Lifescience Industry Magazine Issue 18

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Issue 18 2020

DISCOVERING HEALTH TECHNOLOGY

Impact of Covid-19 on supply chains Practical considerations for businesses to consider

Future Watch

Clinical Need

Going Global

People & Places

Regulatory

New technology and innovations

Meeting unmet clinical needs

Cracking international markets

Inuential people and places in the industry

Updates and expert 1 advice


When you work to keep customers happy. When you solve their most demanding problems. When you deliver rock-solid support. People notice. We make software to solve critical interoperability, scalability, and speed problems. And we’ve been recognised by all the top analysts – as well as our customers – for providing exceptional value. It’s rewarding for us. But our customers’ success is the greatest reward. InterSystems.com/Analyst

© 2020 InterSystems Corporation. All rights reserved. InterSystems is a registered trademark of InterSystems Corporation.


4-6

The impact of Covid-19 on supply chains Practical considerations for businesses to consider

10-11

VR provides distraction therapy for patients

15

Finding the key to detecting antibiotic resistant bacteria

Telehealth with a human touch

26

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

A message from the editor Welcome to Lifescience Industry magazine

novel technologies in the fields of anaesthesia, wound treatment, surgical endoscopy and regenerative therapy, while Going Global includes expert advice on the MDSAP.

This edition begins with a look at the impact of Covid-19 on supply chains, offering some practical considerations for businesses to take into account .

have received significant investment. Finally, the Regulatory section includes tips on IP protection for medical devices.

The People & Places section puts a spotlight on a new CEO for Medilink UK, as well as an award-winning entrepreneur, and Money features two life sciences companies that

The Future Watch section explores innovative uses of VR, smart textiles, AI and digital platforms in healthcare and life sciences. Clinical Need features

Sophie Davies Editor

Future Watch

Clinical Need

Going Global

10 VR provides distraction therapy

22 Bringing innovation to anaesthesia 23 Advanced dressing technology

32 International success for

for patients 12 Transforming healthcare with smart textiles 13 Award-winning team develops air quality sensor 14 Digital platform bridges the gap between social care and healthcare 15 Finding the key to detecting antibiotic resistant bacteria 16 A silver lining around a very dark cloud 17 ABHI leads Chief Innovation Officer call 18 ABHI: The data debate their patients

21 A new healthcare paradigm: Using AI in the nervous system to manage chronic conditions

digital behaviour platform 2012 ISSUE 4

combats wound biofilm

Issue 5

24 Development of flexible optical

33 International platform for UK medical companies at Arab Health 2020

occluder

25 Innovative technology improves

CEO

36 Business award for

Loughborough entrepreneur

37 Awards celebrate the success

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sint occaecat cupidatat non proident, sunt in culpa qui officia 29 Improving health through digitalExcepteur deserunt mollit anim id est laborum. Regulatory connected care Lorem ipsum dolor sit amet, consectetur adipisicing elit, sed do eiusmod tempor incididunt ut labore et dolore5 magna aliqua. Ut enim ad minim 40 Top tips for medical device IP protection 30 Making medicines more secure in

the NHS

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41 MDR: the importance of the Clinical Evaluation Report

Published by Teamworks. www.teamworksdesign.com For editorial and advertising opportunities please contact: Editor: Sophie Davies, editor@lifescienceindustrynews.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. 2020

Supported by

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The views expressed in this publication do not necessarily represent the opinions of individual Medilink UK members unless explicitly stated. © MediWales Ltd. 2012

DISCOVERING HEALTH TECHNOLOGY

35 Medilink UK appoints new

of healthcare organisations across the North of England medical device innovation consectetur adipisicing elit, sed do 26 Telehealth with a human touch eiusmod tempor incididunt ut dolore magna aliqua. Ut 27 Regenerative therapy for sight- labore etMoney enim ad ullamcoin eu destroying conditions 38 Investment boost for nanoparticle manufacturer 28 Innovative toolJess to increase Fisher Editor orem ipsum dolor sit amet, consectetur adipisicing elit, sed do 39 Spin-out offering new hope for dialysis collaboration between tissue eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris sample providers and researchersnisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in

34 Why MDSAP is a driver of Lorem ipsum dolor sit amet,

patient outcomes

20 Speech therapy apps to help clinicians and

People & Places

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www.medilinkuk.com


The impact of Covid-19 on supply chains Businesses have experienced these effects since the earliest cases of the virus in Wuhan, as China is so integral to supply chains across the world. On 17 March 2020, the United Nations estimated that the world economy would decline by 2 per cent as a direct result of Covid-19, costing it $1 trillion. This is thought to be a conservative estimate.

Covid-19 is affecting global supply chains and having an impact on all aspects of international trade. Lorna Bolton from Greenaway Scott shares some practical considerations for businesses to consider.

The UK Government has introduced the emergency Coronavirus Bill, and businesses should make themselves aware of how this will affect trade in the coming months until the end of this pandemic is in sight. Importers and exporters, both for goods and services, should be thinking about what pro-active steps they can take to mitigate the impact of the virus on their business.

Some steps that businesses should consider taking to mitigate the impact of Covid-19 on their supply chains:

Suppliers

Customers

Now

Future

Now

l Are there key suppliers that the business is reliant on?

l Is there an over-reliance on one or a few suppliers?

l Can customers in the UK, Europe or globally take delivery of the goods?

l Are they based overseas and has their status been verified?

l Are they still operating/ have they survived the human and economic impact of the virus?

l Does your business provide products that are component parts of critical or lifesaving goods?

l Is there an alternative source of supply, either internationally or within the UK? l Is there an adequate access to warehouses?

l Ensure as far as possible a range/ breadth of suppliers to avoid key dependencies

l Avoid dependency on key customers

l Consider the benefits and risks of consolidated centres of production

l How can communication systems with customers be updated?

Future

l Has there, or does there need to be, a shift in focus of your customer base? 4

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Stakeholders Now l Check with freight forwarders with respect to freight availability and delivery slots

Future l If not already in place, ensure access to track and trace technology to enable visibility of the supply chain

Employees Future

Now l Ensure employees have access to e-systems to enable documentation such as commercial invoices to be produced

l Take this time to get your house in order

and make sure employees are adequately trained and educated in trade and customs, contingency plans and special procedures

l Do employees have proper relationships with external providers for trade documentation and customs declarations?

l Avoid over-reliance on one or select

l Are all parts of the organisation connected - for example finance, trade compliance, procurement and sales?

l Identify internal gaps between departments

l Consider the need to furlough employees in parts of the business that are not currently being utilised to retain and protect the workforce and assist with cashflow for the business

employees for trade and customs knowledge

and make sure these are addressed and covered. Do internal communications procedures need to be updated?

For daily lifescience news visit www.lifescienceindustrynews.com 5


Ocean and Air Freight Impacts Whilst freight and supply chains from China are restarting, the rest of world is now being impacted as the virus has gradually spread and nationwide lockdowns are being ordered. Freight and vessels are still moving, with capacity, but can be subject to cancellations. Ocean freight is still moving around the English Channel and mega vessels are not making as many port calls as they otherwise would. Where vessels have successfully ported, they may remain inactive for extended periods of time due the unavailability of personnel to accept delivery and move freight for onward transmission. There has been a move from passenger aircraft to freight-only aircraft. Air freight rates have generally been increasing from around $1.50-4.50 per kg to $6-7 per kg, but these rates are dependent on territory.

Guidance: l Businesses should make use where possible of track and trace technology to see where their goods are at all times and plan in advance of cancellations. Arrangements and back-up plans should be made for the onward transmission of goods to get them to their destination. Businesses should also consider country-specific port requirements in light of the virus and see if their goods are on affected vessels. l It is important for importers and exporters to check the goods’ airport of arrival and departure to see if rates have changed, there have been cancellations or any other effects of the virus on the relevant air freight.

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Medical and Protective Equipment Some countries have implemented national controls to restrict the export of medicines and medical equipment, such as face masks, gloves and protective clothing. The EU Commission has discouraged Member States from adopting measures which would limit intra-EU trade, although it has introduced a temporary export ban on exports of certain medical protective equipment to destinations outside the EU.

Guidance: l If your business provides medical or protective equipment, consider where the customers are based and whether or not there is a temporary ban on exports of certain medical protective equipment. l The World Customs Organisation has advised exercising extreme caution when purchasing critical medical supplies from unknown sources, particularly online.


Our vision is to make Wales the place of choice for health, care and wellbeing innovation

Ein gweledigaeth yw i wneud Cymru y le o ddewis ar gyfer arloesedd ym meysydd iechyd, gofal a llesiant

Our mission is to accelerate the development and adoption of innovative solutions for better health and wellbeing.

Ein cenhadaeth yw cyflymu datblygiad a’r defnydd o atebion arloesol ar gyfer iechyd a llesiant gwell.

We inspire collaboration to drive innovative healthcare solutions. We support the life sciences industry, working with partners in health and social care, industry and academia, to identify, nurture and grow ways to make a positive difference to the wellbeing of patients.

Rydym yn ysbrydoli cydweithrediad er mwyn llywio atebion gofal iechyd arloesol. Rydym yn cefnogi’r diwydiant gwyddorau bywyd, ac yn gweithio gyda’n partneriaid ym meysydd iechyd a gofal cymdeithasol, diwydiant a’r byd academaidd, i nodi, meithrin a datblygu ffyrdd o wneud gwahaniaeth cadarnhaol i lesiant cleifion.

Our Welsh identity and shared social conscience are at the heart of everything we do.

Mae ein hunaniaeth Gymreig a’n cydwybod gymdeithasol gyffredin wrth wraidd popeth a wnawn.

Find out more today: www.lshubwales.com Tel: (029) 2046 7030 Email: hello@lshubwales.com

Am fwy o wybodaeth, ewch i: www.lshubwales.com/cy Ffôn: (029) 2046 7030 E-bost: hello@lshubwales.com

INNOVATION DAY 2021 THURSDAY 25t h M A R C H | T H E N O T T I N G H A M B E L F R Y Innovation Day provides a fantastic opportunity to learn from industry leading speakers and network with the who's who of the Life Sciences sector. BOOK NOW www.medilinkem.com/events/innovation-day-2021/

Conference | Exhibition | Networking

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Harnessing the power of Welsh industry in response to Covid-19 Efforts to combat the spread and treat those affected by Covid-19 are seeing businesses from across Wales adapting and innovating at an unprecedented scale and pace. Businesses have restructured their operations, re-engineered production lines and leveraged supply 15 chains overnight in order to offer NHS Wales the equipment and services it urgently needs. However, their successes are not solely a case of quick reactions by individuals to meet new demands – but collaborations between industry and NHS Wales. Life Sciences Hub Wales, an organisation which works to facilitate and support collaborations and innovation between industry, academia and health and social care, has been appointed by Welsh Government to manage all industry enquiries to support NHS Wales during this crucial time. It is acting as a conduit between industry and the health service to encourage and assist organisations to come forward with offers of support. With direct links to both, Life Sciences Hub Wales understands the needs of the health and social care sectors and the part businesses can play in combatting Covid-19. Working closely with NHS Wales Shared Services Partnership and the National Procurement Service - organisations responsible for the procurement of key products - it is processing all initial enquiries and undertaking due diligence to ensure the most relevant and appropriate companies are approached. While the reality is that not all offers are suitable to be progressed, Life Sciences Hub Wales is keen to hear from any business that might be able to help. As lockdown commenced at the end of March, the organisation hosted a major industry-wide virtual event which saw over 150 organisations come together to discuss ways to tackle Covid-19. Since then, hundreds of businesses, across an array of sectors, have come forward. 8

Minister for Economy, Transport and North Wales, Ken Skates, said: “The response to the national effort to beat coronavirus has been truly inspiring. I am immensely grateful to the business community in Wales for the significant contribution it has made using its wealth of expertise and experience. “At a time of a national public health emergency, businesses in a range of sectors continue to play their part to support our NHS and ultimately save lives. We have some of the best businesses in the world here in Wales, not just for the products and services they offer but for the ethics they demonstrate each and every day. Never has that been more evident than now. “I would also like to thank Life Sciences Hub Wales and its staff for the crucial role it has played in supporting our efforts against this virus. By bringing innovation and collaboration together with urgency, they have helped ensure our response is efficient and effective.”


