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Issue 30 November/December 2016
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3D printing through and through Accelerated access to the NHS
Expo 2017
Med-tech 4.0 – setting the horizon
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Med-Tech Innovation Contents
contents ¦ november/December 2016 hoW to contact the team chief operating officer/publisher Duncan Wood
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sales Director colin martin t: +44 (0)1293 710 042
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Walking the talk Bournemouth launches a world-class gait analysis laboratory to help improve orthopaedic surgery performance
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Driving meD-tech WHP shows how best automotive moulding practice translates into effective med-tech know-how
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vital brain Work City University expertise could quickly detect brain trauma and save lives
E: colin.martin@rapidnews.com
group editor lu rahman t: +44 (0) 1244 680222 E: lu.rahman@rapidnews.com
Deputy group editor David gray t: +44 (0) 1244 680222
16-17 compameD ‘16 Micro moulding techniques can embed electronics in human implants
E: david.g@rapidnews.com
content editor adrian lunney t: +44 (0)1293 710 043
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E: Adrian.lunney@medtechcomms.com
Design vincent rohde t: +44 (0) 1484 311000 www.rohdeconsulting.co.uk
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Wearable electronics Designing flexible electronics for human body wear has never been more important
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rapid medtech communications ltd. Carlton House, Sandpiper Way, Chester Business Park, Chester CH4 9QE Subscription: Med-Tech Innovation is free to qualified readers in the UK and Ireland. Register to receive copies at www.med-techinnovation.com or e-mail: circulation@med-techinnovation.com The Publisher endeavours to collect and include complete and current information in Med-Tech Innovation, but does not warrant that any or all such information is complete, correct or current. The Publisher does not assume and hereby disclaims any liability to any person or entity for any loss or damage caused by errors or omissions of any kind, whether resulting from negligence accident or any other cause.
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Med-Tech Innovation does not verify any claims or other information appearing in the advertisements contained in the publication and cannot take any responsibility for any losses or other damages incurred by readers in reliance on such content. All submissions are handled with care. Every precaution is taken to ensure accuracy, but the Publisher cannot accept responsibility for the accuracy of the information herein or for any opinion expressed. Rapid Medtech Communications Ltd. No part may be reproduced or transmitted in any form without the prior permission of the Publisher. ISSN 2046-5424
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November/December 2016 ¦ 03
Med-Tech Innovation RAPID News
Change is the law of life. And those who look only to the past or present are certain to miss the future. John F. Kennedy
Rapid News Communications Group completes acquisition of Med-Tech Innovation Magazine, Website and Expo.
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e are pleased to announce some important and exciting news concerning your industry. As of November the Rapid News Communications Group have acquired the Med-Tech Innovation brands and will be taking over the publishing of the very magazine you are reading and also managing operations for Med-Tech Innovation Expo, the next edition of which takes place in April 2017. The Med-Tech Innovation brand was established in 2010 by Colin Martin and is now firmly positioned as the leading medical device magazine and exhibition for the UK and Irish medical sector. Colin will continue to drive the products under the new ownership bringing his connections and understanding of the medical sector to bear alongside the new owners. Portfolio Rapid News Communications Group, led by the experienced executives Mark Blezard and Duncan Wood, is a specialist B2B media and events company with market leading brands in the life sciences, plastics and 3D
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printing/additive manufacturing sectors. The Med-Tech Innovation products will join a hugely successful media and event portfolio including Interplas, TCT, Medical Plastics News, European Pharmaceutical Manufacturer, British Plastics and Rubber and Digital Health Age. Mark Blezard, CEO, RNCG commented, “We are absolutely delighted to be adding to our strong portfolio in the life sciences sector with this acquisition. The Med-Tech Innovation products clearly increase our commitment to the UK healthcare market and we promise to invest not just money and infrastructure into the magazine, event and digital products but also our 25 years’ experience in the medical device sector. We have a track record in high technology industries and have accelerated media and events with great success in recent years. We look forward to doing the same with the Med-Tech Innovation brands and enhancing them for all stakeholders in the UK and Ireland medical device sector. Positive Change Colin Martin adds, “I am delighted to be able to take the business forward with the resources, experience and
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Med-Tech Innovation RAPID News
expertise of RNCG. Med-Tech Innovation has always been about facilitating communication between all stakeholders in the medical device, innovation, design and manufacturing process and this announcement propels Med-Tech forward in all areas of the business. I look forward to getting started with the team at RNCG immediately.” RNCG will be deploying their resources on the content side to continue to bring you the most up to date information from the sector, and this will fuel a commitment to extend the circulation of Med-Tech Innovation magazine. The UK and Ireland medical sector is growing and the magazine will grow to keep pace. In addition to this, RNCG will be using its Operations, Marketing and Content teams to develop Med-Tech Innovation Expo from its current position into a major national event, with an international reputation, to reflect the industries it serves. Stakeholder Input Duncan Wood, COO, RNCG adds, “We are excited to add Med-Tech Innovation to our portfolio. In particular, we are excited by the opportunity that the medical sector, which is not new to us, offers. We will be working hard to develop a strategy for the next three years to accelerate the development of the brand, in particular the Expo where we see huge potential to bring the UK and Ireland medical sector into the international spotlight, our strong partnerships in Asia, Mainland Europe and North America will help us leverage many opportunities in these areas. I look forward to meeting many of our readers, advertisers, exhibitors and supporters in the coming months as we start to build partnerships for the future. Our first job is to listen to what the industry stakeholders www.med-techinnovation.com
John Wilkinson – Director of Devices at the Medicines and Healthcare products Regulatory Agency ( MHRA)
want for its magazine and event, and then to deliver on those requests. We are keen to hear from as many people as possible and I welcome all approaches to discuss how we might work together.” The Future The last word is perhaps left to Mark Blezard as the founder of Rapid News, and newly appointed Chairman of Rapid Med-Tech Communications Ltd. “I urge you to take the advice of JFK and embrace the future of MedTech Innovation. We promise to invest not just money and infrastructure into the event but also our 25 years’ experience in the publishing sector along with a huge dose of energy which will see the brands reflect the energy in the space. We look forward to working with you. Mark Blezard CEO
Duncan Wood COO
Colin Martin Sales Director
November/December 2016 : 5
Med-Tech Innovation Innovation
NHS aims to accelerate UK med-tech leadership A report with clear recommendations to the UK government to speed up patients’ access to innovative medicines, technologies and products – including the involvement of the country’s Academic Health Science Networks (AHSNs) – has been published.
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he Accelerated Access Review (AAR) says streamlined processes could bring forward patient access to drugs by up to four years and patients will benefit from quicker access to medical technologies too. It also recommends a simpler process for digital technologies, which are often developed by smaller companies, such as healthcare apps for managing longterm conditions. Sir Hugh Taylor, Independent report chair says: ‘The resulting report sets out an ambitious framework for how we can transform our NHS, pulling innovation – medical technologies, diagnostics, digital and biopharma products alike – through the system for the benefit of patients and improving the international competitiveness of our country,’ The Accelerated Access Review outlines recommendations to the government on how to accelerate access for NHS patients to innovative medicines, medical technologies, diagnostics and digital products. Professor Sir John Bell, Regius Professor of Medicine at the University of Oxford, chaired the review’s external advisory group. He explains: ‘It was our intention to propose a new system for accelerating access to all types of innovation in the NHS, including drugs, medical devices and diagnostics and digital tools. We saw opportunities for acceleration at every stage of approval and adoption. We have recommended a process
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for identifying and pulling transformative innovations into the NHS quickly, using the range of emerging regulatory pathways, and facilitating the generation of patient data that defines the benefits of innovation to both outcomes and pathways.’ Bell adds, ‘Collaboration and early dialogue between innovators and the NHS will be critical to enable agreements that exploit this more streamlined approach and the opportunity of new agreements being reached to deliver a win for both parties. The historical model, where innovators simply throw new products at health care systems and allow them to layer these onto existing pathways, is no longer viable. We believe that health care systems and innovators need to work together to demonstrate the way in which innovations change pathways and improve outcomes. This is particularly true with digital, med-tech and diagnostic innovations, but has also been true for pharmaceutical innovations.’ In a nutshell, Professor Bell argues that ‘If the NHS is to see the continued benefits of such innovation, it needs to contribute more actively to its development.’ The report notes that ‘for medical technologies, diagnostics and digital products, the pathway may look slightly different to the pathway for strategically important pharmaceuticals. Medical technologies will often come to market with www.med-techinnovation.com
Med-Tech Innovation Innovation
a less formed evidence base than medicines, due to the different regulatory requirements. This means that a transformative designation is more likely to be given after a CE marking, and products may need further clinical and cost-effectiveness data before the NHS can be clear about their benefits. These benefits will usually arise due to the product’s impact on a clinical pathway.’ And there is more guidance and good news for inventors, innovators and Small to Medium Sized (SME) firms. The AAR acknowledges that ‘innovative med tech products frequently fail to achieve reimbursement and adoption, because the small firms involved have limited resources for the additional clinical testing required to generate the evidence to inform cost-effectiveness decisions. We propose that a small amount of funding – around £20m to £30m over five years – would support the commercialisation of disruptive innovative technologies that significantly change care pathways and have the potential to improve outcomes and create efficiencies. The funding should be targeted at SMEs to promote a vibrant and varied industry.’ In this connection the AAR pays tribute in its pages to the successful work of the SBRI Healthcare programme, which co-develops technology with the NHS, working with clinicians to identify key challenges and priorities. The AAR noted: ‘The resulting technologies bring the opportunity to transform health and care, and grow economic value for the UK. The programme is led by the Academic Health Science Networks and in 2015/16 was able to disburse nearly £20m to almost 50 companies.’
…we can transform our NHS, pulling innovation for the benefit of patients and improving the international competitiveness of our country,’ Solutions have been identified for a number of conditions. In diabetes, for example, Sedgefield based Polyphotonix has developed a non-invasive treatment for macular eye disease, using organic light-emitting diodes housed in a fabric mask which is worn overnight, avoiding costly outpatient visits. The mask (Noctura 400) can be used to prevent and treat diabetic retinopathy and Diabetic Macular Oedema and is currently undergoing phase III trials and a NICE assessment. SBRI-backed companies are reporting jobs and trade growth, private investment of over £45m and a pipeline value to the NHS evaluated by health economists at over £510m. The AAR also recognises that the UK’s Academic Health Service Networks are central to underpinning the work in innovation and in plans to make the NHS the world leader in healthcare innovation. The AAR report includes a clear role for AHSNs to drive and support the evaluation and diffusion of innovative products nationally and locally, both as a strengthened AHSN network across England and as delivery routes to facilitate local evidence collection, and adoption of innovations into secondary and primary care. In addition, the report recommends that AHSNs play a www.med-techinnovation.com
key role in digital health, advising innovators on local areas of unmet need and working with providers, CCGs and clinicians to generate evidence of the benefits of digital products. The aim is to make the UK the best region in the world to design, develop and deliver healthcare innovations, with an NHS that embraces the new drugs and technologies that patients need. Tony Davis, Commercial Director of the West Midlands AHSN, comments: ‘The NHS has huge potential to be creative and innovative, yet the system as a whole is slow to adopt new ideas and best practice. This leads to avoidable variation in patient care and system inefficiencies. This new report offers practical system changes that will result in real benefits to patients, clinicians, the NHS and the wider UK economy. Davis adds that ‘as an AHSN, we welcome the recommendations of working closely with our existing local networks - NHS providers and commissioners, academia and industry - to play a vital role in supporting the testing and diffusion of technologies in the NHS.’ Elements that will be supported by West Midlands AHSN Network include creating an improved pathway for getting new medical technologies, diagnostics and digital products into the NHS at pace. This builds on the successful NHS Innovation Accelerator, which in its first year has supported the adoption of innovation into 388 NHS organisations and helped secure more than £17m investment to help accelerate health innovation. Government Health Minister Lord Prior, commenting on the AAR report said, ‘This government has a strong commitment to the life sciences and to building a longterm partnership with the life sciences industry. We are determined to make the UK the best place in the world to develop new drugs and other products that can transform the health of patients. This report provides us with a strong basis to make the right decisions about how the health system can be adapted to meet the challenges of the future, attract inward investment, grow the thriving life science industry, and use innovation to improve patient outcomes and tackle the financial pressures on the NHS.’ To read the Accelerate Access Review, go to www.wmahsn.org/resources.
