UK Lifescience Magazine Issue13

United Kingdom

Issue 13

INDUSTRY

Advances in health technology

A vision for life science in the UK?

INSIDE: Enhancement:

Improving medical technology

Future watch:

Potential healthcare game changers

Meeting the unmet:

Responding to unmet clinical needs

Going global:

Cracking global markets

A look at the Government’s Life Sciences Industrial Strategy and how it aims to keep the UK a world leader

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A message from the editor

The Government’s Life Science Strategy examined

This edition

Welcome to this edition of UK Lifescience Industry, published in November 2017.

To begin with, the ‘Enhancement’ section highlights wearable technology that is improving patient monitoring for the benefit of clinicians, researchers and the patients themselves, as well as a breast cancer imaging system designed to make screenings safer and more accessible. Other improvements to healthcare include a box for quicker treatment of sepsis, care packs for more comfortable hospital stays, and new technology for better antimicrobial protection.

Issue 5

Moving onto ‘Future Watch’, a study of concussion in rugby could lead to the development of a game-changing diagnostic device. This section also covers a brand new technology to diagnose and monitor COPD, plus an innovation that allows doctors in A&E to more rapidly determine whether a patient is suffering from a heart attack. Meanwhile, a jellyfish collagen manufacturing base has recently been launched in Cardiff and a national healthcare photonics centre in Sedgefield is on its way.

Enhancement

Going global

10 Wearables move patient monitoring outside of the hospital

22 Nordic Life Science Days

11 New technology for improved breast cancer screening Issue 5

24 A global approach to auditing 2012 ISSUE 4 medical device manufacturers

23 International projects for digital health solutions provider 2012 ISSUE 4

12 Care packs for a more Issue 5 2012 ISSUE 4 comfortable hospital stay

25 Northern Powerhouse trade missions

13 Controlled-release antiseptic technology provides better antimicrobial protection

26 Global potential for sight-saving bandage

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Avision for life science in the UK?

A look at the Government’s Life Sciences Industrial Strategy a nd how it aims to keep the UK a world leader The life science industry represents one of the dominant economic sectors in the UK. It has the advantage of very high productivity in comparison to other sectors and generates a wide range of products including drugs, medical technology, diagnostics and digital tools, as well as products for consumer health. The sector is also widely distributed across the whole of the UK and brings significant jobs and growth to virtually every region.

Professor Sir John Bell was asked by the Government to produce a report that laid out the life science industry’s vision of how the UK might exploit its existing strength to increase the pace of economic growth in this sector.

August 2017 saw the publication of the Life Sciences Industrial Strategy, written by Professor Bell in collaboration with industry, academia, charity and research organisations.

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UK Lifescience Industry Magazine

The report seeks to address a series of challenges under five key themes: Continuing support for the science base, maintaining strength and international competitiveness.

Science

Growth

NHS

Data

Skills

Encouraging an environment where companies can start and grow, building on strengths across the UK, including expansion of manufacturing in the sector.

Improving NHS and industry collaboration, facilitating better care for patients through better adoption of innovative treatments and technologies.

Making the best use of data and digital tools to support research and better patient care.

Ensuring that the sector has access to a pool of talented people to support its aims through a strong skills strategy.

One proposal of the report is the creation of a Health Advanced Research Programme (HARP) to undertake large research projects and high risk moonshot programmes. This would enhance the UK’s capabilities for discovery and development of new medicines, create new diagnostics and medtech capabilities, and build companies to develop whole new areas of medical innovation using, for example, data analytics and artificial intelligence.

To reinforce the UK’s science offer, the report gives recommendations for sustaining and increasing funding so that basic science can match international competition and clinical trial capabilities can be improved.

The strategic goals of its suggested measures are to attract discovery scientists from around the globe to the UK and to see a 50 per cent increase in the number of UK clinical trials over the next five years.

In terms of infrastructure, the report notes the importance of ensuring that the UK’s tax environment supports growth and is internationally competitive in supporting longterm and deeper investment. It also highlights the value of nurturing life science clusters and attracting substantial investment to manufacture and export high value life science products of the future.

For improved collaboration with the NHS, the report states that the Accelerated Access Review should be adopted, with national routes to market streamlined and clarified, including for digital products. It specifies that in the next five years, the NHS should engage in 50 collaborative programmes in late-stage clinical trials, real world data collection, or in the evaluation of diagnostics or devices, and that the UK should be in the top quartile of comparator countries, both for the speed of adoption and the overall uptake of innovative, cost-effective products, to the benefit of all UK patients by the end of 2023.

A core recommendation in relation to data is that two to five digital innovation hubs, providing data across regions of three to five million people, should be established as part of a national approach and building towards full population coverage. It adds that a forum for researchers across industry, academia and charities would allow them to engage with all national health data programmes, giving them access to a meaningful dataset. Another suggestion is that the UK could host four to six centres of excellence to provide support for specific medtech themes, focusing on research capability in a single medtech domain such as orthopaedics, cardiac, digital health or molecular diagnostics.

Finally, the report emphasises the importance of a migration system that allows the UK to recruit the best international talent and retain highly skilled workers from the EU and beyond. Also in the area of skills, it recommends developing and delivering a reinforced skills action plan across the NHS, commercial and third sectors based on a gap analysis of key skills for science. This would encompass apprenticeship schemes, technical training, entrepreneur training, school STEM education and more.

As the UK plans its future outside the European Union, identifying and supporting specific sectors of the economy to grow and expand quickly becomes a clear priority. Life sciences are a major component of the current economic base of the UK, with the sector generating £64 billion of turnover and employing more than 233,000 scientists and staff.

The Life Sciences Industrial Strategy was designed to serve as a blueprint for investment by Government and the private sector to strengthen and enhance the UK’s capabilities in life sciences, thereby driving more rapid economic growth and development of new technologies for the ultimate benefit of patients.

Comment from Medilink UK: “We are pleased that the UK Government has identified the life sciences sector as being vitally important for the future economic success of the nation.

The close relationship between NHS and industry, the need to embrace digital advances, and the need to maintain the UK’s research base and skills pool are all essential for the continued success of the sector.

In addition, we would stress the need to increase support for the development of international market opportunities, while recognising the vital role that regional networks and support organisations play in developing the sector across England, Scotland, Wales and Northern Ireland.”

Gwyn Tudor, MediWales

UK Lifescience Industry Magazine

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Enhancement Wearables move patient monitoring outside of the hospital

There are currently around 7,000 rare diseases affecting 30 million people in Europe, 75 per cent of whom are children. Aparito provides wearable devices and disease-specific mobile apps to enable remote patient monitoring outside of the hospital environment. These deliver relevant, real-time patient data to clinicians in a way that supports and enhances monitoring of response to drug therapy and care provision.

Data captured from an aparito wearable can be set to parameters according to disease manifestation including heart rate, ambulation, sleep pattern, body temperature, calories, skin temperature and barometric pressure. The device is able to trigger alerts, empower patients to better manage their disease, and help inform clinicians in treatment decisions.

The fact that wearable devices operate constantly, passively gathering data from the patient, means that a better

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UK Lifescience Industry Magazine

understanding of diseases can be gained. Clinicians or researchers examining the data are able to get a broader, more consistent view of a patient’s condition in a wide range of environments, as oppose to the snapshot that is obtained at a hospital appointment.

Gathering information for clinical trials is often a lengthy, costly process, with patients typically having to see clinicians or researchers at specific intervals in hospital to record data. Remote collection of data via wearable devices makes the process not only more convenient and less time-consuming for everyone involved, but also reduces human error that can sometimes lead to lower data quality. Wearable devices allow trials to be conducted anytime and anywhere in the world, broadening the scope of research, and to collect data in real-time and in a real-world context, meaning that researchers get a more accurate picture of how a treatment works or how a disease progresses on a day-to-day basis.

In addition, aparito offers wearables that are smaller and more attractive to wear, with a longer battery life and no input from patients required. This makes the devices more user-friendly, which is a significant factor in clinical trials.

It is typically more difficult to capture consistent, reliable data from paediatric patients and this leads to many clinical trials showing inconclusive outcomes.

However, aparito wearables are suitable for all ages and their user-friendliness makes them easier to adopt.