Cari-Anne Quinn, Chief Executive Officer of Life Sciences Hub Wales, said: “Our remit is to facilitate collaboration between industry, health and social care. We are pleased to be working with our procurement colleagues and taking an all-Wales approach in responding to offers of support from industry as we face the demands of coronavirus and the pressure on our health and care systems.” Over the last few months, the organisation has worked closely with Welsh suppliers to increase their production. It has supported Welsh distillers to rapidly change their production processes to

create hand sanitiser, ensuring they have access to the materials and expertise required to safely produce and distribute these products. This has led to key products being fast-tracked within NHS Wales to get them to where they are most urgently needed. Life Sciences Hub Wales has processed thousands of enquiries from business offering support. For example, Cardiff and Llanelli-based company, BCB International, has a 160-year legacy of creating lifesaving products dating back to the Crimean War. Following its initial submission, the company has been able to make high strength

alcohol sanitiser products, PPE and first responder medical equipment available to NHS Wales. Similarly, support from Life Sciences Hub Wales has helped Caerphilly company, Transcend Packaging, which manufactures paper straws for McDonald’s, to become certified to produce PPE during Covid-19. Companies like Denbighshirebased, Workplace-Worksafe, are working hard to leverage their existing relationships with UK and international manufacturers to source and to supply vitally needed certified PPE products that are in demand globally.

Businesses looking to submit offers of support in the fight against coronavirus should do so via the Life Sciences Hub Wales website www.lshubwales.com/covid-19

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Future watch

VR provides distraction therapy for patients Rescape is pioneering the use of immersive technology to solve challenges in healthcare, such as reducing pain or anxiety and improving the patient experience.

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ardiff-based company Rescape has created DR.VR which enables pain, anxiety and stress management via virtual reality distraction therapy. The company has developed its product working closely with numerous clinical units from Velindre palliative team and the All Wales Adult Cystic Fibrosis Centre to a very successful feasibility study run by the ICU team in the Royal Glamorgan Hospital.

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Future watch

Initially six VR experiences were created, allowing patients to see cities around the world, animals, underwater environments and more. There were also some more adventurous experiences involving surfing, skydiving and other adrenaline fuelled activities. Each experience lasted 7.5 minutes and required the patient to be a participant rather than just a viewer, increasing engagement and immersing them in the virtual world. When developing DR.VR, a range of needs had to be met. For instance, it was vital for the system to be simple to use (for patients and clinicians), unlikely to cause motion sickness or dizziness, and easy to clean and disinfect. A tablet was used to control the system and also to collect data, allowing clinicians to monitor the anxiety/stress levels of patients pre- and post-experience. Initial trials were conducted with cystic fibrosis patients who were experiencing a lot

of stress and anxiety, and the results showed significant improvements following the VR distraction therapy.

The system includes three meditative VR spaces, designed to help children control their breathing. Artic Beats is a VR game that uses audio to create a sense of flow, while 360 video content takes children on trips to visit dinosaurs, fly around space or swim with sharks. Clinicians and parents can see what the children are watching via a tablet.

Rescape has now built on the success of DR.VR and created an innovative solution to reduce pain and anxiety for children in paediatric departments. DR.VR Junior allows clinicians to use distraction therapy during painful or stressful procedures. It was developed with a user-centric approach, working in collaboration with play specialists. DR.VR Junior has received impressive feedback from patients and clinicians, including a child with ADHD who was calmed after a repeat procedure and a cancer patient who used a nebuliser without complaining. Rescape even received a letter from a 10 year old boy, thanking them for helping reduce his pain when he had his arm reset. He knew it worked because he’d broken his other arm the month before so could compare! The company recently won a Clwster grant to work alongside Cardiff and Vale Midwifery unit to develop a new product for maternity to help woman before, during and after labour. VR is set to impact pain and anxiety management, and healthcare, more widely. The work Rescape is doing today is showing a path to how VR can be adopted at scale tomorrow. www.rescape.me

For daily lifescience news visit www.lifescienceindustrynews.com 11


Future watch

Transforming healthcare with smart textiles Footfalls and Heartbeats are taking wearables to the next level by turning textiles into sensors.

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riginally founded in New Zealand by Simon McMaster, Footfalls and Heartbeats moved to the UK in 2015, with the smart textile company taking up residence in Nottingham - a city steeped in textile history. Footfalls have developed an innovative and patented knitting technique, whereby “The Textile is the Sensor”. This avoids the need for embedded electronics and has the potential to revolutionise the field of smart textiles, offering ground-breaking innovation in a variety of industries such as sports/fitness and healthcare. Splitting into two key areas, Footfalls’ technology comprises pressure sensing and strain detection. Absolute pressure sensors harness optical fibre technology knitted into a piece of fabric, thus allowing the accurate continuous measurement of absolute pressure in real time. Knitted pressure sensors can track multiple pressure points across a surface. This

The potential for this technology is wide reaching, particularly in healthcare. The sensors can transform compression therapy, which is the main method of treatment for Venous Leg Ulcers, and applying the right level of pressure to the wound is crucial. Venous Leg Ulcers are a growing health problem in the UK, costing the NHS an estimated £5 billion a year.

technology has already seen a key application through the creation of a smart shoe, knitted on a state-of-the-art circular knitting machine – the only one of its kind in the UK. The smart shoe has the ability to monitor and offer feedback on the wearer’s daily activity, offering information on walking/running patterns.

The versatile nature of the pressure sensors enables them to be knitted into a range of different surfaces such as seating, bedding and sports mats. This opens up a host of potential opportunities and industries to revolutionise, from aiding sport rehabilitation and injuries, to healthcare and gait management. Footfalls’ final technology is a knitted ‘smart sleeve’ for strain detection, which accurately measures joint movement through tracking flexion and extension. When combined with an interactive display, it can offer detailed tracking and monitoring of joint movement for both the elbow and the knee, all while being a comfortable and convenient knitted sleeve. The smart sleeve technology has the potential to transform the face of sportsrelated rehabilitation, helping to assist those recovering from muscular injuries and track their recovery. The smart sleeve also has promising applications in the field of VR. www.footfallsandheartbeats.com

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Future watch

Award-winning team develops air quality sensor Bluefrog Design has driven the development of an innovative air quality sensor to monitor pollution and therefore improve the public’s health.

T

he Leicester-based product design consultancy first met the EarthSense team at a local exhibition in 2016. EarthSense, a spinout from the University of Leicester, had been developing technology to measure and record air quality since 2002, testing early prototypes with rockets and balloons. By 2015 they had produced the innovative technology needed to measure harmful levels of ambient air pollution, but required the expertise of an external design team to take the sensor, named Zephyr, to the next stage. The designers were able to help the academics to develop a commercially viable product ready for launch. At the point of the first meeting, the Zephyr was a university project with very little in available finance. Bluefrog’s first step was to develop 10 units as prototypes, which EarthSense could then test in the real world, using the results as a basis to apply for additional funding. This in turn led to further design and development of the electronics by EarthSense and the hardware by Bluefrog. As development continued, the designers were able to manufacture prototypes and parts in-house, liaise with suppliers and consider future manufacturing. They identified a number of local suppliers, which were all SMEs – an element that was considered important in a project completely focused on environmental improvement. The Zephyr uses cartridges to capture gases and particulates, which the user would need to access and maintain easily. It was clear that over time the technology or the applications could change, so Bluefrog felt it was important to create a future-proof design. Therefore, the materials are easily identifiable for recycling, and the body itself is made of extruded aluminium. This means it can be adjusted in size without expensive retooling, making it sustainable, suitable for repurposing and appropriate to the circular economy. Initially, the aim was to deliver an air quality sensor that could survive for five years in challenging environments, maintain a highly

controlled air flow around the sensing elements, and be easy and cost-effective to maintain. Working collaboratively, Bluefrog not only met the objectives, but also produced a stylish ‘design icon’ that is aesthetically pleasing without being a tempting target to vandalism, which is vital for something being placed on the outside of public buildings. The finished design is clean, attractive and discreet, yet intentionally it doesn’t entirely disappear into its surroundings. Although EarthSense didn’t want to make the Zephyr so obvious that it might attract vandals, it was also proud of the product and wanted passers-by to take an interest. The result is a matte black case with blue highlights.

Manufacturing of the Zephyr began in August 2018. It is now sold across multiple countries, and used in a variety of ways by local councils and businesses to monitor air quality and consequently improve the lives of humans around the world. As a result of the collaboration, Bluefrog won the award for Design Team of the Year at the 2019 British Engineering Excellence Awards.

www.bluefrogdesign.co.uk

For daily lifescience news visit www.lifescienceindustrynews.com 13


Future watch

Digital platform bridges the gap between social care and healthcare A Norwegian company has found success in the UK with a platform that allows patients to receive follow-up from healthcare providers in their own home.

D

ignio Ltd is the UK branch of Dignio AS, a SaaS healthtech company from Norway. Specialising within remote care, their user-centric connected healthcare platform helps patients to better understand and manage their chronic conditions. It also gives reliable tools to the clinicians so they can remotely monitor their patients, leading to better understanding of signs of impending deterioration.

“To build a sustainable healthcare system we have to work in new ways, and our solution is an important contribution. Our system is all about giving patients better and healthier lives, and at the same time giving healthcare providers a tool for using their resources on those who need it the most.” Ewa Truchanowicz Managing Director Dignio AS

Suitable for many patient groups

An important recognition

The platform is built up of different components, which can all be adjusted to the needs of the healthcare providers and their patients. The company offers telemedicine, remote patient monitoring, medicine compliance, home lab, self-reporting and self-managing. The components are integrated with Dignio’s platform for healthcare personnel and the patient app MyDignio, serving a number of possibilities for connected care.

