Page 1 Issue 42 | May/June 2019



Overcoming commercialisation challenges




a false sense of security?

Are you up-to-speed on the FDA’s postmarket guidance? CSA Group maps it out on page 12


CONTENTS regulars


Regional news

The latest from Health Enterprise East and Medilink UK



Making the switch from doctor to entrepreneur


On the cover

CSA Group on cybersecurity and the FDA


Digital Health Age

Is the NHS fit for the future?



Our guide to the latest young up-starts in medtech

features 15.

Testing & inspection


Through the doors at Vision Engineering


finance and funding What are the opportunities for startups?


med-tech innovation expo


Highlights from this year’s show




Medilink UK and MedTech Innovation toast the stars



Tube-y or not TPE?



material innovation

How two firms are reducing infection in China




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from The editor Stand-up comic, doctor and med-tech innovator

[ he BBC News website ran a great article in May about Dr Jagdish Chaturvedi, an ENT specialist from Bangalore, India. This individual has seriously impressive credentials. As well as his clinical career, he’s a prolific medtech inventor, popular stand-up comedian on the Indian circuit, internet personality and author of three books. He’s also an improv actor, drummer, and guitarist. And all of that by the age of 35. His website lists 18 devices that he has invented over the last eleven years – some of them are still at prototype stage, many are awaiting clinical trials or are ready to commercialise, and some are already in use on the front line. He specialises in devices which target the specific needs of patients in rural India. I wonder if there’s something about the life of a doctor that draws them towards careers in comedy and/or invention. If you were in attendance at this year’s Medilink UK Healthcare Business Awards, which took place alongside Med-Tech Innovation Expo, you’ll remember our host, comedian and author Adam

Kay, regaled the audience with tales of his time as a junior doctor, from his no.1 bestseller, This is Going to Hurt. Given the extraordinary challenges of the job, it’s little wonder we sometimes see doctors turning to secondary — and sometimes careerdefining — pursuits.

is to launch as a startup using one of the many different funding models, pass clinical trials and then look for a buyer in the form of a major OEM. But despite improved access initiatives, the failure rate for this route is still frustratingly high. We’re starting to see major OEMs launch their own incubators, For Dr Chaturvedi, comedy but the flexibility has to be and technology are still there too. Both Lydia and secondary, as he says he has Jagdish manage to balance no plans to leave his practice. their clinical work with their But I suspect he will continue entrepreneurial pursuits, innovating, as a means but not all accelerator of easing the day-to-day models allow such pressures of his work. flexibility. Hopefully the next accelerators to emerge will Another junior doctor take into account the busy who’s branched out into life of the clinical innovator. other fields (not comedy this time, but innovation) is Lydia Yarlott, co-founder Given the of a company responsible extraordinary for an app called Forward. I asked Lydia to open the challenges HealthTech stage at this of the job, year’s Expo, with her brilliant it’s little talk on growing startups in the healthcare space. Like wonder we Dr Chaturvedi, she’s one of sometimes see a growing league of clinical doctors turning entrepreneurs working on new ways to allow her and to secondary – her colleagues to work more and sometimes effectively. I suppose the usual route to success for clinical entrepreneurs at the moment

career-defining – pursuits.



regional news



The number of digital healthcare technologies (DHTs) entering the NHS is growing at a rapid rate. With mounting pressures from budget constraints and limited resources within the health system, it has become more important than ever for innovators to demonstrate the clear economic impact of their technologies if these innovations are to stand a chance of being purchased and adopted by the NHS. NICE EVIDENCE-BASED GUIDANCE Gaining a clear understanding of the economic value of an innovation, and communicating this evidence to commissioners are two substantial challenges which rely heavily on intricate economic methodology. To support both innovators and commissioners, the National

Institute for Health and Care Excellence (NICE) recently published an “Evidence Standards Framework for Digital Health Technologies”, describing the evidence required to demonstrate effectiveness and value in the UK healthcare system. Its aims were to provide digital health innovators with an understanding of the NHS procurement process and the standard evidence required, whilst at the same time helping NHS commissioners hone in on the most critical evidence necessary for making informed decision-making. ONE SIZE FITS ALL? The three priority evidence areas as set out by NICE comprise: economic information/data, economic analysis and economic reporting standards. The guidelines helpfully include a handy data checklist for innovators and specify the economic information required when making a valuedriven case to commissioners. However, it remains up to innovators to weigh up the relative value of specific data selected for use in economic modelling. This could be problematic as inexperienced innovators often leave out relevant data, simply due to lack of understanding of which elements are most significant. The guidance also provides insight into the nature of the economic analysis that should be undertaken. NICE specifies the type of analysis in terms of levels of financial commitment, which may help an innovator pick out an analysis model that is in line with the funds available, from the outset. Once the model has been selected, NICE guidelines reference a number of case reporting standards that innovators should consider when designing the economic

model and interpreting and analysing the results. However, whilst the level and type of economic modelling are defined by NICE, the explicit details of each model are not provided. All that innovators are given is a general overview, and it is left to their own interpretation to select the best economic analysis model. THE “GOLD STANDARD” APPROACH All healthcare technologies and DHTs need to demonstrate the value of their innovations based upon transparent and robust economic modelling. The NICE economic impact standards provide innovators and commissioners with a good general overview of the necessary data and modelling required. The evidence guide does, however, appear to lack detailed explanation to support the innovator in deciding which type of economic modelling would be most suitable. A cost-utility analysis or economic evaluation alongside a clinical trial is often the “gold standard” approach. For early stage developments of innovations, an understanding of the budgetary impact is essential. More explicit advice is needed to ensure that innovators clearly understand the need for early economic modelling, such as a budget impact model complemented by more robust cost-utility analyses. This combination would provide innovators with a robust evidence-based assessment of the economic value and financial impact for each stage of development of their DHT. In turn, this puts them in the strongest position of convincing NHS procurement teams of the true benefits of their new technologies.



EAST MIDLANDS COMPANIES CROWNED WINNERS AT NATIONAL LIFE SCIENCE AWARDS The achievements of four East Midlands life science companies have been recognised at the national Medilink UK awards. The Innovation Award focused on companies which develop new technologies, in particular, new technologies which benefit the business and or end-user. It was won by Ariane Medical Systems, of Alfreton, Derbyshire. Ariane has been in operation for over a decade and aims to optimise the use of low energy X-rays for the treatment of tumours. Judges were particularly impressed by Ariane’s innovative Papillon+ X-Ray Brachytherapy system. The Outstanding Achievement Award was given for an achievement that has had a significant or vital impact on the company. This award was won by Quotient Sciences, of Nottingham. Quotient Sciences works to speed up the development of new drugs for patients around the world. Quotient employs over 800 staff and operates from 6 state-of-the-art facilities in the U.K. and U.S., with headquarters in Nottingham. SurePulse Medical of Nottingham came as a runner-up in the Start-Up category, which looked at companies which have been trading less than three years, and which show a promising future. SurePulse aims to provide specialised neonatal intensive care and resuscitation monitoring, to ensure successful outcomes which will benefit new-borns in years to come. Charnwood Molecular of Loughborough came as a runner up in the Export Achievement Award, which focused on outstanding performance in international trade. Charnwood Molecular provides drug discovery and development services on a global scale.

MEDILINK EAST MIDLANDS INNOVATION DAY 2019 Thursday 4 July 2019 @ 9:00 am - 5:00 pm Innovation Day sits firmly in the Medilink calendar of events and is a must-attend event for those in the life sciences sector across the East Midlands. The day includes a conference, exhibition and networking opportunities. Opportunities are available to exhibit at Innovation Day 2019, the event showcases the latest in healthcare and life sciences within the East Midlands. Be part of the showcase and join the exhibition to share your products and services with the who’s who in the sector. Exhibition stands start from £550 plus VAT for members of Medilink. Registration for delegates is now open. MERCIA INVESTS £2 MILLION IN TRANSDERMAL DRUG DELIVERY SPECIALIST Medherant, which is developing the TEPI Patch, received its first investment from Medilink West Midlands member Mercia’s managed funds in 2015. Since then the company has developed an extensive patent estate and secured an exclusive worldwide licence from Bostik SA for the medical use of a novel adhesive. Mercia now holds a 33.6% direct equity stake in the business. This latest investment will enable Medherant to finalise the selection of three TEPI Patch products to take into clinical development.  Nigel Davis, CEO of Medherant, said: “TEPI Patch technology holds great promise as a better way of delivering many different types of drugs. We are pleased to have supportive investors led by Mercia who are enabling us to progress the development of patch products that will bring significant benefits to patients across the globe.”

