Lifescience Industry Magazine by Teamworks

Issue 17 2019

DISCOVERING HEALTH TECHNOLOGY

The UK landscape for Digital Therapeutics Where we are and what is to come

Future Watch

Clinical Need

Going Global

People & Places

Regulatory

New technology and innovations

Meeting unmet clinical needs

Cracking international markets

InďŹ&#x201A;uential people and places in the industry

Updates and expert 1 advice

For faster digital transformation, look to a 2019 Gartner Peer Insights Customers’ Choice.

See why InterSystems is a data platform of choice at InterSystems.com/gartner

InterSystems was named a January 2019 Gartner Peer Insights Customers’ Choice for Operational Database Management Systems (OPDBMS). The GARTNER PEER INSIGHTS CUSTOMERS’ CHOICE badge is a trademark and service mark of Gartner, Inc., and/or its affiliates, and is used herein with permission. All rights reserved. Gartner Peer Insights Customers’ Choice constitute the subjective opinions of individual end-user reviews, ratings, and data applied against a documented methodology; they neither represent the views of, nor constitute an endorsement by, Gartner or its affiliates. https://www.gartner.com/reviews/customers-choice/operational-dbms ©2019 InterSystems Corporation. All rights reserved. InterSystems is a registered trademark of InterSystems Corporation. All other trademarks are property of their respective owners. 5-19

4-5

The UK Landscape for Digital Therapeutics

Asthma+me: Supporting children with moderate-tosevere asthma

Where we are and what is to come

Assistive technology improves the eating experience

New podcast provides fresh perspectives on health and care innovation

Lifescience Industry is now online – visit www.lifescienceindustrynews.com for the latest news

”

A message from the editor Welcome to this edition of Lifescience Industry This edition begins with a feature on the UK landscape for Digital Therapeutics (page 4-5). Future Watch then puts a spotlight on digital technologies to manage COPD (page 9) and to improve sleep (page 12), as well as a new life science podcast (page 13) and the future of bioelectronics (page 11).

Innovations in the Clinical Need section include a platform for managing paediatric asthma (page 16) and an award-winning urine testing system (page 19), while Going Global features an insight into opportunities for life science companies in Saudi Arabia (page 24). Finally the People & Places section highlights the Health Innovation

Programme (page 34) and MedCity (page 36), both of which were founded five years ago, and the Regulatory section answers some frequently asked questions about the new EU MDR. (page 39). Sophie Davies Editor

Future Watch 8 BESTIE provides mental health support for young people

9 Success for health tech business set up by pensioner with lung disease

10 Doors open for neuroscience challenge winner

11 Bold, hybrid and bioelectric:

protecting ideas in the future of medicine

12 Digital platform to treat poor sleep 13 New podcast provides fresh

perspectives on health and care

Clinical Need

Going Global

16 Asthma+me: Supporting

24 Saudi Vision 2030: Issue 5

children with moderate-tosevere asthma

The opportunities in healthcare

19 Design award for urine testing system

21 New sensor-based technology

brings testing for H202 contents into the clinic

22 Growth for digital health Jess Fisher platform in the NHS

People & Places 2012 ISSUE 4

Editor

23 An integrated approach of

changing cultures in clinical governance and patient safety

28 Africa Health 2019-showcasing the best

of healthcare in the continent Lorem ipsum dolor sit amet, 29 Bring your business to consectetur adipisicing elit,the sedMENA do region with Medilink eiusmod tempor UK incididunt ut labore et dolore magna aliqua. Ut 30 ABHI Accelerator enterseunext phase enim ad US ullamcoin

consultancy launches new global HQ 33 Assistive technology improves the eating experience 34 Hooray for HIP

36 MedCity: Five years on

LRegulatory 38

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ABHI leadership strengthened with digital health at the forefront of priorities

39 New EU Medical Device Regulations (MDR) - Your questions answered

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40 Lifescience Industry Event Calendar 2019/20

Published by Teamworks. www.teamworksdesign.com For editorial and advertising opportunities please contact: Editor: Sophie Davies, editor@uklifescienceindustry.com Executive Editor: Gwyn Tudor, gwyn@lifescienceindustrynews.com Produced5EA by MediWales for Medilink UK Teamworks, The Maltings, East Tyndall Street, Cardiff CF24 7 Schooner Way, Atlantic Wharf, Cardiﬀ CF10 4DZ Designed by Teamworks Design & Marketing 029 2047 3456 Web: www.mediwales.com Tel: 029 2047 3455 Tel: Web: www.mediwales.com Contact: The views expressed in this publication do not necessarily represent the Editor: Jess Fisher opinions of individual partners unless explicitly stated.jess@uklifescienceindustry.com © Teamworks. 2019

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DISCOVERING HEALTH TECHNOLOGY

32 Health economics

Advertising: Charlotte Tyson

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The UK landscape for Digital Therapeutics: where we are and what is to come On 19 June at the DTx Europe Summit in London, MedCity, along with the Oxford Academic Health Science Network (Oxford AHSN) and NHSX, hosted a roundtable to discuss routes to entry to the UK and current learning from best practice in this emerging area. Here MedCity shares some of the key points arising from the discussion, which took place between companies attending from Europe and the US and expert hosts – Neelam Patel (CEO, MedCity), Nicki Bromwich (Head of Commercial Development, Oxford AHSN) and Leanne Summers (Digital Strategy Delivery Lead, NHSX).

When it comes to scaling digital technology development, data generation and analytical capability, there are few that would deny we are on the cusp of something great. The opportunities being presented for digital therapeutics in the UK are on a scale not seen before, and clinicians, innovators and regulators alike are excited by the potential benefits for both patients and healthcare providers. But how do we all get on the same page, especially when it comes to navigating the complexities of the landscape and the needs of our national health service? A lot of work is being done to help companies access the market, and the infrastructure and policy environment is already much more supportive than it has been. For example, the newly boosted Accelerated Access Collaborative (AAC) programme will fast-track promising digital services, medicines and diagnostic tools to NHS patients. As a single payer the NHS is looking to implement digital interventions that deliver improved outcomes supported by a proportionate level of evidence demonstrating effectiveness. Equally, companies ultimately want to produce technologies that deliver these requirements. It’s all about partnership – working together to produce better, more efficient, more costeffective healthcare. What the discussion really highlighted was the ongoing importance of co-production and collaboration between industry, clinicians and academics in developing and adopting technologies that can demonstrate improved patient outcomes and value to the health and social care system.

So, what were the key discussion points at the roundtable?

The role of organisations such as AHSNs, NHSX and MedCity, where they fit into the landscape and their role in supporting companies to access the healthcare system The UK benefits from a forward-thinking government and policy framework and is investing heavily in innovation development and uptake. This has enabled initiatives at multiple levels. The NHS Long Term Plan has been drawn up by frontline staff, patient groups and national experts to secure a health system fit for the future, including a focus on making better use of data and digital technologies. And the second Life Sciences Sector Deal, published in December 2018, announced £1.2 billion of new investment to strengthen the UK

Issue 17

MedCity, one of several regional cluster organisations across the UK, is providing a much-needed front door for companies, focusing on supporting the growth of the life sciences sector in London and the Greater South East. Working with partners including the AHSNs, Academia, the National Institute of Health Research and others, MedCity provides an independent access point to companies, helping connect them with academic and research expertise and infrastructure. In Scotland, the Digital Health and Care Institute (DHCI) brings together the public sector,

Government

Regulators MHRA, CQC, HRA NHSI, NICE

NHS, AHSNs PHE

Patients

MedCity Industry

as a world-leading science base. The newly formed NHSX has been established to provide a policy framework, standards and APIs for digital technologies aimed at the NHS. Similarly, a re-licensed Academic Health Science Network (15 across England) is focusing on evaluation, adoption and scaling of digital innovations across the NHS.

Academia and Research

academia, charities and industry, using a needs-led approach to create new services, products and ways of working through codesign. Meanwhile in Wales, the Digital Health Ecosystem Wales (DHEW) is developing an open API platform, allowing access to NHS Wales data to help companies develop new products.

The common perception that the UK is a hard market to enter, why companies should choose the UK above Europe and beyond Safe access for digital technologies is emerging as a key theme in global health policy, not only here in the UK, and that requires technologies to be evidenced. Far from being hard to enter, the UK market is accessible and there is a lot of support available to help companies navigate it. For early stage digital therapeutics companies wishing to develop products and business models, the UK is a fantastic place for research collaborations, design support and evaluation and grant funding. The convergence of expertise, funding and a data-rich healthcare system is compelling for trialling and evidence generation. For later stage companies wishing to access the NHS, the organisations already mentioned are well equipped to support and signpost resources. Importantly, the AAC has been formed to speed up the pathway to adoption in England. The ambition of the AAC is to launch a single web portal from across organisations to enable easier navigation for innovators by the end of 2019. Scotland and Wales have similar networks and organisations in place to support and signpost resources. For non-UK companies, MedCity works with organisations such as N-Site and London

and Partners that can signpost support with respect to tax and legal considerations.

Evidence and data – what these mean for digital therapeutics Until March 2019, there were no standards available anywhere on what good evidence looks like for demonstrating clinical effectiveness and cost effectiveness for digital health technologies. Prior to this there were significant challenges in evaluating technologies being put forward for NHS adoption. In reality, there was insufficient evidence to assess effectiveness for the majority of technologies, and this was one of the major reasons that there was poor and inconsistent adoption. The Evidence Standards for Digital Health Technologies framework, first published in December 2018, has introduced the means for industry and commissioners to have a dialogue on evidence and use a framework for that dialogue in England. Since its publication, the framework has been shared with countries in Europe and beyond interested in following this best practice and raising the quality bar for digital health technologies. NHSX, NICE and a range of stakeholders including AHSNs and MedCity, are working on how this evolving set of standards is used in practice and providing practical examples of the type of evidence that will be required. We are also working to align adherence with the evidence standards to NHS Funding Mandates to support the adoption of innovations in the NHS. The Framework is being reviewed in Scotland and Wales for the potential to widen adoption across the UK.

Collecting real-world data We expect digital health companies to work with local organisations and AHSNs to develop plans that support the evaluation of their products with real-people in relevant care settings. This is a partnership approach, as we work to mature the health and care system so that it’s ready to adopt the technologies that meet the standards and principles of the tech vision. These include user need, privacy and security, interoperability and openness and inclusion. We want to signal to the market where there are needs to support alignment between local health and care objectives.

For daily lifescience news visit www.lifescienceindustrynews.com

Q: Market entry for non-UK companies Information governance and data protection are paramount for the delivery of good digital technologies. The information governance toolkit that NHS organisations require providers to be compliant with has recently been updated to the Data Security and Protection Toolkit and provides guidance.

