MTI Issue 46

www.med-technews.com Issue 46 | Jan/Feb 2020

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What to see at the Med-Tech Innovation Expo 2020

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What you need to know about EU MDR

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MEDICAL DESIGN & MANUFACTURING INSIGHT

CONTENTS regulars 5.

Comment Lu Rahman talks tech

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Making medtech

A round up of the industry news

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Regional News

The latest from Medilink UK

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In focus

Laura Hughes presents research on EU MDR and the Health Tech Alliance looks at what’s in store this year

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Opinion

Dame Barbara Hakin, outlines why she has long championed healthtech

features

MED-TECH

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MED-TECH innovation

The event that means business

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The latest in 3D printing

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What’s on offer at the 2020 Med-Tech Innovation Expo

More than skin deep:

INNOVATION | NEWS

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Hot shots

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Lu Rahman selects some of 2019’s injection moulding expertise

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Can flexible batteries revolutionise power in medical devices?

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Ian Bolland finds out

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Cover story

Lu Rahman looks at medtech trends and why deeptech is so important to the sector

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In Practise 34

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from The editor It’s all about the tech

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t’s the start of the year so of course, along with every other sector, many of us are looking forward to the coming months, where we should be focussing and what the industry has in store for business between now and December.

For sure, the general election at the end of 2019 raised questions about the way healthcare would progress in the UK. In fact, this issue of MTI offers some opinions on this. What’s clear about healthcare currently is that digital is still a key focus for many manufacturers. We know that Matt Hancock, health secretary, is a selfproclaimed tech enthusiast, which of course strengthens the idea that digital tech will be at the heart of the NHS going forward.

This seems to be the case. Around a year ago, the government set out its Long Term Plan. With a focus to speed up the route by which technology reaches patients, it’s easy to see the importance that digital technology has within the NHS. Playing a key role in the process, the Accelerated Access Collaborative (AAC) which was set in 2016, enables industry, government and the NHS to work together, removing barriers to the uptake of innovation. The AAC identifies and supports

this and highlights products it feels will have the ’biggest impact on patient health outcomes and NHS services’.

These include medical technologies, digital products and diagnostic products.

This plan sends out a positive message to healthtech and digital health flag-wavers. Hancock has been quoted as saying that he believes technology makes humans better, and in this case that’s exactly what it does. On a regular basis we see that medical technology has the potential to change our lives when and where we need it. Technology is moving at a pace and in addition to connected devices and monitoring systems, we are seeing smart fabrics that contain sensors to keep a track on vital signs, or technology embedded in footwear that has the ability to pick up on early onset of Alzheimer’s and Parkinson’s.

It is predicted that the UK digital healthcare market will reach US$28.3 billion by 2025. Likewise, Ireland is no stranger to understanding the value that digital products have within the healthcare system. Back in 2017, the Irish government outlined its healthcare vision for the next decade. This included the implementation of digital health.

The importance of

technology in the healthcare ecosystem was recently highlighted by Deloitte Insights. Its Winning at the Future of Medtech analysis, underlined that medtech companies have the potential to drive the future of health but many may need to form partnerships with consumer technology and digital health companies to meet the needs of the market.

According to authors, the “future of health is expected to be driven by an omnipresent, proactive, and integrated system of health and well-being where transformational technologies (eg. artificial intelligence, quantum computing, cloud storage, augmented and virtual reality, and so on) are poised to play a huge role”.

Digital health is nothing new but the effect of its presence is growing year on year. And thanks to government initiatives its impact on manufacturing is becoming increasingly evident.

THE IMPORTANCE OF TECHNOLOGY IN THE HEALTHCARE ECOSYSTEM WAS RECENTLY HIGHLIGHTED BY DELOITTE INSIGHTS

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Making medtech

HAVE YOU REGISTERED FOR THE MED-TECH INNOVATION EXPO?

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he Med-Tech Innovation Expo is the UK & Ireland’s leading showcase for medical design and manufacturing technology, focusing on medtech, medical plastics, digital devices, pharma and more.

This platform allows you to meet with peers, learn from thought-leaders across three conference stages, gain valuable market information and do business with exhibitors.

In addition to a range of high profile exhibitors, the event also provides the ideal environment to increase your knowledge of and gain intelligence of the medtech sector.

MED-TECH INNOVATION CONFERENCE STAGE This is organised in association with Medilink UK. The programme provides insight and intelligence from a range of blue-chip users, government officials and industry experts.

HEALTHTECH STAGE Hand-picked speakers from within hardware, software, materials and services. You’ll experience first-hand the developments shaping the sector.

INTRODUCING STAGE Exhibitors and their partners will deliver a quick-fire presentation introducing the latest news, innovations and applications within the industry.

For more information go to www.med-techexpo.com/

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SCIENTISTS DEVELOPING DIAGNOSTIC TEST TO DETECT ANTIBIOTIC RESISTANCE IN LESS THAN 45 MINUTES

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cientists are developing a low cost, rapid diagnostic sensor test which aims to show the susceptibility of bacteria to antibiotics within 45 minutes, reports the Medical Research Council.

NHS laboratory testing of samples can take up to two days and the test aims to allow doctors to be able to prescribe the correct antibiotic to a patient for an infection more quickly.

In a research paper published in the journal Biosensors and Bioelectronics, the University of Strathclyde team has demonstrated the system is capable of showing results in less than 45 minutes.

The scientists examined the difference in growth profiles between the common hospital acquired bacterial infections, Staphylococcus aureus, most strains of which are sensitive to antibiotics, and the drug resistant strain, MRSA, which is resistant to several widely used antibiotics and can be harder to treat.

The paper’s lead author, Dr Stuart Hannah, said: “There is a small difference between what makes an organism susceptible to an antibiotic and what makes it resistant.

“In real terms, we were able to distinguish between the two strains in less than 45 minutes, which is a significant improvement on the current gold standard of up to two days.

“The technology uses a low cost, commercially available sensor which acts like a mini culture dish that can deal with any kind of clinical sample.

“Rapid result detection means you could pinpoint bacterial versus viral infections straight away and would be able to start working on the correct treatment more quickly for patients, which is very important for particular infections.

“Antibiotic resistance is less likely to develop if you give a narrower spectrum antibiotic.”

The consultant anaesthetist on the project, Dr David Alcorn from Paisley’s Royal Alexandra Hospital, said: “Being able to quickly diagnose an infection is a great enough ability, but to be able to also detect AMR within such a short period of time could prove to be a wonderful tool.

“It means that vital diagnostic information could be provided for clinicians across intensive care units, operating theatres, and emergency departments, to enable them to give the right drug at the right time.

“There is also scope for this to have an enormous impact within general practice and day-to-day healthcare.”

The researchers hope that if the test is developed for commercial use, it could be used by pharmacists and other points of care.

WOUND TREATMENT SOLUTIONS CREATED FOR MEDICAL MANUFACTURER

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aumedic has developed wound treatment solutions for Lohmann & Rauscher, a provider of medical and hygienic products. The deep drainage solution and the drainage pad are parts of the Suprasorb CNP P3 Therapy that supports the healing process of internal and external wounds. The system offered by Lohmann & Rauscher is designed for use in negative pressure wound therapy.

The key part of the deepdrainage set is a quadruple-

lumen silicone tube. The large inner lumen transports secretion, or exudate, from wounds within the body. The three small lumens in the tubing wall ensure that aeration can be actively managed during drainage.

Raumedic also manufactures a drainage pad for external wound therapy for Lohmann & Rauscher. Here, wound secretion is transported via a port with an integrated aeration ring and a quadruple-lumen PVC tube.

Making medtech

WEARABLE ROBOTS COULD HELP PEOPLE WITH MULTIPLE SCLEROSIS (MS)

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K scientists are to investigate whether wearable robots could help people with multiple sclerosis (MS) get more exercise.

The MS Society has committed to raising nearly £40,000 to support Dr Siva Nair and his team at Royal Hallamshire Hospital in Sheffield, who will examine how powered exoskeletons – or robotic suits – might improve physical fitness in people with mobility issues caused by MS. MS damages nerves in your body and makes it harder to do everyday things like walk, talk, eat and think. Research suggests people with MS should do moderate exercise for 30 minutes, three times a week.

But many find this difficult due to symptoms caused by the condition.

Dr Nair said: “We all know how important exercise is. A lack of it can cause heart disease,

stroke, diabetes, obesity and depression. So we need to find a way to make it easier for people with advanced MS to take part in physical activity. Robotics is the natural step forward. By embracing this technology we are giving people who can’t walk the chance to exercise like everyone else.

“We understand it’s not every day you see someone in a robot suit, and society might need to adjust to such a weird and wonderful sight. That’s why we’re also going to be observing the personal implications of keeping fit in this way – including whether the person wearing the exoskeleton feels it’s an accepted way to exercise.”

Dr Susan Kohlhaas, director of research at the MS Society, said: “More than 100,000 people live with MS in the UK and, for many people living with progressive forms of the condition, there are no treatments available. We believe we can stop MS, but until then we urgently need to find

new and innovative ways to help everyone with the condition live as well as they are able.

“Exercise is not a ‘nice to have’– it’s a proven way for people with MS to slow the build-up of disability, improve their symptoms and even boost their mood. That’s why we’re so proud to be investing nearly £40,000 into this exciting new project in Sheffield. If the study is successful, it could make it easier for everyone with MS to exercise, and has the potential to have a huge impact on our community.”

