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).

This is no time to further unsettle EU medtech legislation

Regulation
27 Jul 2021
Policymakers spent years on agreeing on one of the most modern medtech rules in the world – this should not be undermined by revisions to horizontal legislation. As Brussels powers down for a short summer lull, I find myself in a reflective mode. The pandemic has transformed our lives – suffice to say that we have all worked through our share of challenges. Our industry has worked hard to implement major new legislation while coping with other pressures. The Medical Devices Regulation (MDR) entered into full legal application in May, and we continue to work tirelessly to prepare for the application deadline of the In Vitro Diagnostic Medical Devices Regulation (IVDR) in May 2022. Those of us who lived through the drafting and redrafting of those heavyweight legal texts can attest to the complexity of the process. The regulations will support a level playing field amongst approval bodies and the scope has been tightened up and includes more product groups. There will also be more oversight from authorities, and transparency on products will increase significantly. All of that will hopefully significantly strengthen the trust in the CE marking system, medical technologies and the new legislative framework alike. Nevertheless, there are already signs that the increased complexity for getting to the market – including new post-market responsibilities – may be turning some off investing in innovation or launching new technologies on the European market. Policymakers, industry and other stakeholders have made considerable efforts to ensure ex ante that the MDR and IVDR protect patients and promote access to innovative products and solutions. Medtech innovation, it should be said, is in the interest of patients and consumers. The philosophy embedded in the MDR and IVDR reflects this need. Today, I must confess to a sense of unease when I hear talk of...

Promoting diversity and innovation: European MedTech Week 2016

Value
21 Apr 2016
Do you remember the last time you have used a medical technology product? I think a lot of people, including myself, will answer that it was quite recent. In fact, medical technology is all around us - diagnosing, monitoring and treating virtually every disease or condition. And in the 2nd edition of the European MedTech Week from 13 to 17 of June 2016, everyone will be able to explore how medical technologies help in saving and transforming our daily lives. What is MedTech Week? European MedTech Week aims to raise awareness and create a conversation about medical technology. Innovative companies, national associations and stakeholders in health, including patients, professionals, and carers, will tell how devices and diagnostic tests are transforming our lives and our health. At the first ever MedTech Week last year, we celebrated the value of medical technology via radio programmes, scientific conferences, press interviews, patient testimonials, and museum donations. You can see a summary of our 2015 activities in the MedTech Week magazine . What will happen during MedTech Week 2016? This year, we’ll build on the last edition’s success and promote the diversity, innovation and creativity of the sector. Together with our members, we are putting in place policy roundtables, visits to manufacturing sites, partnerships with patient groups and conversations on social media. There will also be a series of interviews with experts who will give their insights into how medical technology can care for patients and transform lives. You can visit the new website – www.medtechweek.eu - to browse all events happening across Europe during the week. How can I get involved? If you are a patient, health advocate, researcher, healthcare professional or stakeholder with an interest in medical devices and diagnostic tests, we want you to come on board. You can share your stories...

Finding solutions to notified bodies challenge is crucial

Regulation
13 Apr 2016
It is important that the medical technology sector functions within a healthy ecosystem. Our sector needs an environment that is open, supportive and free from unnecessary bureaucracy in order to innovate and provide patients safe and effective solutions to their condition. Within the product lifecycle of a medical technology product, we work with patients, doctors, authorities and notified bodies to ensure that the product meets all the essential safety and performance requirements. Each group has a critical role to play, which in turn enables manufacturers to deliver to patients the medical technology products they need. What’s up? Notified bodies are the authority-controlled third-party, independent entities responsible for assessing whether a medical technology (device or a medical test) conforms to the relevant legislation in force. Over the last three years, however, we’ve noticed a significant decrease in the number of notified bodies. Some have been de-designated, had their scope restricted or voluntarily stepped down as a notified body in the field of medical technology. This decrease has meant fewer notified bodies are available to assess new products and renew certificates needed by companies to operate. At the same time, existing bodies are finding it difficult to find qualified personnel to help with the extra workload. The current situation with respect to notified bodies threatens the stability of the medical technology ecosystem. Without fully functioning notified bodies, our industry’s capacity to innovate is stifled. More importantly, it risks delaying or blocking patients’ access to needed medical technology. Because of these limitations, the approval process can take longer, subjecting products to considerable delays. In a time where product innovation is growing at a fast rate, we need a stable ecosystem of notified bodies that’s able to fulfil their roles and guarantee an efficient and timely service. And without this stable ecosystem, how can...

