Lifescience Industry Magazine

Page 1

Issue 16 2019


Inside digital health

Developing an evidence standards framework for digital health innovations – are we there yet?

Future Watch

Clinical Need

Going Global

People & Places


New technology and innovations

Meeting unmet clinical needs

Cracking international markets

Inuential people and places in the industry

Updates and expert 1 advice




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Developing an evidence standards framework for digital health innovations – are we there yet?


Seaweed technology to treat disease



Neuroscientific approach to treating depression and anxiety Next-gen technology to enhance spinal fusion

Growing the advanced therapies sector



Lifescience Industry is now online – visit for the latest news

A message from the editor Welcome to this edition of Lifescience Industry, launched at MedTech Innovation Expo in May 2019.

Meanwhile, innovations within Clinical Need include an easy-to-use ECG recorder (page 22), an electronic health record for pregnant women (page 24) and an app to help improve patient care (page 27).

In this edition, technologies featured in the Future Watch section are enabling development of a world first e-nose (page 10), using seaweed to create treatments for respiratory diseases (page 11) and offering new therapies for people with tendon, cartilage and soft tissue injuries (page 14).

Lastly, the Regulatory section features expert advice on acquiring simultaneous US/EU approval (page 32).

Going Global highlights a manufacturer of pioneering breath analysis devices (page 30) and the People & Places section explores life science developments in Birmingham, Wales and more.

Sophie Davies Editor

Future Watch

Clinical Need

People & Places

10 Developing next-generation

22 A case study of new tech adoption in

32 Have your vision realised:

11 Seaweed technology to treat

24 Electronic health record for pregnant

sensing technology


12 Anatomical models created with 3D technology

13 The benefits of blockchain in health and life sciences

14 Regenerative technology enables new treatments

15 Next-gen technology to enhance spinal fusion

18 Neuroscientific approach to

treating depression and anxiety

19 Three reasons why new product launches fail

20 Growing the advanced therapies sector

the NHS women

Issue 5

Putting the citizen at the heart of innovation

38 Edgbaston Medical Quarter

33 MHRA inspection success for

new pharma facilities manufacturer Lorem ipsum dolor sit amet, 34 Network launched to consectetur adipisicing elit, sed do 26 How innovative technology impacts improve and ut eiusmod temporhealth incididunt the NHS wellbeing in Wales labore et dolore magna aliqua. Ut 27 New app to help improve patient care enim ullamcoin 35ad Life Sciences Hub Waleseu

25 Innovation award for medical device

28 Alarm systems reduce stress in care

Jess Fisher Editor

Going Global 29 Medilink launches new pavilion at MEDICA 2019

30 Innovative breath monitors go global 31 BioPartner UK Delegations

L 36

unveils ‘door to door’ patient pathway for UK and international patients

2012 ISSUE 4

appoints new CEO

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£4m antibiotic resistance research lab opens in Halifax

37 Rapid growth for specialist clinical CRO

40 Pioneering hip surgery developed in Birmingham

41 Birmingham at the centre of Life Sciences MedTech growth

Regulatory 32 Simultaneous US/EU regulatory approval: How timing could be a factor

46 Life Science Industry register

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48 Lifescience Industry Event Calendar 2019

Published by Teamworks. For editorial and advertising opportunities please contact: Editor: Sophie Davies, Executive Editor: Gwyn Tudor, 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: Tel: 029 2047 3455 Tel: Web: Contact: The views expressed in this publication do not necessarily represent the Editor: Jess Fisher opinions of individual partners unless explicitly © Teamworks. 2019

Supported by


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


goes live

Advertising: Charlotte Tyson

Developing an evidence standards framework for digital health innovations – are we there yet? Continuous and collaborative development A collaborative working group consisting of NHS England, NICE, Public Health England, MedCity and DigitalHealth.London came together to look at how to make it easier for innovators and commissioners to understand what ‘good’ evidence for digital innovations looks like, while meeting the needs of the NHS and patients. This would enable better NHS commissioning and a better understanding of how the NHS makes decisions and the standards expected of SMEs. It would facilitate a dynamic, value driven market. Version two The evidence standards framework was developed over a six-month period through an agile, user-centric process. This included robust evidencebased framework development by the NICE team, refined iteratively through multiple stakeholder workshops, roundtables and meetings. Innovation development is fast-moving by nature, and the resulting framework has been designed to be pragmatic and flexible rather than ‘perfect’.

Since the first publication of the standards in December, the NICE team has incorporated feedback from over 200 survey responses and published a second, updated version. Members of the working group have been active in presenting the standards at industry, investor and NHS events, delivering hands-on seminars to accelerator cohort companies. The team have been invited to present the work overseas to the WHO, as well as to countries looking to England’s example in setting the direction for the evaluation and adoption of quality digital

Application in practice It’s a common misconception that the hard work ends once guidance, regulation or policies are published. In reality, the work is only beginning at this stage, as it’s then that we begin to measure impact through adoption and outcomes. Embedding the standards is a shared responsibility and a continuous process, involving a digital ecosystem with multiple players. As with the collaborative development approach, this needs to involve industry, commissioners, AHSNs, academic researchers and regulators that are using the framework and can keep refining it.

The standards in practice “For all our projects, including our student projects and those we will do with industry partners, we are developing a scoring and categorisation system. In this way any project can be mapped to our priorities, the WHO digital intervention categories, and the evidence standards framework to determine what level of evidence would be required for potential clinical use. The idea of this is to make it easy for us to report on the various different types of activities that we are doing and also so we can provide evidence where we are on the pathway for the various projects, in terms of how close


health technologies. This raises the prospect of the creation of harmonised evidence standards for digital health technologies, which would be invaluable to companies looking for a global market.

Issue 16

or far away they are from being potentially usable. We are also trying to map any appropriate project to the NHSE guidance on best practice for AI, to demonstrate how the project meets all of the appropriate criteria. This is the approach being incorporated into everything from the planning phase forward. Of course, lots of the student projects are never destined to themselves end up as products for clinical use but are often explorations of early principles so not all of these elements would be applicable to every project.”

“Transforming Systems worked closely with YHEC and NICE on the evidence case for the Digital Health Technology Standards for WaitLess. It was a very well thought through process which drew our data sources together in a concise way. This has helped us to improve our presentation to commissioners and providers. Having gone through a NICE accredited process has helped to give commissioners confidence about WaitLess’ impact. This has opened up several new opportunities for Transforming Systems. As it helps to remove barriers to sale, I believe it should be a key objective for SMEs to go through this process.”

Prof Neil Sebire DRIVE unit, Great Ormond Street

Alistair Martin, Chief Commercial Officer Transforming Systems

Having accelerators, in particular the DigitalHealth.London Accelerator and the NHS Innovation Accelerator, use the standards framework to support and guide their cohort of companies in evidence generation has been an important tactic to gain early adoption of the standards within the SME base. The Generator, for example, is an initiative enabling companies within the DHL Accelerator to evidence their products

“As Digital Innovation Lead for an STP that has a 1/4 of all Londoners within the area to support for health, it has been difficult to encourage digital innovation, know what apps to recommend to patients and know what to commission. The financial climate for the NHS is constrained and each CCG has previously done its own commissioning, sometimes swayed by the promises from suppliers without being able to have a clear, robust and dependable ‘measuring stick’ to assess whether this is a good tool. The Evidence Standards Framework for Digital Health Technologies is the document that

through partnerships with the academic research community. The DHLA programme assigns NHS navigators to each company and, with support from partners including HIN and MedCity, has been using the

has enabled me to develop a framework where each digital tool we engage/procure we use the framework to localise our own processes which have enabled me to create a Digital App/Tool Board which has membership from the CCGs, Acutes, Councils to robustly assess effectiveness and economic impact. The framework and guide has given me the ability to use this board to filter through all proposals, which ensure that we are doing things ‘once and for all NWL’. Those that are sceptical or find that the guide is ambiguous need to appreciate that this is a framework which is supposed to be localised and built upon. The framework delivers on its

evidence standards framework to support cohort companies developing evidence generation plans for their products to aid adoption. This has been done on a 1:1 basis as well as through workshops. In addition to this, the generator supports development of the appropriate research methodologies for products that align with the standards.

objective of providing a solid methodology to leverage the best in digital health for our population.” Kwesi Afful, Digital Citizen and Innovation Lead North West London CCG

Contributed by MedCity

For daily lifescience news visit 5

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.

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

Fully funded business support for innovative start-ups and SMEs developing new products and services for the health and life science sector

What the programme offers:

Business support available:

Mentoring and business support

Business planning & strategy

Sector specific expertise

Networking and academic industry collaboration opportunities

Financial advice & accountacy

Funding & bid writing

Regulatory & IP advice

Marketing, market research & health economics

Apply now:

Who can apply? ●

Founders/managers of newly formed businesses or mature small to medium businesses based in the West of England LEP region

Start-ups and SMEs who are looking to further develop novel products or services for the health and life science sector

Find out more and apply for free business support at or by emailing The Health Technology Accelerator Programme is funded by the European Regional Development Fund to support small to medium businesses in the West of England region to develop new products or services for the health and life science sector

Awarding success

Medilink UK Awards 2019 Finalists Hosted by MedTech Innovation Expo The National Conference Centre, Birmingham Wednesday 15th May, 7pm Start-up SurePulse Medical Medilink East Midlands QR Info Pod MediWales Orthocell/Carrera Medilink West Midlands Interactive Me SEHTA Virti London MedTech Haemoconcepts Medilink Yorkshire & Humber

Collaboration with the NHS Xuper Ltd Medilink East Midlands SymlConnect MediWales B13 Technology Medilink West Midlands AliveCor SEHTA C the Signs London MedTech

NeedleSmart Medilink North West

Leeds Teaching Hospitals Medilink Yorkshire & Humber

Lightox Medilink North East

Damibu Medilink North West

Dr Julian Medical Group Medilink South West

City Hospital Sunderland Foundation Trust Medilink North East

Trio Healthcare Medilink Yorkshire & Humber MP & H Packaging Medilink North West Walk to Beat Ltd Medilink South West

Outstanding Achievement Quotient Sciences Medilink East Midlands Creo Medical MediWales Kimal plc Medilink West Midlands Ingenica SEHTA Medopad London MedTech

Export Achievement

FH Intuition Medilink South West

Charnwood Molecular Medilink East Midlands


Orthoplastics Medilink North West

CellPath MediWales

Ariane Medical Systems Medilink East Midlands

Amprologix Medilink South West

Bedfont Scientific SEHTA

AlgiPharma MediWales

GoodSAM London MedTech

The Tinnitus Clinic Medilink West Midlands

Paxman Medilink Yorkshire & Humber

MatOrtho Limited SEHTA

Orthoplastics Medilink North West

MeeTwo London MedTech

Steeper Group Medilink Yorkshire & Humber


THE ABHI UK PAVILION AT MEDICA A critical part of ABHI’s work is to provide the right opportunities for UK businesses to accelerate their growth internationally. To enable this, we have, over several years, built a comprehensive programme of global activity across key markets. In November 2019, UK companies are invited to join ABHI at the UK Pavilion of the world’s largest event for the medical sector, MEDICA in Germany. Participation in the ABHI UK Pavilion provides companies with exposure, opportunities, support and assistance that they would not receive attending independently. The show is a prime opportunity to meet global partners in one place. There are thousands of visitors expected to visit the ABHI UK Pavilion every day, and alongside our extensive publicity campaign, UK exhibitors will enjoy great exposure before and during the show. With a range of added activities and in-market support, companies should act quickly to avoid missing out on being a part of one of the world’s largest HealthTech trade shows. MEDICA 2019 promises to be bigger and better than ever before, with increased visibility for UK companies, press and partnering opportunities. To join the ABHI UK Pavilion, contact:

Exhibitors on the ABHI UK Pavilion will enjoy: l

Exclusive access to a range of high quality exhibition stand options


Increased company visibility through ABHI’s press and media campaigns


Access to ABHI’s Pavilion support stand, including the use our meeting areas, working office, refreshments and internet café


A free listing in the ABHI UK Pavilion Exhibitor Directory


Dedicated one-to-one sessions with DIT commercial officers from selected markets

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

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

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

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

4. Global reach Through dedicated trade missions, presence at the world’s largest HealthTech exhibitions and the ABHI US Accelerator, we help our Members establish links to support their growth outside the UK.