Q: I have a technology that’s responding to a specific national need, is evidenced and is an improvement on current solutions – how do I get this into the NHS system? The best route is to start with the AHSNs. Across the AHSN network they understand needs of the system and can act as a matchmaker between NHS organisations and local authorities and suppliers.

Q: Interactive Care Pathways: how far away are we from having specific digital therapeutics for specific pathways? Some of the Global Digital Exemplars (GDEs) and more digitally mature Integrated Care Systems (ICS) across the NHS are modelling new ways of delivering care. The challenge we all face is how this is then scaled across the health and care landscape. This is within the remit of the Accelerated Access Collaborative and we would be delighted to work with innovators to work through the evidence generation that will support with spread and scale in this transforming NHS.

People and Places

Your front door to the life sciences sector of England's greater south east MedCity is an independent, not-for-proďŹ t cluster organisation that works to promote and grow life sciences investment, entrepreneurship and industry across London and the Greater South East of England. Through our work, we facilitate greater connectivity across the three pillars of industry, academia and the National Health Service. Supported by the Mayor of London, the London Academic Health Science Centres, research institutes and life sciences organisations across the region, MedCity acts as a vital Front Door to the sector. From drug discovery to devices, diagnostics and digital health, we work with industry, researchers and investors looking for partners, investment, infrastructure and expertise.

International EXPO & CONFERENCE

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Thursday 26th March 2020 Hilton London Tower Bridge

2020 SEHTA International MedTech Expo & Conference Devices, Diagnostics, Digital The SME-focused healthcare event for driving collaborations between Academics, Business, Care & Clinicians The conference and expo aims to help delegates: Understand: Make sense of the complexities of healthcare support and challenges of accessing the NHS Find: Funding opportunities (public sector, private, NHS) Navigate: Regulatory, legal and IP issues Identify: Current clinical challenges in the NHS And perhaps most of all.... Make new contacts leading to collaborative partnerships at the event and through our bespoke 1:1 partnering website 6

Issue 16

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NEW EVENT

People and Places

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For daily lifescience news visit www.lifescienceindustrynews.com 7

Future watch

BESTIE provides mental health support for young people It is widely acknowledged that as ‘digital natives’, young people have a wealth of experience and understanding of the digital world. Whilst social media and the online world is an accepted part of children and young people’s social lives, there remain a number of key risks, including addiction/dependency, online bullying and the social pressure caused by social media.

here is increasing national awareness of the impact of social media on children and young people’s mental health and wellbeing, so Worcestershire Health and Care NHS Trust set out to find a way of helping young people find safe online spaces, but also to learn from their digital expertise. The Trust committed to creating a safe but exciting and interactive platform for young people to be able to learn about mental health conditions and get the right help when they need it. Importantly, they ensured the development of this was truly co-owned by medical professionals and the children and young people who would use it. As such, BESTIE was created by a team of young people, NHS mental health and IT professionals from Worcestershire Health and Care Trust, and external IT designers. Each group was crucial to the project and had equal power and responsibility.

BESTIE is an exciting, interactive online platform, designed to help young people learn more about emotional wellbeing and mental health, to find the right help when they require it, and to support their journey through child and adolescent mental health services (CAMHS). The platform’s virtual, interactive world combines digital media, group messaging, built-in games and supportive online help and information, all within a safe platform. Alongside providing an accessible way for young people, parents and relevant stakeholders to find out more about mental health, BESTIE aims to become a valuable clinical tool which will promote changes in motivation and engagement, allowing young people to take more control of understanding, monitoring and managing their mental health needs.

BESTIE was named by young people and stands for Balance, Energy, Support, Thrive, Interactive, Evolve. Currently it is in Pilot with around 140 users, including CAMHS service users, clinicians and professionals from external organisations. It will be available publically and a CAMHS-specific version including more advanced functionality will soon follow.

BESTIE is demonstrating what can be achieved when patients, clinicians and IT professionals work collaboratively.

Recently achieving regional award-winning status with the MidTECH Award for Best NHSDeveloped Innovation at the Meridian Awards, www.camhsbestie.co.uk

Issue 17

Future watch

Success for health tech business set up by pensioner with lung disease A rapidly growing Welsh health technology firm, started by a patient suffering from lung disease, aims to help patients and medics around the world through digital technology.

ond Digital Health was established by entrepreneur Ian Bond, who came up with the idea during retirement. A lifelong smoker, Mr Bond had been diagnosed with Chronic Obstructive Pulmonary Disease (COPD) in his 60s. He became frustrated as he entered the healthcare system and realised something was missing at consultations with his specialist and GP. He found that his treatment was often based on subjective recollections, rather than real evidence. This led him to create a personalised self-management data record so that he could better manage his condition, predict potential exacerbations and present medics with accurate information to support diagnosis and treatment. Co-founder Dave Taylor built the technology required, and it is this technology which has become the cornerstone of the business, based at the Life Sciences Hub Wales in Cardiff. The pair have been given support and advice from the Welsh Government’s business development scheme, the Accelerated Growth Programme (AGP), which provides help and support for firms wanting to expand.

The company, which was established in 2016, has eight full-time and three part-time staff, and this is set to double this financial year. It soon became clear that the company’s app and digital platform could be adapted for use in one of the fastest growing areas of medicine. The digital cloud technology is now an essential component in the growing field of lateral flow diagnostics (the home pregnancy test being the best known example of this), helping not only in the patient-doctor relationship but also in the provision of quantitative data for researchers. Lateral flow diagnostics is a massive area for growth in the global health sector, offering a fast, cost-effective and mobile way of diagnosing a growing range of diseases and conditions. The technology developed by Bond Digital Health can be used in the diagnosis and research of diseases around the world, and the company is preparing for a £1M investment round to finance its expansion.

Mr Bond said he could never have envisaged his retirement being taken over by entrepreneurship – but at the age of 75, he has no plans of giving up.

“Lateral flow technology is an important tool in diagnosing many conditions in both humans and animals, and we are now a world market leader in providing the digital glue that makes it work efficiently. Working with AGP has been worth its weight in gold in helping us get there. “When you are a CEO of a small startup company, you need someone to tell you that you are wrong, because there’s nobody else to. In addition to that honest advice, we could call on the resources of AGP, which was extremely helpful in terms of advice on financial management, marketing and social media. “AGP gave us comfort that we could pick up the phone and talk to someone when we needed to. I don’t think we could have achieved what we have without it.” Ian Bond Founder Bond Digital Health

www.bondhealth.co.uk

For daily lifescience news visit www.lifescienceindustrynews.com 9

Future watch

Doors open for neuroscience challenge winner Brainbox Initiative, the programme to support early career neuroscientists, is starting to have the impact that its founders at Brainbox Ltd were hoping it would have when they launched in 2017.

ne of the first Research Challenge winners, Dr Helen Nuttall, has subsequently gone on to create her own neuroscience laboratory at Lancaster University. She has recently been awarded a research grant from the BBSRC of almost half a million pounds to investigate the cortical resources required for speech perception in age-related hearing loss, with a view to informing and guiding future interventions.

71 per cent of people experience some degree of hearing loss by the age of 70, which can significantly reduce quality of life. Understanding speech in social settings with background noise is particularly difficult for people with hearing loss. This leads to reduced social interaction in noisy environments, which in turn increases isolation and decreases mental wellbeing.

“Brainbox Initiative played a significant role in how my career progressed after my postdoc. Winning the Research Challenge enabled me to successfully build on an idea and collect pilot data very early on in my lectureship. I was then able to use that pilot data in the BBSRC application and achieve funding for an area of research that I hope will have a beneficial impact on our ageing population.” Dr Helen Nuttall Research Challenge winner

Andrew Thomas, Managing Director at Brainbox Ltd, commented: “We’re really proud of Helen and what she has achieved, and we’re delighted that Brainbox Initiative has had a part to play in that. We’ve always believed in the importance of supporting early career researchers, which was why we created the initiative; as a platform to give them opportunities to grow and develop as researchers with promising careers.” Brainbox Initiative’s aim is to offer a significant boost to those looking to make a career in neuroscience by supporting and promoting their research and research ideas. This is achieved through a programme of workshops, awards and an annual conference dedicated specifically to putting early career researchers front and centre.

Several studies have also found a significant relation between hearing loss and the incidence of cognitive decline and dementia. This relation remains after controlling for age, gender, race, education, diabetes, smoking history and hypertension. Adult hearing loss is estimated to cost the UK economy at least £30 billion per annum. It is therefore of paramount importance that we generate new knowledge of how age-related hearing loss affects the brain, and what interventions may be effective. The BBSRC grant aims to inform and guide future interventions by determining how cortical resources involved in speech perception are affected by age-related hearing loss, using a combination of brain stimulation, electroencephalography and behavioural tests. One new avenue for intervention is to capitalise on cortical speech perception strategies, but it has not yet been determined how hearing loss alters the dynamic interaction between sensory information processed bottom-up and the cortical topdown neural influences that act upon it.

www.brainbox-neuro.com

Issue 17

Future watch

Bold, hybrid and bioelectric: protecting ideas in the future of medicine Stephen Blake, Partner and Chartered (UK) & European Patent Attorney at Marks & Clerk, explains the importance of protecting new innovations in such emerging markets as bioelectronics

he application of electronics to the treatment of health conditions is nothing new. For years, pacemakers have been used for the treatment of irregular heartbeats and other cardiovascular conditions.

New technologies and pioneering engineering, however, are opening up whole areas to bioelectronic solutions, and bioelectronic medicine is now a real possibility. Researchers in Washington, for example, have been working on implantable and biodegradable electronic devices that can stimulate nerve regeneration. Likewise, transistors are being developed which can interact with human skin to monitor signals given off by the body – a technology with obvious applications in the treatment of conditions ranging from diabetes to hypertension. It is for these reasons that the World Economic Forum has named bioelectronics a technology that is likely to shape the future of medicine and healthcare. It’s no surprise then that with sophisticated electronic devices being applicable to an increasing range of health conditions, the bioelectronics market is expected to grow substantially in coming decades, with a recent report suggesting it could grow to $60 billion by the year 2029.

and where innovation can be protected with patents, it should be. Given that bioelectronics is a relatively new area of technology, there may not be a great deal of prior art (evidence that an innovation has already been invented or discovered). This in turn means that truly novel, and patented, technology in this area could present innovators with the opportunity to ring-fence a section of the emerging bioelectronics market, and license that technology to the rest of the market – leading to potentially significant returns on initial R&D spend. The hybrid nature of this technology – straddling technologies ranging from electronics to biotech – means that drawing conclusions about the volume of patent filing going on in this market isn’t easy. Medical technology continues to be the largest single patent filing category at the European Patent Office, however, and some of this is likely to be accounted for by bioelectronics. The EPO’s latest annual report reveals that filings in the medtech category grew 5 per cent in 2018. Filings in the categories of measurement, biotechnology, electrical machinery and analysis of biological materials also grew. While not conclusive, this filing could point towards growth in the bioelectronics market already occurring.