Aparito was recently chosen to join DigitalHealth.London’s accelerator programme which aims to speed up adoption of technology in London’s NHS, relieving high pressure on services and empowering patients to manage their health. The company was also selected for the Bayer Grants4Apps scheme in Berlin to enhance the use of digital solutions in clinical trials.

www.aparito.com

New technology for improved breast cancer screening Medical diagnostic company Micrima has developed a unique breast cancer imaging system. The aim of the technology is to help breast screening become safer, more comfortable and more accessible for the global female population, particularly for women with dense breast tissue, such as young and/or pre-menopausal women and women of all ages from the Far East.

Unlike x-ray mammography (XRM) which uses ionising radiation, Micrima’s MARIA™ system uses harmless radio-waves to detect breast cancer. The process takes less than five minutes and requires no breast compression, which some women undergoing XRM find painful.

With discomfort being one of the main reasons given by women for not attending mammography appointments, this new system could improve attendance and therefore save lives.

MARIA™ is a whole breast method of imaging, compared to some systems which use a handheld probe and require the operator to know where to look for a lesion.

It has been trialled on over 400 women in the UK, with further studies taking place at leading European clinical centres, and has been found to be more effective than current imaging methods in dense tissue.

rates had been recognised, Micrima was launched as a spin-out company.

“Breast cancer is the most common cause of death in women between the ages of 35 and 55 in Europe and the leading cause of death for women in many countries. The problem is that many tumours are not discovered early enough, largely due to the difficulty in discriminating between cancers and dense tissue using current imaging technology.

Using harmless radio-waves, the MARIA™ imaging system is capable of detecting tumours in dense tissue and allows routine and repeated scanning without any of the safety or comfort concerns associated with x-ray mammography.”

Roy Johnson Executive Chairman Micrima

The technology was initially pioneered at the University of Bristol, and once the impact that it could potentially have on breast cancer detection and mortality

During 2013, the prototype MARIA™ system was deployed in clinical trials at Frenchay and Southmead Hospitals in Bristol. The successful results from these early trials led to European regulatory approval, via the attainment of CE marking in 2015. Following more funding and clinical trials, the system has now had a controlled launch to the early adopter market. It is currently being used in symptomatic clinics and the company hopes that it will eventually be a viable alternative to XRM in breast screening.

The company has also been granted Innovate UK funding to adapt MARIA™, enabling biopsies to be performed using the same device that is used to capture diagnostic radio-wave images of the whole breast. A prototype of this new system is now being developed.

Micrima won the innovation award at the 2016 Medilink South West Business and Innovation Awards.

www.micrima.com

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UK Lifescience Industry Magazine

Care packs for a more comfortable hospital stay Personal Care Packs is a Leicester-based social enterprise set up by Giving World, a charity that helps the most vulnerable people in the UK. 100 per cent of profits from the sale of their packs are gifted to the charity, with every £100 helping 200 people in need.

Many patients are admitted to hospital at short notice, which means that some come ill equipped for their stay without even basic hygiene essentials. Evidence indicates that nurses spend more than five minutes per patient obtaining essential items for patients, taking up valuable time they could be spending on other tasks. The alternative is that patients survive without, which naturally has a negative impact on their wellbeing.

The packs have been developed in collaboration with over 50 NHS trusts across the UK to address the most common needs of patients and frontline staff. They have also been designed to support key NHS strategies around infection control, falls prevention, sleep and good communication. Packs can be tailored to meet specific requirements and include maps, questionnaires and information about hospital facilities, allowing staff to spend more time on nursing and compassionate care.

In collaboration with the Health Innovation Network, a trial of PCPs took place over winter 2016-17 amongst the network’s South London members, including King’s College Hospital NHS Foundation Trust, Lewisham and Greenwich NHS Trust and Epsom and

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UK Lifescience Industry Magazine

St Helier University Hospitals, as well as in a mental health service for homeless people run by South London and Maudsley NHS Foundation Trust.

During the trial, nursing staff gave the packs to patients. 262 patients filled in feedback cards and 68 nurses completed surveys. The University of Leicester also used observational techniques to understand the impact that the packs had on patient and staff experience.

The study found that 94 per cent of patients felt that PCPs ensured they felt cared for during their hospital stay.

Meanwhile, 84 per cent of nursing staff felt that PCPs saved them more than five minutes per patient. Consequently, the packs have the potential to free up 40 minutes per shift, ensuring more effective nursing and saving the NHS £1,705 for every band four nurse. 93 per cent of nurses in the study also felt that

PCPs encouraged positive interactions with patients.

Personal Care Packs won the award for the Collaboration with the NHS at the 2016 Medilink East Midlands Business Awards.

www.personalcarepacks.com www.sehta.co.uk

Enhancement

Controlled-release antiseptic technology provides better antimicrobial protection Chlorhexidine (CHX) is a common, safe and cheap biocide used extensively in healthcare to kill microbes and bacteria without damaging the contact area. It is used widely in medicine, dentistry and veterinary care to both prevent and treat infection, for instance in pre-and post-surgical skin swabs, oral rinses and wound dressings.

With all current CHX based products, the duration of antimicrobial activity is limited.

The CHX may be delivered to the site of infection or prevention, but it is highly soluble and can be quickly removed by fluids such as saliva or sweat, as well as through bathing or abrasion. Obtaining long-term local delivery of CHX is therefore an aspiration in many fields of healthcare.

Its broad-spectrum efficacy means that if a CHX-rich environment could be maintained in an area at risk of infection, this could provide a potent protective effect. If applied to an area already colonised by pathogenic microbes, a sustained supply could bring the infection under control in addition to providing ongoing protection against reinfection.

“We’re very excited about Pertinax’s potential. In time we expect the technology to also find application in a range of areas in human and veterinary medicine, where it will be a very useful tool, particularly as antibiotic resistance becomes more prevalent and doctors turn to nonantibiotic technologies to protect and treat their patients.”

Dr Michele Barbour Founder and CSO Pertinax Pharma

Bacterial resistance to antibiotics is a matter of global concern, with many mainstream antibiotics beginning to fail as microbes evolve resistance to their specific modes of action. Biocides such as CHX are considered to present lower risk of resistance, since their mode of action is non-specific compared with antibiotics, so genuine resistance is less likely. Furthermore, because Pertinax delivers its CHX payload at a steady and sustained rate, it can maintain a clinically optimal dose of antiseptic for a sustained period using fewer interventions than conventional CHX would require. This eliminates the risk of periods of suboptimal antiseptic concentrations, which can drive resistance.

Pertinax Pharma won the start-up award at the 2016 Medilink South West Business and Innovation Awards.

www.pertinaxpharma.com

Dr Michele Barbour and her research group at the University of Bristol have developed a slow-release technology for CHX. The patented technology, called Pertinax™, provides a continual release over a controllably variable period of time and the duration of its effectiveness can be tuned to clinical need, from days to weeks or even months. It has a proven efficacy against a wide range of bacteria and yeasts, including common organisms such as Staphylococcus, Psuedomonas, E coli and Candida, as well as antibiotic-resistant microbes such as MRSA. In 2015, Pertinax Pharma Ltd was established to commercialise the new technology. One primary market for the company is wound care, where the material will be used to create dressings which protect against wound infection, lowering complications associated with accidental and surgical wounds while minimising dressing changes. Another market is dental materials, where it will help to lower the failure rate of dental fillings following tooth decay.

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UK Lifescience Industry Magazine

Quicker sepsis treatment with SepsisBox Early diagnosis and quick action are vital to the successful treatment of sepsis, which occurs when the body’s systemic response to a microbial infection causes damage to its own tissues and organs. Sepsis can result in multiple organ failure and is responsible for an estimated 44,000 deaths in the UK every year.

Procedure pack specialist Rocialle has created SepsisBox so that healthcare professionals can provide better care for people suffering from sepsis, thereby improving patient outcomes. It is the result of a collaboration between South Wales based Rocialle, Cwm Taf University Health Board and 1000 Lives Improvement.

Inside SepsisBox are six compartments with numbered doors, containing the items needed to deliver each step of the ‘Sepsis Six’. These are measures that have been found to reduce the risk of mortality by 46.6 per cent when performed within an hour of recognising sepsis. By providing these vital items as well as clear guidance on the procedural pathway, the box equips nurses to start time-critical treatment themselves, without needing to wait for a doctor or critical care specialist.