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

Interested in joining ABHI? Ask a member of staff at the ABHI information desk, or contact

Future watch

Developing next-generation sensing technology Altered Carbon is on track to create the world’s first commercially viable, affordable e-nose.


umankind has successfully managed to digitise sight, hearing and touch, and now, thanks to sensor company Altered Carbon, is on the brink of being able to capture and record another sense – smell.

K9sense is the first chemical gas sensor of its kind, utilising graphene ink to create the olfactory chip. Using its unique chemistry, Altered Carbon has been able to create an accurate, responsive and ultra low power gas sensor. The first generation of the K9sense has surpassed expectations, displaying high performance sensitivity in the parts per billion range. The team is confident that with advanced digital circuitry and further R&D, future generations of the sensor range could soon rival the detection capabilities of dogs. Altered Carbon HQ is situated in the Bristol Robotics Laboratory, located at the University of West England (UWE), a vibrant centre for innovative technology development. The team has professional links to the Health Tech Hub, also based at UWE. Teams at the Health Tech Hub facility have been working towards harnessing the medical benefits of such powerful sensor technology, with a key focus on the potential early detection of various diseases. Testing of the sensors has been carried out by world leaders in physical measurement, known as The National Physical Laboratory (NPL). NPL is heavily involved in developing international standards for graphene and the characterisation methods used. The partnership provides benefits for both parties, who are working together on breakthrough discoveries.

continues to negotiate further R&D goals with like-minded companies across the globe. Global partnerships, innovative thinking and flexible development have allowed the company and its relatively small team to make big strides in a short space of time. In a world becoming increasingly connected, investment in SMART technology in homes and cities is a logical step. This next-generation sensing technology provides the data needed to learn how we can change and improve our surroundings. However, Altered Carbon acknowledges that hardware alone cannot provide the complete solution. The company has developed a unique sensor platform, providing a universal plug and play system that even a technophobe could use and benefit from. Their AI and deep learning algorithms will also help analyse big data sets to constantly improve their e-nose throughout its lifetime. The aim is to create a unique digital code for each smell (a ‘smell-print’) which can be identified by the intelligent sensor. The team is working closely with several companies looking to develop the sensors with particular issues in mind. Discussions are underway with companies across the UK in industries

“A dog’s sense of smell is 100 times more sensitive than humans, enabling them to detect all sorts of changes in the environment, from changes in weather to changes in the state of the human body. Imagine having a chip that mimics this ability but is also able to explain what it is sensing without barking.” Ali Rohafza, CEO Altered Carbon

including fresh food transportation and safety, animal welfare, environmental monitoring, explosives and narcotics detection, and advanced farming.

Altered Carbon sent a representative to South Korea as part of a DIT trade envoy and

“A dog’s sense of smell is 100 times more sensitive than humans”


Issue 16

Future watch

Seaweed technology to treat disease AlgiPharma UK is developing innovative technology, derived from seaweed, for treatment of respiratory diseases and chronic infections.


n the treatment of cystic fibrosis, chronic obstructive pulmonary disease and chronic infections, there is a clinical need to mitigate abnormal mucus accumulation, microbial infection, biofilm formation and antibiotic resistance. Cardiff-based biopharmaceutical company AlgiPharma UK, which recently won the award for Innovation at the MediWales Innovation Awards, is developing its unique alginate technology to target these diseases and combat the problems associated with them. In 2006, a collaboration between scientists in Norway and the Advanced Therapies Group at Cardiff University was established to determine whether a low molecular weight alginate oligomer, derived from marine brown algae, might have the ability to modify the physical properties of pathogenic bacterial biofilms in diseases such as cystic fibrosis. It was proposed that these alginate oligomers might disrupt interactions between bacteria and the biopolymeric components of mucus which coats the inner surface of the lungs. The scientists found that these oligomers were not only able to normalise the flow of sputum from patients with cystic fibrosis, but could also inhibit biofilm formation and increase the susceptibility of bacteria to conventional antibiotics.

Further development has also identified novel antibiotic-alginate conjugates that demonstrate a reduced toxicity and could be valuable in the treatment of multidrug resistant infections. The AlgiPharma technology, already listed in the US Cystic Fibrosis Foundation drug pipeline, has now been tested in five separate clinical trials and is showing statistically significant improvements in lung function for many cystic fibrosis patients. A further two clinical phase 2b trials are starting this year with participating sites in UK, Ireland, Germany, Australia and New Zealand. One of these studies is funded by an EU Horizon 2020 grant through a multinational consortium of partners. It is expected that these clinical studies will lead to a unique and novel treatment for mucolytic therapy in cystic fibrosis. Although development in the short term will be focused on cystic fibrosis, the technology has shown potential in other areas, including chronic obstructive pulmonary disease, chronic rhinosinusitis, fungal and bacterial multi-drug resistant biofilm infections, medical device coatings (e.g. catheters and endotracheal tubes) and facilitation of drug transport across mucosal barriers. Another potential application in wound care, through prevention and disruption of biofilm, is also being explored following promising findings in burn wound experiments.

With the combined ability to normalise the properties of mucosal function, directly impact bacterial and fungal growth, disrupt microbial biofilm defence mechanisms and increase the efficacy of antibiotics, the technology has a wide range of potential applications in the treatment of respiratory diseases and chronic infections.

For daily lifescience news visit 11

Future watch

Anatomical models created with 3D technology 3DAnatomica has developed interactive educational media that showcases 3D anatomical models.


ith 20 years of experience in designing 3D medical animations and delivery platforms, 3DAnatomica has taken this to the next level using the latest in gaming technology. The company has created medically accurate, interactive content that informs and educates about the human body, how it works, and how it is affected by disease and treatment.

Pharma marketing strategies are embracing digital offerings, which offer ease of distribution, more visually appealing content and accessibility for users across all sectors. 3DAnatomica has several eDetailing solutions that enable pharma, natural health and

medical device companies to showcase content in an efficient and physician-friendly manner. In response to requests from pharma, they are now enhancing presentation by developing 360ยบ/AR applications for mobile technologies.

The technology combines anatomical models that have been developed for clinicians, disease associations and pharmaceutical and educational institutions. It is easy to use, with navigation via simple hand gestures, and has potential applications for clinicians, patients, educators, students and more.

3DAnatomica has plans to release a comprehensive desktop programme, covering a range of chronic conditions, for clinicians to use in patient consultation. This would allow them to more easily explain and demonstrate disease concepts to patients and their families. The interactive 3D models can be put to equally good use in education for students of health science, nursing and general medicine. In Australia, the company has been working with Life Education Australia to provide visual interpretations of the effects of smoke, alcohol and drugs on the human body. They are also in discussions with the University of South Wales around nurse and clinician education in the UK and Europe. Healthcare is a global industry in which pharmaceutical sales and education has changed significantly in recent years. While traditionally paper-based in format, demand for digitally created and distributed products has increased with the advent of new mobile technologies.


Issue 16

Future watch

The benefits of blockchain in health and life sciences

Jamie Foster and Mark Weston from law firm Hill Dickinson explain the ins and outs of blockchain.


any of us in the health and life sciences sector grasp the basic principle that blockchain is a ‘distributed, decentralised ledger’ but are yet to understand what that actually means in practice…

A brief (and practical) description of blockchain Let’s break down the definition. A ledger is a database. It’s made up of blocks of information or blocks of transactions. Everyone with access has a complete copy of the ledger, which is updated in real time. Each ‘block’ in that ledger is a chunk of digital information, e.g. about a financial transaction, research data or a person’s health. The ‘chain’ is the stringing together of multiple blocks one after the other. But each block is linked to the previous block in such a way that any change to any information in any block alters the contents of every single block. You would notice that! Also, each time a block is added to the chain, it is verified by the other users of the system. So it is impossible to tamper with any block – because it would be glaringly obvious to everyone! Early uses of blockchain were public and permissionless. Bitcoin is a good example. Public: Anyone could see the list of transactions. Permissionless: Anyone can add new blocks which represent the substance of the database (value in this case) or move that value around by listing a new transaction in a new block. However, private and/or permissioned blockchains are becoming increasingly popular.

In summary, blockchain technology is attractive because it is technology that allows the creation of ledgers (i.e. records) which are accurate, verified, secure and can be shared easily.

Healthcare information Cryptocurrencies (e.g. Bitcoin) are just one use case for blockchain technology. But the underlying technology remains valuable for other use cases. In particular, the healthcare industry is well suited to use blockchain technology. Blockchain can be used to store and share specific information such as patient consents or even entire medical records. It can remove the risk of error in the information stored, provide patients with proof that the information cannot be changed, and give confidence that the information is private and can only be accessed by certain individuals who have the relevant permissions. It can also act as means of sharing information with everyone involved in a patient’s care pathway, from payers to healthcare providers and equipment suppliers. This is attractive in the NHS where the frustrations of fragmented care and siloed record keeping are well known. Since the failure of the project to create a single IT system 10 years ago, the NHS has been trying to improve how patient health records are created and shared, including through the Local Health and Care Records Exemplars programme. However, blockchain provides an opportunity for the NHS to make a paradigm shift.

Blockchain technology also offers opportunities in other areas, such as in developing nations where unreliable healthcare systems often mean that medical information is not trusted or correct, and where regional instability can mean patients are forced to relocate. It can give patients accurate, secure and private information which can be shared at their direction. The work of Factom Inc, a Texas-based company, in this field is a good example.

Other uses There are many other potential benefits of Blockchain technology, such as: l Assisting with tracking and verification

of medicines/medical devices to combat the huge counterfeit market and to facilitate recycling of unused medicines and devices

l Providing a mechanism for the

verification of the credentials and registrations of healthcare workers

l Facilitating creation of vast datasets

which are trusted, verified and secure and to which artificial intelligence and machine learning tools can be applied, e.g. to analyse population health trends

l Generating smart contracts, e.g. for

automated claims processing or patient contracts, which reduce transaction costs and speed up transaction payments and processes

For daily lifescience news visit 13

Future watch

Regenerative technology enables new treatments Orthocell has developed innovative regenerative technologies to provide new treatments for people suffering from tendon, cartilage and soft tissue injuries.


ustralian biotech Orthocell is dedicated to restoring mobility and regenerating soft tissue through the use of their unique line of regenerative medicine products. They have developed an important new range of collagen medical devices, autologous cellular therapies and bioactive molecules/growth factors. To date, the company’s cellular therapies have been used to treat almost 1,000 patients each, and its collagen medical device is now entering the European market. Ortho-ATI is indicated for the treatment of damaged or degenerate tendons that have failed to respond to traditional treatments such as physiotherapy, corticosteroid injection and PRP. These treatments traditionally have limited success for chronic sufferers because they do not adequately address the depletion of tenocytes which is the hallmark of chronic degenerative tendinopathy. Orthocell’s OrthoATI technology directly addresses the root

Ortho-ACI is a third generation therapy for the regeneration of human cartilage. It offers an effective treatment for symptomatic defects of the articulating cartilage of the joints, predominately the knee and ankle. The treatment also involves collection of a healthy cartilage biopsy from the patient via arthroscopy. In a manner similar to Ortho-ATI, the chondroctye cells are isolated and grown to a clinically significant number. The cells are implanted to the site of cartilage damage approximately six weeks from the date of biopsy. This procedure is performed by an orthopaedic surgeon.

cause of degenerate tendons through the application of an advanced cellular therapy. The cellular therapy is prepared using tendon cells harvested from the patient’s own healthy tendon and cultured using qualified processes to achieve a clinically significant number. These cells are then implanted into the damaged tendon using ultrasound guided injection.

