MTI Issue 48 by Med-Tech Innovation Magazine

www.med-technews.com Issue 48 | May/June 2020

@medtechonline

PLUS

Tubing Sustainability in medtech Digital health

MED-TECH INNOVATION | NEWS MED-TECH

innovation

LOOKING TO THE FUTURE Vision Engineering on the rise of eyepiece-less stereo microscopes

ADVANCING HEALTHCARE

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CONTENTS regulars

15.

Ian Bolland speaks to Joe Rowan, Junkosha

COMMENT making medtech

The latest industry news

medilink uk

News from the organisation

10.

in focus

Funding awarded to Imperial College London

11.

opinion

From Wilmington Healthcare

12.

cover story

Vision Engineering on the rise of eyepiece-less stereo microscopes

18.

digital health age

Ascensia Diabetes Care looks at diabetes care and healthtech

26.

in practise

THE TEAM

features

THE CIRCLE LINE

MED-TECH INNOVATION | NEWS

16.

GOING WITH THE FLOW

Dr Tracy Brown, TÜV SÜD National Engineering Laboratory outlines the role of microfluidics in healthcare

20.

SUSTAINABILITY AND LIFE SCIENCES Ian Bolland chats to Dassault Systemes

22.

PUT TO THE TEST ZwickRoell on catheter testing challenges

24.

Manufacturing trends and Industry 4.0

25.

SLEEP EASY

Reece Armstrong reviews a neurostimulation headset that targets better sleep

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from The editor

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We need to look to healthtech to protect the vulnerable

e talk a lot about the role of digital tech in healthcare – its ability to speed up diagnosis, manage conditions and improve both patient care and the way in which healthcare professionals connect with patients, for example. In these testing times, it is also becoming apparent that the role of digital has an increasingly important part to play in the way we continue to care for the elderly population. Despite lockdown easing measures, the threat from coronavirus is far from over, particularly for more vulnerable sections of society. As the younger population and those with no underlying health conditions start to move back into a pre-Covid 19 existence, however that may look, it’s important we look to ways to keep the elderly and vulnerable connected, safe and involved. Digital technology is the obvious way to achieve this. There are all manner of solutions making their way to market

- some will be better suited to individual needs than others. The Essence Group for example, offers connected smart devices for elderly care, medical settings, and home security, and claims to have formed a core part of governmental and private efforts around the world to safeguard the health of seniors whilst allowing them to live as independently as possible during Covid-19. The company’s telecare solution, Essence SmartCare, has been adapted to support seniors in lockdown by providing a non-obtrusive, 24/7 care system. AI and voice-based remote monitoring solutions means carers and loved ones know their relatives remain connected and safe. A favourite company of mine is Spirit Digital, part of the Spirit Health Group. The business is continually innovating, which I love. Following NHS England and NHS Improvement Guidance calling for steps to implement a clinical service model for care home support during Covid-19, remote monitoring has been highlighted as vital to this process. Spirit Digital’s CliniTouch Vie is a digital, remote monitoring platform is designed to connect care homes, carers and nurses with their patients’ GPs. Carers can check patients’ vital signs and answer

health questions via a tablet, as frequently as needed. GPs can then connect remotely with carers and patients to provide health and wellbeing advice and intervene where and when more urgent care is needed. It’s exactly the sort innovation that’s needed at the moment and underlines the pivotal role that digital technology has in this section of our community. It is of course, just one way that digital technology can provide huge benefit to the healthcare system but one which is highly relevant given the pandemic and how we address health and care going forward. On a separate note, this is my last issue of MTI. I’m off to a new exciting venture. It’s been great working in this industry and getting to know all of the innovative and forwardthinking companies. At a time when so many sectors are suffering, medtech and heathtech are still showing promise, innovation and that they have a key role in the future success of the UK and Irish economies. Keep up the great work!

ON A SEPARATE NOTE, THIS IS MY LAST ISSUE OF MTI

Making medtech

Imaging tech delivers cancer scan results faster

Ross Hunter has turned his expertise to help those suffering with coronavirus as part of the CoVent-19 Challenge

atients undergoing CT colonography scans are being quickly notified if they do or do not have bowel cancer, following the implementation of imaging technology that has given staff at University Hospitals of North Midlands NHS Trust the opportunity to redesign pathways. The trust first went live with its picture archiving and communication system (PACS) from Sectra in 2017– providing healthcare professionals with faster access to imaging. Radiologists have found the imaging technology has freed up their time. Referring clinicians are notified on the same day as the patient’s CTC scan if their patients test positive for bowel cancer. Dr Ingrid Britton, consultant gastrointestinal radiologist, at University Hospitals of North Midlands NHS Trust, said: “We can now identify patients with colorectal cancer whilst they are still on the scanner. “Now, when radiographers see something during the scan, they alert the imaging team immediately, and using a simultaneous viewing feature in our PACS, radiologists can immediately look at the imaging from their own location and report as the image is generated, before notifying the referring clinician the same day when a patient is positive.”

Scottish engineer only uk finalist in global challenge to invent new ventilator

Scottish design engineer, who is also chief executive of a family business manufacturing outdoor living pods and garden offices, is the only UK finalist in a global challenge to invent a new ventilator to help Covid-19 sufferers. Ross Hunter, chief executive

of Armadilla, has turned his expertise to help those suffering with coronavirus as part of the CoVent-19 Challenge by designing his CORE Vent prototype. He is one of just seven finalists from more than 200 entries from over 40 countries - and the only one shortlisted to be

based outside north or south America - in the eight-week challenge judged by a global panel of experts. He was the only individual entrant to reach the finals and is up against teams from such places as Stanford University. CoVent-19 is described as an open innovation grand challenge for engineers, innovators, designers and makers. The Innovate2Ventilate brief was to develop low-cost, readily deployable mechanical ventilators for use, not only in first world countries, but also developing countries. If Hunter with his newlyformed Team Armadilla - which will comprise a small group of design and manufacturing experts employed at his firm - wins the competition, the prototype will be made by partners to help Covid-19 sufferers in any part of the world. Once manufactured, his CORE Vent product would be available for a fraction of the cost of current ventilators. CORE Vent takes an alternative approach to a traditional ‘bellow’ ventilator system and would not use existing component supplies, so it would not draw on limited

Covaflu respirator mask production increasing to meet demand

linova, the British consumer healthcare company, has increased Covaflu production to 96 million respirators annually following a surge in demand from local councils, emergency services and NHS trusts across the UK, as the UK government recommends masks in enclosed spaces. FFP2 masks create a protective barrier between front-line employees and the COVID-19 virus. Clinova has also received orders for the Covaflu FFP2 respirators from UK-based companies as they plan for post-lockdown working to avoid

the spread of the virus. Covaflu respirator masks were first launched by Clinova in the UK in 2007, proving essential during the previous swine flu and avian flu pandemics. They were the first product designed by Clinova’s founders when the company launched, based on the statistical probability that a viral pandemic was a ‘when’ and not an ‘if’. Clinova’s chief medical officer and general practitioner, Dr Tom Bracewell, said: “PPE is essential for our front-line workers to access during this pandemic. It’s also great that, as a UK-based business, we can play a part in helping

the country cope with this pandemic and also help boost the local economy. We feel proud to think that we are helping to protect firemen, paramedics, doctors, nurses, the police and the public. “As a healthcare company, we have been doing everything we can to help the country get through COVID-19, as we have also added a Pandemic Flu section in our Caidr app with detailed information on the signs and symptoms of COVID-19.”