Protecting innovation

Patent challenges

For innovators in this market, and for patients, there is a huge amount to play for. With substantial investments being made in research, development and gaining regulatory approval, it is vital that innovation in this market can be protected

While presenting potential licensing opportunities, the hybrid nature of bioelectronic technology also presents challenges to both start-ups and more established companies who may be looking to break into this market. Central to these

challenges will be developing the in-house expertise needed to successfully compete in this market and finding the engineers who are as comfortable with circuitry as they are with chronic illness. As the bioelectronics market grows, no doubt the pool of individuals and firms specialising in electronic healthcare solutions will grow too. In the meantime, great care will need to be taken to ensure that pioneering technologies developed in this space are adequately protected and commercialised.

New technologies such as AI and 3D printing are leading to enormous innovation in healthcare – with technological solutions being found for health challenges, ranging from better diagnostics which can reduce over-prescription of antibiotics to the emergence of sophisticated algorithms that can replicate a human pancreas.

The emerging field of bioelectronics will have a huge role to play here and has the potential to lead to ground-breaking new treatments and the creation of world beating enterprises. Protecting this innovation with intellectual property will be key as this industry grows and begins deploying its technology to meet health challenges globally.

www.marks-clerk.com

For daily lifescience news visit www.lifescienceindustrynews.com 11

Future watch

Digital platform to treat poor sleep Sleepio is a clinically validated (9 RCTs and over 37 published papers), personalised, fully automated digital programme based on cognitive behavioural therapy (CBT) that enables whole populations to improve their sleep, mental health and quality of life. It is the first digital therapeutic developed by parent company, Big Health. The problem Difficulty sleeping is the most common mental health complaint in the UK, yet also the most poorly managed. Poor sleep affects one in three adults and, as a chronic disorder, insomnia affects 10-12 per cent of working adults. It is a known risk factor for chronic conditions such as depression, anxiety, diabetes, and heart disease.

placebo-controlled randomised trial for a digital sleep intervention, Sleepio helped 76 per cent of poor sleepers achieve healthy sleep levels - an effect that was maintained 8 weeks later at follow-up. Leading scientific publisher, Nature magazine, indicated this was an outcome “comparable in effect to in-person therapy.”

The solution Sleepio targets users with poor sleep as a non-stigmatised route to tackle poor mental health. Its validated sleep test directs people to the appropriate level of care. Those with insomnia symptoms receive tailored sleep hygiene information, akin to GP advice. Those with insomnia disorder can access gold standard treatment with digital Cognitive Behavioural Therapy (dCBT). Sleepio is fully automated, scalable and in the world’s first

The project Oxford AHSN is partnering with Big Health on a £1m, two year Innovate UK grant. Realworld evidence data is being collected from participants in the Thames Valley region. The objective of the project is to develop a blueprint for commissioning and adoption of Sleepio at scale.

Since October 2018 over 8000 people have accessed the Sleepio programme and are sleeping an additional 5 hours each week, experiencing improved workplace productivity (less stress, improved productivity, reduced absenteeism), reporting improved mental health (reduced anxiety and depression symptoms -GAD-2 and PHQ2) and reduced usage of sleeping tablets.

www.sleepio.com

Issue 17

Future watch

New podcast provides fresh perspectives on health and care With nearly six million adults in the UK now listening to a weekly podcast, Life Sciences Hub Wales has launched the ‘Healthy Thinking’ podcast.

he series aims to raise awareness of current issues, highlight ground-breaking technologies and stimulate discussion around health and care innovation.

Professor Sir Mansel Aylward, Chair of the organisation and host of a number of the episodes, said: “Healthy Thinking is enabling us to share the discussions we are having with senior leaders and innovators, not only in Wales but across the UK and internationally. It is a great opportunity to spark thinking and address innovation adoption in health and social care.” The series has already included interviews with Wales’ First Minister on the place of innovation in the Welsh economy, social prescribing expert Sir Sam Everington on a transformative approach to supporting primary care services and a panel discussion on how to use big data to improve the patient experience.

member, Mark Wardle, said: “It’s just so exciting to step back and reimagine how we can provide health with the digital tools that we now have available. And we just need the ambition to do that.”

“Healthy Thinking showcases innovation to inspire others and contribute to the conversation – enabling it to happen at scale and pace. It’s been great to hear colleagues working across health, social care, the life sciences industry, and academia taking part in the episodes.” Cari-Anne Quinn Chief Executive Life Sciences Hub Wales

Showcasing innovation Recent episodes of the podcast include going behind the scenes at the annual Welsh Health Hack, a two-day innovation marathon which pairs industry experts, digital technologies and data companies with NHS staff to come up with solutions for some of their challenges. A feature-based episode also explores how one medical device manufacturer has made a real difference to patient care, hospital pressures and the economy through an innovative new way of working. You can listen to ‘Healthy Thinking’ on the Life Sciences Hub Wales’ website at www. lshubwales.com/podcast or by subscribing through Apple, Spotify or Google today. A Welsh language version of the podcast, ‘Syniadau Iach’, also considers the issues raised with contributions from experts and industry leaders at www.lshubwales.com/cy/podlediad

Innovation – addressing healthcare inequalities “If we deploy artificial intelligence … it will free people up to do many other jobs that only human beings can do,” said Wales First Minister, Mark Drakeford on the opportunities that AI presents. As a former health minister, he also talked about the importance of innovation within healthcare provision and how it can address healthcare inequalities. From AI to general practice, Sir Sam Everington explained how social prescribing links patients with sources of support within their local community to help them improve their health and wellbeing. He explained that in one of their programmes, “a mental health trust reduced acute admissions by a third” by opening “a café seven days a week, staffed by mental health workers.” Guests from IBM and NHS Wales Informatics and a clinician all championed “opening up” healthcare data through the use of APIs (application programming interface) to transform the way healthcare is delivered. Panel www.lshubwales.com/podcast

For daily lifescience news visit www.lifescienceindustrynews.com 13

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We innovate healthcare At Roche our aim is to improve the health, quality of life and well-being of people around the world by providing an innovative range of diagnostic solutions and medicines. Roche is a global, research-focused healthcare company with Group Headquarters in Basel, Switzerland. Our strategy is clear - the patient lies at the heart of everything we do and our focus is fitting the treatment to the patient through prescription pharmaceuticals and in-vitro diagnostics. What makes Roche distinctive is our pursuit of excellence in science as we deliver the best solutions for healthcare professionals and improve patient outcomes; this is achieved through our unique combination of Pharmaceuticals and Diagnostics. Everyday, our products help patients and the healthcare professionals who care for them by detecting, preventing, diagnosing, treating and monitoring diseases. We are proud to have played a pioneering role in UK healthcare since 1908. Today, we are the leading in-vitro diagnostics company in the UK and the leading provider of pharmaceutical treatments for cancer and viral diseases. We are also a major supplier of medicines for the treatment of transplantation, virology, bone and rheumatology and renal anaemia. In total, our UK pharmaceutical and diagnostics businesses employ nearly 2,000 people.

Personalised Healthcare We combine our strengths in pharmaceuticals and diagnostics to better fit treatments to patients. When genetic differences can be identified, the efficacy and safety of medicines can be improved enormously. To this end we have a companion diagnostic strategy for every molecule we develop.

Diagnostics As the UK leader in diagnostics solutions, we offer a uniquely broad and innovative portfolio of products to patients, physicians, researchers, hospitals, laboratories and universities. Our UK Diagnostics business, headquartered in Burgess Hill, West Sussex, employs approximately 500 highly skilled individuals. Diagnostics is set to play an increasingly important role in the future of healthcare as genetic knowledge presents new and exciting opportunities. Our desire is to provide clinicians and patients with Actionable Health Information - information that reduces the uncertainty in the medical decision making process, enabling them to choose between available alternatives to prevent or treat disease.

Tel: +44 (0)1444 256000 www.roche.co.uk At Roche we focus on developing medicines and diagnostics that will help patients live longer, better lives 14

Issue 16

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For daily lifescience news visit www.lifescienceindustrynews.com 15

Clinical Need

Asthma+me: Supporting children with moderate-to-severe asthma Dr Kevin Auton, Managing Director of Aseptika Limited (Activ8rlives), talks us through a new innovation in managing paediatric asthma.

llis is 9 years old and has severe-to-moderate asthma. Ellis was referred to the hospital after having had difficulty breathing.

“As a baby Ellis had croup, and his night-time cough has continued. It was only recently that the GP referred us to the hospital because Ellis’s croup had disguised his underlying asthma”, his mother explained. “This now means that every few months, he has to have an appointment with a specialist paediatrician at his local hospital – and misses a day of school each time.” Children with moderate-to-severe asthma can miss a lot of schooling due to time off with illness at home, appointments at outpatient clinics, or worse, admission to hospital. Aseptika sought to explore and then address this challenge with a productised child-appropriate version of its Activ8rlives self-care platform, aimed at children with moderate-to-severe asthma from the age of 6-12 years.

Asthma+me, co-developed by Aseptika with a leading UK paediatrician, is a comprehensive CE-marked self-care solution. It includes: education sessions, PUFFClicker smart pMDI inhaler use tracking, lung function monitoring, in-built symptom checkers, online educational syllabus for the child/family, an electronic care plan, and the ability to push data to hospital/GP electronic patient records.

Outpatient clinics in paediatric secondary and tertiary care centres are already overflowing with follow-up appointments, due to a complex interplay resulting from low confidence of patients’ families and an understandable reluctance to discharge patients back to communitybased care by highly dedicated and caring paediatricians and clinical staff.

Healthcare specialists are actively searching to reduce the over-use of outpatient appointments and to address the unmet need to support this group of patients. NHS Commissioners are seeking technology innovations to support this and supported by policy in the NHS LongTerm Plan. Asthma+me was launched as a Class 1 medical device (October 2018) with its development supported by SBRI Healthcare pre-procurement contracts totalling £800,000. This was made possible through rapid development because it is based on the mature Activ8rlives platform. It is being further supported by grants from Innovate UK to fund an RCT with 50 patients on each arm and a further grant to add Aseptika’s neural networks (Artificial Intelligence). This will help to predict and warn of an asthma attack, making it smarter by using AI to recognise signs of impending asthma attack. Acting quickly and knowing how to prevent asthma symptoms progressing into a full attack can make all the difference.