The company’s latest innovation is CelGro, a collagen medical device that augments tissue repair and regeneration. Use of CelGro has been shown to improve tissue repair in multiple applications such as dental guided bone and soft tissue regeneration, augmenting the repair of the rotator cuff tendon within the shoulder, assisting in the re-joining of severed or damaged peripheral nerves, and repairing articular cartilage in the hip. The unique collagen device is bio-compatible, bio-absorbable and biomechanically sound, allowing for multiple uses either on its own or in combination with autologous cells or growth factors. In 2018, Orthocell built a partnership with West Midlands-based Carrera Medical for the promotion and distribution of CelGro, and soon signed its first distribution deal in the UK for its range of dental products. As such, Orthocell UK won the Start-Up award at the 2018 Medilink West Midlands Medical and Healthcare Business Awards, and is predicting significant growth in the coming years.


Issue 16

Future watch

Next-gen technology to enhance spinal fusion Regenerative medicine company Locate Bio has developed novel technologies and products designed to overcome the current limitations in cell therapy and gene therapy treatments. The company’s proprietary technologies, TAOS and IntraStem, are a world first in tissue repair.


ntraStem is a novel peptide-based intracellular delivery technology that overcomes key limitations of viral and non-viral delivery systems to deliver improved gene therapies. Meanwhile, TAOS is a cell delivery system that addresses the major challenge of ensuring that cellular therapies stay at the intended site of action and that they remain viable in host tissues, so that they can exert their therapeutic effect whilst being safe and well tolerated.

The company is currently developing a new product for spinal fusion using state-of-theart regenerative medicine technologies. Specifically, they are aiming to enhance this surgical procedure for patients with type 1 and type 2 diabetes. It is known that this patient group has poorer clinical outcomes

and more frequent complications after spinal fusions with autograft or bone graft substitutes. The underlying cause of these failed outcomes and complications is the compromised function of mesenchymal stem cells (MSCs) which are required to generate new vascularised bone tissue.

genetically-modified cells. A range of new equipment was required for this purpose. With this in mind, the company approached Medilink East Midlands, who awarded them a £6,069 grant through the INSTILS programme, part-funded by the European Regional Development Fund.

There are very high socioeconomic and healthcare costs associated with this patient group, with approximately 6 per cent requiring fusions. The project uses an innovative injectable macroporous matrix and patented intracellular delivery systems to create an easy-to-use regenerative medicine for high value interventions.

The state-of-the-art cell culture suite was created, and a project manager and scientist are being employed. The company has begun development of the process of rejuvenating patients’ stem cells (ex vivo) and the foundations for new cell therapy manufacturing in the UK. The goal of taking products through market approval and commercialisation is on track and substantial investment has already been raised, motivated in part by these early successful steps.

In order to achieve the project’s objectives, Locate Bio needed to expand its research facility at MediCity Nottingham and set up a new cell culture suite, capable of handling

For daily lifescience news visit 15



16–19 JUNE


RENAISSANCE KUALA LUMPUR HOTEL, KUALA LUMPUR, MALAYSIA This conference will provide a forum for accessing the most up-to-date and authoritative knowledge from both commercial and academic worlds, sharing best practice in the field as well as learning about case studies of successfully integrated bio-sensing technologies. Conference Chair


Prof. Richard Luxton Director Institute of Bio-Sensing Technology University of the West of England, UK

The major features required to develop a commercially successful bio-sensing technology are represented in the five themes of the conference: 1. Biomarkers for novel biosensing applications 2. The biosensor surface 3. Novel detection technologies 4. Bio-sensing technology for the internet of things 5. Impact of bio-sensing technology

Organised by

In partnership with

The conference will include:

Supporting Publications 129

Contents lists available at ScienceDirect

Application of hairpin DNA-based biosensors with various signal amplification strategies in clinical diagnosis R. Abolhasan, A. Mehdizadeh, M.R. Rashidi, L. Aghebati-Maleki & M. Yousefi


Novel amperometric genosensor based on peptide nucleic acid (PNA) probes immobilized on carbon nanotubesscreen printed electrodes for the determination of trace levels of non-amplified DNA in genetically modified (GM) soy S. Fortunati, A. Rozzi, F. Curti, M. Giannetto, R. Corradini & M. Careri



A wearable origami-like paper-based electrochemical biosensor for sulfur mustard detection N. Colozza, K. Kehe, G. Dionisi, T. Popp, A. Tsoutsoulopoulos, D. Steinritz, D. Moscone & F. Arduini


Raman tracking the activity of urease in saliva for healthcare S. Hu, Y. Gao, Y. Wu, X. Guo, Y. Ying, Y. Wen & H. Yang


ISSN 0956-5663

Integration of a field effect transistor-based aptasensor under a hydrophobic membrane for bioelectronic nose applications A.E. Kuznetsov, N.V. Komarova, E.V. Kuznetsov, M.S. Andrianova, V.P. Grudtsov, E.N. Rybachek, K.V. Puchnin, D.V. Ryazantsev & A.N. Saurov


Signal-on electrochemiluminescence aptasensor for bisphenol A based on hybridization chain reaction and electrically heated electrode H. Zhang, F. Luo, P. Wang, L. Guo, B. Qiu & Z. Lin


Multifunctionalized ZIFs nanoprobe-initiated tandem reaction for signal amplified electrochemical immunoassay of carbohydrate antigen 24-2 Y. Zheng & Z. Ma


Integrating PDA microtube waveguide system with heterogeneous CHA amplification strategy towards superior sensitive detection of miRNA C. He, M. Wang, X. Sun, Y. Zhu, X. Zhou, S. Xiao, Q. Zhang, F. Liu, Y. Yu, H. Liang & G. Zou


Electrochemical aptasensor for aflatoxin B1 based on smart host-guest recognition of -cyclodextrin polymer S.S. Wu, M. Wei, W. Wei, Y. Liu & S. Liu


2D-porphrinic covalent organic framework-based aptasensor with enhanced photoelectrochemical response for the detection of C-reactive protein X. Zhang, K.-N. Chi, D.-L. Li, Y. Deng, Y.-C. Ma, Q.-Q. Xu, R. Hu & Y.-H. Yang



Volume 4, June 2015

ISSN: 2214-1804

The principal international journal devoted to research, design, development and application of biosensors and bioelectronics

Vol. 4 (2015) 1–118

Full Papers

Fabrication of an ultrasensitive and selective electrochemical aptasensor to detect carcinoembryonic antigen by using a new nanocomposite M. Mazloum- Ardakani, Z. Tavakolian- Ardakani, N. Sahraei & S.M. Moshtaghioun

Volume 129

Sensing and Bio-Sensing Research


Review Papers

15 March 2019

Biosensors & Bioelectronics

Biosensors and Bioelectronics

j o u r n a l h o m e p a g e : w w w. e l s e v i e r. c o m / l o c a t e / b i o s

Vol. 129 (2019) 1–300

◆ Presentations from leading specialists highlighting new opportunities in biosensing technologies ◆ An opportunity to share best practice in the integration of technologies for bio-sensing ◆ An exhibition of leading-edge, commercial technology ◆ A poster forum for unveiling new research ideas and concepts ◆ Networking opportunities ◆ A strong industry focus with companies presenting their technologies

Contents continued on inside back cover

Abstracting Services This Journal is cited in the following Abstracting Services: AGRICOLA database; ADONIS; Bioengineering Abstracts; BIOSIS (Biological Abstracts); Biotechnology Research Abstracts; Elsevier BIOBASE/Current Awareness in Biological Sciences; Cambridge Scientific Abstracts; Chemical Abstracts; Current Biotechnology Abstracts; Current Contents; Environment Abstracts; Embase/Excerpta Medica; Pollution Abstracts; Science Citation Index; Telegen Abstracts. Also covered in the abstract and citation database SCOPUS ®. Full text available on ScienceDirect ® The publisher encourages the submission of articles in electronic form thus saving time and avoiding rekeying errors. Please refer to the online version of the Guide for Authors at


For full details and to register:

Available online at


International Standard Serial Number: 0956-5663






Future watch

Join the Welsh Health Hack 2019! Thursday 23rd & Friday 24th May Life Sciences Hub Wales, 3 Assembly Square, Cardiff, CF10 4PL Over two days, the Welsh Health Hack will again bring healthcare professionals and digital, technology and data companies together to solve clinical problems and challenges from across the health and care system in Wales. Participants will have the opportunity to submit suggestions of challenges to be addressed ahead of the event or simply come along to learn about others’ challenges and be involved in creating solutions, a product idea, or prototype. Contact the events team at Life Sciences Hub Wales on with any questions and keep up to date using #whh2019

Further details and booking:

Future watch

Neuroscientific approach to treating depression and anxiety What do mental health issues look like? TranQuality is enabling people who suffer from anxiety and depression to visualise their mental health problems and identify more objective solutions to combat them.


ach year in the UK, 1 in 6 people suffer with a mental health condition, and the number of adults accessing treatment increased by 24 per cent from 2007 to 2014. Poor mental health is proving to be the biggest health risk to people worldwide and TranQuality aims to change this. Using a non-invasive technique, similar to having an eye test, TranQuality monitors the electrical communication in the regions of the brain that control mood. Partnering with GPs and clinicians across the UK, the

organisation intends to raise awareness of the innovative, neuroscientific solution to treating depression and anxiety disorders. The Mental Health Assessment process, developed by TranQuality, analyses the electrical activity in the brain and generates a visual depiction of what and where any problems lie. By mapping the regions of the brain that require focused treatment, it provides a clear explanation of the mood and anxiety problems being faced, better understanding of how to progress, and an opportunity to objectively see the treatment process at work.

“I have tried many talking therapies and medications but they strike me as being a bit of an estimate. At my TranQuality assessment, being provided with a 3D image of my brain, I realised the treatment would be focused on the particular areas of my brain that weren’t functioning as they should be which gave me a real sense of encouragement.� Phil Merrison Patient

Following the assessment, those suffering from depression and anxiety disorders can take part in Targeted Transcranial Magnetic Stimulation (tTMS), an FDA and NICE approved, non-medicated treatment option that has little to no side effects with proven results in less than two weeks. TranQuality is looking to work with organisations, individuals and healthcare professionals to showcase the benefits and successes of their treatment programme, believing patients should be given another option in treating depression and anxiety disorders in addition to antidepressants and talking therapies. Raising awareness around the rising concerns of mental health, and breaking down the stigmas surrounding depression and anxiety, are key steps for TranQuality, who want to make mental health something that is not just talked about, but visualised and acted upon.