MEDIWALES CONNECTS TO BRING WELSH MEDTECH COMMUNITY TOGETHER On 2nd July, Mediwales will host its Mediwales Connects networking event and conference at Swansea University. NHS colleagues from across Wales, local companies and the wider industry sector will join to share clinical innovation in practice to improve patient outcomes. The event includes keynote presentations, workshops and an exhibition. The aims of the conference are to: • Highlight and showcase the excellent work being carried out by the health and care communities in Wales; • Improve collaborative working between the health boards, industry and research communities; • Raise the profile of NHS Wales and clinical innovation across the UK; • Support closer working relationships between industry, NHS and research groups and clinical trials capabilities. Building on the excellent work that has been done around innovation adoption, delegates 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. The event will showcase 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 and exhibition stands.


The best of both worlds Hannah Montague BSc MCSP is a former NHS service manager. Now she’s joined the ranks of the private medtech sector. Here she explains why knowledge of both sides of the coin is so important.


ecuring the future of our NHS is a primary objective for politicians, commissioners and service directors. Medical technology is placed perfectly to deliver on key improvement measures, with innovations in tech stepping up to fill the gaps in efficiency created by the world’s largest health service employer. I have been personally involved in quality improvement in the NHS, recently moving into the private sector to work on health care improvement from another perspective. It is through the lens of an NHS worker from which I have been inducted into the world of medtech and continue to learn of its vast offerings to health and social care. Having so recently worked in a patient-facing role, the clinical application of medical technology ignites real excitement. The potential of point of care testing (POCT) in particular; the notion that a laboratory can be brought to the patient. The potential to impact Key Performance Indicators (KPIs) is huge, as time to treatment shrinks and containment of infectious


disease expediated. In a trial of point of care testing, Dean Street Express Clinic found that bringing laboratory testing to the patient-side reduced waiting and treatment times, and on average spared one partner exposure to a sexually transmitted infection for every two patients diagnosed. The General Manager of this service concluded that this same model could not only be replicated across the UK but also improve the diagnosis of STIs. A similar point of care test in an acute setting, demonstrated a reduction in the number of days per admission where POCT was used for respiratory symptoms. As an estimated cost per day of a hospital stay is £400 in the United Kingdom, the scale of benefit is considerable. Recognising the value of a product is vital for industries whose objective is to provide meaningful solutions to the NHS. Although, recognising value is insufficient to imbed new technology without policies and clinical pathways supporting the use of a product. As the NHS can

take up to 10 years to adopt new technologies, there is a fundamental barrier to innovation which exists within public health. The successes and failures of the NHS are welldocumented. With regards to new technology, the same issues are raised time and again; a focus on KPIs such as waiting times as opposed to patient outcomes, difficulty upskilling and retaining staff, budgeting allocation which can disincentivise seed investments for long term gain – are among the commonly cited. Observing the private sector’s understanding of innovation, whilst retaining an NHS mentality has provided useful insight into both worlds. Point of care testing has the potential to revolutionise patient care and generate huge efficiency savings. The NHS is a complex system with a structure biased to achieving short term survival as opposed to long term planning. As a result, private health care is often able to fill the gap between public health and medical

technology. This can in turn cause the industry to focus on private health providers, as the NHS lacks the structure to rapidly implement their innovations. Medical technology companies have a responsibility to drive and inspire solutions, which health care can then respond to as it sees fit. The enthusiasm in the industry is tangible, innovative systems are being generated which could be immediately implemented to improve patient outcomes and create efficiency savings. The reality of public health is such that immediate uptake is not feasible, and responsiveness to new technologies is an ongoing challenge. The future of the NHS may be uncertain, but within the system are people waiting to receive all that medtech has to offer. Perhaps through true partnerships with the people as opposed to “the system” of the NHS, barriers to innovations in public health could be reduced.

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Innovation in Miniature

How fast-tracked technology for pre-eclampsia can improve outcomes for expectant mothers Geoff Twist, managing director of Roche Diagnostics (UK and Ireland) explains the firm’s current activities in the field of pre-eclampsia, and why recent changes in the UK are long overdue.


n a welcome move, NHS England earlier this month signalled their commitment to improving outcomes for expectant mothers with preeclampsia, with a focus on rapid and accurate testing for the condition. This has been a long time coming. In recent years, new methods for testing have been made available and approved by NICE. However, uptake in the NHS has been very low, which has meant that less than 3% of women in England have had access to these


more accurate tests. This can lead to unnecessary hospital admissions. In the UK, up to 6% of all pregnancies will be affected by pre-eclampsia, with thousands more suspected of having the condition. The disease is a major cause of maternal and foetal morbidity worldwide, impacting pregnant women and their families. It also places significant economic and capacity burdens on maternity systems. In fact, an estimated 70 per cent of women admitted into hospital with suspected

pre-eclampsia don’t actually have the condition. Moreover, the additional cost for treating pre-eclampsia on the NHS has also been estimated at £9,009 per pregnancy. Better diagnosis of preeclampsia is therefore imperative to not only improve patient safety but to also reduce the burden on maternity service. It is welcome news, then, to see the NHS moving in the right direction and start offering these tests routinely. At Roche Diagnostics, we have a test that can reliably

rule out pregnant women who do not have pre-eclampsia and have a very low chance of developing it. What’s more, the test has been selected as one of seven rapid uptake products by NICE’s Accelerated Access Collaborative (AAC), designed to identify highly transformative innovations and to introduce an accelerated pathway to market. This is an important and exciting route for new technologies that will have a demonstrable impact on patients. Women’s health is clearly one of the high priority areas for NHS England

and this is very welcome. Through the AAC, we are working with NICE to increase the uptake of this cost-effective technology. We are also being supported by the Oxford Academic Health Science Network (Oxford AHSN), which is rolling out and adopting the test in hospitals across the Thames Valley. This collaboration has resulted in patients successfully getting access to this innovation in their region. NHS Trusts have already reported improved patient safety, a reduction in unnecessary admissions, and improved maternity capacity as fewer women are in need of monitoring. Testing for pre-eclampsia has also led to reduced direct costs as it keeps more women on the most appropriate treatment pathway. But most importantly, the most appropriate treatment being provided, meaning better outcomes for both mothers and babies. While we are on the right track, there is still more work to be done to help patients and the NHS with rapid diagnosis. To do this, it is now more important than ever for Trusts to utilise the latest medical technology to help alleviate pressures on the NHS, make life easier for healthcare professionals, and ensure that patients receive the right treatment at the right time.


Roche’s diagnostic test for pre-eclampsia Late last year Roche’s diagnostic test, which predicts with almost 100 percent accuracy that a pregnant woman will not develop pre-eclampsia within the following seven days, was given the green light to be used as standard clinical practice in one of the UK’s biggest acute hospital trusts. The blood test, conducted by Oxford University Hospitals (OUH) NHS Foundation Trust at its John Radcliffe Hospital, measures the ratio of two placental factors - maternal serum soluble fms-like tyrosine kinase (sFlt-1) and placental growth factor (PlGF) - that are released into the mother’s blood. Roche Diagnostics funded the trial, which was conducted at the Women’s Centre at the John Radcliffe Hospital. The trial results were successful and the response from maternity staff was so enthusiastic that the test was accepted as routine clinical practice at OUH. The introduction of the test was cost-neutral for the trust. Pre-eclampsia is a serious disease that occurs in four per cent of all pregnancies. It causes high blood pressure, protein in the urine and oedema and can result in liver failure, kidney failure and seizures in the mother. It can lead to restricted growth in the baby and often premature delivery. Currently, any patients with suspected PE are often admitted to hospital, sometimes for several days in order to make the diagnosis. The trial was led by Dr Manu Vatish, OUH consultant obstetrician and senior clinical fellow with the University of Oxford’s Nuffield Department of Women’s and Reproductive Health. He said: “The stress experienced by mums and their families can be put into context when we see that almost 70 per cent of patients admitted don’t actually have PE. “With this study and the previously published work, we have shown that we can virtually eliminate all those patients who have no risk of developing pre-eclampsia, allowing us to focus our attention on those with an increased risk.” Tim James, OUH head biomedical scientist in clinical biochemistry, whose laboratories carried out the tests, said: “The beauty of these tests is that they are not reliant on analysers that are only available in Oxford. The instruments are available at many hospital sites, meaning that the benefits we have demonstrated can be expanded across the UK relatively rapidly and easily, and pregnant women everywhere should be able to benefit”.