Making medtech

resources. It uses a novel concept to maintain positive end-expiratory pressure (PEEP) through a single, simplified system. It could also be supplied in ‘kit form’ where all the essential components come in a box to be assembled at a facility close to end use. Hunter is now working on the next stage of the challenge to refine the ventilator and submit working prototypes by 21 June, with the winning design being announced shortly after that date. The CoVent-19 Challenge has strategic partnerships with manufacturers, global health NGOs, government agencies and healthcare systems. It will work with the challenge champion to transfer the open source design to a partner manufacturer for production Hunter said: “When I heard about the CoVent-19 Challenge I decided I had to enter to try to help the growing number of Covid-19 sufferers across the world. The pandemic is having devastating effects on people and communities everywhere and one of the best ways to treat sufferers is by ensuing there are enough effective and affordable ventilators available, especially in developing countries that don’t have many resources. Just because we in the UK seem to be getting on top of COVID-19 we mustn’t forget the less fortunate.”

The UK government recommends masks in enclosed space

MED-TECH INNOVATION EXPO RESCHEDULED FOR JUNE 2021

riginally re-scheduled for 29 – 30 September 2020, the event will now take place from 29 – 30 June 2021. The venue for the event, the NEC, Birmingham, UK is unchanged. The decision to postpone the event comes as a result of the global coronavirus pandemic. Duncan Wood, CEO of Rapid News Group, said: “Clearly uncertainties around large gatherings and public events are still very much at the forefront of everyone’s minds. By rescheduling Med-Tech Innovation Expo to 2021 we are first and foremost ensuring the safety of our exhibitors and attendees whilst also striving to preserve the success of the event and the return on investment that our exhibitors deserve.

“We are grateful to the NEC for working alongside us to identify a dateline which we believe will work for the great majority of our exhibitors and I must also recognise the support of our key associations who have been steadfast in their support. “We will continue in earnest with our preparations for the show to ensure it returns in 2021 bigger and better and with renewed vigour as the market recovers from the challenges and difficulties presented by the current climate.” Visitors to the show in 2021 can look forward to a comprehensive conference programme delivered across three stages, each dedicated to enhancing a visit through

the imparting of knowledge, insight and learning. There will also be a host of interactive features, pavilions and networking events including a meetings programme and learning seminars. Med-Tech Innovation Expo will be co-located alongside Rapid News Group’s other successful industrial events: Interplas, The UK’s No.1 Plastics show; and TCT 3Sixty, the UK’s event for 3D Printing & Additive Intelligence. MED-TECH INNOVATION EXPO 2021 WILL TAKE PLACE FROM 29 – 30 JUNE 2021 IN HALL 2 OF THE NATIONAL EXHIBITION CENTRE (NEC), BIRMINGHAM, UK.

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MEDILINK UK

PARTNERSHIP INNOVATES FOR KNEE CONDITIONS

lobal medical device company Apos Medical Assets, and market access consultancy Spirit Access, are partnering to help CCGs and NHS Trusts improve health outcomes with an innovative treatment for patients with chronic knee conditions. There is a pressing need to make the NHS Pathway for chronic knee conditions more efficient. The number of total knee replacements

in the UK has risen significantly over the last 15 years. In 2016/17 the UK National Joint Registry recorded 108,713 knee replacements, an increase of 3.8% over the previous year. The AposTherapy treatment programme can postpone, and even prevent knee replacement surgeries. During the initial year of AposTherapy treatment, 87% of patients avoid surgery. As a result of the

avoided surgeries, one mid-size CCG achieved an estimated savings of £3,330 per patient. In addition to saving costs by reducing the number of knee replacement surgeries, AposTherapy may save additional costs by reducing the amount of musculoskeletal, outpatient visits, radiology, injections and opioid use. Cliff Bleustein, global president and CEO of Apos Medical Assets,

said: “There is a growing need for a clinically proven non-surgical knee pain treatment which can benefit CCGs economically while benefiting patients clinically. We recognise

the need for greater market access in the UK and are excited to be working with Spirit Access in order to make AposTherapy® available to the population through more CCGs.”

Changes at Medical Technologies Innovation Facility

ottinghambased Medical Technologies Innovation Facility (MTIF) has made three appointments to its leadership team. Jacqui Hayes joins with over 30 years’ experience in medical technology and pharmaceutical business development. Hayes will develop MTIF’s commercial offering enabling organisations to accelerate the exploitation of innovative technologies to improve patient outcomes. She was most recently global business development and licensing manager within 3M’s Drug Delivery Division. Max Bardwell is moving from Nottingham Trent University to MTIF as senior business development manager. He will develop

MTIF’s commercial and partnership offer building on his extensive experience of commercialising academic capability for the benefit of industry. Robert Reisel will take up position as technical director from Paul Hartmann in Germany. He has led large, complex, multi-disciplinary projects taking innovative Class I, Class II and Class III products from concept through to launch. Mike Hannay, managing director, MTIF, said “I am thrilled that three such highly talented individuals are joining MTIF. All three will play a pivotal role in driving the MTIF’s future growth and come to us with an impressive track record of delivering sustained growth and market success in each of their previous roles. I look forward to working with Jacqui, Max and Robert to accelerate the development of innovative medical technologies from bench to bedside for the benefit of patients and clinicians.”

SPIRIT HEALTHCARE OFFERS DIGITAL REMOTE MONITORING SUPPORT DURING COVID-19

eicestershire Partnership NHS Trust has increased the number of vulnerable patients across Leicestershire being monitored at home, as local hospital bed capacity is being increased for COVID-19 patients. Patients who are being cared for by the Trust’s community respiratory and heart failure teams, and those who have been discharged from hospital earlier than usual as a result of the pandemic, are being supported by Spirit Digital’s remote monitoring platform CliniTouch Vie. Using CliniTouch Vie,

up to 1,000 patients in and around Leicester will take regular vital signs readings and answer personalised health questions on a smartphone, tablet or computer. These readings are provided directly to specialist clinical staff who can then remotely connect with patients to provide health and wellbeing advice and intervene where and when more urgent care is needed. Professor Sudip Ghosh, clinical director for research and specialist services, Leicestershire Partnership NHS Trust,

commented: “Maximising resource while providing the best possible levels of clinical care for our vulnerable patients is vital at this current time. Digital technology to enhance care is the key to remotely connecting clinical staff with the most at-risk patients and delivering care to them whilst they are in the safety of their own homes. We are delighted to have partnered with Spirit Digital once again to provide this service. The team has worked around the clock in the last few weeks to rapidly expedite the delivery of their latest platform to support us.”