Key facts about paediatric asthma: l 1.1 million children in the UK receive treatment for asthma l 24,744 emergency admissions for asthma in 2012 l 13 children under 14 years died from asthma in 2016 l There were preventable factors in 90 per cent of childhood deaths from asthma

l Less than 25 per cent of the children that died from asthma had a Personalised Asthma Action Plan (PAAP) l Nearly half of the children that died had an asthma attack in the previous year l 30 per cent of the children had daytime symptoms in the previous week l It is the most frequent reason for emergency admission to hospital

Issue 17

l The UK has the third highest risk of death from childhood asthma in OECD nations (Asthma UK) l 10 per cent of children with asthma have what is clinically defined as moderate-to-severe or difficult-totreat asthma and should be treated in specialist paediatric clinics (Asthma UK)

CHILDREN CHILDREN CHILDREN IN UKININUKUK

RECEIVE RECEIVE RECEIVE ASTHMA ASTHMA ASTHMA

TREATMENT TREATMENT TREATMENT

1.1m 1.1m CHILDREN CHILDREN CHILDREN IN UKININUKUK

RECEIVE RECEIVE RECEIVE ASTHMA ASTHMA ASTHMA

TREATMENT TREATMENT TREATMENT

FOR FOR ASTHMA FORASTHMA ASTHMA

UNDER UNDER UNDER 14 1414

DIED FROM DIED DIEDASTHMA FROM FROMASTHMA ASTHMA

IN IN2012 IN2012 2012 IN IN2016 IN2016 2016

Clinical Need

24,744 24,744 24,744

EMERGENCY EMERGENCY EMERGENCY ADMISSIONS ADMISSIONS ADMISSIONS FOR FOR ASTHMA FORASTHMA ASTHMA

THIRTEEN THIRTEEN THIRTEEN CHILDREN CHILDREN CHILDREN UNDER UNDER UNDER 14 1414 DIED FROM DIED DIEDASTHMA FROM FROMASTHMA ASTHMA

IN IN2012 IN2012 2012 IN IN2016 IN2016 2016

Our approach enables the patient and parents/carers to self-care and reduce reliance on NHS services across the ecosystem, whilst still remaining connected to expert support at the paediatric clinics. This level of expertise is not uniformly available in community care and appears to be essential in order to maintain parental confidence.

1.1m 1.1m CHILDREN CHILDREN CHILDREN IN UKININUKUK

RECEIVE RECEIVE RECEIVE ASTHMA ASTHMA ASTHMA

TREATMENT TREATMENT TREATMENT

24,744 24,744 24,744

EMERGENCY EMERGENCY EMERGENCY ADMISSIONS ADMISSIONS ADMISSIONS FOR FOR ASTHMA FORASTHMA ASTHMA

THIRTEEN THIRTEEN THIRTEEN CHILDREN CHILDREN CHILDREN UNDER UNDER UNDER 14 1414 DIED FROM DIED DIEDASTHMA FROM FROMASTHMA ASTHMA

IN IN2012 IN2012 2012 IN IN2016 IN2016 2016

www.activ8rlives.com

For daily lifescience news visit www.lifescienceindustrynews.com 17

Clinical Need

The Health Tech Hub helps businesses to develop and bring to market new technology solutions which promote health and wellbeing

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Issue 16

www.medilinksouthwest.com www.healthtechhub.co.uk

Clinical Need

Design award for urine testing system A pioneering urine testing system has been recognised in one of the world’s most prestigious design competitions. Urine Testing System™ received a coveted Red Dot Award, which is an internationally-respected mark of quality for design and innovation.

eveloped by British company Clinical Design, Urine Testing System is a step change in point-of-care urine testing. Despite being the most common diagnostic test in the world, as 2.8 billion urine tests are undertaken each year, the process is the same whether carried out in a bush clinic in the Sudan or a top London hospital. Manual urinalysis can be unhygienic and subject to variation, with risks of spillages, contamination, and errors in analysis and transcription of results. Oliver Blackwell, Founder and CEO of Clinical Design, set out to change that. Urine Testing System is the product of nine years of development, during which he worked closely with senior clinicians. Hygienic, easyto-use and accurate, it has been designed to improve the entire process from receiving the sample and recording results, to analysis in the laboratory. Digital readings reduce variation in analysis and improve ability to get the diagnosis right first time. Results can be saved into a patient’s electronic health record, and with sealed, leak-proof samples, urine tests can be conducted at a desk.

“I am delighted that the panel at Red Dot recognised the delivery of a complex product in such a simple form. Working closely alongside clinicians, we challenged the inefficiencies and methods people had come to accept. We scrutinised every aspect of urinalysis and asked a lot of questions. The Red Dot award proves to me that I asked the right questions and managed to appropriately translate the answers.” Oliver Blackwell Founder and CEO Clinical Design

In 2019, designers and manufacturers from 55 countries entered more than 5,500 products in the competition. Urine Testing System will be presented in the Red Dot yearbook, museums and online. Past winners have included products from Phillips, Ferrari and Bose.

www.clinical.design

For daily lifescience news visit www.lifescienceindustrynews.com 19

Clinical Need

Major UK distribution deal for tourniquet Olberon Ltd, a medical device innovation company based in Nottingham, working with its commercial partner ASep Healthcare Limited, has negotiated exclusive distribution rights in the UK and Ireland with Independence Products Ltd of Nottingham to win the first UK orders for its Vacuderm™ and Vacuderm for Kids™ tourniquet products.

he Vacuderm is a single-use tourniquet for difficult to reach veins, with a unique suction and pump mechanism to aid further filling of the veins. It has been designed to aid intravenous needle insertion for cannulation, drug delivery and blood collection. A version for children has recently being developed to distract each child at cannulation and to encourage them to ‘assist’ the procedure by pumping the dome Peter Stockley, Managing Director at Independence Products Ltd, said: “We are delighted to be working alongside Olberon Limited to bring the Vacuderm Smart Tourniquet to market within the UK. Failed cannulation attempts are a significant clinical and financial burden to the NHS and are traumatic for both the patient and the practitioner. Each failed attempt increases the risk of infection. We believe the Vacuderm Smart Tourniquet will complement existing practices and

will significantly improve the cannulation experience for both patient and practitioner.” Charles Giblin, Sales Director at ASep Healthcare Ltd, added: “We love this product and rate it very highly for both nurses and doctors for cannulation of patients with difficult to access veins. It should be an essential component in hospitals and clinics to improve the success rate of first attempt venous access, keeping anxiety and stress to a minimum for both patients and clinicians, and reducing wastage, cost and time for the hospitals.” Olberon Ltd was set up in 2005 in the UK and has accomplished a strong portfolio of in-house patented medical innovations, two medical devices that are market ready from concept to commercialisation, as well as offering consultancy services to both the NHS and the wider medical device market. Independence Products Ltd is an established UK supplier of medical devices designed to improve the quality of life of patients with chronic medical conditions. Independence Products was established in 2006 by Peter Stockley and Andrew Leese who each have over 30 years’ experience in the medical device industry.

“We are delighted to work with ASep and Independence products. ASep’s knowledge and experience of the tourniquet market and access into the NHS Supply Chain was a significant factor in our decision to appoint them as part of the Olberon’s global distribution network. Independence Products have an outstanding reputation for selling medical devices successfully into hospitals and clinics in the UK, with a formidable sales team. We look forward to working alongside both companies in the future and hopefully developing the partnerships.” Dr Arash Bakhtyari CEO Olberon Ltd

ASep Healthcare Ltd’s goal is to make blood collection simpler, intuitive and stress-free for caregivers and patients. This led to the development of the award-winning, single-use tournistrip, the only single use tourniquet clinically evaluated by ANTT to promote a safe aseptic technique and reduce the risk of cross infection.

www.olberon.com

Issue 17

Clinical Need

New sensor-based technology brings testing for H2O2 contents into the clinic A new technology from Exhalation Technology Ltd measures hydrogen peroxide (H2O2) levels in Exhaled Breath Condensate (EBC) as a marker of possible oxidative stress, which is typically linked to COPD.

acked up by more than 200 published scientific papers, H2O2 is probably the best documented biomarker in EBC for oxidative stress and inflammatory conditions in airways. H2O2 levels have been demonstrated to be higher in EBC of COPD patients compared to healthy controls. Moreover, it has also been demonstrated to rise further during exacerbations and to correlate with severity of COPD as measured using FEV1. The Inflammacheck® is an in-vitro diagnostic device intended to provide clinical decision support for healthcare professionals when diagnosing, treating and managing patients suspected to suffer from COPD. It is handheld, integrated and fully automated and offers non-invasive ‘point-of-care’ testing (POCT). Testing for H2O2 in EBC has traditionally only been performed in research settings. EBC has been collected using dedicated collecting devices, while measuring H2O2 contents has been performed by means of highly sophisticated laboratory equipment controlled by skilled technicians. The new technology embedded in the Inflammacheck integrates collection of EBC and testing for H2O2 contents in one device. Simple tidal breathing is all that is required from the patient, and the high level of automation means that the device can be operated in an ordinary clinical setting, by healthcare professionals with the normal level of training. A number of different factors are known to potentially impact H2O2 levels in EBC. In 2017, ERS/ATS issued a set of technical standards related to testing for biomarkers in EBC in order to mitigate the potential

impact from these factors. The new technology combines H2O2 testing with recording of other biomarkers to comply with the technical standard. The Inflammacheck has already been proven successfully for diagnosis of COPD through clinical studies performed at the Queen Alexandra Hospital in Portsmouth. In addition, the device is expected to be applicable in management and monitoring of exacerbating COPD patients in medical treatment. Furthermore, its ease of use makes it a potential candidate for home monitoring where COPD patients test themselves in their own homes. Finally, scientific studies suggest that H2O2 in EBC may also be an applicable biomarker in a range of other respiratory conditions. Potential application areas include Asthma, Pneumonia, Cystic Fibrosis, Interstitial Lung Disease and Lung Cancer. The application of the new technology embedded in the Inflammacheck will be further explored and exploited over the coming years.

Exhalation Technology Ltd will present the Inflammacheck at the 2019 ERS International Congress in Madrid, marking the global launch of this new device.

