www.med-technews.com Issue 49 | Jul/Aug/Sept 2020
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MED-TECH INNOVATION | NEWS MED-TECH
PLUS
innovation
Playing to your strengths ‘Medtech centre for cardiology’ Realising quality 4.0
WORKING ROUND THE CLOCK Developing a ventilator to fight COVID-19 ADVANCING HEALTHCARE
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CONTENTS regulars
5.
COMMENT
Ian Bolland highlights the significant role the diagnostics industry plays in the UK
7.
making medtech
A round-up of the latest industry news
11.
OPINION
Wilmington Healthcare explores how medtech should respond in the recovery following Coronavirus
12.
cover story
An insight into TTP’s fasttracked ventilator to tackle COVID-19
26.
digital health age
The data centre at the heart of digital transformation, and the ‘Spotify playlist’ from your GP
34.
Real World Medtech
Ian Bolland talks to Quali Digital, about headset use in a clinical setting THE TEAM editor | ian bolland ian.bolland@rapidnews.com advertising manager | christine joinson +44 (0)1244 680 222 christine.joinson@rapidnews.com
features 15.
Playing to your strengths
MED-TECH INNOVATION | NEWS
Accumold explains how its adapted to a COVID-19 world
17.
IRELAND
Jacqui O’Connor from MedScan3D explains its role operating from Galway
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24.
Realising Quality 4.0 Sempre Group shares a model for success for unifying fragmented data throughout the product lifecycle
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29.
Regulatory
IQVIA highlights key characteristics of a next generation quality management system
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32.
Med-Tech Innovation Awards
We highlight the finalists for the prestigious 2020 Med-Tech Innovation Awards
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from The editor
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Why UK diagnostics deserves a little more praise
am delighted to take on the editor’s role of Med-Tech Innovation News at a time when, from an industry perspective, it is fascinating to watch how it will change and develop as a result of this pandemic. I look forward to working with individuals and businesses in the sector for however long COVID-19 is a factor in our lives, and beyond. Certainly, interest has piqued in life sciences a result, and I have written extensively for our website on certain impacts of our sector. Supply chains, manufacturing, IP, AI and digital technologies are all topics that I’ve tried to cover online. But one thing I would like to address here is diagnostics. In one of his many briefings during this crisis health secretary Matt Hancock has said the UK has become a world leader during the crisis but said the sector had to be built up from
scratch, stating his desire that he would have liked the UK to have had the capabilities of Germany when it came to testing for the virus. From scratch seems slightly disingenuous. While one can sympathise at a desire to have larger lab capacity at the time at the scale of Germany, the headline can allow for something completely different to be thought of. Diagnostics is a key part of a robust sector of the UK economy where innovation is thriving. Lab capacity should have been part of the planning for a pandemic, and maybe that capacity could have been gradually built up if a virus planning group involving senior ministers wasn’t disbanded – as an investigation from the Daily Mail found. That combination could have allowed the government to get on top of the virus in a more commanding way than one that sees the UK with a regrettably high death toll. In 2018 the Office for Life Sciences reported that medtech accounted for £24 billion in turnover. The largest segment of the sector happened to be in vitro diagnostics. Combined with other segments including single use technology and orthopaedic devices – who were in second and third place in this particular table – they accounted for 27% of all
turnover in the core medtech sector. In vitro diagnostics was also the second largest segment after digital health for employment. Again, hardly nothing. Furthermore, PerkinElmer has had a presence in Wales for over 50 years and has worked with the devolved administration in Cardiff to build up capabilities – an example of using a long-lasting relationship to work in the interests of all to source testing kits and lab equipment. Though Hancock is responsible for the response in England, a glance over the border provides an example of a great diagnostics industry in the UK, which is willing to work for the common good. A bit more planning and less selfcongratulation from politicians leading the response to urgent crises going forward probably wouldn’t go amiss.
Diagnostics is a key part of a robust sector of the UK economy where innovation is thriving. Lab capacity should have been part of the planning for a pandemic
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Making medtech
Manufacturers to produce 1m COVID swabs a day
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nvisionTEC, a manufacturer of desktop and full-production 3D printers and materials, has completed a clinical trial to use the EnvisionTEC 3D printed Nasopharyngeal (NP) Swabs for COVID-19 testing. EnvisionTEC, as well as a number of its Envision One cDLM customers, has also registered with the FDA to take part in the endeavour. Many of the owners of these
units produce medical-grade products. The Envision One is capable of producing up to 2400 swabs in 24 hours, leading to a production capacity of EnvisionTEC and its Envision One user network of up to a million swabs per day. The company worked with Beth Israel Deaconess Medical Center (BIDMC) to develop a swab design and material to be printed on its Envision One cDLM 3D printer.
There are over a thousand units of the Envision One currently in use by firms including universities and medical device manufacturers. EnvisionTEC engineers have designed a collection tip for a flexible nasal swab that has completed testing in an IRBapproved clinical trial. Mechanical and chemical testing of both the design and the material was done to ensure that the swabs pick up viral RNA particles and do not interfere with PCA/reagents, that they are chemically safe, that they would bend 180 degrees without breaking, and that the design would be able to safely collect enough virus particles from the nasal passage to effectively test. The EnvisionTEC NP swab continued to perform in the same way mechanically after being sterilised by steam at 270°F at 27 Pa in an autoclave. Dr. Ramy Arnaout, associate director of the clinical microbiology laboratories at BIDMC, said: “Analytical results were positive, with a high level of concordance with the reference swab and with subjective results showing the swab performed neutrally or better than other test swabs.”
Research team develops strong and shapable nylon
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esearchers at the University of Birmingham have developed a new thermoplastic, aimed to be tough and strong but also easy to process and shape. A type of nylon, the material’s shape memory properties enable it to be stretched and moulded but able to reform into its original shape when heated. This makes it useful for medical devices such as bone replacements, where minimally invasive surgery techniques require additional flexibility in implant materials. The material was developed in the University’s School of Chemistry, by a team investigating ways to use stereochemistry – a double bond in the backbone of the polymer chain – to manipulate the properties of polyesters and polyamides (nylons). The study is published in Nature Communications.
Biocompatible polymers are widely used in medicine, from tissue engineering to medical devices such as stents and sutures. Although much progress has been made in the area of resorbable or degradable materials that are broken down by the body over time, there are still only a handful of non-resorbable polymers that can be used for longer-term applications. The new material can be made using standard chemistry techniques and offers a stable, long-lasting option, with mechanical properties that can be tuned for different end products. Senior researcher, Professor Andrew Dove, said: “This material offers some really distinctive advantages over existing products used to manufacture medical devices such as bone and joint replacements. We think it
could offer a cost-effective, versatile and robust alternative in the medical device marketplace.” The research team were able to design and produce the plastic, which is now covered by a patent, and test it on rats to prove its biocompatibility. The team now plans to explore further ways to fine tune the material and its properties before seeking a commercial partner.
Medtech and pharma receive €200m from IDA Ireland
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nvestments totalling €200 million from IDA Ireland have been announced for the pharma and medtech sectors in a new, targeted COVID-19 fund. The organisation acknowledges there is competition for foreign investment in sectors such as medtech. The tánaiste Leo Varadkar said: “Throughout the COVID-19 crisis, the IDA’s extensive client base has shown real grit and resilience in responding to the economic shock caused by the pandemic and many have been to the fore in helping with the COVID-19 emergency. “Medtronic in Galway increased the production of ventilators to meet worldwide demand for the life saving devices, from 200 ventilators a week at the end of February to more than 1,000 a week by the end of June, while Mallinckrodt Pharma in Blanchardstown and Intel are among the many firms who have donated tens of thousands of items Personal Protective Equipment to frontline staff.”
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MEDILINK UK
EAST MEETS WEST IN MIDLANDS TIE-UP M edilink East and West Midlands will operate under Medilink Midlands in a move aimed to serve the best interests of the life sciences sector in the region. This unification was unanimously endorsed, in principle, by the boards of both organisations in June and is the culmination of a strategic alignment that has been developing over the last six years. Under Medilink Midlands, the organisation will have a combined network of over 8,000 contacts within the life sciences sector. This includes the NHS and key universities, along with the many businesses that operate in the
sector, ranging from innovative start-ups, right through to multinationals such as 3M, Walgreens Boots Alliance, The Binding Site, Quotient Sciences, Kimal and Salts Healthcare. The two organisations first began working together in 2014 with the initiation of a Midlands wide skills programme. Since then a number of other collaborative programmes have been established to help grow the sector in areas as diverse as personalised medicine, digital health, defence medicine, inward investment and international trade. This amalgamation will serve to further utilise the skills, knowledge and expertise resident
within the region and will provide a more connected focus on influencing Midlandswide and national initiatives. Keith Widdowson, chair of Medilink East Midlands, said: “This move to bring the two organisations together fulfils a real need in the life sciences market. With the rich history and track record of innovative life science companies across the East and West Midlands, combined with the strength of depth in the supply chain, the future partnership and growth opportunities for our companies will drive the Midlands forwards to ever greater heights.” Prof Martin Levermore DL, chair of Medilink West Midlands, added:
“This is an opportune time to formally bring together the East and West Midlands life science community. The East and West Midlands complement each other wonderfully and there is a clear and logical connection between the two regions. As
Medilink Midlands, we will strive to ensure that what is great in our region is raised to the highest stage and what is already good will be helped by us to become even better giving a pan regional delivery for all Medilink members.”