The role of medical technology in the 4th Industrial Revolution

Value
4 Mar 2016
Digital technologies have made our lives move faster, easier and be more connected. And in the realm of healthcare, we have seen this rapid advancement on how we diagnose, treat and cure patients. The healthcare sector is transforming and evolving fast thanks to the advent of technologies. And our sector, the medical technology sector, is at the core of this transformation. The new revolution At the World Economic Forum in Davos last month, they heralded this rapid evolution as the Fourth Industrial Revolution. According to German Economist Klaus Schwab, we are on the verge of a fourth industrial revolution that will radically change the way we work and live. In his paper, he summarized that the First Industrial Revolution used steam-powered and mechanics to increase production. The Second Industrial Revolution brought electricity and mass-production processes. The Third Industrial Revolution gave the "digitalization of technology". And he claimed that now a Fourth Industrial Revolution is building on the Third, and will bring "fusion of technologies that is blurring the lines between the physical, digital, and biological spheres". The big question remains: How will this revolution answer the pressing challenges we have today in healthcare? All stakeholders have a part to play. But I see the medical technology sector playing a pivotal role in the meeting the challenges of today and of the future. A new world with a continuously growing population By 2050, it has been estimated that the population over the age of 60 will reach nearly two billion. The challenge comes in both ways – First is how to provide care to a larger population and also on how to address conditions associated with aging such as reduction in mobility, the decline in visual and auditory acuity, and changes in cognitive processes. Accessing services locally and using resources efficiently...

My 5 predictions for the medical technology industry in 2016

Value
26 Nov 2015
The year 2016 is just around the corner. While there are still weeks before we say goodbye to 2015, I’m going to write a few thoughts on what I think will be the key themes for the medical technology industry next year. I did a similar blogpost last year and I’ve done another round for you today. Below are my five thoughts on trends for the industry in the coming year: 1. New regulations means new ways of working As we know, the trilogue for the MDD and IVD revisions are coming to an end. While we still don’t know yet the final texts of the regulations, it is certain that these regulations will have a tremendous impact on the medical technology industry. The regulation will change how we operate, do research and distribute our products. While the regulation won’t be implemented next year – businesses will need to start adapting to the new regulation. This will have an impact not only in the European sphere but also in how companies collaborate at a global level. 2. Technology will play an even more active role to healthcare I think this comes as no surprise to a lot of people. Every year, we see new ways of working, travelling and interacting with other people. We’ve seen a rapid change in our society today thanks to technology. In the area of healthcare, this is no different. The medical technology industry is at the forefront of driving this innovation for the sector. How will technology play a role this time? In the industry, the trend will continue towards developing new devices like wearables and sensors. Technology will allow us to deliver and connect more devices, obtain better and more information using big data and be able to define new ways to diagnose, treat...

During Trilogue, IVD and MD files should be treated on their own merits

Regulation
10 Nov 2015
A month ago, the trilogue on the medical devices (MD) and in-vitro diagnostics (IVDs) regulation proposals have started.This discussion between the Council of the European Union, European Parliament and European Commission is one of the last steps of the process to land a consolidated text for the regulation. It’s almost the end of the road yet I can’t help but feel the underlying need to improve how the trilogue process is being organised so far. In the current three-way trilogue, I am concerned that the discussions on the IVD proposal are being overshadowed by topics on the medical device proposal. This concern is shared not only by the industry alone but also by several member states and officials from both the European Parliament and Commission. I’ve written in my last two blogposts the actions and consequences we needed to understand about the in-vitro diagnostics and medical devices proposals. While it may seem that these two medical technology sectors have a lot of similarities, it’s also important to note their striking differences. This is simply because, by nature and function, IVDs and medical devices are two different sectors with each having a distinct use, issues and applications. In reality, unlike other forms of medical technology, IVDs never interact directly with the human body. Their purpose is not to have a direct therapeutic effect, but rather to provide valuable information on a patient's health status. The value of IVDs comes from the information they provide. This means that the expertise of the healthcare professional in using an IVD is crucial to ensure the correct decision making for patient treatment and care. This sets IVDs apart from medical devices and pharmaceuticals, and is part of what makes them unique amongst health technologies. Given this reality, the requirements that will be put in place...