Six questions The AAR says that medical technology innovators should ask themselves the following six questions: • How will this innovation change clinical pathways and establish a new standard of care? • What will be the clinical, social and economic impacts from this new standard of care? • How will we measure the impacts with sufficient precision to provide evidence for adoption? • What changes in workflow will be required? • How will the re-engineering of this workflow be resourced? How can the benefits be spread across and between healthcare delivery systems?
November/December 2016 : 7
Med-Tech Innovation Wearables
Wearables in Clinical Trials
Wearable med-tech represents a very large part of the medical future, bringing together materials science, electronics and ergonomics in the service of the user/patient.
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ere for Med-Tech Innovation magazine, Ian Dardani, Master’s student in Bioscience Enterprise at Cambridge University and Vangelis Papagrigoriou, PhD, Marketing Lead Medical Technology Division, Cambridge Consultants, discuss some current and specific applications in clinical trials. Pharmaceutical companies are currently upgrading clinical research with new technology in hopes of easing a risky and muddled clinical development process. The cost of clinical-phase development is up to $1.46 billion per approved drug, an amount that reflects the meagre 11.8% rate of clinical success. Among the difficulties of clinical research, many of the current measures used in trials cannot adequately capture a patient’s condition, leaving insights buried in noisy or subjective data. Hoping to improve this, some pharmaceutical companies are giving trial participants a wearable device to collect data that can help to understand a drug’s efficacy and safety. The key advantages of using wearables reside in their capacity to capture novel insights from data that is otherwise not possible to collect. For example, in wearables with accelerometers, data on free-living activity can be summarised into endpoints such as ‘hours of activity per day’ or ‘metabolic equivalent hours’. Wearables such as those from Actigraph or Phillips Respironics use accelerometry to measure sleep quality and duration, providing insight into a drug’s efficacy or safety. With more advanced data analysis, wearables such as the Great Lakes Neurotechnoloies Kinesia 360™ are being used to identify movement patterns of interest in Parkinson’s such as mobility, tremor, and dyskinesia. While many applications are yet to be fully exploited using accelerometry, some wearables are being packed with even more sensors to generate further insights, such as Empatica’s Embrace Watch to detect seizures,
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Ian Dardani
Vangelis Papagrigoriou
Preventice’s Bodyguardian Heart to detect arrhythmias, and MC10’s flexible patches to address multiple neurological conditions. In present-day trials, wearables are mostly being used to produce exploratory endpoints and data for post hoc mining. Further along, they may also be used to support a regulatory submission as a validated surrogate endpoint to support a regulatory submission, a status that is yet to be achieved. This uncertainty is dampening the overall adoption of wearables in trials. However, industry credits the FDA for being open to see wearables used in trials, having stated its willingness to review any data that is “fit for purpose”, including that from unregulated apps and wearable devices. The specifics of this have not yet been released. Hoping to remedy this, the FDA’s Clinical Trials Transformation Initiative has launched a Mobile Clinical Trials program, which is collaborating with industry to chart out a path for qualifying endpoints involving wearables and mobile devices. Which conditions will see wearables-based endpoints developing towards a validated status is yet to be determined, but industry insiders point to a few applications as a good fit. For example,an endpoint associated with movement disorders such as Parkinson’s disease looks promising. Wearables may also find uses for other neurological conditions with physical manifestations, such as dementia, Multiple sclerosis, epilepsy, and Huntington’s disease. In addition to these areas, many industry insiders think the 6 Minute Walk Test (6MWT) is ripe for an alternative. This test is typically used in pulmonary hypertension trials, but also with others such as heart failure, COPD, and pulmonary fibrosis. According to the ClinicalTrials.gov registry, the 6MWT is used in 146 trials each year, including 52 drug trials, of which 10 per year use the 6MWT for the only primary endpoint. Despite its common use as a surrogate endpoint, the validation of the 6MWT to significant clinical outcomes is being questioned in pulmonary hypertension. A recent interventional study of a heart failure treatment used a wearable which detected that the treatment decreased activity levels – an effect opposite to what would be assumed – while the 6MWT did not reveal any significant effect. The study offers hope that a wearable can achieve greater sensitivity than existing measures. Arguably, wearables can provide qualified endpoints that are more meaningful to patients, but reaching that point will require clinical expertise and communication with regulators. With such little experience in this area, the industry is clearly on a learning curve. www.med-techinnovation.com
ANN_SP_105x297_70TH_en.qxp_MedTech Innovation 2016 04.04.16 10:26 Page1
Med-Tech Innovation
THE ORIGINAL Neurophysiology MEDICAL PUSH-PULL CONNECTOR
Novel Elbow Splint trial Health Enterprise East (HEE), a leading NHS innovation hub, is beginning clinical trials of the Cambridge Ulnar Splint for treatment of patients suffering neuropathies at the elbow.
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his common condition, sometimes known as Cubital Tunnel Syndrome, is caused by nerve entrapment that often results in numbness of the little and ring fingers, and sometimes considerable pain and disability for patients. It is particularly prevalent in jobs such as manual labour and office work where repetitive tasks with protracted periods of elbow flexion are involved. The trials are taking place at the Cambridge University Hospitals NHS Foundation Trust and the splint has been developed by Dr Andy Michell, a consultant in Clinical Neurophysiology there. Last year the device won an HEE Innovation Award and the funds were used to prepare for clinical evaluation through early stage prototyping and device manufacture. Once developed, the Cambridge Ulnar Splint will be available to patients over the counter. It provides a flexible exoskeleton to help alleviate direct pressure on the trapped nerve, and it also stops the nerve irritation that causes symptoms such as pain, numbness and tingling in the fingers. The device deploys a simple mechanism whereby flexion of the elbow can be restricted as and when required, making it adaptable and patient-friendly. James Clulow, Technology Associate at HEE said: “This is a great example of HEE working collaboratively with innovative individuals within the NHS to develop their ideas and help prepare a device that is ready for clinical trials.’ Dr Andy Michell adds that ‘This is the first splint specifically design to protect the nerve at the elbow, unlike the braces and splints currently available to patients. We anticipate it being used like the carpal tunnel splints, which are popular worldwide. The Cambridge Ulnar Splint could be purchased directly by patients, or provided in primary care.’ The results of the first clinical trials will be announced early next year and commercial partners are currently being sought to take the splint to market. . For more information on HEE supported projects visit www.hee.org.uk
www.med-techinnovation.com
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Med-Tech Innovation Virtual Reality Training
Walk the talk with BUORI A new world-class orthopaedic gait analysis laboratory – the ‘GRAIL’ (gait real-time analysis interactive laboratory) – and state-of-the-art virtual reality training equipment have been installed at Bournemouth University’s Orthopaedic Research Institute (BUORI) thanks to a £700,000 local growth fund investment secured by Dorset Local Enterprise Partnership.
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he GRAIL, one of just three in the UK and of 23 world-wide, is being used by Bournemouth University for the first time ever, to analyse the outcomes on patients of orthopaedic surgical procedures and devices. The GRAIL includes a selfpaced treadmill with integrated force plate, a 10 camera motion capture system, and a 180-degree floor-to-ceiling surround screen featuring augmented reality scenes. The blue-chip virtual reality training equipment is one of the first modules in the world to give surgeons Virtual Reality (VR) training in orthopaedic surgery, ahead of actual patient surgery. It includes: • virtual reality arthroscopy (a VR training system for hip arthroscopy based on virtual reality VR techniques). BUORI will be the only place in the world to offer this type of keyhole surgery training. • virtual reality TKR (a VR training system for total knee replacement). BUORI will be the first centre in Europe to offer this facility. The funding secured through Dorset LEP has also been invested in equipment for muscle testing (Primus RS), joint angle measurement, muscle force testing as well as models of hips, for demonstrations and video recording equipment.
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It is anticipated that the cutting-edge laboratory and equipment will further establish BUORI as a centre of excellence in orthopaedics, attracting qualified practitioners and students from around the world to train at Bournemouth, as well as generating up to £100 million of investment into Dorset alongside 500 new jobs. Professor Rob Middleton, head of the ORI, says; ‘Our virtual reality training simulators now allow us to train surgeons in the ORI labs, whereas in the past they would be going through a learning curve on real patients. It’s a big advance and we’re generating huge interest from around the country and abroad.’ Middleton adds: ‘The new gait lab allows researchers to study human motion to improve sporting performance and treat injury and arthritis. Its unique contribution for studying joint replacements and their outcomes has attracted over 30 national and international companies to visit ORI over the last year. I am pleased to say that nine companies have now signed agreements and partnerships to work with our unit here. Without Dorset LEP’s support we could not have attracted this work to Bournemouth.’ www.med-techinnovation.com
Med-Tech Innovation
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June/July 2016 : 11
Med-Tech Innovation Plastics processing
WHP ideally placed for medical drive Since 1973 White Horse Plastics (WHP) has specialised in the development and production of tight tolerance technical injection mouldings and sub assemblies – all produced through lean manufacturing principles.
