MTI Issue 39

www.med-technews.com Issue 39 | Sept/Oct 2018

@medtechonline

PLUS

Getting the best out of Compamed 2018

MED-TECH INNOVATION | NEWS MED-TECH

innovation

MAUCHER JENKINS ON THE IMPLICATIONS OF BREXIT FOR THE MEDICAL DEVICE AND PHARMACEUTICAL SECTOR

ADVANCING HEALTHCARE

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CONTENTS 6-7.

MED-TECH

Headlines

INNOVATION | NEWS

8-11.

Opinions

12-13.

On the cover

6

23.

Tubing, catheters and stents

25.

Implants

12

26-27.

Compamed

29-31.

25

Ireland

32.

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STARTR THE TEAM editor | dave gray +44 (0) 1244 680 222 david.g@rapidnews.com

senior sales executive | amy miller +44 (0)1244 680 222 amy.miller@rapidnews.com

reporter | reece armstrong reece.armstrong@rapidnews.com

head of media sales, plastic & life sciences | lisa montgomery +44 (0)1244 680 222 lisa.montgomery@rapidnews.com

head of content | lu rahman lu.rahman@rapidnews.com

head of studio & production | sam hamlyn

brand director | colin martin +44 (0) 1293 710 042 colin.martin@rapidnews.com

art | matt clarke publisher | duncan wood

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from The editor

T

[

The Famous Five

his year has been an interesting one for NHS innovators. Just recently I attended the launch of the latest cohort of startups on the DigitalHealth.London accelerator, and I was struck by how much this type of event has grown.

When I first started writing about digital health back in 2014, I remember thinking how hard it was to get NHS stakeholders in the same room as the ideas people. Now, you can’t keep them away.

Perhaps it’s because the accelerator/incubator model is now timetested and proven to work. Initiatives like DigitalHealth.London are actually delivering on their promises – both to startups and to the health and care system.

The London launch was just one of five accelerators announced across the UK on the same day, signalling a more co-ordinated approach.

There are dozens of these projects all over the UK, but the AHSN has thrown its weight behind five key regions: London, Manchester, the South West, East Midlands, and Kent, Surrey and Sussex.

Prior to the establishment of the five networks, DigitalHealth.London has spent the past two years successfully nurturing young companies and getting them access to the NHS – with many still on the road. The 60 companies previously enrolled in London have, I’m told, collectively saved the NHS about £50 million in various tech-related efficiencies.

These accelerators will be great for digital pioneers.

They’ll get training, R&D support and product development, networking opportunities, and, perhaps most valuable of all, access to clinicians – the very people who want and need them to succeed the most.

As you can probably tell if you’re reading this – I really like accelerators.

I like the way a creative vibe permeates through the (often very dry) subject matters of approvals and adoption – inevitable talking points among these meetings. The community spirit is always really strong in the room at these events, there’s nothing competitive about it, and nothing particularly commercial either.

I do, however, have one nagging little criticism of the UK’s health accelerator landscape: namely, the focus seems to be almost exclusively on digital software, rather than connected hardware. I can see that adoption is, arguably, easier to achieve with smartphone apps. They’re a low-cost investment, the platforms are largely in place and they generally don’t require much re-training.

Medical devices on the other hand are costly to reimburse, can cause interoperability headaches, and can require specialist training. But surely all of the above factor as good reasons for a renewed focus on initiatives for startups in the med-device space.

It’s been well documented that the new secretary of state for health is a huge advocate for the use of better tech, and he’s been warmly received amongst the digital community.

But will he have anything to offer more traditional medtech innovators? The growing infrastructure around the five aforementioned regions is a positive start, but there needs to be more access for those with a great idea for a new device.

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CAN PROSTHETICS BE INTELLIGENT?

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ELECTRICAL IMPLANT HELPS PARALYSED PEOPLE TO WALK AGAIN A small group of patients has had a device implanted that electrically stimulates their spinal cord.

According to the BBC, the device, “which is placed below the injury, helps lost signals from the brain reach leg muscles”.

The breakthrough has come out the University of Louisville and the Mayo Clinic. One of the participants, Kelly Thomas, 23, has experienced positive results from the treatment. She said: “Being a participant in this study well and truly changed my life, as it has provided me with a hope that I didn’t think was possible after my car accident.