IN FOCUS

IMPERIAL COLLEGE LONDON lands funding for COVID-19 test

A team led by Imperial College London will receive over €500,000 from EIT Health as part of a COVID-19 ‘Rapid Response’ drive from the EU network.

he team at Imperial, alongside partners from Imperial College Healthcare NHS Trust, the London School of Hygiene and Tropical Medicine and Abingdon Health, will develop a rapid and ultrasensitive point-of-care diagnostic test for the virus. The consortium will develop the test, QwikZyme, over the next six months. The test is designed to be able to detect ultra-low concentrations of the virus itself, with the aim of earlier diagnosis – and results within an hour. QwikZyme lead, professor Molly Stevens, said: “SARS-CoV-2 is an unprecedented challenge on healthcare systems worldwide. Since last December, the virus has spread all around the world in a few months affecting all continents. The WHO is advocating the need to “test, test, test” to control the spread of the virus. We are developing a point of care device that builds on our expertise in ultrasensitive diagnostic technologies to enable rapid ultrasensitive early virus detection. Our team has direct collaborations with virologists, clinicians, contract manufacturers, the Imperial NHS Trust and the London School of Hygiene and Tropical Medicine. “We are aligned to the WHO REASSURED guidelines for point-of-care testing of infectious diseases (Realtime connectivity, Ease of specimen

collection, Affordable, Sensitive, Specific, User-friendly, Rapid & Robust, Equipment-free, Delivered).” EIT Health has announced funds of over six million euros in the fight against COVID-19, which will be dedicated to 14 specially selected health innovation projects across Europe. The projects will focus on immediate and impactful solutions that can be found to arm health services with better tools in navigating the pandemic. In its ‘Rapid Response’ initiative, EIT Health evaluated existing budget provisions for planned projects in 2020 and were able to reallocate funds to support promising solutions that may assist in the fight against COVID-19. The 14 projects selected cover biotechnology, diagnostics, digital health and medtech, and will be run by 36 partners. The projects will work directly with healthcare services as part of the consortia so that the solutions can be built in line with clinical needs and implemented without delay. Jan-Philipp Beck, CEO, EIT Health, said: “We are proud of the fast and invaluable action taken by our employees, partners and wider network in response to the devastating COVID-19 pandemic. COVID-19 has highlighted our vulnerability but it also allows us the opportunity to come together and collaborate to find new ways of strengthening our health systems and create solutions to better equip the healthcare professionals working tirelessly to get us through this extremely difficult time. The projects that we have selected all show great potential using the power of the EIT Health network to develop cutting edge solutions.” The projects, which will all be completed by the end of 2020, focus on: • The creation of faster and more effective COVID-19 diagnostics.

• Clinical triaging solutions so that healthcare providers can identify patients who require care in hospital versus those who can be managed at home under remote supervision. • Home monitoring solutions so that healthcare professionals can closely monitor patients outside of the hospital environment while quickly being able to detect deterioration or worsening of symptoms. • Digital solutions for healthcare professional training and data resources to improve patient management, prognosis and outcomes. • Data-powered initiatives to identify biomarkers associated with the progression of COVID-19 and treatment response at early stages of the disease. • Measures to reduce shortages in personal protective equipment (PPE), sanitary products and medical supplies. Jorge Fernández García, director of innovation, EIT Health, said: “We thank each and every one of our partners who submitted to our Rapid Response, we received a high volume of creative and innovative proposals focussing on impactful solutions across many areas of pandemic response. The projects have been selected based on their scientific and technological innovation, and address areas of immediate and high unmet need in relation to COVID-19. All projects demonstrated that their implementation could and would be rapid with the support of EIT Health, and that they could be scaled across multiple geographies ensuring that access for many European citizens can be front of mind. Our network means that we are ideally placed to support the collaboration of industry, research, academia, and, crucially, health service delivery (such as large hospitals across Europe), to put solutions in the hands of those who need them.”

How has Covid-19 changed the NHS customer landscape? Oli Hudson, content director at Wilmington Healthcare, explores the rapid and startling changes to the NHS customer landscape – and how it will affect medtech

wo months ago, the NHS had a customer environment that was often challenging, sometimes frustrating, but largely predictable. Change appeared at a stately pace and in line with the NHS Long-term Plan, which set out to foster gentle collaboration rather than competition. So integrated care systems were emerging, but yet to contract officially with integrated providers; some hospitals within trusts were being divided into ‘hot’ (emergency or specialist) and ‘cold’ (elective) sites; limited partnership between trusts and joint purchasing strategies were being developed, but slowly; and pilot programmes for pathway change, specialisation, and digital adoption seemed the norm, rather than the wholesale transformation desired. Some elements of the plan, such as a move away from long-term hospital bed use towards care in social, community, primary and home settings, were

well intentioned but happening sporadically in areas where all the players within an ICS could agree. Smart medtech companies were watching, with a view that organisational relationships between their customers, and between their customers and them could change, albeit slowly; perhaps the most crucial thing was the change in the national procurement model. Two months later, the coronavirus outbreak has made all these assumptions null and void.

Integration

The crisis has forced the pace with integration – with all the players within integrated care systems including acute, primary, community, specialist, ambulance and social care, as well as representation of local housing, transport, education and police, having to come together to make decisions on resource and capacity. Meanwhile, the Long-term Plan’s drive to create more coherent governance models in the shape of CCG mergers is ahead with increased fervour. This lays a baseline for a more integrated stakeholder map, with some ICS representatives saying they have achieved more in seven day timelines than had previously happened in 18 months. The learning? ICSs will be the standard operating unit of the NHS after the outbreak, and their decisions will affect which hospitals do which procedures and how pathways that involve medtech are managed.

Acute care

Within acute care, we are seeing changes to the purpose of hospitals– with whole units given over to Covid-19. Operating theatres have been turned into ICUs, and staff not previously specialising in respiratory or critical care requisitioned for this emergency. Departmental structures that previously existed within large hospitals have been shaken up beyond recognition, with clinicians working well beyond their normal disciplines. In places like London, a reconfiguration is underway between hospitals dealing with Covid-19 patients, and ones which are specialising in other areas, with Royal Brompton and Harefield forming a ‘hub’ model for heart disease, the Royal Marsden for cancer, and St Bartholomew’s for emergency elective treatment. The NHS has even enlisted the entire private sector to increase its critical care capacity. As a landscape, it is unrecognisable. There is also developing a backlog of long-term conditions treatment, outpatients and elective care. The medtech products used to treat them will be needed at some point, but when? Acute care will be a confusing and challenging customer environment for medtech during the outbreak – and industry may have to change its approach, determining the route to engagement – for example, via digital and remote channels. It is unlikely that hospitals will revert to the pre-Covid

working-in-a-vacuum strategy. There will be trade-offs and resource sharing. This is likely to foster closer collaboration in procurement in the future.

Long-term conditions

The emphasis on Covid-19 has detracted from other groups of patients – vulnerable groups such as respiratory, diabetes, cancer, heart and autoimmune conditions. How are these patients now being catered for and will the outbreak mean changes to care pathways? Cancer surgery has been affected, with patients being risk-stratified into four groups. Some groups will not receive treatment, depending on the likely outcome, whether it has a clinically meaningful aim, whether the patient is likely to gain significant extra life, and whether operating will expose the patient to a Covid-19 risk that is greater than not operating. Such measures have been outlined across most therapy areas by NICE in its series of rapid response guides, and will affect operations performed that use medtech for some time.

Industry impact

Hardly anything industry does with the NHS will be unaffected by this pandemic. It is important that industry stays well informed, prepares to be agile, offers solutions that deliver value and address issues of rapid, reliable and consistent supply and distribution – and act as a partner to the local and national NHS during this crisis.

on the cover

LOOKING TO THE FUTURE

EYE RELIEF AND EXIT PUPIL If you wear glasses (and most of us do) you may know how difficult it can be to use binoculars. Old models will clatter against your glasses and, even with the rubber eyepieces of more recent models, your glasses soon become smeared from the contact. Much more frustrating is the difficulty in getting a clear unimpeded view. This is because for a comfortable view each eye needs to be at the point in front of the eyepiece where the image is formed. This point is called the ‘exit pupil’ and is typically 4 to 5mm in diameter, or not much bigger than the size of your pupils in daylight. A comfortable viewing position is achieved when the exit pupil completely covers the pupil of the eye and can be held there without difficulty. Problems arise for glasses wearers when their eyes cannot get close enough to the exit pupil. When this happens the image is in focus but the field of view is restricted and it is difficult to keep the exit pupil over (or within) the eye pupil, a slight shift in its position can cause shadowing in the field of view. Another way of describing this problem is that the exit pupil is too close to the eyepiece lens. This distance, called ‘eye relief’, is around 10 to 15mm for most binoculars. The distance is well named as for glasses wearers it is a relief to use binoculars where it is around 18 or 20mm. CONVENTIONAL STEREO MICROSCOPES AND DISCOMFORT Stereo microscopes are typically in the 5x to 100x magnification range and are widely used in medtech component inspection and testing. As with binoculars, they have separate optics for each eyepiece and so each has a different viewpoint of the subject giving the viewer depth perception, or a 3D view. In fact the 3D effect is much stronger with stereo microscopes because the subject is very close and so the difference between the viewpoints is more pronounced.