DEVELOPMENT IN CLEANING ADDITIVE MANUFACTURED MEDICAL IMPLANTS LAUNCHED

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uyson International has come up with a solution to a problem during additive manufactured orthopaedic implant manufacture. Its Powder Flush has been designed to flush residual additive manufacturing (AM) powders from medical implant trabecular structures, which aid the interlocking human bone growth into the implant.

Orthopaedic manufacturers are turning to additive manufacturing to drive the long term change in the increased complexity of medical implant design and demand for tailor made patient-specific solutions

(rather than one-size-fits-all) with the change in manufacturing from subtractive to additive techniques, with all the benefits that can bring.

Additive manufactured orthopaedic implants are typically made by SLS, SLM or EBM processes (Selective Laser Sintering, Selective Laser Melting or Electron Beam Melting) from titanium powders.

After manufacture, the implants have the bulk of the residue powder removed from the build block with brushes and vacuums, sometimes followed with an airwash or blast process to remove any semi-adhered powder particles, but because of the

nature of the porous trabecular structures, small residues of powder are often still trapped inside the component and this must be removed. This is where the Guyson Powder Flush can be used, offering directed jets for component flushing followed by compressed air-wash.

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THE LATEST ANNOUNCEMENTS FROM THE MEDILINK UK COMMUNITY

SYNOVA PROVIDES CASH BOOST FOR CHARNWOOD MOLECULAR INNOVATION DATE CONFIRMED The date has been set and venue confirmed for the Medilink East Midlands Innovation Day 2020: -Thursday 2 July 2020 at Delta Hotels Nottingham.

The annual event aims to provide an opportunity to network with key figures in the life science sector.

LINKING UP

SLS ACQUIRES WOLFLABS Medilink East Midlands member SLS has acquired Wolflabs. The newly enlarged group will provide better choice and a wider range of products to the scientific community. SLS is a distributor of laboratory products. Wolflabs is a predominantly web-based provider of laboratory equipment that prides itself on the provision of immediate access to marketpriced product information and value for money. The combined group will offer complimentary business models allowing both sets of customers and suppliers to take advantage of more products and routes to market.

Commenting on behalf of SLS, Peter Chapman, managing director said: “SLS has grown significantly over its 28-year history through a solid commitment to people and a tailored, flexible approach to serving our customers. We have done this by maintaining an independent approach and retaining a personal touch that marks us out from our global competitors. To be able to welcome Wolf Laboratories into the SLS Group of Companies indicates our continued commitment to serve the laboratory marketplace and we are particularly excited to see how the unique business models of both SLS and Wolf can collectively provide benefits to both our customer and supply partners.”

Sean Woodward, managing director, Wolf Laboratories, said: “Both Wolflabs and SLS have excellent records in the provision of market-leading products to scientists in the UK and beyond.

Within the SLS Group Wolflabs will be able to offer customers both a wider choice of brands and a greatly extended choice of product categories to choose from.”

If you would like to get involved, please get in touch with Medilink - it has a number of exhibitor and sponsor opportunities available info@medilinkem.com

FORESIGHT INVESTS £749K IN UNIVERSITY OF NOTTINGHAM SPIN-OUT PROMETHEAN PARTICLES Foresight Group has invested £749,000 in Medilink East Midlands member Promethean Particles, a nanomaterials manufacturer. The finance boost will allow the firm to create new jobs, scale its production capabilities and enter untapped global markets.

The investment has been made using finance from the Midlands Engine Investment Fund and is part of a £1.25m funding round led by Foresight and supported by the University of Nottingham, East Midlands Early Growth Fund (managed by the British Business Financial Services), and other existing investors.

Promethean was founded in 2007 as a spin-out from the University of Nottingham, to commercialise an innovative technology based on the research of Professor Ed Lester.

The company designs and manufactures high-specification nanomaterials which carry specific chemical and physical properties.

Medilink East Midlands member Charnwood Molecular has announced that Synova Capital has completed a significant investment in the company. The deal will provide Charnwood with additional investment to support its continued development and growth.

Synova will help Charnwood deliver a growth plan, built upon increasing investment in the business’ core capabilities as a trusted partner in innovative chemistry, alongside expanding its service offering into complementary scientific disciplines.

Commenting on the investment, Steve Allin, founder and CEO of Charnwood, said: “We are extremely excited about what we can achieve in partnership with Synova. Synova supported our business over an extended period prior to their investment, helping us to develop a strategic plan that we are all committed to delivering.

They were able to leverage their sector expertise and introduced the business to a number of leading industry figures who will help us to grow going forwards.

With Synova’s support we now have the resources to accelerate growth of our core service offering and to develop further specialist services to support our clients to develop innovative new treatments.”

Tim Ashlin, Synova partner and head of healthcare, commented: “Having tracked Charnwood’s progress for a number of years, we are delighted to announce this investment to fuel Charnwood’s ambitious growth plans. It’s exciting to be supporting a business that is focused on developing the next generation of cutting-edge pharmaceuticals, and to support the continued growth of the UK life sciences industry.”

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A Tory win: what now for medtech?

Oli Hudson, of Wilmington Healthcare, explores some of the issues affecting medtech in 2020 now the Conservatives have won power.

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or healthcare communities, many unanswered questions remain about the sizeable Conservative election win on the 12 December.

Many are to do with Brexit: what shape will the future trading relationship with Europe take, what will it mean for regulation, standards, supply chains, and the movement of the people that staff the service? How will it affect our relationship with the rest of the world, and the import and export of medical products?

The NHS will be affected by the result of all this, and in the coming months the medtech industry will be watching closely to see how the situation develops.

Brexit aside, what we can do in the meantime is take a sober look at the manifesto and attempt to pick out what will be implemented.

HOW MUCH MONEY WILL THE NHS NOW HAVE? We can assume that base funding for the NHS will increase by 29 per cent - £650 million extra a week by the end of the parliament. Is this amount enough to get the NHS out of trouble? Bodies such as the Nuffield Trust think it might be – and speak positively about the Tory spend in relation to the other parties.

What is less clear is how social care will be paid for – which will have a huge impact on demand, which in turn is the problem we keep coming back to. The manifesto hopefully suggests prevention will see investment, but it is difficult

at the moment to see if this will be enough to effect real change – especially as no figure has been put on this. Will this mean growth in CCG and ICS budgets?

WHAT WILL THIS MONEY ACTUALLY BE SPENT ON? According to the manifesto, staff and buildings. The 50,000 new nurses pledge has been much-analysed (and the figure debunked down to 31,000).

However, targets like this have been missed in the past and the NHS Visa policy – which will fast track staff from abroad – is an unknown quantity.

While the numbers have been much debated, the manifesto does say 40 new hospitals will be built over the next 10 years. This will mean, of course, a new market for OT, suites and facilities. Some of the larger medtech companies will wish to keep a close eye on this and what it will mean for procurement. There are already opportunities to connect on this with some 34 hospitals that have received so-called ‘seed funding’ to develop business cases for building later in the next decade. Managed service contracts could see a boost.

We do however need to take this programme with a pinch of salt. Another health think tank, the King’s Fund, has said: “On the face of it, the various schemes being pledged by the government certainly sound like substantial investment, but these piecemeal announcements are not the same as having a proper, multi-year capital funding plan.

The lack of clarity around how the new schemes have been

selected and how the pledges fit within the Department for Health and Social Care’s overall financial settlement makes it difficult to tell how generous the government is being.”

One sector that will see growth is diagnostics and screening technology, with some specific pledges to cancer diagnostic machines across 78 hospital trusts to boost early diagnosis.

GIRFT The Tories pledge to “study carefully the recommendations of the ongoing review led by NHS clinical staff into A&E and clinical performance”. This suggests such initiatives as GIRFT – getting it right first time – will continue to be rolled out, and the drive towards efficiency, in technique, process, staffing and procurement – is far from over. We can expect the full range of GIRFT reports to be published over the next couple of years and the socalled ‘GIRFT teams’ – which visit hospitals to oversee transformational work – will stay with us.

The initiative started under the Cameron and May governments that became the Accelerated Access Collaborative looks likely to stay.

It aims, via the work of the AHSNs, to aid high speed adoption and diffusion of innovative technologies. The AAC has already published a programme of deliverables. It links successful applications to funding and advice, including an innovation and technology tariff payment for providers; and offers bespoke support of categories of early stage products.

In addition there will be a launch of a single horizonscanning platform across all partners; a pilot expanding real-world testing within NHS, leveraging private capital; significant spread of AAC rapid uptake products, and AHSN national programmes.

THE FUTURE OF HEALTH TECHNOLOGY? There is also a pledge to create an ‘annual health technology summit’ – though whether this will take the shape of some kind of expo, or will effectively be an outsourced policy-making and procurement strategy body – is unclear.

In general, the Conservatives will be keen to keep the life science industries onside and investing in post-Brexit Britain; and this of course includes home-grown SMEs.

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IN FOCUS

A

Are you prepared?

s the deadline for European Medical Device Regulation (EU MDR) is rapidly approaching, MPN editor Laura Hughes provides a brief summary of the regulation and shares the results of MPN’s recent survey.

WHAT IS EU MDR? EU MDR is scheduled to come into effect in EU Member States from 26th May 2020.

This regulation will apply to all manufacturers selling medical devices within Europe and aims to provide greater protection of public health and safety.