Dignio recently won the start-up award at the Medilink West Midlands Medical & Healthcare Business Awards.

Managing Director Ewa Truchanowicz has noticed an increasing demand in the UK, commenting: “Dignio’s solution bridges the gap between social care and healthcare, and with stretched budgets and workforce demands, allows NHS staff to prioritise their attention according to the patient’s needs. We now have active patients on the solution and we are getting very positive feedback from both the patients and the healthcare providers.”

Truchanowicz commented on the achievement: “Launching a new service and a new way of thinking in a new country is not easy, and we have worked hard to get where we are today. This is an important recognition for us and gives us great motivation going forward. The demand for connected care is growing rapidly, and Dignio is well positioned in the UK with our solution. Hopefully this will contribute to even more patients getting the opportunity to live better and healthier lives with our health technology.” The company’s clients include hospitals, municipalities and other private healthcare providers. They also have several research projects underway in Birmingham, Norway and China. www.dignio.com/en/

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Future watch

Finding the key to detecting antibiotic resistant bacteria Vitamica is bringing a new nano-optical approach to the global challenge of detecting antibiotic resistance in pathogenic bacteria. The method shows real promise at being able to distinguish resistant from susceptible bacteria in just a few minutes.

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family member suffering from a difficult to cure bacterial infection was the trigger for nano-optical physicist Dr Massimo Antognozzi at the University of Bristol to think hard about how to help prescribing clinicians make informed decisions on antibiotic use. Massimo was interested in how particles on a surface interacted with light, and had developed a technique that could visualise tiny movements within bacterial cells.

During the two years since Vitamica was created, the need for a rapid method to help clinicians decide on antibiotic choice has become more pressing. Author of the UK Government’s report on antimicrobial resistance, Lord Jim O’Neill, recognised that the development of rapid diagnostics will reduce unnecessary prescribing and prevent antibiotics becoming an expendable commodity. Good progress has been made in the Vitamica labs towards developing a rapid diagnostic test, with the focus being on analysis of bacteria from patients with urinary tract infections.

Was it possible that antibiotics could cause the pattern of light reflected from the moving contents of bacterial cells to change? And would cells resistant to the antibiotics have a different interference pattern from those that were killed by the antibiotic? Remarkably, the answer to both questions was ‘yes’, and this discovery led to the formation of spin-out company Vitamica in early 2018.

Collaborators with experience in clinical microbiology, artificial intelligence, automation and health economics have all contributed to the challenge of carrying forward Massimo’s original idea, committed to the cause of improving healthcare through prudent use of antibiotics. There are still pitfalls to overcome, and many questions remain on the journey from concept to clinical use of the instrument. However,

throughout this, Massimo’s original vision is still strong; that every time an antibiotic is used, the doctor has access to convincing evidence that it will cure the infection. Vitamica recently won the award for innovation at the 2020 Medilink South West Healthcare Innovation Awards.

“The commercial opportunity for a nearpatient, rapid antibiotic susceptibility test is a powerful driver of innovation, and the method being developed by Vitamica is distinctly different from other methods being applied to the challenge.” Dr Paul Meakin CEO Vitamica

www.vitamica.co.uk

For daily lifescience news visit www.lifescienceindustrynews.com 15


Future watch

A silver lining around a very dark cloud

Andrew Davies, ABHI’s Digital Health Lead, considers how the Covid-19 pandemic could have an impact on how technology is used within healthcare in the future.

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e are currently in the midst of a war, the fight against a global pandemic, and thoughts, of course, go out to all those that haVe been impacted by Covid-19, as well as those leading the frontline fight.

As well as being reinforced by a veritable army of volunteers, the NHS is also being supported by technology. The history of war, be that traditional armed conflicts, cold wars or space wars, has shown that they can generate, in the longer-term, a beneficial effect on economic and technological development. In general, wars tend to accelerate technological development to solve specific military needs which, over time, are synthesised into non-military applications. The expectation is that this war against coronavirus will follow exactly the same path. This could be the silver lining to the cloud of the virus hanging over us. Already we are seeing significant changes in the way technology is used in the NHS; l Primary care has been transformed from a walk-in service to a “dial-in or click-first service” in the space of weeks. l Hundreds of thousands of people across the country are turning to digital services, such as the NHS App or 111’s online service, for help about their conditions. l Electronic patient records and other essential technology services have been installed within days at new field hospitals across the country. l Remote health and social monitoring are a growing part of the armoury for hard pressed GP and outpatient clinics. l Several new Apps have been launched and adopted into the NHS, with an online status checker rolled out nationally.

The challenge will be to hold on to these gains that have come out of necessity (which we all know is the “mother of invention”),

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and to further adapt them to “peacetime” use. It is already becoming clear that even once Covid-19 is beaten, it will not be business

as usual for the NHS. Already, ABHI is discussing with the NHS and Government the challenges that await the service in dealing with the backlog of treatments building up, as electives are cancelled, cancer treatments delayed, and even organ transplants suspended. However, I am optimistic, as we shouldn’t look at the situation in the NHS in isolation. In some respects what is happening in the NHS now, due to Covid-19, is bringing it closer to the technological reality that is common in so many other facets of our life. We are now seeing that it is possible to manage our health online, in a similar same way we manage our finances online. For most of us reading this, homeworking and video conferences is the new normal. The same is true across the NHS, and of course Government, with cabinet meetings now being held virtually. I predict that the pressure from within, and outside of the system, will keep digitisation adoption on track…a silver lining around a very dark cloud.


Future watch

ABHI leads Chief Innovation Officer call In 2017, ABHI, working with the Nuffield Trust, set out to investigate why the NHS struggles to make the most of new innovations.

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f the findings, one of the biggest barriers to adopting innovation is that too often it is not embedded in routine processes and operational management decisions. It is frequently seen as a luxury, only to be attempted when everything else is going well rather than as a core part of improving quality and efficiency. NHS Trust Boards see regular metrics on finance and performance, quality and safety, and workforce, with Executive Directors responsible for these important areas. As part of their “Well Led� inspection framework, NHS organisations are required to have robust systems and processes in place for learning, continuous improvement and

innovation. But, with few exceptions, nobody at a Board level holds this portfolio. Until this is actively built into a senior job description, it is unlikely to become business as usual.

hospitals to deliver efficiencies whilst adopting life changing HealthTech. As part of each hospital Board, Chief Innovation Officers can make a fundamental difference to the NHS, whilst ensuring maximum value to the taxpayer.

To find out more, contact eleanor.charsley@abhi.org.uk

This is why ABHI is calling on every NHS organisation to appoint a dedicated Chief Innovation Officer whose role will enable

www.abhi.org.uk

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 For daily lifescience news visit www.lifescienceindustrynews.com 17


Future watch

ABHI: The data debate Contributed by Andrew Davies, Digital Health Lead, ABHI

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n my role as Digital Health Lead for ABHI, I have been looking into the area of trust, ethics and data. Personally, I do not see significant progress being made in the debate. Around the many and varied tables where I have been discussing this, there is a good sense of unanimity about what needs to happen to ensure the continued trust and engagement of patients and citizens. Namely, that we need a robust public dialogue on the subject. That is why we at ABHI have called for funding towards a public communications programme, informing citizens of the benefits to themselves and others of sharing health data.

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Issue 17

The Research The Open Data Institute (ODI), working with YouGov, has tested public attitudes on data ethics, with the NHS outperforming the rest of Government and the wider public sector. 59 per cent of people say they trust the NHS to be ethical in its use of their data. However, this shows a decline since a similar survey in early 2018, which recorded a score of 64 per cent. Is the decline a blip or a trend? Other research has found that patients have not yet fully bought into the use of technology. The first Digital Dispatch referenced a report from the RSA, entitled

Patient AI, which found some resistance to the introduction of digital technologies, as patients believed that their introduction was part of a “political agenda� rather than for improved patient care. Furthermore, there continues to be incidents of unconsented data sharing, or at the very least, a lack of transparency in how consent data is used. Recent articles highlight this, and when it comes to data, the UK is not an island. Health data misuse, even in other jurisdictions, could easily cause concern and slowly erode trust, leading to a reticence to

share data.


Future watch

The Conversation It is against this backdrop that I hear a shift in the conversation around data. At the start of the year, most people were talking about data ownership. Whose data is it? Patient? NHS? Device/diagnostic manufacturer? Big tech company? Many thought such questions were both too difficult to answer and unhelpful. The real issue was consent. This progressed to a discussion on

“assumed consent” on the basis that the NHS and the public have a Social Contract, which seems reasonable… theoretically… although research conducted around genomics showed a lack of unfamiliarity with the terminology around ‘Social Contract’. Hardly surprising given this terminology is largely confined to ‘those in the know’ and nothing is written or explicit.

their information, in anonymised form, has been used by a company without their knowledge. While also there are obvious benefits in the possible datasets that could be constructed.

The Outcome

This should be a situation where everyone wins. According to Ernst & Young, the NHS could get Building on the idea of assumed consent, nearly £10bn a year through savings, improved the discussion has shifted again to focus outcomes and economic benefits. Industry on governance and how the public can be gain access to a potentially unrivalled dataset included in the processes to ensure propriety to develop new technologies and processes. and transparency since their consent is there. Patients and citizens reap the benefits of both, seeing enhanced population health, better I believe there is risk for industry in the idea of and earlier diagnosis and improved treatment assumed consent if patients subsequently learn outcomes, all from new, more accessible care settings. But we need the dialogue to happen, we need a public ethical framework and we need trust in the system. Let’s see how the conversation develops... .

www.abhi.org.uk

For daily lifescience news visit www.lifescienceindustrynews.com 19


Future watch

Speech therapy apps to help clinicians and their patients

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n 2010, Sam Brady, a Speech & Language Therapist, was working at Frenchay Hospital, Bristol. She was working with a patient with Parkinson’s Disease whose speech was unclear due to its fast rate. She wanted to trial existing Delayed Auditory Feedback (DAF) technology to help him to speak more slowly but the existing DAF device was bulky, awkward to configure and not readily available. It was also expensive, making it unviable as an option for patients to purchase themselves and use as a long term help. Sam’s husband Garry, a software engineer at Hewlett Packard, listened to her frustrations and created a prototype of DAF on his Android phone. Within a few weeks, their app “DAF Pro” had been created. Sam and Garry continued to solve other clinical problems by developing further speech therapy apps. Speechtools was incorporated in 2014 and Garry has worked full time for the company since 2017. Sam designs and updates their apps and also continues to work as an NHS Speech and Language Therapist in Bristol.

product is over £1k, the app is priced at £9.99 making it readily available to clinicians and their patients. It has replaced expensive, standalone voice recording machines in Speech & Language Therapy Departments. Speechtools has been sent many messages and reviews showing that clinicians who use Voice Analyst in their clinics would be lost without

For the first time clinicians and patients can use the same clinical app to monitor and change their voice - particularly useful for those with Parkinson’s Disease or other neurological/voice conditions. People can see their pitch or volume on a screen and then play it back and look at the statistics about it. They can then aim to speak at a higher/lower pitch or volume, using the visual or statistic feedback as guidance and objective measurement.

it, and patients love being able to practice their voice exercises in the comfort of their own home to augment their speech therapy sessions. It is recommended by Parkinson’s UK. Voice Analyst has transformed the way Speech & Language Therapists work and Speechtools hopes to integrate it into patient records in the future, thus improving patient care throughout the patient pathways. Speechtools now has a portfolio of 5 apps, available on both Apple and Android, which are used by Speech & Language Therapists and patients in over 170 counties. Each app that they have created has been developed to solve a clinical problem and extended further following patient and clinician feedback. Their apps are now used by 10,000 people a month. Sam and Garry love combining their skills of speech therapy and technology and working in the exciting health tech field. It is a rapidly growing area that they have been proud to be part of from the early days of the smartphone. Current and future technologies will continue to enhance, improve and transform the way Speech & Language Therapists work and Speechtools is proud to be leading the field in this area.