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on the cover

A false sense of security?


Major advances in medical technologies over the last few decades have contributed to early diagnosis of diseases, more efficient delivery of treatment, and longer, healthier lives. Network-connected medical devices in particular are redefining 21st century healthcare. With many life-sustaining and life-supporting medical devices residing on hospital networks – and many more connected wirelessly – the risk for cyber-attack is high, and this could compromise a device’s functionality, personal information, and patients’ health and safety. Implementing cybersecurity measures for devices and the networks to which they connect is critical. That is why the Food and Drug Administration’s (FDA) Guidance on Postmarket Management of Cybersecurity in Medical Devices makes it very clear that manufacturers should monitor, identify, and address cybersecurity vulnerabilities and exploits as part of their postmarket management plans. Here are some main things you should know about FDA’s Postmarket Guidance: IT APPLIES TO ANY MARKETED AND DISTRIBUTED MEDICAL DEVICE These include: • Medical devices that contain software, firmware, or programmable logic • Software that is a medical device, including mobile medical applications • Medical devices that are considered to be part of an interoperable system • Legacy devices

Are you up-to-speed on the FDA’s postmarket guidance for cybersecurity in medical devices? CSA Group explains everything you need to know. 12

IT PROVIDES A RISK MANAGEMENT FRAMEWORK TO DETECT, ASSESS, REPORT, AND MITIGATE CYBER THREATS The FDA takes a holistic approach to cybersecurity by providing recommended measures across the entire product lifecycle, including when it’s in use. Since introducing postmarket guidance, medical device vendors have reported 400 percent more vulnerabilities per quarter – a sign of growing compliance, as identifying these vulnerabilities is the first step in managing the risk of an attack. Manufacturers have also begun to patch some of the flaws.

on the cover

Specific postmarket recommendations for manufacturers include: • Having a way to monitor and detect cybersecurity in their devices • Undertanding, assessing and detecting the level of risk a vulnerability poses to patient safety • Establishing a process for working with cybersecurity researchers and other stakeholders to receive information about potential vulnerabilities • Deploying mitigations, such as software patches, to address cybersecurity issues early, before they can be exploited and cause harm. IT IDENTIFIES FEDERAL REGULATIONS FOR POSTMARKET MANAGEMENT Effective cybersecurity risk management incorporates both premarket and postmarket life cycle phases to address cybersecurity needs from medical device conception to obsolenscence. Covering the entire product lifecyle will involve adhering to the following from the Code of Federal Regulations: • 21 CFR part 820: Quality System Regulation requires manufacturers to establish quality systems that help ensure their products consistently meet applicable requirements and specifications. These quality systems are referred to as current good manufacturing practices. • 21 CFR part 820.198: Complaint Handling identifies what consistutes an actual complaint and how it should be handled based on its origin. This includes incidents that could have resulted in harm or death of the patient, which would require immediate action, or a review of data that identified a problematic trend, which would require postmarket surveillance. • 21 CFR part 820.22: Quality Audit requires that manufacturers establish procedures for quality audits and conduct those audits to assure the quality system is compliant. The regulation also states that individuals who do not have direct responsibility for the matters being audited, should perform the audits. There also requirements for documenting audit dates, results, and corrective actions (e.g. reaudits). • 21 CFR part 820.100: Corrective and Preventive Action requires manufacturers to establish and maintain procedures for implementing corrective and preventive actions. Procedures should include requirements for identifying and investigating causes of nonconforming products, identifying corrective or preventive

actions, verifying the efficacy of those actions, implementing and recording changes in methods or procedures, disseminating information related to quality problems, and submitting information for management review. • 21 CFR part 820.30(g): Software Validation and Risk Analysis requires manufacturers to establish and maintain procedures for validating device design, including software where appropriate. The results, including identification of the design, methods, the date, and the individuals performing the validation, must be documented in the Design History File (DHF). • 21 CFR part 820.200: Servicing requires manufacturer to establish and maintain instructions and procedures for servicing and verifying that the servicing meets specified requirements. Service reports must include important details such as the name of the device serviced, unique identifier or product code, date of service, the service performed, name of the individual servicing the device, as well as test and inspection data. THERE ARE SPECIFIC METHODS FOR APPLYING THE RISK MANAGEMENT FRAMEWORK The exploitability of the cybersecurity vulnerability and the severity of patient harm are two critical factors in how the risk management framework is to be applied. The Common Vulnerability Scoring System (see image below) helps manufacturers evaluate the severity and potential impact of cybersecurity vulnerabilities and threats. The resulting score then informs the actions that need to be taken with respect to reporting and remediating the risks.

is an active participant in an ISAO, then the report is not required. Additional requirements and definitions for risk management of medical devices for manufacturers are found in the following standards: • ANSI/AAMI/ISO 14971: 2007/(R)2010: Medical Devices – Application of Risk Management to Medical Devices; and • AAMI TIR57: Principles for Medical Device Security—Risk Management IT RECOMMENDS FOLLOWING THE NIST CYBERSECURITY FRAMEWORK One of the FDA’s recommendations to manufacturers is that they apply the National Institute of Standards and Technology’s (NIST) core principles for improving critical infrastructure cybersecurity, which are already in use by over 30 percent of U.S. organizations. Managing the risk of a cyber-attack on a medical device can be challenging, even as more guidance documents and best practice frameworks emerge. A manufacturer’s strategy to assure the security of their medical device postlaunch should include the services of an accredited third party that can verify compliance with key standards and regulations. CSA Group offers security testing verification, training, and security assurance certification and attestation for medical device manufacturers. 1) Jessica Davis (January 24, 2019). “Improving Medical Device Security Beyond Patching, Traditional Tools”. Online: Health IT Security <> 2) Nantional Institute of Standards and Technology. Industry Impacts: Cybersecurity Framework. Online: < cybersecurity>

If there is no risk of patient harm or the risk can be controlled, then routine updates, patches, and enhancements will suffice. A Report of Corrections and Removals may be required for an uncontrolled vulnerability. However, if there are no adverse events, the vulnerability is remediated within the specified timeline, and the manufacturer


Assistant editor Ian Bolland went along to Vision Engineering’s headquarters in Woking where he was given a sneak peek of


the company’s new product — the Deep Reality Viewer — which was launched at Control in Stuttgart earlier this year.

ase of use, deep analysis and vivid perception are the three priorities that went into the development of the company’s new Deep Reality Viewer (DRV). Vision’s new 3D imaging microscope is designed to work across several sectors, not least the life science and medtech industries. Unlike traditional mono digital microscopes, Vision Engineering’s Deep Reality Viewer creates stereo high definition 3D images, without using a monitor or requiring operators to wear headsets or specialist glasses: images ‘float’ in front of a mirror. Using Vision Engineering’s patented TriTeQ³ digital 3D display technology, the DRV-Z1 (Zoom model 1) incorporates a microscope and is the first device of its class to be launched by the manufacturer.