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The Cwm Taf version of SepsisBox facilitates delivery of the Sepsis Six as follows: 1. Give oxygen to maintain saturations >94 per cent

The box is single-use, so there is no need to frequently replenish the items inside and there is only one date to check. The items are each inside their own sterile packaging.

2. Take urine samples and commence accurate urine output measurement

NICE has initiated an extensive campaign to have sepsis treated as an emergency, in the same way that a suspected heart attack is addressed.

A rapid response to sepsis is crucial, as it can save lives and also lower the risk of complications such as limb amputation, long-term organ or tissue damage and post-traumatic stress.

With better patient outcomes, patients spend less time in hospital and fewer patients need to be transferred to the

4. Using ANTT, insert IV cannula to facilitate antibiotic therapy

UK Lifescience Industry Magazine

3. Take blood cultures and consider source control, measure serum lactate and send full blood count

5. Administer empiric intravenous antibiotics 6. Start intravenous fluid resuscitation

Critical Care Unit, so costs are cut and strain is reduced for the NHS. SepsisBox has been adopted by NHS and private hospitals in both Wales and England, and the collaboration between

Rocialle, Cwm Taf UHB and 1000Lives has won awards from Insider Magazine and MediWales.

www.rocialle.com

Enhancement

Optimising your clinical trial master files Patricia Santos-Serrao, the market segment manager of global pharmaceutical, blood and biologics at MasterControl, provides an insight into optimising clinical trial master files.

With evolving regulatory and global industry challenges, effectively managing clinical trials is an ongoing issue. To comply with regulatory requirements pertinent to clinical trials, every organisation that launches a clinical trial must manage and maintain all trial-related content, documents and data in a manner that not only supports the claims to the safety and efficacy of a product, but also serves as evidence that the trial was conducted in a compliant manner. Depending on the regulatory jurisdiction, this information may be stored in a collection called a trial master file, or TMF, which today most commonly takes the form of an electronic trial master file (eTMF).

The eTMF needs to be both accurate and organised in a way that is acceptable for evaluation by regulatory inspectors as well as sharing internally and externally.

An often forgotten aspect of an eTMF is the need to exchange, share and collaborate on documentation with external parties such as clinical research organisations, sponsors, medical writers, principal investigators and other external contributors to the study. A number of documents are originated from clinical sites, such as CVs, FDA forms and IRB approvals. Multiply these by the number of sites and studies that a clinical associate interacts with and it can become a full-time job managing, importing and indexing documents.

Managing thousands of clinical study documents, tasks and processes using a paper-based or hybrid TMF system can be overwhelming and introduce errors and oversights that put a clinical trial at risk of noncompliance. Leveraging eTMF best practices can allow an organisation to have the insight needed to efficiently manage clinical trials and, ultimately, get products to market faster.

TMF Reference Model The best way to create and manage an eTMF is to follow the standards set by the Trial Master File Working Group.

This was born in 2010, from a team of more than 500 individuals comprised of biopharmaceutical clinical trial sponsors, non-commercial trial sponsors, CROs, service vendors, technology vendors, consultants and non-profits from more than 280 organisations in 30 countries. The group came together to identify what the true content of a standardised TMF should be, and how best to organise the content in a logically outlined manner. The result was the TMF Reference Model, which is a single,

unified interpretation of the regulations and best practices related to trial master files that would be accepted by all clinical trial stakeholders, which can be adaptable and adopted by anyone.

Organisations that adopt the TMF Reference Model have seen a number of benefits not only for themselves, but also for the users, partners, auditors and inspectors.

It has been found that implementing the TMF Reference Model increases productivity, efficiency and completeness of their TMF. These efficiencies come about as a result of the TMF becoming the single point of truth and centralised location for all information involved in a clinical study.

The most recent version of the TMF Reference Model is version 3.0.

www.mastercontrol.com

In addition to containing adequate and accurate data, an organisation’s eTMF must be organised in a way that is suitable for evaluation by inspectors and for sharing with clinical study team members, both internally and externally.

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Future watch Rugby study explores signs of concussion The University of Birmingham is developing a rapid, non-invasive test to determine whether concussion is mild, moderate or severe, which could prove to be a game changer in emergency medicine. Rugby players from the Aviva Premiership Rugby and the Greene King IPA Championship are taking part in a study that will run throughout the 2017/18 rugby season and is the biggest of its kind to take place in the history of UK sport.

A major issue with concussion studies is that the condition is subtle. It can evolve over many hours or days, meaning that follow-up must be well timed and thorough. Concussion in rugby is almost certainly underreported, and the sport came under significant scrutiny after a 2015 report revealed a sharp rise in the number of concussions suffered by Premiership players in the 2013-14 season. The Rugby Football Union, the governing body for rugby union in England, is constantly engaged with research into player safety.

Dr Simon Kemp, the Rugby Football Union’s Chief Medical Officer, explained the rationale for involvement in the study: “There is currently no reliable or proven biomarker or objective test for the diagnosis of concussion and this lack of objectivity is the biggest challenge facing medical professionals in dealing with this type of injury.”

The study will examine the hypothesis that micro-RNAs found in saliva and in urine are differentially expressed within minutes of a sport-related concussion.

Micro-RNAs are small endogenous RNA molecules that have emerged as serum biomarkers for several diseases due to their stability and the fact that they can be detected in minute quantities.

In recent years, a correlation has been found between the concentration of specific micro-RNAs in saliva and the severity of concussion. This raises the possibility of a test to determine how patients with head injuries are triaged in emergency medicine.

The Birmingham study group is led by Professor Tony Belli, a neurosurgeon with a research interest in brain metabolism following mild and severe traumatic brain injury.

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Rugby players participating in the study will provide saliva and urine samples to act as a baseline benchmark. During a match, those with confirmed or suspected concussion will provide saliva samples immediately following injury.

Players will also provide follow-up saliva samples, as well as urine samples, as they go through the return-to-play protocol. These will be compared to the baseline benchmarks, plus those from players in the same game who did not suffer a head injury and from players who had other injuries. If there are no Head Injury Assessments or confirmed concussions in a match, then no samples will be collected.

If the results of the study validate the use of micro-RNA biomarkers to determine concussion, it will pave the way for development of a hand-held diagnostic device that would provide a readout within minutes. This would assist return-to-play decisions in sport, evacuation decisions in emergency medicine and triage decisions in a hospital setting.

The study is part of the University of Birmingham’s Repetitive Concussion in Sport (RECOS) project and is funded by the British Medical Association, the National Institute for Health Research, the Ministry of Defence, the Medical Research Council and the Rugby Football Union. The university is currently in discussion with commercial partners, with a view to developing the technology that arises from the study.

www.birmingham.ac.uk

Future watch

National Centre for Healthcare Photonics to enable novel diagnostic and therapeutic devices The Centre for Process Innovation (CPI) has secured funding to build the National Centre for Healthcare Photonics at NETPark in Sedgefield, UK. The new Centre will provide the muchneeded infrastructure and support for companies to take their healthcare photonics innovations forward to successful commercialisation.

Photonics technologies depend on the detection, generation or control of light, and are being developed for many new products across diverse application areas including healthcare, aerospace, manufacturing, telecommunications and more.

Healthcare photonics is an area of particular interest within the UK and worldwide. This rapidly growing industry has the potential to provide rapid, noninvasive, personalised and cost-effective new technologies for diagnostics and treatment of many different diseases.

For example, photonics technologies are currently being developed for cancer care, neurology, ophthalmology and wound healing, among others.

The UK’s research capabilities in healthcare photonics are worldclass, but many of these early-stage inventions fail to reach commercial stages due to barriers such as the costs of development and manufacturing, the associated risks, and a lack of expertise in product development and commercialisation.

The National Centre for Healthcare Photonics will help innovators to overcome these barriers by providing open-access facilities. These will include laboratories, equipment and office space, as well as expert advice services in areas such as access to finance, clinical trial planning, seeking regulatory approval, CE marking, intellectual property protection and more.

Such support will enable small- and medium-sized companies to increase their chances of commercialisation, at reduced risk and with increased capital efficiencies. The Centre will also encourage larger companies to undertake more disruptive innovation.