Dick Fielding, Vision Engineering’s inspection product specialist, explains why eyepiece-less stereo microscopes are an increasingly healthy option

However, a key problem with conventional stereo microscopes is user discomfort: back fatigue, neck fatigue and eye fatigue. It is caused by poor posture and eye strain as, in general, users need to bend over the instrument to bring

on the cover

Surveys suggest 90% of microscope users report visual problems, with headaches reported in over 50% of users their eyes to the eyepieces and must retain a fixed position with very limited head movement. Users are also not able to view the subject directly without moving back from the microscope, looking down and refocusing their eyes. All these are serious drawbacks particularly as tasks often require working for several hours a day, perhaps doing repetitive tasks or tasks requiring close hand-eye coordination, and where accuracy is of critical importance. The effects on health are significant; surveys suggest 90% of microscope users report visual problems, with headaches reported in over 50% of users. Over 80% of users report neck strain and around 60% musculoskeletal problems in the back.(i) Glasses wearers have particular difficulty in achieving a comfortable view of the subject yet probably account for the majority of potential users: just under 40% of people in 20 to 40 year age group wear glasses, this increases to 55% for 40 to 50 year olds and to over 80% for 50 to 65 year olds.(ii) So the most experienced stereo microscope users are likely to wear prescription glasses. If users needed to wear protective eyewear such as safety goggles, the eyes could not be positioned at the eyepieces and it would be very difficult to use a conventional stereo microscope effectively. EYEPIECE-LESS DESIGN AND ERGONOMICS The main challenge then is to find a way in which the user can sit at the microscope in a comfortable position. The key to achieving this is to increase the eye-relief and the exit pupil diameter of the microscope to allow the viewer to be further from the eyepiece and have some freedom of head movement without causing shadowing. This cannot be achieved purely through optical design considerations. The solution Vision Engineering has developed over many years incorporates a spinning lenticular disc within the

optical system and which merges the images formed from each of its 3.5 million micro-lenses. As with conventional stereo microscopes, an image is formed for each eye but crucially the diameter of each (the exit pupil) is several centimetres rather than a few millimetres. The eye relief distance is also substantially increased. No eyepieces are required; the user simply looks into a viewing screen. The eyepiece-less design enables a comfortable and relaxed viewing posture. Users can work for long periods at the instrument without experiencing discomfort or fatigue, and small movements in eye position no longer cause shadowing. There are other benefits; the increased lateral head movement heightens the depth perception of the 3D image and if the viewer needs to look down at the subject directly, they can do so without shifting position or having to refocus. This greatly eases handeye coordination tasks. Because of their contactless design, they are frequently used inside laminar flow cabinets and, most importantly perhaps, glasses wearers enjoy exactly the same comfort and easeof-use benefits. LOW INFECTION INSPECTION I began with a binoculars analogy and I was rather dismissive of the annoyance of getting smears on our glasses from contact with the eyepieces. Instead I concentrated on the discomfort for glasses wearers. When translated to stereo

microscopes, there are significant health benefits in addressing this discomfort (to say nothing of the productivity benefits). However, it turns out that the most important aspect of eyepiece-less design may be that there are ‘no smears on your glasses’ i.e. that there is no contact between the user’s eyes and the instrument. The current coronavirus (Covid-19) crisis is raising awareness of workers’ health in general and particularly on the need to reduce infection risk in the workplace. Instrumentation is a potential source of contamination. With conventional stereo microscopes, the user’s eyes come into contact with the eyepieces and eyepieces will therefore need to be cleaned thoroughly before and after use. If protective eyewear is a requirement it would be extremely restrictive on the usability of the instrument. As well as their ergonomic advantages, eyepiece-less stereo microscopes present clear advantages for minimising cross-contamination: the viewer’s eyes are not in contact with the instrument, greatly reducing the risk of infection from shared use, and wearing protective eyewear is no restriction to their usability. Hopefully, right now, they are proving a useful tool in containing and defeating this virus.

(i) Garima Jain and Pushparaja Shetty Occupational concerns associated with regular use of microscope: International Journal of occupational Medicine and Environmental Health 2014;27(4):591–598 (ii) CBS. Jan-Willem Bruggink. See. https://www.cbs.nl/en-gb/news/2013/38/ more-than-6-in-10-people-wear-glasses-orcontact-lenses

As well as their ergonomic advantages, eyepiece-less stereo microscopes also minimise cross-contamination as the viewer’s eyes are not in contact with the instrument

TUBING

Ian Bolland spoke to Joe Rowan, president and CEO of Junkosha in Europe and the US to talk about the company’s tubing offering, PHST and the challenges facing the company in that sector

ne of Junkosha’s main strengths is that peelable heat shrink tubing (PHST) is prominent when in the catheter market, with the material able to provide solutions that cater towards smaller catheterbased products and procedures. Explaining more about the innovations that has gone into Junkosha’s development of PHST, Rowan says: “By increasing the shrink ratio to 2.5-1, which nobody else has accomplished, we’ve been able to allow customers to either consolidate part numbers or consolidate processes. Rather than having to perhaps do a couple of pre-shrink processes, customers can now achieve the final catheter product with minimal pre-shrink and can accomplish a finished catheter by eliminating or minimising processes. They can actually use lower tolerance materials, lower cost materials because of the take-up in inherent in the 2.5-1 approach or solution.” The company’s 65 years of experience has brought about deep knowledge in fluoropolymer manipulation along with processing, elongation and expansion techniques – which Rowan claims is the only product that features these characteristics – which he believes is to Junkosha’s advantage. “I think our strategy has been to focus on our core competence and to leverage that core competence to address unmet needs in the market. That is when you’re able to hit that kind of sweet spot that gives you a sustainable business advantage.”