This research is based on two treatments: Epidural stimulation of the spinal cord and locomotor training.

Epidural stimulation is the application of continuous electrical current at varying frequencies and intensities to specific locations on the lumbosacral spinal cord.

Locomotor training aims to ultimately retrain the spinal cord to ‘remember’ the pattern of walking by repetitively practicing standing and stepping. In a locomotor training therapy session, the participant’s body weight is supported in a harness while specially trained staff move his or her legs to simulate walking while on a treadmill.

headlines

“Intelligent prosthetics are prosthetics that perceive their surroundings via sensors.

Based on these perceptions, they then adapt their functions appropriately to meet the patients needs,” explains professor Arndt Schilling, head of research and development at the clinic for trauma surgery, orthopaedics and plastic surgery at the University Medical Center Göttingen. He is one of the more than hundred international speakers at the Medica Connected Healthcare Forum.

The forum will focus on personalised medicine for the treatment of chronic diseases and health monitoring to match, among other topics. ResMed, for example, offers solutions for sleep apnoea as well as noninvasive ventilators for home use.

Korean company Ybrain uses neurostimulation to treat depression. Ybrain has developed the Mindd headband which emits mild electrical impulses to the frontal lobe of the brain. This shocks the frontal lobe out of its depressive inactivity (depression is associated with inactivity in this region of the brain). The system is connected to a smart phone app which allows users to evaluate the intensity of their depression.

On 13 November everything at the forum will revolve around smart patches. Examples include TracPatch. This allows patients’ progress to be tracked after an operation. It records agility for example and measures body temperature to give an indication on inflammations, making this an ideal device to use for training purposes or in mobilisation therapy after an operation.

REGISTRATION OPENS FOR MED-TECH INNOVATION EXPO Registration is open for MedTech Innovation Expo, the UK and Ireland’s leading showcase for medical design and manufacturing technology.

For the first time, the event will be held at the NEC, Birmingham.

The move was announced during the 2018 expo and means a larger show with more exhibitors and exciting new features.

With vastly improved accessibility both for UK and international attendees, the organisers are anticipating a step-up both in overall visitor numbers and also in the percentage of those attending from abroad. Holly Delaney, marketing manager for MedTech Innovation Expo said; “We’re so excited for Med-Tech Innovation Expo 2019. There’s so much more on offer and all in a bigger space with better travel links, more accommodation and even more of the high-quality exhibition stands our visitors have come to expect. We’re in one of the largest and fastestgrowing industries in the world, its time our community had a show on the scale they deserve.”

Med-Tech Innovation Expo will be held in Hall 2 of the NEC, Birmingham (UK) from 15 - 16 May 2019. For more information, visit www.med-techexpo.com.

WORKSHOP TO EXPLORE IMPACT OF MDR ON COMBINATION PRODUCTS

J&J BOOSTS SPINAL IMPLANT PORTFOLIO THROUGH ACQUISITION

DATA REVOLUTION DRIVING FLURRY OF M&A IN MEDTECH

The Regulatory Affairs Professionals Society (RAPS) and The Organisation for Professionals in Regulatory Affairs (TOPRA) have joined forces to deliver a workshop to help regulatory professionals understand the impact of the EU’s new Medical Device Regulation (MDR) on combination products.

Th workshop, entitled Addressing the Impact of the EU MDR on ‘Combination’ Products, will take place in Brussels, 20 November 2018, and bring together representatives of the European Commission, Member State medicinal and medical device authorities, notified bodies and industry experts to explore the complex issues of MDR specific to combination products.

The goal of the workshop is to generate white papers highlighting practical considerations to be shared with regulators and other stakeholders as they deliberate on implementation issues.

The workshop will include a brief review of the changes MDR will introduce, but more time will be devoted to discussing the anticipated practical implications of the changes and sharing the concerns and expectations of all stakeholders as the regulators establish future implementation expectations.

Paul Brooks, executive director of RAPS, commented: “MDR is the single biggest challenge currently faced by those involved in the regulation of healthcare products.

Combination products are particularly challenging to manage, and collaboration across the sector is essential if we are to consistently understand the regulators’ interpretations and expectations in meeting the new requirements.”

