FOREWORD
Welcome to the first edition of Medilink News reflecting the merger of Medilink Yorkshire and Humber, Medilink North West and Medilink North East into Medilink North of England. Below you can see regional perspectives from leading figures in the NHS, Industry and Academia.
The views of Foreword contributors do not necessarily reflect the views of Medilink.
PROFESSOR SIR JOHN BURN. PROFESSOR OF CLINICAL GENETICS, UNIVERSITY OF NEWCASTLE. CHAIRMAN, QUANTUMDX. NON- EXECUTIVE DIRECTOR, NHS ENGLAND. CHAIR, NEWCASTLE HOSPITALS NHS FOUNDATION TRUST.
I am delighted to contribute to the inaugural issue of Medilink North of England Newsletter, with its theme of regulation.
It has been my privilege to have been involved in genetic research for over forty years, and as Professor of Clinical Genetics at the University of Newcastle, I have seen a rapid expansion of genomics and the study of DNA, which will undoubtedly have a major impact on modern medicine and on our future healthcare delivery.
In my role as Chair of QuantuMDx, I understand the challenges that life science companies face in translating science and technology into commercial products. QuantuMDx has innovated the entire molecular diagnostic process to create rapid diagnostic solutions for global diseases. This has included developing the Q-POC™: a simple-touse, portable, molecular diagnostic analyser to diagnose a range of infectious diseases, at the point of care, in under 20 minutes.
The impact of nucleic acid extraction, amplification and detection and their applicability to diagnostics and genomic medicine was not fully understood when the existing medical device / in-vitro diagnostic regulations came into force and this is one reason why the new European IVD regulations are being introduced. Patient safety continues to be paramount in healthcare delivery across the world and of course to manufacturers of medical devices / IVDs. Whilst Brexit creates many uncertainties, it is clear that greater global harmonisation of regulation- which the new MDR and IVDR regulations support- is an essential development.
Medilink play an important role in the regional life science landscape, enhancing connectivity and ensuring that key stakeholders are kept up to date with important developments, such as the changes in regulation highlighted in this edition.
PROFESSOR CATHY JACKSON. HEAD OF SCHOOL OF MEDICINE. EXECUTIVE DEAN, FACULTY OF CLINICAL AND BIOMEDICAL SCIENCES, UNIVERSITY OF CENTRAL LANCASHIRE.
I am delighted to be contributing to the inaugural Medilink North of England newsletter.
As a relatively new school of medicine in the region, we recognise the importance of innovation and collaboration with partners across the health economy. The pressures on health care providers in the North are well documented, as is the need to increase the capacity and sustainability of the medical workforce and address the significant health and workforce challenges regionally.
To meet these demands, our health economy is transforming at a rapid rate. In this environment it is essential to both maintain and improve the quality of provision through innovation linked to external scrutiny and regulation. As a school, we work closely with our NHS partners and patients to ensure our students are trained to meet the new demands. We offer a medical curriculum which considers what the workforce of the future may look like and ensure that students are exposed to both primary and community health care from year one. Additionally, we not only train the next generation of doctors, but offer a range of innovative undergraduate and post-qualification courses, responding to the needs of our students and the future medical economy. Our research continues to grow at our Preston campus, and also the Mackenzie Institute for Clinical Research at our Burnley campus and the National Centre for Remote and Rural Medicine and the Digital Health Institute at our Cumbrian campus.
By widening recruitment to medical education, developing new innovative curricula and bringing funded research and teaching opportunities to the region, we are helping to recruit and retain a sustainable, diverse workforce, making a positive difference to local communities. Since our establishment some five years ago, the School of Medicine has quickly become a trusted and sought-after education partner in the regional health and social care economy. I hope we may look forward to collaborating with some of you in the near future.
SIR ANDREW CASH. CHIEF EXECUTIVE, SOUTH YORKSHIRE AND BASSETLAW INTEGRATED CARE SYSTEM
This year NHS England celebrates its 70th anniversary, 40 years of which I have had the privilege of serving this remarkable institution, 16 years as the CEO of one of the largest hospital trusts in the country, the Sheffield Teaching Hospitals NHS Foundation Trust.
New and more advanced treatments delivered to a growing and ageing population continues to place more pressure on NHS service delivery than ever before.
The system is having to constantly adapt through a greater integration in health and social care delivery and through enhancing the adoption of new science and technology solutions. Throughout this transformation process a focus on safety and quality of care continues to be central to NHS delivery.