For daily lifescience news visit www.lifescienceindustrynews.com 21

Clinical Need

Growth for digital health platform in the NHS

Spirit Health Group, formerly Spirit Healthcare, was set up in 2009 by Chris Barker with the aim of transforming healthcare. The company’s range of innovative products and services deliver value in healthcare by empowering people to take control of their health, make best use of NHS resources, and utilise new technology to improve patient outcomes and add value for clinicians.

ne of Spirit Health Group’s innovations, CliniTouch Vie, is a secure cloud-based software platform that allows patients and clinicians to manage long-term conditions, including COPD and heart failure via a tablet device from the patient’s home. The device can support early discharge from hospital and management of patients post-surgery. Through the iNet project (the predecessor to Medilink EM’s SoLSTICE project), Medilink East Midlands supported Spirit Healthcare to approach the Leicester Partnership NHS Trust, resulting in the platform being trialled by 70 COPD patients . Each day, patients included in the trial completed a short digital health questionnaire and provided readings on their blood pressure, pulse and blood oxygen levels. This information was securely stored in the NHS cloud and could be readily

accessed by clinicians. This enabled clinicians to prioritise their caseload and identify patients where early-stage intervention was required to better manage their condition and, as a result, led to a reduction in hospital admissions. The trial demonstrated that CliniTouch Vie reduced the average number of patient admissions by over 67 per cent when compared with a control group, saving Leicester City Clinical Commissioning Group (CCG) £363,000 over the course of the project. The platform has since been rolled out across all three Leicester CCGs and is a key part of COPD treatment across Leicester and Leicestershire. As a result of the success of CliniTouch Vie for COPD patients, the platform has since been rolled out for patients with heart failure. Since being introduced to the Academic Health Science Network (AHSN) by SoLSTICE, Spirit has delivered services in over

50 CCGs across the UK and has taken over the management of three GP practices in Leicester and one in Rugby. The company has also been able to raise its profile by presenting at several SoLSTICE Special Interest Groups (SIGs) and speaking at the Diabetes Innovation Exchange, which is a major regional event hosted by the East Midlands AHSN and managed by Medilink East Midlands. In just three years, the company has grown from 20 employees to over 130. Currently 50,000 patients are engaged with Spirit programmes, but the company wants over 1,000,000 patients to have access to the benefits of their products and services by 2020. www.spirit-health.co.uk

Issue 17

Clinical Need

An integrated approach of changing cultures in clinical governance and patient safety Julie Romano and Daniel Hodgkiss explain how Walsall Healthcare NHS Trust Patient Safety Team managed to shift away from learning solely when things went wrong and towards learning proactively to prevent harm occurring.

n August 2016, Walsall Healthcare NHS Trust launched a pilot of Learning from Excellence and wanted to expand on the use of Safety II initiatives in order to embed a paradigm shift in safety culture throughout the organisation. Hollnagel et al describe Safety-II as: “Safety management should therefore move from ensuring that ‘as few things as possible go wrong’ to ensuring that ‘as many things as possible go right’… it relates to the system’s ability to succeed under varying conditions.” (Hollnagel et al, 2015).

During 2017/18, the Patient Safety team implemented Safety Huddles, Incidents at a Glance, Patient Safety Boards on every ward area, a Family Liaison Role as part of investigations to better support families and more. Another initiative was to develop the organisation’s understanding of Appreciative Inquiry: “Appreciative Inquiry is about the coevolutionary search for the best in people, in their organisations, and the relevant world around them…Appreciative Inquiry, in a central way, is the art and practice of asking questions that strengthens a system’s capacity to apprehend, anticipate and

heighten positive potential.” (Cooperrider and Whitney, 2005). The team began working collaboratively with West Midlands Patient Safety Collaborative (WMPSC) and Appreciating People during 2017/18 to train a number of staff from across the organisation in Appreciative Inquiry methodology. Following the training, the Patient Safety Team has been using the methodology to support the introduction of human factors into investigation and developed ‘Right Cause Analysis’ as a way to inquire further into Learning from Excellence nominations. The ‘Right Cause Analysis’ tool is based around the principles of the 4D model of Appreciative Inquiry. Where ‘Right Cause Analysis’ has been used, it has looked to enhance the initial excellence recognised by developing a plan for how the work can be shared more widely to encourage strength-based improvements to multiple systems. WMPSC shared Walsall’s approach regionally and encouraged the Patient Safety Team to write an abstract for the World Appreciative

Inquiry Conference 2019, as the use of Appreciative Inquiry is limited within healthcare settings and particularly within the UK. Julie Romano and Daniel Hodgkiss represented the team and delivered a 75 minute workshop at the conference in March 2019. There were a number of networking opportunities and the team were sought out by organisations across the world to provide support on the practical use of Appreciative Inquiry to change cultures, especially within healthcare. Walsall’s Patient Safety Team has since provided support to a number of UK based healthcare providers, such as Thames Valley, and presented at the national Infection Prevention and Patient Safety Conference in June 2019. The team has recently been awarded the Patient Safety Award at the Meridian Awards 2019 – a Celebration of Innovation for its ground-breaking programme.

References: Hollnagel E. Wears R.L. and Braithwaite J. (2015). From Safety I to Safety II: A White Paper. The Resilient Health Care Net: Published simultaneously by the University of Southern Denmark, University of Florida, USA, and Macquarie University, Australia. Cooperrider, L. and Whitney, D. (2005). A Positive Revolution in Change: Appreciative Inquiry. Case Western Reserve University and Taos Institute. Accessed: 09th October 2018.

www.walsallhealthcare.nhs.uk

For daily lifescience news visit www.lifescienceindustrynews.com 23

Going Global

Saudi Vision 2030: The opportunities in healthcare Nathan Nagel, CEO of Middle East Medical Portal, provides an insight into opportunities for healthcare and life science companies in Saudi Arabia…

he Kingdom of Saudi Arabia accounts for around half of the GCC’s $1.6trn economy, making it the biggest market in the Arab world and the 19th largest worldwide. Known for its rich oil reserves, the likes of which have allowed Saudi to remain the world’s biggest oil supplier for decades, times are now changing. On a global scale, tumbling oil prices and subsequent OPEC cuts in oil production over the last two years have dealt heavy blows to Saudi’s economy.

Organisation (WHO), Saudi Arabia’s public health sector is ‘overwhelmingly financed, operated and monitored by the Ministry of Health (MoH).’ With 2,390 healthcare centres and 279 hospitals, there are significant needs to be met.

With this in mind, the kingdom is shifting from a dependence on oil by restructuring its economy – including the privatisation of healthcare. According to the World Health

Large-scale issues include a system which needs an overall quality overhaul and a lack of primary healthcare, the latter of which has resulted in over-stretched services at the tertiary level. According to data from the Open Journal of Emergency Medicine, the average waiting time to be seen at a hospital is three hours, with a quarter of patients waiting more than four.

However, the ministry faces an uphill struggle due to an ageing population. The kingdom’s existing healthcare model will be unable to meet the future healthcare needs of its population. Nor is it sustainable on an operational or financial level.

Furthermore, there are the medical challenges: Saudi Arabia has one of the highest rates of obesity worldwide, with some 80 per cent of its population categorised as such according to data from

Issue 17

The Lancet. Provisions will need to be made for the future health complications brought on by an overweight population. Another key challenge is the fragmentation of provision of care, which has resulted in a silo approach to delivery of healthcare services. Saudi health officials also lack data to help them create an accurate picture of outcomes and costs, and gaps within the country’s education system mean there are not enough healthcare graduates entering the workforce. However, changes are being made. In April 2016 the government announced Saudi Vision 2030, an initiative to transform the kingdom’s economy and pull away from a dependence on oil. In the meantime, the Saudi Cabinet also launched the National Transformation Programme 2020 (NTP). Revealed in June 2016, NTP will assess the progress of Vision 2030, of which one of the key focus areas is healthcare. The NTP has an objective of increasing private healthcare expenditure from 25 per cent to 35 per cent of total expenditure by 2020. This represents an annual increase in healthcare revenue from SAR3bn to SAR4bn. In addition, the MoH

plans to spend more than SAR23bn on new initiatives over the next five years, with the NTP having identified the following strategic objectives for the ministry and the Saudi Food and Drug Authority. Innovations in digital healthcare are another key part of Vision 2030, with the MoH aiming for at least 70% of citizens to have unified digital records by 2020. It is also hoped that improvements in IT will strengthen the quality of services offered by healthcare providers. The NTP also places a great deal of emphasis on healthcare education and training, with plans to link up with worldrenowned institutions and increase publicprivate partnerships in order to increase homegrown talent. There is a recognised need for qualified Saudi healthcare practitioners and support staff as healthcare requirements increase. At present the sector is mostly supported by expatriate workers. Saudi Arabia is mostly dependent on imports for its pharmaceutical requirements and there is a need for medicines to be

manufactured locally to ensure a constant and adequate supply. Foreign pharmaceutical manufacturers are being actively encouraged to establish plants in Saudi Arabia through publicprivate partnerships and joint ventures with national entities. Incentives are being offered in the form of preferential treatment in future volume tenders. As an additional incentive, foreign pharmaceutical manufacturers already operating in Saudi Arabia can distribute and sell medicines themselves, whereas imported pharmaceuticals can only be distributed through a local distributor. Currently the majority of medical devices and equipment are manufactured abroad and imported into the country. The Ministry of Health is supporting local manufacturers by partnering multinationals with Saudi companies with the incentive of guaranteed volumes for Ministry of Health purchases and preferential treatment in future volume tenders. Furthermore, foreign owned manufacturers within Saudi Arabia have the additional benefit of being able to distribute

Vision 2030 and the NTP also present major opportunities for foreign companies looking to enter the healthcare market by allowing them the ability to: l

Establish medical facilities

Increase medical insurance

Use local information technology

Receive healthcare education

Access improved training facilities

Provide professional development

Manufacture medicines using local pharmaceuticals

To discuss these opportunities further, please contact Nathan Nagel, CEO of Middle East Medical Portal â&#x20AC;&#x201C; nathan@middleeastmedicalportal.com

and sell medical devices within the country without the need of a local distributor.

www.middleeastmedicalportal.com

For daily lifescience news visit www.lifescienceindustrynews.com 25

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Showcasing UK Life Science Globally BioPartner UK is the independent, accredited trade organisation that promotes international partnering for trade, investment and collaborations with UK life science companies. We work with events organisers, in-country agencies and overseas networks to provide the best discounts and business opportunities for UK companies. We have negotiated exceptional discounts to attend some of the world’s finest quality biopharma partnering events. In collaboration with our alliance partners we manage the UK presence at key overseas conferences.

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Join the BioPartner Programme for significant extra benefits: l Extended deadlines and 30 day payment terms l Reduced costs of attending, exhibiting, presenting potentially up to £3,500 annually per delegate l Contacts and advice to assist your internationalisation l Reduced admin burden - drop us an email and we’ll sort things out l Access to BioPartnerUK Online resource - news channels, messaging, quick event registration l Access to partner discount offers and member rates l Savings and exclusive offers from our Preferred Suppliers

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internationalising UK Life Sciences

Going Global

Africa Health 2019 – showcasing the best of healthcare in the continent Africa Health is celebrating its best ever year of attendance with the continued growth and success of the event. Since its launch 9 years ago, Africa Health has welcomed thousands of professionals from the Middle East North Africa (MENA) region and across the world.