The DRV can be used for both detailed analysis and quality control. During the demonstration, implantable medical devices such as pacemakers were used as an example to illustrate the importance of quality control in the sector. It can also be used for a host of other processes, including measurement, polishing and finishing, bonding and joining, approval or liability testing, soldering, alignment and positioning, marking, etching, coating, and dissection and cutting. Its industrial applications include aerospace, automotive, plastics, precision engineering, electronics, analysis, precision instrumentation, MEMS, polymers, medical devices and security. Vision designed the DRV using its core TriTeQ³ technology, which aims to exclude sensory isolation, in turn allowing the product to exploit the user’s peripheral vision. TriTeQ³ is the firm’s stereo image presentation system designed to provide fully interactive real time natural 3D visualisation with outstanding depth perception. The company has also received two Innovate UK grants for optical and digital technical development in 2018-19, totalling £750,000 – helping to support the development of the DRV. The name came about because the company says it “sees the commonality between augmented reality and virtual reality”. Managing director Mark Curtis said: “It essentially provides real-time, full HD stereo images. It then gives you full communicability, full sensory stimulus. So if you’re on the production line, you see something you don’t like, you get your supervisor to look at it. It’s as simple as that.”

testing and inspection

Part of the company’s strategy was to exploit potential interest in the latest trends emerging in the sector – such as virtual reality, augmented reality, the internet of things, blockchain and artificial intelligence. Curtis explained that the split between the optical systems and digital systems that Vision develops is currently at 50/50, but with the trend moving in a more digital direction, he foresees a 70-30 split in favour of digital within the next two-to-three years. The most fascinating demonstration was an analysis of the spine of a dog – using 3D imaging of a CT scan of the animal. The image could be moved around with ease allowing for a more detailed examination – not only could the facility allow for improved insight from healthcare professionals. Ahead of the product’s launch, Paul Newbatt, sales and marketing director said: “TriTeQ blends Vision Engineering’s long-established, industry-proven and awardwinning optical stereoscopic technologies and digital monoscopic technologies. DRV-Z1 delivers a technological breakthrough, and is a game changer for inspection and quality control processes.”


finance and funding

Ian Shott, chair of the Royal Academy of Engineering Enterprise Committee, looks at how

to overcome some of the commercialisation challenges facing medtech scaleups.

A FUNDamental truth


he UK medtech industry is thriving; recently valued at £21 billion, the UK is the third largest medical device market in Europe and sixth largest in the world. This is not only encouraging for the economy, but essential if we are to keep pace with technological advances that can genuinely improve the quality of healthcare. There are an estimated 3,700 medtech companies here in the UK, the majority of which are small to medium sized enterprises. Thanks to a number of government-funded schemes, such as the Knowledge Transfer Partnership, innovative research has been transformed into business growth for early-stage companies, which in turn has led to a rapid expansion of new technology in the sector. For entrepreneurs looking to commercialise their innovations, there can be significant hurdles to overcome, in particular the need to secure sufficient investment to sustain them throughout the scaleup period. I have seen countless businesses fail because they have focused on early-stage investment, without consideration of follow-up funding to support them through to scaleup stage. Fortunately, medical technology is a favoured industry when it comes to funding, which means there is plenty of support


available for businesses looking to scale up. Given that equity funding is the most expensive and challenging approach for technology startups and SMEs, it is important to first examine other funding mechanisms. Options that are not intrusive and do not dilute equity include funding from Innovate UK and charitable organisations like the 1851 Commission and the ERA Foundation. These organisations, for example, provide funding for Enterprise Hub Fellowships at the Royal Academy of Engineering. Grant funding is the most attractive form of financial support for technology businesses as considerable sums of money can be raised without taking equity from the founders. It usually relies on a level of collaboration with a university, innovation centre, or a more established company, which is an important impulse for developing the technology. For example, my pharmaceutical contract research and development company, Arcinova, successfully raised grants over around £2.5 million from UK Research and Innovation between 2017 and 2019, and secured multimillion investment from the institution investor, Business Growth Fund. Medtech businesses ought to take advantage of government

schemes such as the Biomedical Catalyst (BMC) programme that supports the development of innovative healthcare technologies for disease prevention. European-led schemes such as Horizon 2020 have historically played an important role in supporting innovative and purpose driven SME business. With the future role of European funding unclear, it is imperative that government and institutions commit to carefully designed and targeted funding for highpotential companies, to ensure continued growth in industry. Venture capital and R&D tax relief has also been an impetus for the sector. R&D tax relief supports companies that work on innovative science and technology projects that advance their field. Uniquely the tax credit can be claimed on legitimate technology development projects even if these are not currently making money. This can be a significant help as it allows entrepreneurs greater freedom for to invest in ventures they believe in. Accelerators, incubators and charitable organisations such as the Royal Academy of Engineering’s Enterprise Hub, provide crucial support that goes beyond pure funding for

finance and funding

startups and scaleups alike. This includes mentoring, training and access to its extensive networks of experienced and like-minded entrepreneurs and helps business leaders to develop an attractive business case for institution investors. Gaining the support of a prestigious organisation like the Enterprise Hub can create a “halo of approval” for businesses, demonstrating they are a robust team with the right skills to scale up effectively. In my experience, this helps overcome one of the biggest barriers that engineering and technology scaleups face in securing funding; establishing credibility. The Enterprise Hub has long recognised that good business skills are just as important as access to finance for growing a successful engineering and technology company. Engineers equipped with essential business skills, as well as ambition and a great innovation, are not only

better at navigating new markets, but are also more likely to be able to capitalise on growth opportunities and are therefore viewed as less of an investment risk. Through schemes such as the Enterprise Hub’s SME Leaders programme, the UK’s most promising high-growth engineering SMEs develop the necessary leadership skills to scale up their business. To date the Enterprise Hub has supported over 100 entrepreneurs, one of whom is David Tuch, CEO of Lightpoint Medical, a global leader in precision-guided robotic surgery for cancer treatment. Having joined the programme in 2017 to develop his management skills, David has been able in take his business to the next level, and most recently secured a large follow-on investment as a result of continued support from the Hub’s community of Royal Academy of Engineering Fellows

and investors. Follow-on investment is an area that is often overlooked, especially in the UK where there is a trend of starting up, securing money and exiting at the earliest opportunity. As a nation, our research is world class, but if we are to ensure these ideas become long-term business ventures then we must move towards a “relay culture”, where there is a clear changeover of one form of investment to another. This is the only way entrepreneurs can maintain sustained support and guarantee the most value out of their businesses. Innovation in medical technology has never been so promising; we must think big and work collaboratively to support innovative ventures that have long-term potential. To do so we must continue to provide clear access to both funding and training, to help tomorrow’s medtech leaders achieve ambitious growth.


21.3” Ultra-wide, Superfine TFT Display Designed for Medical Applications Available from RDS is the new NL204153AC21-25, a 21.3” ultra-wide viewing angle display (IPS/SFT). Developed specifically for medical applications it has a high brightness of 800cd/m², high contrast ratio of 1,400:1 and long-life backlight with built in LED driver. Plus, it’s surface is anti-glare. Features include: • High luminance 800cd/m² • Wide colour gamut • High contrast ratio 1,400:1 • Resolution 2048 x 1536 pixels • Active Display area 433.152 (H) x324.864(V) • 16.77M colours • LVDS Interface 4 port • LED Driver is built in • Wide Viewing Angles 176°/176° (IPS/SFT) For more information on this and other displays go to: or call us on +44 (0)1959 563345 e:


med-tech innovation expo

SEE YOU NEXT YEAR This year the Med-Tech Innovation Expo took place at its new home, the NEC, Birmingham. This sector-leading event contained some exciting new features, including a third conference stage, signalling significant growth for this annual event. a wide range of major OEMs, government officials and industry experts. Tom Clutton-Brock, clinical director, MD-TEC said: “It was a great pleasure to be invited to the Med-Tech Innovation Expo. I spoke on the Introducing Stage, which I must say was a packed audience. We had a great stream of people coming up to the stand to talk to us afterwards.” The Introducing Stage was a new forum for exhibitors to meet with delegates and demonstrate their technologies first-hand. Also new to the show floor was the Acceleration Zone, a forum for taking new ideas and organisations to the next level. Other additions included two new conference sessions: a global perspectives session as well as a panel discussion on the role of women in engineering.   Med-Tech Innovation Expo is the UK’s only dedicated, standalone exhibition for medical device engineering and manufacturing. The event was complemented by the MedTech Innovation Conference organised in partnership with Medilink UK. This year saw an expansion of the show floor to accommodate a record number of exhibitors nearing 300 from 14 countries. The event connected almost 3,000 attendees across the two days from 34 different countries, with an exciting and diverse range of businesses, on hand to help them solve their medical design and manufacturing challenges. Chris Philpott, business development manager, Boddingtons Plastics said: “Med-Tech gives us the opportunity to show and discuss the types of services that Boddingtons Plastics can offer to our customers. We’ve seen really good footfall and had several new leads for new devices. The show has been a great success for us and in fact we’ve booked for next year already.”