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hese competences served WHP very well in the competitive world of the automotive supply chain through the 1980s and 90s. This year, however, the company’s successful winning of the ISO 13485 standard have put a new sectoral horizon in place. The same polymer processing expertise and production disciplines are now being made available to the med-tech sector. Paul Bobby, WHP Factory Manager, says ‘We sense that OEMs in med-tech, healthcare and pharmaceutical markets are becoming ever more sophisticated in their sourcing and purchasing criteria and are looking for the best partners and suppliers. WHP will aim to be first among their number.’ Located in the Vale of the White Horse in Stanfordin-the-Vale, the current WHP technical competencies include a fleet of over thirty injection moulding machines, CAD/CAM facilities, CNC optical measurement, CMM systems, insert loading and camera inspection, a fully equipped tool room and dedicated med-tech manufacturing space. A dedicated ‘white room’ area for med-tech related production has also been developed this year. WHP material experience ranges from standard polymers, nylons, acetals, polycarbonates, ABS and TPEs etc, through to the more exotic engineering polymers. This blend of WHP technical and commercial expertise was combined to good effect in some recent work this year for leading med-tech supplier Clement Clarke International (CCI). CCI has been a leading light in worldwide medical instrumentation since 1917. Based in Harlow, CCI is a regular exhibitor at the prestigious annual Medica exhibition in Düsseldorf (see pp18 this issue) and became part of the Haag-Streit group in 1989. One of CCI’s leading specialities is the design 12 : November/December 2016
HR Flo-Tone and reed activation testing Flo-Tone AS Training Device
Colin Voller (Quality Manager) checking Flo-Tone reeds on OGP optical measuring machine
and production of inhaler training devices about which there have been many papers published, detailing the misuse of pMDI and DPI use among patients. Clement Clarke International have used their expertise to concentrate on this area of products, which has led to the introduction of the ‘Inhaler Technique Training’ range. Each product is targeted at the training of inhalation technique, guiding patients to inhale at the correct/ optimum flow rate for the device being used. WHP, along with tooling partner Scott Tools Ltd, have assisted CCI with the product development and production of the intricate sounding whistles and reeds that need to be designed and very precisely moulded to sound at a specific air flow rate dependent on the device they are being used in. ‘The CCI project certainly brought out the best in WHP’ says Paul Bobby, Factory Manager. ‘We love a challenge and this project demonstrates to us how our team-based thinking and the lean approach, developed over years working with demanding automotive suppliers, can provide substantial cross-over and benefit to medical clients. ‘The process begins with our experience in design-formanufacture with a focus on cost-out which embraces all our skills - in polymer selection, testing and metrology, through to tool design and process optimisation, followed by product testing and validation.’ Bobby adds that WHP’s ISO 13485 qualification now enables the company to pro-actively market these manufacturing skills to the worldwide medicalmanufacturing supply chain. In addition to ISO 13485, WHP also holds the universal quality management system ISO9001, the environmental standard ISO 14001 and the automotive quality standard TS 16949. www.med-techinnovation.com
Innovation SWISS Med-Tech CONTRACT Plastics MANUFACTURING
A partnership in polymer process
FROM STOCK TUBING IN STAINLESS STEEL
St Austell-based polymermedics recently worked with equipment supplier Piovan in order to produce a modified version of the latter’s Quantum Q7 gravimetric blender, achieving new levels of reliability and minimising dust creation. polymermedics employs more than fifty people, making precisely injection-moulded plastic parts, primarily for the medical and pharmaceutical industries. The products include tamper-proof seals and packaging for pharmaceuticals. Piovan is headquartered in Venice, Italy. The task of evaluating its Q7 blender, and suggesting the relevant changes, fell to process engineer Sharon Mitchell. ‘I looked at the system from an operator’s point of view, and how I want it to work,’ she says. By feeding polymer regrind directly back into the throat of the blender and ensuring a perfect blend of material is fed into the barrel, Sharon realised she could dramatically simplify the production process; further improving reliability, efficiency, and colour consistency, while reducing dust generation in the company’s clean moulding environment. Sharon Mitchell, process engineer at polymermedics
A breathing revolution Revolutionary Medical Devices (RMD), based in Tuscon Arizona has partnered with Teknor Apex to create the first nasal-only alternative to the standard fullface oxygenation and ventilation masks that medical practitioners have used for decades. The single-use mask consists of a transparent rigid polypropylene (PP) component with access ports for an anesthesia circuit or hyperinflation bag, plus a TPE cushion that is over-moulded onto the PP structure. The super soft TPE cushion is moulded with Medalist® MD-10105 medical elastomer from Teknor Apex Company, and it plays a critical role by providing a strong yet comfortable seal to the patient’s face. ‘At the prototype stage we turned to Teknor Apex for the TPE because they can provide very soft medical compounds that comply with all biocompatibility requirements right out of the gate,’ said Tom Reilly, RMD’s Chief Operating Officer. Use of sedation in medical procedures is increasing as a result of more sophisticated surgical techniques, an aging population, and a greater incidence of obesity. The new mask is an alternative to full-face masks and nasal cannulae, and it is particularly advantageous for intra-oral procedures such as upper endoscopies and bronchoscopies. ‘Over-moulding the Medalist TPE onto a PP substrate was challenging for two reasons,’ said Chris Morehouse, market manager of regulated products for the TPE Division of Teknor Apex. ‘First, the lower the durometer of the TPE, the more difficult it is to make it adhere to PP. Second, the TPE part is complex, with thick and thin wall-sections and recessed areas, or undercuts, that must retain their shape during ejection of the part from the mould.’ www.med-techinnovation.com
medical devices needles and probes
Unimed SA Lausanne, Switzerland phone +41 21 624 21 51 fax +41 21 624 53 32 www.unimed.ch November/December 2016 : 13 e-mail: info@unimed.ch
Med-Tech Innovation Teaching hospitals
City team to develop novel (nICP) monitor Thanks to a £510,165 National Institute of Health Research (NIHR) Product Development Award, biomedical engineering researchers from City, University of London, are developing a novel non-invasive intracranial pressure (nICP) monitor.
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he research project team comprises principal investigator, Dr Justin Phillips (Royal Academy of Engineering/Leverhulme Trust Senior Research Fellow) and co-investigators Professor Panayiotis Kyriacou (Director of City’s Research Centre for Biomedical Engineering) and Mr Christopher Uff, Consultant Neurosurgeon and Head of Neurotrauma at the Royal London Hospital. Medical treatment received immediately after traumatic head injury is critical to the survival and recovery of the patient. Brain swelling often causes a rise in pressure within the rigid confines of the skull. This rise in so-called ‘intracranial pressure’ can cause a reduction in blood supply to the brain leading to irreversible injury or death in patients with severe head injuries. Standard pressure monitoring requires insertion of a sensor through a hole drilled into the skull by a neurosurgeon, a procedure that carries risks of life-threatening bleeding and infection, as well as a delay in starting the monitoring process. This research project aims to develop a system for continuous non-invasive monitoring of intracranial pressure
Dr Justin Phillips
Easy sharing A digital histopathology partnership between Sheffield Teaching Hospitals, Hull and East Yorkshire Hospitals and Philips has been launched.
using an infrared sensor placed on the forehead. The intracranial pressure will be displayed to the clinician in real time, enabling rapid assessment of newly admitted head injured patients. The new system will be able to indicate the need for emergency procedures, such as drainage of fluid from around the brain, and will also allow doctors to plan long-term treatment. The proposed monitor could lead to significant improvements in survival rates, shortened hospital stays and reduced long-term disability. The new technology could also benefit patients suffering from stroke, meningitis, hydrocephalus (water on the brain), liver failure and migraine. A final version of the system, designed for use in ambulances, emergency departments or intensive care units, will be developed and tested in healthy volunteers and hospital patients. Dr Phillips says, ‘We are delighted with the assistance provided by the NIHR. This award will enable us to develop a completely new technology with the potential to revolutionise the management of traumatic head injuries, as well as providing opportunities for better monitoring and treatment of patients with strokes.
L-R: Dr Branko Perunovic and Dr Jonathan Bury from Sheffield Teaching Hospitals NHS Foundation Trust with the new EASY Path system.
The EASY Path network is the first of its kind in the UK, and simplifies collaboration between two histopathology departments of two independent NHS trusts. It offers a solution to the growing demand for specialist histopathology services. It also enables the workload to be shared across both organisations, whilst avoiding the need for the physical transfer of glass slides and the expense of employing locum doctors or external reporting agencies. The partnership is supported by the Philips IntelliSite digital pathology platform. 14 : November/December 2016
www.med-techinnovation.com
Med-Tech Innovation Keyhole Surgery
Clarity through the keyhole
This summer saw a new product and process aiding surgeons in their keyhole surgery. Bill Townsend, Project Leader at IMI Precision Engineering explains the highly collaborative process behind bringing the OpClear® – a new laparoscopic device – to the market.
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ioneered in the early 20th century by a succession of surgeons across Europe, keyhole or laparoscopic surgery has become a popular method for performing a multitude of procedures in the abdomen or chest cavity areas. Known to minimise blood loss, decrease the risk of haemorrhaging, and reduce pain and scarring, the procedure typically relies principally on a laparoscope inserted through a 5-10mm cannula, attached to a camera, which then relays the image onto a screen in the operating theatre. Although a powerful tool, such a small-scale device is frequently smeared with bodily fluids or condensed by the body’s internal humidity, obscuring the surgeon’s view and necessitating the removal of the laparoscope for cleaning and reinsertion. A clean laparoscope is essential for a safe surgical procedure, but the internal conditions of the human body are rarely conducive to maintaining a clear lens. To combat these issues, a variety of solutions had been explored; but for the specialist team at Cipher Surgical, the answer lay in a puff of CO2. The original idea was to develop a sleeve to encase the laparoscope, containing a mechanism that could dispense an on-demand, precise amount of CO2 over the lens in order to clear it. However, CO2 is stored in liquid form at very high pressures and can be difficult to control. A pressure regulator was sought - and this led Cipher Surgical to IMI Precision Engineering. Due to the particular requirements of medical applications, it was clear that an off-the-shelf standard pressure regulator would not be appropriate: the need to use medical grade CO2, guarantee patient safety, and also fit within the small envelope required of a theatre equipment trolley all pointed towards a bespoke solution. Both teams worked together from the outset to finalise risk assessments and failure mode analysis. This led to the development of an entirely new pneumatic circuit, fully integrated with electronic components and with customwritten software. www.med-techinnovation.com
Running concurrently was the development of the sleeve itself. The ultimate aim was to minimise the amount of CO2 used for the optimal effectiveness, whilst also optimising the flow rate and pressure. A two-stage initial testing process then followed – firstly testing the circuit with a standard components to prove both the concept and the success of the circuit, and latterly testing the full integrated manifold after each refinement. In order to circumvent the clouding issues of human fatty tissue, the team began to factor in the use of saline; deploying a second CO2 delivery mechanism to actuate a syringe and also deliver a measured dose of saline solution along with the CO2 pulse – all operated on-demand and hands-free via a foot switch. The greater kinetic energy of gas over liquid meant the saline was strong enough to move the most stubborn of fat cells, leaving the team with a system able to deal with both hydrophilic and hydrophobic substances covering the lens. This refined device, named OpClear®, obtained CE approval earlier this year and has been used in operating theatres during early summer 2016. Tangible clinical benefits have been identified by surgeons who have commended OpClear®’s patient-centred features – from shortening surgeries to reducing the likelihood of repeat procedures being required, and indeed lessening the risk of full open surgery. A further benefit of the OpClear® device is the ability to position the laparoscope closer to the focal area during critical phases of the procedure, primarily to increase accuracy. Historically, surgeons had been limited by anticipated spatter and kept the lens at a distance - with a compromised view of the surgical site – in order to prevent the need for removal. This is now negated by the CO2 or saline blast and allows the device to be moved closer. For further information please visit www.ciphersurgical. com and www.imi-precision.com November/December 2016 : 15
Med-Tech Innovation Compamed
Boddingtons show success Tibbs says that ‘Boddingtons has had a very successful four days here in Düsseldorf with many enquiries for us to process next week. Our new factory launch on November 1 undoubtedly played a part in attracting new interest to our stand. Key UK med-tech companies - some of which are themselves exhibiting in the adjacent Medica 2016 show - have been able to visit us, and our manufacturing expertise has also enjoyed some strong interest from the Continent. We are looking forward to taking all projects forward in the coming weeks.’ Some 15% of the new Boddingtons factory floor space is now being used as modular Class 7 cleanroom manufacturing. Demand for these services in the medtech supply chain is increasing. Boddingtons company competences include injection moulding, finishing and assembly processes, printing, welding, packing and packaging, together with regulatory and technical support for Boddingtons customers. It has been a whirlwind Q4 so far for Boddingtons. The company’s newly launched £4.6m state-of-theart injection moulding factory was a key factor in the business, winning the prestigious 2016 Plastics Processor of the Year category of the Plastics Industry Awards at the London Hilton on September 30th.