The 2019 exhibition welcomed more than 10,000 visitors and 605 exhibiting organisations from 39 different countries. The surging demand of the event meant that two additional halls were introduced to the exhibition, allowing even more companies to showcase their products and services.

Medilink UK have managed the UK pavilion at Africa Health for 8 years and encourage British healthcare companies to showcase their technology, products and services both at home and internationally. At Africa Health 2019, Medilink UK supported 17 UK-based companies of varying sizes and including those for whom Africa Health was the first step towards exporting, as well as established exporters retuning to Africa Health. Africa Health offers attendees a specific networking opportunity, where a range of

healthcare professionals from Sub-Saharan Africa, such as distributors, suppliers, dealers, manufacturers and clinicians are present. With the appointment of a new Her Majesty’s Trade Commissioner (HMTC) for Africa and support from the Department of International Trade, the region is becoming an important trade partner for UK businesses. In 2016, more than £28 billion worth of goods and services were traded between the UK and Africa.

You can register your interest in Africa Health 2020 by contacting the International Team at Medilink UK at international@medilink.co.uk or calling 0114 232 9292.

Issue 17

Going Global

Bring your business to the MENA region with Medilink UK Arab Health is the biggest healthcare event in the Middle East and North Africa (MENA) region, where you can network with industry professionals from more than 150 countries and increase your international presence. Medilink UK is delighted to organise a British pavilion and help enhance brand exposure of UK companies at this four-day event.

With more than 100,000 visitors, Arab Health creates connections and collaborations between dealers, distributors, clients and clinicians from MENA and other regions of the world.

In 2019, Medilink’s pavilion for Arab Health sold out more quickly than in any other year, so we would urge you to book your 2020 space with Medilink today. Our International Team will assist you through the entire show at Arab Health, providing you with logistical and administration support, as well as travel and accommodation advice. Arab Health provides an exciting opportunity to showcase your products and services to a

global audience, working alongside Medilink’s professional in-market team and functional stand space, to ensure you get the most from the event. Medilink has secured UK Government TAP grants of £2,000, which are subject to availability and eligibility for interested companies.

Johannesburg, South Africa

Dubai, United Arab Emirates

To book your space at Arab Health 2020 and for more information, visit www.medilink.co.uk/events/arab-health-2020

For daily lifescience news visit www.lifescienceindustrynews.com 29

Going Global

ABHI US Accelerator enters next phase Paul Benton, Managing Director, International, ABHI

ne of ABHIâ&#x20AC;&#x2122;s core roles is to provide the right environment for UK businesses to connect with new customers around the world. In recent years, we have focused much of our activity on supporting UK companies enter and grow in the US, through the dedicated ABHI US Accelerator programme. I am delighted, therefore, to announce its expansion. Building on the significant network we have developed in Texas, the ABHI US Accelerator is now a national offering, enabling deep connections to the network of institutions and hospital groups we have developed across the US. Currently, 16 companies are taking advantage of this offer - its platform having led to over 25 research projects and new business generated for UK industry. Our enhanced offer connects UK businesses to a host of in-market specialists, designed to guide companies on critical issues, such as regulation, reimbursement

Issue 17

and technology appraisal. The programme also facilitates introductions to hospital executives, clinical champions and supply chain leaders, allowing companies to liaise directly with decision-makers to build evidence and support adoption. Participating companies have full use of ABHIâ&#x20AC;&#x2122;s dedicated workspace and office at the Dell Medical in Austin, with access to their facilities and the support of senior faculty. ABHI US Accelerator members will also now benefit from a nationwide mission programme, delivering more personal and lasting ties with the networks we have cultivated over the years. There are 30 places available for the 2020 cohort, with applications now open. More information is available at www.abhi.org.uk or you can contact me directly for an informal discussion on the opportunity: paul.benton@abhi.org.uk

Going Global

THE BENEFITS OF JOINING ABHI ABHI is the UK’s leading health technology trade association. With over 300 Members, ABHI supports the HealthTech community to save and enhance lives. Join us for a host of benefits, including:

1. Engagement and representation ABHI strengthens the relationships between industry, the NHS and government to enable a collaborative network, with Members able to shape our interactions.

2. Insight and Intelligence riefings, meetings, webinars, and conferences provide up to date intelligence, market B analysis and guidance of the sector’s principles, ethics and best practice.

3. Networking opportunities embers benefit from engagement with a highly developed network of leaders, regulators, M policy makers and fellow companies.

4. Global reach hrough dedicated trade missions, presence at the world’s largest HealthTech exhibitions T and the ABHI US Accelerator, we help our Members establish links to support their growth outside the UK.

5. Expertise in regulation and policy matters e work with regulatory authorities to define and establish regulatory frameworks that W are fit for purpose in the changing HealthTech environment. Members benefit from monthly regulatory intelligence updates, so they can stay up to date with, and anticipate, regulatory changes.

Interested in joining ABHI? Ask a member of staff at the ABHI information desk, or contact angela.jeffery@abhi.org.uk

www.abhi.org.uk For daily lifescience news visit www.lifescienceindustrynews.com 31

People and Places

Health economics consultancy launches new global HQ BresMed’s new global HQ at Steel City House in Sheffield is the heart of the company’s worldwide operation. Commenting on the move, CEO Nic Brereton said: “I am so proud to be expanding BresMed to these premium premises in the city. The building very much fits with our brand – it’s iconic with a quirky feel and, like us, it dares to be different.” The company has come a long way since Nic moved into a one-person office in the city many years ago, adding: “Actually, it was more a cupboard! However, it helped me launch the business.” BresMed supports pharmaceutical companies and medical device manufacturers to identify, evaluate and demonstrate the clinical and economic value of their products to governments and other healthcare payers and providers. From 2014 to 2017, a significant period of expansion saw employee numbers increase and offices open worldwide. Further office space was taken at North Church House until the decision was taken last year to begin the transition to Steel City House.

In July, employees joined health economics experts and business leaders at the grand opening. A tour of the premises followed a welcome speech from the Nic: “This is a vibrant working environment and we are absolutely delighted with how it looks.” BresMed’s bond with Sheffield is clear when you see meeting rooms named after Sheffield icons such as Ennis, Jarvis and Hendos. The new head office is set up to allow great IT connectivity with the company’s other sites in Dublin, Manchester, Gurugram, Utrecht and Las Vegas. This includes strong links with the University of Sheffield, including BresMed Chairman Ron Akehurst, described by Brereton as the ‘Godfather of Health Economics’, and also the founding Head of ScHARR – the School of Health and Related Research at the University of Sheffield. Many of BresMed’s employees hold degrees from the University of Sheffield or worked there prior to joining the company.

“The move to Steel City House signals an exciting time for BresMed’s continued growth, and we are now a major part of a global industry that helps ensure the cost effectiveness of healthcare. Billions are spent worldwide on healthcare and health products. We understand and continue to study the economics of the process from laboratory to patient, providing governments and insurers with robust data to help them make lifechanging funding decisions.” Ron Akehurst BresMed Chairman

www.bresmed.com

Issue 17

People and Places

Assistive technology improves the eating experience The Neater Eater was originally designed over 25 years ago to reduce essential tremor when eating for people with Ataxia. The viscous damping, combined with spring loading, absorbs essential tremor and other uncontrolled movements in the arms. The user holds onto the arm of the eating machine, which acts as an interface to their food with a self-levelling spoon and rotating plate.

he system is suitable for people with Athetoid Cerebral Palsy, Huntington’s Chorea, Friedrichs Ataxia, Parkinson’s Disease and intention tremors associated with Multiple Sclerosis. It has also evolved over the years to cater for users with weakness, and its modular design has additional components and reduced damping to make it suitable for users with Arthritis, Stroke and Muscular Dystrophy.

New features of the Neater Eater include: l Adjustable fluid damping to enable unit to adapt from strong tremors to very weak users l Forward and back stops can be enabled as standard l Spoon self-levelling mechanism now has mouth level raising function l New modern appearance and ultra slim baseboard l Easy access adjustments for spoon height and speed

Jon Michaelis started Michaelis Engineering in 1986 to commercialise the Neater Eater system and formed a new company, Neater Solutions Ltd, to carry things forward in 1998. Neater Solutions has continued developing and supplying assistive technology since then – particularly eating and drinking equipment, but also wheelchair add-ons and other innovations.

The company recently decided to create a new and improved Neater Eater. To optimise movements such as food scooping, spoon wiping and smooth straight-line movement of the spoon into the user’s mouth, the firmware required development. Further firmware changes were needed to manage charging of the robot battery and the tablet used by the operator to control it, as well as to store relevant data about the robot setup and movements on the robot’s electronic hardware. With this aim in mind, Neater Solutions approached Medilink East Midlands for support and was awarded a £3,088 grant through the INSTILS programme, part-funded by the European Regional Development Fund. www.neater.co.uk

For daily lifescience news visit www.lifescienceindustrynews.com 33

People and Places

Hooray for HIP Developing an idea into an NHS-ready product can be a daunting proposition. Thousands of innovators every year attempt to navigate the NHS business landscape but find it a difficult process. This is why some of the Academic Health Science Networks (AHSNs) came together with SETsquared in 2014 to create the Health Innovation Programme (HIP). It is now in its fifth year and continuing to support innovators across the South of England, from Kent to Cornwall.

he training programme, created in partnership with SETsquared, the global no.1 university business incubator, specifically addresses the needs of healthcare innovators and covers core skills in entrepreneurship. It’s an intensive, fully-funded, fourday personal development course that helps entrepreneurs across the South of England to develop business propositions with real potential for health and care.

During the bootcamp delegates build their skills in many aspects of entrepreneurship, from market analysis to funding strategies.

Issue 17

To help navigate this complex sector, they also benefit from tailored health and life science sector specific modules, such as the NHS as a market place, health economics, regulatory standards, and collecting and evaluating evidence. The course provides an opportunity to make a compelling pitch to an experienced panel (think Dragons’ Den!) and is a supportive and friendly environment to network with like-minded innovators and try out ideas.

Lucy Hadley, Director of the Development People, attended the West of England AHSN HIP. She commented: “I have found the structured and practical approach to reviewing our business idea invaluable. As a business we are now clear about what we need (and don’t need!) which means we have clarity, focus and energy to move forward! I enjoyed meeting others in similar positions and sharing our learnings and ideas. The environment of the course is supportive and fun.”