IS THERE POTENTIAL FOR EU MDR TO BE DELAYED? The United States issued a statement to the World Trade

Organisation (WTO) in 2019 writing: “Our industry is worried about their continued access to the EU’s $125 billion USD medical device market, $20 billion USD of which is supplied by US products.”

However, the EU commented in July 2019: “There are no grounds for the time being to explore any amendment to the transitional periods.”

involves the reprocessing of single-use medical devices.

Additionally, the EC’s draft standardisation has been heavily criticised. The US statement addressed the issue to the WTO stating: “Industry maintains that the product standards necessary for compliance with MDR cannot be completed before the deadline.”

WHERE ARE WE NOW? To date the European Commission (EC) has designated nine Notified Bodies (NBs) against MDR. The EC previously predicted at least 20 NBs. The EU acknowledged that the final number of designated NBs could be “slightly lower” than originally anticipated. The US statement to the WTO explained how they do not believe this number is enough to, “ensure continued regulatory approvals by May 2020.”

COMMENTS Some industry figures have shared their views on the topic.

Only one of the regulations that has been put forward has been adopted to date. This regulation

Reiner Thiem, head of regulatory affairs, Raumedic “We have intensively worked over the last three years to gain an understanding of the new regulatory landscape.”

Peter Rose, managing director - Europe at Maetrics, a life sciences consultancy firm: “Three year transition periods are well established in our industry, but never have I seen a transition period being used to get the system ready.”

MPN CONDUCTED A SURVEY ON PEOPLE SELLING MEDICAL DEVICES WITHIN EUROPE. THE RESULTS OF THE SURVEY ARE DISPLAYED BELOW. The survey was completed by people from the following countries:

Q Did you use any consultancy service as part of your preparation?

50% 40% 10%

N/A

2%

2% 2%

2%

2% France

15%

Spain UK

Canada

12

2%

32%

YES NO

2%

Germany

39%

Poland Ireland

Greece

IN FOCUS

Q On a scale of 1-5, (1 being not ready at all, and 5 being ready to go right now) how prepared are you and your business for the new EU MDR?

9.52%

26.19%

40.48%

19.05%

4.76%

1

2

3

4

5

Q Which class of medical device is your company primarily a manufacturer of?

28%

55%

12%

5%

Q Do you think the implementation of EU MDR will have a detrimental effect on patient outcomes?

This regulation will apply to all manufacturers selling medical devices within Europe

Q What do you think are the most challenging aspects of these new regulations?

Class II medical devices

Class III medical devices

No response

60%

40%

35.71% Unsure

11.9%

Q When did you start making preparations for EU MDR?

Within the last 6 months

9.52%

Within the last 3 months

0.00%

Within the last month

11.90%

Not started

Scott Whittaker, president and CEO, AdvaMed “We are now in the critical period of transitioning to the new system, which needs to be completed

by May 2020 (and May 2022 for IVDs). Industry is concerned that while we are prepared, key elements of the new EU regulatory system will not be ready sufficiently ahead of these deadlines to enable industry to comply with the new rules in time. In particular, we believe the capacity of the “NBs” (approval bodies) will not be adequate to allow for the re-certification of tens of thousands of existing and new products ahead of the May 2020 MDR implementation deadline.

Appropriate and urgent action

by European institutions will be essential to ensuring continued access to existing life-saving and life-improving medical devices and diagnostics that hospitals, doctors, patients and families rely on every day.”

Sandi Schaible, senior director of analytical chemistry and regulatory toxicology, WuXi Medical Device Testing “The year of MDR is here. And device manufacturers are under more pressure than ever before.

With so many questions about NBs, whether Europe will delay implementation, and EUDAMED, the uncertainty and stress is palpable. Device manufacturers, you are not alone. We’re in this together. But don’t sit idle and risk having your devices pulled from market. If you’re behind, it’s time to lean more heavily on laboratory testing partners, if they have capacity. Put your foot on the gas and approach partnerships with transparency. Being forthcoming with details and giving your lab partners visibility to forecasts, intervals, and timelines will help you make up for lost ground in these final months before the 26th May 2020 deadline.”

14.29% Required documentation

4.76%

Available resources

19.05% Clinical data for existing products

14.29% Q Do you believe the guidance for EU MDR is clear enough?

33.33%

S

23.81%

O

Within the last 12 months

N

54.76%

Notified bodies

YE

Class I medical devices

66.67%

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20/01/2020 12:14

News analysis

Healthcare in 2020:

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WHAT YOU NEED TO KNOW

, healthtech, device design, patient outcomes…what will be key to the medtech sector in 2020? Some of the industry’s experts share their insights The global healthcare sector in 2020 will see expenditures continue to escalate, driven by rising staff shortages, increasingly squeezed budgets, and an ageing / growing population. In fact, figures from the PwC’s Health Research Institute (HRI) project a 6% medical cost trend (the projected percentage increase in the cost to treat patients from one year to the next, assuming the benefits remain the same). To mediate this issue, healthcare systems will need to innovate and embrace new medical technology to improve care delivery and better streamline efficiencies.

USING AI TO GIVE HEALTHCARE A PERSONAL TOUCH Dr Ian Roberts, chief technology officer at Healx “AI is transforming every industry in which it is implemented, with its impact upon the healthcare sector already saving lives and improving medical diagnosis. However, the transformative effect of AI is set to switch healthcare on its head, as the technology leads to a shift from reactive treatments targeting populations to proactive prevention tailored to the individual patient.

“The future is set to see AI-generated healthcare recommendations extend to include personalised treatment plans.

An example of this is the ability to mitigate the risk of a person developing a chronic illness by having the foresight to make changes in lifestyle choices ahead of diagnosis. This medical understanding will be formed in part by their own genome, combined with machine learning algorithms. To date, consumer personal genomics companies such as 23andMe are already helping to inform people of the need to manage their health; this ranges from avoiding coffee late at night to elevated risks of dementia and certain cancers.”

IMPROVING PATIENT OUTCOMES WITH DATA Alan Jacobsen, chief data & analytic officer at Alteryx “In 2020, we can expect to see better patient outcomes fuelled largely by the growing prevalence of data science and analytics. Much of the data that is required to solve some really key challenges that exists in the public domain, and in the next year we expect more and more healthcare organisations will implement tools that help to assess this rich information as well as gain actionable insight.

In 2019, we have seen issues such as the over prescription of opioids in the UK come under scrutiny, and data analytics has gone a long way in showing the patterns between misuse and other factors such as geography and social demographics. The first step to making a change is identifying these patterns, and we expect to see other challenges benefit from solutions that let not only technical staff, but workers in all lines of healthcare input data and extract value.”

KEEPING VITAL SYSTEMS SAFE Chris Sherry, regional VP EMEA North at Forescout “Increasingly, hospitals and other healthcare organisations are enjoying the benefits of IP-connected medical devices such as infusion pumps, heart monitors and even smart inhalers. The improvements they can bring to patient care are becoming well-known, as are the security issues these devices can pose if not appropriately monitored; in 2020, we’d expect to see budgets align with the issue of securing these devices effectively so that hackers can not take advantage.”

CONNECTING PATIENTS WITH IOMT Bob Zemke CISSP CPHIMS, director of healthcare solutions at Extreme Networks “The rapid growth of Internet of Medical Things (IoMT) over the last few years has brought huge benefits to medical organisations and their patients alike. However, creating increasingly connected environments also brings new risks as cyber criminals try and exploit device and network vulnerabilities to wreak havoc. In fact, our recent global survey found that 1 in 5 healthcare IT professionals are unsure if every medical device on the network has all the latest software patches installed - creating a porous security infrastructure that can easily be bypassed. 2020 will be the year where healthcare organisations of all sizes will need to realise that they are easy pickings for cyber criminals, and put a robust, reliable and resilient network security infrastructure in place to protect themselves adequately.”

HEALTHCARE AND FOUNDATIONAL TECHNOLOGY Mark Gaydos, CMO at Nlyte Software “Healthcare is an industry where technology and results are closely intertwined, so delivering improved digital outcomes for patients in 2020 will be a natural aim for global healthcare providers. In the main this will come from the ease with which healthcare providers are accessing and analysing data through analytics.

The technology underlying must support the trend to public or private cloud-delivered services and so 2020 will naturally see a greater focus on compliance with industry regulation, and a desire to optimise existing systems prior to moving them to more modern platforms, or to better speed up the process of digital delivery for online services.”

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News analysis

What 2020 can hold for a united healthtech industry

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KRITTIKA BHATTACHARYA, HEALTH TECH ALLIANCE, EXPLAINS HOW THE HEALTHTECH SECTOR HOLDS GREAT POTENTIAL FOR THE NHS IN 2020

s we enter a new year, following a turbulent few months of political infighting and election battles, one thing has been made abundantly clear – that the NHS and its values remain deeply important to the electorate, across the country. As services struggle under winter pressures, stretched budgets and an ageing population, polls showed that healthcare was the most important issue to voters at this election, ahead of Brexit.

We, the Health Tech Alliance believe that the UK’s thriving healthtech sector holds enormous potential in alleviating pressures on clinical staff, enabling greater self-care among patients and reducing bed days – all of which benefit both patient outcomes and easing the immense burden on the NHS. It is therefore our mission to ensure that patients can access the wealth of cost-effective and transformative innovation that are being produced by alleviating the market access and reimbursement obstacles that currently affect companies of all sizes.