SurePulse secures £1m investment for baby heartbeat monitoring
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ottingham-based SurePulse Medical, which developed a newborn baby heartbeat monitoring device, is set to explore foreign markets and grow its product portfolio thanks to £1 million secured from existing and new, private investors. The company was established in 2014 as a joint venture between the University of Nottingham and Derby-
based Tioga– combining academic strength with the expertise of one of the UK’s top electronics manufacturers. James Carpenter, CEO of SurePulse, said: “Despite the uncertainty surrounding the Coronavirus, investors continue to be upbeat about the long-term commercial potential of the business, and have reinforced this through new investment.
“The need for innovative medical devices is more important than ever as our healthcare systems experience unprecedented pressure. This investment will help SurePulse to drive market-share gains and continue and continue its exciting product development plans.” SurePulse VS measures a baby’s heart
rate with a forehead sensor that sits inside a specially designed, disposable cap, which transmits pulse information back to a wireless display. The device provides simple, hands-free, accurate, and uninterrupted monitoring; enabling clinical staff to make fast, confident decisions and focus on performing procedures in timecritical situations. It was awarded its CE mark in 2019 and has been trialled in NHS hospitals on over 300 newborns. The optical sensor technology underpinning the hands-free heart monitor was developed in the Faculties of
Engineering and Medicine at the University of Nottingham. The research teams were led by Professor Barrie Hayes-Gill and Dr Don Sharkey – both academic co-founders at SurePulse Medical. Professor Hayes-Gill, research director at SurePulse, said: “It is a great achievement to see a medical device that was designed and trialled by our collaborative research groups reach clinics around Europe. SurePulse is another spinout success story and one that aligns with the UK Government’s Industrial Strategy to commercialise research and deliver skills and jobs in STEM fields.”
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How will medtech recover in the recovery? Wilmington Healthcare examines key areas of the Life Sciences Recovery Roadmap report, exploring how medtech should respond in the recovery following Coronavirus.
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ransforming partnership with the NHS, an agile approach to regulation, and accelerating patient access to new and improved treatments will be of utmost importance in the post-COVID landscape, according to a joint statement by Life Science professional bodies.
Life Sciences Recovery Roadmap: A joint report to
the Life Sciences COVID-19 Response Group highlights six areas that will be crucial to the way medtech works with the NHS in the future: • Transforming NHS partnership and supporting the Long Term Plan • Developing a comprehensive strategy to improve UK manufacturing capability and supply chain excellence • Encouraging ‘globally competitive’ R&D incentives • Transforming the UK clinical research process • Taking an innovative approach to regulation • Accelerating deployment of new and existing technologies
Supporting the Long Term Plan
Building on and learning from the COVID-19 response, NHS leadership should develop strategic processes to involve industry in work to support NHS transformation and healthcare provision, the report says. This should include the retention of changes in adoption of innovation and digital solutions, but also embedding new ways of working, including harnessing the potential of data, promoting self-care, bringing healthcare closer to home, and diagnosing and treating faster. Industry is keen to work with the government on how the NHS and health infrastructure can be supported during the COVID-19 recovery process and thereafter, and seeks longer-term recognition from NHS England/Improvement (NHSE-I) of the life sciences sector as a strategic partner in improving health outcomes. Manufacturing and supply chains Although the report noted that supply chains had generally responded well in the crisis, it said additional resilience could be provided through improved demand forecasts and
transparency along the supply chain. It called for support for supply diversification, international inventory management and the development of a strategic reserve of essential products. In parallel, there should also be a focus on targeted support for UK manufacturing of medical technology and diagnostics. It recommended this be achieved by setting up a new group that is equipped to focus on supply resilience across the life sciences industry or through expanding existing groups. Manufacturing facilities being built in the UK could be supported by grants, and innovation funding made available for collaborative R&D. A specific Life Sciences Council workstream to support growth in the SME base would also ensure that UK manufacturing capability is broadened.
Accelerating deployment of new and existing technologies
The report notes that the COVID-19 response has shown that rapid scaleup of existing treatments, devices and diagnostics can significantly improve patient outcomes while making more effective use of NHS resources. It saw the need for decisive action to build on this, especially as the NHS will now have to address the backlog of care for nonCOVID patients. The learning from the pandemic should be factored into a rapid evolution of NICE methods to support patients
getting fast access to new treatments and technologies, it argued. It also called for a practical assessment of opportunities and challenges in the health technology procurement system, that should be carried out with the support of the Health Technology Partnership. In order for all this to happen, there would need to be a shared vision and a joint working group across DHSC, OLS, NHSE, NICE and industry to set out the level of ambition - and support NICE to make the changes that are necessary. Conclusion The life science industries are gearing up to make the positive changes made possible by the pandemic a standard part of the UK healthcare landscape. Procurement, regulation and assessment are all areas for swift and beneficial development. Future procurement strategy for critical devices should not be based on lowest cost alone, but should also consider value, secure plurality of supply and a multi-vendor approach in critical areas. It links the constant emphasis on price in the NHS and single supplier contracts, with manufacturing being driven to low cost labour markets, weakening the resilience of UK supply. Ultimately, a partnership approach is needed: systems should be rebalanced to include a commitment from the NHS to purchase as well as a commitment from industry to supply, at least for critical supplies.
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on the cover
WORKING ROUND THE CLOCK
Bradshaw explained that whilst other organisations – such as in the aerospace and automotive sectors – were tasked with developing ventilators with modifications to existing design, TTP was given a brief to rapidly develop a ventilator from scratch. For TTP, this was about creating a new prototype that responded to the specific COVID-19 challenge – this level of innovation is usually unheard of in such a tight time frame. TTP developed a ventilator ready for MHRA approval in six weeks, a project that would normally take between two to five years. One of the main considerations, given this was a health emergency affecting other parts of the world, was TTP could only use parts readily available in the UK supply chain and ones that could easily be manufactured. The companies involved had to avoid conflict when selecting items. Bradshaw said it could have been a real challenge but was full of praise for the supply chain, describing the response as surprisingly easy and heartwarming. “It was a challenge that people were aware of right from the outset. It starts with the selection process, when we were thinking about technologies, parts, components, or indeed manufactured items. “We had a team here at TTP who co-ordinated with the Cabinet Office to make sure what we were selecting was available in the UK, and available in volume. “We had to ensure that the design, including the materials used in it, are intrinsically safe. You know that it’s safe because of what you’re selecting. It does restrict the number of materials or components you might use because you don’t have the access to testing to prove it.”
Ian Bolland spoke to Douglas Bradshaw from Cambridge-based technology and development company, TTP plc. The company developed the CoVent ventilator following a call from government to increase ventilator capacity as part of Ventilator Challenge UK, as part of the country’s efforts to battle COVID-19. 12
The three main aspects that informed the design of CoVent was to make sure the device was safe, clinically effective, and could be manufactured in high volumes. Developing a ventilator during a national and international health emergency in the space of six weeks might be unheard of, in part helped by derogation in CE marking in order to bring the devices to the front-line as quickly as possible, but in terms of its development Bradshaw suggested the company was able to take it in its stride.
on the cover
It was quite evident that it was a crisis, there was very clear direction provided by ministers, the goal was set out pretty clearly Given the urgency of the impending national emergency within 24 hours a team of experts that quickly grew to 140 people came together and began to carry out all these tasks in parallel (Figure 1). By necessity, the pneumatics, mechanics, user interface and electronics of the ventilator were all designed simultaneously before the first MHRA device specification had been released. The regulatory documentation plan was being put together without a clear idea of what the device would be. Prototype units were being designed and built at the same time the production line was being laid out. The instructions for use were being drafted prior to having a functioning prototype. All of this happened without a traditional line management structure but instead with highly distributed authority and responsibility. What surprised those at TTP is that they didn’t see all the mistakes and substantial knockon consequences that would be expected when working in such a fashion.
and clinically effective ventilators into the NHS in volumes, the fact that we achieved that goal and we are ready and able to do that again if it’s needed - God forbid - it gives me a great sense of pride that we were able to do that.” Developing a ventilator that was clinically safe and effective meant the company worked closely with the MHRA and NHS clinicians from the outset. As TTP employs clinicians and has an established network of medical experts, including those from the NHS, getting real time information from the front-line about the disease helped inform that aspect of the design.
“At TTP, in a sense it’s what we do every day. People come to us to achieve the impossible or the seemingly impossible, and so for us in many ways it was quite routine to be faced with a seemingly insurmountable challenge.
“One of the challenges that countries have faced is that the disease is not particularly well understood, and this is true in the UK as it was abroad. The main involvement of the MHRA was helping to identify what the clinical requirements were as that understanding evolved through the early days and weeks of the crisis, and then how you translate that clinical insight into design requirements. As the clinical picture of the disease changed, we rapidly implemented additional functions for suction to remove lung secretions and support for spontaneous breathing.
“The fact that there was this goal of being able to potentially deliver safe
“Ostensibly, TTP is right in the middle of helping translate that
clinical requirement into a technical specification – one that the design teams can make sure that what we’re designing is a product that’s not only safe and been manufactured in volume, but also clinically effective.” Bradshaw also shared some insight as to what it was like working so closely with government at a time of national emergency – saying the gravity of the situation was clear from the outset. “It was quite evident that it was a crisis, there was very clear direction provided by ministers, the goal was set out pretty clearly. “They’ve also been very keen to make sure it’s consistent across the board. It was patently clear there was consistency and fairness in the way they’ve treated all parties in terms of information and the support that they’ve given. “The combination of TTP, the relationship with government, the relationship with our suppliers and manufacturing partner, I don’t think you could ask for more.”