Issue 16

Future watch

Three reasons why new product launches fail Developing products for the healthcare sector is complex and fraught with risk. It is well documented that 9 out of 10 projects will fail. So what are the typical problems that companies encounter and what basic techniques can they use to mitigate the impact of these to improve success rates? Dr Patrick Trotter, Medilink North of England’s Head of Innovation and Commercialisation, examines three of the most important barriers.


Market opportunity analysis – your market isn’t as big as you thought

Do you really understand the market you are developing for? Have you taken the time to identify the actual cohort who will use your product? Do you understand the patient pathway well enough? By evaluating the market in detail, you can identify the real addressable opportunity, identify additional opportunities and pivot to other opportunities and projects if appropriate, saving you time and money.


Customer needs identification – your customer doesn’t like the product in its current form

All too often, products are developed to the point of launch without identifying the specific customer needs. You may have an idea of who the customer will be, but have you investigated the reasons why that need exists or adequately defined the problem? There are a number of sophisticated innovation techniques that can be used to characterise, segment and prioritise these needs and convert them to design inputs, in order to develop concepts that have a high probability of commercial success.


Value proposition – your customer wants more evidence before buying your product

You’ve conducted your clinical trials and have been awarded your CE mark, but your procurement conversations have stalled, your customers want more evidence and sales are not meeting expectations. Do you understand the flows of money and procurement processes in the NHS or other target markets? Have you truly aligned your product or service to challenges your customer is facing? Understanding the value you are offering to the customer before conducting clinical trials is critical in ensuring you are collecting the right forms of evidence in the right amounts to convince your customer. This level of evidence may be different to the amount required to support your indications and claims. Medilink North of England’s Innovation & Commercialisation experts work with companies of all sizes to de-risk their product development projects. Call 0114 232 9292 or email for more information and assistance.

For daily lifescience news visit 19

Future watch

Growing the advanced therapies sector By 2015, over 1000 jobs had been created in the advanced therapies sector, and it is estimated that the market will be worth between £9-£14 billion per year by 2025.


commercialisation and, earlier this year, the network of Advanced Therapies Treatment Centres was set up to help overcome the barrier of clinical delivery.

The UK government is clearly committed to supporting this sector. The Cell & Gene Therapy Catapult was established in 2012 and is working hard to bridge the gap between scientific research and full-scale

As a backdrop to this activity, there is also a need for deeper collaboration between academia, industry and the NHS in order to really advance the advanced therapies sector. Two new programmes have been launched to achieve this aim, led by London Advanced Therapies and delivered by MedCity.

owever, the challenges in advanced therapies are unique and require new approaches. Clinical trials, investment, data analytics and reimbursement all need different ways of working compared to the traditional pharma pipeline.

Advanced Therapies Network (ATN) The ATN was set up in November 2018 with the aim of creating a network of people from across industry, academia and the NHS who are working in advanced therapies. At the heart of the network is a series of events for members which discusses topics of interest and specific challenges in commercialisation. The first of these was held in February and focused on setting up clinical trials where speakers provided insight on resources and support, alongside presentations of valuable case studies of clinical trials. The second event in May will bring together speakers from organisations who have invested in the sector alongside advanced therapies companies to present both sides of the investment journey. The event is titled ‘What is the recipe for an advanced therapies unicorn?’ and will be held at 6.00 pm on 14 May 2019 at the Silicon Valley Bank, Moorgate, London.

Collaborate to Innovate: Advanced Therapies This second round of Collaborate to Innovate offers a focused end-to-end solution for SMEs working in advanced therapies with specific R&D needs. It helps define those needs, then matches them to expertise in Higher Education Institutes with the aim of leading to innovative advanced therapies products. Each of the participating SMEs in the scheme receives support to help them tap into academic expertise and key capabilities from the university delivery partners up to a value of £150,000. The successful projects will be launched in June 2019.


Issue 16

London Advanced Therapies (LAT) brings together the London scientific community working in the field of cell and gene-based therapies. Funded by Research England, and led by King’s College London, Imperial College London and University College London, LAT aims to catalyse London’s capabilities and outputs in the area of Advanced Therapies, through fostering collaborative work, facilitating commercial partnerships and creating a microclimate for innovation. Within this mission and working with MedCity as a delivery partner, LAT has launched a number of initiatives including the Advanced Therapies Network and Collaborate to Innovate: Advanced Therapies.

Future watch

For daily lifescience news visit 21

Clinical Need

A case study of new tech adoption in the NHS Glyn Barnes, UK Country Manager for AliveCor, explores the key factors that led to the med tech start-up’s success.


n 2011, Dr Dave Albert, a Harvard trained cardiologist now with 45 patents to his name, founded a novel med tech company in Silicon Valley, California. Working with his co-founders, two Australian engineers, they took an idea that they thought could change the way doctors, nurses and patients manage a key component in healthcare. The company AliveCor was born along with Kardia, a miniaturised device that produces medical grade ECG by simply using an app and a smartphone or tablet. Once the product was produced in a commercialised form, the next step was to seek approval from the FDA in America. This was achieved relatively quickly and CE marking in Europe followed. The challenge then began to achieve acceptance and adoption by the NHS. Although only six years ago, Kardia was met with scepticism by the clinical community. Could this little device really give a medical grade ECG recording by which clinical decisions can be made? Is it just a gadget? AliveCor UK was faced with similar challenges to all new start-ups: limited funds, only one person in-country, slow revenue returns and so on. So, what were the factors that led to the company’s ultimate success? There was no single factor leading to the product’s general approval and adoption. It was more a combination of events and efforts, which when combined, made Kardia a realistic proposition to healthcare professionals. Firstly, the NHS through its own research became very aware that atrial fibrillation was a serious problem in the UK. The


Issue 16

statistics showed that approximately 2.4 per cent of the population suffered with AF and the overall cost, once the post-stroke care is considered, ran to around £2 billion per year. Thus there was a keen interest to provide a solution. Secondly, the NHS, faced with an inevitable tide of new technologies, apps and software, realised that perhaps one way to significantly improve healthcare and save costs, was to embrace this ‘new world’. Consequently, five years ago they created the Academic Health Science Network (AHSN). Their role is to specifically search for these new technologies and assess them for validity, return on investment etc. It shouldn’t be ignored, however, that the product had to deliver on its promise of quality recordings, reliability and price. Price positioning was a key component to success. An attractive proposition will always make things easier and Kardia was no exception. The downside of course, is that lower prices mean less revenue to invest in support services. AliveCor’s KardiaMobile was accepted into the first group of products to be assessed by the AHSN and subsequently to their Accelerator programme. As this was a thorough process of due diligence before recommendations could be made, it still took nearly two years before evidence was provided to NHSE. However, this resulted in the purchase of a significant number of devices that have now been distributed through both primary and secondary care. Effectively ‘seeding’ the product across the country, this has helped enormously in terms of product awareness, acceptance

and further local orders. Results are being monitored, and hopefully will provide the evidence to encourage additional national purchases.

A further NHS initiative is the Testbed programme. AliveCor was also accepted into this, partnering with Care City AHSN in 2018. This project proved the value of using KardiaMobile to screen patients for AF in high street pharmacies. By establishing a ‘fast track’ route directly into Barts Hospital for those patients testing AF positive, the project managed to reduce the time to diagnosis and treatment from twelve weeks to just two.

Undoubtedly, a key factor for the success of AliveCor was the publication of numerous clinical, peer-reviewed papers in medical journals. Now numbering around 60, these have given us the clinical validation and the doctor’s confidence to begin using the product in earnest. They have also led to an ever-increasing number of key opinion leaders in cardiology willing to endorse the device. The net result of the various factors mentioned is that many of our sales result from a GP, nurse or cardiologist recommending their patients to buy KardiaMobile for themselves and then send in their recordings for review. Having Amazon as one route to purchase has greatly enhanced this process.

Clinical Need

So, in conclusion, there are three key factors that contributed to AliveCor’s success in the market place: l A high quality, accurate and reliable product with clinical validation and a realistic price l Support from various networks, key opinion leaders and agencies wherever possible l An element of good fortune – if your product provides a solution to a burning issue, all

the better

What is clear, as a still relatively small, young start-up med tech company, is that no one factor is the key to success. Having a great, well-priced product is not a guarantee for adoption. It is more akin to creating a series of jigsaw pieces that, when finally linked together, can lead to a picture of success.

For daily lifescience news visit 23

Clinical Need

Electronic health record for pregnant women SymlConnect designs intelligent digital health solutions that eliminate paper processes, enhancing clinical and cost efficiency.


ales currently uses an ‘All Wales Maternity’ handheld record, with some health boards implementing separate hospital in-patient electronic records. Powys Health Board feeds into eleven different District General Hospitals, all using different systems that cannot communicate with one another. The effectiveness of the paper document is reliant on the patient remembering to carry it with her and on the healthcare professionals remembering to update it. There is also no back-up copy should the record be lost or damaged. Swansea-based SymlConnect set out to digitally transform the current system by creating an ‘Electronic Community Pregnancy Health Record’. The company initially connected with Powys midwife research leads. Discussions soon identified the need to involve NHS Wales Informatics Service (NWIS) to ensure clinical standards, security governance and feasibility of

integration with the Welsh Clinical Portal. This partnership between SymlConnect and the NHS was supported and sustained with a Bevan Exemplar award. Co-designed with midwives, the offline prototype follows clinical standards, triggering prompts to improve data recording. Auto-generated management plans highlight essential information with added safety features. Data completion requirements are displayed and risk factors are flagged up to ensure a superior level of care delivery. Midwives generally have five to seven consultations per day. Achieving NWIS integration with the Welsh Clinical Portal, midwives estimate cutting the admin time for each visit by half. Additionally, a mum’s app, built for Android and Apple devices, allows for a read-only, up-to-date copy of the clinical records to be accessed, for example in emergencies. Personal health questionnaires and information leaflets could also be e-transferred to the mum’s app.

A mum-to-be survey was conducted as a part of a ‘maternity day assessment changes’ project launched through social media. Powys midwives also carried out face-to-face discussions during their homevisit consultations to gauge the response to a potential digital version of the hand-held record. SymlConnect obtained a general consensus from partners and stakeholders within NHS Wales and NHS England, where support for the mum’s app concept was overwhelming. The new digital system allows for more streamlined recordkeeping, real-time data sharing and improved security. It also reduces the risk of information being duplicated and enables accessibility anywhere at any time. The collaborative project received the award for Partnership with the NHS at the 2018 MediWales Innovation Awards.


Issue 16

Clinical Need

Innovation award for medical device manufacturer MatOrtho Ltd believes in safe innovation and, as a result, has a proven history of successful hip and knee joint replacements. The medical device manufacturer recently won the SETHA award for Innovation in relation to the development of their hip portfolio.


ocated in Leatherhead, Surrey, MatOrtho (previously Finsbury Orthopaedics) was established by Mike Tuke in 2010 to continue the pioneering work of almost four decades in the orthopaedic industry. Today, the company’s products are delivering some of the best clinical results worldwide, and the greatest driver behind this is to always put the patient first. In particular, MatOrtho and its predecessor, Finsbury, were pivotal in the successful innovative design of hip resurfacing implants. Hip resurfacing removes less bone than a total hip replacement and therefore provides younger and/or more active patients with conservative surgical options that allow continued high levels of activity. Evidence demonstrates that hip resurfacing patients return to activities sooner, without the same restrictions to participate in sports that a total hip replacement would generally pose. The ADEPT metal-on-metal (MoM) hip resurfacing implant stands as a testimony to getting the design right, together with a very careful rollout through clinical assessment. But the company is now taking this concept a step further by introducing a ceramic-on-ceramic resurfacing implant named ReCerf. This will be another game-changing implant, with all the benefits of a MoM resurfacing device but without the worry for patients of metal ions. In addition to this, the technology and design principles provide more innovative implant steps that promise affordable improvement for all conventional hip replacements worldwide, eliminating hip dislocation, improving range of motion massively, and preventing wear.

