Serge Bernasconi

Mr Bernasconi has 40 years’ experience in the world of pharmaceuticals, medical technology and trade association leadership. He has worked in senior leadership position in companies such as Johnson & Johnson, Schering Plough (now Merck), and Medtronic. He has exercised his leadership in various geographical areas around the world, including, the US, Europe (France, Italy, Belgium, Switzerland), Turkey, the Middle East and Africa.Throughout his career he has been involved in trade association activities and responsibilities both for the pharmaceutical industry and the MedTech Industry. Prior to become the CEO of Eucomed and EDMA and then MedTech Europe, he had been elected President of APIDIM (The French Association for the Promotion of Innovation in Medical Devices), and Vice President and Treasurer of SNITEM (French Medical Technology Industry Association).

In my view, a good legislation needs to be clear and feasible. A regulation that breeds complexity doesn’t help anyone. The medical device discussions are coming to an end with the current trilogue discussion between the European Council, Parliament and Commission. While we welcome the general direction of this regulation, I worry about the unnecessary complexity that remains in some areas. As I said in my IVD regulation blogpost , we want this regulation to happen. However, it is key for all stakeholders to understand that the new regulation must be clear, feasible and applicable. The medical device industry is the backbone of our healthcare systems. Patients are the ones who benefit from these technologies. I want that this new regulation guarantee a combined vision that advocates for people’s rights to live a healthy life. And with the trilogue just starting, I invite our policymakers to be vigilant and attentive in evaluating the impact of the regulation. There are points in the medical device file that need to be reviewed, and we have highlighted them all in our medical device regulation position paper . And for my blogpost this month, I have decided to summarize a few key points to make my case: If scrutiny is added, then it needs to be workable The medical device industry undergoes a strict control process to ensure that the products we release are of high quality and are safe for patients. These quality controls are very important for all stakeholders, particularly for patients and also for us within the industry. Within the existing rules, there are officially approved entities called notified bodies that review and implement this process. We support strengthening the capacity of these notified bodies across Europe to provide an improved standard of checks. However, placing a duplicative system to further...
The medtech industry in Europe is made up almost uniquely of Small and Medium-sized Enterprises (SMEs). These have brought incredible innovations to patients, healthcare systems, the economy and society, and will continue to do so in the future. But if we put ever more data demands on these companies, in return, they need to be able to operate in a clear, efficient and predictable funding environment. Pop-quiz: What is the most innovative industry in Europe, measured by patents filed? It’s not the ICT industry. No, it’s not the pharma industry neither… It’s the medical technology industry, a sector that in general files over 10,000 patents per year. And it’s the SMEs that make up 95% of this sector in Europe that are the drivers of innovation. These deliver value at every level: Patients live longer, healthier lives Healthcare systems can use products that make more efficient use of limited resources European economies benefit from a brake on rising healthcare expenditure, while The medtech industry creates jobs (over 575,000 of them!) and growth (a positive trade balance of €15 billion). The medtech SMEs in Europe form a rich ecosystem that we cannot simply equate to the pharmaceutical sector, which in Europe is predominantly made up of multinationals and has product lifecycles of 10-15 years. At the same time, healthcare systems want more data and evidence of the value of innovations. The medtech industry, including SMEs, are committed to providing this data. However, while large multinational companies can easily move around (human) resources to cope with the additional work, this is much more difficult to do for companies that work with staff of between 1 and 250 people. Moreover, new legislation set to be introduced in a number of member states will considerably impact how innovations get reimbursed. Germany for instance has...
From 15 to 21 June the European medtech industry will organise its first “European MedTech Week”, a series of activities and events to celebrate medical technology throughout Europe. This week will be an opportunity for every healthcare stakeholder to experience a whole range of medical technologies in the convenience of their own country. The medtech industry will showcase its innovativeness in unique and creative ways. So what can you do to make sure you benefit to the fullest from this week? Outside of the circle of healthcare stakeholders it is clear the role and value of medical technology is not yet well understood. Do the test yourself and ask your spouse, parents or friends about the value of our innovations. Chances are they won’t be able to come up with much more beyond ‘’They allow me to be healthy again following a medical intervention”. What’s clear from this is that the majority of people are unaware of the vastness of our industry, nor the value it brings at multiple levels. Lots of material on this very topic is already available widely on the internet (we have a great infographic here , moving stories here and several blogs here ). But together with our member companies and associations, we also want to share more about medical technology throughout Europe. What is the MedTech Week? Organised for the first time this year, the “European MedTech Week” is a series of events that will be organised throughout Europe from 15 until 21 June and which will put the value of medical technology front and centre. At European level, we will be coordinating the various events and initiatives being organised, and curating all material – photos, videos, … - on the event's website which will be launched shortly. But the real action will take...
Europe is known for its excellent startup ecosystem. Moreover, the medtech industry in Europe is made up of 95% SMEs. If we want the innovation successes of past and present to continue well into the future, it is critical that the bigger medtech players, and the financial and investment ecosystem keep taking the pulse of European medtech startups.
The future of medtech
This time last year, I wrote a blogpost about the priorities MedTech Europe would be working on in 2014. This year, I've decided to take a different approach. Based on what I see, hear and read every day, I'll outline what I believe to be the major medtech trends, topics and evolutions we'll be talking about in 2015. Europe is clamouring for honest and transparant communication, patients are asking for involvement in managing their own health and budget holders want to keep the rising healthcare expenditure manageable. So what does this mean for the medtech industry in Europe? 2015 will see the drive towards openness and greater transparency further increasing. As you could read in my last blog , both EDMA and Eucomed recommended to their memberships how to improve our respective Codes of Business Practice. The emphasis of these recommendations lies on phasing out direct sponsorship of healthcare professionals (HCPs) to third-party organised medical educational conferences with rules for the indirect sponsorship of HCPs becoming more stringent. Naturally, we will continue our consultations both within the MedTech industry and with external stakeholders such as physician groups to ensure we are all behind the course for industry’s continuous support to the future of Continuous Medical Education (CME). More transparent and open communication is the way forward for our industry Companies themselves will also continue the push towards more transparent and open communication on manufacturing, clinical trials, educational sponsorships to name but a few. It is what patients, policymakers, payers and all our other partners in healthcare demand from us, and it is the way forward for our industry. Another major trend which we will see blossom in 2015 is the use of wearables and apps by patients, and with it the consumerisation of care . The wearable market is set...
You may have heard recently that the leadership of EDMA, Eucomed and MedTech Europe made some very important recommendations to their memberships about how to improve the EDMA and Eucomed Codes of Ethical Business Practice, which together we’ll ultimately refer to as the MedTech Europe Code of Ethical Business Practice.