Serge Bernasconi

Mr Bernasconi has more than 30 years experience in the world of pharmaceuticals and medical devices, working in companies such as Johnson & Johnson, Schering Plough in US and Europe, and more recently Medtronic. In his capacity as President & International Regional Vice President of Medtronic France, he was 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).

Last week, the European Parliament and the Council of the EU led by the Dutch Presidency came to an agreement on the medical devices and in vitro diagnostics regulations. To say the least, it has been a long process, and for the medical technology industry, we expect these regulations will have a significant impact on our products and services. Our industry needs this modern legislation. And I welcome the fact that the specific nature of medical technologies was considered during the legislative process. With over 500,000 medical technologies registered, it is important that these regulations take into account the diversity of our products and services while acknowledging our sector’s significant role and relevance in the healthcare continuum of patients. Importance of these new regulations to patients Medical technologies save lives, improve health and contribute to sustainable healthcare. These technologies are developed and produced for the welfare of patients. Despite the sweeping overhaul, many of the proposed updates in the regulations are welcomed by our industry as they will enhance patient safety and facilitate access to new technology for patients. I believe that the new regulations are critical in filling in the gaps of the existing laws and in bringing more harmonised set of guidelines across the region. Implementation will be key Now watch out, there’s still a lot to be done. Now, we are entering an even a more critical phase for the industry. After the lengthy legislative and political discussions, our regulatory focus will now shift towards the implementation process. And this is going to be more complicated. Once this agreement has been formalised, a set of legal process will take place including translation. From our side, we at MedTech Europe, Eucomed, and EDMA expect to work on a deeper analysis once we get a sight of the consolidated...
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...
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...
In an earlier statement this year, the European Commission highlighted that cooperation on Health Technology Assessment across the EU is necessary and may soon become a permanent mechanism across member states. The impact of European cooperation on HTA for the medical technology industry will be strong and I want to ensure that our industry is part of the process in getting it right. What is HTA? Health Technology Assessment (HTA) refers to the systematic evaluation of properties, effects, and/or impacts of health technology. It is a multidisciplinary process to evaluate the social, economic, organizational and ethical issues of a health intervention or health technology. i It should be used to determine the level of reimbursement or funding of the health technology being assessed. HTA for medical technologies focuses on finding out the effectiveness and the value for money through comparative scientific methods. Timing is important: for medical devices, HTA is ideally done when the device is already out in the market and has been used in real life situations. For IVDs, HTA is also ideally performed in the post-market phase, and using data from the clinical assessment of the IVD’s utility. This data is gathered through testing and reviewing its value to both the individual and the broader population. Yet, HTA has not been proven to solve the chronic deficit of healthcare systems across Europe. HTA should not be confused with regulatory processes and reviews. HTA focuses on assessing the overall value of a product to determine its level of reimbursement. What a regulatory process address are the safety, efficacy and applicability of medical devices or diagnostics, HTA process merely looks into the reimbursement and financial impact to a healthcare system. It may happen that a product gets regulatory approval and access is given to patients, but a national healthcare...
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...
Happy New Year! The year 2016 is set to be yet another eventful year for everyone. The world will be busy in 2016 with the Summer Olympics in Rio de Janeiro, and the European Football Championship across France. And we at MedTech Europe, EDMA and Eucomed are gearing for an exciting year ahead as well. I expect this year will continue to be busy as ever, with changes ahead of us - which I can assure you will impact the industry and the healthcare sector at large. At last December’s MedTech Forum and in front of the associations’ general assemblies, I presented our priorities next year for MedTechEurope, EDMA and Eucomed. And below, I listed our key priority areas in 2016: MD and IVD regulations: End of the road In 2015, the trilogue on the IVD and the medical regulation revisions started. While expectations that the trilogue would be finalised by end of last year, we knew that it would take more time due to the complexity and technical specificities of the two files. The trilogue will continue again this year, and with more provisions still waiting to be addressed, we expect the process to take more time and effort across the different stakeholders involved. We will remain an active contributor in safeguarding that this regulation upholds patient safety and welfare. Nevertheless, we will continue to ensure the industry is prepared and ready to make the adequate changes and investments to support the regulation. Value 2.0 The successful rollouts of our value initiatives in 2015 with the first ever MedTech Week and MedTech Discoveries, we are gearing up towards pushing these activities to the next level. The next MedTech Week in June 2016 will continue to bring members, partners and health stakeholders across Europe in promoting stories, facts and insights...