In addition to the packed conference and seminar programme, visitors experienced a range of exciting show features. The Medilink UK Pavilion featured a range of Medilink member businesses, including Loughborough University, Piota and White Horse Plastics, an excellent platform to highlight their solutions to industry challenges. “It’s a good mix of exhibitors, we came to speak to a couple of clients and the conversations turned out very fruitful”, commented Robert Johnston, injection mould tooling expert, GSK. Duncan Wood, chief executive of Rapid News Group, owners of Med-Tech Innovation Expo said: “We are delighted with another significant step forward for this event as we work to create a defining event experience for the UK medtech sector. The two days contained many highlights, new products, new companies, world-class presentations and stunning applications. Whilst as organisers we have had superb feedback, we recognise we can’t do it without industry support, so we thank all our exhibitors, speakers, sponsors and partners for their efforts; they make the show.” NEXT YEAR’S MED-TECH INNOVATION EXPO WILL TAKE PLACE FROM 1-2 APRIL 2020 AT THE NEC, BIRMINGHAM, UK.

In all, more than 50 engaging and inspiring presentations took place across three stages, along with a wealth of exciting and educational show features. Visitors saw presentations from


med-tech innovation expo

ON THIS NIGHT OF A THOUSAND STARS On 15 May 2019, the Medilink UK Healthcare Business Awards celebrated the best-in-class of the industry’s talent. The sell-out gala evening showcased a host of innovations among the winners. The awards were presented by Adam Kay, award winning author of the hilarious bestseller This Is Going to Hurt - recollections from his days as a junior doctor. Adam provided post-dinner entertainment to rapturous applause. Adam said: “It’s been an absolute pleasure and an honour to be invited along tonight to be part of this evening and to present awards to some wonderful companies doing crucial work, supporting through their innovation the healthcare and life sciences sector.” In total, 10 companies from across the UK and overseas were presented with either a Medilink UK or Med-Tech Innovation award. Nick Rodgers, vice-chair of Medilink UK commented: “The Medilink UK Healthcare Business Awards have been a raging success once again, congratulations to all of the award winners, runners up and finalists. It’s been fantastic to see so many people from across the industry coming together to celebrate the outstanding achievements and contributions to the Life Sciences sector.”

As coolant passes through the cold cap to extract heat from the patient’s scalp, inline temperature sensors ensure the cap maintains the scalp at an even, constant temperature. A neoprene cover is provided with the Paxman cap to assist in the efficiency and operation of the system. Paxman cold caps are attached to the scalp cooling system with quick release, non-drip plastic couplings. Once the treatment is finished, the cold cap can be disconnected from the cooling line and washed with soap and water or detergent ready for the next patient.

Dave Gray, group editor, Med-Tech Innovation commented: ‘‘It’s been a privilege to learn about all of the exceptional work being done in the UK and overseas to advance the healthcare sector. This year the awards have shone a spotlight on not only those suppliers serving the healthcare front line, but also the engineers and innovators working behind the scenes to set the pace of change.’’

Meanwhile UK-based ES Precision was recognised with an engineering award for its laser perforating process which contributes to a better, more comfortable experience for amputees when wearing artificial limbs. Judges applauded the fact that the company has developed an efficient and effective way of manufacturing prosthetic silicone inserts by laser drilling.

One of the firms celebrating a win was Paxman, which scooped the export achievement award for its scalp cooling technology for preventing hair loss in chemotherapy patients. Paxman’s cooling caps are made from high grade silicone material, designed to provide a close fit around the patient’s head.

Finally, closing the night, the materials innovation award was given to Nova-BioRubber Green Technologies, which was chosen as a result of its green processing technologies for the production of hypoallergenic and sustainable biolatex, biorubber and inulin, designed to tackle latex allergy and satisfy growing rubber demand in a sustainable way. Judges said that the material could help deal with a significant problem in the healthcare world, and that a hypoallergenic and sustainable biolatex could make a huge positive impact on the industry. THE FULL LIST OF WINNERS AND RUNNERS UP CAN BE FOUND AT WWW.MED-TECHEXPO.COM


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13/03/2019 16:57

Extractable and leachables


ARK TURNER, MANAGING DIRECTOR OF MEDICAL ENGINEERING TECHNOLOGIES (MET) DISCUSSES THE RELEVANCE OF CHEMICAL CHARACTERISATION IN MEDICAL DEVICE COMPATIBILITY. CHANGES TO ISO 10993 In January 2018, seismic changes took place in the world of medical device toxicity assessment. The new edition of ISO 1099311 added the requirement for a chemical knowledge of any device, whilst also requiring the driver to use this knowledge to understand the potential toxicity of the device. The potential toxicity then becomes, in its turn, the driver for risk assessment which may finally lead to a testing requirement. The toxicity end points have not changed, although there are some changes to the biocompatibility matrix. A short term, surface contact device still has the end points of cytotoxicity, sensitisation and irritation for which the risk versus benefit analysis must prove positive. A more invasive, permanent implant still has these end points



plus sub-chronic, genotoxic and implant end points with the addition, now, of chronic toxicity and carcinogenicity. It is not always essential to use biological testing to show that there is acceptable toxicity for each of these end points, and it is stated in the standard that biological testing should not be the first resort. The approach should be data gathering and assessment first. Extractables and leachables2 along with other materials characterisation3 techniques will be required if all the chemicals and their abundance cannot be defined for a device. This information is not generally known because exactly what chemicals input materials come into contact with cannot be defined. There may be multiple chemicals in the production process and many of the specified materials may contain undeclared additives. This information is then fed into a toxicity risk analysis. Finally, toxicity testing is applied when the safety of a material or mixture of materials cannot be defined as safe from data available. `BIOCOMPATIBILITY MATRIX The ISO 10993-1 biocompatibility matrix provides a guide to the selection of information requirements, with chemical analysis now added to every category.

MATERIAL CHARACTERISATION It is nearly always the case that it is not known exactly what materials a patient may be exposed to from the device and its supply chain. Because of this an investigation is needed. Material characterisation as described in ISO 10993-184 should be applied. Characterisation includes consideration of the chemical materials present and also morphology and the nature of the surfaces. The surface investigation may be concerned with features that encourage ingrowth or bacterial colonisation. There might be concerns with particular surface chemistry or catalytic properties of the surface. Methods of investigation could include electron microscopy, elemental analysis, infra-red spectroscopy or other techniques. The primary study will always be an investigation of materials released from the medical device in use – extractables and leachables, and particulate. The leachables are described in ISO 10993-175 as ‘released constituents that potentially contact the individual during clinical use’. The extractables include additional entities that can be forced out of the materials of construction, in the ISO 10993-17 definition ‘constituents that can be extracted in the laboratory’. The reason for identifying and quantifying the extractables, in pharmaceutical container studies, is that there is a risk of them transferring into the formulation at some point during its storage. Similarly, the reason for examining