MatOrtho continues to evolve concepts with intelligent feedback and application of modern technologies. There are many other projects underway that aim to bring better solutions for patients. Mike Tuke explains: “The very point of a safe approach and safe clinicalled innovation is never forgetting who has to live happily with a product for the rest of their lives – the patient.”

For daily lifescience news visit 25

Clinical Need

How innovative technology impacts the NHS Dr Damien Marmion, CEO of Ingenica Solutions, shares an insight into the company’s recent award win and the impact of its innovative technology on the NHS.


cooping the title of ‘Outstanding Achievement’ at the SEHTA Healthcare Business Awards, as well as being finalists in two other categories, is a significant achievement and a tremendous boost for everyone at Ingenica Solutions. Our recent performance in the healthcare market and our strong partnerships with the NHS really mark us out from the competition, and as winners we have also been entered into the Medilink UK National Awards where national winners are recognised at one of Europe’s largest healthcare innovation exhibitions, MedTech Innovation Expo. Our entry showcased the value we have delivered working in partnership with NHS organisations to improve their supply chain and procurement practices. Ingenica Solutions’ 360 IM provides NHS trusts with a 360-degree view of supply chain cost drivers; tracking and tracing products, people and equipment. Applied in this way, the technology contributes to better patient safety across the NHS, and is being used to track medical supplies, such as high value implants, from point of manufacture to point of care with patients. This may seem basic, as this process already exists in other industries, but for the NHS it is a significant evolution as the environment is so much more complex.

We also ensure that innovative technology of this type brings positive change and benefits to individuals working in the NHS around the UK, from senior leaders, clinical managers and supply chain teams to frontline clinicians, making a difference to the roles and responsibilities of the whole workforce.

The NHS is set to receive close to half a billion to fund innovative technology in hospitals to make it safer for patients, and allow clinicians to spend more time on the frontline. Secretary of State for Health and Social Care, Matt Hancock, has stressed the importance of government healthcare initiatives to encourage this, with Scan4Safety, GS1 and e-procurements being key ones.

Scan4Safety is deemed a world first in healthcare, and is expected to generate efficiency savings across the NHS of more than £1 billion over seven years. It’s

about bringing improvements across the entire supply chain by adopting global standards, GS1 and PEPPOL, to drive efficiencies. We support both adoptions of GS1 standards and the Scan4Safety programme, and our founders were instrumental in this initiative getting off the ground by working on pathfinder projects and inputting to the government’s early strategy for procurement and supply chain improvement. We were also the first GS1 certified solution for inventory management in the NHS, working hard to ensure that our solution is flexible enough to deal with the multi-faceted and challenging clinical environment. We continue to work with many trusts that are part of the tech transformation, improving quality and costs. These trusts demonstrate how the innovative use of technology improves value financially as well as value to the patients. Trusts are achieving 100 per cent traceability on implants, substantial cost savings, and the release of clinical time from administration duties. Our projects in Lancashire, Portsmouth, Berkshire, Taunton & Somerset, Cornwall, and Kettering (to name a few), are replicable across the country and provide the NHS with an opportunity to scale savings and efficiencies without affecting quality. We hope our successful projects inspire more NHS organisations to use innovative technology in order to drive better procurement and supply chain processes and deliver first class healthcare.


Issue 16

Clinical Need

New app to help improve patient care B13 Technology designed an award-winning app to provide NHS staff with the most accurate, up-to-date Clinical Guidance information.


irmingham-based B13 Technology like to think of themselves as ‘Digital Explorers’ – using technology to help businesses go further, break new ground, investigate challenging ideas and solve everyday problems. This approach led to them being crowned SME Business of the Year at the 2018 Birmingham Post Business Awards.

accessing guidance notes with no way of knowing whether they were up-to-date. This was putting them at risk of providing outdated clinical advice and following incorrect procedures.

Being controlled by one central administrator makes it impossible for anybody using the app to access or view out-of-date notes, thereby ensuring best clinical practice and mitigating the risk of potential clinical negligence claims. Now that the app is up and running, clinical staff have increased trust in the information they access, are able to work more efficiently and deliver better, safer care to patients.

Digital health is a current focus for the company, who are part of the West Midlands Academic Health Science Network and a member of the Digital Health WM Incubator within the Serendip Smart City Incubator. For a project in this field, they recently won the award for Partnership with the NHS at the 2018 Medilink West Midlands Medical and Healthcare Business Awards.

Working in partnership with the Children and Family Directorate, B13 built a version-controlled application, managed by a central administrator, which allows all employees to view accurate and current Clinical Guidance notes on IOS, Android and Blackberry devices. This means they can access the notes in any location, e.g. outside of clinical settings on patient visits.

For founders Tom Haworth and Jon Swinbourne, agile is the most important word in B13’s vocabulary. “From culture to delivery, agility is absolutely key,” they explained. “No matter the topic – software development, apps, system integration or incubator support – we guide clients (from start-ups dipping their toe in the digital waters, to wellknown brands looking to push innovation to its limits) through all parts of the digital landscape. Delivering an agile, scalable service and utilising a broad spectrum of digital, we strive to take clients to new frontiers.”

The award-winning project was set up to address a problem: that many of the Child and Family Directorate’s clinical team were

For daily lifescience news visit 27

Clinical Need

Alarm systems reduce stress in care Alert-iT is a forward thinking manufacturer specialising in the design, production, distribution and support of care alarm systems across the UK.


he Alert-iT radio system with a pager is a proven, failsafe alarm system for protecting vulnerable people by detecting epilepsy seizures, falls and enuresis episodes. The company is now evolving their current technology platform to include low power Bluetooth near-field communication, and finding cost-effective new ways to support nurses with issues around fall management. The Alert-iT radio system with a pager is a proven, failsafe alarm system for protecting vulnerable people by detecting epilepsy

The company’s various assistive technology products include: Ep-it: Epilepsy monitors to detect the symptoms of a seizure. Comf-it: A unique moisture detecting system to help with management of incontinence issues. Sense-it: Monitors to discreetly support those at risk of falls.

seizures, falls and enuresis episodes. The company is now evolving their current technology platform to include low power Bluetooth near-field communication, and finding cost-effective new ways to support nurses with issues around fall management. By developing the existing alarm system, the benefits of Alert-iT can be brought into the hospital environment. A key innovation is the addition of location identification using low cost NFC labels that can identify the room or user being used by the alarm monitor, and pass this information on to the pager or nurse call system. This means that continuous monitoring can be provided without a constant or intrusive caring presence, promoting better confidence for carers and dramatically improving the experience and quality of life for those being cared for. Alert-iT sought funding in order to carry out the innovation, specifically for the design of a custom case to house system components, the design and generation of a prototype tooling for the casing, and the production of prototype casing samples for testing and evaluation. Medilink East Midlands provided the company with a £7,170 grant under the SoLSTICE project, which is part-funded by the European

“Medilink have provided much needed expertise in securing the support and funding we required to allow this project to move forward in a timely manner. Because of their excellent support and guidance, we’re currently in the process of applying for additional SoLSTICE support, to enable us to move forward with our goal to provide up to date technology supporting the growing demands of the care industry.” Tony Bullars Director Alert-iT Care Alarms

Regional Development Fund, enabling them to undertake Medical Technology Trials (MTT). Thanks to the funding, the project could go ahead in a far more rapid and robust manner, allowing the evaluation of several design options as well as the trialling of prototype casing samples.


Issue 16

Going ClinicalGlobal Need

Medilink launches new pavilion at MEDICA 2019

Medilink UK is proud to launch its latest British Pavilion at MEDICA 2019. The exhibition space, combined with additional activity in market, offers UK companies a unique and high profile entry point in to the world’s largest Healthcare & Life Sciences exhibition.


s the world’s largest event in our sector, MEDICA has been firmly established on every expert’s calendar for more than 40 years. Medilink has a successful track record of developing and executing international strategies for our members. The team listens to your needs, understands your market, and provides practical market entry strategies and direct support to help you secure your share of the rapidly growing global market for healthcare products and services. Following feedback from Medilink’s members and clients about the prohibitive costs for SMEs wishing to exhibit at European trade shows, our new pavilion at MEDICA 2019 offers a cost-effective option for participating companies from across the healthcare and life science sectors, while creating an opportunity to expand

their businesses in Germany and other European countries. The Medilink team offers a valuable and personal service to all of our exhibitors. As well as stand space on a high quality, UK branded pavilion, you can benefit from pre-show administrative assistance and in market support – from international trade advice to free refreshments – to ensure that you have a stress-free show. MEDICA 2019 will take place from 18-21 November 2019 in Düsseldorf, Germany. Year on year, leading individuals from business, research, and politics attend the exhibition alongside tens of thousands of national and international experts and decision-makers. Book your place with Medilink UK and showcase your business at the world’s largest healthcare and life sciences event.

In 2018 MEDICA welcomed over 120,000 visitors through its doors including 6,070 exhibitors from 66 countries around the world. Within the 17 halls of exhibition space, over 280 British businesses were represented.

In addition to the assistance and on-hand knowledge of the experienced Medilink team, in partnership with the Department for International Trade, there is limited funding available to support companies towards their exhibiting costs, subject to eligibility criteria. Get in touch with the International team for more information.

Call 0114 232 9292 or email to book your place today.

For daily lifescience news visit 29

Going Global

Innovative breath monitors go global Bedfont Scientific was named South East Exporter of the Year at the 2018 SEHTA Healthcare Business Awards for its success in exporting pioneering breath analysis products.


he company, based in Kent, has been manufacturing breath analysis medical devices for over 40 years, and they are now available in over 82 countries across the world. Bedfont’s breath analysers include Smokerlyzer, used to aid smoking cessation, and the ToxCO, used by emergency services to mass screen for carbon monoxide poisoning. Smokerlyzer is a hand-held, non-invasive monitor that measures the amount of carbon monoxide on a smoker’s breath. For healthcare professionals, it offers a way to biochemically establish a person’s smoking status, For the smokers themselves, it can serve as a motivational visual aid, encouraging them to quit and allowing them to measure their progress.

“In 10 years we’ve managed to establish a network of distributors, whom we regard as an extension of the Bedfont family. Our first distributor was established in 1988 and we still work with them today. Through this network, we have managed to increase our exports significantly, and they now account for 80 per cent of our turnover.” Jason Smith Managing Director Bedfont

ToxCO is a non-invasive breath and ambient air monitor, with three different sampling modes designed to reduce unnecessary

hospital admissions through instant screening and save lives. The mouthpiece and face mask sampling modes allow the user to test a patient independent of their consciousness, while the ambient sampling mode safeguards the user, alerting them if they are entering an area with high levels of carbon monoxide. The company has also developed the NObreath monitor, which analyses airway inflammation for the control of asthma, and the Gastrolyzer monitor, which offers hydrogen breath testing to aid in the detection of gastrointestinal disorders and food intolerances. Quick and non-invasive, these medical devices are demonstrating that breath analysis is the new blood test. Another of the company’s innovations is the Medi-Gas Check range of portable pipeline monitors, used to verify the quantity and quality of piped medical gas. Bedfont now has six exporting accolades to its name, and the company’s ambition is to continue innovating and improving health, one breath at a time.


