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As healthcare advocates, we know that dialogue between patients and the medical technology industry can deepen understanding between those who develop new healthcare solutions and those who use them. That is why our organisations, the European Patients’ Forum (EPF) and MedTech Europe, devised the Patient-Medtech Dialogue as a forum for regular interaction on topics of mutual interest in a transparent and open way. Our experience to date has been positive: The Patient-MedTech Dialogue is an initiative that began in 2011 with the aim of providing a platform for the exchange of perspectives between the patient and medtech communities. At our latest meetings, on 24 and 25 May, we co-hosted two half-day workshops, exploring two hot topics in healthcare: Health Technology Assessment (HTA) and community care in the context of improving access to medical technologies. We were delighted about the high interest and engagement of the patient organisations and MedTech companies that joined. In addition to the exchange between patients and industry representatives, the dialogue also engages with experts and other stakeholders. For example, these recent sessions benefited from the contributions of a European Commission official and senior representatives of HTAi, and Health First Europe. Health Technology Assessment The first workshop on HTA provided us with an opportunity to exchange perspectives on the European Commission’s legislative proposal on health technology assessment and on common rules for clinical assessment of health technologies undergoing HTA. There were also calls from various participants for greater transparency about how patient involvement in HTA processes translates into decision-making, and detailed discussion of the need for funding and training to ensure effective patient input. Care in the community The second workshop focused on community care – healthcare provided outside the hospital setting. We see technology helping to empower patients to manage their conditions and connect with specialists,...
New Medical Device Regulation – an obstacle to progress
On May 25 th , 2017, a new era began. The date marks the beginning of the Medical Device Regulation, the MDR in short. It provides a new framework for the certification of medical devices in Europe and is supposed to increase the transparency of the approval and application of medical devices, as well as to improve patient safety. New guidelines are challenging for all parties involved Patient safety is always of utmost priority; everybody agrees on this goal. However, with the new EU legal framework, we, in the medical technology industry, are faced with existential challenges: New clinical requirements as well as comprehensive documentation and reporting obligations will result in an increased bureaucracy. This also threatens to overstrain the notified bodies, which will be intensified through the decline in the total number of bodies and also through the loss of the British notified bodies in the course of Brexit. A lack of implementation regulations due to delayed detail regulations of the MDR significantly reduce the three-year transitional period for companies’ implementation. In my opinion, this represents a very critical situation for the medium-sized MedTech sector. But it is not just the medical technology companies that are affected by the current developments: Patients’ immediate access to modern procedures, devices, and examination methods will be made more difficult, and innovation will be delayed. Pragmatic solutions for a stronger culture of progress A development that I see as very critical, considering that our goal is to bring medical progress to patients more quickly. Meaning there is a stronger culture of progress in patient care through new technical solutions, a positive atmosphere for medical and technical progress, and a quicker transfer of research findings. To expedite this development and to protect and improve the health of people all around the world, we need...
I'm greatly looking forward to the European MedTech Forum meeting in Brussels in December, where I’ll be talking at the plenary about payers and hospitals aligning expectations and sharing values. I'll also be taking part in a panel session on personalised and precision technologies. NICE is ideally placed to help the medical technology and diagnostics industries to meet increasingly challenging expectations in resource-constrained health systems. Through our Medical Technologies Evaluation and Diagnostics Assessment Programmes we produce evidence-based guidance and advice on innovative medical and diagnostic technologies for the National Health Service (NHS) in England, recommending those that are clinically and cost-effective. Payers are often most uncertain about the value of a new technology at the point where an adoption decision is needed for the whole health system. NICE is able to help in these situations by targeting further evidence development on the specific uncertainties remaining about the use of the product once we have done our evaluation. We work with academic evidence assessors to produce a protocol which the company can then use to target their research on those uncertain outcomes, enabling us to update our guidance at a future point. Of course, we would prefer companies to undergo a NICE evaluation with the correct evidence already in place, so we also offer a Scientific Advice service to companies as they plan their trials. The cost of developing evidence is a major concern to companies facing short patent lives, “fast-followers” and frequent device iterations. NICE is involved in a work stream of EUnetHTA Joint Action 3 that seeks to create a quality tool for registers being used to collect health outcome data. The aim is to give guidance to register developers (including companies) and those using the data for HTA, a common set of standards so that companies don’t waste...
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...
I just read the minutes of the joint meeting EDMA, Eucomed, COCIR and EUnetHTA had last May and it got me thinking: why try to put a square peg in a round hole? Medical devices, in vitro diagnostics, imaging equipment and pharmaceuticals - while all health technologies - are very different in nature, in their mode of action, in the benefits they bring to people’s health and well-being, and in the way they contribute to sustainable healthcare. Because of these and many more differences, trying to apply a Health Technology Assessment (HTA) model designed for pharmaceuticals to other health technologies is like trying to shove a square peg into a round hole – it won’t work.
EU regulations
The revision of the IVD and MDD Directives has ensured that the last quarter has been a really colourful, hectic and interesting one. The revision process has now entered a new phase where Council will need to agree on a position, after which it will have to negotiate this position with Parliament. That negotiation should then lead to the final texts for IVDs and devices. In terms of timelines, the Parliament is set on finalising both processes before the European elections of May 2014. Until then, I'm sure the evolutions will provide me with plenty to blog about.