This is why the new EU regulation surrounding medical devices and in-vitro diagnostics is so important, as we strive to consistently achieve the highest levels of health and safety whilst embracing new technology solutions.
The centre pages of this newsletter provide more information on these changes. These primarily relate to manufacturers although the new regulations include obligations that health institutions need to meet including changes to the health institution device exemption, implant cards for patients with implantable devices, unique device identification for certain classes of device etc.
Having served on the Board of Medilink for 13 years, I have observed first-hand the excellent work that they are undertaking in enhancing collaboration and driving innovation in the life science sector.
I wish them every success with Medilink North of England Ltd and hope that the readers of this newsletter value the new cross regional opportunities that it affords.
MEDILINK NORTH OF ENGLAND LIMITED –
ANOTHER MILESTONE IN OUR CONTINUED DEVELOPMENT
Having celebrated the 20th anniversary of Medilink last year, this magazine marks another major milestone in Medilink’ s continued success, the merger of Medilink Yorkshire & Humber, Medilink North West and Medilink North East into Medilink North of England Limited, with this being our inaugural issue of the Medilink North of England Magazine.
There was a unanimous vote from our membership for the creation of Medilink North of England Limited, with members expressing the value they put on cross regional connectivity, at a General Meeting held towards the end of last year.
This has resulted in the creation
Faced with uncertainty on a Brexit deal, the life sciences sector has to act now to mitigate the impact of a‘ hard’ Brexit. As nothing is agreed until everything is agreed, businesses need to identify areas of concern and implement plans to address them. Without such preparation, there is a risk of disruption to manufacturing and supply chains, product shortages and delays in accessing the EU market. The MHRA has sought to provide reassurance that they would be pragmatic and measured in relation to the UK regulatory framework. However, unless there is a deal, the status of the UK as a third country means that we would fall out of the EU regulatory regimes. This impacts on every stage of authorisation, manufacturing, pharmacovigilance, the location of key personnel, batch release testing, reference products, CE marking and labelling. of a new Board of Directors with representation from each of the three Northern Regions and the creation of three Regional Advisory Groups( each with representation from industry, the NHS and academia), which will ensure the continuation of a regional voice in future Medilink activity.
Earlier in the year, we held our first combined Medilink North of England Healthcare Business Awards in Manchester( supported by Business Insider), which attracted a record attendance( see page 5). This event is the highlight of our year, as we see the contribution of companies and their employees to advancing patient care and to supporting the regional economy, recognised and rewarded.
I would ask all of you to really get behind this year’ s award ceremony to boost attendance even further and make the Medilink Northern Healthcare Business Awards the envy of the UK.
Medilink was founded on the need for academic, business and clinical communities to work closer together to bring about continued transformation in health delivery, and with the rapid convergence in Med Tech, Bio Tech, Pharmaceuticals and
Digital Health, partnership working is more important now than ever before.
We are delighted to have forewords in this edition of Medilink News from leading figures from the academic, business and clinical communities.
The infrastructure supporting health innovation, needs to constantly adapt to rapid changes in technology and globalisation, but with healthcare delivery we cannot ever take our eye off the ball in respect to patient safety and quality of care, and this is one reason why we have seen updates to the EU regulation covering medical devices and in vitro diagnostics.
We hope that you find the different perspectives around regulation in Medilink News illuminating – and please contact us with your thoughts on content for future issues of the Medilink North of England Magazine.
Kevin Kiely Chief Executive Medilink North of England Limited
ARE YOU READY FOR A“ HARD” BREXIT? RACHEL FETCHES HGF
It will also affect the treatment of active substances, finished products and devices imported into the EU27 from the UK. To ensure continued access, changes have to be implemented before the end of March 2019.
Companies also need to consider how Brexit might impact on key contracts. For licensed technology, what is the territory and will the UK still be covered? Who is responsible for transfers or changes to authorisations, manufacturing and testing sites, labelling and the relocation of key personnel? Which party will be responsible if there are delays in the supply chain or the interruption of exports / imports? Who will pick up any shortfall in funding or additional tariffs?
Despite the political uncertainty, conducting a hard Brexit review and making considered decisions on the commercial risks to your business is a pragmatic step that all businesses can take now to ensure a continuing, safe supply of products to patients.
The views expressed are those of the author, and not necessarily Medilink. www. hgf. com enquiries @ hgf. com
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