The alliance is an informal coalition of healthtech companies, seeking to do this by working collaboratively and

problem-solve with the various health service bodies. Chaired by Dame Barbara Hakin – former deputy chief executive of NHS England - the alliance has engaged regularly with key stakeholders from within NICE, NHS England, NHS Digital, NIHR, the Academic Health Science Networks and government and civil service. Members benefit from regular, intimate working groups where they can engage directly with stakeholders across the health system, share best practice with industry peers and explore opportunities for further collaboration with leading market access experts and other members.

Why this focus on collaboration, rather than competition? Well, the Alliance has found that utilising the expertise of our industry members to develop constructive ideas and clear evidence of the benefits of technologies to the NHS and the wider society, engenders a more productive response from the health service.

While these efforts may not produce an immediate level of reimbursement, they can lead to a cultural shift that allows key decision-makers to see innovation as part of the solution to pressing issues facing the NHS, rather than a luxury to be invested in down-the-line.

It is clear too, that as policy moves in a positive direction, a unified voice is required from the sector. The refreshed Accelerated Access Collaborative, the introduction of the Long-Term Plan and its commitment of a medtech funding mandate all demonstrate high-level ambition but as we enter a new decade the health service and industry must work to implement these measures efficiently and effectively.

Wider changes will also present opportunities and challenges for industry – the advent of Integrated Care Systems and the impact of leaving the EU on medical device regulations are just two issues where it is fundamental that the voice of companies is heard when informing decisions. The Alliance regularly engages with government departments, health bodies and parliamentarians to ensure that the voice of healthtech is considered on behalf of our members.

The challenges that the UK’s health service face are widespread but through collective, constructive and collaborative dialogue, innovative technologies have a positive impact and - most importantly significantly enhance patient outcomes.

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Med-Tech Innovation

EcoPower medical 55 – 300 t

Opinion

NEW DECADE, new healthtech solutions IN THIS EXCLUSIVE PIECE, DAME BARBARA HAKIN, OUTLINES HER ROLE AS CHAIR OF

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THE HEALTH TECH ALLIANCE AND WHY SHE HAS LONG CHAMPIONED HEALTHTECH

In my forty years of experience in the NHS, I dealt with many difficult and varying challenges, whether as a practising doctor or as a senior manager; as CEO of a PCT and a SHA or latterly as COO and deputy chief executive of NHS England. Over this time the health service has evolved massively; we are treating record numbers of patients, curing conditions previously deemed untreatable and saving more lives than ever. But as we end this year and begin a new decade, there are still a number of fundamental challenges facing the NHS that have not been solved since I started as a GP all those years ago.

Technology has become increasingly valuable to the NHS as an ageing population and stretched budgets make it harder to sustain the high levels of care that we expect from our health service. If we get it right however, then technology really does have the potential to solve a lot of the persisting problems plaguing the NHS. But technology is not yet a panacea to all of the NHS’ problems. Widespread adoption of healthtech has been slow across the entire NHS, bogged down by structural barriers which are limiting innovation. We are also still in the infancy of AI, which is already

starting to revolutionise our health and social care system, but unless integrated effectively into existing practices, then will only provide short-term relief rather than long-term solutions.

I have long-believed that healthtech will be crucial in providing the level of integrated and personalised care that patients expect and deserve in the next decade and beyond. This is why I became the chair of the Health Tech Alliance, a coalition of innovative healthtech companies working to drive the adoption and uptake of health technologies, devices and diagnostics across the NHS. Working collaboratively with health service bodies such as NIHR, NICE and the Academic Health Science Networks, the Alliance seeks to ensure that proven, cost-effective technologies can reach patients with greater ease.

But our Alliance alone cannot solve this challenge. This is why the Health Tech Alliance decided to launch the inaugural Parliament & Healthtech Conference on 28 January 2020. The biggest healthcare challenges facing our country can only be solved if they are confronted by the entire spectrum of the health and social care system and civil society working collaboratively through a united strategy. This means that our policymakers in Westminster,

our staff in hospitals, our healthtech businesses in industry and our supporters in civil society need to come together on a level never seen before to discuss how we can work together to ensure the long-term viability of our health service.

Health and social care remains by far the most important political issue in our society, which means that there is significant appetite from both policymakers and civil society to outline an ambitious and courageous strategy that we all know is needed.

This half-day conference will provide that forum, and stakeholders will come together to discuss issues such as the key challenges that industry faces in securing the adoption and spread of health technologies and ensuring a more streamlined pathway for lifechanging products.

We should not underestimate the scale of the challenges ahead. Solving the problems facing the NHS may well be the biggest and most difficult challenge that our society undertakes over the next decade. But if we get it right, then there will be no doubt that every ounce of effort would be worth it. So, as we begin a new decade, the time is now to come together and get to work in solving these challenges.

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Cover story: Medtech trends

In at the deep end…

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he start of the year is all about trends. Deeptech: Why is it on the rise; why is the healthcare sector particularly relevant and what exactly is it? Lu Rahman finds out The conception of disruption is nothing new. And the healthcare sector is certainly no stranger to the idea, particularly over recent years. The effect that digital technology has had on patients and clinicians is evident, and it has definitely altered the way care is both accessed and delivered. When I started working in life science journalism, I would regularly be told that this sector innovates but does so slowly… medtech transformations didn’t happen overnight, but incrementally.

That may be the case with some devices, but when you look at the pace and growth of digital technology within the industry over the last five years for example, it’s hard to think that anything in the sector goes at a slow pace.

Let me introduce you to deeptech, disruption at a different level, a disruptor with a difference. It takes what you know and changes it for the good of us all. And for those of you that say innovation moves slowly in medtech, this takes it to another scale. Deeptech covers disruptive technologies based on scientific discoveries that have a significant impact on our lives. But they have taken years to develop due to extensive research, testing and often work around intellectual property.

One of the key sectors feeling the effects of deeptech is life sciences. The phrase was

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coined by Swati Chaturvedi, CEO Propel(x). She says: “There are countless technology disciplines and startups comprising the ’high-tech’ world’ but we needed a way to categorise startups in the life sciences, energy, clean technology, computer sciences, materials and chemical sectors.

After many hours of debate among ourselves and others, we decided to use the term ‘deep technology’ to build a new category of technology startups.”

Chaturvedi says that the definition of deep technology is, “companies founded on a scientific discovery or meaningful engineering innovation’. If you think this applies to most technology companies, then Chaturvedi says think again as most technology companies are built upon business model innovation. Deeptech companies are different.

“They are trying to solve big issues that really affect the world around them,” she says. “For example, a new medical device or technique fighting cancer”.

BCG and Hello Tomorrow have carried out research into deeptech. They have identified seven fields of deeptech that includes advanced materials, AI, biotechnology and robotics, among others.

So how where are the opportunities for medtech?

Companies that are looking to utilise technology in a significantly disruptive way, will be the ones that benefit. With AI showing huge promise in the UK – 2018 was a record year for AI investment in the country – businesses that drive the healthcare market forward using this type of technology, will be the ones to watch.

Companies such as Babylon Health have started to do this.

One look at the company’s mission statement: ‘Babylon’s mission is to put an accessible and affordable health service in the hands of every person

on earth,’ and it’s evident that this business is out to disrupt in a significant way. Using AI technology Babylon Health offers a selection of services that allow you to ask a healthrelated question, talk to a doctor, undergo a health check, or monitor and manage your health.

CMR Surgical is also working to change the way we access care. The company’s aim is to make minimal access surgery available to everyone and has designed a tool to fit into an operating room, working with the surgeon to improve patient outcomes.

The company says: “While our technology represents the next-generation in roboticassisted surgery, we’re just as intent on breaking the mould when it comes to the way that our systems are developed, delivered and managed. We believe in building long-term collaborative partnerships that deliver sustainable benefit for everyone involved.”

Deeptech has huge potential.

My favourite outline of the technology has to be from Uzma Choudry, Octopus Ventures.

She says: “We think about deeptech as the technology that allows us to transcend the status quo. Current technologies eventually block progress and deeptech is the un-blocker.

Existing computer chips, for example, can’t handle the ravenous computing demands of AI and machine learning algorithms. Deeptech describes the radical new solutions that break open these bottle necks. Model T Ford motor cars weren’t just ‘faster horses’, to paraphrase Henry Ford.

Whatever examples you choose, deeptech is central to the accelerating flow of progress in the world. Advancing technology now touches every aspect of life, from agriculture to education, health, commerce and communication. Deeptech is what will power the next industrial revolution”.

Cover story: Medtech trends

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Johns Hopkins study found that medical errors are the third leading cause of death in the U.S. To achieve sustainable healthcare that both gives us the best outcomes and dramatically reduces costs in the coming decades, technology advancements are critical.

Artificial intelligence e (AI) and medical devices are going to be huge parts of healthcare in the near future, and it will be important to establish safety guidelines and ensure regulatory standards are met but not prohibitive to the development of breakthrough technology. As we head into 2020, here are three industrychanging healthcare trends to watch out for.

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A SHIFT IS COMING FROM HOSPITAL TO HOME CARE In the next ten to 20 years, AI will place emphasis on home care over hospitals to allow for more continuous patient care. While apps that monitor health and symptoms at home e injector devices (i.e. wearable for diabetes) are available today, AI will allow for more comprehensive disease management and coordinated care that merges the virtual and physical across monitoring, planning, and treatment. Further, AI will make it possible to predict what will happen at various stages of care, allowing for even greater personalization e that is designed to achieve significantly improved outcomes.