Johnson & Johnson will acquire a manufacturer of 3D printed titanium implants in an effort to enhance its implant portfolio, the company has announced.

Johnson & Johnson Medical will acquire Emerging Implant Technologies (EIT) to give its orthopaedics business, DePuy Synthes access to EIT’s portfolio of implants. EIT’s implants utilise advanced cellular titanium, consisting of an open and interconnected porous structure that allows bone to grow into the implant.

The acquisition gives De Puy Synthes access to 3D printed cellular titanium which can be used for both minimally invasive and open spinal surgery.

“Our goal is to offer a complete portfolio of interbody solutions that provides surgeons with even more options for the treatment of their patients,” said Aldo Denti, company group chairman of DePuy Synthes. “We are excited to welcome the skilled team at EIT, and together, we aspire to bring to market technologies that allow surgeons to perform spinal fusion procedures reliably and with consistent outcomes.”

The company states that EIT’s portfolio will complement some of its recent technology introductions, designed to treat patients with degenerative disc disease.

The latest Healthtech M&A Market Report from international technology mergers and acquisitions advisors, Hampleton Partners, reveals how big data is fast becoming the common currency that lies at the heart of high-value business models in the healthtech sector.

In addition to booming strategic investment in the sector, the first half of 2018 saw record private equity investment and five multibillion-dollar deals.

Billions of individual electronic health records (EHR) are replacing paper files and the data from decades of medical research and clinical trials need to be stored. Data management and analytics platforms and medical collaboration software are in demand to take advantage of the huge potential the data revolution offers to advance medicine.

Jonathan Simnett, director and healthtech sector principal, Hampleton Partners, said: “The data revolution is helping transform healthcare and is offering individuals, as well as clinicians, the opportunity to track, manage and improve health states in real-time by using healthtech wearables and personalised apps.

“These trillions of health and well-being data points all need monitoring and analysing to provide the effective diagnostics that practitioners need to improve outcomes.”

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Designing medtech for the Internet of Things

OPINION

In the past, only a handful of established device makers were able to create blockbuster gadgets for world markets. But that’s changing.

With the advent on IoT, hundreds of small start-ups are trying to cash-in and mimic the big manufacturers and bring new devices to global markets at a fraction of the price. Crowdfunding platforms such as Kickstarter are flooded by these projects.

Designing a connected product requires specialist expertise in antenna, EMC, mechanics and thermal design, and calls for timeconsuming prototyping and testing. Let’s delve deeper.

ANTENNA: Nowadays, many devices feature metal casings, which is a very challenging operating environment for an antenna. Antennas are found in increasingly smaller devices and in devices held near or inside human body.

Hearing aids, smart watches sensors, smart rings are typical examples.

The small size of the device and the proximity of the human body put special high demands on the concept of an antenna. Antennas require high efficiency and design for high-frequency 5G devices is really challenging.

Propagation, range and carrying capabilities at high frequency are lower and that poses a profound demand

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HOW CAN STARTUPS LEVERAGE IOT TECH TO BREAK INTO THE CROWDED MEDTECH MARKET? TATU KARVINEN, MANAGING DIRECTOR OF FINNISH INSIGHT ENGINEERING FIRM CONVERGENTIA, MIGHT HAVE THE ANSWER.

on manufacturers. In antenna design, requirements vary by country and region and compliance with official requirements requires special expertise in design.

EMC: the operating environment for smart devices is becoming more demanding as the volume (quantities) is growing. Devices should not interfere with signals from other devices or interfere with others. Such reliability is particularly important in health and military environments, but also in standard mobile devices for the consumer. A touch screen often causes interference with the receiver.

Designing effective EMC solutions has traditionally been hit and miss and rely on hope that it will somehow work. Through simulations, the design process can be undertaken in a precise and controlled way. Typically, a device maker understands its EMC design needs only after the build phase when the problem is detected.

With simulations and lab measurements, the problem can be analyzed early and accurately.

THERMAL: more and more power is required from devices, leading to more powerful batteries and processors. LED displays tend to heat up especially in handheld devices, and this often causes problems with

user safety and comfort. There is also a set of specifications for the warming of the equipment that manufacturers have to conform to in order to get a product on the market.

