innovation

On 26 th of May 2021 the EU Medical Device Regulation (MDR) became fully applicable. It is a modern piece of legislation that strives to ’ establish a robust, transparent, predictable and sustainable regulatory framework for medical devices which ensures a high level of safety and health whilst supporting innovation’ . It further aims ’to ensure the smooth functioning of the internal market as regards medical devices, taking as a base a high level of protection of health for patients and users, and taking into account the small- and medium-sized enterprises that are active in this sector’. ’ Both objectives are being pursued simultaneously and are inseparably linked whilst one not being secondary to the other ’, it states . I could not agree more with these phrases. There are two main objectives that are inextricably linked and need to be balanced: safety and innovation are mutually dependent. Fortunately, there are thousands of innovative ideas designed to improve people’s lives. The European Patent Office (EPO) [1] data for 2020 shows that the medical technology sector made the highest numbers of applications – 14,295 to be precise – putting it ahead of digital communication, electrical machinery, energy, transport, pharmaceuticals, and others. But the medtech industry is telling me a different story about the future! Many innovation projects in times of implementation of the MDR are being abandoned while improvements to existing products are no longer being made. Where manufacturers are seeking regulatory approval of medtech innovations, geographies beyond Europe with faster and more predictable pathways (e.g., in the US and others) tend to be preferred, at least for now. We are facing an imbalance between the above-mentioned goals of the MDR. More and more often I hear that products that are certified under the provisions of the old directives pose a...
The medical technology sector welcomes the European Commission’s 3 rd edition of the EU Research and Innovation Days (R&I Days). This event could not have come at a more important time, as this year marks the official launch of Horizon Europe, the EU’s most ambitious research and innovation program to date. The response to the Covid-19 crisis has driven prominent medical breakthroughs, a tech investment boom, greater adoption of digital health technologies, and a renewed focus on the preparedness and resilience of health systems. Together, these developments have ushered in a flourishing era of health innovation – and the medical technology industry is an integral part of this story. As we enter the recovery phase, our industry continues to build on its strong history of driving innovation and multistakeholder collaboration – a key element of the EU’s research and innovation agenda. The medical technology sector would like to continue building on these strong foundations and contribute to making the EU the leading market for research and innovation. Innovation in medical technology is thriving, and European medtech companies – 95% of which are start-ups and SMEs –are at the forefront. In 2020, more than 14,200 patent applications were filed with the European Patent Office (EPO) in the field of medical technology, accounting for 8% of the total and representing the highest percentage among all the sectors in Europe. The rate of patent applications has also doubled over the past decade, while other healthcare fields remained comparatively steady. A Collaborative Partner in the Innovative Health Initiative (IHI) Recognising the increasing importance of the medical technology sector to health innovation, the EU and healthcare industry sectors have designed the new cross-sectorial partnership IHI, based on the lessons learned in previous joint undertakings like IMI and ECSEL. We believe in the potential of IHI...
More than a year ago, COVID-19 swept across the world, sending us all into lockdown as we battled the pandemic. Today, as we gradually emerge from the impact and experiences of the past year, I am proud and inspired by how resilient we have been and our ability to find new ways of connecting with patients and customers to add value. Throughout this pandemic, we’ve been constantly challenged to rethink the delivery of care, and we now have a unique opportunity to reimagine the future of health today – whether it’s through developing meaningful innovation that drives better patient outcomes, prioritizing long-term health and wellness, or promoting health equity in underserved communities around the world. Although COVID-19 has been incredibly challenging for the healthcare system, it has also served as a remarkable catalyst for accelerating shifts in healthcare. And with respect to the medtech industry, we’ve been compelled to adapt and prioritize patients and customer needs, accelerate innovation, and find creative solutions to elevate the standard of care. The pandemic has shown us just how creative we can get when it comes to medtech. With the rapid advancement of technology, it is now possible to deliver care in novel ways and even create entirely new categories of care, ensuring that medical intervention will become smarter, less invasive, and more personalised. In fact, I’m very excited about what’s on the horizon as J&J MedTech develops an end-to-end digital ecosystem that connects technologies across the continuum of patient care. We are also doubling down on digital solutions, including digital patient engagement, telehealth, remote case management, telementoring and virtual surgeon training to reach doctors and healthcare providers around the world, and expand coverage to emerging sites of care. We recognize that digital solutions represent new ways of working in the medtech industry, and...