For example, the startup KenSci is using AI to analyse data across sources like electronic e medical records, public records, demographics, claims data, and devices to enhance healthcare outcomes. It can identify patients who are at risk of COPD before they are admitted and remotely monitor COPD patients’ symptoms, physiology and treatment at home via data from medical devices.

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An eye on the prize SIMIN ZHOU, UL VENTURES, LOOKS AT THE TOP THREE HEALTHCARE TRENDS TO WATCH IN 2020

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TECH IS REDEFINING SAFETY IN HEALTHCARE WITH USABILITY PLAYING A GROWING ROLE With healthcare and technology coming together, there’s an increasing need to study how human beings interact with technology in a clinical

environment to reduce human error. With so many new devices and technological aspects to care, it’s critical that healthcare professionals and patients alike use new tools properly and with relative ease. Emergo by UL is the world leader in human factor engineering research and it’s already looking into the usability of connected injection devices (CIDs). CIDs typically involve an injection device with embedded connectivity to a smartphone app and cloud-based datae storage. Developers need to account for potential usability issues such as what happens when a user’s phone runs out of battery power and the app isn’t accessible.

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GREATER EFFICIENCIES NEEDED FOR COMMERCIALISING NEW MEDICAL DEVICES The global patchwork of regulations causes enormous delay in getting new medical devices to market. The time it takes to assess the steps for bringing a product to market in different geographies exacerbates that delay. Required upfront regulatory and market research is one step in the process that can be sped up to e allow faster iteration and make it easier to replicate successes.

This is another area where digital health solutions are providing innovation, making it possible to standardize and automate regulatory processes by aggregating data and providing actionable insights.

This will reduce workload and errors that consume companies’ time and drives up costs in the development phase. RAMS, created by UL, is an example of a new digital platform that simplifies and automates this part of the development process.

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CONCLUSION Technology has the potential to dramatically improve our healthcare system, and with an aging population and people living longer, time is of the essence. We must shift more care away from overflowing hospitals and focus on preventative and continuous care at home. In order to continue to drive innovation in healthcare in 2020, we need to focus on bringing new technology to market in a faster and responsible way.

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med-tech innovation expo

The event that means business THE MED-TECH INNOVATION EXPO OFFER INSIGHT AND INTELLIGENCE TO THE MEDTECH SECTOR, BRINGING BUSINESS, MANUFACTURING AND INNOVATION TOGETHER, SAYS LU RAHMAN. THIS YEAR’S EVENT WILL TAKE PLACE ON 1-2 APRIL AT THE NEC, BIRMINGHAM

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edical technology contributes significantly to UK and Irish manufacturing. Whether it’s tests, materials or healthtech devices, the industry continues to innovate with one aim – improving the health and wellbeing of us all.

Connected devices are experiencing an upward trajectory to say the least.

Healthcare professionals are pushing prevention techniques as well as cure, resulting in growth areas for monitoring and diagnostic devices. Alongside this we have the continued development of high-end medical technology – scanners, pacemakers, diagnostic machines, for example – that are continually fine-tuned to ensure increasing accuracy.

Industry stakes are high as manufacturers push the boundaries of technology to improve and extend life.

In order to do this, medtech companies need the right conditions: insight and intelligence to address the devices of the future; design and manufacturing excellence, and the opportunity to forge lasting business relationships.

The Med-Tech Innovation Expo combines these elements giving visitors and exhibitors the opportunity to grow and develop their businesses. It is designed for companies targeting the UK and Irish medtech markets. The UK life science sector is worth £73.8bn, according to the Office of Life Sciences. Medtech is a significant market that boasts 3,700 UK medtech companies while nine out of ten of the world’s top medtech companies have a base in Ireland.

WHAT THE EXPO OFFERS THE MEDTECH MANUFACTURER It is crucial that medtech manufacturers stay on top of the latest technology, materials and product trends that healthcare professionals value.

The expo offers two days of

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presentations from medical device OEMs highlighting the latest and future medical device developments – from ideation to commercialisation. Attendees can learn about the clinical trials process, regulatory hurdles, usability testing, materials compliance from experienced designers and CEOs. Designing and manufacturing medical technology is not a simple process. Market knowledge, awareness of regulations, specialist technology, materials, software and components are required along with intelligence on the healthcare sector and what it requires for present and future treatment. The design and manufacture of medical devices is complex. Making the right connections is crucial for sharing best practice, market knowledge and innovating.

The Med-Tech Innovation Expo provides the perfect platform to meets peers, designers, engineers and innovators that will grow your medtech business.

Biovation Orthopaedic Solutions will be at the Med-Tech Innovation Expo explaining how it can offer full service from concept to design

Carclo Technical Plastics (CTP) is a contract manufacturer specialising in injection moulding and assembly of thermoplastic components and devices for the medical and optics markets. The company boasts ISO13485-accredited production facilities in Eastern and Western USA, UK, Czech Republic, China and India.

Typical products include drug

delivery devices; diagnostic components; point-of-care diagnostic cartridges; ostomy bag fittings and surgical disposables; lenses and optical components.

CTP will present pressure sensing technology for optimisation, monitoring and control of the injection moulding process. Stand F17

CTP will be presenting pressure sensing technology for optimisation, monitoring and control of the injection moulding process

Clearworks consultancy develops leadership in the biotech, medtech and pharma sectors.

“Clients tell us they’re looking for leaders to be emotionally intelligent, agile and flexible. They want charismatic presenters, leaders of people, influencers of direction. No small ask. But all these things can be developed. The joy of this sector is that the people are switched on, focused, motivated to genuinely create breakthrough for their customers and for patients,” says Aly King-Smith, director.

King-Smith will be on the Introducing Stage on Wednesday, 1 April 1pm.

Stand D48 Connect 2 Cleanrooms (C2C) will be showcasing its bespoke modular cleanrooms. These enable organisations to convert existing facilities into classified clean environments.

Each process and facility is unique, so C2C works collaboratively from its UK bases to develop the most appropriate

med-tech innovation expo

cleanroom. Process flow is balanced with the factors that provide regulatory compliance, such as air changes and pressure differential.

C2C uses its Kingspan Precision panels to deliver a fully flush cleanroom solution, along with hardwall and softwall solutions that will be showcased at the exhibition.

Stand C10 Faulhaber will be showing an integrated encoder for flat motors. The BXT motor family, comprising outer rotor BLDC motors with short design, has been expanded with the diameter-complaint IEF3-4096 magnetic encoder. With 6.2mm of additional length, the motor/ encoder units remain short as is fully integrated in the motor housing. The encoder can be combined with the BXT housed series of BLDC motors where precise position and high torques are required in a limited space, eg, medical technology.

The company will also be offering a new GPT gearhead family with numerous gear ratios. Stand C18

Kaleidoscope Consultants will be talking about the impact of Brexit on European compliance, especially the links between the Medical Device Regulation (MDR) and General Data Protection Regulation (GDPR).

Kaleidoscope understands GDPR and UK law, and how GDPR varies between European states.

Most medtech manufacturers know they need to move their certification partner to an EU state prior to Brexit, and the need to appoint an EU representative to satisfy MDR, but many do not realise they have to do this for GDPR too.

Stand B70 Pod A Luso will be exhibiting its range of medical grade power supplies from major global manufacturers, such as Efore, Excelsys and Delta.

These will include plugtop and desktop adaptors; board mount dc/dc converters; embedded SMPS from 25 to 1200W and configurable modular units that can cover any requirement.

Including the industry leading CoolX fanless unit that is available in units up to 1800W. Specialists will also be on hand to discuss applications and advise on solutions. Stand E45

Faulhaber’s integrated encoder for flat motors will be on display at the expo

Intertronics’ stand will feature the latest technology in UV curing systems, sealants and coatings plus adhesives, designed for medical device assembly, with ISO 10993 and/ or USP Class VI certifications. It will also be showing dispensing technologies that offer accuracy and repeatability.

Intertronics will advise medical device manufacturers how to improve productivity and achieve a repeatable, verified process through adhesive selection and dispensing methodology. Attendees can also hear about ‘Designingin Light Curing Adhesives for Medical Device Assembly’ from managing director, Peter Swanson. Stand A30

Luso will be exhibiting its range of medical grade power supplies including the Delta

Maxon says its DC motors are reliable, have low vibration, can be sterilised, and don’t sacrifice high power density and efficiency, even in miniature formats with diameters as low as 4mm. The company has a range of medical applications including surgical robots, heart pumps, drug delivery systems, hand and leg prosthesis, surgical hand tools and exoskeletons. Its motors also come in a compact design and both have low electromagnetic interference and noise. Maxon medical products are ISO 13485 certified.

Stand B10

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Mi3 will be discussing medical device designs. It offers a bespoke service in design, development and contract manufacture of scientific, medical and surgical complex and single use devices together with regulatory support.

From the moment the design concept is conceived through to its development, registration and successful launch – Mi3 is an integral part of its client’s growth and development.

Recent projects include more complex medical devices with electronic, mechanical and chemical integration.

With innovative development engineers who support the development cycle together with two cleanrooms, injection moulding, extrusion, HF welding and wet chemistry capability, Mi3 offers a range of options to clients. Stand B118

allows customers to create an innovative, bespoke packaging design or improve an existing one.

It also has multiple testing capabilities and is primarily focused on the physical testing of the sterile barrier system and the functionality of the chosen substrates. Stand D79 Precision Polymer Engineering designs and manufactures highperformance elastomer sealing solutions for critical life science applications.