Boddingtons wrapped up a successful exhibiting presence at Compamed 2016. Andy Tibbs (right) celebrated some recent business here on the stand with Peter Ramsey, Managing Director of Meditech Endoscopy.
Andy Tibbs, Managing Director says: ‘We view our new moulding facilities in Marden, Kent as the equal of any in Europe, if not the world. It provides our med-tech clients with a one-stop shop for all their needs, including regulatory and technical support. And so we have made sure to come to Düsseldorf fully equipped to tell that story - featuring details of our new manufacturing facility, both in video and in print format.’ The exhibition is established in order to provide a visitor footfall of leading OEMs, healthcare and medical manufacturers who are seeking manufacturing suppliers, and contractors to the worldwide medical and healthcare industries.
An exterior view of the company’s new Class 7 cleanroom
Micro medical from Wittmann The leading supplier of injection moulding equipment exhibited a working production cell on show at the fair. The company’s twin strengths, in established micro moulding techniques and in cleanroom ready injection moulding machines, are currently combining to powerful effect. All kinds of critical med-tech components – including implants technology, dental products, and components with electronic inserts – can be moulded via the new Wittmann Battenfeld systems.
Wittmann Battenfeld exhibited under the Austrian trade banner in Hall 8b at Compamed.
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The Compamed 2016 exhibition this year celebrated its 25th annual edition. It was primarily established in order to provide a visitor footfall of leading OEMs, healthcare and medical manufacturers who are seeking manufacturing suppliers and contractors to the worldwide medical and healthcare industries. Many of these are present in the co-located Medica exhibition. Compamed was this year located in halls 8a and 8b of the Düsseldorf Messe complex. Some 19,000 visitors passed through the exhibition over November 14-17, 2016, looking at product innovations and medtech manufacturing. There to meet them were over 770 exhibitors from 37 countries. The dates of the next Medica and Compamed exhibition in Düsseldorf has been set at 13-16 November 2017. www.med-techinnovation.com
Med-Tech Innovation Compamed
Spang & Brands shows its strength Veteran exhibitor at Compamed, Spang & Brands, showed the qualities that enable its continuing growth and penetration of that marketplace.
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irector Friedrich Echterdiek explained the full development of the company to MTI magazine. Established in the Frankfurt area in 1909, the company mould-tool and moulding business then dedicated itself to the medical industry from the early 1980s, based on an in-depth understanding of injection moulding production and extremely high precision moulds and tooling. The Spang & Brands business now employs some 150 people in total and deploys some 65 injection moulding machines, many located in Class 7 and 8 clean rooms. It provides a one-stop-shop for all levels of medtech production, from initial ideas, to the production of complete med-tech devices supplied in packaging. Devices such as the newly launched Mofixx laparascope control and holding device, show off the maturity and competence of the company approach. Mofixx (Move and Fix) removes some physical wear and tear from the surgeon, while providing great scope and accuracy in micro procedures. It is the result of close cooperation between Mofixx, INDES and Spang & Brands. Mofixx is firmly fixed – not to the surgeon’s arm, but to the operating table; and can be applied flexibly not just using laparoscopes but also with a variety of other instruments required for keyhole surgery. There are consequently no more complex instructions to assistants to position the trocar equipped with a micro-camera. Results are achieved with the use of a stabilizing swivel
arm equipped with a ball-and socket joint (sphere), enhanced with a spindle motor and base. Echterdiek notes that; ‘The system comprises 12 separate components. The most appropriate polymers had to be selected and all components had to be functionally matched to one another and had to comply with the requirements of Move and Fix.’ The Mofixx laparoscope control and holding device made its debut at Compamed 2016 and was successfully used for the first time in 2016 by urologist Dr Arto Boeken, during a kidney operation at the UMC Utrecht.
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Med-Tech Innovation Medica
Medica ’16 thriving The annual Medica exhibition in Düsseldorf, Germany – adjacent to the much smaller Compamed show – typicially attracts the cream of UK producers of medical and healthcare products. The UK Government takes an active exhibiting role here, as does the Association of British HealthCare Industries (ABHI), managing the impressive and extensive British pavilion in Hall 16. UK manufacturer Rober used Medica 2016 to show its range of zeropressure ulcer mattresses that cater for a variety of needs, including patients that are immobile, bariatric or have existing pressure injuries. Developed in conjunction with clinicians, the mattresses feature technology that prevents pressure injuries from developing and also have therapeutic properties that promote the healing of established ulcers. Pressure ulcers are a rising problem around the world and in the UK alone, they affect over 700,000 people a year and add an additional £4,000 per ulcer onto each person’s care bill. The mattresses are fully automatic, and patients nursed upon them require less frequent manual repositioning, thus relieving the pressure on busy nursing staff. They can be used in everyday nursing environments, as well as acute care facilities.
We visited with Paul Benton, ABHI Commercial Director (see facing page) and also noted a number of Medica ’16 highlights from the UK (below).
Developed with surgeons, for surgeons, Single Use Surgical was present at Medica 2016, exhibiting its wares. Each suction tip is atraumatic for patient safety, as well as curved for maximum visibility and improved reach in difficult-to-access areas. Single Use Surgical was established in 2001 as a direct response to UK hospitals’ concerns over the cleaning practices involving fine lumen instruments, and how it posed a high risk of cross contamination between patients. Since then, the company has developed the widest range of high quality and specialist single-use suctions capturing the same look, feel and functionality as the reusable equivalent. Unlike many other disposable instruments, Single Use Surgical manufacture their products with stainless steel tubes rather than aluminium, a factor that has helped them to become a global leader within the single-use medical devices market. Their range spans many specialities including ENT, Head and Neck, Gynaecology, Laparoscopy, General and Vascular surgery.
A pioneering diagnostic system that is having a significant impact on the changing clinical pathway for cervical cancer was exhibited at Medica 2016 by Zilico Ltd. Cervical cancer is the 7th most common disease globally, and the third most prevalent in woman. The disease is caused by the persistent highrisk human papillomavirus (HPV) infection, which triggers changes in the cervical cells. The ZedScan™ is a portable, handheld device that uses patented Electrical Impedance Spectroscopy (EIS) to detect the development of pre-cancerous abnormalities of the cervix, known as cervical intraepithelial neoplasia (CIN). The system helps clinicians manage growing colposcopy referrals generated by the introduction of primary HPV testing. In a recent review of over 1500 women referred to an NHS colposcopy clinic, the adoption of ZedScan resulted in a 13% increase in detection of high-grade disease (HGCIN) across all patients, with 50% increase reported in women with low-grade cytology. In 92% of these cases, disease was confirmed with a single biopsy.
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Pelican Feminine Healthcare used Medica 2016 to showcase the FETOfit®, a strapless foetal monitoring solution and PELIspec® Pro-Wall, a vaginal speculum designed to offer added vaginal wall support. Simple, secure and strapless, the FETOfit® is a disposable device specifically designed to secure both TOCO and CTG transducers quickly and easily for foetal monitoring. The hypoallergenic adhesive pads adhere directly to the front of the abdomen with a flexible material that moulds to the body’s contours, offering a secure fit whilst promoting maternal comfort and mobility, with easy access for epidural.
www.med-techinnovation.com
Med-Tech Innovation ABHI
ABHI flies the flag for UK plc at Medica Med-Tech Innovation met up with Paul Benton, ABHI International Director on the UK Pavilion at Medica 2016, to find out more about the ABHI and its role within the healthcare industry.
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he Association of British Healthcare Industries (ABHI) is now in its 25th year and boasts a community of over 250 members, many of whom are key customers for the med-tech manufacturing supply chain. It champions the use of safe and effective medical technologies in order to support high quality patient outcomes and health system efficiency.
Paul – welcome to MTI magazine. Firstly, how can the ABHI - and its members - help the UK medtech manufacturing supply chain? ABHI supports UK med-tech manufacturers across short and medium to long-term horizons. UK manufacturers often require practical support, whether that is ensuring they can recruit and retain the best talent, or having access to finance for their working capital or investment needs. The UK Government is developing an industrial strategy that focuses on raising productivity to achieve a high-wage, high-skills economy. ABHI welcomes that aim; and we work with manufacturers to ensure their medium and long-term needs are addressed, through appropriate government actions.
What value does the ABHI offer its members and the wider med-tech community? The ABHI represents the industry and our membership base to government, the NHS, policy makers, regulators and other key organisations in the UK and abroad. Our focus is on the UK market, ethics and compliance,
international business development and the regulation of medical devices. We work extremely hard to address operational issues in healthcare delivery and provide strategic input to the broader policy environment; and we have a number of working groups that promote the contribution of medical technology to the health and wealth of our country.
Can you tell me more about your recent highlights in 2016? 2016 has been a great year for us. One example is the recent ABHI mission to Texas supported by Government, which saw a group of UK healthcare technology companies visit the state. The aim was to establish long-term relationships between UK firms and hospitals and healthcare providers, showcase British cutting-edge innovations and highlight how our developments are transforming the lives of patients and clinicians across the globe. We have also organised the UK Pavilion at shows such as this one, Arab Health and CMEF, where healthcare technology companies are keen to develop and nurture worldwide trade links.
What is the value for UK med-tech companies in being present on the UK Pavilion at industry events such as MEDICA? Global congresses such as Medica provide UK companies with the platform to meet with distributors and buyers from around the world to discuss business and meet with industry peers. Being part of the UK Pavilion means that companies can benefit from the UK branding, which is globally recognised for quality and innovation. Exhibitors can also access all the in-market support that we offer; such as a business resource hub, hospitality and meeting room facilities. We work hard to market the UK Pavilion and drive as much traffic to it as possible.
What is the ABHI’s view on the general state of British med-tech manufacturing - and the future? We take a very positive view. Many of our members have research and development, as well as advanced manufacturing facilities, in the UK. This means that the next generation of health treatment discoveries will not only be developed in Britain, but also produced in Britain. www.med-techinnovation.com
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Med-Tech Innovation 3D Printing
Addicted to printing Five good reasons why. Additive manufacturing, including 3D printing, is fast becoming a staple ingredient in cutting-edge med-tech and dental practice. Darren Webb, Commercial Manager at Paragon Rapid Technologies Ltd, here explains why the 3D habit is here to stay.
