body were our key factors for success.
Talking about Novartis and your team. You manage a team of 10 who are based in Switzerland, Spain, France, and Italy. In the past you also had team members based in the US and Poland. A surprising fact is that the average age within the team is 35.
Most of the team members came to Novartis as young contractors. They did a great job and got hired afterwards. Novartis is always looking for young talent. We pride ourselves in developing people. Young talent brings about innovative ideas and new ways of working. I like that.
What do you look for when hiring talent?
New hires should be open, curious, and inspiring. We look for great team players but also candidates who can take on new challenges and lead projects on their own.
We speak about how young talent – particularly university students and recent graduates – benefit from internships and work placements. But how do large companies like Novartis benefit from such programmes?
We are in contact with university students in their last year of study and recent graduates who are looking to enter the market. Internships and work placements are very interesting programmes to us. We get to know the candidates in a daily work environment. And they find out what area of work they like more. It is a fair and transparent trade. It is a win-win for both parties.
Do you have any tips for recent graduates who would like to enter the industry, or move fields?
Find out what you like. Work in a lab. In Quality or Regulatory. In Development or Manufacturing, or in Sales & Marketing. That will give you a benchmark for what you like more versus what you don’t like so much. Be open-minded and curious. Embrace change. Changes will guide you throughout your career.
The healthcare industry will continue to be an important and innovative field. Regulatory requirements are constantly increasing and that means that a lot of professionals will be in high demand. The transition from “traditional medicine” to “digital treatments” will be the next revolution.
➡️ Would you like to work in this industry? Email us to learn more about paid work placements in Switzerland at: school.sitem@unibe.ch.
➡️ Find out more about the Medical Device industry through our MAS Medical Device Regulations & Quality Assurance programme.
Ivan Santos, Marketing & Communications Development Manager