The state-of-the-art facilities will accommodate collaborative and

interdisciplinary working for R&D, validation and manufacturing of new products to a pre-commercial level. Initial areas of focus will encompass biomedical imaging and photonic-enabled diagnostics and treatments, with the aim of reducing manufacturing costs of photonic devices, particularly for mobile diagnostics and personalised therapies. In order to support the new infrastructure, CPI plans to recruit for several key positions, which will contribute to the success of the National Healthcare Photonics Centre.

www.uk-cpi.com

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UK Lifescience Industry Magazine

Speeding up treatment of chest pain in A&E Doctors and managers are always looking for new ways to combat congestion in emergency departments.

One innovation that could significantly reduce waiting times comes in the form of a portable device, which helps physicians to determine whether a patient is suffering from a serious cardiac condition in just a few minutes.

Approximately 1.3 million people in the UK go to emergency departments each year with chest pain. Around 75 per cent of these patients are eventually found to not be suffering from a serious cardiac-related condition. However, this can currently only be determined by putting them through the lengthy and costly triage process of someone who is having a heart attack.

This process involves various tests, such as ECGs and troponin blood tests, which only serve to rule in rather than rule out conditions. It can take between six and 24 hours altogether, causing potential stress and also costing the NHS between £1,000 and £2,000 per patient.

To help treat the patients who are most in need quicker and to manage resources better, Creavo Medical Technologies has developed a device that helps doctors to rule out significant cardiac conditions such as heart attacks in just three to five minutes. As a result, Vitalscan, the first device of its kind, could revolutionise the way that patients with chest pain are managed in emergency departments.

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UK Lifescience Industry Magazine

fluctuations of the heart, while maintaining the accuracy and efficacy of older technology SQUID devices. MCG can detect extremely small magnetic fields in the heart, identifying any significant changes that would indicate the patient is suffering from a serious cardiac condition.

Vitalscan is currently undergoing clinical trials at A&E departments in Sheffield Teaching Hospitals NHS Foundation Trust, University Hospitals of Leicester NHS Trust, North Bristol NHS Trust and Nottingham University Hospitals NHS Trust. This marks the largest ever clinical trial of a magnetocardiography device.

By allowing a large number of patients to be ruled out early, the new innovation could significantly free up bed space and resources and enable staff to spend more time treating priority patients. Estimates indicate that it could save the NHS up to £200 million a year in triage costs – the equivalent of £3.85 million a week and £382 a minute – if rolled out across all A&E departments in the UK. It would also reduce patient anxiety by ensuring they are diagnosed and get their necessary treatment faster.

The device is portable, so it can be deployed directly to the patient’s bedside, and works by conducting a quick, non-invasive (through clothes) scan. The technology, which has been developed by Chief Scientific Officer Professor Ben Varcoe, harnesses magnetocardiography (MCG) to measure the electromagnetic

Steve Parker, CEO of Creavo Medical Technologies, explains: “MCG generates more accurate signals and has clear advantages over a traditional electrocardiogram. Initial feedback from the clinical trials has been extremely positive. Physicians have welcomed the possibility of it helping them to quickly identify patients who aren’t having a heart attack and subsequently prevent them from going through the triage process. This is good news for NHS staff and patients as it eases the burden on emergency departments at a time when they are facing unprecedented pressures and means that patients can receive peace of mind and return home much quicker. Our clinical trials are on track to complete in Spring 2018.”

Creavo Medical Technologies received two awards at the 2017 Medilink West Midlands Medical & Healthcare Business Awards, winning in the startup and innovation categories.

www.creavomedtech.com

Future watch

Launch of jellyfish collagen manufacturing base Medtech and biomaterial company Jellagen has launched a 7,500 square foot jellyfish collagen manufacturing base in Cardiff. The first-of-its-kind facility allows the extraction of high-purity collagen from jellyfish. This sophisticated engineering and manufacturing achievement will make Jellagen the first commercial manufacturer of jellyfish collagen for research, medical, biotech and pharmaceutical markets.

While collagen has been used in medical device and research applications for many years, it typically comes from mammalian sources – namely pig, cow, rat and horse.

As these carry a risk of disease and are also associated with certain religious and ethical issues, Jellagen is pioneering the move away from mammalian sources and has developed a next generation collagen with unique functional benefits.

The company is able to provide a nonmammalian, BSE and disease vector free product.

“Jellyfish collagen is in essence the root of all collagens and is compatible with a broad range of cell types. This makes it ideally suited to support the growth of a wide range of human cells, enabling it to be an effective biomaterial for applications such as cell culture, wound care and regenerative medicine.”

Professor Andrew Mearns Spragg CEO and founder Jellagen

Fibrillar collagens such as type I, II, III and V exist as a triple helix. These form strong fibers that can be made into structures with low antigenicity, excellent biocompatability and biodegradability, making collagen a highly versatile biomaterial. The extraction process for Jellagen’s collagen preserves its triple helix structure producing a functional collagen.

Jellagen carries out sustainable harvesting of jellyfish off the west coast of Wales in some of Europe’s blue flag beaches.

The company was also recently awarded £329,087 grant funding from Innovate UK’s Industrial Strategy Challenge Fund Competition for the development of a functionalised jellyfish collagen for wound care. This funding will be used to support the optimisation of a method of functionalising collagen to tackle the two main clinical issues associated with chronic wounds – sepsis and maintaining healthy blood flow to the site of injury. The

project will seek to develop a prototype device composed of jellyfish collagen and evaluate its biological activity in models of wound healing, targeting chronic wounds such as diabetic foot ulcers.

Over the course of this 19-month project, Jellagen is working with research support at Scotland’s University of Highlands and Islands and Neem Biotech Ltd, based in South Wales, with the aim of developing new intellectual property and wound care products.

Founded in 2013, Jellagen has expanded quickly, raising more than £2 million in funding from grants and angel investors.

The next step for the business is attaining ISO13485 certification, allowing them to produce material suitable for medical devices and clinical applications which can be sold to the market.

www.jellagen.co.uk

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UK Lifescience Industry Magazine

New technology for detection of lung disease PulmonIR has developed a new technology which uses infrared spectroscopy to better diagnose and monitor Chronic Obstructive Pulmonary Disease (COPD).

COPD is primarily caused by exposure to tobacco smoke, but can also occur as a result of inhaling other noxious materials.

The lungs of people with COPD have narrowed airways due to damaged tissue and inflammation, so it becomes more difficult to move air in and out. Common symptoms include breathlessness, wheezing and frequent chest infections.

Methods of managing COPD include quitting smoking and using an inhaler or medication to make breathing easier.

The condition is irreversible, but by treating its symptoms, its progression can be slowed down. If left untreated, it can become exacerbated resulting in hospitalisation. COPD affects over 330 million people worldwide at an estimated cost to healthcare providers of over $2 trillion a year.

PulmonIR was established in 2016 to commercialise new technology developed at Swansea University.

Where COPD is present, the surface of molecules within a sample of sputum (coughed up mucus) contains a specific configuration of sugars. Professor Paul Lewis found that shining infrared light onto a sample allows COPD to be detected from the unique frequencies of light bouncing off the sugars. If a patient has COPD or if their condition exacerbates, the molecular structures of

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UK Lifescience Industry Magazine

the sugars change and absorb different frequencies of light. This provides unique biomarker profiles for patients in a non-invasive way.

The technology could allow COPD patients to be tested and diagnosed in as little as ten minutes. By speeding up diagnosis and improving monitoring of the condition, it has the potential to save lives, in addition to lowering hospital admissions and reducing treatment costs in the NHS. PulmonIR has recently concluded clinical studies in collaboration with Swansea University and Cwm Taf University Health Board. These studies, funded through investment secured from the Welsh Government’s Health Technology & Telehealth Fund, IP Group, Finance Wales and the Swansea University Innovation Fund, have delivered results that confirm and extend the earlier research carried out by Professor Paul Lewis.

“We will now focus on further product development work, with the aim of commencing regulatory clinical trials on its products towards the end of 2018. Other applications for the technology, including the diagnosis of lung cancer, are being assessed for future development and investment. There is now a real opportunity for PulmonIR to create high value jobs in Wales over the next few years, to benefit the NHS and its patients through better disease management, and to export respiratory diagnostic products into key overseas markets including the EU 27, the USA and China.”

Dr Mark Bowman CEO PulmonIR

PulmonIR won the start-up award at the 2016 MediWales Innovation Awards.

www.mediwales.com/members/pulmonir-ltd/

Future watch

IP advice for the life sciences sector Patent attorney Jim Robertson from Wynne-Jones IP explains how effective intellectual property (IP) strategy is integral to preserving the future of innovation across the biotech industry.