The company’s suite of medical rubber grades combines mechanical strength with universal chemical resistance and hygienic sealing capability. Precision Polymer Engineering will be displaying its Perlast family of FFKM material grades. Perlast G74S – a white FFKM with high temperature capability up to 260°C – is resistant to steam, amines and solvents, making it ideal for withstanding SIP and CIP cleaning regimes.

Stand C50

Mi3 will be discussing medical device designs

NES Global Talent recruits professionals for the pharmaceutical, biotechnology and medical devices industries.

It provides permanent and contract candidates covering quality, clinical, regulatory/ compliance, and engineering disciplines.

The company has dedicated NES Life Science recruitment hubs in Switzerland, Germany, Singapore, China, Australia and the UK and, following its purchase of US life science specialist Redbock in 2018 says it is one of the biggest life science staffing providers globally. Stand A6 Oliver Healthcare Packaging will be promoting its technology centre for European customers.

Package design is a critical part of a successful product launch and thanks to its renovated, customer-focused centre in Ireland, customers can work with packaging experts, enabling real time ideation and exploration from concept to commercialisation. The centre

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Precision Polymer Engineering designs and manufactures high-performance elastomer sealing solutions for critical life science applications.

Röchling Engineering Plastics (UK) will be showcasing its medical grade biocompatible thermoplastic materials and component manufacturing capabilities.

The company offers precision plastic machining, assembly, cleaning and packaging for the medical, healthcare and life science industry. It has recently opened a £1.2M dedicated medical machine shop, incorporating a range of multi-axial CNC machining centres, assembly, finishing and part marking capabilities, as well as an ISO Class 7 cleanroom.

Materials and manufacturing are certified to ISO13485.

Stand C38

With a recently acquired GMP certification, a European producer of medicinal cannabis needed a packing process that could handle its delicate products, meet the requirements of white room processing and offer safety, purity and precision. It found this in the SchurStar Concept.

The products are packed under white room conditions on a SchurStar 2060 C using double bag filling and camera control, equipped with thermal transfer Videojet printers to add product information and traceability coding. Stand E8

ZES accelerates its GxP clients towards engineering compliance and provides expertise which improves productivity, product quality and patient safety. Its GxP engineering consultancy and validation service covers pharmaceutical and medical device manufacturing.

This includes a specialist engineering service for projects, maintenance and validation, enabling tasks to be outsourced to a single contact.

The company’s pharmaceutical and medical device manufacturing compliance meets FDA and MHRA regulations.

Managing director, Davis Easton will be speaking at the event: ‘Ever wondered why a project was not a resounding success, but were too afraid to ask?’

Stand D97

The SchurStar 2060 C uses double bag filling and camera control, and is equipped with two thermal transfer Videojet printers

The West Group supplies components and production services for the miniature fluid control market and offers expertise for manufacturers requiring a specialist outsourcing partner.

The company has developed long-standing relationships with customers due to its ability to combine component and service elements. It has also become a trusted partner to many medical device manufacturers.

At the expo, the company’s display will include its range of check-valves, filters and pumps, all of which form an important part in each fluid control design.

The West Group offers quality assurance with ISO13485.

Stand D2

ZES offers a comprehensive GxP engineering consultancy and validation service

The Med-Tech Innovation Expo offer insight and itelligence to the medtech sector

A large part of the West Group’s display will include its range of checkvalves, filters and pumps

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3D printing

More than skin deep:

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the latest innovation in 3D printing

esearchers at the Rensselaer Polytechnic Institute in New York have developed an innovative method of 3D printing vascularized artificial skin for grafting onto patients. The result is artificial skin containing vasculature (blood vessels) that greatly assists in the integration of the skin with the host. This allows transfer of blood and nutrients between the host and the graft to keep the graft alive.

By making use of recent developments in additive manufacturing, the researchers were able to deposit bio-inks to form a skin-like structure in the lab. The skin was printed in two layers – a vascularized dermis layer containing cells for the vasculature such as endothelial cells and pericyte cells, and an impermeable epidermis layer for protection. The tissue was then cultured in vitro to allow it to mature before being grafted onto a host (in this case, a mouse).

The researchers found that over the course of two weeks in vitro, the skin graft started to develop a biologically relevant vascular structure. This has previously been difficult to produce due to the complexity of biological systems.

Pankaj Karande, the lead researcher on this work, explains: “As engineers working to recreate biology, we’ve always appreciated and been aware of the fact that biology is far more complex

than the simple systems we make in the lab. We were pleasantly surprised to find that, once we start approaching that complexity, biology takes over and starts getting closer and closer to what exists in nature”.

This indicates that, whilst the ability to 3D print complex biological structures might be beyond current additive manufacturing techniques, such complexity can be developed in vitro after the appropriate biological material has been printed.

Once the skin was grafted onto the host, the vasculature of the host integrated with that of the graft. This is an important step in ensuring that the graft remains healthy.

The developments by Professor Karande and his team are indicative of the wider spread of additive manufacturing beyond its original use in the rapid prototyping of mechanical products. As the technology develops, it becomes a feasible manufacturing method in a wide variety of fields, including biotechnology, medical devices, pharmaceuticals and food technology.

This can be particularly important where processes may be distributed geographically. In this digital age, there is no need for a 3D printer to be controlled locally. The designer and controller can be located remotely to the 3D printer. Whilst this be a great benefit in improving access to technology to more remote areas, this can also pose issues when it comes to protecting innovations as legal rights tend to be issued in individual jurisdictions.

This increased crossover in technologies helps to foster innovation but also poses disruptive risks for established businesses.

Furthermore, as with all technology development, it is important that new innovations are protected in order ensure that their value to businesses in maximized.

These risks can be resolved through the careful crafting of intellectual property protection, but forward thinking is necessary. Given the 20 year lifespan of a patent, products that may be unprintable today may be easily produced via additive manufacture before the expiry of the patent. Innovators should therefore look to future-proof their intellectual property against further developments in additive manufacturing.

The traditional avenues of protecting innovations (such as patent and design right protection) will need to adapt in order to cope with this changing landscape of technology.

Biotechnology companies that are used to protecting methods of manufacture and products manufactured by specific processes may not be aware that protection could equally be obtained for software processes, such as the control or design of an additive manufacturing process.

With the growth of 3D printing, and as traditional areas of technology become increasingly intermingled, it is important for businesses to adapt to ensure that they are not left behind. Businesses involved in product research and development need to start planning now for a brave new world and, in particular, ensure that the intellectual property protection that they are applying for today will stand up to the test of time, and still be fit-for-purpose 20 years down the line.

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DIGITAL HEALTH AGE

www.intersystems.com/uk

Compamed and Medica: healthtech at its best

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rom digital twins to the role that fake data can play in the future of healthcare, it was all on offer at Medica, says Lu Rahman As ever, Medica never disappoints and the 2019 event lived up to its promise of delivering tomorrow’s healthcare to its audience. Of course, the size of the event makes it impossible to see everything – global healthcare expertise from over 5,500 companies wasn’t designed for a whistle-stop tour – but it was still possible to come away with a sense of excitement about global healthtech.

No trip to Medica and Compamed would be complete without paying a visit to the Health IT Forum. Every year, this event highlights the future of technology in the healthcare space. This year AI, digital twins, digital medicine and 5G were the key topics.

“What sounded futuristic just a few years ago, has now entered the healthcare sector and has already become the standard in many countries,” explained Dr Nana Bit-Avragim, digital health expert at Brandenburg Medical School Theodor Fontane, before the session began.

According to Bit-Avragim voice recognition will continue to have a significant place in healthcare. This is something that we’re already seeing.

Zana, for instance, mixes voice recognition and AI to develop an interactive health assistant.

Zana interacts with the user over various channels such as internet chats and speech.

At Medica the company also discussed the ways health data can be tracked and relayed back to the patient. Zana reminds patients to measure vitals, it carries out health checkups, reminds patients to take medicine, detects critical clinical data and informs the patient on disease and treatment.

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Another product using similar technology is My Diabetes Coach. This app collects data from connected devices such as sleep trackers, scales, blood glucose monitors, and also monitors daily food intake. Using Amazon’s Alexa it helps people manage their diabetes properly.

DIGITAL TWINS One of the most interesting healthcare themes recently for me, has to be the digital twin.

The role that a digital twin can play in the treatment of illness and disease is fascinating and this was a key theme at the Health IT Forum. Christina Rode-Schubert of Orange itb explained how digital twins – the transference of real objects to the virtual world via data analysed by AI algorithms have a significant role to play in research.

The work being carried out

by Siemens Healthineers in this field is interesting - Siemens has years of cardiology experience providing data that can be used to map the digital twin of a human heart’s physiological system. Supported by multiscale models, electrophysiology, biomechanics, and haemodynamics, the company is collaborating with partners in the simulation of trends in specific patients and their response to treatment.

It was interesting to hear about the work being carried out by the European research initiative DigiTwins, supported

by Department of Microsystems Engineering IMTEK at Freiburg University.

Comprising more than 200 partners from industry, economy, and clinical research in 32 countries, this community is working towards establishing a personal digital twin for each and every European citizen.

It intends to revolutionise the healthcare sector and biomedical research for the benefit of the citizens and society and, by creating digital twins, to afford a contribution

to the European strategy for a digital domestic market. It’s an ambitious project and one which relies upon sufficient quantities of data.

