Medilink NOE News Summer 2020 Summer 2020 | Page 7

REGULATORY SUPPORT LEEDS GENERAL INFIRMARY IS PLANNING TO EXPAND ITS FACILITIES AND SERVICES Last October, Leeds Teaching Hospitals NHS Trust revealed exciting proposals for a brand-new development to transform Leeds General Infirmary (LGI). Plans for two state-of-the-art hospital buildings, including a dedicated Children’s Hospital on the Leeds General Infirmary site have been submitted to Leeds City Council. They are part of an ambitious, long-term vision for the LGI called Hospitals of the Future, which aims to revolutionise health services for patients in Leeds and the wider region. There will be a new theatre suite dedicated to day procedures, endoscopy and radiology as well as a pharmacy to support a central Outpatients department. The extension of health services for adults will be the focus of the first hospital building, which will be joined to the LGI’s Jubilee Wing. Greater critical care capacity will enable LGI to expand its highly specialist services, like major trauma or cardiac care. These services benefit people in the community and beyond. The second hospital building will be a new Leeds Children’s Hospital. Bringing together services and staff from the existing Children’s hospital, it will deliver healthcare for children and young people in a purpose built facility dedicated to their specific needs. The new hospital buildings will be designed to support advanced treatment and care based on the latest technologies and innovation. For patients, this will mean more efficient, individual healthcare in modern comfortable surroundings. Flexible spaces will be used to adapt and respond to changing patient needs over the lifetime of the hospital. Julian Hartley, Chief Executive, Leeds Teaching Hospitals said: “This is a really exciting development for our hospitals that will be a huge step forward in the way we provide healthcare for patients in Leeds and the wider region. “By designing hospital buildings from the ground up, we’ll be able to embrace new technologies and innovation to deliver modern, efficient health services that are tailored to our patients’ needs, not just now but in the future.” To find out more about the Leeds General Infirmary’s vision and plans for the future development, please visit https://www.leedsth.nhs.uk/about-us/building-theleeds-way/. Regulation is the number one issue facing Lifescience businesses now that the worst of the Covid-19 crisis has hopefully subsided. The additional requirements of the impending new European Medical Device Regulation (May 2021) and the new Invitro Diagnostic Regulation (May 2022), the major under capacity in our notifi ed bodies and Brexit combine to create one of the biggest threats to Lifescience businesses in a generation – not just in the North but nationally. Taking just one of these factors, SMEs are particularly unprepared for the new MDR as evidenced in a recent national Medilink UK / ISO Life Science report* with transitioning to MDR being costly and complex, with MDR requiring signifi cantly more in terms of clinical evidence, risk assessments, post-market surveillance, supply chain obligations and new IT systems (for the Unique Device Identifi cation (UDI) system and the new EU Eudamed database), not to mention new packaging and labelling. Medilink North of England are in the process of rolling out a new Medilink Regulatory service to support MDR implementation - this brings together Medilink’s internal expertise e.g. regulatory gap analysis and authoring of clinical evaluation reports, with that of a network of accredited regulatory consultants, but it is clear that direct government intervention will be required if we are not to lose key indigenous Lifescience companies. Of course, the terms on which we leave Brexit will determine whether there will be yet another complex recertifi cation process required which would again have a disproportionately negative impact on SMEs. Whether you are seeking a specialist to undertake a compliance gap analysis, a regulatory consultant to assist with MDD/MDR or IVD/IVDR transitioning, or someone to write ‘Clinical Evaluation Reports’ or ‘Biological Evaluation Reports’, please contact us at [email protected]. HEALTHCARE PROFESSIONALS INVITED TO HELP SHAPE THE WORKFORCE OF THE FUTURE Employers and experienced practitioners from across the health and science sectors are being invited to participate in an exciting programme to help shape a new suite of government-commissioned technical qualifications. Due to launch in September 2020, T levels are a highquality, work-focussed alternative to A levels for young people aged 16-18 once they’ve completed their GCSEs. The programmes consist of theory-based technical learning combined with practical activities, English, maths and digital content, plus an extended work placement. They are designed to bridge the gap between the classroom and the workplace, supporting progress into higher or degree level apprenticeships, higher education, or employment. Medilink member and National Awarding Organisation, NCFE, is working with Government to develop T level qualifications for: health; healthcare science; and, science. Employer input to the development of these new qualifications is vital in ensuring that T levels reflect the needs of the occupations they’re designed to serve. To that end, NCFE is now looking to build on its network of leading experts and employers from across the digital, and health and science sectors to gain additional support in the development of these qualifications. This represents a great opportunity for employers and professionals to help influence the qualifications that will create the next generation of skilled workers in the health and science sectors. Contributors don’t need to be education experts. NCFE are simply looking for experienced practitioners in relevant health and science occupations to reflect on the knowledge and skills they need in their work to help create qualifications that set learners up for success. Input can be provided remotely and at whatever time of day, night, week or weekend suits colleagues best. Those interested in supporting this work are invited to contact NCFE T Level Partnership lead, Zac Aldridge (zacaldridge@ ncfe.org.uk / tel: [phone]). For more information, visit: www.ncfe.org.uk/t-levels/tlevels-for-employers. THE IMPACT AND LEGACY OF COVID-19 - A VIEW FROM CHRIS KENNELLY, CEO CIEVERT Coronavirus will have a legacy that is broader and farther reaching than the impact of lockdown. How we work, shop, socialise, communicate and more has all changed, and is unlikely to return to BC (Before Covid). Healthcare is no different. In fact, the change to how we access healthcare may be the greatest legacy of coronavirus. For many, healthcare is passive – it’s something to receive or endure when you’re unwell: a trip to the GP, a tablet to make you better… Coronavirus has reminded us that effective healthcare is two-way. It’s taught us that prevention is preferable and that what we do as individuals has a huge influence on our continued wellbeing. Lockdown has accelerated the use of technology in healthcare, but the focus of this technology has mainly been about replacing like for like – a consultation via video call is still a consultation. The long-term legacy will be an increasing acceptance of technology. Technology will increasingly, be expected by patients – it is this that will deliver lasting change and improvement. At Cievert we’re already using technology to track patient symptoms and outcomes in clinical areas as diverse as cancer, gastroenterology and renal. We identify clinical need when it presents and we automatically alert clinical teams when required. Identifying clinical need outside of traditional healthcare immediately provides opportunity for healthcare to be delivered in innovative and more effective ways. Technology-led healthcare may not be for everyone, but taking a day off work for a hospital appointment isn’t for everyone either. A legacy of Coronavirus will be an increased willingness from both doctors and their patients to broaden how healthcare is delivered, and embracing technology will be at the centre of this approach. And that must be a good thing. 12 13