Figure 1
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MICRO AND NANOTECH
PLAY TO YOUR STRENGTHS
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Aaron Johnson, VP of marketing and customer strategy, Accumold, writes about managing and building relationships with medical device manufacturers during COVID-19.
s we work through the wake of the pandemic lockdown, I guess it is fair to say that as individuals and businesses we have all had time to contemplate and learn some lessons – including me personally and for Accumold as well. Typically, Accumold attends numerous trade shows and one-to-one meetings with customers and potential customers alike. For the last few months, this has obviously not been possible, and so we have faced the issues, and adapted. The key to success in keeping a business going in times like this are not magic tricks, but redoubling efforts company-wide to emphasise your strengths, and keep working with customers in a pragmatic way that engages with them constructively and sensibly. We work with customers from across the world that require sometimes impossibly small and complex plastics parts for medical applications. Most, if not all, of these companies have had to put in place plans to mitigate disturbances caused by the COVID-19 pandemic. For most there were two possible courses of action, on or off (with off not being an option), and they have had to work with their supply chains to create solutions where possible.
One of the areas I think will demand significant attention over the upcoming months and years is supply chains. There will be numerous companies, especially some backed by national governmental initiatives, that will look to address the vulnerabilities of long and unwieldly international supply chains. In addition, it will be seen as desirable to cut down the actual number of areas of design and product development that are outsourced to third parties. For Accumold, these trends play to our inherent strengths. We are a successful micro moulder that produces parts and components that few companies across the world can – a product of our history as a micro moulding innovator stretching back over 30 years, and possible because of a knowledgeable and dedicated team. Our medical device customers don’t view us as a manufacturer, but more a consultancy that also manufactures. They buy into our knowledge of micro moulding to influence the product development process from design to automated assembly.
possible because we are truly vertically integrated, with the experience and knowledge of micro tooling experts, micro moulders, QA/QC personnel, and automated assembly / packaging teams are all combined to optimise outcomes under one roof. This also means our customers can rationalise the number of companies in their supply chains, reducing vulnerabilities highlighted by the COVID-19 pandemic, but also more generally promoting the achievement of products that are right first time, fit for purpose, and manufactured in a timely and cost-effective fashion. During lockdown, barring the inability to interact on a face-to-face basis, we have, if anything, seen a strengthening of the bond between us and the medical device companies that we serve. It is at times like this that reliance on tried and tested procedures and methods of design and manufacture become even more critical.
integration and the expertise to provide best-in-class advice concerning Design for Micro Moulding (DfMM). This is the key to success in micro moulding, in ensuring robust and long-term relationships with customers, and to being chosen as a micro product development partner especially in times of uncertainly and instability. DfMM is an art and a science, and it is something that requires an innate understanding of the vagaries and unpredictability of micro moulding. Without a certain and secure understanding of DfMM, costly and time-consuming failures are almost inevitable, and especially in times of economic fragility, need to be avoided at all costs.
Our customer facing positioning has been to simply re-enforce our credentials and credibility; such as true vertical
They see us as strategic partners as we can mitigate risk of sub-optimal products or products that cannot attain exacting tolerances. This is
Our customer facing positioning has been to simply re-enforce our credentials and credibility
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IRELAND
In Profile: Operating in the ‘medtech centre for cardiology’ Ian Bolland spoke to MedScan3D’s technical director Jacqui O’Connor, about its offering, the advantage of its Galway base and the part it played in helping front-line health workers in Ireland during the COVID-19 pandemic.
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t the start of lockdown many companies from several different sectors were switching their production lines to cater for the urgent need of medical equipment for front line medical staff and key workers. It was the same for MedScan3D in Galway. At a time when business slowed in terms of demand for its anatomic models, the company switched its focus to developing protective face shields for Irish care homes. The company set up a GoFundMe page to allow donations to cover the cost of developing and delivering the equipment to the frontline.
Jacqui O’Connor, technical director at MedScan3D explained: “At the end of the day we have the capability to print these face masks, and I couldn’t ethically sit back and ignore it.” The company has since launched products to try and keep people in the workplace safe as life begins to return to some sort of normality, launched under the brand name AMBI Safe. Products are manufactured by 3D printing technologies in an antimicrobial material containing nano-copper ions, which self-sterilises the material from microbes on an expedited time span. It’s hoped that in addition to other guidelines in place, such as using PPE and
social distancing measures, workplace absenteeism can be low. Anatomic models for surgery remain the focus at MedScan. O’Connor explains the company came about when she was on maternity leave. Her husband, James, runs 3D printing supplier 3D Technology, and when he received interest in anatomic models, O’Connor thought it was something she could do – with demand leading them to set up a different sector known today as MedScan3D. Explaining the company’s offering, O’Connor elaborates: “We sell ourselves as a consultancy firm, an extension to an R&D team. We work with different R&D teams and bring our expertise in on biomedical engineering. “We come to the table with more than just a file to print kind of service. It’s more of a project we take on with the companies to develop anatomical testing models they can use for their medical devices. “A lot of the time it would possibly be something to do with the heart, possibly a stent, or a catheter put in. They might want to have a specific part of the heart they’re testing on. They might want it to be patient specific or they just want a clinically relevant model that they can test on.” MedScan3D then takes files that are supplied to them, a lot of the time patient specific from surgeons and doctors, so they can be converted or segmented into a 3D printable.
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“Once we have that then we do a prototype using 3D printing, they can do preliminary tests on that and then if they’re happy with the design we can go to silicone casting, so they can do ongoing tests with that model. Within that model before we go and print it our CAD designer can then add different ports, can edit it to suit their demand, basically, if it means they want to slot it into a simulation model they already have.” The Galway base has its advantages for the company as a lot of its business tends to be focussed around its cardiology offering, which O’Connor acknowledges, as companies such as Medtronic and Boston Scientific are close by along with many more. Though O’Connor describes Galway as the “medtech centre for cardiology devices,” she’s keen to stress the company can focus on other areas, though the vascular space is where most of MedScan3D’s business is done. “There’s probably a couple of hundred companies on our doorstep and the bulk of our business comes from that. But we can do orthopaedics, ortho dentistry. “Bones are also quite easy compared to vascular. Vascular is quite complicated to convert into 3D image because you have to separate all the different blood volumes and vessels and things like that. That’s where our expertise comes into play because we can convert and segment something that we see a lot of. It’s what we look at all day.”
IRELAND
Strong present, bright future: Why Ireland’s start-up scene is full of promise
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Ian Bolland takes a look at a recent example of start-up interest which shows the strength of Ireland’s medtech reputation.
ust looking at the names of the companies that operate in Ireland, it doesn’t take you long to recognise that medtech is a significant part of Ireland’s economy, and an attractive place to do business. With nine out of the world’s top 10 medtech companies based in Ireland, it’s safe to say it’s one of the world centres for the industry, and an essential sector for the country’s economy. Interest in medtech has increased dramatically during the course of COVID-19 – much of the focus has been dedicated to those who have provided parts for ventilators, personal protective equipment, testing, as well as pharmaceutical companies playing their part in a search for a vaccine. Medtronic, with a Dublin base, was at the forefront of the global response to ventilator shortage as it shared its specifications for the PB 560 ventilator to enable multi-industry participants to rapidly manufacture devices to aid the front line. They received over 100,000 registrations for the specification – including from large scale manufacturers in Canada, Vietnam and Taiwan.
There is good reason that upwards of 200 companies operate in Ireland. Being able to act as the bridge that can serve and facilitate both the U.S and European market also helps its cause, along with its reputation for innovation, research and manufacturing – helping it become the second largest exporter of medical products in Europe. Away from the more household names in the sector, its start-up scene appears to be in rude health, and has also played its role in combatting the pandemic facing the world. In June EIT Health announced that 10 of the 89 start-ups to receive €40,000 worth of backing from its Headstart programme were from across Ireland. By comparison, six UK firms had received the same backing. Though cliched, it’s an example of how the country punches above its weight given its population, but the reputation the sector has developed in
Ireland over the years means this should not surprise anyone with knowledge of life sciences. The range of solutions on offer from the 10 companies also speaks volumes considering the pressing needs of the Coronavirus pandemic while addressing other needs. These include reproduction, diagnostics for sepsis, the use of nanotechnology to help with surgical procedures along with those that a more at home with general public like AI solutions and wearables, showing that innovation doesn’t exist in one specialist area in the country, but across the entire medtech spectrum. Little wonder that, per capita, it’s among the largest employers of medtech professionals in Europe. From a competitive standpoint, Ireland is going to take some beating.
Boston Scientific, BD, Baxter and DePuy are also among those located in the country, while in this issue, Jacqui O’Connor from MedScan3D describes Galway as “the medtech centre for cardiology devices” given the vast amount of companies operating in the field.
Its start-up scene appears to be in rude health, and has also played its role in combatting the pandemic 17
ANTIMICROBIALS
TESTING TIMES
Combatting antibiotic misuse and antimicrobial resistance Kfir Oved, chairman, co-founder and CTO of MeMed Diagnostics, writes about the development of its new technology aiming to combat antibiotic misuse and antimicrobial resistance (AMR).