DATA OR FAKE DATA? This leads nicely onto another theme at the forum – fake data and whether it has legitimate role to play in the future of healthcare. This was the cornerstone of Alexandra Ebert’s presentation, from mostly.ai. This company’s synthetic data engine Generate, is designed to generate an unlimited number of realistic synthetic customers that correspond to the patterns and behaviours of actual customers on a level never seen before.

This data engine analyses customer data to generate anonymised, synthetic data for the properties and activities of real people. It is no longer traceable and therefore in no need of data protection. Then part it has to play in meaningful healthcare is fascinating – does fake data have a significant role to play?

The British healthtech industry employs over 127,400 people* There are 3,860 healthtech companies in the UK and the industry has a combined turnover of £24bn* The Irish government allocated €85million to ehealth in 2019. This will rise to €100million in 2020 and €120million in 2021.

According to Deloitte Insights’ Winning at the Future of Medtech Novel partnerships with consumer tech to transform care delivery, medtech companies have the potential to drive the future of health but many may need to form partnerships with consumer technology and digital health companies to meet the needs of the market. *Source: ABHI

DIGITAL HEALTH AGE

sponsored by

Making waves: 5G and the medtech manufacturer

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E’RE HEARING MORE AND MORE ABOUT THE USE OF 5G IN MEDICAL TECHNOLOGY. JOHN O’GORMAN, S3 CONNECTED HEALTH, EXPLAINS HOW THE USE OF RADIO TECHNOLOGY IS HELPING MEDTECH COMPANIES OVERCOME HOSPITAL CONNECTIVITY CHALLENGES

According to Gartner, 5G and high-functioning networks will accelerate mobile capabilities in healthcare and help connect more than 90 per cent of inhospital medical devices by 2025.

While these predictions are extremely promising, they don’t consider the huge connectivity challenges hospitals experience sending data externally to medtech companies. With thick concrete walls, congested networks, and complex connected medical devices such as MRIs taking priority; 5G, wifi and Bluetooth can’t be relied on to send patient vitals, or drug and device data from hospitals to medtech companies in real time.

So, how does a medtech company connect to an inhospital device in a complex and secure manner to access patient and device data in real time?

The simple answer is they can’t, until now.

RADIO TECHNOLOGY: A SOLUTION TO THE HOSPITAL CONNECTIVITY CHALLENGE The solution arrived almost by accident, and in the surprising form of radio technology.

During an open day held by Trinity College, Dublin, I was shown the new prototype for Long Range Wide-Area Networks (LoRaWAN). The technology uses radio waves to broadcast data, has a range of 20 – 30 km, can broadcast a few bytes of data per day - which is enough to send information such as device activity or flag when vital medicine is low - and has a battery life of a year.

Not wanting to get ahead of ourselves, we started testing it at S3 Connected Health’s Dublin

HQ. The team was perplexed to see us wandering around the grounds with antenna to judge if signals could find a way through our building’s concrete and glass infrastructure; it turned out our building acted as a great model for a hospital.

Next, we worked with the CONNECT Centre, Trinity College to create a roadmap for the technology. We then collaborated with leading Irish universities on two aspects: Firstly to develop bespoke antennae for using LoRaWAN in hospitals, and secondly to profile the radiation pattern from the antenna to create integration methods that would work for all hospitals, regardless of their infrastructure.

Once we’d finished the development phase, we were ready to put LoRaWAN to the test in live hospital settings. We were confident that by using the technology we could: • Allow medtech companies to receive data from inhospital connected devices after each use: By receiving data every time the device is used, medtech companies can regularly monitor device activity and flag any issues as they arise. Also, by accurately monitoring medicine inventory levels, they can avoid tying up their capital in ordering excess stock of medication, where hospitals only pay per use.

• Enable hospitals to operate more efficiently: With medtech companies able to monitor medicine inventory levels and device efficiency after each use, devices can operate at peak efficiency, and vital supplies of life-saving technology and medication never run out.

• Improve the speed and accuracy of patient care:

By improving operational efficiency for medtech companies and hospitals – through the use of timely data – medical professionals have peace of mind that the right supplies will always be available for patients.

Also, they no longer have to manually operate a device, or log and order medication. This frees up more of their time to spend with patients.

DEMONSTRATING THE EFFECTIVENESS OF RADIO TECHNOLOGY IN HOSPITALS Once we had a fit for purpose product we partnered with four hospitals in Ireland and one in the US to pilot the technology and track results.

We discovered that we could use one router in conjunction with the LoRaWAN to connect an entire hospital ward, compared to the ten to 20 routers that were previously needed with conventional hospital systems. This transmitted data faster both across and out of the hospital and was more cost and timeeffective to set up. In fact, in one hospital, installing one LoRaWAN gateway allowed us to receive transmission through the entire building, which had previously been using 300 Wi-Fi repeaters without achieving full connection. With a Wi-Fi-based system, engineers are also required to visit the hospital to programme each device and router manually.

Our mission is to help medtech companies and hospitals work together seamlessly and improve the quality of healthcare; this is just step one.

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Recruitment

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Talent show

u Rahman looks at recruitment in the medtech sector and where to find help attracting top talent for your business The medtech sector is all about innovation. And this requires talent.

According to the Office of Life Sciences, the UK medtech sector contains 2,730 businesses, employing 97,600 people. 81% of these are SMEs. In Ireland the sector employs around 40,000 people.

The concept, design and manufacture of medical technology is demanding, requiring skilled individuals.

From the type of materials used, to human factors considerations to incorporating digital technology – it is vital that medtech companies have the best talent at their fingertips. The fact that the market continues to grow – Forbes says the figure will exceed $500billion by 2021 - means that businesses need to stay ahead of manufacturing trends and developments, and do this through their workforce. This isn’t necessarily a straightforward task.

Companies not only have to find talent but they have to retain it also.

It’s important that any potential employee has received the right training. There are currently around 17 universities offering medtech degrees in the UK. In Ireland, University College Dublin is one of around five institutions that offer similar training. But what about further down the line? Finding the right person to take responsibility for a complex medical device, can be a drawn-out process. Not only are you looking for a highly

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skilled professional but one who has a decent understanding of the market and its regulatory framework.

There are companies that can help with the recruitment process. Ryan Luckman, director and meditech team leader at FMC Global Talent says: “The market for regulatory affairs talent right now is very candidate driven. Demand has spiked and supply can’t keep pace, so the price in the market has gone up. More and more professionals are having their heads turned by higher basic salaries, lucrative contracting roles and fixed-term contracts over permanent ones.

“In a period where having regulatory affairs specialists is crucial, companies can’t afford to lose their talent to competitors.

“Manufacturers need to think outside the box to retain and attract candidates so that they can deal with the increased workload brought in because of the MDR.” RBW CONSULTING specialises in life science recruitment, working globally with both small and large companies.

RBW clearly has its eye on industry momentum and understands the competitive nature of its markets. With this is mind it offers a screening process that focuses on the technical requirements of a role as well as the personality fit and behaviours needed to fit into a team and the wider organisation.

SRG TALENT prides itself on being a STEM recruitment agency that puts people first, creating ‘meaningful human connections that empower individuals and businesses alike to shape tomorrow’s world’.

The company applies specialised industry knowledge

to science, clinical and engineering jobs and talent solutions. It also recruits across the product life cycle, covering scientific research and technology, clinical trials, manufacturing and engineering disciplines.

SRG’s website is full of highly useful information including a piece on ‘How to Attract Top Talent Through Diversity’.

Its content on skills is particularly strong: “Skill shortage is a hot topic, especially in a highly skilled industry such as STEM. Although it is estimated that the amount of STEM roles will double over the next 10 years, hiring the required talent can be challenging.

The UK government’s 2017 industry strategy white paper reported that 40% of employers said a shortage of STEM graduates was a key barrier in recruiting appropriate staff. STEM Learning found that, 400 HR directors that rely on staff with STEM skills, experience several hiring problems: seven out of ten said it was difficult to hire staff with required skills in 2017; nine out of ten said that recruitment is taking 31 days longer than expected; 48% look overseas for the right talent.”

SRG Talent says that diversity can help with STEM recruitment challenges by opening up the recruitment pool allowing more access to talent.

There is plenty of recruitment expertise on offer for the medtech market enabling SMEs to access the skills and keep them in the business longterm.

Injection moulding

HOT shots

injection moulding at its best

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LU RAHMAN SELECTS SOME OF 2019’S INJECTION MOULDING EXPERTISE

It was a good year for RJG Technologies which was recognised with Best Injection Moulding Process Support Specialists 2019 at the SME Midlands Enterprise Awards.

The award followed on from RJG Technologies winning the Best UK Plastic Injection Moulding Consultancy in the Pharmaceutical Manufacturing & Packaging Awards.

According to the company the team at RJG takes great pride in everything it does and winning the Best Injection Moulding Process Support Specialists in the SME Midlands 2019 Enterprise Awards is recognition of this.

The company was pleased to be recognised for the support it gives to its customers in its region through its training and consultancy services. It works with many well-known names in the plastic sector helping them to succeed in what they do.

In the last 12 months it has supported a number of initiatives that have been delivered on time meeting the customers’ expectations, and says it has developed a reputation for delivering what it says it will.

The global respiratory care devices market is expected to grow at a rate of 9.65% in the next five years. Medical device manufacturer, Armstrong Medical has ensured it is in a prime position to take advantage of future opportunities, by adding to its injection moulding machine portfolio.