Issue 16

BioPartner UK Delegations Showcasing UK Life Science BioPartner UK Delegations promote the UK presence at international conferences. We work with events organisers, in-country agencies and overseas networks to provide the best discounts and business opportunities for UK companies travelling with the delegation. We have negotiated exceptional discounts to some of the world’s finest quality biopharma partnering events. In collaboration with our alliance business partners, we manage the UK presence at key overseas conferences.

Exclusive discounts for many of the world’s leading biopharma partnering events.

Anglonordic 9th May London

UK Delegation and discounts available

BIO-Europe 2019 11th-13th Nov Hamburg

UK Delegation and discounts available

BIO Convention 3rd-6th June Philadelphia

BioPharm America

UK Delegation and discounts available

11th-12 Sept Boston

UK Delegation and discounts available

See our website for details of these and other opportunities. Join the BioPartner Programme and be kept up to date!

internationalising UK Life Sciences

People and Places

Have your vision realised: Putting the citizen at the heart of innovation There are more people alive today than ever before, which on its own places enormous pressure on public funded systems like health care. If we add the fact that living longer results in us having more health issues, it becomes clear that a major paradigm shift in the way we deliver health and care is needed, and the scale and pace of change that we need is considerable.


nnovation is essential if we are going to move to sustainable healthcare systems in the future, and in this context it becomes important to have a dialogue between end users (basically all of us) and those tasked with improving things.

hyvr is a social media platform developed by The West of England Academic Health Science Network with Cyber Media Ltd. It is designed to provide a safe and trusted place for conversations to happen between people who have experience of living with or caring for those with health issues, health and care professionals and with innovators.

hyvr was born out of an initiative called Design Together Live Better which sourced ideas from end users for new products based on unmet need. Ideas were crowd sourced and prototyped in partnership with the design charity Designability based in Bath.

West of England Academic Health Science Network is one of England’s 15 Academic Health Science Networks (AHSNs). Over the last five years they have become known as the ‘innovation arm’ of the NHS. The AHSNs operate locally as part of a national network of Innovation Exchanges to identify common challenges and quickly bring people and organisations together to develop, test and spread solutions.

Cyber Media is a digital health and wellbeing specialist with expertise in citizen engagement, caseload management, online referral networks and User Experience Design (UXD). Cyber Media’s products support early intervention and social prescribing initiatives, as well as the management of public health services such as smoking cessation.

The difference between hyvr and many other social media platforms is that it also has functionality for innovators to test ideas with potential end users by asking them to join polls and express their views. As it is operated by West of England AHSN it is free to the end user, does not harvest data and does not sell space for advertising, and you can join and talk in private or public hives.

and traditional PPI (Public Patient Involvement) hyvr uses the advantages of digital social media to scale to wider online communities.

of England Nature Partnership to develop and maintain a practitioner network to strengthen green care to support holistic wellbeing.

It is based on the concept of swarm intelligence, looking for people to build communities that swarm around topics that interest them. By signing up to hives, you can converse with like-minded people around key topics and create a bit of a buzz around your topic of interests. Compared to focus groups

We have just launched several campaigns working with voluntary sector partners to test the usability of the system at scale. For example we have been working with the Knowle West Media Centre to help test new guidelines for physical activity and technologies for assisted living. We have also been working with the West

The platform has been designed to have the capability to test ideas for new products or services by accessing additional facilities for accepted superusers to be able to refine products using views of people with lived experience of health conditions.

Find out more and sign up to hyvr at Or get in touch with us at


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People and Places

MHRA inspection success for new pharma facilities The new pharmaceutical spray drying manufacturing facilities of Upperton Pharma Solutions at Nottingham Science and Technology Park have successfully passed inspection by the UK Medicines and Healthcare products Regulatory Agency (MHRA).


pperton Pharma Solutions, a pharmaceutical spray drying contract development and manufacturing organisation (CDMO), moved to its new facilities in Nottingham Science and Technology Park from its previous headquarters at BioCity Nottingham in March 2018, as part of a planned expansion of its services. The company has invested heavily in the new facilities both in terms of building enhancements and in the expansion of its processing and analytical capabilities. The successful MHRA inspection provides Upperton Pharma Solutions with the necessary MHRA licenses for manufacture, downstream processing into capsules and tablets, as well as release of spray dried formulations of Biotherapeutics and small molecule APIs for clinical trials. The company is now able to develop pharmaceutical formulations for oral, nasal and pulmonary delivery from early feasibility studies to Phase I & II clinical manufacture, from its Nottingham Science and Technology Park site.

“We are absolutely delighted with the expansion of our capabilities in GMP clinical manufacturing and look forward to seeing our clients’ projects progress within Upperton, from early formulation development studies right through to clinical manufacture. The positive endorsement by the MHRA will enable a seamless transition from R&D to GMP manufacture within the organisation, ensuring that all of the project-specific knowledge and expertise developed in R&D will flow through to the GMP manufacturing processes.”

“This is a great opportunity for our business and is a result of our team’s commitment to achieve the targets and aspirations of our business. We are looking forward to working with our clients and offering services from early stage development through to clinical manufacture. These are exciting times for Upperton as we continue to move forward and expand our capabilities.” Paul Kelsall Director Clinical Trials Manufacturing Upperton Pharma Solutions

Richard Johnson CEO and Founder Upperton Pharma Solutions

For daily lifescience news visit 33

People and Places

Network launched to improve health and wellbeing in Wales Monday 25th March saw the partnership launch of the Innovation Network for Health and Social Care in Wales between Life Sciences Hub Wales and the Welsh Government.


he first of its kind in Wales, the network aims to bring together innovation champions, leads and practitioners from across the health and care system, academia and government. In creating a peer group of innovation experts, it will identify examples of best practice to support the scale up of effective innovative activity across Wales.

“A Healthier Wales sets out the shared policy direction for health and care innovation in Wales. An important characteristic of A Healthier Wales is engagement and co-production. It is important that all our innovation programmes are complemented by engagement and partnership, which is why I am pleased to launch a Welsh health and social care innovation network, led by the Life Sciences Hub Wales. This network will bring people together on an all-Wales basis, to source, share and showcase good practice around health and care innovation and to support scale up of innovative activity.” Vaughan Gething AM Minister for Health and Social Services Welsh Government

The network was officially launched by the Minister for Health and Social Services, Vaughan Gething AM


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Over 80 leaders and practitioners representing every health board and trust in Wales, along with partners from the social care sector, the third sector, universities across the whole of Wales and the Welsh Government attended the launch event. Many more who were unable to attend have also joined as members. Dee Puckett, Head of Health and Care Engagement at Life Sciences Hub Wales said: “In convening the innovation network, we are bringing together teams and expertise to identify and develop innovative solutions. In doing so, we hope to accelerate effective ideas and projects by learning, sharing and scaling up at pace across Wales and beyond. I’m delighted at the appetite for innovation that exists and very much look forward to driving this agenda forward for the benefit of the people of Wales, both from a health and wellbeing perspective”. For more information on Life Sciences Hub Wales’ engagement with health and social care:

People and Places

Life Sciences Hub Wales appoints new CEO


he health and care sector in Wales faces acute challenges driven by an ageing population, increasingly complex chronic diseases and the desire from patients for better access to data relating to their diagnosis and treatment. The need to seek innovative solutions in advanced areas such as genomics, stem cells, artificial intelligence and, of course, the huge growth potential for digital innovation, has never been greater. Life Sciences Hub Wales has embarked on a journey to address and respond to these challenges and opportunities, to support and nurture businesses, identify opportunities and work with the health and care sectors, including NHS Wales. The aim is to find innovative solutions that will have a tangible impact on the health and care of the people, and on the economy of Wales. Wales is already home to progressive companies within the life sciences industry and is well placed in terms of scale, integration and access to markets to develop new business opportunities.

“We have a real opportunity to make a difference. Our work to inspire and enable partners from health, industry and academia to come together, collaborate and embrace innovation, is now well underway. I’m proud that the founder of the NHS, Aneurin Bevan, was born and raised in Wales. Fearlessly embracing systematic change, he was an original health innovator and, in calling for the establishment of the NHS, stated ‘As I see it, the undertaking to provide all people with all kinds of health care calls for something bolder than a mere adaptation’.” Cari-Anne Quinn CEO Life Sciences Hub Wales

To fulfil this brief, Cari-Anne Quinn was appointed as CEO in October to lead and steer Life Sciences Hub Wales. Cari-Anne has a substantial track record of bringing forward jobs to support the economy in Wales and attracting health-related initiatives and companies to enhance the health of the people in Wales. In her former role, she was Head of Life Sciences and policy adviser to the Welsh Government, where she supported business to locate, evolve and thrive in Wales.

Read the full story at

About Life Sciences Hub Wales Life Sciences Hub Wales aims to drive transformational systematic change within the health and care sectors to create a better future for the people of Wales. We know that health and economic wellbeing go hand-in-hand. Our role is to inspire innovation and collaboration between industry, health and social care, and research organisations to make a positive difference to people and families across the nation. We are a catalyst for change. We work with NHS Wales to understand issues and identify how innovation can help deliver better care. We support businesses to create health and care solutions. We create connections. We enable people and organisations to work with us in partnership and create networking and matchmaking opportunities for innovators.

For daily lifescience news visit 35

People and Places

£4m antibiotic resistance research lab opens in Halifax Innovative healthcare product manufacturer, GAMA Healthcare, opened their state of the art research facility in Halifax in March.


he Fellows Research Facility is the home of groundbreaking antimicrobial resistance (AMR) research, committed to finding a workable solution to this global health crisis. Leeds University Vice-Chancellor and former Chief Executive of the NHS, Alan Langlands, carried out the opening of the vital facility in a joint ceremony.

GAMA Healthcare’s £4m research facility will be staffed with up to 20 qualified professionals conducting high-tech, valuable research in all aspects of microbiology, infection control and analytical chemistry. The Fellows Research Facility focuses specifically on researching and developing products to combat the public health fight against antibiotic resistant infection. The West Yorkshire-located lab has been welcomed by local figures, thanks to the positive impact the facility has had on the resident science cluster. Local MP Holly Lynch

“This is the latest development in the long story of GAMA’s progression from a new company with a handful of employees to the point we are at now, where we have an international reach and multiple facilities in the UK. All credit and thanks goes to those who have worked so hard to ensure that this ambitious project has become a reality.” Dr Guy Braverman MD and Co-founder GAMA Healthcare

praised GAMA Healthcare’s investment in Halifax and warmly welcomed the expert healthcare product distributors to her constituency.

“We are thrilled that GAMA have chosen Halifax as the location for their new development, and that they have recognised the potential of this area as welcoming to business and innovation. Having followed the development over the last few years, I am glad to see the work of all those involved coming together, and I would like to wish GAMA all the success and a warm welcome into the community.” Holly Lynch MP for Halifax

The research facility was named after the company’s Research Director, Adrian Fellows – whose local Halifax connection inspired the West Yorkshire location of the lab.