Of course, it is far more effective to design a device according to a specification from the beginning than to hope that an already made design conforms to a specification.

Simulations can be used to find at an early stage what solution will work and what will not. In most cases, simulations are applied for corrections to the existing design to match the specification. Also, the power consumption of 5G base stations is really high, which also requires accurate thermal design to prevent cooling problems.

MECHANICS: Equipment transported can carry more than before, meaning they have to endure a wide variety of applications in environments. For example, the wearable sector’s growth is reflected in this trend. Various devices must withstand body moisture, under water use and other challenging conditions. For example, simulation of drop, vibration and seal tests can be used to avoid large and costly prototype cycles that are often needed to make durable products. Assembly simulations such be used to avoid assembly problems.

Start-up equipment manufacturers often take a reverse approach to device design. It’s not unusual for them to take a cheap Chinese bulk antenna only to discover after extensive and costly prototype rounds and testing that it does not work at all.

This “instant” engineering approach often proves more expensive than if the antenna was custom designed to fit the device right from the start.

The same can be said for every other design area. Early phase engineering should be taken into account first in the product development process. It will save both time and money. Simulations and virtual prototypes can also be used to effectively compare different concepts such as component changes.

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What medical device manufacturers can learn from the auto industry

OPINION

Medical device manufacturers compete in such a fastmoving industry that there has to be a big commitment to technological innovation, but this sharp focus can sometimes push out of view other ways of improving profitability. Manufacturing itself is a prime example.

Factory infrastructure, equipment utilisation and employees’ production-line working processes might not sound as exciting as new product development, but all can be improved in ways that make a worthwhile difference to the bottom-line.

Because of the cost sensitivities of emerging markets, increasing pressures to deliver value to customers and stakeholders, and tightening regulations requiring flawless quality controls, medtech manufacturing efficiencies are now more important than ever. The ways in which other industries have met such challenges can be instructive.

What’s really illuminating is how the most efficient makers of high-quality engineered products have adopted

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two key disciplines: lean manufacturing and continuous improvement.

You might have heard some businesses say that they ‘tried’ lean manufacturing and were disappointed by the results.

Unfortunately this has been a widespread phenomenon.

Lean manufacturing is inextricably linked with continuous improvement, with the emphasis on ‘continuous’.

Day after day, month after month, year after year, the determination to make things better through self-critical attention to detail must never end. If this sounds daunting, it doesn’t have to be. Lean manufacturing and continuous improvement are attainable by introducing methodical, repeatable processes. These processes bring a rigorous structure to evaluating a plant, so that problem areas and inefficiencies can be identified, analysed, and improved. And it’s surprising how little these improvements typically cost.

The world’s most successful practitioner of lean manufacturing is widely acknowledged as Toyota

MANY MEDTECH BUSINESSES COULD MAKE MORE MONEY BY COMBINING LEAN MANUFACTURING PROCESSES WITH CONTINUOUS IMPROVEMENT.

Motor Corporation, and Toyota is willing to share insights into its working practices with manufacturers who aren’t competitors. Hence medical device and pharmaceutical companies were recently invited to a workshop and factory tour at Toyota’s Deeside Engine Plant in North Wales, home to the Toyota Lean Management Centre.

This event was co-hosted by SMMT Industry Forum, for whom I’m chief executive.

SMMT is the abbreviation for Society of Motor Manufacturers and Traders, but for years now Industry Forum’s consultancy and training services have helped transform the manufacturing competitiveness of businesses not just in the automotive sector but many others too.

A wide range of sectors are also assisted by the Toyota Lean Management Centre, which works with companies in food, chemicals, aerospace, pharma and medtech.

Courses run at the Centre allow access to the Deeside plant for unique study and benchmarking opportunities.

This plant employs about 700

THESE METHODICAL PRACTICES HAVE PAID-OFF HANDSOMELY IN OTHER INDUSTRIES, AS DR CHRIS OWEN, CHIEF EXECUTIVE OF INDUSTRY FORUM, EXPLAINS.

people and produces close to 340,000 car engines per year for shipping to vehicleassembly plants in the UK and overseas, including Japan.