The ‘Voice Analyst’ app records, analyses and stores the human voice and was awarded the 2020 South West Medilink Award for Health Tech Innovation. Originally, it was born out of a frustration with lack of access to and cost of the existing technology. Voice Analyst is the only app that accurately detects pitch of the human voice (not instrumental pitch), gives visual feedback and provides a clear, easy to use interface. Whereas the legacy hardware voice analysis

www.speechtools.co

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Issue 18


Future watch

A new healthcare paradigm: Using AI in the nervous system to manage chronic conditions Contributed by Emil Hewage (co-founder and CEO) and Oliver Armitage (co-founder and Chief Scientific Officer), BIOS Health

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I is arguably powering a healthcare revolution. Everywhere you turn, there’s commentary about the role AI can play in transforming healthcare by making health services more efficient, improving diagnostics and patient outcomes, and giving people more control over their health. Increasingly there are practical examples, the majority of which are evolutionary, iterative enhancements to existing services. But what if we set our sights higher for using AI – to create a new generation of therapies, and a new paradigm for healthcare? At BIOS, it is our mission to transform healthcare by developing a full-stack neural interface platform, that is optimised to decode and encode the signals from the brain to the body, to treat chronic health conditions. Our vision is that patients will have their chronic conditions managed via the nervous system directly by AI, giving personalised and accurate treatments, making the burden of pills and doctor visits a second resort rather than a daily reality. The need is great to find step-change solutions. Chronic diseases account for almost 90 per cent of all deaths and nearly $2 trillion in healthcare spend per year in Europe and the US alone. Yet ROI in pharmaceuticals to tackle these challenges is decreasing, costing billions more every year to bring fewer drugs to market. We need ways to develop treatments that are more effective, cost less to deliver and do this more quickly if we are to tackle the burden of chronic diseases and provide greater quality of life for millions of people.

Scientists have long known that faulty signals in the nervous system play a key role in driving chronic diseases. A major bottleneck has been the speed and accuracy with which scientists could discover and recreate the exact neural signal patterns (biomarkers) capable of affecting our health. Previously there was no way to leverage the nervous system in this way because we were not able to process or analyse the vast amounts of data and complexity within it. But now, BIOS has combined neuroscience and artificial intelligence, software engineering and medicine to develop the capability to decode and encode the signals going from the brain to the body.

There are three parts to our technology: 1. BIOS’s standardised hardware interface connects directly with the nerves to isolate the signals that travel between the brain and the body. 2. BIOS’s AI decodes and encodes this neural information from hundreds of thousands of individual neurons, tens of thousands of times per second, and sends corrected signals back into the body. 3. Using this neural code, BIOS can build a whole digital healthcare treatment though software that continuously updates, trains and enhances the treatment, via the cloud.

We have pioneered a method to automatically extract the neural signals regulating physiological biomarkers using an AI-enabled neural interface – creating a new way of investigating conditions that will accelerate the discovery of neural biomarkers, and making us the first to automatically isolate biomarkers in neural data This breakthrough has made it possible to understand the “language” of the nervous system for the first time. Using machine learning to find biomarkers of organ function in neural data and be precise about which nerve activity relates to a specific condition will mean effective neural treatments can be developed to replace drugs.

This neural approach can be used for some of the most life-threatening or debilitating chronic conditions including hypertension, diabetes, and rheumatoid arthritis, and in the future potentially diseases of the brain itself such as Parkinson’s or Alzheimer’s. We’re focused on building a platform technology that enables third parties to create neural treatment applications using our AI technology. Heated debate on the future of AI-powered healthcare and what it should look like will continue. But for us, it’s about realising our vision for a future where we can scale effective, cost-efficient, and personalised care to millions of patients with chronic conditions – changing their lives in the process. www.bios.health

For daily lifescience news visit www.lifescienceindustrynews.com 21


Clinical Need

Bringing innovation to anaesthesia

Somnus Scientific, which recently won the Outstanding Achievement award at the Medilink South West Healthcare Innovation Awards, is using innovative technology to change the way anaesthesia is administered.

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y allowing anaesthetists to measure venous blood propofol concentrations, the use of TIVA (Total Intravenous Anaesthesia) can be made even safer and more reliable.

Triple Aim The use of Somnus Scientific’s realtime blood propofol monitor during general anaesthesia or sedation satisfies the essential tests of the Triple Aim in Healthcare. Improving the health of patients having surgery. TIVA, supported by real-time blood propofol monitoring, improves the health of surgical patients by reducing the untoward effects of inhalational anaesthesia, such as impaired cognitive function, nausea and vomiting. There is also evidence that using TIVA can provide better long-term survival for patients who have cancer. Improving the whole experience of healthcare. The patient’s experience is improved by a reduction in side effects and a smoother post-operative recovery period. Real-time blood propofol

monitoring enables this as it facilitates the use of TIVA over gaseous anaesthesia. It can also be used to reduce the total dose of drug given, thus minimising the unwanted effects of excessive dosing. Reducing the per capita cost. Administering TIVA with an autonomous feedback loop has been shown to reduce the total quantity of drug used, and so reduces the cost of general anaesthesia. TIVA also reduces the length of stay in the recovery room and overall length of stay in hospital, which are two drivers of anaesthesia related cost.

Environmental Benefit Traditional anaesthetic uses greenhouse gases which damage the environment. A recent scientific paper showed that an anaesthetist using low flow gaseous anaesthesia and undertaking three operating lists a week, over a 40-year career, will dump to the atmosphere the equivalent CO2 of 880 return flights from Heathrow to JFK – one flight each working week. TIVA is clean and environmentally safer than gaseous anaesthesia. Compared across the whole life cycle of each drug,

the greenhouse gas impact of propofol is 10,000 times smaller than that of anaesthetic gases. Somnus’s realtime blood propofol monitor makes switching to TIVA safer and more effective. Facilitating the use of the only alternative anaesthetic technique (TIVA) can therefore also improve the health of the population of our planet.

Innovation Propofol is a phenol that is relatively insoluble in water and thus carried in lipid. Somnus has overcome the practical difficulties of measuring propofol in a real-time system that does not require blood withdrawal from the patient. The company’s newly invented biosensor utilises an enzyme on an electrode and the principles of voltammetry to consistently and reproducibly measure propofol down to remarkably low concentrations. In the months ahead, Somnus will continue to refine the function of the sensor, whilst at the same time considering partners for commercial development of products aimed at segments of its target market. www.somnus-scientific.com

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Issue 18


Clinical Need

Advanced dressing technology combats wound biofilm ConvaTec has developed an innovative wound dressing to combat biofilm – a previously unmet clinical need which is one of the key causes of wound chronicity and delayed healing.

Antibiotic resistant bacteria inside a biofilm, 3D illustration

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iofilm is naturally produced by bacteria to protect themselves from external hostilities such as biocides, antibiotics and host immune cells. Its prevalence and influence on wound healing are now widely recognised. The annual cost to the NHS in managing hard-toheal wounds has been reported as being in excess of £5 billion. Since biofilm is one of the key barriers to healing, effective biofilm wound management is essential.

With the clinical implications of wound biofilm in mind, ConvaTec’s R&D team in Deeside, Flintshire embarked on a project to identify chemical and biological agents that could break down protective biofilm and subsequently expose wound bacteria to the antimicrobial action of silver. Nearly 250,000 chemical combinations were considered, and over a three-year period more than 60,000 of these were screened using rapid laboratory assays. A combination of three chemical agents, including silver, was found to be

extremely effective in killing bacteria, including those that are antibioticresistant, in biofilm form. This unique combination technology was subsequently incorporated into the company’s AQUACEL Extra dressing, which is manufactured at its sites in Rhymney (chemistry) and Deeside (textiling and packaging). The resultant dressing is known as AQUACEL Ag+ Extra. Following initial product manufacture, both laboratory and clinical studies were performed to demonstrate product safety and effectiveness. In a pivotal safety study in 2015, led by Professor Sir Keith Harding of Cardiff University and the Welsh Wound Innovation Centre, the dressing was found to be effective at facilitating healing of infected and noninfected chronic leg ulcers that were likely compromised by biofilm. By introducing the new dressing into management protocols involving hardto-heal wounds in healthcare facilities across Europe, the USA and Canada, the

ConvaTec team observed widespread and rapid progression towards wound healing. Complete healing was observed in around 30% of wounds within a period of 4-7 weeks. A sub-set of the non-healing wounds that were unresponsive to systemic antibiotics showed dramatic improvement when the dressing was introduced. Consequently, the dressing can support initiatives to reduce the current overuse of antibiotics in chronic wound management.

The anti-biofilm technology can be used in other dressing formats (e.g. surgical and foam dressings) in order to cater for a wider variety of complex wound types. The patent-protected technology could also be used in other medical devices to help manage a wide range of healthcare associated infections.

www.convatec.co.uk

For daily lifescience news visit www.lifescienceindustrynews.com 23


Clinical Need

Development of flexible optical occluder DHC Innovations Ltd has developed a hands-free alternative to currently available occlusion devices.

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s a long-term sufferer of uveitis, the creator of the Optishield had been left with troublesome diplopia (double vision). Needing to occlude one eye while reading, there were no products available to suit her needs. The subsequent creation of a soft silicone slip-on occluder has been the result of four years of development. The device was offered an initial investment boost of £10,000 awarded by the Beacon Visionary Challenge, a sight charity based in the West Midlands. This investment was built on with both practical and financial guidance from the University of Wolverhampton and Keele University. With a clinical background, the developer was aware of the patient and healthcare provider requirements of a new medical device, but the Optishield needed strong business acumen to succeed. The design went through a number of stages, including computer aided design and 3D printed prototypes.