KFIR OVED
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ntibiotic misuse and the resulting global health challenge of antimicrobial resistance (AMR) has been around for decades. Unfortunately, despite numerous new technologies having been introduced to the market over the last few decades, we have not achieved a significant impact on this core problem. The first step in trying to solve this problem is to ask why state of the art technologies, developed by great teams, have failed to make a change in the rates and spectrum of antibiotic misuse and AMR? The clinical dilemma that faces physicians when a patient presents with a fever is seemingly simple: to treat or not to treat with antibiotics? The challenge arises because bacterial and viral infections are often clinically indistinguishable, and physicians may feel there is often little choice but to prescribe an antibiotic because of the lack of clarity about the disease aetiology. Numerous pioneering technologies have been developed in recent decades including multiplex PCR, rapid culture systems, rapid testing, and single biomarker analysis, all with the aim of helping physicians identify the pathogen and help guide treatment. In order to create a real game change in antibiotic prescription habits, any technology must fulfil a list of requirements including: • Accuracy of the test (>90%) • Short time to results (minutes) • Solution for inaccessible infection sites
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• Inert to the presence of the natural flora • Robust to rapidly evolving pathogens • Accessibility at the point of need • Cost-effective • Easy to use While many of the newer technologies improved on one or more of these aspects, no single technology has ticked every box, and have not made a significant impact on antibiotic misuse. To find a solution, we went back to basics. What is the problem? To treat or not to treat with antibiotics. What did we look for? A way to distinguish between bacterial and viral infections that meet the requirements above. How did we do this? We utilised a very sensitive and accurate system that was crafted by nature: our immune system. What did we discover? The immune system responds differently to bacterial and viral infections, but there is no single biomarker that gives us this information accurately enough. Using a large-scale discovery process, we have identified the relationship between a key group of biomarkers: TRAIL, IP-10 and CRP, that decodes the host’s immune response to the source of infection. If we go through the above list, this approach ticks all the boxes. A multiparametric signature that captures the immune response during infection was shown to be highly accurate in numerous doubleblinded, multi-centre clinical studies (>90% sensitivity and specificity), testing using immunoassays can be done in minutes, there is no need to access the infection site, and
the immune system is robust to the presence of colonisers that are part of the natural flora and to detection of emerging pathogens. The combination of our three-protein signature and proprietary algorithm is the MeMed BV test. After defining what should be measured, we asked how we measure it? This impacts on time to results, ease of use, access at the point of care and cost-effectiveness. For this purpose, we developed a miniaturised immunoassay platform based on magnetic beads and chemiluminescence – the MeMed Key platform – which can run the BV test in 15 minutes. Both platforms were awarded CE mark clearance, allowing physicians to distinguish between bacterial and viral infections and confidently rule out the unnecessary prescribing of antibiotics. Our aim was to tackle antibiotic misuse by developing a diagnostic solution that distinguishes between bacterial and viral infection with central lab precision at the point of need. Data from more than 15,000 patients shows we have done this. The next stage of our journey will be to utilise this approach to provide physicians with new, clinically relevant information based on our body’s response to diseases and injury.
Lasting change: The legacy of COVID-19 on health and care delivery Dr Anne Blackwood, chief executive, Health Enterprise East explains how COVID-19 will change health and care delivery for years to come.
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t is without doubt that the COVID-19 pandemic has impacted practically all aspects of our lives – and of course, health and care services are at the very forefront of this. Now, as the crisis period begins to subside, and with routine services starting to resume, we can start to consider what the future holds. ‘Normal’ working practices have been thrown out of the window due to the Coronavirus, and in their place digital health technologies have become commonplace for healthcare providers. An easy example is the huge uptick in remote consultations, be that over the phone or using video platforms. We have also seen the mobilisation of big data and artificial intelligence (AI) to track COVID-19 cases and help in the race to develop vaccines. There will be far too many to list, but it is certainly clear that such new innovative ways of working have all helped lead the fight against the pandemic. We are seeing lockdown restrictions relaxed, but it is clear that social distancing measures will remain in place for quite some time. This brings with it a continued impact on capacity for the
NHS, but also, and more positively, an extended timeframe for recently adopted technologies to really become embedded into the way care is delivered. Enhancing the efficiency of task-based activities and therefore freeing up clinician’s time and reducing costs is as vital as ever, and there are digital health platforms that do just this. For example, Medic Bleep, which provides secure and real-time communication between healthcare professionals, with a potential to replace outdated pager technology and facilitate safe clinical handover when shifts end. There is also MediShout, which uses digital technology and AI to solve logistical platforms, enabling clinicians to instantly report issues and even the potential to predict future problems. These digital health companies are gaining momentum because they understand it’s not just about the tech but understanding people and workflows too. Maintaining momentum In the past, an overstretched and fragmented system has seen new
innovations fall by the wayside, with cultural and financial barriers often hindering rapid widespread adoption. In the last few months however, it is the barriers that we have seen begin to fall away – and it’s this progress that the medtech industry must hold on to. In the current uncertain economic climate, it may feel tempting to press pause on certain research and development (R&D) projects and concentrate instead on sales of existing products – but this would be a mistake. At present, the NHS is more receptive than ever to needs-based innovation, something that innovators must utilise. Accessing financial support will be critical for companies to see their innovations through to adoption, especially when venture capitalists might be focusing primarily on their existing portfolios rather than investing in new opportunities. The government’s £1.25 billion support package for innovative tech start-ups is particularly welcome in this sense, while there are also smaller-scale industry schemes such as
Health Enterprise East’s own MedTech Navigator programme which has recently launched Innovation Grants for SMEs. One thing that has been hugely uplifting is the way health and care providers and industry have worked together to face the crisis. By directly engaging with one another, the NHS’ access to much-needed equipment in short supply has been greatly helped. Long-held commercial interests from pharmaceutical companies have also been put aside, for instance lending their knowledge to collaborate on potential vaccine candidates. In future, we might see these bigger businesses seeking out more partnerships with innovative smaller players, rather than spend on internal R&D projects that are less certain. Maintaining this spirit of collaboration is absolutely critical. Whatever the future may hold, industry is key to helping provide answers to some of the biggest health and care challenges of our day. With engagement strong and communication lines open, innovation can enhance health and care services now, and in the future.
At present, the NHS is more receptive than ever to needsbased innovation 19
M&A’S
Why medtech remains robust during a downturn Ian Bolland spoke to David Mardle, partner at Goodwin’s Technology and Life Sciences practice, about the health of the M&A market during the COVID-19 pandemic.
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t a time when the UK, and the global economy, is experiencing one of its deepest recessions on record, medtech, perhaps unsurprisingly, is one area that is robust for mergers and acquisitions. The UK economy shrank by in excess of 20% during April to contribute to its deepest recession on record. But, throughout this period, medtech fared better than most. Mardle explains that the robustness may be because of the broad range of sectors that medtech covers, with more digital health offerings and technology that can be supported by video calling and other virtual operations boosting the market. He said: “I think the appetite for investing in the sector is robust and growing, it’s actually a growing sector as people become more comfortable and aware of the opportunities. When you talk about medtech you’re talking about a broad range – you’ve got software at one end and advanced engineering at the other and all sorts of things in the middle. There’s plenty of room for people to find something they are interested in. “I do think that particular convergence in funds that have been successful in backing enterprise software businesses are pivoting into businesses which are playing on that interface between patient care and medical professional.
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“Medtech as a space is actually doing really well as it’s not the high risk, really complicated science stuff that investors
do struggle to get their heads round. You can talk to software people. If you’ve done software deals elsewhere you know how to calibrate the opportunity. Doing diagnostic plays that’s a bit more complicated, you need to know a bit about advanced manufacturing and engineering. Again, there are plenty of funds that do that so they’re all pivotal in working towards this. That’s driving a lot of attention and noise. “Why are the buyers looking? The short answer is much of what they need to sell into their own supply chains, they don’t actually own. They need to go and buy it. They’ve got the distribution networks, they’ve got products going through the distribution networks, but they need more. I think that’s driving a huge amount of interest in businesses across the space but in medtech in particular.” Though there might be lots of interest and deals closing in the sector, it’s not without its hurdles as people have been adapting to enforced changes because of the Coronavirus – the legal profession included, as and when agreements have been signed. Inability to make site visits and travel has prolonged the process in some cases. Though some of the deals that were being closed under the more stringent lockdown regulations saw some of the groundwork done beforehand. “There had already been some kind of physical interaction there in some trust building exercise in the conventional way and they’re closed out. The one’s being
originated now, in some cases the people concerned have never met. “There are a few legal processes that have had to be modified. From a UK lawyers’ point of view, we had 300 years of law that had to suddenly pivot into a digital environment. A classic example is we use deeds for our transactional paperwork, and it requires a witness for it to be effective, but you did not have the ability to have effective witnessing going on during lockdown. “The practice of law has had to adopt more flexible approaches to get around these problems. It’s not a big issue in the scheme of things but it’s a good example of how a sudden correction in people’s behaviour in societal norms has these ripple-on effects.” While many businesses are likely to face several challenges to get back on track following the economic hit brought on about the pandemic, Mardle feels that the challenges surrounding medtech aren’t specific to COVID-19 itself, though has identified at least three areas that SMEs and start-ups might find challenging. “People, and the ability to get people by paying them and incentivising them in a world where there is a backdrop of economic bad news, and convincing those people you’re the right proposition because without the right people to scale the business up, your start-up is never really going to get the return that you need.