Despite that 65-year pedigree, Rowan feels that the company is still a well-kept secret – having only entered into the European and US markets from 2009 onwards, initially through a partnership with WL Gore – making it one of the company’s biggest challenges despite feeling as though the business is a leader in this particular space. “After we went our separate ways, Junkosha took it upon themselves to be masters of their own destiny in the western world. We really have only been exposed directly to customers in the western world since around 2011 or 2012. In that time we’ve made really good progress. Our revenue has increased significantly but it’s an ongoing challenge to increase our awareness since we are relatively new to the western world even though we’ve been around such a long time in Japan. “I think what has happened with our key customers is that they have been exposed to our capabilities, they’ve used the products, been delighted with the products and the services we provide and we have grown very healthily with key customers since we have executed very well. So, this whole awareness thing is slowly, but surely, taking care of itself. “I do think that is the biggest challenge we have rather than perhaps a technical one since we have really been the leader and have frankly owned this whole PHST space. We have innovated very strongly in that area, and

I think our strategy has been to focus on our core competence

I think it is fair to say that we’re looked upon as the leader and innovator in that space.” While the company maybe dealing with fairly niche areas of the supply chain, and is therefore not as exposed as others, Rowan insists that niche is good if it is done well. “Niche is actually good if the niche itself is of significance and of some magnitude, which is why the focus on the catheter market has turned out to be a really good choice. It is a large market, it is a growing market, it has unmet needs that are very well aligned with what we do and that has proven to be a good choice for us.” For such a niche element of the market, one would anticipate that there are challenges in the supply chain when it comes to the development of tubing and the material required, but the solution appears to be in-house. “We make our own fluoropolymers. In fact, one of our strong areas of intellectual property in embedded IP is our know-how and trade secrets accrued over that 65-year period. We make our own equipment in terms of processing the tubing. In terms of the other side of the supply chain we have our own highly trained peel salesforce which focus on the key customers in the global catheter market. That has proven to be very successful.”

MICROFLUIDICS

Going with the flow Dr Tracy Brown is head of life sciences at TÜV SÜD National Engineering Laboratory. She outlines the role of microfluidics in healthcare in particular improving infusion drug delivery techniques

commensurate impetus for greater metrological understanding. Precision medicine is expected to change fundamentally the delivery of medical treatments and is predicated on the idea that different sizes of dose can be delivered accurately. The journey towards therapeutic and prophylactic interventions tailored to individuals that take into account their genetic blueprint, environment and lifestyle is underway. Intrinsically, this will necessitate the need for enhanced measurement capability to ensure the accurate dosing of infusions containing novel complex therapeutics designed to treat niche illnesses.

Infusion is the most common form of therapy in a clinical setting. Each day, millions of patients worldwide receive intravenous infusion treatment, eg nutrient or electrolyte replacement, anaesthesia, chemotherapy. Its widespread use in critical healthcarea settings means infusion errors are often made which can lead to adverse incidents, morbidity and, at worst, prove fatal. While monitoring a patient’s vital signs can indicate potential dosing errors, they cannot be relied upon as a means of ensuring safe drug delivery and only indicate the error after it has occurred, ie. when it is too late. The growing focus on a personalised approach to healthcare brings with it a

TÜV SÜD National Engineering Laboratory based in the UK is part of a consortium of European national measurement and designated institutes, universities and manufacturers that has embarked upon a three-year project aimed at improving dosing accuracy and enabling the traceable measurement of volume, flow and pressure of drug delivery devices used in infusion therapy. It will develop traceable calibration procedures for medical flow devices such as infusion pumps, down to very challenging low flow rates in the nanolitre (nL) per minute range necessary for infusions in certain patient groups, eg. neonates. It will develop techniques for generating and measuring the response or delay time of these devices and examining the influence of fastchanging flow rates and innovative approaches, for example, optical methods, to make these challenging measurements. It will also investigate how mixtures of

DR TRACY BROWN

According to Tracy Brown TÜV SÜD National Engineering Laboratory, OOAC microfluidic devices present exciting opportunities across the drug discovery pipeline

icrofluidics technology provides tools that enable the precise control and manipulation of fluids in the microlitre to picolitre range (less than one thousandth of a mL). Its growing application across healthcare and pharmaceutical fields, including drug infusion and organ-on-a-chip (OOAC), is creating demand for increased fundamental understanding of microflows.

liquids with differing viscosities mix and flow in multi-infusion systems and how this affects the therapeutic drug concentration over the course of an infusion. Such rigorous metrology will prevent harm to patients arising from inappropriate mixing such as therapeutic failure or toxicity. The primary infusion devices used for administration have a significant impact on metrology. In the case of intravenous administration, for example, various devices with differing purposes may be used (syringe pumps, peristaltic pumps, insulin pumps). Each method must be capable of delivering traceable, accurate and reproducible metered doses of drug. Understanding the sources of, and minimising, measurement uncertainties attributable to the operation of each device is key to achieving this and is a fundamental aspect of the work being undertaken in this multipartner project where uncertainties of 1-2% are being targeted. In addition to existing drug delivery devices, the metrology infrastructure and standards arising from this project are also aimed at future technologies for managing drug delivery for quality validation and reproducibility. Amongst these are microneedles, which are, essentially, miniaturised needles offering more effective drug delivery with less pain. There are different types including dissolvable microneedles which, as their name suggests, dissolve following insertion into the skin and release of the drug enclosed within them. OOAC microfluidic devices are evolving rapidly and present

MICROFLUIDICS

exciting opportunities across the drug discovery pipeline from candidate identification to efficacy, toxicity and safety. These microscale in vitro human physiological models are efficient and cost-effective with their added potential to reduce the use of animal models offering an ethical alternative to conventional preclinical drug discovery approaches. Moreover, OOAC technology can be used as implantable drug delivery devices capable of producing continuous, non-continuous or pulsatile delivery patterns by less painful means. Fluid flow measurement has an integral role to play in the translational journey of these novel microfluidic applications from bench to clinic. For example, the interconnection by microfluidic flow of single organ models enabling the study of biological interactions between organs. The burgeoning adoption of technologies such as OOAC in healthcare will necessitate the development of a metrological infrastructure to validate their accuracy and reproducibility.

Accordingly, a further aim of the collaborative European metrology project is the development of a proof-of-concept microfluidic microchip flow pump for use as a moveable traceable transfer standard for the calibration of drug delivery devices used in drug discovery and OOAC for ultra-low flow rates (below 100 nL/min). Regulatory compliance underpins every innovation or innovative methodology within the medical device sector; an obligation which is set to increase from May 2020 when the new Medical Devices Regulation (Regulation (EU) 2017/745) comes into full force. The increasing innovation and complexity of drug infusion systems will inevitably see metrological information form an essential part of the regulatory approval process for these medical devices. Their characteristically judicious approach will see regulators seeking to require device manufacturers to apply metrological standards at national, European and international level. Not only will this entail the

development of existing standards, it will require the creation of new ones to address their diversity and increasing complexity. Whilst at an embryonic stage, microfluidic technology is progressing apace. In parallel, work is needed to define measurement standards for microfluidic devices covering areas such as the control and quantification of fluid flows. Developing microfluidics measurement standards will facilitate their uptake across the pharmaceutical and health sectors by providing the necessary accuracy and reliability in their manufacture and performance. The advantages of microfluidic devices as drug discovery and delivery platforms cannot be underestimated; they are quick, inexpensive, portable and effective. However, developing a robust flow metrology infrastructure to validate their quality, reduce dosing errors and ensure device efficacy and safety is key to unlocking their potential.

The advantages of microfluidic devices as drug discovery and delivery platforms cannot be underestimated

DIGITAL HEALTH AGE

sponsored by

Digital monitoring deviaces and apps are providing more flexibility in how diabetes is managed implemented as part of a comprehensive ecosystem, one that factors in all aspects of life that may affect a person’s experience with diabetes, from medication, to diet, to mental health. Adding meters and apps to an already complex landscape of diabetes management can confuse both PWDs and HCPs, and this needs to be managed, along with minimising the effort required from PWDs to integrate digital health solutions into their lives. Diabetes already comes with a long list of diabetes relates tasks and considerations, and additional management tools should seek to simplify and not complicate. Interconnected diabetes management (IDM) focuses on treatment beyond the pill. By providing people with much-needed guidance alongside a simplified, holistic management tool, it harnesses digital solutions to bring together multiple aspects of diabetes management which are currently managed in silos. IDM also aims to improve collaboration with healthcare systems and others involved in a person’s diabetes care, in order to improve outcomes. Health2Sync is one such solution that captures data and makes it available to those involved in a person’s diabetes management. The app enables people to easily log blood glucose, blood

pressure, weight and daily activities, and allows them to share this information with family members and HCPs. It also helps to provide customised recommendations and reminders, based on the data collected. And there is growing data to suggest that this holistic digital management approach can improve outcomes in type 2 diabetes.