Faced with a need to increase production after negotiating a contract to supply a carbon dioxide absorbent for use in anaesthesia the company acquired a hybrid Systec Servo 160 from Sumitomo (SHI) Demag.

Back in 2007 a fire engulfed the company’s premises.

Armstrong Medical rapidly reconstructed the production facility it had built up since 2003, ordering replacement injection moulding machines from Sumitomo (SHI) Demag. Just two years later the firm received The Queen’s Award for Enterprise for International Trade.

“All of the assembly and manufacturing areas were destroyed, but we managed to keep a warehouse that had only been handed over the previous week,” recalls Nigel Simpson, plastics project manager at Armstrong Medical. “That was a turning point for us because we were able to rebuild the way we wanted to and set the operation up to suit our needs.”

Today, the company has 11 injection moulding machines, two bench top moulding machines, a liquid silicone rubber (LSR) production cell and various other pieces of equipment tailored exclusively to Armstrong’s production process.

Exporting to over 120 countries – and being predominantly involved in the production of high quality, innovative respiratory disposables for anaesthesia and critical care – Armstrong Medical’s plant also features class 10,000 and 100,000-type assembly cleanrooms.

A regular at the Med-Tech Innovation Expo, Boddingtons recently won the Industrial design Award at the Plastics Industry Awards for its work with Cytosystems on a new bladder cancer detection product – BladderLight – which involved thirty moulded products.

The company’s £4.6m manufacturing facility – incorporating a modular Class

7 cleanroom – was launched

by Lord Digby Jones at the end of 2016 and is now undergoing further investment and development.

Since the launch of this manufacturing facility, Boddingtons has expanded the scope and volume of its medtech manufacturing services.

It is certified to ISO13485 and ISO9001 Quality Management Systems Requirements and is also compliant with FDA 21 CFR Part 820.

Andy Tibbs, CEO, says: “Our aim at Boddingtons is to be nothing less than a world-class supplier of injection moulding competences to the global medical and healthcare sectors – from first concepts to final assembly and shipping and all manufacturing and injection moulding points in between. We invite all in the sector to partner with us for future growth.”

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Medilink UK Medilink UK is the UK’s largest network of life science and health technology organisations, with over 1,600 members and a database of over 48,000 contacts.

Our experts can provide specialist support in: ●

●

We encourage innovation in the sector and nurture collaboration between academics, clinicians and industry.

With offices based across the UK, members of Medilink UK have access to opportunities and events on both a national and a regional level.

●

●

To find out more about Medilink UK and the regional offices, visit www.medilinkuk.com

New product development and market research Selecting and reaching your target market, whether it’s in the UK or abroad Clinical research and NHS procurement Sourcing funding and finance

IAN BOLLAND ASKS

ABOUT THE EFFECT

EJ SHIN JENAX AND

FLEXIBLE BATTERIES

ANDY BAKER, HP1

COULD HAVE ON

TECHNOLOGIES,

MEDICAL DEVICES

Sensors & electronics

Can flexible batteries revolutionise power in medical devices?

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his interview followed a webinar on how flexible batteries can be used in the manufacturing process, ‘creating product innovation breakthroughs with flexible power.’ It covered the importance of continuous innovation, changing the mindset of what batteries can do, and new standards of safety, flexibility and control.

According to MarketsandMarkets the flexible battery market is estimated to grow from US$97 million in 2016 to US$958 million by 2022, propelled by the miniaturisation of electronics devices, and the demand for wearables.

EJ Shin, Jenax notes that wearables can benefit from flexible batteries.

There is also a use within clinical setting, allowing medical professionals to manoeuvre easily instead of carrying power banks.

Shin adds: “Flexible batteries can be an enabling technology for many devices and for many aspects in the medical field.”

So where is the opportunity within medical device design? Is the demand for flexible batteries being driven by device design, or are the

batteries leading to more innovative designs?

“I would say it’s the synergy of both,” Shin explains. “Device makers want to make the device more flexible so flexible components are needed.

We want to find a perfect or usable application that can be benefitted by flexible batteries.”

The batteries were also shown to have a life comparable to standard batteries, while also showing that when they have been cut through, there is no sign of leakage – a potential selling point when it comes to being used in a field when safety is imperative.

“Making the flexible battery is one technology and also making the entire battery safe is another.

We combine the two. We have made it safe by developing semi-solid electrolytes and also years of testing and experience on production knowhow.”

Last year Jenax, announced a breakthrough in battery safety with non-flammable liquid electrolytes.

This aims to solve the problem of batteries that catch fire or explode in extremely hot temperatures or when short circuited. This technology can increase the safety of wearables.

Andy Baker, CEO – sport and leisure – HP1 Technologies, which builds printable graphene-based sensor systems, developed a helmet containing over 20 sensors on the surface.

Baker recently attended an NFL conference. The reduction in concussion in the sport is a key issue. The helmet requires sensors, so needs flexible batteries.

He explains that connectivity is a huge consideration but it’s possible to include flexible batteries in devices such as

smart bandages; and suggests there is room for diversification as well as highlighting safety features.

“The main point for health is they do not explode when pierced or leak corrosive substances. Flexible batteries can be pierced and cut and will still supply power until replaced and will only leak a small amount of a polymer gel which is harmless and can be on the skin without causes any discomfort or burns.

“I think the main message is to think differently, if you think differently you can power differently.”

WEB OF INTRIGUE… Inspired by jumping spiders, researchers at the Harvard John A. Paulson School of Engineering and Applied Sciences (SEAS) have developed a compact depth sensor that could be used on board microrobots, in small wearable devices, or in lightweight virtual and augmented reality headsets. The device combines a multifunctional, flat metalens with an ultra-efficient algorithm to measure depth in a single shot.

Jumping spiders have evolved to efficiently measure depth. Each principal eye has a few semitransparent retinae arranged in layers, and these measure multiple images with different amounts of blur. If a jumping spider looks at a fruit fly with one of its principal eyes, the fly will appear sharper in one retina’s image and blurrier in another. This change in blur encodes information about the distance to the fly.

The researchers demonstrated metalenses can simultaneously produce several images containing different information. Building from that, the team designed a metalens that can simultaneously produce two images with different blur.

The research is published in Proceedings of the National Academy of Sciences (PNAS).

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Head start: Can a head set help treat mental health issues?

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ACH ISSUE IAN BOLLAND WILL BE LOOKING AT THE USE OF MEDTECH IN THE REAL WORLD. THIS ISSUE HE EXAMINES THE CURRENT TREND FOR HEADSETS TO TREAT MENTAL HEALTH CONDITIONS.

In practise Mental health has crept steadily up the agenda in recent years – there are more efforts to raise awareness about conditions while funding surrounding treatment has landed on the political agenda.

CBT is widely used on the NHS alongside medication – faceto-face counselling is often well used for CBT while more and more treatments are being developed for online use, such as with Xenzone who Kooth use in its digital health platform.

But an increasing trend appears to be the use of neurostimulation headsets to try and address mental illness.

Below we look at three that have emerged over the last year.

CEO and co-founder Daniel Månsson, said: “The headset uses transcranial direct current stimulation (tDCS), a form of neurostimulation that delivers a gentle electrical signal, which activates neurons in the left frontal cortex of the brain. People diagnosed with depression often have a lower activity in this area and the stimulation works to rebalance this activity. During this process the user interacts with a virtual therapist, via the app, to specifically treat the symptoms of depression. The app teaches the user about depression, and how to reduce it using techniques for improved sleep, healthier eating, effective exercise and stress-reducing meditation.”

The product is currently being used as part of a clinical study evaluating how patients with depression respond to the product. Flow is also providing the product to certain NHS Trusts.

NEORHYTHM From MDCN Technologies, the NeoRhythm headband uses medium-intensity magnetic fields with magnetic flux density of 20-25 Gauss (22.5 mT) in a bid to generate the right frequencies for brainwave entrainment. It aims to emits scientifically confirmed frequencies that are characteristic for a certain state of mind. The brain adapts to these frequencies meaning it should reach the desired state of mind quicker and easier.

All the frequencies emitted

by NeoRythm in its seven stimulation programs are based on scientific studies.

In an interview with our sister title, Digital Health Age,

MODIUS SLEEP Neurovalens has been

FLOW Earlier this year, Flow launched a headset and app combination for depression – using transcranial direct current stimulation (tDCS), a form of neurostimulation that delivers an electrical signal to the head.

This is combined with behaviour therapy involving lifestyle changes.

The device stimulates the sleep neurons in the brain, in the hope it reduces the time it takes to fall asleep 34

through this before. Having previously developed the Modius Slim, the Modius Sleep follows on from it as it aims to use neuroscience to help its users sleep better.

The device stimulates the key sleep neurons in the brain, in the hope it reduces the time it takes to fall asleep and keeping you asleep longer. The Modius Sleep headset is worn for 30 minutes before bed and works by sending an electrical pulse into the vestibular nerve that influences the areas of the hypothalamus and brain stem that controls the user’s circadian rhythm and sleep patterns.

Neurovalens CEO, Jason McKeown, said: “This new headset taps into the power of the brain’s hypothalamus, which acts as a mini-computer and influences many areas of the brain, including weight loss and sleep. Our aim is to help people avoid sedatives and sleeping pills as they mask the underlying problem and produce unpleasant side effects. We use neuroscience to improve lives through safe, innovative, non-invasive products and have complete confidence our Sleep device is just as life-changing as our Slim device has been.”

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