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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