ASCENSIA SOLUTION

Ascensia Diabetes Care has shown clinically meaningful results from the use of IDM and demonstrated how such a solution has the potential to improve type 2 diabetes management. A study found that using an investigational IDM solution decreased HbA1c levels of 0.43% in people with type 2 diabetes over 12 weeks, independent of any changes to medication. This suggests that IDM solutions could lead to better glycemic control through an improvement in self-care. The Ascensia solution combines remote behavioural coaching and a mobile application to collect, store, and analyse key data about a person’s health from a variety of sources, which in my opinion represents the ideal digital solution for type 2 diabetes. The coaching needs to be based on the data that is gathered by the app to offer tailored guidance, providing PWDs with actionable information in support of their individual self-management. The use of digital coaching for diabetes is estimated to increase from 240,000 users in 2017 to 3.8 million by 2022, but the type of coaching is also an important

consideration. Coaching should be provided by a combination of humanbased and machine-based systems, in order to efficiently manage large populations of people with type 2 diabetes. For example, machine-based support can be used to provide simple recommendations based on analysed data, while regular interactions with trained staff, such as diabetes educators, can provide the more specific coaching for people to make positive behavioural changes in areas such as glucose monitoring, food choices, activity levels, stress, and sleep. The contributing factors to diabetes management outcomes are varied. Ascensia’s study assessed 25 impactful behaviours which could be addressed by the IDM solution it is currently developing. Behavioural changes, education, more frequent readings, as well as a feeling of being supported leads to PWDs enjoying a healthier and better quality of life, at whatever stage of their diabetes journey they may be. It can help to improve outcomes and studies are starting to show that it can lead to better managed diabetes. Additionally, the interaction between a patient and a CDE through a digital solution provides access to valuable guidance when visits to HCPs can be infrequent. By educating users remotely and providing tools to track progress, PWDs are still supported whilst payer costs and burden on the healthcare system are reduced. In fact, the total cost of diagnosed

diabetes rose by 26% between 2012 and 2017, with costs in the US at $327 billion in 2018. HCPs, payers, and healthcare systems are increasingly calling for bundled services. Simply offering a patient a drug and glucose monitoring device is no longer enough, with those involved now looking for each aspect of diabetes management to be carefully considered and interconnected in a holistic solution; with a view to improve patient outcomes. We are just at the start of the digitisation of diabetes management, but we are making progress. Digital solutions are already beginning to demonstrate their benefits, with 52% of those using a health or wellness app to manage their diabetes seeing positive results . Increasing that figure will require more seamless integration of IDM and digital health solutions into every-day diabetes care. By taking a more holistic approach to digital management in type 2 diabetes, we can reduce the impact of diabetes on society and healthcare systems, and improve the lives of PWDs everywhere.

https://www.idf.org/aboutdiabetes what-is-diabetes.html 2 Digital Diabetes Care Market 2018-2022. Research2Guidance (September 2018) 3 Klaff, L. et al. Poster presented at the American Diabetes Association’s 79th Scientific Sessions, San Francisco, California, USA, 2019 4 Digital Diabetes Care Market 2018-2022. Research2Guidance (September 2018) 5 https://www.diabetes.org/ resources/statistics/statisticsabout-diabetes - accessed 20 December 2019 1

SUSTAINABILITY

SUSTAINABILITY AND LIFE SCIENCES: HOW TO MAKE IT HAPPEN Ian Bolland spoke to Richard Coxon, Dassault Systemes, to discuss sustainability in the life science sector and achieving net-zero carbon emissions IB: What kind of things can manufacturers and innovators do to be more environmentally friendly, and in turn, help health service providers?

IB: What can life sciences learn from other industries when it comes to more sustainable and environmentally-friendly manufacturing practices?

RC: There is a huge opportunity for further innovation in the healthcare sector and this starts by moving towards low-carbon health systems, so the sector can mitigate its own impact on the climate and become more resilient to the impacts of climate change. One way the sector can do so is by using technology to improve processes and become more sustainable. An example of technology that the sector can use is collaborative 3D designs, which are based upon breaking down knowledge silos and allowing organisations to create sustainable solutions for the future. We can create virtual copies of buildings and transport systems to identify efficiencies and reduce waste. We can then help use these 3D virtual models for example, to help design a new building or how to make the most efficient retro-fit project or how to select sustainable materials that perform as well as traditional building materials.

RC: It will be a difficult but necessary journey for the life sciences sector to become more sustainable and it will involve learning from other industries and following their best practises. When it comes to sustainability, the challenges faced by the life sciences sector are very similar to challenges faced by other industries. The life sciences sector obviously consumes and transports a lot of goods, so it is vital that it is doing this in the most sustainable way that it can. This includes using electric vehicles rather than petrol and ensuring that the supply chain is as maintainable as possible. At Dassault Systèmes, we help businesses to do this by using 3D technology to build a model supply chain in the virtual world which shows how medical devices are being transported, which allows us to see where the chain can be made more efficient.

Another key area is Dassault Systemes’ long-term ambition of creating virtual twins or copies of people. These virtual twins will be utilised in health treatment hypotheses as well as in designing, testing and development of therapeutic products. It is still a long way off being a full human model of course, but we are making good progress with specific organs such as the living heart project. These virtual models offer huge potential for reducing waste – very little material is required – and environmental impact would reduce through needing less travel. In clinical trials this would have a significant impact.

Looking at other industries, we are in an era of ‘industry renaissance’, where the real and the virtual worlds merge to create new ways of inventing, learning, producing and doing business. This is enabling new categories of industrial firms to create new categories of solutions for new categories of customers. The various industrial sectors of the 21st century are much less concerned with flows of parts than with flows of usages and virtual models, existing in an economy that eliminates friction and optimises the life cycle using intelligent systems whose data is energy. This becomes the very definition of an industry. So, from air taxis to data-

driven crop science, the power of virtual worlds created and managed on virtual platforms is enabling entire new business models that delight customers with previously impossible experiences that also offer far more from a sustainability perspective. Life science organisations can apply the same knowledge here, as rich and accessible knowledge and know-how are the new keys to success, determining humanity’s capacity to invent innovative and sustainable solutions that address previously intractable global challenges. The ability to access and apply knowledge and know-how at hyper-speed is the new prerequisite for survival, and virtual worlds on virtual experience platforms deliver this. One example of a business in another industry that is doing this is Laboratoires M&L, the manufacturing division of L’Occitane Group, which uses Dassault Systèmes’ DELMIA Apriso to help optimise its global production and logistics operations. With real-time availability of information, Laboratoires M&L has more foresight thanks to better planning and the availability of information in real time, which also improve decisionmaking, while reducing the rate of non-quality, waste by 50%. IB: When do you think is a realistic timetable for the industry to get to net-zero?