M&A’S
I think the appetite for investing in the sector is robust and growing “Issues around getting access to capital, I think for medtech at least, is not the drama that it might be in other sectors for start-up businesses. “Then you’ve got all of the issues surrounding getting engagement with third parties like potential customers and channels to market. That is an issue in medtech because many of the things that people are trying to do are disruptive of really quite well established
businesses. If you’re building a robot to go into a hospital to do keyhole surgery, for example, and you’re a start-up then you’ve got to go and talk to people who are pretty conservative buyers, and you’re coming up against some very significant existing players such as large, often US, corporates. This “traction issue” might be something that many medtech companies would identify as the most pressing challenge.
Mardle explained: “How do you get your customers? How do you get them to scale? Because that’s what allows you build some recurring revenue that allows you to raise more money which allows you to get more customers. Those issues are not COVID related. They’re probably made more difficult by COVID because it comes back to that standard thing of how do you meet these people? How do you build a rapport with them?”
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CATHETERS AND STENTS
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MAKING STENT delivery simpler
fter finding issues delivering stents during endovascular surgery, former head surgeon Krister Liungman, founder and innovation lead at Endovab, developed an idea to make the process more straightforward. Ten years ago, patients who needed their aortic aneurysms repaired were performed by surgeons, who made the change from open surgery to endovascular surgery due to the high risks for the patient to get infections whilst being operated on. As well as the long recovery time, the new technology with radiology and medical products meant that endovascular surgery was able to be established. It was now possible to have a patient that may have had a higher mortality chance in an
operation to have a catheter inserted in a vein and then you can use a guidewire to pass a stent into the position where the aneurism needed to be repaired. This meant that it was no longer required to open the patient but with the use of x-ray you could see inside the body. This meant that the time the patient was supposed to be in an operation was reduced, resulting in safer surgery. However, nothing is always straightforward which is when Krister Liungman, who had worked as a head surgeon for 20 years in Uppsala Hospital, Sweden with open surgery, started with endovascular surgery and found an issue with the guidewire that was used in delivering the stents. The guidewire is not flexible, you can puncture an organ and he felt the most frustrating thing about this piece of equipment was that when you think you have it in the right place and you are wanting to deliver the stent, it moves and you have to start the whole relocation again.
Liungman spent 12 hours with his first operation with a patient on the table and this was the point he realised that there needed to be an anchor system so you locate the right place and you can then distally secure it in the correct location. Also 30% of aneurysms are complicated and the were made possible with fenestrated EVAR and this is why the anchor was invented, but in a wider perspective the anchor can revolutionise the endovascular area. With any medical technology and invention it inevitably took time and lots of money. Liungman set out on a journey of how could he create the right product so he set off with many drawings and to find the right partner that could produce a protype plus that would be great at
supporting and giving advice. Once this started to take shape then the re-equipment for patenting the product was important as well as finding financial backing. To be able to fund an idea like this Liungman was awarded with a grant from the Swedish innovation system. There were also many animal studies completed and patient operations so there was the right data in place for the regulatory requirements for patient use. Fast forward 10 years and nearly â‚Ź2 million the product exists as Liungman Guidewire Fixator, there is a global patent family, it was awarded its CE mark in 2020 and there are products sitting in Uppsala, Sweden ready to help an endovascular surgeon perform safer surgery.
In a wider perspective the anchor can revolutionise the endovascular area
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industry 4.0
Realising quality 4.0 Jason McGlynn, The Sempre Group, shares a model for unifying fragmented data throughout the product life cycle.
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etrology is fundamental to ensuring a medical device operates to design intent and therefore meets the safety and performance requirements for the patient, such as measuring critical features of an insulin pen or inhaler device to ensure that it dispenses the correct dose. Medical devices are becoming more complex and less intrusive, bringing added complexity. Customers require nano and micro precision measurement equipment that is repeatable, reproducible and compliant. From dimensional to surface characterisation and contamination, there are many applications for measurement throughout the product lifecycle. Though ISO 13485 and many other standards lay out how to maintain an effective quality management system in line with regulations, there are still many decisions for medical device companies to make. The two regulations are due to be combined soon, but historically the FDA has not mandated traceability between stages, while ISO 13485 has, so many companies will be looking for guidance on how to improve quality in line with the new, combined guidance.
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The Quality 4.0 revolution
Industry 4.0 brings with it a data-driven, digital approach to quality, which can help medical device manufacturers improve decision making, traceability and reporting. Quality 4.0 would make clear if anything changed on the line, where, why and how it happened, providing complete data integrity and traceability. The first component of Quality 4.0 is to integrate quality management into an electronic quality management system (EQMS) in line with ISO 13485 and 21 CFR part 11, to prevent any human errors or duplications that occur when working with paper. Then, incorporate programmable systems to automate key manufacturing and measurement processes, as well as to automatically collect data. Connectivity is king — pulling together all data and integrating it with your manufacturing execution system (MES) means you can assess top level trends and take proactive decisions to decrease scrap and boost productivity. As a result, compliance is easy — users can automatically generate reports to comply with relevant standards.
Full visibility, total data integrity
Let’s consider some examples. A small medical device company is looking to bring its first product to market. It needs to make sure that the measurement system meets the design authority intent as outlined in the drawings. However, it is unable to link the measurement data with the 2D drawing and 3D model accurately — if a failure arises, how can the manufacturing team tell where it occurred? Using artificial intelligence metrology software, you can now link the two together and overcome this challenge. A larger medical device company can work with several contract manufacturing organisations (CMOs) globally. All CMOs are working from the same drawing, but the products are measuring differently across locations. The problem has occurred because the MDC is struggling to standardise its approach to measurement data and reporting from wacross the locations. A software platform could link all the sites into one interactive system, so the medical device company can support CMOs through continuous improvement.
A fully integrated approach to metrology and quality removes the challenges associated with integrating data from multiple sources. A software platform like High-QA and ProLink, can connect to all measurement and manufacturing systems, integrate with an MES, and provide a foundation for tracking and trending data throughout the product life cycle.
Productivity
A Quality 4.0 approach can help bring products to market more quickly. But many of the benefits come during manufacturing, by ensuring measurement systems are accurate, repeatable, and reproducible to the design intent. In addition, getting metrology equipment right first time during the NPI phase can drastically reduce the time it takes to perform measurements during validation, removing metrology bottlenecks and speeding up production. In addition, staff can move away from monotonous inspection roles into more productive ones. The connectivity inherent in Quality 4.0 can also provide the visibility needed to improve yield. Manufacturers can identify and address anomalies, reducing the number of defective products.
INDUSTRY4.0
Enhancing speed and precision in testing Stewart Goulding, managing director at mechatronic drive system supplier EMS, explains how precision motors can enhance speed and accuracy in medical testing laboratories.
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hen the patient’s condition is not visually detectable during a doctor examination, clinical samples such as blood, skin cells or saliva are sent to medical laboratories for various tests. It’s important that these tests are performed quickly and accurately so patients can receive treatment as soon as possible, therefore minimising discomfort and preventing disease progression. For some diseases, such as cancer, early treatment is critical for the patient to experience a good treatment outcome. A medical laboratory can carry out up to 3,500 different diagnostic tests. With so many tests occurring at once on a large number of samples, an organised and efficient laboratory is vital. Automated laboratory equipment increases testing efficiency and decreases the possibility of human error.
EFFICIENT TRANSPORTATION
With each sample requiring its own unique combination of tests, transporting the samples to the correct area is crucial. Time spent in transport is time not spent in testing, so samples must be moved between areas as quickly as possible. Conveyor belts provide a steady and efficient way to transport samples around the laboratory. The motors inside the conveyor must have high torque to provide quick transportation. Precise speed control is important to accommodate frequent stops and starts, and to ensure all the motors are moving at the same speed to keep the conveyor steady.
When a sample reaches its relevant testing area, it is scanned to determine the required type of analysis. Robotic arms can then pick the samples from the transport container and place them in the relevant testing area according to their digital records. The robotic arms can repeatedly move many small samples at a greater speed than human laboratory technicians. The motors used within the robotic arm must be small and lightweight to allow quick and agile movements. They must also have high precision to ensure the sample is held firmly and correctly in a highly controlled grip to avoid damage — too tight a grasp may cause the sample to deform or shatter.
PRECISE PROCESSES
In addition to careful transportation, accurate processing of the samples is vital for a correct diagnosis. Many samples require a degree of manipulation using a range of equipment before, and during, analytical tests. Preparing the sample correctly ensures the test results are reliable. Centrifuges can separate a sample’s components so that only the material that is needed for the test remains. For example, blood can be centrifuged to separate it into its plasma, buffy coat and erythrocytes — a process known as blood fractionation. The individual blood components can be used for different tests, such as analysing plasma to detect the amount of proteins in the blood, such as globulin, which supports the immune system and blood clotting. The motors
Using compact, high torque motors with precise speed control to power automated laboratory equipment ensures an increase in accuracy and efficiency of sample testing
in the centrifuge must operate at high speeds to ensure a complete separation of sample components. Pipetting is used to divide samples up for different tests, move samples between containers and add testing liquid into a sample. Every drop counts when dealing with samples and testing fluids as an incorrect measurement could skew the results. Therefore, accuracy of an automated pipette is key to delivering a correct diagnosis. Automated pipettes that contain motors with precise speed control can remove and decant the exact amount of fluid needed. Mixing and stirring is important for preparing testing substances and distributing them evenly within samples. Consistency within the sample is important to achieve an accurate result. Motors used in automated mixing and stirring machines must have fine speed control to allow different turning speeds. They must also be able to operate reliably for long periods of time. While urology remains an important subject, medical tests have progressed far beyond medieval urine charts for disease diagnosis. Doctors today can send patient samples for a range of clinical laboratory tests to get to the cause of medical problems. Using compact, high torque motors with precise speed control to power automated laboratory equipment ensures an increase in accuracy and efficiency of sample testing, which brings patients relief faster.