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People and Places

Rapid growth for specialist clinical CRO Since its inception in 2014, Aptus Clinical, a specialist clinical Contract Research Organisation, has gone from strength to strength.


aving won BioNow’s Start-up of the year in 2016 and been a shortlisted finalist for OBN’s Specialist CRO of the Year in 2018, Aptus Clinical continues to impress industry watchers with the breadth and depth of pharma industry expertise that it brings to support the design, conduct and delivery of innovative, value-creating clinical studies. Founded by three former AstraZeneca colleagues, Aptus Clinical has grown to a team of 48 people in four years. Based at Alderley Park in North West England, once the global research site for AstraZeneca’s oncology franchise, Aptus Clinical specialises in providing biotech companies with seasoned drug development expertise, insight and infrastructure, to support clients in transforming their promising assets into valued medicines. Aptus has recently commenced impressive new collaborations in the Cell and Gene Therapy arena in iMATCH. Being a part of iMATCH (a Manchester-based consortium funded by Innovate UK) offers exciting opportunities to help scale-up the delivery of advanced therapies in the NHS for a range of debilitating conditions.

Expansion plans recently received a significant boost when Aptus secured £150,000 loan from the Northern Powerhouse Investment Fund (NPIF) - FW Capital Debt Finance, managed by FW Capital, allowing additional investment in infrastructure, staff and capabilities to better serve the needs of a growing client base.

“I am both delighted and proud that Aptus Clinical is going through such a positive period of growth and expansion. The additions to our team, internal promotions, restructuring and office move to a fantastic new space in Alderley Park are all a reflection of the incredible work being carried out by our team.” Steve McConchie Aptus Clinical CEO

To help realise their ambitious growth plans, Aptus Clinical has recruited several key hires to its senior leadership team, with the aim of driving the company’s four core functions of Commercial, Corporate & Clinical Governance, Clinical Services and Business Services. They have also moved within Alderley Park to a significantly larger office suite, to better accommodate future growth.

For daily lifescience news visit 37

People and Places

Edgbaston Medical Quarter unveils ‘door-to-door’ patient pathway for UK and international patients A new patient pathway that provides a ‘door-to-door’ service for private patients seeking complex healthcare treatment within Edgbaston Medical Quarter in Edgbaston, Birmingham, has been launched.


ocated in the heart of the UK on the Calthorpe Estate, Edgbaston Medical Quarter is a beacon for world-class medical and healthcare excellence and has become an ideal place for both UK and international patients to find cutting edge medical treatment. Patients and referrers now have a choice of medical concierge options which enables them to access the best of UK treatments in a range of specialisms including oncology, orthopaedics, trauma, diabetes, rehabilitation, fertility and mental health.

The concierge services, from Medstars Concierge and Lexihealth guide patients through every aspect of their needs, providing easy access to world-class healthcare thus avoiding any stress. Whether this is choosing the right medical consultant to arranging logistics such as travel and accommodation for patients, their family or companions, right through to rehabilitation and repatriation. Dedicated medical concierge gives referrers and patients choices, helping to deliver the best outcome by transparency, complete independence, trust and quality care. The personalised service also includes lifestyle requests such as organising translators, chauffeurs and booking restaurants. Birmingham is the second largest city in the UK and is extremely cosmopolitan, with over 40 per cent of the population being from


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“Choosing a properly qualified independent healthcare practitioner whom you can trust, especially if you are from a different country, can be extremely difficult. Regulation and pricing structures can also be confusing, but Medstars Concierge can guide people through every step of the way from medical sourcing to a billing service and a personal concierge service. Every patient can tailor the service to meet their needs and those of their family or companion.” Dr Mahnaz Hashmi Co-founder of Medstars Concierge

ethnic minorities. It has great road, rail and flight transport links from across the UK, and excellent worldwide connections through Birmingham International Airport which offers direct routes to over 150 worldwide destinations. Within Edgbaston Medical Quarter there is a wide choice of accommodation options that can be selected to suit the individual patient needs. Within walking distance of many of the medical and healthcare providers, there are a range of 4-star luxury hotels including Park Regis, the Marriott and the newly opened University of Birmingham Hotel, right

People and Places

through to high end boutique hotels such as The Edgbaston to the more informal The High Field Townhouse. For longer stays there are also a range of family group hotel suites, services apartments or homes to choose from. Close to the hotels is Edgbaston Village set in the heart of the Calthorpe Estate. The vibrant leisure and lifestyle location is home to a range of award-winning restaurants including Michelinstarred Simpsons. These are complemented by a choice of high-end places to shop and relax including OKA and Neptune home interest stores. Furthermore, there is a world class art gallery and range of stunning botanical gardens within walking distance of the Village.

Birmingham boasts 571 parks – more than any other European city – totalling over 3,500 hectares (14 sq mi) of public open space.

The city offers some of the finest shopping and entertainment in the UK including The Mailbox with Harvey Nichols, Grand Central with John Lewis and The Bull Ring shopping

centre featuring a Selfridges department store, along with renowned theatres and sports arenas for football and cricket. In addition, the region has seen the gastro scene go from strength to strength. It is now a mecca for fine dining and is home to six Michelin starred restaurants. Coupled with the fact that it is less than a one-hour commute to Bicester Village which specialises in luxury shopping and Stratford-Upon-Avon, the birthplace of William Shakespeare, it makes for a very attractive location. To find out more information about Edgbaston Medical Quarter please contact Calthorpe Estates on +44 (0)121 248 7676 or visit www.

“Patients choose Edgbaston because of its healthcare excellence, value, and access to eminent clinicians and the latest cutting-edge treatments. It is a culturally diverse and welcoming city, easy to navigate around with beautiful green open spaces and a wide range of leisure facilities, all-in-all making EMQ the perfect place to be treated, relax and recover.” Mark Lee Chief Executive Calthorpe Estates

For daily lifescience news visit 39

People and Places

Pioneering hip surgery developed in Birmingham Sir Andy Murray’s pioneering hip surgery was first developed in Birmingham by the world’s leading hip and knee expert and the inventor of the Birmingham Hip Resurfacing (BHR) procedure.


ubbed ‘the father of hip resurfacing’, the eminent surgeon Professor Derek McMinn invented the technique which has enabled thousands of patients, including many high-profile athletes, to reduce pain and increase mobility.

Although no singles player has returned to the professional circuit following hip surgery, the American professional doubles player Bob Bryan had a BHR last year and was playing again competitively five months later. It was on his advice that Murray began researching the procedure.

Andy Murray had hip resurfacing surgery in January 2019 following years of suffering with acute osteoarthritis. During interviews the two-times Wimbledon champion said he chose Birmingham Hip Resurfacing because he knew it was his only chance of playing professionally again.

Professor McMinn has performed over 4000 Metal-on-Metal Hip Resurfacings over the last 28 years and is the most experienced surgeon in the world in this field.

Hip resurfacing in its modern form is a bone conserving technique intended for active patients. It is less invasive than other options and enables patients to keep on leading highly physically active lives. It replaces arthritic surfaces with thin layers of cobalt chrome rather than using a large stem and mimics the natural movement of the joint. It has now been used for 21 years and has excellent results.

“By closely following up our patients, it became clear over the years that the BHR was a highly successful procedure and it proved to work very well in young active patients. Activity promotes strong bone and inactivity usually associated with an arthritic hip weakens the femoral neck. The BHR procedure offers younger active patients the best chance of retaining as much movement as possible, essential for professional sports players.” Professor McMinn


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His latest innovation in conservative hip surgery gets rid of the Metal-on-Metal bearing altogether. This is a Metal-on-Crosslinked Polyethylene cup hip resurfacing and releases no metal ions. 88 cases have been performed in the last 3.5 years with no failures. Developing the bone ingrowth surface for the Crosslinked Polyethylene cup took seven years. He is also the inventor of the Birmingham Knee Replacement (BKR) and is constantly developing new devices and surgical techniques. He maintains a busy practice at the McMinn Centre in Edgbaston Medical Quarter that receives patients from all over the world. Within Edgbaston Medical Quarter, there is a strong collaborative cluster of medical and healthcare excellence, along with advanced research centres, healthcare institutions and academic centres. The McMinn Centre is a hub for research and development in hip and knee implant development and conducts invaluable long-term research into hip and knee care. Over the last 20 years the McMinn Centre Research team has produced 156 academic publications and transactions. Mark Lee, Chief Executive, Calthorpe Estates, which is home to Edgbaston Medical Quarter, added: “We are delighted to have the renowned Professor McMinn on the Estate and within EMQ. He is, along with other innovative medical businesses in the region, helping to enhance healthcare procedures, deliver cutting-edge medical treatments and provide tomorrow’s treatments today.”

People and Places

Birmingham at the centre of Life Sciences MedTech growth In the heart of the UK, within the Midlands and Birmingham, there is a thriving MedTech cluster. Life Sciences is a key area for growth in the region and forms a key element of the Local Industrial Growth Strategy. It has ambitious plans to be a global centre for data-driven testing of devices, diagnostics and healthcare technology.


ith the West Midlands currently home to the UK’s largest medical devices cluster, along with the latest research which shows that Birmingham has been named as the best city outside London to develop a career within the digital industry, it can only strengthen the region’s MedTech credentials.

Data released by analysed a variety of factors across cities in the UK, including digital economy growth, available digital jobs and quality of life to create an overall score. Factors that brought Birmingham out on top for the digital industry included the availability of over 437 digital jobs, combined with 33 per cent industry growth year on year and average salaries of over £43,000. This was coupled with the average cost to rent a one bed home being £638 and the cost of a pint being £4. Neil Rami, Chief Executive at the West Midlands Growth Company, said: “The latest data from global jobs site Monster reinforces Birmingham’s reputation as a world-class, burgeoning hub for

tech and digital. The city has more incubators and accelerator programmes than any other city outside London, a dynamic, young talent pool and a host of unique, co-working spaces to support growing tech firms. Complementing this is a rich tech supply chain, with more software developers, programmers and software architects in Birmingham than any other regional city in the UK. “Yet, the city’s tech scene is only at the beginning of its growth curve. Becoming the UK’s first 5G technology testbed has created unprecedented opportunity for companies in Birmingham and the West Midlands, paving way for a new era of UK innovation. It is an exciting time for savvy tech professionals and businesses to become part of our journey”.

“The region has a proud manufacturing heritage along with a thriving medical and healthcare sector and is home to over 550 medical technology companies, more than any other region across the UK. Birmingham has for over 5 years been named as the UK’s most entrepreneurial regional city and the Midlands’ 20 universities produce over 100,000 graduates each year who provide a rich talent pool for industry. All this, coupled with the burgeoning tech and digital hub, can only help to enhance our cutting-edge research, Life Sciences and MedTech sectors.” Mark Lee Chief Executive Calthorpe Estates

For daily lifescience news visit 41

Health Technology Consultancy Did you know that SEHTA is providing organisations like yours with expert consultancy, ranging from partner searching to writing, managing and delivery of major projects Do you need help with any of the following: • Cluster and capabilities mapping and network building • SWOT analysis and business intelligence • Writing applications for funding and project management • Cost-benefit analysis (including NHS)

• Business planning, strategy and funding advice • Technical and clinical evaluation, including trial design and delivery • Introduction to potential customers, including the NHS and solution providers

Did you know that we offer • Not for profit membership support network – over 1000 members • Provide grant-writing + project participation (over £2 million raised for SMEs since 2017) • Consultancy – business development, commercialisation, fund-raising, marketing

Past and present customers: Aerobit Brunel University London Greater London Authority Kent County Council


Anglia Ruskin University Cystic Fibrosis Trust Greenwich University Kent Surrey Sussex AHSN MedCity Oxford Heartbeat Psephos Biomedica Toshiba

Wessex Clinical Research Network

Wiltshire County Council

London South Bank University Oxford Brookes University Portsmouth NHS Hospital Trust

AT Kearney

Beamline Diagnostics

East Sussex Hospital NHS Trust

Exhalation Technology

Imperial Innovations Knowledge Transfer Network

Mosaic Surgical PDD Innovation

Imperial College London London Borough of Tower Hamlets Nano-Nose Pfizer

The SEEK Group University of Portsmouth Xenzone

University of Surrey xim

Swindon Borough Council

So why not contact SEHTA today to find out what we can do for you - email

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.