“Nowhere is an efficient and targeted plan more productive than in the biotech industry, particularly in protecting the rights of medical researchers and firms involved in developing the latest industryleading drugs, therapies, medical devices and related technologies,” said patent attorney Jim Robertson at leading intellectual property firm Wynne-Jones IP, which has offices in Cardiff, London, Cheltenham and Telford.

enhanced manufacturing process, or equipment.

“With endless potential for innovation in this field and increasing collaboration between industry, academia and individual companies, a well-structured strategy is vital in ensuring ownership of the rights to a discovery and how it can be utilised for maximum success.

“In order to maximise success, a strategy should be aligned with the business aims.

This will allow inventors to pinpoint which

“These creations not only have an intellectual value, which could enhance the care of millions of people, but also a commercial value, which is realised when the products are introduced across the pharmaceutical industry,” he added.

For companies investing in developing new pharmaceuticals and medical technologies, it is critical that the companies see a profit in order to return a dividend to investors and help fund future work.

The patent attorney, who specialises in advising the biotech/life sciences sector, said that the key to doing this is implementing an effective IP strategy.

He explained: “An IP strategy is vital to helping a company identify its strengths and weaknesses, the opportunities and threats that exist in the marketplace, and creating a framework for managing the IP portfolio going forward. Part of this is typically identifying what intellectual property it possesses, why and how it should be protected, and where it needs to be protected.

“In the case of the biotech and pharmaceutical industry, intellectual property can protect a product, such as a drug, enzyme or antibody, or a method, such as a synthetic pathway, an

industry enough. Having this in place will ensure those in the medical profession receive their intellectual property rights and enjoy the commercial benefits.

“A strategy also highlights the value of intellectual property as a commercial tool, helping to better inform key decision makers about where to allocate research funding, enhancing the company’s value and encouraging further investment.

“When developing a strategy, one of the first roles to undertake is conducting an audit of existing intellectual property and compare this against new inventions which are to be commercialised.

Developing a product or drug, at great expense, and then discovering it infringes an existing patent could result in the abandonment of an invention without realising its commercial potential along with unnecessary costs.

“Having an effective plan in place from the beginning reduces the likelihood of infringing existing patents and resulting disputes, and protects the invention from being targeted by competitors.

features they feel warrant protection, and to focus on the most commercially lucrative aspects, consequently helping to further market potential.”

Many, however, forgo investing in intellectual property during the initial stages of development.

Mr Robertson continued: “A professionally crafted IP strategy is a wise investment in terms of protecting your initial development, achieving success and longevity. Researchers will be aware of the expense of investing in creating a viable asset, carrying out research and launching it into a competitive industry.

“As such, I cannot emphasise the importance of a strong IP strategy in this

“In the medical industry, a strategy can also help to sharpen the focus in what can often be a multifaceted approach. For example, the administration of a drug could be revolutionised through the use of a newly discovered technique. As a result the rights to this should be protected in the strategy.

“The plan or strategy should also ensure that the rights to the intellectual property are clearly defined in commercial agreements with third party researchers, suppliers and collaborators, in order to avoid consequent conflicts at a later stage.”

www.wynne-jones.com

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Going global

Nordic Life Science Days Nordic Life Science Days, the largest partnering opportunity of the year for the fast-growing Scandinavian life sciences industry, was recently held in Malmö, Sweden.

The meeting was located close to AstraZeneca’s former global respiratory and inflammation research site in Lund. Now called Medicon Village, it is linked via the Øresund bridge to companies and sites of scientific excellence in Denmark to create Medicon Valley, one of the leading life sciences clusters in Scandinavia.

Alderley Park in Cheshire is another former AstraZeneca global research site turned science park, and is home to Aptus Clinical, an oncology focused

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clinical CRO. Since its formation in 2014, Aptus has experienced exponential growth and awardwinning recognition. So, what attracted Aptus to this Nordic conference?

“The chance to reconnect with former AstraZeneca colleagues and meet so many innovative companies, who like us, are passionate in applying great science for the benefit of patients, was an opportunity not to miss”, said Jonathan Lewis, Business Development Director and co-founder.

“Our aim is to help transform our client’s promising therapies into valued medicines by innovatively designing and expertly delivering clinical studies. Scientific innovation happens all over the globe, and we firmly believe that it’s partnering conferences like this that provide the perfect environment for us to meet potential collaborators’”

Jonathan is also convinced that the UK is the best country to conduct translational and early clinical research, and these events allow them to showcase the advantages the UK offers companies engaged in clinical development.

“One of the presentations I attended during the conference examined how compounds that have been ‘parked’, despite having clinical potential, can be progressed to bring potential future patient benefits. The world leading academic expertise and research infrastructure, tax efficiencies and favorable regulatory environment in the UK make it the ideal location to support such research”, he added.

www.aptusclinical.com

Going global

International projects for digital health solutions provider Surrey-based company Docobo provides digital health solutions supporting seamless care for patients with longterm conditions. These solutions enable clinicians to identify patients, monitor and observe them in their own homes, and track the effectiveness of interventions, enabling the shift from current reactive models of care to a more proactive and preventative approach. The technology also empowers patients to better selfmanage their condition, while allowing clinicians to monitor remotely for signs of deteriorating health. This has been shown to improve patient outcomes and reduce unplanned admissions, saving precious NHS beds and resources.

The company’s solutions consist of two main elements: doc@HOME® Telehealth – remote monitoring, management and self-help support for patients in their own homes and in care homes.

ArtemusICS™ – population health intelligence tool that provides current and predictive intelligence for clinical and commissioning purposes.

They are currently taking part in two large-scale international programmes. The first is eSMART, an EU research project to demonstrate how technology can be instrumental in the delivery of patient focused, anticipatory care that improves outcomes and quality of life for cancer patients. The clinical trial aims to evaluate the impact of remote monitoring during and post chemotherapy treatment, monitoring symptoms and looking for signs of neutropenia in people diagnosed with non-metastatic breast, colorectal or hematological cancer.

Docobo has collaborated with UK universities and oncology centres throughout Europe to develop the technology, which works off a smartphone, to record the symptoms of the cancer patients involved in the trial.

The Advanced Symptom Management System (ASyMS) solution involves the clinician assigning personalised questions designed to capture necessary details about the patients’ symptoms and treatment. This data can then be used to keep clinicians informed of the patients’ health status during chemotherapy. eSMART began in February 2014 and runs until January 2019. It is funded by the European Commission’s Seventh Framework Programme and coordinated by the University of Surrey. The project is being conducted across 17 sites in Europe and its results will facilitate changes in clinical practice, leading to improved delivery of cancer care.

The second of Docobo’s international projects is DO CHANGE, a healthcare research and innovation project co-funded by the European Commission and the Taiwanese government. Its primary goal is to develop a health ecosystem enabling integrated disease and lifestyle management for hypertensive and cardiac patients.

The focus of DO CHANGE is on empowering individuals with tools and services to optimally monitor and manage their condition. Consequently patients will become more involved in their own health. A key advantage of the DO CHANGE approach is that it dynamically integrates behaviour change with the gathering of real-time nutritional and other sensor data, physiological and

symptomatic patient data, and healthcare professional inputs. The use of behavioural prompts puts an emphasis on timely, actionable feedback, which will bring about changes to improve patients’ lifestyles.

Within the project, Docobo is responsible for the design and implementation of the health ecosystem architecture. This enables the clinical symptomatic health related data and non-clinical personal data to be brought together, providing a holistic view of the health and wellbeing of the patient who is undergoing the programme for behavioural change. Docobo has developed the first version of the system to enable recording of patient data, which allows the researchers to gain full access to this patient information.

Docobo is also currently undergoing and agreeing a partnership with a medical device partner in China. With a large, aging population, this is a huge market with lots of potential. There is limited primary care in China so the common way to see a doctor is in hospital. Therefore, the Chinese government are looking for innovative solutions such as Docobo’s to improve access to care.

www.docobo.co.uk

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A global approach to auditing medical device manufacturers Peter Rose, Managing Director Europe at Maetrics, explains the Medical Device Single Audit Program.