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DIGITAL HEALTH AGE
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KEEPING DATA CENTRES FIGHTING FIT WITH THE DIGITAL TWIN Jonathan Leppard, director at Future Facilities discusses the data centre, the heart of what is helping digital transformation take place in a COVID-19 world.
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ll eyes have turned to how the latest advances in technology can rescue us from our current crisis. From track and trace, to monitoring regional spikes in cases. These digital transformation initiatives have seen legacy systems overhauled and the introduction of tools that allow health records to be stored and accessed from one database. There is only so much frontend investment organisations can make before gaping holes are found in the back-end infrastructure. One of the most important parts of the digital operating environment under increased pressure is the data centre. With lives on the line, it is imperative the data centre industry does not make the mistakes which will make this a reality. The past few months have pushed the data centre industry to the brink. As the public has relied heavily on cloud-based applications to work and socialise, a huge amount of stress has been seen on the world’s digital infrastructure. Both Microsoft Teams and Zoom grew from 200 million to 300 million users in one month! Amongst this strain, healthcare data scientists have also relied on public cloud resources, using AI and
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machine learning tools to contribute to urgent Coronavirus research. Two years ago, we saw a tech failure in the NHS which cost the government £7 million just to stabilise. As the amount of data flowing through the system has never been higher, senior healthcare officials must prioritise their tech infrastructure to avoid a further crisis. Meanwhile, industry operations have become complex. Data centre managers are faced with the challenge of balancing a vastly increased workload with new measures to keep their employees safe. To manage this, data centre facilities have restricted access to only the most essential personnel. Older facilities, designed for much lower power, are particularly challenged when modern high-density equipment has to be shoehorned in. Without accurate insight into power consumption to help
improve control and decrease cost, legacy data centre operators turn to overprovisioning or underutilisation to maintain reserve margins. The combination of high demand and operational challenges has created a tension point which only has one solution. Data centre operators must address the fundamental inefficiencies which lie at the core of planning and operations; and accept they cannot rely on the ‘rule of thumb’. Across the industry, accurate decision making on cooling, power and capacity is being compromised by the pressures that teams are under. Future Facilities recently commissioned a study which found 29% of data centre managers are compromising on decision making all of the time, while 45% are at least some of the time. It’s clear the damage that a lack of data is doing. Performance, quality of work and meeting
deadlines are all affected from not having the right information at the right time. To rectify this, data centres backing up our medical organisations must look to technology which helps them run more efficiently and reduces the chances of downtime. The latest trend supporting efficiency in the industry is the introduction of digital twins, which are integral components to engineering fields with zero margin for error. Think about the modelling of aircraft before hundreds of thousands of pounds are spent on construction. It is time data centre operations are treated the same. Data centre performance is a delicate balance between capacity, efficiency and compliance. The use of a digital twin allows operators to find the optimal balance to save energy and maximise performance. Once a setup has been found that achieves the desired results, it is then implemented in the physical data centre itself, safe in the knowledge it has been rigorously tested. This process saves money in designing and operating a data centre and mitigates the risk of unplanned changes while improving infrastructure reliability. Increased demands mean we need to rethink how we operate and ensure we are up to the challenge. This is vital to properly support the medical industry as it becomes dependent on technology that keeps us safe. Demands aren’t going to reduce any time soon, so we need to take a scientific, data led approach.
DIGITAL HEALTH AGE
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I
HOW AN IMMERSIVE APP CAN HELP BOTH DOCTORS AND PATIENTS
an Bolland spoke to Dr Tim Ringrose from Cognitant to discuss the Healthinote platform which provides immersive technology to a user via an app – and via virtual reality. The technology aims to offer a simple way for clinicians to give patients more information that they don’t necessarily have the time to provide to them during a consultation. The app uses QR technology so patients can be provided with the appropriate content for their condition. Dr Ringrose explains: “When we talk to clinicians, particularly in secondary care, they are very keen on a really simple way of being able to give information and prescription to patients. We developed the QR code idea which meant that a patient can be given a simple sheet of paper with a QR code printed on it and that enables them to download the content really easily. “It’s digitalising the old way of being given information which actually only happens in a minority of consultations. Our research shows that in only about 30% of consultations doctors give health information for patients to take away – and
that’s usually print. What we’re trying to do is digitalise it and make it much more accessible for the patients, but also to make it really easy for the clinicians.” The QR code is scanned by a smart device or a patient is provided with a code to allow them access to information and guidance about a specific condition or treatment. We were provided with access to more information surrounding rheumatoid arthritis. After a member of my family who has the condition trialled it, they believe having the platform available to them from their initial diagnosis would have enabled a greater understanding of the condition and its effects. The video content, which provides an animated guide to the conditions, caters for different learning types – including visual, text and audio learners. The platform was developed in consultation with research surrounding health information given to patients. “Across Europe it’s thought that 47% of population don’t have the educational standard to understand a typical health information leaflet.
“I think it’s important not to make too many assumptions but to provide patients with information in a variety of formats that people can understand.” The visual approach can also be accommodated in a virtual reality format, with a Google Cardboard headset available for home use. As opposed to working centrally with the NHS, Cognitant worked with a variety of clinical groups to develop the platform including Academic Health Science Networks, and different hospitals and institutions on a different clinical subject. “Plenty of pretty good technologies come along which don’t get very good uptake because it either takes a little bit of time or you’ve got to invest a lot or change management to do things differently. We’ve tried to head that off by making it really easy for doctors to use and help them save time. “What we’ve found is that doctors really welcome it
because, in particular in general practice, they’re frustrated they’ve only got less than 10 minutes for each consultation and they know they’re not answering all of the patients’ questions.” The overriding benefit, Dr Ringrose suggests, is that more information can be given to patients from clinicians so anything that can be missed in a time constrained consultation can be accounted for – with the patient provided with the health equivalent of a Spotify playlist. “The main benefit for clinicians in the health service is to improve the efficiency of their services and help to manage more patients remotely. I know a lot of GPs are trying to manage as many consultations by phone or video as possible. If you can provide good information alongside that you can maximise those and avoid as many face-to-face consultations as possible. There’s a lot of benefit for the patient, the health service and the clinicians.”
“Using visual approaches as well as text is very important so that quite complicated concepts can be communicated to people of all ages and educational backgrounds.
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REGULATORY
CULTURE CLUB
Three key areas to build a foundation of quality Jon Speer, founder and VP of QA/RA at Greenlight Guru offers his thoughts on developing strong quality control and assurance culture in the medical device industry.
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hange has always developed at a rapid pace in the medical device industry. These changes compounded with new challenges brought forth by COVID-19 can leave industry leaders feeling uncertain about how to innovate and ramp up production to meet soaring demand, all the while ensuring quality remains a core focus. To navigate the rapidly evolving landscape, medical device companies must prioritise quality and the culture that surrounds it by conducting practical training, utilising the best medical device quality management system (MDQMS), and seeking out the right strategic partners. Let’s take a closer look at how you can find success in these three areas, particularly as it pertains to quality assurance and quality control of your medical device. Create a True Quality culture amongst your team Proper training of employees is an essential investment, as this will pay dividends throughout a company’s existence. The best teams are trained through methods that reinforce a company’s quality culture and values in order to further establish quality as a strategic asset for their business. A critical aspect of training medical device professionals is placing an emphasis on the key differences between quality assurance and quality control. Quality assurance is a process-driven function that ensures ongoing maintenance and preservation of a quality product. Quality control focusses on the standards by which the quality of a product is measured and whether the outputs meet specifications. Adopting an industryspecific MDQMS, rather than paper-based or general-
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purpose quality systems, is the most efficient way to manage the quality of a medical device. Equip teams with the best quality tools If a restaurant doesn’t receive any health code violations, does that mean they are making great food? Not necessarily, and it also doesn’t guarantee they will be in business tomorrow. The medical device industry works in quite the same way. If a manufacturer doesn’t have any noncompliance violations, this doesn’t mean its device is a quality product. Many medical device companies struggle to keep quality a focus because managing their current quality system is already too painful and challenging of a process, limiting their focus to compliance-only. General-purpose and paper-based systems are not scalable solutions and do not have the capabilities to execute necessary tasks, collect signatures, and achieve closedloop traceability in an easy and efficient way. The Greenlight Guru platform manages every process that occurs throughout the product life cycle with workflows that follow industry best practices. Users of the MDQMS software have end-toend traceability by integrating pre- and post-market processes, like CAPA management, design controls, and risk management activities every step of the way. The benefits of an MDQMS amount to
streamlined processes that enable access to reliable data, accelerate device clearance timelines, reduce risk, facilitate real-time audit readiness, and promote the culture of quality necessary to be a top performer in the industry. Work with the right strategic alliance While compliance cannot replace quality, it’s essential to build a strategic network of people you trust who can help you accomplish both. This is why we formed a strategic alliance with Emergo by UL to deliver an all-in-one quality management and regulatory affairs solution to medical device companies. Our alliance is one example of how a trusted network can enable success; together we help medical device manufacturers bring devices to market faster and ensure quality and compliance in today’s constantly changing landscape. True Quality is a company-wide effort and should be prioritised in every stage of the medical device life cycle. Your devices can change patients’ lives and make a difference, which is why companies must build a culture focussed on quality and provide employees with best-in-class tools that enable them to produce quality products. By implementing proper training, utilising industry-specific tools, and building the right strategic network, your business can find success and continue to set the bar high for innovation and True Quality.