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roduct development in the medical sector poses a challenge for even the most competent of designers: as an area of significant technological advancement, new processes and techniques are under continual development in areas from medical devices to implants and prosthetics. In such a demanding environment, stringent regulations are defining each stage of development, and product specifications are becoming more and more precise. Fortunately, advances in manufacturing technologies haven’t been left behind, with Additive Manufacturing (AM) and 3D printing processes revolutionising the way in which both leading medical suppliers and emerging startups are bringing new products to market. Indeed, the sector has contributed to the advancement of these technologies as an early adopter, and it is now reaping the rewards. At Paragon Rapid Technologies we have identified at least five trends that tell us that the process is here to stay. 1. Customisation – for surgeon and patient The user interface has become liberated through these new techniques. Processes such as Selective Laser Sintering (SLS) have been embraced by surgeons and clinicians to aid them with reconstructive surgery and with the pre-operative evaluation process. Such applications, particularly in joint replacement and in dental and maxillofacial reconstruction, have been widely publicised. In theory and in practice, completely bespoke structures can be created to suit every individual patient. 2. Reducing time to market Rapid prototyping is faster and more accurate than it has ever been. The ability to quickly generate multiple iterations of a physical evaluation model through 3D Printing can dramatically reduce product development times. This in turn allows designers to explore more variations and eliminate failures faster. By accelerating the early development phase through the use of rapid prototyping technologies, manufacturers can lay down production tooling earlier and with much more confidence, allowing them to maximise their competitive advantage 20 : November/December 2016
and benefit from a quicker return on investment. 3. Catalysing validation and user trials The ability to replicate the shape, texture, and functionality of a medical device or model through additive manufacturing processes allows extensive tests to be carried out using fully working prototypes. This has become key within the medical sector, where it often is necessary to make a clear, detailed assessment of how the end product is likely to perform. Advances in production-grade materials have made this possible, such as Stereolithography’s Class VI USP rated WaterShed® 11122, which complies with stringent requirements for medical devices or surgical equipment that may come into contact with human tissue. The compounds approved are durable and resistant to environmental factors, highly protective, non-absorbent, and non-toxic, displaying properties similar to those of final production materials.
Paragon Rapid Technologies supplies prototype and low volume solutions to a number of design consultancies and manufacturers in the Medical sector.
4. Enabling Low Volume Manufacture Due to the nature of the Medical market, products are often only required in low volumes, where quantities won’t allow the amortisation of tooling investment across the production run. Furthermore, complex, free-form designs can be produced through 3D printing that are stronger and lighter, with a reduced carbon footprint, as material is selectively “added” during their manufacture. 5. Reducing product development cost In an industry where market research and testing is paramount, the ability to produce rapid and inexpensive prototyping offers a huge advantage. 3D printing gives Medical manufacturers flexible low cost access to multiple test parts that cannot be matched by traditional production methods. Outgoings are reduced in terms of expensive tooling, warehouse storage, shipping and a host of other costly resources. For more information on 3D printing, email 3DPrint@paragon-rt.com www.med-techinnovation.com
Med-Tech Innovation
An X-Ray revolution
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European health consortium is developing a set of low radiation, low cost, flat panel X-ray detectors that use novel photonics technology to make diagnosis safer for patients, hospital and dental staff. Coordinated in Germany by Siemens Healthineers, the project is made up of partners from Switzerland, Belgium, Netherlands, and Italy, including BASF Switzerland, Belgian microelectronics centre IMEC, Dutch research company TNO, Belgian chip designer ICsense NV, and Italian simulation specialist MorphwiZe. The consortium claims to have generated some of the highest resolution images ever seen in rapid moving body functions, such as malicious growths or the beating heart of a baby. With over 22 million X-rays being recorded in the NHS in England last year, they are a diagnostic test that most of us are familiar with. Scientists have often sought to reduce harmful ionizing radiation, the high-energy particles that penetrate tissue to reveal internal organs and bone structures that can damage DNA, Curved IGZO TFT backplane from single x-ray records or CT scans. Although this ionizing radiation can be reduced, traditionally it has come at the expense of the image resolution and type of detector. As a result of the two types of X-ray technology that exist today, diagnosis can only take the form of 3D view Active Pixel a high resolution image, seen with ‘Direct Converters’ that are used in mammography, or a low radiation dose, seen with ‘Indirect Converters’ that are used in radiography or fluoroscopy. Combining these advantages the DiCoMo, (or ‘Direct conversion hybrid-organic X-ray detectors on metal oxide backplane’) project is developing a new digital X-Ray detector capable of producing high-resolution images that, in the envisioned product, rival a 16 mega-pixel photograph. With lower radiation doses, and at a fraction of the cost, this bodes well for radiologists or dentists and for patients, particularly small children. Early last year, the DiCoMo consortium received funding of €3,277,034.75 from the Photonics Public Private Partnership, via the European Commission’s H2020 program for a three year research project in a Research and Innovation action. Current indirect detectors, which offer a lower dose of radiation, generate light in all directions as soon as an X-ray photon is absorbed in it, hitting a large number of pixels on the photodetector array and creating limited spatial resolution. Project coordinator Dr Sandro Tedde of Siemens Healthineers explains: ‘The result is like a blurred photograph, or ‘frosted’ bathroom glass, where light bounces off the surface at different angles. In indirect converters there is always a compromise between resolution and sensitivity. DiCoMo combines the advantages of both technologies by fusing radical innovations in the frontplane, the part of the device converting X-rays into electrical signals, and also the backplane, which stores and drives the signals from the pixels to the readout circuitry and digital image reconstruction. The fastest flat panel X-Ray detectors, with state of the art technology, deliver around 60 frames per second, whereas DiCoMo aims to double this by capturing at 130 fps, permitting a physician to examine vital organs not only in high resolution, but also moving images in slow motion.’ Hoping to have these revolutionary new x-ray detectors ready within 5 years, Tedde is excited about the implications for the future. www.med-techinnovation.com
We are there, when reliability is of top priority. Our innovative sensor solutions make medical devices even safer and more efficient.
www.first-sensor.com November/December 2016 : 21
Med-Tech Innovation Bioengineering
Second skin from BioDan Madrid-based BioDan is a bioengineering company that specialises in regenerative medicine. The company claims to have developed the only technology on the market that can produce 100% living human skin from a single biopsy. BioDan is set to close distribution agreements in the UK and UAE in the next 6-12 months. It currently works with a number of high-profile partners such as Praxis Pharmaceutical and Sanitas Internacional in order to increase its profile in the regenerative medicine industry. A 3D bio printer that can reproduce this living human skin on a more large-scale basis is being developed by the company and is expected to be completed later this year. The BioDan technology is set to have two main initial applications: • Autologous skin to treat and heal severe burns, wounds and ulcers • Allogenic skin for in vitro drug and product testing, eliminating the need for animal testing
Innovation with bone Evonik is conducting cutting-edge research into biodegradable high-strength composites. These materials could potentially replace metal in implants used for the internal fixation of fractured bones. Implants play a key role in supporting bones until they heal. Today’s metallic devices typically remain in the body for the rest of the patient’s life or require additional surgery for removal. The aim of the new research is that Evonik’s new materials will be absorbed by the body gradually, once the bone healing process has taken place. These materials consist of polymers and of substances that naturally occur in bones. The future possible benefits for patients are already clear. Patients will no longer need to undergo additional surgical procedures to remove the implanted devices. Specific device designs may also help
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bones regenerate faster. The project is one of a number currently being conducted at the Medical Devices Project House in Birmingham, Alabama, USA. There is a significant need for high-strength biodegradable materials in the US market. The number of implants required for the fixation of bone fractures is substantial: osteoporosis, for example, is responsible for 8.9 million fractures every year. Additionally, the 300 billion-euro global medical technology market is growing at around six percent annually. Medical device manufacturers currently use RESOMER® polymers, marketed by Evonik’s Health Care Business Line, to make bioabsorbable screws, pins and small plates. These are primarily used for torn ligaments in the knee or shoulder, and for fixation of smaller bones in fingers or the face. The aim of the new materials research is to take these principles further, into load-bearing bone structures. Further ahead, and with the right materials, the researchers could harness 3D printing to create made-tomeasure implants for individual patients. The long-term goal is to create polymeric scaffolds with living cells that could serve as a true biological implant. This approach, for example, would make it possible to regenerate cartilage. www.med-techinnovation.com
Med-Tech Innovation Engineering
Renishaw invests in Centre
Global precision engineering company Renishaw plc has opened a new Healthcare Centre of Excellence at its Miskin site, located close to Cardiff, South Wales.
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he Centre provides a facility for the manufacture of custom medical devices, as well as education and training for the life sciences community. Med-Tech Innovation magazine reports. The Renishaw Centre highlights the company’s continuing technology advances for the healthcare sector, including patient-specific implants, dentistry and neurosurgery. It contains a mock non-sterile operating theatre and facilities for education, training, workshops and lectures, and also a facility for the manufacture of class 3 custom medical devices produced on Renishaw metal additive manufacturing (3D printing) machines. A mock operating theatre suite is included within the Centre. It mimics a real-life hospital setting, but without the complication of a sterile environment. In the stateof-the-art suite, which is lead-lined to enable X-ray use, surgeons can be trained to perform highly complex stereotactic neurosurgery procedures using the Renishaw range of neurological products. Stereotactic neurosurgery is a technique used by neurosurgeons to locate surgical targets within the brain in a minimally invasive way. Surgeons would most commonly use this technique in procedures including deep brain stimulation (DBS), stereoelectroencephalography (SEEG) and biopsies. The manufacturing facility within the Healthcare Centre of Excellence produces custom medical devices under an ISO13485 quality management system. Here, Renishaw’s manufacturing knowledge combines with its latest metal additive manufacturing machines to enable the precision production of dental frameworks, craniomaxillofacial patient specific implants, jigs and guides. Renishaw’s metal 3D printing systems are also made at the Miskin site - the only such products made in the UK. The close proximity of Renishaw’s manufacturing operations to the Healthcare Centre of Excellence is seen as being highly beneficial for collaboration between engineers and healthcare professionals, as they work together on current and future healthcare challenges. A demonstration area within the Centre also showcases Renishaw’s full range of metrology and healthcare technologies, including Raman spectroscopy instruments, neurological products and therapies, dental scanners and frameworks, molecular diagnostics and additively manufactured implantable devices. The new Healthcare facility was formally opened on 29th September by The Rt Hon Carwyn Jones AM, First Minister of Wales, who also originally opened the Miskin site in October 2012. Of the new facility he said: ‘Today, what I have seen is truly astonishing; products with the potential for extending life and for improving life – for www.med-techinnovation.com
A view of the operating theatre within the new Centre
Renishaw is a member of the ADEPT programme – Additive-Manufacture for Design-led Efficient Patient Treatment (ADEPT). The three-year project will advance design and 3D printing in cranio-maxillofacial surgery in order to produce bespoke implants. It involves the collaboration of four UK partners and is funded by Innovate UK and the Engineering and Physical Sciences Research Council. ‘ADEPT aims to transform the patient specific cranial-maxillofacial implants market by overcoming the barriers of cost and efficiency in bespoke implants,” explained Bryan Austin, Director and General Manager of the Medical Dental Products Division at Renishaw and ADEPT Chairman. ‘The work is now in the latest stage of user trials and the collaboration of the four companies strengthens UK expertise in innovative manufacturing for craniomaxillofacial surgery.’
example, ensuring that people don’t have disfigurement for the rest of their lives. I’ve been incredibly surprised by what I’ve seen. It’s world beating innovation.’ He added, ‘I would like to thank the company for having faith in Wales, having faith in the Welsh workforce, but above all else, for developing, in partnership with others, many things that will improve the lives of so many people around the world in the future.’ Renishaw purchased the Miskin site from Robert Bosch Limited in September 2011, and it has now been fully refurbished. The 460,000 sq ft facility also includes the manufacture of metal components, electronic subassemblies and healthcare R&D activities. Sir David McMurtry, Renishaw’s Chairman and Chief Executive, noted, ‘When this site was formally opened I talked about our commitment to South Wales and the huge potential for the future. Four years on we have now invested over £40 million pounds at Miskin. The Healthcare Centre of Excellence is the latest example of that ongoing commitment. November/December 2016 : 23
Med-Tech Innovation MediCity Scotland
MediCity Scotland gains its first tennant Medical image analysis company OracleBio has become the first tenant to move into MediCity Scotland, a new medical technology incubator on the BioCity Scotland campus in Lanarkshire.