FOUNDATIONS FOR CONTINUOUS IMPROVEMENT Challenge: It is vital to have a medium- and long-term vision, and this will almost always necessitate managing change.

To ensure that the forwardlooking vision is sharp, there has to be detailed study of manufacturing processes and capacity.

Respect: Toyota starts with the belief that all people want to do a good job and the company regards itself as being responsible for creating the environment in which people can develop and grow.

A development map is created for every individual, with a clear path for training and advancement.

Kaizen: This is the process of making small improvements continuously, targeting the elimination of waste and nonvalue-added activities. Toyota Deeside assembly-line staff members are rotated between

four (of the six) different line tasks every day so that they stay engaged with the job and keep looking with fresh eyes for ways to eliminate waste.

Every staff member is also asked to come up with at least two improvement ideas per month. To encourage Kaizen, information about targets and performance is displayed prominently at many locations throughout Toyota’s plant.

Hoshin Kanri: In corporatespeak, this means ‘policy deployment’, but to everyone in the workplace - and I really do mean everyone - it means teamwork. This is how Toyota’s strategic goals drive progress and action at every level. The company uses Hoshin as its starting point to align business strategy with shop floor activity, then deploys high-level strategy at all levels through daily management. What’s

more, all levels in the company create their own Hoshin, with assigned responsibilities.

Genchi-Gen-Butsu: Translated as “Go and see,” this spells out that it is imperative for managers to go to the production line and see whether individuals are all working to exactly the same, standardised methods.

Standardised work is a tool that can be applied to any process involving human interaction by organising and defining process-steps and human movements.

This ensures that safety, quality and efficiency are built into human processes.

One Toyota manager told us: “We standardise everything - but we don’t stifle creativity, because the challenge for our members is to create the standard and then constantly improve it.”

Assembly-line team leaders observe that standardised procedures are adhered to and this manual monitoring is supplemented by the location of video cameras around the plant. Far from being the first step in a blame game, the cameras are there to help identify where mentoring and support is needed. One manager told us: “Trust is essential. We’re not using the cameras to catch anyone out, but to bring improvements.

We never blame the individual, we analyse and improve the process.”

To understand the importance of standardisation, consider this: out of all the 337,516 engines produced at Deeside last year, only 13 defects were found. Toyota says “that’s 13 too many” - and every one of those could be traced to lapses from standardised procedures.

The payback from continuous improvement is that waste elimination and efficiency gains are also continuous.

The results of such disciplines are hugely impressive at Deeside and representative of what Toyota is achieving

elsewhere. The Deeside plant produces 1,300 engines per day, yet has cut the number of engines stocked from 2,700 to 450 - and is now targeting 350. This plant was designed to produce an engine every 54 seconds (simultaneously producing 25 variants of that engine) and started by achieving the production rate of 57 seconds, but has now got that down to 42 seconds.

No big investments were needed to achieve this valuable productivity gain. It was arrived at, step by step, entirely through Kaizen and eliminating waste. It is true that some of the easiest and biggest gains from continuous improvement are usually made first, and that it becomes necessary over time to look harder for smaller rewards - but when every member of the company is looking, as they are at Toyota, small improvements keep on coming in such large numbers that they add up to something truly significant. Medtech companies who are willing to open their minds to these possibilities have much to gain.

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ON THE COVER

T

he Withdrawal Agreement provided details of a transition or implementation period starting from the UK’s exit from the Union on 29 March 2019 at 11.00 pm and ending on 31 December 2020.

During that period, all EU rules and regulations will continue to apply in the UK (subject to any variations or exceptions contained within the Withdrawal Agreement). On 6 August 2018, the UK Government published guidance confirming that during the implementation period: • Batch release testing and Qualified Person certification can continue in the UK, with this being recognised in the EU and vice versa; • Marketing Authorisation Holders (MAHs) and Qualified Persons for Pharmacovigilance (QPPVs) will continue to be able to be based in the UK and will have access to EU markets; • UK based firms can continue to apply for Marketing Authorisations via either the centralised or decentralised procedures; and • Conformité Européene (CE) marking will continue to be used for medical devices and recognised for the UK and EU markets, and there will be no need for UK-based companies to appoint an EUauthorised representative in the EU. UK notified bodies can continue to conduct third-party conformity assessment tests in the UK and the results will continue to be used and recognised in the UK and EU markets.