Since 2014, 84 innovators have been through HIP in the West of England alone. This includes delegates from member NHS trusts and universities.

Rebecca Porter, Managing Director of BlueKit Medical, was one of the 12 entrepreneurs at a recent HIP run by Kent, Surrey and Sussex AHSN. Her company provides a range of Single-Use Procedure Packs. She explained:

People and Places

“We’re at a stage now where we want to get ourselves in front of investors so having that time and preparation to make a good pitch is fantastic, and the speed mentoring and feedback on the presentations and pitches was priceless.” Kate Phillips, Business Development Advisor and co-ordinator of the West of England AHSN HIP programme, says: “We are always looking to support innovative healthcare ideas. This could be a product or service already in development or simply the germ of an idea, but the concept must be realisable into a sustainable business model/proposition and you will need to be genuinely passionate about taking your proposition forward. We’ve some amazing ideas come through our course over the years, and it’s great to see some them flourishing.”

“A very useful start, trying to put some order to the tangled plate of start-up spaghetti!” Matthew Burnford Director, Response Associates Attended the West of England AHSN HIP

“I was in a unique position on the Health Innovation Programme, as I had a more fully developed business proposition compared to other participants. That didn’t matter though – it was still a really valuable programme which provided a helpful insight into the NHS and the way in which it commissions services. Understanding the complexities of commissioning, accepting the complexity and working out how we can work with it, focusing in on customer needs and the importance of getting our processes right so our early adopters receive a really positive experience. I would advise other healthcare entrepreneurs to access all the support available to them. You’ll need to persevere, dig deep and believe in what you’re doing but be prepared to take feedback. It’s important to sense check what you’re doing to ensure you don’t go off on tangents. There’s no easy, quick route but the Health Innovation Programme will put you on the right track.” Amy Manning Managing Director, S12 Solutions Attended the Wessex AHSN HIP Amy is now an NHS Innovation Accelerator (NIA) Fellow and on the Innovation Technology Payment (ITP)

Case study Who? Chen Mao Davies, Director of Latch Aid Ltd, HIP Delegate 2018 What? LatchAid is a breastfeeding app that utilises interactive 3D technology and virtual breastfeeding support groups to help mothers learn breastfeeding skills and connect with others for peer-to-peer and expert support anywhere and anytime.

Why? Chen is a mother of two and had first-hand experience as a once-struggling

but later successful breastfeeding mother. Her personal experience motivated her to develop the LatchAid app to help other mothers to succeed in breastfeeding. Chen holds a PhD in Computer Graphics and has 15 years software R&D experience, working for the last eight years on visual effects for blockbuster movies, including the Oscar-winning Gravity and Blade Runner 2049. Applying her industry expertise in the Visual Effects industry, she founded LatchAid and started to develop the LatchAid app whilst on maternity leave. Her daughter also attended HIP and set the record for the youngest age of a delegate at four months old! Chen commented: “The Health Innovation Programme is amazing! It’s packed with practical lectures, workshops and discussions, and ends with a pitching day to a panel of experts. It brought great opportunities to meet other inspiring healthcare entrepreneurs and business advisors and to get valuable feedback on the start-up business for future development. “We have benefited so much from HIP and the association with West of England AHSN since last year for training, networking, grant applications and business development. We would recommend HIP and the West of England AHSN to anyone and couldn’t appreciate enough their support!”

The West of England AHSN, Wessex AHSN, South West AHSN and Kent, Surrey and Sussex AHSN all continue to run Health Innovation Programmes in partnership with SETsquared. Visit www.setsquared.co.uk/support-programmes for upcoming opportunities.

For daily lifescience news visit www.lifescienceindustrynews.com 35

People and Places

MedCity: Five years on This year MedCity celebrates its fifth anniversary. In April 2014, the Mayor of London launched MedCity at Imperial College London. Founded by the Academic Health Science Centres of the region, MedCity’s aim was to stimulate collaboration across the life sciences sector and, through this, drive economic growth.

nderstandably it was met with a mixed response. At one level, there was excitement that there was a commitment both politically and financially to support the sector in London and the Greater South East. At another level, there were questions about how this would be practically implemented and what MedCity would actually ‘look like’. Most reports in the press at the time, which included The Guardian, The Telegraph, New Scientist and Forbes, celebrated MedCity’s launch but also took a ‘wait-and-see’ approach.

Our support of companies, the ‘front door’ and insight to the region’s strengths: Since MedCity began, we have worked with over 1,000 companies and organisations who have been looking for insight into one

or several aspects of the life sciences sector, whether that be investment, manufacturing, clinical trials, real estate or a means to partner. No two requests are ever the same, and for some it is a one-off conversation, whilst for others we have developed a deeper relationship and helped at various points along the company’s development. Over a third of these companies and organisations have been from outside the UK. MedCity has attended or led delegations to BioJapan and Bio International Convention in the US every year and, on average, we are involved in about 60 life sciences events a year. Based on conversations with stakeholders, we have published eight reports on the state of different aspects of the sector including digital

So, after five years of development and growth, we are able to answer some of those questions…

April: Launch of MedCity at Imperial College London

Jan: First ‘Future of Healthcare Investor Forum’ with London Stock Exchange

Feb: Launch of DigitalHealth.London – MedCity is one of the founding partners

June: First MedCity delegation at Bio International Convention US

July: MedCity’s ‘London Life Sciences in focus’ report launched at City Hall

June: First MedCity event at London Tech Week

Sept: First £2 million funding raised through Angels in MedCity

Feb: Launch of MedCity’s ‘Collaborate to Innovate’ programme to bring together academics and SMEs to work on research projects

Oct: Launch of Angels in MedCity programme

Oct: First MedCity delegation to BioJapan and launch of MedCity’s ‘Cell and gene therapy in London, Oxford and Cambridge’ report

April: Publication of MedCity’s ‘Planning for Growth – Demand for healthcare R&D space in London’ report. July: First cohort selected to join DigitalHealth. London Accelerator Oct: Publication of MedCity’s ‘A Digital health hub: Discover Cambridge, London and Oxford for digital health’ report

2014 36

2015 Issue 17

2016

health, cell and gene therapies, medtech and neuroscience. Alongside this we have produced cross-cutting analyses looking into investment and life sciences space in the region. Over the last five years, we have listened to the needs of the UK’s life sciences ecosystem and helped develop means to overcome some of the current challenges to health innovation. One key example of this is our work on the development of the evidence standards framework with NICE, NHS England, Public Health England and DigitalHealth.London, which has provided standards for companies working with digital health technologies who are looking to demonstrate their effectiveness to the NHS.

Developing vehicles for successful connections, collaborations and growth: We have launched three programmes that work across academia, industry and the NHS. Since we started our Angels in MedCity programme in 2015, we have had 77 companies pitch at our events which has helped secure them a total of £5.6 million of angel

Feb: First showcase event of NIHR Biomedical Research Centres in the region, organised by MedCity. Publication of ‘Accessing research and clinical expertise in London and the South East’ report. March: Announcement of fifteen Collaborate to Innovate projects April: Publication of MedCity’s ‘Neuroscience Network’ report October: Business Minister, Lord Prior, joins MedCity delegation to BioJapan

investment. Still in its early years, another of our programmes, Collaborate to Innovate, has created 15 successful partnerships between life science SMEs and academic research groups, and there will be two more cohorts announced soon, working in advanced therapies and stroke research. Launched in 2018 as part of the London Advanced Therapies initiatives and delivered by MedCity, the Advanced Therapies Network has over 480 members across industry, academia and the NHS, and we have run three events covering subjects such as clinical trials, investment and reimbursement. There are more figures we could provide but probably none of them give a real insight into the nature of our work. The business of connecting and catalysing is not easy to measure and over the years of collecting data on our impact we recognise that the real body of our work lies in the encounters at our events, the links made between people with common visions and the sharing of knowledge. It is this that forms the basis of the life sciences ‘community’ we are building. Looking to the future, MedCity plans to keep connecting this community. Exciting shifts are happening to bring academia, industry and the NHS closer together both in terms of physical location and the nature of their work. The White City zone and King’s Cross Knowledge

MedCity’s programmes will continue to bring together the right people in the right place to produce real investments, real partnerships and real impact for the sector and region. Alongside this we are also working with other life sciences hubs and organisations including Northern Health Science Alliance (NHSA), MediWales, Life Sciences Hub Wales and the newly founded HIRANI (Health Innovation Research Alliance Northern Ireland) to ensure we are as connected as possible to attract and support foreign investment, which was one of MedCity’s founding aspirations. Five years on, we are providing answers to some of the questions raised and have become an organisation with which international clusters want to collaborate. There certainly has been no shortage of political, social and technological changes that have happened during this time, which has meant that MedCity’s work has become even more important in providing an open door to the region. Indeed the sustained interest in life sciences within our region and the UK demonstrates the commitment to this sector and the enduring value that life sciences hold for patients, the economy and society. We’re looking forward to the next five years!

Jan: Publication of MedCity’s ‘The Genomics Revolution’ report

Jan: First Advanced Therapies Network (ATN) event

Jan: MedCity becomes supporter of NHS England Clinical Entrepreneur training programme

Feb: London Advanced Therapies and MedCity open a round of Collaborate to Innovate for advanced therapies

March: Launch of MedCity’s ‘Accessing Cell and Gene Therapy Research Expertise’ report

March: MedCity awarded innovator and start-up visa endorsement role for life sciences

March: First Mayor of London Medtech awards, MedCity is a partner Nov: London Advanced Therapies launch Advanced Therapies Network, with MedCity as the delivery partner Dec: NICE publish evidence standards for digital health technologies, MedCity is on the working group

2017

Quarter in London, the Babraham Research Campus in Cambridge and Harwell Healthtec Cluster in Oxford are shining examples of this. We have been at the forefront of this development and plan to keep working to ensure these life sciences hubs deliver innovative and collaborative work.

2018

April: MedCity meets its 1000th client through its front door service since its launch in 2014 July: Together with Stroke Association, MedCity opens a round of Collaborate to Innovate for medical devices and digital health therapeutics for stroke

2019 For daily lifescience news visit www.lifescienceindustrynews.com 37

Regulatory

ABHI leadership strengthened with digital health at the forefront of priorities

Digital health is now at the forefront of the UK’s largest HealthTech trade body’s priorities. In a move that will support its growing digital membership base, as well as its current members who are entering the market, ABHI is undergoing a programme of engagement to ensure health systems are equipped to adopt these new technologies safely.

ed by ABHI’s senior Director Andrew Davies, the Association is utilising its long-standing market access and regulatory expertise to help shape a patient-focused digital policy agenda in the UK. The work will sit alongside Regulation, Brexit and Procurement in the list of ABHI’s top priorities, with the Association also strengthening its offer to the SME community.

regards to the UK’s ability to adopt these new technologies and services.