Optishield received a huge surge in interest when Medilink West Midlands introduced the team to the Medical Devices Technical Evaluation Centre, based at the Queen Elizabeth Hospital in Birmingham. They arranged for a formative usability study to be carried out at the Aston School of Optometry. The highly experienced optometrists perceived the device as a valuable aid for visual acuity testing. Current occlusion is provided by handheld paddles, but it became clear that a hands-free option was desirable. The study identified a 100 per cent completion success rate, with the participants considering the device to be a helpful aid, resulting in a direct positive impact on their usual clinical practice. Knowing that the Optishield is sitting securely in the right place gives the optometrist the confidence to concentrate on the test taking place, instead of having to think about the positioning of the occluder. Therefore the examination is more comfortable for both the clinician and the patient.

“Innovation in healthcare relies on more than just a great idea. You need a lot of help to navigate an increasingly complex health innovation environment. But happily, the help is available, and there are some excellent medical business advisors that offer great support for small enterprises. Their knowledge, connections and energy have been a tremendous boost for us in achieving what we have done this year. We have moved from proof of concept to actual sales, with a growing number of enquiries from around the world.” Rebecca Harrison DHC Innovations Ltd

For creating the Optishield, DHC Innovations Ltd recently won the Outstanding Achievement award at the 2019 Medilink West Midlands Medical and Healthcare Business Awards. www.optishield.co.uk

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Issue 18


Clinical Need

Innovative technology improves patient outcomes Working in partnership with key opinion leaders, Creo Medical has developed CROMA, an advanced energy platform, and Speedboat, an endoscopic device.

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he technology enables suitable patients to have a procedure as a day case in the endoscopy suite, as opposed to the procedure being completed surgically in the operating theatre. This means that a less invasive procedure is now available with a reduced length of stay in hospital for certain patients.

Creo Medical strives to improve patient outcomes by bringing laparoscopic surgical capabilities to the field of flexible endoscopy – the new frontier of minimally invasive surgery. The Chepstow-based company has developed CROMA, a proprietary advanced energy platform, that uniquely delivers bipolar-RF and high frequency microwave energy via a single accessory port. Creo’s first device, Speedboat, is now in use worldwide with great success, and multiple patients have been treated with life changing outcomes.

Chris Hancock CTO Founder (Creo Medical)

Speedboat was developed in collaboration with key opinion leaders at St Marks and East Kent Hospitals. The clinical lead at East Kent has adopted Creo’s Speedboat at its Complex Polyp clinic. Before the introduction of Speedboat, certain complex cases at these hospitals involved surgery and the associated stay in hospital. With Creo’s Speedboat device, patients can have certain complex lesions removed and treated as day patients under mild sedation rather than requiring general anaesthetic. The procedure utilising Speedboat enables treatment under sedation to take place in 3090 minutes, as opposed to an average 4-hour surgical procedure with other complications and costs. Therefore, there is an opportunity for more patients to be treated. A typical surgical resection currently requires up to 5-days stay in hospital at an average cost in excess of £10k.

Speedboat has led to better patient outcomes, increased convenience and reduced hospital costs. It has also changed the pathway in the treatment of certain colorectal conditions. “Following the introduction of Speedboat, we have been really pleased with the results for both our patients and our service. With the development of this service, we are now able to offer patients treatment closer to home. The use of Speedboat enables us to offer patients treatment in the endoscopy setting and we are keen to expand this service using the new device.” Lisa Neal East Kent Hospitals University NHS Foundation Trust

The ability to treat patients with as short a delay as possible is particularly advantageous when treating lesions in the bowel. A relatively quick procedure at a local hospital in an endoscopy suite is generally far easier on the patient than more invasive surgery with a longer recovery time. As the new device allows en-bloc removal of lesions, this leads to fewer and less frequent follow-up scoping appointments. Creo Medical won the award for industry partnership with the NHS at the 2019 MediWales Innovation Awards. Two hospitals now offer Speedboat procedures and the company aims to increase this number in 2020. www.investors.creomedical.com

For daily lifescience news visit www.lifescienceindustrynews.com 25


Clinical Need

Telehealth with a human touch ‘Nellie’ is a unique collaboration between Staffordshire-based Bitjam’s software development and Simple Shared Healthcare’s telehealth methodology, creating a multinational project that improves the speed and quality of clinical outcomes.

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he innovative SMS telehealth system was first developed in 2008, and subsequently rolled out worldwide. Nellie (Australia), Florence (UK) and Clara (international demo system) are all based on the simple premise of a chatbot that any patient with a standard mobile phone can use. The patient is sent a reminder message to track readings for weight, blood pressure, temperature, blood pressure and heart rate. It is fully customisable by the clinician and can measure a wide variety of data. These systems are speeding up healthcare processes, allowing clinicians and patients to interact and communicate easily.

Nellie has also been successfully rolled out in the areas of diabetes, mental health, smoking cessation and weight management. It has been proven to be a highly effective, low cost and simple system, which has enabled positive behaviour change. For example, in the area of weight management, in addition to supporting safe weight loss, benefits have included a reduction in further medical interventions, GP visits and prescribed medication. Reports from other projects are similarly conclusive. Phil from Simple Shared Healthcare took Nellie to Arab Health 2020 in Dubai, showcasing the system alongside many other latest innovations in healthcare. One standout feature of Nellie is her

multi-language/time zone capabilities. Bitjam can configure the system to talk in any language and this unique capability is of interest to the Arab market, so it was well received at the conference. The system is designed for clinicians, by clinicians, allowing Doctors and Nurses to collaborate on the management of patient communications. Since the introduction of Nellie and her sister systems, clinicians have consistently recognised the importance of supporting patients outside of face-toface care to improve outcomes, due to the benefits seen from improved utilisation of manpower resources and healthcare professional time.

Cutting edge telehealth technology is extremely powerful, as it allows the NHS to care for more people in their own homes, thereby reducing GP visits and hospital admissions and saving money. Many people are finding the system useful because it is “telehealth with a human touch”.

An advantage of the customisable system is that it can be tailored to specific projects such as heart failure pathway. The chatbot will ask the patients for daily responses about how they are feeling, or about their symptoms in conjunction with their symptom checker to increase awareness and confidence of any actions they need to take.

www.bitjam.org.uk

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Issue 18


Clinical Need

Regenerative therapy for sightdestroying conditions NuVision Biotherapies is a regenerative company, spun out from the University of Nottingham in 2015, that was established to commercialise clinically available and highly versatile biotherapies for treating ‘front of the eye’ disease and trauma, as well as wider wound care purposes.

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he company’s platform regenerative therapy, Omnigen, is based on many years of extensive human amniotic membrane (amnion) translation research carried out at the University of Nottingham by NuVision’s founder, and CSO, Dr Andrew Hopkinson.

Omnigen harnesses the natural regenerative properties of amnion, which surrounds babies in the womb and is normally discarded at birth. The healing properties of amnion, which is part of the placenta and is the innermost layer of the sac that surrounds

and nurtures the baby during pregnancy, have long been recognised. It has natural wound healing, anti-inflammatory and anti-scarring properties, and because it is not recognised by the immune system, it can be transplanted to patients with minimum risk of rejection.

Until recently, processing amnion for clinical use involved storing the amnion frozen at -80 degrees. However, freezing damages the tissue and reduces its wound healing properties. The tissue needs to remain frozen until use and delivery can take 24 hours, making it unsuitable for emergency and routine in the office setting.

Omnigen is made from waste tissue given by women undergoing an elective Caesarean section. They are screened for health conditions beforehand and their blood is tested for communicable diseases. The amnion is processed in specialised laboratories, using a process called Tereo, into a dry sterile sheet and cut into discs to be stored. As a dry and stable product, Omnigen can be easily shipped to be used or readily stored at the point of care. Applied directly to the human eye dry, the natural moisture in the eye or wound rehydrates the patch, where it reduces pain, protects against infections and promotes healing.

It allows effective treatment for a range of sight-destroying ocular surface disease, providing comfort for the patient. Conventionally, surgeons suture it to the eye to promote healing and repair defects. Unfortunately, patients therefore still have to wait to be referred for costly surgery to receive this therapy. NuVision’s latest innovation, OmniLenz, overcomes this problem. OmniLenz is a unique and bespoke bandage contact lens that uniquely allows the application Omnigen, in a simple five minute ‘in the office’ procedure, eliminating the need for complex surgery and sutures. With OmniLenz, Omnigen can be routinely applied directly to the eyes of burns or trauma victims, patients enduring persistent corneal ulcers, and now patients suffering inflammatory diseases such as dry eye disease, Sjogren’s and graft versus host disease, providing conform and relief to alleviate pain by up to 70 per cent and to promote wound healing. More patients may benefit from treatment earlier, and therefore potentially more effectively, from first presentation. With OmniLenz application of Omnigen, NuVision aims to dramatically shorten the treatment pathway to improve patient care whilst delivering significant costs and resource saving to the already pressured NHS. Routine in clinic application of Omnigen may revolutionise the treatment approach for ocular surface disease. Omnigen is the currently the first UK dry human amnion derived product to have delivered encouraging proof of concept, and is now being used in over 60 UK hospitals, 14 different countries and delivering ~6000 sight saving treatments for patients. NuVision is currently working with hospitals to generate the necessary data to obtain widespread clinical acceptance, with several major clinical trials starting in coming months.

www.nu-vision.co.uk

For daily lifescience news visit www.lifescienceindustrynews.com 27


Clinical Need

Innovative tool to increase collaboration between tissue sample providers and researchers

The difficulty of sourcing samples from the NHS is a common cry, with demands remaining unfulfilled locally and a reported 75 per cent of samples being sourced from overseas. In contrast, recent reports also highlight that only a small percentage of samples donated in the UK are actually used in research.

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or tissue banks and researchers, this is an expensive and time-consuming business. Yet, the answer seems simple – put the researchers in touch with Biobanks and tissue providers.

This is exactly what the UKCRC online Tissue Directory aims to do. The directory is a national web-based portal used by Biobanks to advertise their tissue sample holdings data to researchers. However, for Biobanks and biorepositories there is still the challenge of getting their data to the directory.

Every Biobank has its own way of working and categorising and classifying tissue samples, but the Tissue Directory naturally expects data to be provided in a standard format and using definitions. Due to the overheads involved in retraining and redefining processes, Biobanks are reluctant to change how they work in order to fit with the data standards and formatting rules required by the directory. They also don’t want to spend hours fiddling with data to put it into the right format every time it needs to be uploaded. Birmingham-based Interactive Software Limited’s Achiever Medical LIMS provides the answer. Achiever Medical is a complete sample tracking and lab information management system that makes it easier for Biobanks to leverage the UKCRC’s online Tissue Directory.

Its dynamic transformation tool enables Biobanks to map their terminology and classifications to those needed by the Directory in the software. Importantly, it does this for both the data values and column names. What’s more, Biobanks can choose exactly which sample holdings data to send to the directory – and how often. Biobanks only need to set everything up once and then the software does the rest, automatically sending dynamically transformed and updated data. As a result, Biobanks don’t need to spend days reworking processes and retraining teams. Researchers can source tissue samples from one centralised location and generously donated tissues get used for their intended purpose – to further research. Interactive Software’s UKCRC Integration Module recently won the Innovation award at the Medilink West Midlands Medical and Healthcare Business Awards 2019. www.interactivesoftware.co.uk

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Issue 18


Clinical Need

Improving health through digital connected care

An award-winning London company is using digital health technology to change the way in which patients and healthcare providers manage chronic conditions.