REGULATORY
The importance of a next generation QMS for EU MDR
Kari Miller, product management and regulatory leader, IQVIA, highlights five key characteristics of a next generation quality management system.
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very day, medtech and other life science organisations rely on their quality management system (QMS) to drive people and processes to improve product quality, minimise risk, ensure patient safety, and help maintain regulatory compliance. A next generation QMS delivers even greater value by taking an organisation’s quality maturity to the next level, also ensuring your operation is efficient and inspection-ready. With the EU Medical Devices Regulation (2017/745) (MDR) and IVD Regulation (2017/746) (IVDR) medtech manufacturers are facing an increased focus on the links between regulatory activities and the QMS. The new EU Regulations are much more prescriptive than their Directive counterparts with regard to quality management systems. Although the need for a quality management system is not new, MDR Article 10.9 and IVDR Article 10.8 now specifically require manufacturers to establish, document, implement, maintain, keep up to date and continually improve a quality management system to ensure compliance with the regulation. The quality system has to cover all parts of the
organisation which deals with the quality of processes, procedures and devices. In seeking to ensure compliance with the regulations, medtech manufacturers may consider upgrading their QMS, so here is how a next generation QMS can advance quality maturity and examine the five key characteristics that enable the technology to optimise quality system performance.
Advancing your quality maturity
Quality maturity can positively impact the total cost of quality. Those organisations that are further along on their quality maturity journey benefit from a lower cost of quality. As organisations increase in maturity, the focus moves to prevention, and the organisation becomes better able to anticipate and manage risk. This can be driven and supported by integrated quality and IT systems. In higher stages of quality maturity, companies become more proactive and can harmonise processes across the business and even beyond to better manage supplier quality and other contracted activities. At the highest level of maturity, organisations are
operating within a true culture of quality, with endto-end quality processes and the ability for metrics to help sustain and improve overall quality. The goal of this journey is to achieve higher stages of maturity to gain the benefits of higher product quality, improved compliance, and reductions in overall cost of quality.
Five key characteristics of a next generation QMS
1. Built for life sciences – With stringent regulatory requirements, it is critical that your QMS is compliance-ready and closed-looped for accuracy and efficiency. A purpose-built, integrated QMS should help eliminate siloed systems, drive harmonisation, reduce overall cost of quality, and enable informed, data-driven decision making, while maintaining compliance with industry regulations and standards, such as 21 CFR Part 11, MDR/IVDR and ISO 13485. 2. Quality intelligence and reporting – Easy access to complete and accurate quality system data is
Quaity Maturity from Development to Leadership Driven by people and processes. Fuelled by technology.
*Total Cost of Quality (TCoQ) as a percentage of Revenue
• Culture of Quality • End-to-end quality processes
• Predictive and prescriptive metrics
Leader
3% - 7%
Harmonized
8% - 11%
Integrated
12% - 17%
• Focussed on prevention • Integrated systems
• Key metrics measured
Controlled
18% - 24%
• Focussed on compliance • Short-term, reactive focus
• Siloed, disperate systems
Developing
25% - 40%
• Enterprise-wide, proactive focus
• Disconnected from corporate goals • Manuual, rwactive processes
• Best-practice processes • Global platform
• No improvement initiatives
Increasing Quality Maturity
TCoQ*
critical for making informed, data-driven decisions. Robust business intelligence (BI) combined with standard reports should provide instant feedback into quality trends, enabling your teams to make the right decisions at the right time. Personalised dashboards facilitate easy manipulation of data and adjust views to be relevant for the viewer’s role. 3. Cloud – A highly secure, reliable, and efficient cloud environment will protect quality system data in an industry-compliant environment. The cloud should scale as the business grows in order to accommodate changing business needs. 4. End-to-end eQMS deployment and optimisation –To optimise your next generation QMS deployment, the solution provider needs deep life science expertise for your journey to process harmonisation and proactive quality. 5. Intuitive and modern user interface – Having a consumer-grade user interface improves user adoption and allows for the inclusion of myriad users across the organisation. The simplification of tasks improves user acceptance, utilisation, and inclusion. An intuitive user interface can assist in shortening cycle times, reducing errors, and minimising training needs.
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LABELLING
Will the EU MDR
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reprieve improve compliance?
ichard Castle, PRISYM ID, explores the impact of the new EU MDR timeline, the challenges that medical device companies face, and what industry needs to do to achieve labelling and packaging compliance from a global perspective. COVID-19, social distancing measures, and the obligation felt by the medical device industry to prioritise its pandemic response, have prompted the European Parliament to delay the implementation of the EU MDR for 12 months. EU MDR, which commenced in May 2017, imposes rules on companies involved in the design, manufacture, approval and commercialisation of devices that are sold in the EU. Its application has huge implications for labelling, introducing detailed requirements that place a key emphasis on a company’s ability to capture, manage and share data across their global organisation. The new milestone is now confirmed for 26 May 2021, with full application of EU MDR, followed by EU Database for Medical Devices (EUDAMED) officially going live a year later (26 May 2022). Its impending enforcement presents numerous labelling challenges that could ultimately prevent organisations from being able to sell their products in Europe if they are not addressed.
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Organisations face the daunting prospect of changing every label and they must therefore evaluate their labelling capabilities to ensure they have the tools to manage that global change. With the rules mandating the redesign of every single label – from symbols and warnings to location and readability - it appears unlikely that medical device companies can rely on traditional methodologies and legacy labelling systems to handle the change. Moreover, with other imminent modifications to regulation in key markets outside of the EU and US, organisations need to make sure that future systems have in-built agility to respond to change, as and when it happens. It all means a rethink in the arenas of product data management and labelling operations. Those companies without a clear and coordinated strategy face the risk of encountering insurmountable commercial barriers. Historically, departments in many organisations have often maintained their own product data because they do not trust other sources. This has led to the use of multiple systems, each operating in isolation and capturing information in self-serving silos. This approach, which hinders compliant labelling operations, is fraught with risk and no longer acceptable. Companies need to develop a culture of data integration and sharing. They need to put systems in place that establish a ‘single source of the truth’, allowing EU MDR-compliant data to be pulled from disparate systems, interfaced as a single view and shared across the organisation.
The cost of making a global label change – using traditional processes built around multiple systems – has historically been expensive. As a result, a growing number of medical device companies are adopting ‘touch once’ strategies where they undergo a wholesale redesign of their global labelling processes all in one go, rather than repeating the cost and disruption of additional implementations further down the line. By implementing an effective and global touch once strategy, processes can be streamlined and reduce the cost of future changes by as much as 90%. The approach, which accelerates speed-to-market and reduces the risk of non-compliance through the efficient use of automation, also allows companies to futureproof their business as regulations and country requirements evolve over time. For medical device companies facing a steady barrage of complex, impactful regulatory changes, the deployment of data-led labelling systems can ensure they only need to touch their labels once, while meeting their impending deadlines safely and effectively. So, will the EU MDR reprieve improve labelling and packaging compliance? Yes, it could certainly help, but only for those companies who are already implementing or now considering a more holistic approach to their management of product data and labelling operations. Ideally, it’ll be through a one-touch approach, futureproofing companies in preparedness for multiple forthcoming, and perhaps as yet unforeseen, regulatory changes.
AI
THE REVOLUTION POWERING medtech innovation Innodisk considers what it calls a quiet, medical-grade revolution underway in the healthcare industry.
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nder the radar and away from buzzwords, new innovative solutions are upgrading medical equipment across the board. Pairing the latest computer hardware with cutting-edge software solutions medtech megatrends such as the Internet of Things (IoT) and artificial intelligence (AI) promise to bring a technological revolution to the medical sector. However, one of the main challenges is that medical equipment manufacturers cannot simply take top-of-the-line consumer-grade computer hardware, put it in a different form factor, combine it with medicineoriented software, and call it a day. Not only do consumer-grade products not reach the reliability, stability, and longevity required by medical applications but additional provisions must also be made to guarantee that unique challenges in healthcare applications are fully satisfied. These challenges have caused a significant mismatch in terms of expectations and hype around medtech and the real-world implementation of such solutions. The reality is that the technologies revolutionising other industries often are not ready to make the same monumental impact in healthcare. New technologies and innovations in the computer hardware space are now turning this on its head, paving the way for rapid and safe adoption of cutting-edge technologies in the medical field.
SMARTER MEDICAL IMAGING While imaging applications like MRI machines and PET scanners may be considered the most high-tech equipment in hospitals, they are usually low-tech in other ways.
as well as the critical nature of what they do, upgrading medical imaging equipment with state-of-the-art computing abilities has not been a priority for most manufacturers. However, the increasing sophistication of all the other pieces of such equipment means that the amount of data that is generated – and requires processing – is beginning to put strains on the traditional work processes. At Innodisk, customer demand for industrial computing solutions that are designed with special protection against the strong magnetism found in imaging equipment is at an all-time high. This is part of a larger trend to equip imaging equipment with more computing power to ensure quicker results, involve less manual labour, and make way for AIassisted diagnosis.
the three fundamental requirements for components used in medical equipment – reliability, stability, and longevity – are difficult to fulfil. With other typical requirements added on top, such as legacy support and environmental protections, finding suitable components for medical equipment can seem impossible. At Innodisk, we have devoted resources to bridging this technology gap, as we aim to bring top-tier industrial computing hardware to medical applications without compromise. That means taking our product series and making it fully compatible with the requirements posed by medical applications.