This proactive step follows ABHI’s 2017 decision to rebrand the Association, acknowledging the convergence of the health and technology sectors, and how such products and services improve health, rather than just treat disease.

ABHI Digital Lead, Andrew Davies said: “Digital technologies have the ability to support a more efficient and effective health system, with significant benefits to patient care. Access to well curated data sets is critical for industry to apply their skills, knowledge and resources, unleashing the potential low of life saving and enhancing innovations. We are therefore working with the NHS, and the health system more broadly, to develop the necessary security, regulatory and ethical infrastructure that will enable the development and adoption of such innovations.”

With over 11,000 people in the UK working in digital health, the sub-sector is now the largest employer within HealthTech, with 59 per cent of companies in the space forming within the past 10 years. In response, ABHI has convened a dedicated Digital Health Policy Group for its members to jointly develop industry’s position as

In a further boost to its leadership function, ABHI have hired the former Senior Government Affairs and Public Policy Manager of Baxter Healthcare, Luella Trickett, in the role of Director, Value & Access. Trickett will lead on embedding value based practices across patient pathways. The additional capacity will also

enable ABHI to drive forward a compelling strategy on diagnostics.

“Supporting the system to bring about the right changes that recognise and reward whole system value is fundamental. This is true for established technologies, as it is for new digitally-enabled products and services. As a long-time supporter and contributor to ABHI’s work, I look forward to driving forward the strategic agenda of the Association and working alongside the members we represent.” Luella Trickett Senior Government Affairs and Public Policy Manager Baxter Healthcare

www.abhi.org.uk

Issue 17 www.abhi.org.uk

Regulatory

New EU Medical Device Regulation (MDR) – Your questions answered Patrick Trotter, Head of Innovation and Commercialisation, Medilink North of England

he regulatory challenges facing health technology companies are unprecedented, with the new more onerous Medical Device Regulation (MDR) coming into force on the 26th May 2020, a significant reduction in the capacity of Notified Bodies to undertake audits and the changing Deal / No Deal Brexit regulatory scenarios all occurring simultaneously and adding complexity. Given that companies are becoming increasingly confused as to where they stand, we have put together a guide with a few answers to the common questions that we are asked:

Question: What is my position if I have a current CE Mark?

Question: I am due to launch a new product before 26th May 2020. Should I be MDD compliant or MDR compliant? Answer: Legally you only need to be MDD compliant, but it is best practice to be MDR compliant and have your device certified according to the MDR.

Question: We have a problem identifying a notified body for MDR. What do I do?

Answer: For products placed on the market before 26th May 2020, they can be legally marketed in the EU until their certificate runs out or up until 26th May 2024 when devices will need to comply with the MDR (irrespective of when they were placed on the market).

Answer: Don’t panic, there are companies that have applied for notified body status but haven’t yet been approved who will be coming into the market, and although there is a bottle neck, this should not be the case for long.

Question: We have LRQA as our Notified Body. My products have a CE certificate that expires after the 90-day notice period given by LRQA. Can I continue to sell my product?

Given that the new EU Medical Device Regulation will place additional requirements on your company (e.g. additional clinical evidence requirement) and that to get a slot for an audit will probably take much longer, it has never been more important to get it right first time. To fail an audit, and in particular have a clinical evaluation report rejected (now one of the most common non-compliance areas), would mean significantly longer delays in securing a repeat audit and substantial remediation costs.

Answer: You may be able to, but only with the express permission of the MHRA. You must write to the MHRA explaining your orphaned manufacturer status and you may then be offered a letter of support and grace period allowing you to continue to sell your products for a specified amount of time. The offer is also conditional on your organisation continuing to look for a notified body during this time

Question: My product has a CE mark but it expires before May 2020. What should I do?

Question: My CE certificate expires after 25th May 2020. When do I need become compliant with the MDR?

Answer: In this scenario you cannot legally sell your products until the certificate is recertified. However, you should contact MHRA, as there are examples where MHRA have granted certification until the end of September 2020, providing the company can demonstrate that they are actively looking for a notified body.

Answer: You need to get your products certified under the MDR when your current certificate runs out or by the 26th May 2024, whichever is sooner. Don’t wait until then to get your documentation sorted out - start now and if you don’t have a notified body find one soon.

Medilink UK is working with Innovate UK and ISO Life Sciences Ltd to produce a survey which will provide UK SMEs with the opportunity to give input, to help inform decision making processes within the UK Government Agencies regarding specific problems and support needs associated with the implementation of the MDR. To participate, you can find the survey, which will take no more than 10 minutes to complete, at www.surveymonkey.co.uk/r/ InnovateUKMDRsurveyon We would urge you to have your say.

www.medilink.co.uk

For daily lifescience news visit www.lifescienceindustrynews.com 39

DISCOVERING HEALTH TECHNOLOGY

Now taking ﬂight online ... November

November

Bio-Europe Hamburg, Germany

Northern Powerhouse Trade Mission to Medica Dusseldorf, Germany

November

UK Healthtech Cardiff, UK

December

Discover the latest life science news online 11-13 17-21 18-21

Medica Dusseldorf, Germany

November

SEHTA: EU MDR IVD Workshop London, UK

MediWales Innovation Awards Cardiff, UK

December

Medilink East Midlands Awards Derby, UK

January

Northern Powerhouse Trade Mission to Arab Health Dubai, UAE

March

Bio-Europe Spring Paris, France

from the only magazine dedicated to the UK’s life science sector

With contributions from leading membership and support organisations working with life science businesses, academia and healthcare providers from across the UK and beyond. December

2-6

ABHI Trade Mission to Texas Texas, USA

December

www.lifescienceindustrynews.com For editorial and advertising opportunities: January

13-15

Biotech

January

23-24

Showcase +44 (0)29 20473456 San Francisco, USA

Health Hack -

January

27-30

Arab Health

North Wales Dubai, UAE info@lifescienceindustrynews.com Anglesey, UK

27-30

Written by PROMOTIONAL the sector, for the sector OPPORTUNITIES WITH LIFESCIENCE INDUSTRY www.lifescienceindustrynews.com

February

13 40

Medilink West Midlands Awards Birmingham, UK

March

Issue 17

MediWales/One Nucleus: Wales Life Science Showcase London

March

19-22

KIMES Seoul, South Korea

23-25

Event calendar 2019-20

November

ECHAlliance 5 Nations MultiEcosystem Gathering Cardiff, UK

November

BIA 16th Annual bioProcessUK Conference Liverpool, UK

November

Medilink West Midlands: Getting AI Right Birmingham, UK

December

BioFIT 2019 Marseille, France

December

One Nucleus: Genesis London, UK

December

SEHTA: Commercialisation Foundation for Healthcare Workshop London, UK

January

Bridging the Gap Midlands Leicester, UK

February

Medilink South West Awards Bristol, UK

February

SEHTA 2020 MedTech Business Awards London, UK

February

Medilink North of England Healthcare Business Awards Manchester, UK

March

Tomorrowâ&#x20AC;&#x2122;s Health Llandudno, UK

March

SEHTA International MedTech Expo & Conference London, UK

April

Medilink UK Business Awards Birmingham, UK

April

Med-Tech Innovation Expo Birmingham, UK

27-28

10-11

25-26

27-28

November

28-29

January

1-2

Wales Cancer Innovation Challenge Cardiff, UK

Health Technology Wales and MediWales - Industry Engagement Cardiff, UK

For daily lifescience news visit www.lifescienceindustrynews.com 41

DECEMBER 4th 2019

EXHIBITION

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FINANCE LT H T

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Regulatory updates

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Investor workshops

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Finance and funding seminars

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Support for spin out and early stage companies

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NHS access and innovation talks

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Innovation in healthcare technologies

Join delegates to network, meet collaborative partners and build business development opportunities. Listen to a programme of valuable sector updates and gain insights and intelligence across the life science and healthcare sectors.

WORKSHOPS

UK HealthTech brings together key speakers to discuss the major strategic issues and policy developments facing the life science and health technology sector.

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PARK PLAZA

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CARDIFF

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WHAT WE DO The Interim Export Resource service benefits include, but are not limited to: • Research and creation of a market entry strategy • Prospect and initiate new relationships internationally • Expedite ongoing negotiations to get you to market quicker • Up-skilling of existing staff and support for evolving businesses • Interim resource to cover leave of absences, ensuring your export strategy stays on track • Staffing at events locally or internationally without hampering your day-to-day business

Contact our International Team for more information: international@medilink.co.uk / 0114 232 9292 / @MedilinkINT

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National & Regional Partners

Medilink East Midlands BioCity Nottingham Pennyfoot Street Nottingham NG1 1GF Tel: +44 (0)115 822 3154 www.medilinkem.com

Medilink West Midlands 4 Greenfield Crescent Edgbaston Birmingham B15 3BE Tel: +44 (0)121 452 5630 www.medilinkwm.co.uk

Medilink North of England Hydra House Hydra Business Park Nether Lane Sheffield S35 9ZX Tel: +44 (0)114 232 9292 www.medilink.co.uk

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Workplace Churchgate House 56 Oxford Street Manchester M16EU Tel: +44 (0)7734 383 407

South East Health Technologies Alliance Lancaster’s West End Lane Henfield West Sussex BN5 9RB Tel: +44 (0)7905 201857 www.sehta.co.uk

Medilink South West c/o Institute of Bio-Sensing Technology University of the West of England Coldharbour Lane Bristol BS16 1QY 46 www.medilinksw.co.uk

BioPartner UK 16 Old Queen Street London SW1H 9HP Tel: +44 (0)20 7193 7815 www.biopartner.co.uk

Life Sciences Hub Wales 3 Assembly Square Cardiff CF10 4PL Tel: +44 (0)29 2046 7030 www.lshubwales.com

ABHI 107 Gray’s Inn Road London WC1X 8TZ Tel: +44 (0)20 7960 4360 www.abhi.org.uk

MedCity 4 Christopher St London EC2A 2BS Tel: +44 (0)20 3179 8100 www.medcityhq.com

Edgbaston Medical Quarter Calthorpe Estates 76 Hagley Road Edgbaston Birmingham B16 8LU Tel: +44 (0)121 248 7676 www.emq.org.uk

West of England Academic Health Science Network South Plaza Marlborough Street Bristol BS1 3NX Future Space UWE North Gate Filton Road Stoke Gifford Bristol BS34 8RB Te: +44 (0)117 900 2604 www.weahsn.net