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martMed Global was born from a desire to enhance the levels of healthcare provided to millions of people across the world. The company has built a digital health platform designed to put the patient at the centre of care. It focuses on four key elements to provide care that not only improves the health of the patient but also increases the efficiency of providers. The platform brings together communication, self-care, adherence and remote monitoring in a unique way.

For example, through regular vital signs and wellbeing monitoring, the company’s mobile healthcare (mHealth) system, SmartMed HomeCare, empowers patients to effectively self-manage their own longterm, chronic conditions.

Patients can take their own readings from the comfort of their own home, which is particularly beneficial for people who find it difficult to attend appointments at hospitals or clinics, and the information is then remotely assessed

by qualified healthcare professionals quickly. The platform’s algorithm enables data to be triaged quickly, thus saving time and resources. The healthcare provider can then intervene in a timely manner, ensuring the patient gets the best possible individualised care. Using the latest mobile telecoms and device technologies, SmartMed HomeCare enables patients to live healthier lives by enabling them to manage their own health monitoring from the comfort of their own homes. In addition to enhancing patient wellbeing, the platform has modules to support adherence and self-care tools to ensure that patients are fully supported in a holistic way. Furthermore, it can reduce costs for the healthcare provider (by reducing the need for unnecessary appointments) and improve the efficiency and quality of the care provided. In the long run, it can aid healthcare providers such as the NHS in taking on the challenge that is presented by the rise in chronic illness. Within the SmartMed platform, the company has built flexible solutions to help lessen the burden on community nurses and other healthcare workers as well. SmartMed HealthWorker goes a step further by equipping community nurses or healthcare workers with a set of connected medical peripheral devices, as well as a unique smartphone or tablet app and

patient records database. It allows community care providers to visit more patients in their home or community setting and gather a broader range key vital signs data and symptoms. The patient data is then uploaded to the central clinic or hospital, where specialists can analyse the results and make recommendations to the healthcare worker on treatment or referrals. The advantage is that it cuts down on healthcare workers needing to keep coming back to clinics and also uploading the data, as this is done by the SmartMed app. The SmartMed HealthKiosk provides a community healthcare solution similar to HealthWorker, except the patient comes to the Kiosk which is mostly static and can be located in a community building such as a school, library, clinic or factory. Kiosk is specifically designed for the developing world and it enables a broader range of quality healthcare assessments to be delivered into the heart of remote communities or workplaces. This is an ideal solution for online consultation in remote areas. SmartMed currently operates in a number of countries, including in Malaysia where they are working with the largest private hospital group KPJ. The company recently won the Outstanding Achievement award for the London region at SEHTA’s 2019 MedTech Business Awards. www.smartmedglobal.com

For daily lifescience news visit www.lifescienceindustrynews.com 29


Clinical Need

Making medicines more secure in the NHS

Security experts Abloy UK have worked alongside a number of West Midlands hospitals to implement its CLIQ locking technology, including Queen Elizabeth Hospital, Birmingham City Hospital and Sandwell General Hospital. MedCity is an independent, not-for-profit cluster org

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LIQ utilises mechanical, high security disc cylinders combined with highly encrypted electronic locking and identification. It provides a system of remote key management, providing access audit trails and the ability to remove lost or stolen keys.

Within healthcare, installing CLIQ on drug cabinets has made medicines more secure. As the key provides power to the lock, it also requires no batteries or wires, making it an ideal retrofit solution for the NHS. The system gives every nurse their own key, programmed to provide entry to every cabinet they are authorised to have access to and validated for the duration of their shift.

and grow life sciences investment, entrepr Subsequently, this frees up nurses’ timepromote looking London and the Greater South East of England. Thro for keys allowing more time to care and quickly administer medicines. In one instance, greater connectivity across the three pillars of indus figures from an audit of patients who felt Health Service. their painkillers were given promptly jumped “The healthcare sector is facing enormous from 79 per cent to 92 per cent following the so we’re constantly striving to the London Aca installation of CLIQ. Supportedstrain, by the Mayor of London, deliver value and innovations that will research institutes and life sciences organisations ac Abloy UK recently won the award for relieve some of that pressure. We’re a vital Frontincredibly Door to the sector. From drug discovery Delivering Innovation into Health and Care proud of the CLIQ system and at the 2019 Medilink West Midlands Medical digital health, we work withit brings industry, researchers an the tangible efficiencies to many and Healthcare Business Awards. This award trusts across the country.” investment,NHS infrastructure and expertise. recognises innovations adopted by the NHS Aaron Yule which demonstrate an impact on efficiency, Managing Director Find out more patient outcomes and system costs. Abloy at UK MedCityHQ.com or follow us on Tw www.abloy.co.uk

Your front door to the life sciences sector of England's greater south east MedCity is an independent, not-for-profit 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.

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Find out more at: MedCityHQ.com or follow us on Twitter @MedCityHQ


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When your communications really matter...

Clinical Need

Crafting design & communications for science, innovation and technology clients.

@teamworksdesign

www.teamworksdesign.com

For daily lifescience news visit www.lifescienceindustrynews.com 31


Going Global

International success for digital behaviour change platform An innovative digital platform which rewards exercise has achieved success on a global level.

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weatcoin is a clinically validated (BJSM & JMIR mHealth) application that helps individuals walk more. By providing instant reward to individuals for walking, the app overcomes the present bias that leads to physical inactivity and obesity.

The Problem In the UK, 1 in 4 adults do less than 30 minutes of physical activity a week. Obesity has grown globally by 4 per cent since 1995 and there is now an 8-year difference in the average lifespan of the richest and poorest in the UK. Obesity is estimated to have a £27 billion impact on the UK economy and is responsible for more than 30,000 deaths a year along with increased risks of colon cancer, heart disease and diabetes.

There are some existing solutions: gym memberships, fitbits and cycle-to-work schemes to name a few, but these rarely make large differences in people’s lives. In addition to gym memberships and fitbits being expensive, most gym memberships are unused by ‘blue Monday’ in January and the average fitbit’s lifespan is only 42 days, while cycle-to-work schemes are far from universal. Unless there are drastic changes, obesity levels are predicted to rise consistently.

The Solution Sweatcoin tracks and validates the steps of each individual before converting them into ‘sweatcoins’. These coins can then be used to purchase physical products and digital services from the app’s marketplace. By introducing instant rewards, Sweatcoin helps its users overcome their ‘present bias’, i.e. a preference for short-term gratification over a larger reward in the long-term. Present bias has been shown to have an adverse affect on health, as it results in individuals being less active. To counteract this, Sweatcoin

grants individuals access to immediate gratification from the most immediate, and accessible, form of exercise – walking.

Success Despite being only 5 years old, Sweatcoin has achieved global success, being launched in over 50 countries and approaching 38 million users. The app has also been number 1 in app stores across North America, Europe

and the rest of the world. The company recently won the Export award for the London region at SEHTA’s 2019 MedTech Business Awards. Not only has Sweatcoin grown across the globe, but two journals have shown that after 6 months of using Sweatcoin, individuals are 19 per cent more active than they were before.

Side Story - Sweatcoin, Diabetes and the NHS Sweatcoin is now working with the Merton CCG in London in order to help pre-diabetic patients prevent the onset of Type 2 diabetes. With Sweatcoin, the programme has seen retention increase by 30 per cent, as well as increases of up to 45,000 steps a week from some of the patients. www.sweatco.in

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Going Global

International platform for UK medical companies at Arab Health 2020 Arab Health is one of the largest healthcare exhibitions in the world and attracts businesses wishing to export their products and services to the MENA (Middle East and North Africa) region.

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his year, between 27 and 30 January, the exhibition hosted over 100,000 visitors, including clinicians, distributors, buyers and government officials, and 4,000 global exhibitors from over 160 countries. Exhibitors had a unique opportunity to showcase their products and services to leading industry experts and key decision makers, and to embark on new international collaborations. For over 20 years, Medilink UK’s International Team has organised the UK pavilion and offered professional logistical and administration support throughout the event to the huge variety of UK life sciences companies that choose to exhibit. Combining with regional and national government, Medilink UK’s International Team ensure the best provision for exhibiting and visiting UK companies. Alongside this, they have built relationships

with commercial and government partners across the Middle East and North Africa, making these connections available to UK companies wherever possible. Melissa Erwin, Medilink’s International Officer, said: “Each year at Arab Health, we support a broad variety of UK life sciences companies that want to target this region, whether they are new or experienced exporters, manufacturers or service providers – we work closely work them to understand and help deliver their goals. “Arab Health is not only one of Medilink’s key international events, but over the last 20 years has become a firm commitment in many UK life sciences companies’ annual marketing plans. We ensure that this is bolstered by supporting them in a personalised way, to ensure they get the best return on their investment when they choose to exhibit with us.

“Working alongside the Department for International Trade, every successive year at Arab Health we see ever more truly innovative products and services on offer, representing the very best that the UK has to offer.”

If you would like to find out more about Arab Health also hosted 14 conferences given by industry key players, covering areas such as radiology, orthopaedics, obstetrics & gynaecology, emergency medicine, patient experience, primary care, diabetes, healthcare investment, quality management and many more.

If you would like to find out more about Arab Health and explore international opportunities for your business, please contact Medilink UK’s International Team on 0114 232 9292 or at international@medilink.co.uk

For daily lifescience news visit www.lifescienceindustrynews.com 33


Going Global

Why MDSAP is a driver of medical device innovation Contributed by David Jensen from MasterControl

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he International Medical Device Regulators Forum (IMDRF) made 2019 a landmark year for the medical device industry. The organisation recently implemented the Medical Device Single Audit Program (MDSAP), which promises to move medical device innovation into the fast lane. With the amount of effort necessary to prepare submission materials, MDSAP will be a game-changer for medtech companies competing in the global arena.

What Is MDSAP? By definition, MDSAP allows a recognized audit organisation (AO) to conduct a single regulatory audit of a medical device manufacturer’s quality management system (QMS) based on the requirements of all regulatory authorities participating in the program. In simpler terms, “Some of the toughest regulators in the world agree on a standardised audit. If you are a participant, you will be good to go,” said Luis Jimenez, vice president of business development at Brandwood CKC. Completing a single audit instead of multiple separate audits is a huge advantage. The US Food and Drug Administration (FDA) agrees that MDSAP minimises the regulatory burden by promoting a greater alignment of regulatory approaches and technical requirements based on international standards.

The MDSAP Audit A MDSAP audit typically lasts five days with two inspectors on-site. The FDA Group recommends becoming familiar with ISO 13485:2016 as MDSAP uses it as a framework. Also, approximately 30 per cent of the audit is nearly identical to a CE (European conformity) audit. The requirements apply to the medical device organisations, suppliers and third parties providing products or components. MDSAP uses a point-based nonconformity grading system instead of the traditional grading criteria that includes “significant finding,” “regular finding” or “significant opportunity for improvement.”