Extractable and leachables

SHIFTS extractables in medical devices is that they might become leachable at some point during the device’s lifetime. ISO 10993-126 gives us the extraction conditions (area to volume ratio, time and temperature, solvent polarity). The leachables concept transfers quite well to medical devices. This can be considered ‘in use’ or ‘simulated use’ leachables which likely to be delivered to a patient in use. Leachables can be taken from the device in question much as they have been traditionally in biological tests. The biggest difference in the leaching process is solvent changes between the two methods. Biological tests generally use cotton seed oil as the non-polar extract and water or saline as the polar extract. Whilst chemical analysis is generally carried out using hexane as an example non-polar solvent and water as polar, along with possibly a third solvent or mixed solvents. Extractables become more important for long term products. There may be substances that are released after a long delay that are not apparent in a 72 hour extract. Testing with more aggressive solvents, higher temperatures and longer soak times may be required. Here the concept of ‘simulated use’ leachables is introduced. Clearly it is not possible to wait for many years for the extractable to migrate into solution for analysis. Therefore, forced extraction is used, the strength of which (whilst being based in ISO 10993-12)

can be adjusted according to the environment and duration of use. Hence, ’simulated use extract’. As we go up the invasiveness scale, we increase the strength of the solvents and consider increasing the extraction times and temperatures. ‘Consider’ because we are only interested in materials that will be present in use not degradation products produced in the extraction process by temperature or other processes not relevant to the ‘in use’ environment. There are specific tests for degradation products detailed in standards such as ISO 10993-137. TOXICOLOGICAL RISK ANALYSIS8 The analytical chemistry produces information identifying which materials are present and in what quantities. To be useful this information must be interpreted in terms of the toxicity end points given in the biocompatibility matrix. If no materials of concern are found or the patient contact is transient, then this can be quite a simple assessment. As more materials are identified and the patient contact becomes more intense the requirement for a toxicological risk analysis increases. This analysis is the domain of a registered toxicologist, who takes each material found and calculates the patient dose per 24 hours and over the product lifetime. A variety of information sources are then used to quantify the potential toxicity of the materials individually and combined. There are several end points which are difficult to assess from published data (as used by

the toxicologist), these include haemocompatibility and local effects such as implantation and irritation. CONCLUSION A knowledge of all chemicals released by a device in use is now required in ISO 10993, and this is listed in the testing matrix for every category of device. Although, materials characterisation led by extractables and leachables is not the only route to obtain this information, it is the most likely method to find unexpected materials. The vigour of application of chemical analysis should be tailored to the body contact and risk analysis for the device. Usually the chemical information, through a toxicological risk analysis, can be used to address all the toxicity end points without any need for animal testing. REFERENCES

1.ISO 10993-1:2018Biological evaluation of medical devices --Part 1: Evaluation and testing within a risk management process 2. 3. 4.ISO 10993-18:2005Biological evaluation of medical devices --Part 18: Chemical characterization of materials (under review) 5.ISO 10993-17:2002 Biological evaluation of medical devices --Part 17: Establishment of allowable limits for leachable substances (under review) 6.ISO 10993-12:2012 Biological evaluation of medical devices --Part 12: Sample preparation and reference materials. 7.ISO 10993-13:2010 Biological evaluation of medical devices --Part 13: Identification and quantification of degradation products from polymeric medical device 8.


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he future of the medical tubing sector is highly dynamic, not least because there are a variety of pressures on organisations within this space to provide solutions that are not only of the highest quality but also deliver cost savings throughout the product lifecycle. Take the catheter market as a prime example of these challenges. In the world of neurovascular and other complicated techniques, catheter manufacturers are being pushed for solutions that not only deliver complex procedures more efficiently but also provide cost savings at every turn. In what is a highly cost-conscious marketplace, PHST products that enable catheter manufacturers to advance efficiencies through streamlining their workflows is going from ‘nice to have’ to becoming a critical requirement. The PHST market is an exciting area to be in. Not only does it aim to address healthcare customers’ unmet needs, solutions including ultra-small PHST also pave the way for progressively smaller catheterbased procedures - a continual requirement for medical device manufacturers. The reasons, aside from their desire to meet the healthcare sector’s needs, are because PHST ultimately reduces Total Cost of Ownership (TCO) for the catheter manufacturer. Since

companies no longer have to use the process of skiving the heat shrink material from the catheter, PHST can help them produce the final product more rapidly with improved yields and lower inspection levels while being more ergonomically safe.

In addition, as the healthcare sector continues to push for cost savings to be made all the while delivering excellent patient care, solutions such as Junkosha’s 2.5:1 PHST are a viable option. Providing the ability to rationalise processes in the manipulation of a catheter’s baseline materials by reflowing these quickly and efficiently, this solution can potentially act as a catalyst to provide cost savings for catheter manufacturers. According to Robert LaDuca, CEO of medical device tubing and catheter components manufacturer Duke Empirical, there are a number of applications where this new high ratio PHST technology will enable better processes and cost savings. These include tapered cardiovascular devices such as multi-lumen braid reinforced Peripherally Inserted Central Catheters (PICC), alongside a wide variety of next generation catheter designs that have varying diameters such as cardiac implant delivery systems where the implant is located in a distal segment of the catheter that is usually larger than the proximal portion of the shaft.

In addition to enabling new processes for manufacturers in their development of innovative products, and the faster and more forceful recovery of the 2.5:1 PHST products can help reduce or eliminate air entrapment which can be an unwanted cause of bubbles and associated product defects such as fish eyes, voids, and insufficient strength of bonded layers. Into the future, numerous challenges face the medical tubing supply chain in the US and European markets including; stringent regulation, the need to make procedures less invasive and the enablement of a wider variety of operations across harder to reach parts of the body, increasing health care costs and the need to streamline workflows and processes - especially for catheter manufacturers. Although these various challenges differ around the world, they all require one thing - innovations that improve outcomes for patients and provide clinicians and other end-users with technologies that make their lives easier, reduce costs, and save time. For this reason, continuous innovation must be at the heart of the health care sector’s requirements. Without this, the unmet needs will continue to be just that: unmet.





housands of tracheotomies and laryngectomies are carried out every year. These procedures lead to function loss of the upper airways, which could be anything from filtering, warming and moistening breathing air through to voice loss. Tracheostomy tubes and speaking aids are essential and the industry offers an extensive range of ultra-modern tubes and aids which are optimally tailored to the demands and requirements of each individual patient. Although metal tubes are offered, these have thin walls and are rigid, with a larger inner volume than silicone and plastic tubes which feature thicker walls, minimally limit inner volume and are distinguished by a high degree of wearing comfort, and a comparatively lighter weight. Most tube wearers could benefit from tracheal tubes made from lightweight, soft plastic material as these lead to less irritation of the sensitive tracheal mucus membranes and


less mechanical irritation of the tracheostoma. Additionally, plastic is advantageous compared to metal tubes, as metal cannot be inserted during radiotherapy due to reflections on the tracheostomy tubes possibly preventing the calculated radiation dose from being applied or causing uncontrolled radiation exposure. As in many areas of medical technology, most plasticbased tracheostomy tubes are manufactured from polyvinyl chloride (PVC). However, an increasing number of customers are requesting solutions from the manufacturers of medical technology which are free of PVC and plasticisers. All tubes in technical medical applications are obliged to comply with a wide variety of requirements as they are used in highly-sensitive areas where it is often a matter of life and death. The material compound used must also be developed with care and display maximum quality, as the wrong material mix could result in fatal consequences.