Introduction - the key benefits Ten years after its inception, the Medical Device Single Audit Program (MDSAP) provides a consistent and unified global approach to the auditing and monitoring of medical device manufacturing. It is now active in five countries – Canada, Australia, Brazil, USA and Japan – although it is only mandatory for regulatory submission in Canada. Designed to improve safety on an international scale, the MDSAP allows Auditing Organisations (AO) to conduct a single regulatory audit of a medical device manufacturer that satisfies the varying requirements of multiple jurisdictions. This significantly streamlines the compliance process and creates new possibilities for simplified trading with the participating countries.

The MDSAP can also be considered an opportunity for manufacturers, as it covers the existing ISO 13485 standard at the same time as local regulations and standardises processes within Quality Management Systems (QMS) and other regulatory submissions.

Non-conformities The audit process The MDSAP will take three years and is phased as follows: The Initial Audit – An essential documentation review to assess readiness of the manufacturer to undergo a Stage Two audit, an implementation review of the ISO 13485 standard and the regulations of each participating country. The goal is to rigorously review the QMS to check that products are safe, effective and meet the required standards.

The Surveillance Audit – This reviews the QMS again to ensure compliance but a Stage One audit is not necessary if no significant changes have been made since the last audit.

The Recertification Audit – Its goal is to evaluate the effectiveness and performance of the QMS to check that it satisfies all relevant standards and regulations in the scope of the MDSAP.

Non-conformities (NCs) that emerge during the audit are graded on a scale of one to five, with four and five considered serious.

The Auditing Organisation has to inform regulatory authorities within five days if one or more grade five NCs are identified, two or more grade four, any public health threat or fraudulent activity. Auditing Organisations must provide the audit package including NC grading to the authority within 45 days after the audit, and the manufacturer then provides a remediation plan for each NC within 15 calendar days of the report being issued. Manufacturers usually have an unannounced visit from auditors six to nine months after this, to assess whether suitable remedial steps have been taken to rectify the flaws.

It is to be expected that some stakeholders view the MDSAP as a burden, in light of the fact that manufacturers will be required to train their internal auditors and potentially reallocate resources in order to transition to the new unified audit program. But it is felt that the benefits to manufacturers substantially outweigh any initial burden or investment, as the ultimate goals of simplification and transparency are of great advantage to the industry as a whole as it seeks to further enhance products, regulatory processes and patient outcomes.

www.maetrics.com

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Going global

Northern Powerhouse trade missions The Department for International Trade and Medilink UK are leading groups from the north of England to two of the world’s most prominent and influential exhibitions for Healthcare and Life Sciences.

The first, Arab Health 2017, held last January in Dubai, successfully hosted a trade mission involving 63 companies from the UK. The 2017 exhibition saw a total of 102,666 participants, including 4,072 exhibitors and 96,925 visitors. Contracts worth millions of dollars were also negotiated and signed, with 32 per cent of visitors conducting $250,000 - $1,000,000 worth of business.

UAE’s healthcare market is set for significant growth over the coming years, with a large investment in a hospital build programme taking place. This is turning the country into the leading medical tourism hub in the Gulf, resulting in massive opportunities for companies.

The mission offered companies a detailed briefing on the UAE healthcare system, a visit to a leading hospital in Dubai, time at the Arab Health exhibition and extensive support before, during and after the mission.

MEDICA gives businesses in the medical sector the chance to showcase Northern Powerhouse expertise and innovation internationally and to meet and connect with international buyers, establishing valuable contacts.

Companies on the Northern Powerhouse trade mission to MEDICA 2017 are given the chance to showcase their expertise

“The opportunity here is fantastic and we have attended for a number of years.

The access to ‘C’ level contacts and the market information you obtain from the exhibition are invaluable in helping companies progress to expanding internationally. It helped us to look at global markets and the reach of the conference is truly global. I would recommend to anyone thinking of attending for the first time to work with the team at Medilink and dip their toes into this international hub.”

Sam Whitehouse COO of QuantuMDx

and innovation internationally and to meet and connect with international buyers, establishing valuable contacts.

They are supported by DIT Life Sciences Sector Specialists and get access to private meeting rooms, access to the

British pavilion facilities and a meeting programme with international buyers and DIT Sector Specialists, MEDICA visitor tickets and daily transfers between the hotel and the Messe Düsseldorf exhibition centre. Eligible companies can also apply for a support grant of £200 towards the £621 cost.

For more information contact international@medilink.co.uk

www.northernpowerhouse.gov.uk

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Global potential for sight-saving bandage In a bulletin published by the World Health Organisation in 2001, corneal disease or injury was identified as the second greatest cause of blindness worldwide, with trauma and corneal ulceration accounting for 1.5-2 million new cases of monocular blindness every year.

In 2001 Dr Andrew Hopkinson, Principal Research Fellow in Academic Ophthalmology within the Division of Clinical Neuroscience at the University of Nottingham, was performing research into amnion used as a transplant material to repair corneal damage.

NuVision spun out from this division of the University of Nottingham and was incorporated in 2014 with Dr Hopkinson as Founder and CEO. The first product launched by NuVision was Omnigen, a dry amniotic membrane derived matrix. Research conducted

by Dr Hopkinson and the team at the University of Nottingham led to the development of an amnion product which is dry, pre-cut into discs or sheets, and can be transported by standard post. This brings a revolutionary approach to detailed, delicate and often complex surgery.

Originating from the sac that protects and nurtures a baby as it grows in the womb, amnion has been used in corneal surgery since the 1940s.

It is traditionally cut into squares and frozen for use in surgeries for structural repair and regeneration of damaged tissue. The frozen product requires temperature-controlled transportation, on dry ice, and once defrosted needs to be used or disposed of within 48 hours. The defrosted tissue becomes very sloppy and therefore difficult to position, size and suture.

Whilst focusing on the human ophthalmic market, Dr Hopkinson was also approached about the potential to sell the same product to veterinary surgeons. Amnion is special in that it is immune-privileged, which means there

are no antibodies that can be rejected by a recipient, whether the recipient is human or not.

Veterinary ophthalmologists were already using (frozen) horse amnion cross-species, so human amnion was acceptable to the market. By working with specialist ophthalmic veterinary surgeons and attending international conferences, it has been proven that there is a demand for this product. It enables animal patients to recover sight in eyes that were not expected to heal.

International sales of Omnigen started with animal patients while the first UK NHS patients were receiving Omnigen and experiencing results that exceeded expectations. For instance, the first surgery outside of Nottingham had the objective of not removing the eye and the outcome was actually retained sight.

Ocular surface disease with severe consequences is far more prevalent in countries which have poor access to healthcare as well as logistical challenges.

In such environments, the use of frozen amnion is impossible. Dr Hopkinson has established relationships and supplied Omnigen to surgeons in India, Syria, Mexico, Egypt and Cameroon. NuVision is now conducting an active clinical trial in India at state hospitals in a range of locations and hopes to develop sufficient data that will lead to Indian national regulatory approval.

NuVision currently has distribution agreements covering the whole of the UK and Ireland, Finland and Norway for the human market. There are also regular UK and overseas orders from veterinary surgeons, plus sales across Europe (East and West), The Americas (North and South), The Middle East and Asia.

Amnion is used overseas for epithelial repair and regenerative therapy throughout the body, in cases such as trauma, burns, non-healing wounds, pelvic surgery and diabetic foot ulcers.

NuVision has high hopes for the future.

www.nu-vision.co.uk

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Going global

How to start cracking new markets UL Compliance to Performance offers some advice on the basics of breaking into new markets.

For pharmaceutical and medical device companies seeking to enter foreign markets, the opportunities are huge. If done appropriately, they can vastly increase their market share and total lifetime profitability. The challenge is understanding how and when to navigate the formidable obstacles facing new market entry, because the truth is that a business model and processes that worked at home may, quite simply, fail when executed in a new region.

When entering new markets and geographies, the stakes are high in any industry.

However, for companies in the life sciences space, the most regulated in the world, the stakes are even higher.

There are four main steps in preparing to crack new markets: 1. To avoid unwelcome bombshells, assess local regulatory issues and requirements early. Develop strategies and roadmaps for regulatory compliance – identify risks and gaps in product design, quality system, technology infrastructure, IT validation and competencies relative to specific country requirements with timelines and critical milestones.

2. Mobilise insider teams who know what outsiders cannot to help understand regulatory/application specific requirements – from process redesign to quality systems management, competency mapping, audit preparation and registration readiness.