SUSTAINABILITY

The advantages of microfluidic devices as drug discovery and delivery platforms cannot be underestimated RC: The UK became the first major economy to pass net zero emissions legislation in 2019, making 2050 the target for the UK to reduce emissions to zero. Yet, the UKâ&#x20AC;&#x2122;s life sciences sector has a very large carbon footprint, with the NHS making up 5% of all UK GHG emissions. The sector itself provides care to over 60 million people in the UK and on top of this, medical devices and pharmaceuticals account for 25%

of the total health and social care footprint. Therefore, the healthcare sector needs to prioritise playing a pivotal role in finding solutions to this climate change challenge, in order to realistically reach the 2050 legislation. Achieving these objectives means that it needs to be looking into solutions for building housing patients or research facilities, to the energy and water requirements and waste produced, through transport and procurement of materials used to produce pharmaceuticals and medical devices. Itâ&#x20AC;&#x2122;s worth bearing in mind most emissions come from the procurement of goods and services; better management of the supply chain would help reduce the impact of the delivery of goods. There are also several ways research and development can be improved and technology

will most certainly form the backbone of these solutions. 3D and virtual models will play a key role in learning how to scale up sustainable practices, and to realise efficiencies and cost savings at the same time. Virtual universes can transform the entire life sciences industry, from therapeutic product discovery, all the way to delivery of care and improvement of health for every single individual. One example of an organisation in the life sciences industry leading the way with on getting to net-zero is AstraZeneca, with the company recently unveiling an ambitious programme for zero carbon emissions from its global operations by 2025 and to ensure its entire value chain is carbon negative by 2030. This is exactly the type of initiative that will help the life sciences sector become sustainable and ultimately get to net zero.

Testing & inspection

PUT TO

THE TEST

anufacturers of catheter systems develop standard and custom catheters, stents, and guide-wires to meet surgical needs. ZwickRoell highlights some of the catheter testing challenges it meets using its expertise

Increasing regulatory pressure is challenging medical equipment manufacturers to meet strict requirements in design, testing, and production. This trend is reflected in catheter systems that are used for vascular surgery along with coronary stents. There are many types of catheters including those used to transport small instruments or repair devices to a particular site in the body. Some catheters have small built-in tools so that a surgeon can repair a problem in the patientâ&#x20AC;&#x2122;s body without having to perform open heart surgery, while some can deploy a stent that will keep an artery open.

For surgeons, challenges associated with such procedures include feeding catheters into femoral arteries, navigating sharp turns, and advancing the device without damaging tissue. Manufacturers of catheter systems work closely with surgeons to develop standard and custom catheters, stents, and guide-wires to meet these challenges. Catheter manufacturers continually monitor their product by physically testing the complete units, as well as individually testing the component parts. To properly test such devices, catheter manufacturers need

Testing & inspection

ZwickRoell has developed a system that controls the test machine crosshead and special automated pneumatic grips to replicate the condition of a patient lying on an operating table and a surgeon inserting a catheter. ‘Pull-off’ testing is important because joined parts should not fail when the catheter is inside the patient. Stents are tested, both in compression and flexure modes, and the frictional behaviour of the complete catheter is measured as it is pushed through a simulated artery known as a ‘tortuous path’. To facilitate this action, ZwickRoell has developed a system that controls the test machine crosshead and special automated pneumatic grips. The horizontal machine is essentially a test bed that incorporates space above and below the main test axis to accommodate 3-D models and water baths. In a typical test, the testing machine pushes the catheter into the tortuous path for a designated distance before the pneumatic grip then releases the catheter and the crosshead moves back to the original start point. The pneumatic grips close onto the catheter, moving the crosshead forward once again. This sequence is repeated until the catheter has been

fully inserted into the simulated artery. This test procedure, which is fully automated, can easily accommodate different sizes of tortuous paths and the machine software enables the following results to be calculated: Track force, push efficiency, insertion force measurement, guide-wire movement, flexibility, guide-wire and catheter lubricity track measurement. The results can be calculated with high precision. The extremely stiff load frame with digital control and drive systems ensures that forces measured during the test originate from the sample under test and not from within the machine itself. The machine control system has such a high degree of accuracy and resolution that it can position the crosshead of the machine to less than 1 µm, and read forces to an accuracy of better than 0.5% down to values of less than 0.1 mN. The machine software platform can control all of the test parameters including the safety features of the testing machine. At the same time, it can acquire and process the raw test data in real-time and store this data,

as individual data points and as calculated result data. Stringent regulatory environments require the ability to maintain accurate records of the testing procedures and results. Record keeping requirements are described under FDA 21 CFR Part 11. Part 11 requires drug makers and medical device manufacturers, biotech companies and other FDA-regulated industries to implement controls, including audits, system validations, audit trails, electronic signatures, and documentation for software and systems involved in processing electronic data that are required to be maintained by FDA predicate rules or used to demonstrate compliance to a predicate rule. Record keeping to satisfy Part 11 standards, can be integrated as an option into software. Medical device companies can take full advantage of this feature and save the costs of third party accreditation. The software includes the functions; “Electronic Records and Signatures” for complete digital documentation of all safety critical tests. Test results can be automatically stored in the customer’s database. Operator and environment safety concerns are also critical. The testing equipment can be supplied with splash-proof electrical connectors and a supplementary emergency stop button for additional safety. A software plug-in is available that enables a standard video camera to be connected to the system to record the test sequence. The incoming video signal is automatically synchronised with the force and displacement data. It allows a more complete record of the test to be saved or transmitted to interested third parties.

industry 4.0

Which manufacturing trends will enable Industry 4.0?

Nokia and ABI Research identify key trends in manufacturing investment to enable Industry 4.0

okia has teamed up with ABI Research, an independent research firm, to survey more than 600 manufacturing decisionmakers to assess investment strategies related to 4G/LTE, 5G and Industry 4.0.1 The survey found that 74% of respondents are looking to upgrade their communications and control networks by the end of 2022 with more than 90% investigating the use of either 4G and/or 5G in their operations. Just over half of respondents (52%) believe that the latest generation of 4G/LTE and 5G will be necessary to meet their transformational goals. The research also identified key business use cases that would drive investment in 4G or 5G. Respondents reflected the need to digitalise and improve existing infrastructure (63%), automation with robotics (51%) and achieve new levels of employee productivity (42%). Manish Gulyani, vice president marketing, Nokia Enterprise said: “We have reached an inflection point in Industry 4.0 transformation as the fast, secure, low latency connectivity underpinning its implementation now becomes available. This research indicates the strong marketplace appetite for industrial-grade wireless networking to capture the transformational benefits of digitalisation and automation. We believe that demand, combined with easy-to-deploy private wireless solutions, will drive adoption.”

Reference:

The research examined nearterm drivers influencing buying decisions for new industrial systems across IT (information technology) and OT (operations technology). IT drivers primarily focus on reducing downtime (53%), improving operations efficiency (42%), and enhancing security (36%). In comparison, OT drivers reflect a desire to replace aging infrastructure (43%), improve efficiency (40%) and increase capacity (38%). Further highlights indicate: • 88% of respondents stated that they were familiar with private wireless (4G/5G) networking • 84% that are considering 4G/5G will deploy their own local private wireless network in their manufacturing operations • leading priority buying areas are automation and machine upgrades (47%), IIoT initiatives (41%), with cloud infrastructure following at (37%). Ryan Martin, principal analyst, ABI Research said: “Importantly, research findings indicate a preference for deploying private fully-owned and operated wireless networks, with manufacturers favoring in-house management to allay security concerns. It’s evident that respondents are not entirely committed to Wi-Fi/ WLAN and will consider latest generations of wireless technologies.