Audit Stages

Documentation

The MDSAP audit begins with the AO conducting a two-stage initial audit, called the Initial Certification:

The initial audit for MDSAP requires a significant amount of documentation for each process and audit task.

Stage 1: Documentation Review – The application and relevant documentation are reviewed to assess the company’s preparedness for stage 2.

Surveillance Audits

Stage 2: On-Site Assessment – Once the AO is satisfied with your documentation and preparedness, it completes an on-site assessment to determine how the QMS complies with ISO 13485 and any other regulatory requirements of the IMDRF regulatory bodies. A MDSAP companion document includes details about the requirements and includes preparation tips.

Within two years of the initial certification audit, the AO conducts surveillance audits to assess compliance with the MDSAP QMS requirements. These audits address changes to products or a QMS since the initial audit. During the fourth year, the AO conducts a recertification audit, which assess the ability of a QMS to continue meeting the MDSAP requirements.

Countries Currently Participating in MDSAP MDSAP is progressing rapidly. Several regulatory entities in key global markets have become full participants: United States – Food and Drug Administration (FDA): Accepts MDSAP as a substitute for routine inspections. However, for cause, compliance follow-up, pre-approval or post-approval, and Electronic Product Radiation Control (EPRC) regulation inspections are still required. The FDA’s website has become the repository of documentation for the program. Canada – Health Canada: Recognizes MDSAP certificates as evidence of conformity to Medical Devices Regulations, sections 32(2)(f), 32(3)(j) and 32(4)(p). Canada is currently the only country where MDSAP is mandatory for companies selling devices in Canada. Australia – Therapeutic Goods Administration (TGA): A MDSAP audit, combined with Canadian, Japanese or FDA approval, can be used to obtain TGA registration, which includes the Australian Register of Therapeutic Goods (ARTG) of a medical device. Brazil – Agência Nacional de Vigilância Sanitária (ANVISA): Recognizes MDSAP as evidence of conformity to RDC No. 16/2013 requirements. Japan – Pharmaceuticals and Medical Devices Agency (PMDA): May perform an off-site instead of an on-site inspection or reduce documents for off-site inspection when companies submit a MDSAP report.

MDSAP Is Poised for Expansion MDSAP is expected to continue growing as more countries become participants. “So far, both medical device companies and regulators are encouraged by the program, saying the audits are well planned, more consistent and make better use of inspectors’ time,” said Jimenez. MDSAP audits reduce or eliminate steps for country-specific requirements in IMDRF jurisdictions. Manufacturers who are ISO 13485 certified are already well on their way to compliance. www.mastercontrol.com/uk/

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People and Places

Medilink UK appoints new CEO Medilink UK, the largest representative body for the Health Technology sector in the UK, has appointed Kevin Kiely as its CEO.

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evin was co-founder of the Medilink model over twenty five years ago, which for the first time brought together in a formal regional association, the health technology and related life sciences industry, the NHS and universities, to drive innovation across the sector.

During this time, he has developed a deep understanding and connectivity with the sector throughout the UK and overseas, which plays a key role in the health and wealth of the nation. Kevin is uniquely placed to work with national agencies to ensure that the needs of the health technology and related life sciences sector are fully considered in all future developments and that opportunities, post Brexit, are realised. Bill Cruise, Medilink UK Chairman, said:

Our industry has always been on the front line when it comes to responding to the changing needs of healthcare delivery but never before has this been more visible than in the current Covid-19 crisis - whether this be in developing antigen / antibody tests, precision engineered components for ventilators, the supply of PPE or accelerating the production of urgently needed medical equipment. It has never been more important for Medilink UK to have national representation and I feel privileged to have been asked to undertake this role.”

“The strength of Medilink UK continues to be the in-depth relationships that its constituent Medilink organisations have in regions across the UK. However, the sector is facing unprecedented challenges, not least with the current Coronavirus pandemic, and it has become clear that Medilink UK needs to play a more proactive national role if challenges are to be overcome and future opportunities realised. I am therefore delighted to announce the appointment of Medilink UK’s first national CEO, Kevin Kiely.” Kevin Kiely said: “Having been involved in the development of regional Medilink organisations across the UK for over 25 years, and seeing the Medilink UK infrastructure grow to a point where it is now the largest representative body for the health technology industry, I understand many of the challenges facing our members, not only now with the unprecedented impact of the coronavirus pandemic but with the ongoing challenges of innovation (particularly regulation) and internationalisation.

Medilink UK is a national representative organisation for the health technology and related life sciences sector. It is a unique partnership between industry, the NHS, universities and UK Government organisations, with a strong track record in increasing the viability of manufacturers, service providers, designers, OEMs and suppliers of healthcare technology. Medilink UK plays an important role in driving the health and wealth of the nation by addressing the day-to-day issues that face the health technology and related life sciences sector and helping drive the development of products and services from concept through to commercialisation, as well as nurturing collaboration between academics, clinicians and industry. Medilink UK brings together regional Medilink organisations into a vibrant national partnership and is the largest representative healthcare technology body in the UK, with over 1600 member organisations

www.medilinkuk.com

For daily lifescience news visit www.lifescienceindustrynews.com 35


People and Places

Business award for Loughborough entrepreneur Pharmaceuticals boss and business leader Dr Nik Kotecha OBE has been named the Entrepreneur of the Year at the 2019 Lloyds Bank National Business Awards.

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he flagship national awards honour the UK’s most creative and innovative businesses and business leaders who set new standards of excellence within their industries. Dr Kotecha was nominated alongside some of the country’s most inspiring and visionary entrepreneurs for his work in growing Morningside Pharmaceuticals from a garage start-up in the 1990s to one of the Midlands’ leading life sciences businesses today.

Morningside Pharmaceuticals, based in Loughborough, manufactures and supplies quality medicines to the UK and internationally. Since inception, the company has exported to more than 100 countries globally, in addition to supplying NHS hospitals and pharmacies twice daily in the UK.

Dr Kotecha said: “I am truly honoured and humbled to receive this award, which I would like to dedicate to the hard work, dedication and commitment of our employees. Morningside was founded through an entrepreneur’s dream of making quality healthcare an affordable and accessible reality throughout the world, and has grown to become one of the Top 100 companies in Leicestershire today. Our focus has been on innovating and developing niche generic drugs, which in turn has enabled Morningside to grow to a size so we are in a position to support a wide range of good causes connected to sport, education, health and the community. Our commitment is to work with communities to bring them together and improve the quality of life of the people living there. I hope this national award helps shine a light on how successful businesses, through corporate social responsibility, can make a real difference to the communities they operate in.”

In the true spirit of an entrepreneur, Dr Kotecha was also honoured for establishing his own Charitable Foundation, which is focused on saving lives, helping the socially disadvantaged and improving quality of life for those in need in the UK and around the world. The Randal Charitable Foundation has already donated significant grant funding to a number of local, national and international good causes. In addition to his business and philanthropic work, Dr Kotecha also gives his time to the local community through involvement with Board and Advisory positions for business organisations, government departments, industry associations and charities. This includes being a CBI Regional Councillor and a Department for International Trade (DIT) Export Champion. The award judges were impressed with Dr Kotecha’s history of innovating to grow his businesses. They also commended his clear philosophy of learning every part of his companies in detail, while building a team around him, and then moving onto his next challenge.

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 “The leaders we meet are truly premium premises in the city. building very much inspirational, andThe Dr Nik Kotecha’s work fitswith withMorningside our brand – it’s iconic with a quirky Pharmaceuticals feelisand, like us, it dares beinnovation different.” a stellar example ofto the

and leadership it takes to grow an The company has come a long way since Nic organisation from the ground up. We’re moved into a one-person office in the city delighted to be able to celebrate this many years ago, adding: “Actually, it was more incredible story of UK and international a cupboard! However, it helped me launch the success.” business.” Richard Alvin Interim Awards Director

Dr Nik Kotecha OBE www.morningsidepharm.com

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People and Places

Awards celebrate the success of healthcare organisations across the North of England The Medilink North of England Healthcare Business Awards 2020 brought together pioneering healthcare organisations from across the North to celebrate their achievements and the contributions they have made to patient care.

“I’d like to congratulate our winners and our runners up, for all the hard work they have done in improving patient care and driving the Northern economy.” Kevin Kiely Chief Executive Officer of Medilink North of England and CEO of Medilink UK

Individuals and organisations from across the NHS, academia and industry competed in several categories, including primary care, acute care, digital health, exports and innovation. The winners were as follows: Innovation Award

Primary Care Award

Sky Medical Technology

Evergreen Life

Sky Medical Technology is a global medical devices company based in Cheshire. Developer of the innovative bioelectronics technology platform OnPulse, the business is helping clinicians solve some of healthcare’s biggest challenges.

Wellness and GP services app, Evergreen Life empowers everyone with access to up-to-date, personalised health and wellbeing information, helping you make informed decisions to increase your healthy and happy years.

Export Achievement Award

Cievert

Tissuemed Ltd in Leeds is a company specialising in the development, manufacture and worldwide sales of a unique surgical sealant technology.

Cievert provides the NHS with innovative software to better manage patients from diagnosis to recovery in oncology and beyond. Its software has helped treat well over 100,000 patients to date.

Advances in Digital Healthcare Award

Start Up Award

National Pathology Exchange (NPEx)

LightOx

NPEx enables laboratories to exchange requests and reports for send-away tests electronically and offers a globally unique and integral service, contributing to the future proofing and efficiency of diagnostics in healthcare.

LightOx is developing light activated drugs for the treatment of oral cancers. It aims to provide clinicians and patients with alternative options to surgery in pre-cancerous and early stage cancer.

Tissuemed

Partnership with Academia Award

Acute Care Award

University of Manchester and MIRA Rehab The University of Manchester’s research has real-world impact beyond academia. It is at the forefront of the search for solutions to some of the world’s most pressing problems, seeking to be a global force for positive change.

Outstanding Achievement Award

Yourgene Health

Yourgene Health is an international molecular diagnostics group which develops and commercialises genetic products and services, enabling scientific advances to positively impact human health.

www.medilink.co.uk

For daily lifescience news visit www.lifescienceindustrynews.com 37


Money

Investment boost for nanoparticle manufacturer

Foresight Group has invested £749,000 into Promethean Particles, a Nottingham-based company specialising in the manufacturing of nanomaterials.