Thermoplastic elastomers (TPEs) possess good processability which makes them ideal for all conventional injection moulding and extrusion plants. TPEs also have very low emissions, good reusability and are cost effective. Additionally, they can be sterilised, conform with the Food and Drug Administration, International Standards Organisation and United States Pharmacopeia classes, whilst displaying very good sealing and adhesion properties. Actegaâ&#x20AC;&#x2122;s ProvaMed TPEs are an example. These tracheostomy tubes are typically manufactured in extrusion or injection moulding processes, and their material properties need to be adapted accordingly. Extrusion requires exact setting of the material flow properties to the processing method while injection moulding offers the possibility of manufacturing the tracheostomy tubes and neck flange in a single step. Multi-component injection moulding enables economic manufacturing of multiple components such as a connector


made from a thermoplastic and the soft components made using TPE. This is particularly applicable when the materialâ&#x20AC;&#x2122;s adhesion properties need to comply with the connector material, therefore requiring optimisation. ProvaMed TPE display perfect adhesion to polystyrene and acrylonitrile butadiene styrene (ABS). The more diverse the types of tubes, the more extensive the areas of application and the more detailed the requirements. Another area of focus is represented by solvent bondability. Micro-tubes are often inserted through the neck flange in the case of transporting air to the cuff or for optional secretion removal, where the micro-tubes need to be bonded to the outer tubes. Manufacture and printing are followed by sterilisation. TPE can display their particular advantages as only minimal changes in terms of mechanics and optics can be ascertained after sterilisation. The terms single-lumen tubes and mono-layer need some explanation. After all, lumen comes from the Latin and literally means light. Mono-layer, however, is actually a biological term and refers to a culture of single-layer cell layers based on individual cells. Nevertheless, the use of these terms within the context of medical tubes makes sense as lumen describes the cavity of an organ or vessel and, within the context of singlelumen tubes, represents the cavity in a tube. Mono-layer

describes an individual layer in the corresponding tube. Single-lumen tubes and monolayers are suitable for a range of applications. For transporting liquids and medication, they are used for infusions, enteral and parenteral feeding, and in urology and endoscopy. Their classic tube geometry can also be fitted with additional features. Multi-lumen or multi-chamber tubes represent key solutions for special areas of application in which air, material or liquids are transported and several functions can be carried out simultaneously in the same space such as suction and rinsing. They are used in acute dialysis, as centralvenous catheters in urology, and as liquor drainage in the case of hydrocephaly. Multi-layer tubes make it possible to realise the most complex profiles. The advantages of a wide variety of materials can be combined with this manufacturing process. The areas of application here include infusion lines and filling tubes for bag systems, pressure lines for angiography, administration of medication in oncology and highly-flexible working channels with low sliding friction coefficients in endoscopy. Thread-reinforcement involves reinforcing using wound or braided metal or polyamide (PA) threads in order to guarantee resistance to tube bending, bursting or vacuum. One example for medical technology is represented by respiration tubes. The range of materials available

for manufacturing medical tubes is enormous, but not every material is suitable for all areas of application and not every material combination makes sense for the respective characteristics profile required. It always depends on the characteristics that are required for the application. Interactions between tube material and pharmaceutical substances or those produced naturally by the body which could impair the human organism must be prevented at all costs. There must be no interaction with the plastic, medication absorption must be avoided, the material must be entirely resistant to media and should also in certain cases be ultraviolet-stable in order to avoid embrittlement, deformation and opacity. Accordingly, liquid content remains visible enabling visual flow control. Tube systems in clinical applications should also display radiopaque strips in the tube wall to enable the position of the tube to be tracked in the body and the localisation of implanted drainage or surgical components using x-rays. Bacterial resistance should be increased in the form of antimicrobial coating. Buckling resistance is necessary to guarantee the free flow of substances through tubes. In the form of ProvaMed, Actega offers a TPE portfolio which is free of latex, silicone and phthalates displaying the requisite material qualifications in terms of normative, toxicological, biological and customised requirements.



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terile containers are used in hospitals, dental offices, outpatient centers, as well as other medical practices to sterilise surgical instruments and maintain sterility until use in surgery. About one in 31 hospital patients acquires a healthcareassociated infection (HAI) on any given day as a result of poor cleaning or disinfecting practices around a surgical procedure at a healthcare facility. To combat this issue, Xianfeng uses the Porex Virtek PTFE venting and filtering solution, which Porex claims allows for a safer, more efficient and convenient autoclave sterilisation of surgical instruments. The vent not only acts as a protective barrier against bacteria during subsequent storage but also improves efficiency and convenience for healthcare workers who no longer have to replace single-use paper or textile filters. The Porex Virtek

PTFE vent/filter can be used for thousands of autoclave sterilisation cycles. “Life-saving and health betterment procedures often leave patients vulnerable to HAIs, which can have a devastating emotional, financial and medical impact; at times, these infections can even lead to death,” said Michael Lei, Porex’s commercial leader for greater China. “Our Porex Virtek PTFE venting solution challenges the industry standard material and allows for greater infection control. We are excited to collaborate with Xianfeng to create a more durable and reliable product that contributes to greater patient safety.” Porex has engineered this porous venting/filtering component using its proprietary medical-grade sintered PTFE hydrophobic membrane. The filter, which is made up of particles fused together through heat and pressure, does not require supporting layers (or a scrim), unlike expanded PTFE film. Porex Virtek PTFE has high airflow for optimal venting during the autoclave sterilisation process and high bacterial filtration efficiency to maintain sterile integrity during transport and storage. With its 3D sintered pore structure, the filter can also withstand repeated autoclave sterilisation cycles, making the

filter reusable and improving cost, performance and production efficiencies. This eliminates the need for singleuse paper and textile filters. “As new legislation and regulations for better patient outcome and greater healthcare worker safety continue to emerge in China, there is a tremendous need to deliver high-quality innovations for decontamination and sterilisation to the medical device industry,” said David Chen, of Guangdong Xianfeng Medical Technology. “With Porex’s venting and filtering technology, we are able to provide our customers a sterile container that meets these goals, effectively sterilising surgical instruments and blocking bacteria and ensuring a higher level of sterility assurance.”






It’s encouraging to see that the Royal College of General Practitioners (RCGP) has recognised the unreasonable demands placed on GPs and outlined a vision as part of an extended report, set out with the intention of redressing the issue. However, what’s immediately clear is that the report doesn’t go far enough – markedly underestimating the pace of change that is required. I have a lot of sympathy for my GP colleagues. Every day they’re being asked to deliver the impossible – they’re being asked to see 35+ patients in their office, conduct tens of phone appointments, chase blood and pathology test results, send referrals to secondary care, meet clinical targets, complete an evermounting volume of reporting paperwork and, all the while, they’re being asked to find the time to demonstrate their competence through revalidation paperwork. On top of this, GP Partners have to find time to run their Practice accounts and regulatory affairs, taking inordinate amounts of personal financial risk to do so. As a result, many are finding themselves in the “last man standing” position – facing financial ruin. And they take all this risk on just 9% of the NHS budget. We’ve ended up in this situation through a progressive trend of more paperwork, more secondary care work getting farmed out into the community as hospital beds are closed, more clinical targets, a proliferation of disconnected data silos and this is on a background of a progressively ageing


population with more co-morbidities. It has been the perfect storm. The buffers are now exhausted. Over the past decade, GPs have been working harder and harder with less remuneration in real terms to try to absorb this extra work. Typical workdays for a GP are 7:30am-8pm. Only a superhuman can deliver thorough care that ticks all the boxes in a 10-minute appointment, and I can imagine how demoralising that must be for our GPs. But now there is no more spare effort to give. Hardly any GPs I know want to work a full 9 sessions per week. Many have taken early retirement. I see the fallout from this in my Emergency Department: we are picking up more and more Primary Care problems. Patients frequently cite 3-week waiting times for routine appointments and the fact that duty doctor appointments are all booked within 10 minutes of a Surgery’s phone line opening. This is not the fault of our GPs, it is the fault of a system of inertia, fragmentation and underfunding. The “Fit for the Future” report by the Royal College of General Practitioners explores these causes and recommends the right approaches to fixing the issue. I just don’t think it’s anywhere near radical enough. First and foremost, if we have our hearts set on delivering more care out of hospitals and in the community, 11% spend primary care funding is nowhere near enough. I estimate it needs to be above 16%.