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he company, which was established in 2010 by former Merck & Co employees Dr Lorcan Sherry and Dr John Waller, currently employs a team of eight staff and has an international client base covering a number of top 10 ranked pharmaceutical companies. The business is now moving to MediCity from its current home in the BioCity life sciences incubator. Medicity Scotland is expected to enable the creation and growth of over 50 new healthcare businesses over the next 5 years, creating over 350 jobs as a result. Several further potential tenants and corporate partners are in the pipeline. It is housed within a fully refurbished, formerly vacant building on BioCity Scotland’s Newhouse site. Dr Lorcan Sherry, Chief Scientific Officer of OracleBio says that ‘we have experienced a significant upturn in the demand for our histopathology image analysis services from the pharmaceutical industry over the last two years, especially in the field of oncology clinical trials. We attribute this success to the combination of our expert image analysis capabilities and our pharmaceutical research background, which has resulted in increased and repeat business from our clients. Consequently, OracleBio has experienced substantial growth and we now require more office space to accommodate our current and future expansion. We chose MediCity not just for the excellent facilities present there but also to allow OracleBio the opportunity to work alongside and collaborate with other Scottish medical companies in what will be a highly innovative and scientifically-focused environment.’ BioCity Scotland received £1.012m of capital investment from Glasgow and Clyde Valley City Deal, with funding from the UK Department of Business Innovation and Skills, in order to establish MediCity Scotland, with additional funding from North Lanarkshire Council and Scottish Enterprise. MediCity will follow a similar clustering model to the one already successfully in action at BioCity Scotland. It will bring together entrepreneurs, clinicians, developers, innovators and investors in a supportive environment that will facilitate and accelerate opportunities. The partners will include 13 Scottish universities, NHS Scotland, and large and small companies. One of the benefits of clustering similar businesses together is that it 24 : November/December 2016
Dr Lorcan Sherry and Dr John Waller of OracleBio
leads to a higher survival rate – for example, businesses at BioCity Nottingham have a 91% survival rate. Dr Diane Harbison, Managing Director at BioCity Scotland said: ‘I’m delighted that Medicity’s first tenant company is one I already know very well, as they’ve been with us at BioCity Scotland since just after we opened in 2012. I hope that many more exciting companies will follow their lead. MediCity Scotland will replicate what has already been achieved on the highly successful MediCity Nottingham site and enhance what BioCity Scotland can already offer MedTech projects or early start-up companies. MediCity Scotland will also have the advantage of being included in Scotland’s fifth Enterprise Area, a status that was announced recently by the Scottish Government. Having Enterprise Area Status means that businesses based at MediCity Scotland will be able to take advantage of business rates relief, faster planning applications, skills support and assistance in accessing international markets.’ She adds that ‘these benefits all add up to MediCity Scotland being the ideal place for young and growing MedTech companies to base themselves in order to maximize their chances of success, take advantage of high-quality, newly refurbished facilities, and learn from a community of experts and peers.’ www.med-techinnovation.com
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Med-Tech Innovation Money for Med-Tech
Funds for high growth The combination of medical expertise and venture capital know-how is a potent one. Andrew Elder and Christoph Ruedig of Albion Ventures are leading the way.
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lder practiced as a surgeon for six years, specialising in neurosurgery, before joining the Boston Consulting Group (BCG) as a consultant in 2001. While at BCG he specialised in healthcare strategy, gaining experience with many global clients. Ruedig initially practiced as a radiologist before spending 3 years at Bain & Company. In 2006, he joined 3i, working for its Healthcare Venture Capital arm. Prior to Albion he worked for General Electric’s healthcare division, where he was responsible for mergers and acquisitions in the medical technology and healthcare IT sectors. Conversation with the two men reveals a scenario where many med-tech companies are increasingly choosing to look away from traditional bank lending to more alternative forms such as those offered via the venture capital route. One of the many benefits of the latter is a more dynamic approach and the hands on support offered by a team such as Elder and Ruedig. Experience and success breeds more of the same. Some of Albion’s investments have included Abcodia, Dysis Medical, Heamostatix, and Aridhia. For their part, Elder and Ruedig need to see clear and high growth and an evident exit strategy that allows Albion to realize its return on investment. ROI. The
Christoph Ruedig
Andrew Elder
attrition rate – the number of medical business ideas considered in relation to those green-lit – is high. A typical year might see 600-700 proposals and ideas cross the Albion desks, of which thirty might involve some detailed work and discussion and from which some five projects might go forward for actual investment. Albion also has its preferences and track record in med-tech to bear in mind; software, imaging and test kits to name but three. The guiding rule in all medtech business according to Elder is a clear one: ‘better medical outcomes at lower cost; including a proven ability to demonstrate the same.’ It seems clear that Big Data and Industry 4.0 methods will play a key part in catalysing the medicine of the future; patient-centric solutions that currently go by the name of Precision or Personal Medicine. Albion recognises the trend and is accordingly investing in a number of high growth and data-driven projects that will, no doubt, accelerate the process. Elder notes: ‘It takes a long time to develop a gold standard in medical products or procedures – fifteen to twenty years.’ The combination of Albion expertise and medical and computing advances seems likely to reduce that horizon significantly over the coming years.
Help for measurement Dr Gugs Lushai, CEO of Life Sciences Healthcare Ltd, reports that the UK Government’s new programme of funding for innovators is likely to be helpful and relevant to the med-tech industries. Analysis for Innovators, A4I, is a new £6.5 million funding programme that targets competitiveness and productivity head on, primarily by offering cutting edge R&D, expertise and facilities to UK companies that want to solve an analysis or measurement problem from within their existing business. This could be an issue of precision or accuracy of measurement on a production line for example, which companies have been unable to solve using standard technologies and techniques. Gugs says that ‘Innovate UK have some key technical partners involved in this programme - NPL, STFC, NEL & LGC. These run some of the most advanced cutting edge facilities, techniques and technologies in the world – available here in the UK.’ Innovate UK will make these measurement and 26 : November/December 2016
metrology resources available to successful applicants to A4I and expects the programme to particularly appeal to manufacturing companies, especially those involved in complex supply chains. And since this funding addresses real measurement issues in manufacturing, it will most likely be of interest to companies that previously didn’t consider applying for R&D funding. Any sized business with any type of measurement or analysis problem is able to apply. Analysis for Innovators opens January 2017, and Innovate UK are running a series of roadshow events around the UK prior to Christmas, to explain the programme and how it differs from other funding competitions, both in terms of scope and the application process and schedule. A4I will be run as a two-stage scheme. At the first stage, Innovate UK requires applicants to describe the problem: its nature, any techniques you have already tried and the value to your business of solving it. Funding applications open in January 2017.
Dr Gugs Lushai
www.med-techinnovation.com
Med-Tech Innovation Medical Equipment News
MIME for First Aid Newly incorporated MIME Technologies Ltd, is progressing towards making its innovative first aid support technology available for wide spread use. MIME, which stands for “Managing Information in Medical Emergencies” is technology specifically designed to support the first aider as the first person on-scene. To help these Highlands-based entrepreneurs reach their goal, they were supported by the British Red Cross who trialed their system at the BT Murrayfield Stadium on the opening weekend of the 2016 Six Nations Championship. MIME consists of proprietary intelligent software running on mobile devices that link with next-generation, non-invasive wireless medical sensors. The result is a lightweight wireless tool that enables the safe assessment and monitoring of a patient’s vital signs during a medical emergency. The company is a spin out from
the University of Aberdeen, with the technology originally developed through extensive research with specialist clinical input led by Professor Philip Wilson. MIME Technologies Ltd is based at the Centre for Health Sciences, Inverness. The company’s aim is to create a high growth MedTech company around lightweight, wireless platform technology that simplifies the capture, reporting and audit of medical emergency data. In 2015 the company was recognised in the top six of the Converge Challenge and the top ten of the Scottish EDGE Higgs Award. Before a full market launch, MIME Technologies decided to undertake a study to further explore MIME’s usability and usefulness in a real life situation. The new CEO for MIME Technologies, Dr Alasdair Mort, a digital health specialist, said that ‘thanks to the British Red Cross we’ve had a tremendously valuable opportunity to trial MIME in the field. MIME has been developed through collaboration with the Scottish Ambulance Service and the Digital Health & Care Institute specifically to address the problems that first aiders face and I’m delighted by the positive response we’ve received from the first aiders.
Expansion at Pelican Pelican Feminine Healthcare, part of the Eakin Group, has strengthened its position within the UK women’s health sector, thanks to investment in a new Axis AX-10 Series sterilisation unit. The investment of over £400,000 means Pelican Feminine Healthcare can now not only manufacture medical instruments on its site in Cardiff, but sterilise them as well, making it one of the few companies in the UK capable of doing so. The company, which focuses on single-use medical instruments for Gynaecology and Obstetrics, sees the new sterilisation unit as a key component in its growth and crucial to its vision of leading the UK women’s health sector. Richard Carter, Managing Director of Pelican Feminine Healthcare explains that ’having this capability enables us to provide a quicker response to our customers’ requirements and lowers the carbon footprint by eliminating the 450 mile round journey for sterilisation. It is also planned that the excess capacity of the chambers can be utilised by other Welsh companies assisting medical device business development within Wales.” The sterilisation unit uses Ethylene Oxide (EtO) to ensure products are 100 percent ready for medical www.med-techinnovation.com
use and can handle a much wider range of materials compared to steam and dry heat processes. This includes heat and non-heat resistant materials, rubber, metal, mechanical and electromechanical materials, surgical materials, and laboratory equipment. The sterilisation process takes some eight hours to complete. During this time the temperature is maintained at 54˚ C and the items are exposed to the EtO gas. The cabinet is constantly under negative pressure with the pressure commencing at -50Kpa and rising to -22Kpa when the gas has entered the chamber. The main beneficiaries of Pelican’s new capability will be the NHS throughout the UK, Universities, as well as some clients in Southern Ireland. The unit will see approximately 5.25 million medical instruments pass through it every year. November/December 2016 : 27
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Med-Tech Innovation Universities
Nottingham Trent Leads UK Innovation The Queen’s Anniversary Prize for Higher and Further Education was awarded to Nottingham Trent University in November 2015. It is the highest national honour for a UK university and recognises the institution’s world-class research. These research fruits are certainly being witnessed in the med-tech field.