New advancements in the design of industrial-grade DRAM modules, flash storage devices, and embedded peripherals allow medical imaging equipment manufacturers to make their devices smarter and more powerful than ever before. With powerful data processing capabilities connected directly to medical imaging equipment, system designers can enable real-time processing of the imaging data generated by their equipment and feed all pertinent information to medical professionals for further analysis and diagnosis.
In practice, this means lots of customisations and product adaptations– but the result is always the same: it makes the dream of medical IoT possible. For example, Innodisk’s healthcare-optimised DRAM modules come with protections against data errors caused by radiation and other types of interference. Flash storage devices, meanwhile, can be equipped with customised firmware and hardware solutions to ensure stability and protection against unstable power supply. With embedded peripherals, electrostatic discharge and surge protection as well as wide-temperature support, these are key technologies for meeting medical application requirements.
PAVING THE WAY FOR THE MEDICAL IOT While medical imaging equipment presents challenging applications for industrial-grade computer hardware, critical components intended for less challenging medical applications also fail to meet their requirements. Even
These leaps in technology mean that the stage is set for the introduction of truly innovative medical IoT applications in real-world healthcare settings. Not only does that mean the promise of healthcare boosted by technological prowess is becoming true, but also patients will receive better care than ever.
Due to the intense magnetism and radiation emitted by such machines,
The technologies revolutionising other industries often are not able to make the same monumental impact in healthcare
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med-tech innovation AWARDS
sponsored by
EYE ON THE PRIZE Med-Tech Innovation News Magazine is delighted to be able to take over from the live events team to recognise and celebrate the great and the good in the medical technology industry.
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his year’s live Med-Tech Innovation Awards evening has been postponed along with the Med-Tech Innovation Expo to June 2021. We want to make sure that the good work of 2019 and 2020 still gets the kudos it deserves. Here we present the finalists across our five categories who had their work assessed by our expert panel of judges. 3D PRINTING Entrants have demonstrated how 3D printing has enhanced or fundamentally improved the design or manufacture of a medical device. This could be as a design development aid, a manufacturing jig or fixture, or the additive manufacture of end-use products. Axial3D Axial 3D’s surgical model service uses machine learning algorithms to aid in the conversion of patient scan data to 3D anatomical models resulting in reduced lead times. ExpHand Prosthetics ExpHand has developed an affordable, expandable, customisable 3D printed prosthetics for children aged three to ten, with an adjustable universal socket that can be fitted at home by parents. FabRx Ltd. The M3dimaker 3D printer prints solid oral medicine enabling personalised doses of medicine to meet specific health and therapeutic requirements in a single pill.
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MedScan3D MedScan 3D offers a 3D printed anatomical surgical model service which uses expert adaption to produce anatomically accurate silicone test simulators for medical devices.
University of Liverpool A digital electronic imaging system has been developed to enhance the quality control of the EBAM additive manufacturing process to improve the reliability in the manufacture of bespoke orthopaedic implants. CONNECTED HEALTH Entrants will have played a part in the design or manufacture of a cutting edge connected medical device. This might have been through the supply of miniaturised sensors, conductive materials, or may have been involved in the production of assembly specific components – as well as software and digital service providers. Ainostics Limited Ainostics has developed an AI analysis engine which uses multimodal patient data (scans, patient records, wearable sensors, etc) to perform highly accurate diagnosis and prognosis for early dementia. FeelTect Tight Alright is a connected wearable device for measuring and monitoring sub-bandage pressure during compression therapy, reducing healing times and improving quality of life. Game Doctor Game Doctor has developed a healthcare analytics and education platform using mobile gaming to map and predict health behaviours in patients and the public. The London Ambulance Service NHS Trust An online Point of Care Testing (POCT) service for the London Ambulance Service (LAS) enables en route pathological testing with results available online for the destination hospital - reducing
patient treatment time and improving clinical outcomes. Nemaura Medical Inc. SugarBEAT is a non-invasive continuous glucose monitor and lifestyle app for diabetes, providing a personalised and progressive behaviour change app to manage and prevent type 2 diabetes. DESIGN AWARD Entrants demonstrated how design principles have been used to create a futuristic solution to meet a clinical need. They have described the detail and complexities involved in designing the product, plus the material and processing decisions that were made to enable successful design. NEMERA Safe’n’spray is a smart drug delivery device with a reusable child-resistant locking unit and fingerprint identification, to monitor drug delivery and prevent overdosing. Oxford VR A virtual reality therapy platform with a computer-generated virtual coach for personalised treatment of mental health conditions. Great success at clinical trial has led to adoption in four NHS trusts. SleepAngel This patented medical barrier bedding allows the bedding to breathe whilst being 100% barrier to allergens and pathogens, reducing hospital-acquired infections and increasing sustainability in the hospital setting. TheMoment M-co is a non-invasive wearable device utilising pulsed cueing and
med-tech innovation AWARDS
sponsored by
focussed vibrotactile stimulation to ease the symptoms of Parkinson’s. ENGINEERING AWARD This award recognises an idea which resulted in the breakthrough or improvement to the manufacture of a specific product or component. For example, if a part design was reevaluated, or a different material was selected to overcome a specific issue – with the benefits of the strategic decision highlighted. Biovation Orthopaedic Solutions Ltd An instrument kit used to perform cartilage replacement implant surgery for big toe arthritis has been redesigned to eliminate pre-operative lead times, reduce manufacturing costs and lead times as well as allow for more accurate surgery. Carclo Technical Plastics Specialist in-tool process control and monitoring equipment has been introduced to the injection moulding process of a drug delivery device to improve quality control and reduce inspection costs. Emerson Emerson has developed a micro solenoid valve for use in portable oxygen concentrators which is light and compact with a higher flow rate than competitor valves, enhancing the quality of life of the user. Freudenberg Medical Helix iMC technology continuously measures the inner geometry of silicone tubes during the extrusion process to improve product quality and productivity as well as reducing waste and time to market.
Marsden The Patient Transfer Scale is a transfer board with an inbuilt weighing scale to enable immobile and time critical patients to be weighed instantly and accurately to allow for precise administering of drug doses and treatment. MATERIALS INNOVATION Recognition for new and ground-breaking material, and applications in which material choice was pivotal to the success of the final product. 3M Medical Materials and Technologies 3M Extended Wear Medical Transfer Adhesives suite is a set of advanced solutions for stick-toskin wearable devices which offer water resistance, breathability, elasticity and long wear times. PAXXUS StreamOneR is an ultra-high barrier, hermetically sealable medical packaging solution designed for the number 1 polyester recycling stream providing a higher performing and sustainable alternative to polypropylene medical packaging. Spyras Spyras have developed an affordable, disposable, paperbased wearable device for continuous real-time breathing analysis in hospitals. The device is designed to automatically alert clinicians to early signs of patient deterioration. Stratasys Specialist digital materials have been developed to allow the Stratasys Digital Anatomy Platform to replicate human anatomy which has the same biomechanical properties as native bone and tissue for realistic anatomical models.
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From Drive Thru to the OR
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How headsets have made it to the frontline
an Bolland spoke to Tom Downes, CEO of Quali Digital, about how the wireless headsets his company manufactures can be used in a clinical setting. Downes began by explaining that the headsets were originally deployed in fast food restaurants. Anyone who had visited one of the many outlets will recognise the devices being used by staff behind the counter. This also managed to find its way into the retail sector before eventually being adopted by health services. Downes explains: “It’s simply to make their operation more efficient, because otherwise people would spend the whole time waiting for something to happen that they could’ve easily resolved immediately if they could have spoken to the right person.” The principle is the same in health as it is in hospitality and retail – though entering the health sector came after an enquiry from Philips
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following a problem with communication in CATH labs and BT labs. “Because the amount of radiation that’s used in those processes, some of the staff are in the OR and some are through the glass in the monitoring room. All of whom need to be in close communication, but they are not physically able to hear each other properly because of the physical objects in the way. “The same pattern develops. It’s a team of six, eight or 10 people who need accuracy, immediacy, efficiency who need to be able to speak. The headsets that we make for healthcare are really addressing the same underlying issue as everybody else’s – it’s just they are designed differently – as are retail as are Drive Thru for their particular market.” Following the outbreak of COVID-19, Downes explained Quali has been approached by orthopaedic operation rooms who need the headsets to be worn under
personal protective equipment. By protecting themselves from infection, wearing hoods can blight communication, therefore having a PPE friendly headset for communication becomes critical – and up to 30 users are able to use the headsets. “They are now wearing this entirely closed device suit and for the rest of the team hearing them is a real challenge, because you really have to be almost standing beside them or looking at them face-to-face. Of course, that is unlikely if a surgeon is looking down at a knee during a procedure. There are several other people in the room involved. Most of them are either behind or away from them or away from the table. “The headsets are made of microbial plastic, as you’d expect, they are within and inside the protective equipment. They’re put on and then the PPE is put on over the top of them, so the headset is not outside. When they take the protective equipment off the headset should be in the same state is was when they put it on, as it’s not outside and therefore exposed.” To sum up the main benefits of using the devices, Downes cites motivation and peace of mind for the team using it. “A surgeon would say that it is their ability to keep the team properly briefed and properly motivated during a procedure. I think the stress on staff by not being able to hear what’s going on and feeling they might compromise the procedure as a result, in itself, is unnecessary and this system will bridge that completely.”
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