Find out more today: Tel: (0)29 2046 7030 Email:

Mae ein hunaniaeth Gymreig a’n cydwybod gymdeithasol gyffredin wrth wraidd pobeth a wnawn. Am fwy o wybodaeth, ewch i: Ffôn: (0)29 2046 7030 E-bost:

'A Healthier Wales’ - Delivering adoption and building community healthcare partnerships






2nd July 2019 Swansea University ● Building on the excellent work that has been done around

innovation adoption, we will consider the challenges involved in scaling change and adoption of new products, services and processes that deliver impact for patients across the whole NHS. ● Showcasing new technologies, digital health, NHS innovations and

a wellbeing zone including sports, arts and music health therapies. ● This NHS led event includes keynote presentations, interactive

workshops, exhibition stands and technical demonstrations. ● NHS teams and colleagues from the health and care community

across Wales, as well as the wider industry sector, will share clinical innovation and insights to improve patient outcomes. ● Over 400 delegates from clinical and care communities, industry

and academia from across Wales and the UK.

For further information:

Supported by:

Andrew Goodall Director General, Department for Health and Social Services and Chief Executive NHS Wales


Simultaneous US/EU regulatory approval: How timing could be a factor David Jensen from MasterControl provides advice for companies looking to get regulatory approval in two of the largest global markets.


s the world of medical device technology continues to gain momentum, companies are looking for every opportunity to get products on the global market faster. One approach to speed things up is seeking simultaneous regulatory approval in two of the largest global markets – the US and the EU. The current push toward more global regulatory harmonisation could make this a viable course of action. However, governing entities in both regions are embarking on changes that will likely disrupt the way medical device companies approach their regulatory strategy, potentially putting simultaneous regulatory approval further out of reach.

FDA Modernises 510(k) The cornerstone of the US Food and Drug Administration’s (FDA) medical device regulation has always been safety and efficacy. Using these elements as a standard requirement, the agency set up the 510(k) as a pathway for achieving regulatory approval for new medical devices. In a nutshell, the 510(k) was designed to demonstrate that a device is at least as safe and effective as an existing (predicate) legally marketed device. One issue with this method is that technology and innovation evolves, yet the FDA continued to base the “seaworthiness” of new devices on a decades-old benchmark. Recognising the need for an upgrade, the FDA recently announced plans to modernise the 510(k). “We believe firmly in the merits of the 510(k) process. But we also believe that the framework needs to be modernised to reflect advances in technology, safety and the capabilities of a new generation of medical devices,” said FDA Commissioner Scott Gottlieb in a November 2018 news release.


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FDA’s Goals for Modernisation Gottlieb asserted that while the FDA plans to pursue more modern safety and performance criteria for medical devices, the agency remains determined to ramp up its efforts to make innovative and potentially transformative devices for treating devastating diseases available to patients. The following are highlights of the FDA’s initiative to make the 510(k) more contemporaneous:

l Regulatory approvals will be based

on more recent predicates.

l Innovation will be streamlined by

enforcing more stringent postmarket oversight – pledging to consistently be first among the world’s regulatory agencies to identify and act upon safety issues related to medical devices.

l Implement an active postmarket

surveillance system that relies on realworld evidence and timely receipt of robust safety information.

l Set up a unique device identification

(UDI) system for devices, which involves assigning a unique code for tracking a device through its distribution and use in clinical settings.

l Embrace advances in material science

and other advancing technologies to drive innovation and progress in the medical device industry.

EU’s MDR Pumps the Brakes on Medical Device Innovation Meanwhile, in the EU, regulatory bodies are adopting more restrictive approval processes that will inherently slow the pace of innovative technologies and market approval. The impetus for a more circumspect approach to regulatory approval was likely based on scenarios where unsafe medical devices reached consumers. One such product was the Poly Implant Prothèse (PIP) breast implant. In 1991, a company called Poly Implant Prothèse began production of silicone breast implants, manufacturing over two million sets over the course of 20 years. It was later discovered that the implants were made from a cheap, industrial-grade silicone that was not approved for medical use. The implants experienced a high rate of rupture, which subsequently caused inflammation and, in many cases, scarring and other adverse effects. What followed was a global health scare and a major overhaul of European medical device regulations, which led to crafting the new Medical Devices Regulation (MDR). The MDR was set into motion in May 2017 with a three-year transition period for medical device manufacturers to make the necessary preparations. The new regulation is slated to fully replace the current Medical Devices Directive (MDD) in May 2020.


EU’s Goals for MDR Some of the key changes to the EU’s regulatory processes include: l

More emphasis on clinical data and clinical evaluations. Manufacturers will need to gather and provide more in-depth clinical data to substantiate safety and performance claims.


More stringent and comprehensive postmarket surveillance requirements.


A new risk classification system for in vitro diagnostic medical devices.


Creation of a national registry where manufacturers must register themselves and their device’s UDI code in a central database (EUDAMED).


Greater transparency along the entire medical device manufacturing supply chain.


Increased rights and responsibilities for Notified Bodies in their oversight of medical devices.

The Prospect of Simultaneous Regulatory Approval While there is some overlap in each governing body’s regulatory revamp, the changes each entity is proposing for their respective regulatory processes aren’t quite balancing the scales. The MDR is currently in the middle of its three-year transition period – many issues still need to be sorted out as companies prepare to comply with the new regulations. The FDA, while still in the early stages of rolling out its strategic priorities for the 510(k), is moving ahead with other modernisations and smoother pathways to regulatory approval for medical devices. Consequently, the time frames for the review and approval processes of both regulatory bodies are still unknown. “It will be difficult to plan simultaneous market launches unless a company’s marketing group wants to wait for clearance from both US and EU, which will likely be staggered – I assume they would not,” said Adam Cargil, senior associate, advisory services, KPMG.

For daily lifescience news visit 45


Life Science Industry register goes live


he relationship between industry and those working in the health system has long been an important factor in developing and delivering advancements to patient care. As such, HealthTech employees engage with NHS staff and patients on a daily basis, and it is important that these interactions take place within a professional, ethical and safe framework.

Trusts must confirm the identity, credentials and training status of individuals who visit their sites. Historically, this responsibility has been that of the individual trust. However, this has led to variable practices in the processes used within the NHS to check the credentials of the on-site industry staff. It was therefore felt that the creation of a high-quality, national credentialing register was the most appropriate course of action to ensure consistency, regardless of where you are in the country. Over the past few years, a coalition of trade associations from across the life science industry have been working with wider industry, NHS England and the Department of Health and Social Care, to establish such a process for industry staff. Its overarching aim is to safeguard patients and health professionals, while also supporting NHS and industry collaboration.

The Life Science Industry (LSI) register, which is now fully operational, will: l

Establish, and periodically validate against, minimum acceptable standards for registrants and training provision


Maintain the required standards of conduct, education, training and health & safety criteria


Provide a single point for NHS staff and the public to verify an individual’s status against agreed criteria and eligibility to engage with the NHS


Support Trusts with regard to credentialing and management of conflicts of interest


Support the improvement of standards without restricting access to approved individuals

To ensure the highest standards of governance, the register has also been independently accredited by the Professional Standards Authority - the same body that accredits other significant registers.

Not only does the register provide a framework for supporting interactions between relevant HealthTech employees and those in hospitals, but it will support joint working in pursuit of improved patient safety and improved system efficiency.


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Discover a community of medical and life science excellence

Birmingham is a city that is investing in the life sciences sector and over the coming years world-class medical use sites are set to expand dramatically. Edgbaston Medical Quarter, just a mile from the city centre and within the Calthorpe Estate, is integral to this healthcare growth.

To join EMQ or find out more, contact us on 0121 248 7676 or visit Offices / Residential / Retail / Medical / Leisure / Education

2019 May Medical Device Audit Fundamentals Training courses are available for businesses to learn about the requirements for all types of medical technologies. Designed for Small and Medium Enterprises (SMEs), but valuable to all life science companies and individuals, these courses are provided at highly competitive rates.

Medilink member discounts are available

For more information: 0115 822 3154

June Regulatory Requirements for Medical Device Software September European In Vitro Medical Device Directive (IVDD) Basics and Transition to the In Vitro Medical Device Regulation (IVDR) October Product Management Training Additional courses will be available thereafter, covering topics including: The EU Medical Device Regulation

ISO 13845 Compliance Clinical Evaluations and Post-Market Surveillance

For all of our events, visit our website:


Now taking flight online ... May

Anglonordic Life Science Conference


MedTech Connects: SMEs to Universities


9 onlineLondon, UK Discover the latest life science news from the only magazine dedicated to the life science sector. With contributions from leading membership and support organisations working with life science businesses, academia and healthcare providers from across the UK and beyond.

BIO International Convention



Philadelphia, USA



London, UK



MedTech Innovation Expo

Birmingham, UK

ABHI UK Market Conference London, UK For editorial and advertising opportunities: June July


+44 (0)29 20473456

FIME 2019



Connects: Miami Beach, NHS USA

Collaboration Conference


Medilink East Midlands Innovation Day




Swansea, UK

Nottingham, UK



11-12 48

BioPharm America


Boston, USA


Issue 16

ABHI Procurement Conference London, UK




Düsseldorf, Germany


Pacifico Yokohama, Japan

Event calendar 2019





Welsh Health Hack


6th International Conference on Bio-Sensing Technology


ON Helix


Cardiff, UK


Africa Health Johannesburg, South Africa

SEHTA AGM & Annual Conference




Health and Care Innovation Expo


Nordic Life Science Days





London, UK


Lille, France

Kuala Lumpur, Malaysia





Cambridge, UK

ABHI Regulatory Conference London, UK


Manchester, UK

Hamburg, Germany



Copenhagen, Denmark


DĂźsseldorf, Germany


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 At Roche we focus on developing medicines and diagnostics that will help patients live longer, better lives

UNLOCK THE WORLD’S LARGEST HEALTHCARE EXHIBITION WITH MEDILINK Medilink UK is offering British companies ‘cost effective access’ to the World’s largest exhibition in the Healthcare & Life Sciences sector. Medica 2019 will exceed: • 120,000 visitors • 6,100 exhibitors • 66 countries represented • 126,000sqm of exhibition space • 280 British companies Eligible UK companies can access financial support from the Department for International Trade when exhibiting with Medilink on the British Pavilion. Contact our International Team: / 0114 232 9292 /@MedilinkINT






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Partnership is the key to a flourishing Lifescience Industry


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 National & Regional Partners

Medilink UK Partners Medilink East Midlands BioCity Nottingham Pennyfoot Street Nottingham NG1 1GF Tel: +44 (0)115 822 3154

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

Medilink North of England 3 Smithy Wood Drive Sheffield S35 1QN Tel: +44 (0)114 232 9292

MediWales The Bonded Warehouse Atlantic Wharf Cardiff CF10 4HF Tel: +44 (0)29 2047 3456

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


Medilink South West c/o Institute of Bio-Sensing Technology University of the West of England Coldharbour Lane Bristol BS16 1QY

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

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

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

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

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

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

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 Tel: +44 (0)117 900 2604

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