3. Look internally. This will help to develop an understanding of how new and existing regulations will impact the product development activities, processes and systems.

4. Stay ahead of issues and violations, drive operational efficiencies and operational excellence to create a competitive advantage.

It is paramount that a company obtains a clear understanding of regulatory requirements, best practices and functional risks critical to the regulatory process. One way to apply this understanding is to perform a gap analysis of the product, processes, systems and competency relative to requirements. This will give the company

a baseline for where to start and what the key steps are in navigating the proper registrations and approvals for the target market, with timelines and critical required milestones.

This navigation will require an operating plan to address and meet requirements of regulatory bodies such as the FDA.

The plan should include the creation of risk mitigation strategy (based on ISO 14971 or ICH Q9), a Quality System Governance plan, a training and competency plan for staff and a GxP system design. The plan will also need to include tactics on resources, tools and process changes needed for regulatory compliance that can be outlined.

Take for instance the US market for life sciences companies, which is the world’s largest and potentially the most lucrative. The important procedures and registration activities are myriad and the FDA registration process can be complex.

US FDA requires that any importer responsible for import of a drug or device must ensure their facility is listed under the foreign manufacturer’s site establishment registration. Key data such as Importer Name, DUNS, telephone number and e-mail address must be submitted electronically to the FDA by the foreign establishment.

Life sciences companies seeking growth opportunities in new markets do so for good reason. Yet capitalising on these opportunities often means facing high levels of risk and uncertainty. The best strategy for dealing with the challenges is to think and analyse the risks and regulatory issues as early as possible, and then partner with professionals when needed to address the most critical issues and help make the best plans and decisions possible. And finally, in an ever-evolving global political environment, it is absolutely critical to stay flexible. Those that do will find their opportunities are much bigger than their challenges.

www.ulcompliancetoperformance.com

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Meeting the unmet 3D printing solves medical challenge Bluefrog Design, a product innovation consultancy based in Leicester, has used 3D printing to help a man with a longstanding skin complaint, succeeding where a host of traditional approaches had previously failed.

The patient suffered from a serious case of paresthesia, which affected his quality of life and severely impacted on his ability to cope with normal day-to-day activities. Paresthesia is an abnormal and uncomfortable sensation, often feeling like tingling, tickling, prickling, numbness or burning of the skin with no apparent physical cause. In this particular case, it produced a prickling sensation from the rib cage to the collarbone whenever the man’s clothes came into contact with his body.

In order to alleviate his condition, Bluefrog designed and built a structure, cage-like in appearance, that stopped his garments from touching his upper torso, thereby improving his wellbeing and comfort.

First of all, they identified the patient’s most sensitive areas and 3D-scanned his body to find the desensitised locations from which they could hang a support to keep his clothes away from his skin.

Using remote scanning rather than contact measuring, they were able to avoid touching him and causing any further

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irritation, while capturing precise data to use in the design with 3D CAD. What they produced was entirely bespoke, following the contours of the patient’s body, as well as being costeffective and time-efficient. The part was 3D printed in-house using medical-grade material, and hung from the patient where he suffered no irritation. The design was lattice-based and therefore light, giving a material saving of up to 60 per cent compared to traditional production methods. This also provided ventilation to keep the patient cool, as air can flow through the device between the clothes and the body.

3D printing is key to Bluefrog Design’s core business, beyond medical work and into other sectors too. As an industrial and product design consultancy, they often design prototypes and produce short run, high value products. Frequently very technical, these are the kind of products

that traditional processes cannot produce as quickly or economically as 3D printing can.

An advantage of 3D printing is that ten or more of the same product can be made, and then if further iterations are required, the 3D CAD can be tweaked so that a variant of the original product can easily be manufactured, assembled and finished. It would be technically challenging to adopt the same approach with injection moulding, as this would require frequent and costly modifications.

www.bluefrogdesign.co.uk

Lifelike 3D printed spines to help training of surgeons Researchers are 3D printing replica human vertebrae which act and feel like real bone tissue to help train spinal surgeons before they go into live operations. The project led by Nottingham Trent University aims to give trainee surgeons the knowledge of how it feels to partly remove or drill into vertebrae before undertaking real procedures on patients.

The models, which are created using powder printing technology to help achieve a lifelike porosity of real bone, feature hard outer layers and a softer centre. They are made from polylactic acid (PLA) and a binding agent and are coated in polyester. The softer inside is made from polyurethane and the discs between vertebrae are made from silicone.

“Consultants undertaking delicate and precise procedures like spinal surgery need as much knowledge and experience as possible as part of their surgical training before going into live operations,” said Professor Philip Breedon, from the university’s Design for Health and Wellbeing Group.

“One error can lead to catastrophic, lifechanging consequences for a patient, so it’s imperative that surgeons can prepare themselves thoroughly. This research will enable clinicians to experience how

performing spinal surgery feels both physically and mentally, but in a safe training environment.”

The project involves collaboration with consultant spinal surgeon Professor Bronek Boszczyk, from Nottingham University Hospitals Trust, who is a visiting professor at Nottingham Trent University.

The models are aimed at surgeons looking to perform procedures such as laminectomies, to relieve trapped nerves, which can involve the removal of bone tissue. Individual models can also be created from CT scan data to provide accurate representations of people with complex conditions such as scoliosis.

“Until a surgeon goes into a live operation, he or she has very little knowledge of how it feels to perform spinal surgery. This research provides consultants with a realistic representation of spinal surgery which allows them to learn in a safe and calm environment. By better communicating these experiences, we can improve the skills of surgeons in the classroom and help enhance operative outcomes for patients in real life.”

Joseph Meeks Postgraduate Student Nottingham Trent University

www.ntu.ac.uk The next stage of the research is to print replica bones which vary in strength, to give surgeons an accurate experience of operating on people with conditions like osteoporosis. It is hoped that the technology will be used in the classroom within the next few years.

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Digital system enables better planning for surgery

Oxford Heartbeat develops medical device software that makes planning for cardiovascular surgeries simpler, faster and more accurate. Better preparation means reduced complication rates and associated costs, as well as improved patient care.

A stent is a short, wire-mesh tube that acts like a scaffold to help prevent rupture or keep an artery open. Despite a rapidly growing number of stent deployment procedures performed in the UK, there are currently no preoperative solutions assisting surgeons with critical decisionmaking.

The differences between patients and the vast range of devices available on the market mean that the choice of the best stent for a patient can be extremely difficult. Without the right tools it is impossible to predict how a specific device is going to ‘sit’ in a patient’s blood vessel. The problem is particularly acute in brain interventions, where the vessels are tiny and the new braided designs show complex mechanical behaviour. High

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complication rates and a large number of secondary surgeries result from these difficulties, bringing additional costs to the hospitals.

Oxford Heartbeat provides a digital solution which enables surgeons to unlock and visualise crucial information in preparation for surgery, to see what would happen inside blood vessels during surgery. Combining the power of predictive computations, big data and AI, the software gives surgeons an opportunity to rehearse interventions in advance and find the device that will work best for each individual patient. This innovative technology brings certainty to clinicians’ choices and reduces the risk of complex procedures. It aids clinical decision-making and improves quality of care and outcomes, while saving time and costs for hospitals.

Oxford Heartbeat won the start-up award at the 2016 SEHTA Healthcare Business Awards, followed by the national start-up award at the 2017 Medilink UK Healthcare Business Awards. The company was also

“Before constructing a bridge, engineers perform a thorough analysis of stresses and strains in the structure, and the implications it has on the ground and environment.

These powerful methods have not yet been translated into clinical practice and it is our mission to change that. This will define the medicine of tomorrow and make the world a healthier place.”

Katerina Spranger Founder and CEO Oxford Heartbeat

a finalist at Pitch@Palace 7.0 and a Gold Award Winner at MassChallenge UK 2016, in addition to winning the 2017 EIT Health Headstart Award for UK-Ireland.

www.oxfordheartbeat.com

Meeting the unmet

NHS Scotland and SMEs collaborate to drive patient care innovation Six Scottish small- and medium-sized businesses have won new contracts with NHS Scotland to help drive treatment and innovation in the areas of dermatology, diabetes and Inflammatory Bowel Disease (IBD).