1 Respondent data: 602 individual respondents, with various decision-making job roles across automotive (201), consumer goods (201), and machinery (200) markets. The geographic spread of respondents was U.S. (161), Germany (100), Japan (100), China (40), India (40), Australia (40), U.K. (41), Canada (40), and France (40). The survey was completed at the end of 2019, and thus before the onset of the Covid-19 pandemic.

As a result, 2020 is a critical year for networking suppliers to educate the market regarding the merits of 4G/LTE and 5G. “Based on this research we also observe a pan-industry need to quantify not only the potential ROI of investing in private wireless, but also to clearly indicate the cost of inaction – vendors need to make the case for investing in Industry 4.0 today to gain a clear competitive advantage over those who choose to wait.”

• 74% of manufacturing decisionmakers surveyed plan to upgrade comms and control networks in next two years to advance digital transformation and Industry 4.0 • More than 90% are investigating use of 4G/5G for their operations • 84% that are considering 4G/5G will deploy their own local private wireless network in their manufacturing operations

DEVICES

Sleep easy Reece Armstrong reviews a neurostimulation headset that targets better sleep and more. But does it work?

he rise in wearables has resulted in a blurring landscape for medical and health-related technology. Commercial companies have started to move into the realms of medtech and our health has become not just the focus of the healthcare industry, but that of the technology players, too. Sleep has been one such area and a host of products are available aimed at helping people get to magic land of nod. From deviously simple weighted blankets, devices that analyse your movements during shut eye, and even headsets that promise better sleep through lucid dreaming: technology and sleep in many ways now go hand-in-hand. Med-Tech Innovation News was sent the NeoRhythm headset to try out. Developed by OmniPEMF, the headset deviates from other sleep wearables by being marketed as a ‘neurostimulation device for better living’. Not only does NeoRhythm aim to

improve users’ sleep, it also includes a range of other stimulation programmes to improve pain management, help de-stress or meditate, and also enhance mental capacity.

WHAT’S IN THE BOX?

NeoRhythm comes in a sleek box with minimal fuss. The headband, whilst not exactly stylish, is aesthetically pleasing in the clean, minimalist way that is often associated with tech products. Since NeoRhythm is gesture controlled, there’s little in the way of set-up, with instructions plainly printed on the box in a handy quick-start guide. The booklet in the box guides users through the science behind NeoRhtyhm, who can and can’t use it (people with pacemakers or other electronic implants!) and more in-depth information for continued use. The NeoRhythm app too is fairly easy to navigate with each programme offering range of handy

information as to when to use the device and for how long. The app comes with a calendar which shows you which programmes you’ve completed so you can ascertain whether or not extended use of NeoRhythm has worked. However, it doesn’t offer data such as sleep patterns so users will have to correlate any perceived benefits with data from other wearables. For the most part the device was easy to use, though programmes occasionally stopped working via the app, requiring me to restart the device.

HOW DOES IT WORK?

NeoRhythm is based on the study of pulsed electromagnetic field therapy, or field magnetic stimulation. Basically, the device generates non-invasive electromagnetic fields that pulse at certain frequencies, causing the wearer to produce neural oscillations (brainwaves) which the brain then associates with certain activities. For instance, by generating a frequency that is typically associated with sleep (4hz), NeoRhythm can help improve a person’s sleep. Or at least that’s the idea.

DOES IT WORK?

I used NeoRhythm over a period of two weeks, following up with intermittent uses of various programmes, and had mixed results. Primarily, I tested NeoRhythm’s sleep The NeoRhythm headset. Credit: Marko Kadunc (MDCNTECH)

programme, which is to be used 20 minutes before one goes to sleep, or you can put it under your pillow for an eight-hour session. Not wanting to have an electrical device directly beneath my head for that amount of time, I opted for the former. I found that it did lull me into a sense of tiredness during the first couple of nights, and the following mornings, I felt as if I had slept better. However, following uses failed to provoke any effect and my sleep was as normal: that is to say, erratic at best. Other programmes also failed to have any effect on me, whether it was NeoRhythm’s programme for enhancing mental capacity to battle morning brain fog or improving my energy after a physical workout. I assume, in the case of sleep, I’m simply not the right person for it. I take a fairly long time to fall asleep, and the 20 minute window required by NeoRhythm may not be right for me.

IS IT WORTH IT?

It’s tough to say. At €285 NeoRhythm is a major purchase and with mixed results I’d argue anyone wanting better sleep should focus more on achieving regular sleeping cycles. However, NeoRhythm is backed by two (admittedly small) double-blind, placebo controlled studies, and its mild effects on myself indicate that it could work better for other people.

In practise

MAKING THE CONNECTION

an Bolland spoke to Mehfuz Dasu Patel, senior development manager at Issa Group about the company’s medication adherence solution Biodose Connect Issa is a community pharmacy first and foremost which undertakes the normal duties of packing and dispatching medication to its patients. It came across the original Biodose tray that allowed the company to organise and dispense the medication. The pharmacy bought Biodose after its original parent company went into liquidation at the end of 2019 and has developed the monitored dosage tray into a device that can improve medication adherence further along with Vaica, which manufactures a range of adherence platforms. Biodose Connect comes with a removable tray that is split into 28 pods – which can each hold up to 10ml of liquid medication or seven solid dose medications. The device stays with the patient while the empty trays are

refilled with medicines by a nominated pharmacy – in this case Issa. Patel explains the initial product was designed for care homes, but had subsequently been offered to care agencies, local authorities and people with complex medication regimes Commenting on the initial product and what it has grown into, he said: “What this does is make sense of a complex medication regime to increase adherence first and foremost, and make sure the patient is taking the right medication at the right dose at the right time. “We put it into a patient’s home so it’s got this device which has sensors including a light sensor and a movement sensor. It’s got a GSM chip in it as well which can send out messages via any sort of GSM network.” The connected device isn’t used in a care home. The USP of the Biodose Connect device is that it’s for those who aren’t in the care of others and need help with medication adherence in their own home rather than the trays without the connected element which are developed for use in a care setting. In a home environment, the connected device can pair up to a mobile phone or web portal. “We don’t see this as a closed system, we see this as an open system, and we see ourselves as a pharmacy that packs these trays and we’ve got a device that manages

that tray. You can have the notifications sent to whoever you want, however you want, because it all relies on an SMS system. It can be easily configured to ping off to another sensor and sends it through.” The tray is configured to a specific time. When a patient removes a pod, it is then logged through its sensors and can inform patients of when they have removed the incorrect pod. There is also scope for patients to delay the time they want to take their medication, but louder alert prompts can sound if they have missed their time. The device’s tailored programme of alerts can include flashing lights under each pod, customisable alarms and voice messages to indicate when a dosage is due. The combination, along with the pairing with a web portal, allows the patient themselves, their carer or family member to keep track of their medications – and can prevent care services from stretching their resources. “A lot of people who are living in their own home, they only need this for taking their medication. “It just a provide a feedback loop between the patients and their family members. Rather than calling a family member or a carer you’ve got this telling you up to four times a day that the patient is ok.”

Efficiencies appear to be one element which allows Biodose Connect to appeal to local authorities, following a study Issa commissioned through the University of Nottingham, which found that a quarter to a third of patients get put into care because someone needs to make sure they are taking their medication. “At the moment the only way around that is for a home care agency or a local authority to patient’s home four times a day,” Patel explains. “What we’re saying to local authorities is with this device you can put it into a patient’s home and monitor them taking their medications remotely. “Rather than spending five minutes with a patient four times a day, you can use this device and send your carer round once a day – who can spend half an hour with the patient. Let them interact with the patient and help them with things they need help with.”

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