High-value innovations in care delivery play an essential role in solving the challenges facing Europe’s health system. However, ensuring adoption and uptake of new technology solutions is far from simple. Current reimbursement and access models have served Europe well but are now reaching their limit in ensuring timely patient access to truly cutting-edge technologies and services. Therefore, it is time for innovative approaches to better integrate innovation into existing health systems. To that end, a new Value of Innovation and Partnership access model (or VIP for short) is proposed. Innovative models Let’s look at how access works today. The current approach has three main elements: regulatory approval, reimbursement and procurement. The problem is that some really innovative technological advances do not always fit neatly into existing reimbursement pathways. They may have high potential value but require additional investment or structural changes in how care is delivered. My new opinion paper, ‘Access to Medical Technology Innovations: A Proposal for a Value of Innovation and Partnership Model’ , sets out in more detail the shortcomings of the current access model. Any new model needs to find ways to reward high-value medical technology innovations; provide timely access to these innovations; and ensure that health systems are sustainable. The proposed VIP model aims to do this in a spirit of partnership between healthcare providers and innovators. It has two phases: 1) The research & innovation phase: testing and assessing safety, clinical performance and claimed benefit 2a) The health system accessibility phase: special innovation access programmes to address unanswered questions 2b) The routine usage phase: adoption of a new technology, along with reimbursement or a new finance scheme Accelerated Coverage Pathways for Innovation For most technologies, phase 1 and 2b are sufficient as they will fit into existing reimbursement systems. However, phase 2a applies to...
For start-ups working in paediatrics, competitions can offer funding, exposure and invaluable access to mentorship. Despite advances in medical technology, the fruits of progress are not shared equally across age groups. One of the biggest challenges we see in the paediatric domain, and especially among those younger in the age spectrum, is the lack of available life-saving medical devices. Children are not getting the benefit of many health care innovations because of the mistaken perception that children are generally healthy and thus the small market does not justify the financial return on investment. This can mean some young patients miss out on life-saving interventions while others are treated using adult devices adapted by their clinicians. Medtech start-ups have the ideas and courage to reverse this trend. I know this because I have had the pleasure of meeting dozens of small companies with big ideas for children’s health. For many young companies working on medical technologies, the relative lack of innovation in paediatric and neonatal care is an opportunity. However, they face a number of barriers that make turning their ideas into products a real challenge. Some of these problems are common to all start-ups – limited experience and a lack of funding. In my opinion, pitch competitions can play a vital role. A high-profile competition, hosted by prestigious institutions who collaborate to support paediatric innovation, can be a priceless platform for early-stage firms looking to make an impact. Competitions connect entrepreneurs with experts and mentors. They are an opportunity to win prize money and attract investors. The attention from media and industry influencers can also provide new momentum and, perhaps most importantly, competitions are a way to get new ideas out there. Innovation can offer significant benefits to young patients, particularly in fast-moving areas of research. This includes emerging infectious...
One of my great frustrations is to see start-ups fall at the final hurdle. Too many early-stage companies with promising innovations spend their energy – and funds – answering crucial questions about the safety and effectiveness of their products, only to find that they have no answers to the additional questions asked by payers. HTA bodies and procurement officers need to know the real-world impact of a new technology. How will it influence patient outcomes and experience? How will it change workflows and how clinicians spend their time? How will it shape the efficiency of the health system? If a researcher or entrepreneur cannot answer these questions, nobody cares how cool their gadget is. This is a tragedy. Great ideas wither and die; innovators flee for the US or Asia. From a European perspective, I see it as a waste of intellectual energy and potential innovation that could add much-needed value. I don’t blame the start-ups. They are working within an outdated framework that tells them their technologies are ‘mature’ when they reach what’s known as Technology Readiness Level 9 (TRL9) – a commonly used conceptualization of the path from idea to market. But, in reality, the road to TRL 9 ends before the widespread adoption of a medical technology. TRL 9 is not the destination; it’s just the end of the beginning. Introducing the iLoop It is time for a rethink. Looking at the bottlenecks facing late-stage research groups and early-stage companies, I believe the solution is to marry the development of evidence supporting CE marking with the generation of real-world evidence demanded by payers. That’s where the Innovation Loop (iLoop) comes in. When companies begin testing their prototypes, they should also measure the impact of their technology on the healthcare organisation; its usability and acceptance; and its sustainability...