The companies secured research and development funding as part of recent open innovation competitions. These competitions are designed to open up traditional procurement processes and look for new solutions from a wide range of businesses that can help drive new revenue streams, while simultaneously addressing big service challenges faced by the NHS and public sector organisations.

This new open innovation approach will deliver £1.35 million of collaborative funding from Scottish Enterprise and the Scottish Government’s innovation and healthcare teams to support companies participating in these competitions. The competitions are run by NHS Scotland, in conjunction with Innovate UK as part of its Small Business Research Initiative (SBRI) mechanism to fund UK business innovation.

Companies are funded to progress their ideas through feasibility, prototype and/ or demonstrator stages, and they also retain full intellectual property, which

means that they are free to develop and exploit their product or service further by offering it to other customers and other markets.

The six Scottish companies who have won funding are: AxSys Technology in Glasgow (diabetes) Epipole Ltd in Rosyth (dermatology)

“Using open innovation means we can help with two of Scotland’s business and healthcare challenges – get more businesses innovating and find new creative solutions to patient care. We’re making excellent progress in encouraging more Scottish SMEs to embrace innovation to open up new global revenue stream opportunities for them.”

Jim Watson Director of innovation and enterprise services Scottish Enterprise

Euan Cameron, CEO & Founder of Cohesion Medical, commented: “Cohesion is delighted to have been a successful award winner for the SBRI Dermatology and the SBRI IBD competitions. As a young Scottish SME specialising in connected digital health solutions,

Storm ID in Edinburgh (dermatology) Cohesion Medical in Glasgow (Dermatology and IBD) Digital Treetop in Perth (IBD) OpenBrolly Health in Elgin (IBD)

we are excited about the emerging opportunities of developing our technology to optimise clinical workflow and enhance patient experience in these specialisms. The value of the SBRI is in facilitating a level of user engagement with NHS Scotland which would have been difficult to access otherwise.

Creating commercial opportunities for Cohesion to sustain high-skilled employment for developing technology solutions for global healthcare markets is another major benefit.”

www.scottish-enterprise.com

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Improved clinical outcomes with neuromuscular electro-stimulation device Sky Medical Techology’s geko™ device increases blood circulation to prevent deep vein thrombosis, reduce swelling and encourage wound healing.

The size of a wristwatch and worn at the back of the knee, geko™ is a batterypowered, self-adhesive, disposable device, powered by the company’s OnPulse™ neuromuscular electrostimulation technology. Through gentle electrical impulses, geko™ stimulates the common peroneal nerve activating the calf and foot muscle pumps, which increases venous, arterial and microcirculatory blood flow. The increase in blood flow is similar to that achieved by walking – up to 60 per cent – without a patient

having to move or exert any energy. By increasing blood flow in the veins of the leg, it reduces the risk of deep vein thrombosis and prevents the build-up of pre- and post-surgical swelling.

A 2016 study by Professor Andrew Nicolaides and Dr Maura Griffin measured the effect of the geko™ device on blood flow in the deep veins of the calf. The results demonstrated significant volume and velocity increases within the gastrocnemius, peroneal and posterior tibial veins. This was the first time that a mechanical

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device had reported enhancement to blood flow in the deep veins.

The device has now been clinically proven to reduce pre-operative oedema (a buildup of fluid that causes swelling) in ankle fracture patients, saving two bed days per patient on average when compared to all other methods. By reducing time to theatre-readiness in this way, the use of geko™ generates an average saving of £569 per patient.

Pre-operative oedema can often delay surgical fixation for ankle fracture patients due to the risks associated with operating on swollen tissue.

The current standards of care for managing readiness for theatre include leg elevation in combination with a backslab plaster cast. A study recently completed by researchers at the James Cook University Hospital in Middlesbrough has shown an average reduction in pre-operative bed days from 3.66 to just 1.66 days per patient when fitting geko™ above the backslab plaster cast, meaning operations can be carried out sooner.

“We saw the potential for the geko™ device to significantly improve current care pathways for our surgically treated ankle fractures.

The prospective and retrospective study, completed in partnership with Sky Medical Technology, shows the geko™ device can be used safely and effectively in this patient population and can help to streamline care.”

Paul Baker Orthopaedic Consultant and clinical lead of the research team

Bernard Ross, CEO of Sky Medical Technology, added: “Whilst the geko™ device has already achieved NICE guidance and FDA clearance for reducing the risk of deep vein thrombosis, this new study provides further evidence that our platform technology, OnPulse™, has the potential to serve a wide range of clinical applications and to make substantial cost and efficiency savings for healthcare providers”.

Sky Medical Technology won the award for Collaboration with the NHS at the 2017 Medilink UK Healthcare Business Awards. www.gekodevices.com

Meeting the unmet

Smart bandages, next generation blood pumps and on-the-spot hepatitis diagnosis Swansea University’s Institute of Life Science is leading research into bandages which use real-time 5G technology to monitor how a wound is healing. The new smart bandage is to be trialled within 12 months.

“This intelligent dressing uses nanotechnology to sense the state of a wound at any one specific time.

It would connect the wound to a 5G infrastructure and that infrastructure through a patient’s telephone will also know things such as where you are and how active you are at any one time.

“You combine all of that intelligence so the clinician knows the performance of the specific wound at any specific time and can then tailor the treatment protocol to the individual and wound in question.”

Professor Marc Clement Chairman Swansea Institute of Life Science

Meanwhile, the first next generation blood pump for the treatment of chronic heart failure in the UK is being developed

by Swansea University based Calon Cardio-Technology Ltd. Clinical trials are due to begin in late 2018, with the aim of a full rollout of the pump two years later.

Calon Cardio, which is located within the Medical School’s Institute of Life Science 2, is developing the affordable, implantable micro blood pumps – commonly known as ventricular assist devices, or VADs – for the treatment of chronic heart failure.

Until recently only heart transplants offered a cure for advanced heart failure, but the very limited supply of donor

hearts means that transplants are available only for a very lucky few. The new MiniVAD pump is implanted into the failing heart. The main objective of the pump, which should last about 10 years, is to better manage the blood to minimise adverse effects.

Stuart McConchie, Calon Cardio’s chief executive officer, said: “This is the first British pump, and the most advanced pump of its kind, to be built for treating blood flowing through the pump extremely gently while not causing damage to the blood. There are other pumps that have been built that do cause some damage to the blood and, as a result, patients have adverse events that diminish the impact of the implantation and the treatment.

“If we can demonstrate that we have reduced the adverse events and patients don’t have to go back into hospital for correction of these events, the cost benefit becomes substantial.”

Researchers from Swansea University are also collaborating with institutions in China and elsewhere in the UK on a project to develop a graphene-based sensor, which aims to provide an easy, low-cost way of diagnosing hepatitis on-the-spot. The two-year, multi-partner project is funded by the UK’s Newton Fund and led by Swansea-based BIOVICI, developing the next generation of pointof-care diagnostic devices.

Graphene is a 2D material with unique electrical and mechanical properties. Its characteristics make it ideal for sensor applications, including those used for medical diagnosis. To date, graphene electrochemical biosensors have been developed predominantly for detection of single biomarkers.

The new sensor will be the first to target a simultaneous test for three types of hepatitis – A, B and C – out of the five types that exist. The test will be simple and rapid, similar to a blood glucose sensor or pregnancy test, but will test the patient’s saliva instead of blood.

A graphene-based sensor

It is anticipated the new device will have significant impact in countries with a high incidence of this highly infectious liver disease, such as China, with the sensor helping to prevent the spread of hepatitis by speeding up its diagnosis and treatment. It is estimated that if the sensor is produced in large quantities, each device could cost as little as £1.

www.swansea.ac.uk

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6-7 March 2018 Join us at one of the largest Life Sciences conferences in the UK Wales Millennium Centre, Cardiff Bay, UK

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2018

101 reasons Kent makes business sense 52. Kent’s innovative businesses are changing the world This is just number 52 of the 101 compelling reasons why Kent is the optimum destination for business. Ideally located in the UK between London and Europe, Kent’s life science cluster of over 300 companies have raised funding in excess of £50m and have discovered some of the world’s leading drugs. With world class facilities, industry leading talent and access to funding, Kent is a fast-evolving hub for innovation and growth. There is no better time to set up or expand your business here.

Find out how Kent can make business sense for you, visit locateinkent.com or email enquiries@locateinkent.com

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