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ne of the University’s researchers, for example, has recently pioneered a new way of 3D printing to help human bone tissue regenerate following major damage. Manolis Papastavrou, of Nottingham Trent University’s Design for Health and Wellbeing Research Group, is controlling the micro-structure of a bone scaffold. The research aims to improve the toughness of synthetic bone substitutes. This is one of the main requirements for patients who have lost a large volume of bone tissue, following, for instance, treatment for cancer or a catastrophic fracture. The bone scaffold – a 3D lattice – acts as a temporary bridge to allow the regeneration of natural tissue. It can be printed to the exact size and shape of an individual’s requirements based on medical imaging data and can be porous to allow for blood flow and cell growth.
www.med-techinnovation.com
The scaffold - which is made from the same minerals found in natural bone – is designed to be dissolved and replaced by new tissue as the patient recovers. ‘The secret behind the toughness of many biological materials is the way their components are arranged from the molecular all the way up to a macro level. Using this design strategy could help engineer bone scaffolds, whose porosity does not compromise their strength. In the long term, this research could contribute towards replacing the use of metal in orthopaedic implants with materials that can be broken down by the body.’ The University has also lately hosted research that could transform the smartphone into a medical device that is then able - hands free - to reduce botched injections by easily locating vein tissue in arms. The researchers say that their design is a low cost way to help clinicians with difficult injections, such as those on small children or people with a fear of needles. ‘Intravenous injections are one of the most routine, invasive medical procedures in the world, but it can be difficult to find and puncture a suitable vein,” said Professor Amin Al-Habaibeh, professor of intelligent engineering systems, who led the project. ‘Inserting a cannula, for instance, can be distressing and painful if multiple attempts have to be made before a needle is positioned correctly. Existing vein locators can be specialised and expensive. But this is a simple idea which has the potential to make a significant impact on the way injections are administered around the world. By providing clinicians with a simple, cost-effective way to use smartphones to highlight veins, we could save valuable time and money while also making things easier for patients.’ The design – which is patent pending – has been proved using a 3D-printed prototype which is fitted to the patient’s arm with a strap that also acts as a tourniquet. A simple modification to the smartphone camera is required by fitting the lens with a near infrared filter and adjusting the flash to the correct frequency. The modified smartphone is then inserted into the holder, allowing the clinician to see the veins without having to hold the phone steady. November/December 2016 : 29
Med-Tech Innovation Wearables
Wearable electronics Aspects of US-based med-tech, such as some wearable technology, have a clear global lead over the rest of the world. The need for good design software for flexible printed circuit boards (PCBs) is becoming ever more important
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ounded in 2008, MC10 develops wearable electronics that combine breakthrough technology with state-of-the-art engineering. The company is dedicated to extending insight into human activity through gathering complex physiological data with electronics that are virtually invisible and wearable. Its technology platform combines conventional electronics and novel mechanics to enable a new generation of thin, orthomorphic electronic systems that can stretch, bend and twist seamlessly with the human body. BioStampRC plays a key part in the MC10 portfolio. It is a wearable sensor patch that can be placed anywhere on the human body in order to gather data and insights into physical issues, such as muscular disease. As an electronics pioneer across a wide range of new digital health, consumer and medical applications,
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MC10 needed to find an advanced PCB design software solution that would allow the company to push the boundaries of traditional electronic design. Most electronic systems that power digital life are flat and inflexible, and designed for use in rigid devices, such as computers and other electronics — not on a constantly moving and flexing object like the human body. The prize for successful wearable med-tech is large – the market is estimated to be some 37 billion dollars by 2020. PCB design tools are therefore required that harness flex circuit design and provides the ability to create and use non-standard shaped boards. Boards designed for the BioStampRC are small and dense, with a lot of board cut-outs, odd geometry and strangely shaped polygons with very accurate radiuses. Often on a 3-5 cm board there would be up to 300 custom-drawn polygons. In addition, once such a non-standard design is completed, it has to be easily shared across multiple contract manufacturers (CM) to be able to get the best quotes without compromising production time and quality. Therefore, the design package has to include smooth and precise design, be portable and manufacturable to lower production risk and speed up the time-to-market. Having previously used Altium Designer, MC10’s design engineers were comfortable with the unified environment, where they wouldn’t have to leave the application in order to manage components or documentation. The Altium ‘all-in-one’ business model made it easy to add and maintain additional licenses. Altium Designer also included additional features intended to ease the flex design challenges. A favourite feature used in the BioStampRC designs is the teardrop element. It ensures precision in placement, and that all lines have smooth and fluid curves. Altium Designer allows the precise placement of teardrops in order to avoid misalignments that can lead to lower production yield. Altium Designer allows the user to modify and edit multiple custom polygons with its various polygon tools. With such tools, designers are able to save time in the redrawing of polygons. If something is incorrect the designer can edit the existing polygon, tweaking it to ensure the fit is correct. Altium also offers a PCB Layer Stack Management system. By joining rigid sections of PCBs together via flexible sections, it is possible to design complex, hybrid PCBs that can be folded to fit into unusually shaped enclosures. www.med-techinnovation.com
Med-Tech Innovation Diabetes
Big Data for Diabetes The two-day CPD accredited conference and exhibition Diabetes Professional Care, at London Olympia on 17th November played host to Arjun Panesar, CEO of the UK’s biggest and fastest growing diabetes patient forum, www.diabetes.co.uk.
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anesar is the co-founder and CEO of Diabetes. co.uk and has a background in Artificial Intelligence and a decade of experience with intelligent systems and big data. With diabetes-related healthcare costs on an unsustainable trajectory, digital health and the use of big data has emerged to enable evidence-based approaches that are dramatically more cost-effective and precise. Panesar’s presentation included: • Understanding the current application of big data in healthcare • Understanding the application of evidence-based medicine within diabetes • Understanding how genomics and evidence-based medicine can be combined to deliver precision medicine for patients The session also included a showcase of the free 10week Low Carb Program which has had over 164,000 downloads since its launch on World Diabetes Day in November 2015. Designed to be a healthy sustainable lifestyle intervention that is experience-led, rather than a quick fix ‘diet’, the Low Carb initiative www.diabetes. co.uk/lowcarb takes people through the theory and also provides the practical application on how to implement a low carb lifestyle. The forum provided a place where people were able to openly share their experiences or discuss low carb lifestyles. The diet currently sits outside of NICE guidelines. However, there is now growing medical evidence that type 2 diabetes can be reversed through diet and lifestyle changes.
The educational conference includes keynote presentations from NHS England and The Diabetes Think Tank and will see diabetes experts and healthcare professionals share insights across an array of critical subjects. Jonathan Valabhji, National Clinical Director for Obesity & Diabetes at NHS England, and Dr Partha Kar, Associate National Clinical Director for Diabetes at NHS England, took to the stage together to present the show’s first keynote session. Valabhji discussed ‘Diabetes and the NHS in England in November 2016’, and Kar concluded by looking at ‘The art of the possible’.
Dexcom in Scotland Dexcom, a leader in continuous glucose monitoring (CGM) systems for patients with diabetes, has opened its EMEA HQ in Edinburgh, Scotland, creating over 60 new jobs for the region within the next three years. The office was officially inaugurated by Keith Brown (left) MSP, Cabinet Secretary for the Economy, Jobs and Fair Work, on November 14th – World Diabetes Day – and John Lister, General Manager , EMEA of Dexcom. It will support various Dexcom business functions for Europe, the MiddleEast and Africa. This move will give patients across the EMEA regions access to Dexcom’s technology, which includes a CGM sensors that wirelessly transfers realtime glucose levels every five minutes to mobile applications via Bluetooth. The company’s latest offering, the Dexcom G5 Mobile CGM System is the world’s first mobile CGM system. The new premises, based in Tanfield, enjoy the support of Scottish Enterprise.
www.med-techinnovation.com
November/December 2016 : 31
Med-Tech Innovation Med-Tech 4.0
Automation and Enforcement for the Med-Tech industry Med-Tech Innovation is committed to tracking future manufacturing methods and systems as evidenced by developments such as Industry 4.0. Here Pat McLoughlin, Seabrook Technology Group’s PLM Consultant, reviews current practice with an eye to likely emerging scenarios.
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edical device manufacturers and regulatory authorities continue to put improved patient safety and patient outcomes on top of their list of priorities. In order to deliver on these objectives, medical device manufacturers strive to maintain and improve quality performance for existing product lines and to also develop new product lines that can improve patient outcomes. Along with this heightened emphasis on improved product performance, there are a number of external changes also taking place, which also require medical device manufacturers to advance their manufacturing systems. Along with the recent updates to the European Medical Device Regulations, ISO 13485. 2016, we now have the latest revolution, Industry 4.0, in which increasingly advanced technology is used, resulting in Smart Manufacturing. This is the key trigger and facilitator for companies to transform their existing operations in order to meet the demands sought by external changes. The current manufacturing climate is ripe for most manufacturers to look at their systems’ maturity and to then put the necessary plans in place to bring this to capability maturity model Level 4 and on to Level 5. In this era of change, what should we be aiming for? This can be discussed under two headings, product development and manufacturing. Product Development Regulations require the existence of records to capture how a device is developed, known as the Design History File (DHF) and how it is to be manufactured, which is Device Master Record (DMF). 32 : November/December 2016
A properly implemented Product Lifecycle Management system should be able to ensure that all activities carried out at the product development stage or during Engineering Changes are captured. It should also ensure that all required quality documents exist, are in the right place and are in the correct state for their stage in the process. The system must be able to automatically produce the Technical File or country specific documentation. The project lifecycle management (PLM) tool should also demonstrate the management of suppliers, Corrective Action Preventive Action (CAPA) and post market surveillance. Manufacturing PLM and Manufacturing Operations Management (MOM) systems lie at the heart of Smart Manufacturing. A MOM system will enforce compliance all the way through the manufacturing process, with the materials, personnel and equipment used, taking in inspection, Unique Device Identifier (UDI) and packaging. At the end of the process, the MOM system will automatically create an electronic DHR (automatic Device History Record). The MOM system can continuously collect manufacturing, equipment and inspection data at appropriate points through the process. This data can be consumed through dashboards and displays to help managers, supervisors and operators understand how the process is performing against a range of targets. Many organisations are now analysing this data in realtime and using the information to react to trends that can prevent a number of issues occurring, including product quality problems, equipment problems and operator fatigue . At the Seabrook Technology Group it is our believe that the requirement to change also brings the opportunity to change. The right PLM and MOM tools will enforce and capture compliance. This will allow medical device manufacturers to concentrate on designing and building the highest quality products that will improve the lives of patients and ultimately secure the future of their business. www.med-techinnovation.com
Med-Tech Innovation Hospitals
Customised for Kings Leicestershire based Bennett Engineering Design Solutions has successfully developed a bespoke 3D printed Cardioplegia clamp for London-based King’s College Hospital Foundation Trust, one of the UK’s largest teaching hospitals.