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The report explores prevention as a long-term strategy. This is excellent in principle, but we need both quick wins and a serious investment in prevention now. We can’t keep cutting public health funding, because today’s lack of preventative care (especially around obesity, type 2 diabetes and its complications) will be tomorrow’s problems landing into the GP & A&E safety net. We also need to incentivise people to take more responsibility for their own health. Integrated Care has been cited in the report as the future, and thus we should design for it. I agree, however once again the recommendations are not radical enough. We have disjointed data systems across Primary and Secondary Care. The baton is getting handed between them in the form of clinical referrals and discharge letters, inefficient and incomplete data exchange. We are wasting resources repeating tests in Primary Care that have recently been conducted in Secondary Care, it’s just that the GP can’t access the results. We need to hold clinical software vendors to account here. Primary and Secondary Care IT systems should be interoperable via published standards by default and at no extra cost to the healthcare organisations involved. It is not acceptable for an electronic medical records system manufacturer to try to charge an NHS Trust or GP Practice to be able to link their system to a third party system because that is holding patients’ data to financial ransom. We need to evict vendors who rely on lock-in strategies like this from our NHS because it is

harming patients and driving up the costs of care. We built PatientSource to be as interoperable as we can for these reasons. Finally, we need to look at GP as human beings when it comes to attracting people to the area of Medicine. Ask yourself: would you seriously put yourself through 5-6 years of university study, rack up £70k worth of debt, be moved around from hospital to hospital every 4-6 months until your 30s, miss out on weddings/holidays/ family events at the whims of a rota coordinator for six more years, to do a job where you work 12 hour days yet are repeatedly hounded by the media for “not working hard enough”, and take on personal financial liabilities of hundreds of thousands of pounds as a partner in a GP Practice? And that’s excluding the stress of Revalidation, the uncertainty of the medical pension pot and the Damocles Sword of GMC Fitness to Practice hearings. It is a career that through all these small stressors no longer seems worth it to many young medical students and doctors. RCGP needs to blast away all these points of friction if it ever hopes to recruit the number of new GPs we need. While we don’t want a swathe of challenging change deadlines to further burden GPs, we do need the Royal College of General Practitioners to make their voice heard to ensure that GP services evolve at pace. The suggestions that the RCGP makes are already being carried out in pockets throughout the NHS, it shouldn’t take 11 years to amplify and propagate these across primary care.



industry 4.0 MICROFLUIDICS


SCIENTISTS 3D PRINT ALL-LIQUID LAB-ON-CHIP hat we demonstrated is remarkable. Our 3D-printed device can be programmed to carry out multistep, complex chemical reactions on demand,” said Brett Helms, a staff scientist in Berkeley Lab’s materials sciences division and molecular foundry, who led the study. “What’s even more amazing is that this versatile platform can be reconfigured to efficiently and precisely combine molecules to form very specific products, such as organic battery materials.” Last year, a study co-authored by Helms and Thomas Russell, a visiting researcher from the University of Massachusetts, pioneered a new technique for printing various liquid structures – from droplets to swirling threads of liquid – within another liquid. “After that successful demonstration, a bunch of us got together to brainstorm on how we could use liquid printing to fabricate a functioning device,” said Helms. “Then it occurred to us: If we can print liquids in defined channels and flow contents through them without destroying them, then we could make useful fluidic devices for a wide range of applications, from new types of miniaturised chemical laboratories to even batteries and electronic devices.” To make the 3D-printable fluidic device, lead author Wenqian Feng, a postdoctoral researcher in

Berkeley Lab’s materials sciences division, designed a specially patterned glass substrate. When two liquids – one containing nanoscale clay particles, another containing polymer particles – are printed onto the substrate, they come together at the interface of the two liquids and within milliseconds form a very thin channel or tube about 1mm in diameter. Once the channels are formed, catalysts can be placed in different channels of the device. The user can then 3D-print bridges between channels, connecting them so that a chemical flowing through them encounters catalysts in a specific order, setting off a cascade of chemical reactions to make specific chemical compounds. And when controlled by a computer, this complex process can be automated “to execute tasks associated with catalyst placement, build liquid bridges within the device, and run reaction sequences needed to make molecules,” said Russell. The multitasking device can also be programmed to function like an artificial circulatory system that separates molecules flowing through the channel and automatically removes unwanted by-products while it continues to print a sequence of bridges to specific catalysts, and carry out the steps of chemical synthesis.


“The form and functions of these devices are only limited by the imagination of the researcher,” explained Helms. “Autonomous synthesis is an emerging area of interest in the chemistry and materials communities, and our technique for 3D printing devices for all-liquid flow chemistry could help to play an important role in establishing the field.” Added Russell: “The combination of materials science and chemistry expertise at Berkeley Lab, along with world-class user facilities available to researchers from all over the world, and the young talent that is drawn to the Lab is unique. We couldn’t have developed this program anywhere else.” The researchers next plan to electrify the walls of the device using conductive nanoparticles to expand the types of reactions that can be explored. “With our technique, we think it should also be possible to create allliquid circuitry, fuel cells, and even batteries,” said Helms. “It’s been really exciting for our team to combine fluidics and flow chemistry in a way that is both user-friendly and userprogrammable.” The technology is available for licensing and collaboration, interested parties should contact Berkeley Lab’s Intellectual Property Office,




olomite Microfluidics has announced a new partnership with Emulseo – a start-up company producing surfactants for droplet-based microfluidics – to distribute FluoSurf, a highperformance continuous phase surfactant specifically formulated to stabilise aqueous droplets in microfluidic systems. FluoSurf is compatible with a wide selection of reagents in the droplet phase that would disrupt the stability of emulsions formed with traditional stabilisers, and is ideal for applications in fields such as droplet formation and microencapsulation, according to the two firms. This copolymer comprises ambiphilic polymer blocks that allow stabilisation of the interface between aqueous droplets and fluorinated oils. Dolomite says it offers fast droplet formation rates and enables the creation of highly stable emulsions of a broad range of

monodisperse droplet sizes that can be readily broken when desired. Quentin Jochyms, CTO and co-founder of Emulseo, said: “FluoSurf was developed and optimised specifically for dropletbased microfluidics applications, and will meet the demand for a biocompatible surfactant that provides batch-to-batch reproducibility.” Richard Gray, vice president of particle engineering and microfluidics at Dolomite Microfluidics, added: “We chose Emulseo as our partner to offer FluoSurf to our customers worldwide. We are delighted to be distributing this product, which will greatly improve the market for emulsion stabilisers, and look forward to a fruitful collaboration with Emulseo.” Meanwhile US-based Redbud has announced an expansion to its MXR (“mixer”) microfluidic chip family with the introduction of MXR Blue. The MXR Blue line of chips is a new formulation of the company’s proprietary Redbud Post technology designed to maintain performance in sampleto-answer cartridges without the need for additives. MXR Blue is designed for use in a range of applications, especially for system developers seeking to improve diagnostic sensitivity, shorten time-to-result, or simplify the consumable for a multiplexed genomic or proteomic test. With MXR Blue, assay developers can now flood chambers directly with raw biofluids such as blood or urine, cell media, pure water, and other high-surface tension fluids.

“We developed MXR Blue based on customer demand,” said Dr Jay Fisher, vice president of R&D. “Researchers and systems developers alike have been seeking out the mixing advantages of MXR, but were restricted in their ability to utilise surfactants in their assays. Thanks to MXR Blue hydrophilic characteristics this is no longer an issue. Developers can integrate the cartridge-ready chip into their protocols and immediately reap the rewards of MXR-enhanced mixing. With MXR Blue, it’s now possible to work directly with non-diluted biological fluids like whole blood, urine, cerebral spinal fluid, saliva, synovial fluid, plasma, serum, etcetera.” Redbud’s MXR chips are recognised for their rapid mixing capability in microfluidic volumes where reliance upon diffusion kinetics limits the performance of sample-to-answer assays. MXR chip models are assembled microfluidic components, wellsuited for use with microarrays, reagent reconstitution and microfluidic cartridges. MXR Blue comes in two standard chip assemblies.


STARTR Our guide to the latest young up-starts in medtech


Grace is an automated tracking and cooling bracelet designed to detect and prevent hot flushes in menopausal women. Users can keep track of and understand their hot flushes in more detail via a smartphone app.


Nurokor has developed a series of devices designed to treat injury and allow people to recover from workouts. Using pressure pads, a band, flip-flops and gloves, the use of electrodes aims to stimulate recovery from any muscle pains and aches, and has had the endorsement of former Olympic athletes.


Aquarate has developed products that allow healthcare professionals to monitor the fluid intake of their patients in realtime â&#x20AC;&#x201C; removing the manual process of fluid monitoring.


Virti has recently been accepted onto the NHS Innovation Accelerator programme. Itâ&#x20AC;&#x2122;s an education technology platform that allows users virtual and augmented reality to train and coach users in real-life situations. It also provides mental health support to health professionals and patients.






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MTI Issue 42  

MTI Issue 42