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he investment has been made using finance from the Midlands Engine Investment Fund. It is also part of a £1.25m funding round led by Foresight and supported by the University of Nottingham, East Midlands Early Growth Fund (managed by the British Business Financial Services) and other existing investors. The finance boost will allow the firm to create new jobs, scale its production capabilities and enter untapped global markets. Promethean was founded in 2007 as a spinout from the University of Nottingham, to commercialise an innovative technology based on the research of Professor Ed Lester. The company designs and manufactures high-specification nanomaterials which carry specific chemical and physical properties. To date, the production of nanoparticles has largely been restricted to batch manufacturing or dry technologies that can experience issues

relating to quality, safety and scalability. Promethean has developed a revolutionary continuous flow reactor, the largest continuous multi-functional nanoparticle production capability in the world, which provides the ability to manufacture at scale and improve process reproducibility and reliability. Promethean is working with industry-leading organisations to enhance the efficiency and effectiveness of speciality chemical inputs in a range of markets including inks, printed electronics, and gas capture and storage. The investment is estimated to support the creation of over 20 new jobs in the next three to five years. Commenting on the investment, Adam Huckerby, Investment Manager at Foresight, said: “Promethean has developed a truly unique design and manufacturing capability and is well-positioned to meet the market opportunities present. We are looking forward

to partnering with Laurie, Ed and the wider team to support the growth of this innovative, local business over the coming years.”

“We are delighted to have Foresight’s backing through the Midlands Engine Investment Fund and it will be a terrific asset to be able to tap into their experience and expertise in the region. This investment comes at a key stage in our growth cycle, and the support of Foresight and our existing investors will be significant in helping us achieve our long-term commercial goals.” Laurie Geldenhuys CEO Promethean Particles

www.prometheanparticles.co.uk

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Money

Spin-out offering new hope for dialysis patients raises funding Invizius, the University of Edinburgh spin-out whose technology could help reduce the high death rates amongst dialysis patients, has raised £2.75m from a consortium of investors.

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he funding round was led by Mercia and included Downing Ventures, the University’s Old College Capital fund and the Scottish Investment Bank. This latest investment will support the company as it conducts pre-clinical testing and manufacturing, and prepares to enter clinical trials and to raise Series A funding. Invizius’s technology stems from research by the company’s co-founder and CTO, Dr Andy Herbert, and his team who believe it could reduce the huge death toll from cardiovascular disease among long-term dialysis patients. Currently life expectancy on dialysis is just onethird of normal, and half of patients die from cardiovascular complications. The problem is that the immune system sees the dialysis filter as a foreign body, creating inflammation that damages the cardiovascular system over time. The company’s H-Guard product is a powerful anti-inflammatory which can be used to coat the filter surface to ‘hide’ it and prevent an immune response. The technology also has

potential for use with devices such as heart and lung machines, stents and grafts or in organ and cell transplants. Invizius has won awards including OBN Best Innovative Medtech and was named as one of the Fierce 15 Medtech companies to watch. Invizius was Mercia’s first investment following its partnership with the University of Edinburgh. Since its initial £500,000 investment in April last year, it has worked with the company to develop its offering and attract other investors. The Invizius team is supported by Edinburgh Innovations (EI), the University’s commercialisation service. EI has also helped develop the partnership between Mercia and the University, and manages Old College Capital. Dr George Baxter, Chief Executive Officer of Edinburgh Innovations, said: “This substantial investment reflects the great promise we’ve seen in Invizius from the initial identification of novel science, and the University is pleased to

join the consortium in backing this technology, which holds so much potential for so many people.” Invizius received early-stage funding from Scottish Enterprise’s High-Growth Spinout Programme, with the agency now following this up with support from its investment arm, the Scottish Investment Bank (SIB).

“Our goal is to bring much-needed improvement to the lives of three million dialysis patients. This investment allows us to take a big step towards this, and we are delighted to have won the backing of a consortium of smart, well-funded investors.” Richard Boyd Co-founder and CEO Invizius

www.invizius.com

For daily lifescience news visit www.lifescienceindustrynews.com 39


Regulatory

Top 5 tips for medical device IP protection Katherine Wright, of AdamsonJones gives her top 5 tips on intellectual property protection for medical devices...

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in development about the potential protection that might be obtainable are crucial, as a patent application must be filed before the product is made public.

1. Freedom-to-operate

Choosing the appropriate time to file a patent application is also important: too early and there may be insufficient information available to file a strong application, but a delay until every aspect of the product is finalised risks a third party developing and seeking protection for a similar product in the meantime. Early and ongoing discussions with a patent attorney can help to identify the most appropriate point in the development of a technology to file a patent application.

he field of medical devices is highly innovative and an area in which there are large numbers of existing patents and registered design rights. When developing new products, it is important to consider both your freedom to work in view of existing rights, as well as potential protection for your own products.

As protection is often sought for even minor innovations in medical devices, there is a crowded field of pending and granted patent and design rights relating to all types of medical device. These existing rights can stand in the way of a medical device you intend to bring to market, or it may be possible to design around them. Seeking advice during the development phase of your product enables potentially problematic patents and/or registered designs to be identified and analysed at an early stage, before significant amounts of money have been invested into tooling and equipment.

2. IP protection – is it possible and/or appropriate? It is also important to consider whether a new device or process can be protected by a patent and/or by design rights, and whether trademark protection is appropriate for the product name or logo.

3. Discuss patent options early in the development process A patent can be used to protect a technical innovation or new manufacturing process. Where patent protection is a possibility, discussions at an early stage

4. Consider protecting the appearance of the product with a registered design Design rights protect the appearance of a product and may be applied for in conjunction with a patent application, to protect the appearance as well as the function of the product. Alternatively, a design right may be sought where the new development is not sufficiently innovative for a patent protection application to be worthwhile, but where the appearance of the product is original. Unlike when applying for a patent, there is a short grace period (six months) after a product has been made available to the public, during which an application for a registered design right may be filed. In addition, registered designs are granted comparatively quickly, providing fast protection, but their validity is not tested unless and until the design right is asserted against an infringer.

5. Consider trademark protection before a name or logo is finally fixed For any medical device, there are typically a number of companies producing goods that fulfil a similar need, and the ability to differentiate your product from those of your competitors through a distinctive brand is important. A trademark is a sign, symbol or graphic which identifies products from a particular source, and registering your trademarks enables you to prevent a third party from being able to copy the name or logo associated with your product. An application for a trademark may be filed at any time, but there are certain limitations e.g. the trademark may not be descriptive of the product. In addition, the trademark application may be opposed by companies who hold similar marks. Although it is normally possible to overcome oppositions of this nature, perhaps through settlement or agreement to limit the trademark to a particular subset of goods, consideration of trade mark protection before a name or logo is finally fixed means that there may be some flexibility to modify or change a mark should it be found not to be allowable.

In summary Particularly in the crowded field of medical devices, freedom-to-operate and potential protection (patents, designs and trademarks) should be key aspects of any product development, considered alongside and helping to drive the development process. Ideally, these issues should be considered at an early stage of product development, with regular reviews to ensure that significant time is not invested in technology already protected by a third party, and to ensure that the correct protection is being sought for your own innovations. www.adamson-jones.co.uk

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Issue 18 www.abhi.org.uk


Regulatory

MDR: the importance of the Clinical Evaluation Report

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ollowing the introduction of the Medical Device Regulation (EU 2017/745), the amount of evidence and analysis required to demonstrate product safety and benefits has increased, creating an issue for companies on tight budgets and with limited experience of compiling regulatory documentation. The most likely source of non-conformities during audits is not having the right clinical evidence in the right format within the technical file. This means companies fail to present sufficient clinical evidence to support indications and claims they are making with the appropriate level of analysis to show that the benefits outweigh any risks.

and creation of CERs to MEDDEV/2.7.1. Rev4 and MDR standard, having written them for both SMEs and multinationals since 2010. Working with you on strategy for your product portfolio through to production of individual CERs, we have a proven track record of quality, receiving excellent feedback from the notified bodies.

Clinical Evaluation Report (CER) The CER is much more than just a comprehensive list of available clinical evidence. It is a substantial document requiring regular updating according to device classification, accompanying the product throughout its lifecycle.

Medilink is your ideal partner for maintaining regulatory compliance.

It must be aligned with all marketing, product literature and even the product website. Authors must be qualified according to criteria laid down in the MDR and equivalent data is no longer acceptable under most circumstances.

For a no obligation chat about your CER needs, please call Tom Wright on 0114 232 9282 or email innovation@medilink.co.uk to discuss your requirements.

Medilink North of England is a highly experienced team specialising in the planning

Business Services Who are we?

• One of the largest not-for-profit health technology networks in Europe • Over 1300 members from over 20 countries representing Academia, Business and Care/Clinicians, representing around 1000 Healthtech SMEs • Provider of support on a one-to-one basis through our consultancy services and one-to-many through an extensive programme of workshops, training and other topical events

What’s the offer? • Access - through us to our unrivalled address book of over 14,000 contacts in business, universities, the NHS and care sectors • Grant-writing + project participation - including SBRI, InnovateUK and NIHR (over £3 million raised for SMEs since 2017) • Consultancy - commercialisation strategy, market understanding, health economic modelling, product development focus groups, fund-raising, and IP, regulation and product design through our partners • Mentoring and coaching - 1:1 Accessing the NHS and Care Sector and Business Planning Surgeries – with over 300 carried out in the last 3 years • Event organisation - support and management for profile raising, partnership building and networking

Past and present customers: Aerobit Clean Blue Greater London Authority Hygga

Psephos Biomedica

Anglia Ruskin University Cystic Fibrosis Trust Greenwich University Imatis Kings College London Mind over Matter Oxford Heartbeat Queen Mary University London

Toshiba

University of Portsmouth

Xenzone

xim

Kent Surrey Sussex AHSN MedCity ORCHA

Applied Nanodetectors

AT Kearney

Brunel University London

DynamX Medical

East Sussex NHS Trust

Exhalation Technologies

Hempsons Imperial College London

Hepro Imperial Innovations London Borough of Tower Hamlets NIHR i4i

Hill Dickinson Kent County Council

Knowledge Transfer Network Mosaic Surgical PDD Innovation Savonia Finland University of Surrey

Pfizer Tekiu Wessex Clinical Research Network

Contact SEHTA today for more details – info@sehta.co.uk

London South Bank University Odin Vision Portsmouth Hospital NHS Trust The SEEK Group Wiltshire County Council

www.sehta.co.uk

For daily lifescience news visit www.lifescienceindustrynews.com 41


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MEDICAL DEVICE PRODUCT DESIGN & VA L U E E N G I N E E R I N G

Working in partnership with the medical and pharmaceutical industry our product design optimisation has helped deliver medical advances and commercial success for many clients. Our multi-disciplinary design engineering team will analyse and optimise the design to improve a products’ function and form, alongside a review of the manufacturing costs. Find out how we could improve your medical products.

www.g xg ro u p.co m +44(0)1291 673437 PRODUCT DESIGN

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VA L U E E N G I N E E R I N G


Partnership is the key to a flourishing Lifescience Industry

DISCOVERING HEALTH TECHNOLOGY

Written by the sector, for the sector. In print and online, Lifescience Industry magazine is supported by some of the UK’s most respected medical organisations.

Partner organisations Medilink UK Partners

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

MediWales The Maltings East Tyndall Street Cardiff CF24 5EA Tel: +44 (0)29 2047 3456 www.mediwales.com

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 44 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