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ennett Engineering Design Solutions was approached by the head of clinical perfusion science for the Trust, Michael Whitehorne, to help develop a bespoke solution to support the use of Cardioplegia Sets in its operating theatres. The Trust had been pleased with the quality of a pressure gauge holder developed previously by the design team and wanted a clamp based on similar principles. John Bennett, director, Bennett Engineering Design Solutions, says, ‘The clamps that were available at the time for holding the Cardioplegia Set’s heat exchangers – which cool down the patient’s blood during cardiac surgery – were no longer meeting the Trust’s requirements. The clamps simply didn’t secure the heat exchangers well enough; they could also be sometimes slow and difficult to use.’ The Trust needed a solution that would attach easily to standard masts and instrument stands, quickly changeable in an emergency. The unit needed to be easy to clean, suitable for sterilization and adjustable through 360°. ‘The challenge with the design,’ says Bennett, ‘was to create the right geometry to satisfy the Trust’s requirements. Our initial prototype needed to be improved to make the changeover quicker. Adjusting the geometry of the catch took two iterations. We also needed to minimise the number of parts required, to ensure ease of use, whilst being aesthetically pleasing too. The clamp for example features an over-centre clip finger for the attachment, so the removal of the heat exchanger is simple and intuitive to use. We chose to develop our design using 3D printing
John Bennett
as we believed it offered greater flexibility on the design geometry, enabling us to create more organic shapes. This was then followed by the use of the material Alumide, to deliver a tough, highly professional ‘look and feel’ to the end product.’ Alumide is a composite of nylon and grey aluminium powder. It provides both lightness and strength, is cost effective to print, and can be sealed for cleaning and sterilisation – ideal therefore for certain types of medical equipment. The completed design used standard components along with 3D printed parts to achieve a simple and cost effective solution. By adopting 3D printing, complicated geometry and shapes could be included at no extra cost, allowing the design team far greater design freedom to deliver improved aesthetics. No manufacturing tools were required, which helped to ease this critical design update and change of parts during the product development process. This took just eight weeks to complete and has been in use by the Trust since the middle of this year. It also benefits from a bespoke design solution, rather than the generic clamps produced in high volume by heat exchanger manufacturers. The Cardioplegia clamp, although a bespoke design, can also be adapted for use in any operating theatre by the expert team at Bennett Engineering Design Solutions.
Prosthetics automatically The use of the Intertronics Thinky ARE-250 non-contact planetary mixer has transformed the production of medical prosthetic devices at University Hospital Coventry. The Thinky process, by means of both rotation and revolution of the material, mixes and degasses at the same time. The constituents are simply measured into a container, which goes straight into the machine, saving time whilst reducing material waste and clean-ups. Originally, mixing at the hospital was carried out by hand using a palette knife in two stages www.med-techinnovation.com
– mixing and then flattening on a flat glass plate to squeeze out the air. This was arduous, especially for larger quantities required for hands, breasts, facial and other components. Jim Dimond, Consultant Clinical Maxillofacial Prosthetist says, ‘I have been doing this work for about 12 years and for the past 12 months have used the Thinky a great deal. It has allowed us to quickly produce homogenous silicone in large quantities that is free of air, transforming a time-consuming physical task into an automated effortless one.’ November/December 2016 : 33
Med-Tech Innovation Finance
Diagnostic firm benefits from
R&D tax assistance The total number of R&D tax credits claims made by UK SMEs rose from 13,140 in 2014 to 16,160 this year, an approximate 23% increase. There was also an increase in the total level of qualifying expenditure; £14.3 billion this year, an increase of 7% over last year.
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IT looks at the recent experience of Lein AD, bringing measurement and diagnostic devices for diabetes to the healthcare and industrial markets. Forecasting significant investment in R&D in the continued development and adaptation of its technology, the company identified an opportunity to make savings by applying to HM Revenue & Customs (HMRC) R&D Tax Credit scheme, which provides tax relief on qualifying expenditure to incentivise businesses to innovate and develop. Lein AD’s technology, which has applications in metrology, pharmacokinetics and diabetes care, is based around a scanning confocal technique that miniaturises the engineering normally seen within a conventional confocal microscope. This has been achieved by combining the source, detector and pinhole assembly into a single compact device. As its CEO Dan Daly explains, ’One of the most significant benefits of the technology in diabetes diagnosis is that it gives us the opportunity to measure blood sugar levels by holding a device such as a mobile phone up to the eye. The aqueous humour in the eye is a far more optically accessible fluid than blood, which requires penetration
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of the skin to reach, meaning our solution is completely non-invasive and is aimed at increasing the comfort and ease by which glucose readings can be taken.’ R&D tax credits’ policy intent is to encourage investment in development and innovation by addressing scientific and technical uncertainties, a number of which Lein AD was required to confront in developing its technology. The funding structure for Lein’s R&D projects was multi-layered and complex, which had several implications when it came to making an R&D tax credit claim. It relied upon a mixture of internal funding, external venture capital funding, as well as grant funding – including two Technology Strategy Board (now Innovate UK) grants. This was significant because the presence of notified state aid has a bearing upon SME scheme eligibility and, therefore, the amount of relief available. R&D tax credits are classified as state aid in themselves, meaning if even a penny of state aid is received in the form of a grant qualifying for R&D costs, that company is automatically excluded, subject to certain exceptions, from claiming under the SME scheme. It can then only claim under the less generous Large Company Scheme for all project costs affected by that aid. To take a simplistic working example, a profitable SME spending £250,000 on qualifying R&D could receive up to £65,000 in R&D tax relief. If that company had accepted notified state aid, the claim could be reduced to as little as £15,000. This presented Lein with the dilemma of whether to accept state aid in future, knowing that the monetary value of a future R&D claim might be greater than the total amount received through grants. Lein therefore sought the expertise of tax credit consultancy ForrestBrown For Lein AD, the value of the scheme was in providing an additional revenue stream to allow it to further its research into technology and patents. Dan Daly says; ‚For us, the scheme is a virtuous circle: it allows us to invest more in R&D, benefit from the subsequent tax credit claim, and so the process goes on. Having ForrestBrown on board as experts opened our eyes to the potential of being able to make a claim against a far broader range of activities and expenditure. www.med-techinnovation.com
Med-Tech Innovation MedTech Accelerator
HEE leads £1.5m fund for med-tech concepts Health Enterprise East (HEE) has helped to launch the Medtech Accelerator, a new proof of concept financial awards scheme to progress medical technology and software innovations developed primarily from within the NHS.
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ith awards on offer between £15K and £125K, this new joint venture brings together the NHS, local authority and local business. The Medtech Accelerator will support and finance development projects at an early stage in order to maximise the potential for success in bringing new lifeenhancing technologies to patients. Awards are available to NHS organisations, with a total of £1.5 million on offer for innovations that show the greatest promise, including the potential to create future spin-out companies. Awards are aimed at supporting proof-of-concept work which typically includes market research, product and market validation, prototype development and testing, and IP protection. Led by Health Enterprise East (HEE), a leading NHS innovation hub, the initiative includes New Anglia Capital Ltd, a subsidiary of New Anglia Local Enterprise Partnerships (LEP), Greater Cambridge & Greater Peterborough (GCGP) LEP, and the Eastern AHSN. LEPs and Eastern AHSN have each invested £500K and will have access to HEE’s expertise in proof of concept and technology transfer and to its existing pipeline of NHS technologies through its membership base, including internationally renowned centres of healthcare research and innovation. Health Enterprise East (HEE) is a leading NHS innovation hub committed to improving healthcare through the provision of professional business and innovation management services. The HEE team works with NHS organisations nationally and Med Tech companies globally, in order to support the development of innovative products and services which meet currently unmet healthcare needs. HEE is closely affiliated with founding member Papworth Hospital NHS Foundation Trust and ensures that pioneering innovations from staff across the NHS are identified, developed and commercialised for the benefit of patients, staff and society. HEE has already successfully commercialised two of its portfolio companies; Northwood Medical Innovation Ltd, a spin-out from West Hertfordshire Hospitals, was bought in December 2015 for its novel treatment for prominent ears by the global pharmaceutical company Allergan. Ablatus Therapeutics was spun-out of Norfolk & 36 : November/December 2016
Dr Anne Blackwood, Chief Executive at HEE
Norwich University Hospitals NHS Foundation Trust in July 2016 in order to commercialise its pioneering cancer treatment. Dr Anne Blackwood, Chief Executive at HEE says: ‘The Medtech Accelerator is the first scheme of its kind that brings together local authority, business and the NHS across a specific geography in order to invest in MedTech. There is a current lack of funding for early stage proofof-principle work and together we have the opportunity to not only help patients but also bring economic growth to the region in the form of jobs, revenues and the scope to leverage additional investment.’ Chris Dashper, Head of Programmes at New Anglia LEP, says: ‘We are delighted to be involved in this project, which links technology and software innovations from the NHS to the private sector. Making funding available at an early stage through projects like the Medtech Accelerator is very important, as it sets up projects well, so they are able to benefit from additional private sector support in the future.” Neil Darwin, Chief Executive of the GCGP LEP, said: ‘New ideas define the future of Medtech, and we know that some of these projects can be held back by a lack of early stage funding. By investing in the new Medtech Accelerator we can help to support the development of these technology and software solutions to fast track their success and application.’ www.medtechaccelerator.co.uk www.med-techinnovation.com
NEC BIRMINGHAM, UK | 26-28 SEPTEMBER 2017
INJECTION MOULDING
EXTRUSION
ROTATIONAL MOULDING
BLOW MOULDING
RECYCLING
THERMOFORMING
M AT E R I A L S
VAC U UM FO R M I N G
DESIGN
FILM EXTRUSION
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80084 Check Valve FLL Inlet, MLL Outlet
80036 In-Line Flow Indicator, Barbed
79004 Dual Check Valve, High Pressure MLL Outlet with Swivel Nut FLL Inlet, FLL Control Port
91014 High Flow Check Valve Barbed
80369 Tuohy Borst Adapter MLL with Spin Lock 11083 Adjustable Pressure High Flow Check Valve
80330 Tuohy Borst Adapter MLL
33057 One Handed Hemostasis Valve Y Connector Rotating MLL FLL Sideport
D002501 Pressure Relief T Valve
97337 In-Line Flow Control Switch FLL Inlet, MLL Outlet
80065 Duckbill Check Valve FLL Inlet, MLL Outlet
22827 Tuohy Borst Adapter Large Diameter 80407 Tuohy Borst Adapter MLL Connector
80185 Check Valve Normally Closed FLL Inlet, MLL Outlet
80114 Luer Activated Valve FLL, MLL 11741 Twist/Pull Drain Valve
80373 Double Hemostasis Valve Y Connector Rotating MLL FLL Sideport
90404 Closed MLL to Barbed Valve Connector
80354 Tuohy Borst Adapter FLL Cap
80187 Dual Check Valve MLL Outlet FLS Inlet FLL Control Port
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80329 One Handed Hemostasis Valve Y Connector 80191 Rotating MLL Swabbable Pre-Slit FLL Sideport Transfer Valve
2002-Q Orville Drive North, Ronkonkoma, NY 11779
+1 631-242-3000
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8/30/2016 4:30:39 PM
Latest Valve Additions
80505 Check Valve FLL, Barbed
80192 In-Line Duckbill Check Valve
80507 Check Valve Barbed, MLL
80462 Hemostasis Valve Y Connector MLS, FLL Sideport
80303 Hemostasis Valve Y Connector Rotating MLL FLL Sideport
80503 Check Valve Barbed
80300 Hemostasis Valve Y Connector MLS, FLL Sideport 80464 Tuohy Borst Adapter ML Connector with Spin Lock
80460 Tuohy Borst Adapter Swivel MLL FLL Sideport
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8/30/2016 4:34:24 PM
Barbed Check Valves
• Feature a low, 0.087 psi cracking pressure • Ideal for infusion, drainage and irrigation applications • Provide controlled directional flow • Eliminate the need for bonding
Request your Free Samples Today! 2002-Q Orville Drive North, Ronkonkoma, NY 11779
+1 631-242-3000
qosina.com
M1614--MedTechInnovations_210x297mmBackCover.indd 2
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8/30/2016 4:31:45 PM