Reuben Jacob, partner and head of life sciences, and Dr. Janet Strath, paralegal, both from legal firm Maucher Jenkins, look at what the recent guidance issued by the UK Government on the Brexit implementation period and the life sciences sector will mean for regulation and compliance.

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In its technical guidance, the Medicines and Healthcare products Regulatory Agency (MHRA) further explained that the UK would be able to participate in reviewing new Marketing Authorisation applications, but it would not be able to act as the leading authority or Reference Member State (RMS) for risk assessments, examinations, approvals and authorisations pursuant to Article 123 of the draft Withdrawal Agreement. The Coordination Groups for Mutual Recognition and Decentralised Procedures have confirmed that transfer of an RMS (from the UK to another member state) will

ON THE COVER

not be permitted before an MA application procedure is concluded.

Consequently, the guidance states that applicants for Marketing Authorisations which are still being processed and who “wish to ensure that procedures involving the UK as RMS will be completed by 29 March 2019 are requested to submit responses to outstanding lists of questions as soon as possible”.

During the implementation period, the MHRA and the Veterinary Medicines Directorate (VMD) can attend European Medicines Agency (EMA) and EU Committees, and participate in all discussions that are relevant to the UK. However, “the exact nature of this participation is a matter for further discussion”.

The MHRA and the VMD will carry on discussing issues with EU counterparts and sharing information as they currently do (including continued access to EMA and EC databases and sharing of vigilance data) but some elements of the MHRA’s and the VMD’s role will change; for example, the UK will no longer have a vote in any decision making by the EMA and EU committees.

The EU Medical Devices Regulation (MDR) will be fully applied from May 2020 (during the implementation period) but the new EU Regulations for in vitro diagnostic (IVD) medical devices does not apply until May 2022 (outside of the implementation period). However, the MHRA notes that elements of both new devices regulations have applied in the UK since May 2017, meaning that medical devices (including IVDs) can already be legally placed on the UK market provided that they conform to the new regulations, invoking all relevant requirements.

Companies should therefore budget for the additional work required to place a device on the European market and keep it there, which will involve additional cost and time. New certificates will need to be issued for devices that did not need CE certification by a notified body before, such as reusable surgical instruments and software; the compliance of all medical devices will have to be assessed against the current requirements and standards, and all resources connected to outsourcing regulatory,

clinical or certification activities will be a trifle busy. Manufacturers will also have to put measures in place to compensate for the fact that under the MDR, users can claim compensation for damage caused by defective devices.

Although the UK Government is confident that it is unlikely that the UK will leave the EU without a Brexit deal, on 23 August 2018 the Department of Health and Social Care released a guide explaining how medical devices would be regulated in the event of the UK becoming a third country (used in Treaties to mean a country that is not a member of the Union and is not party to an agreement between two other countries) by 30 March 2019, and more technical notices are expected to be published next month.

As regards medical devices on the EU market, in the event of a hard Brexit all of the UK notified bodies would no longer be able to conduct conformity assessment in accordance with EU rules in relation to medical devices. The CE marking issued by these notified bodies prior to 29 March 2019 would also cease to be valid. This means that any medical devices which have been CE marked by UK noticed bodies and placed on the EU market will, after Brexit, need to be CE-marked by a Notified Body licensed by the competent authorities of one of the 27 EU Member States.

As regards medical devices on the UK market, the Government has stated that after 29 March 2019 if there’s no deal it will continue to recognise the CE Mark for a timelimited period, during which time such devices would be accepted on the UK market if they meet all EU requirements, which for all but the lowest-risk devices would include certification by EU notified bodies.

This will mean additional resources will need to be allocated in order to seek approval in the UK as well as the EU market, which could mean that small to medium sized medical device companies will suffer.

As well as the export market, the UK Government has also undertaken analysis of supply chains for medical devices and clinical consumables identifying the proportion of product

routinely imported into the UK from other countries in the EU. In a letter to suppliers of medical devices and clinical combustibles , the Health and Social Care Secretary Matt Hancock said that: • separate contingency plans are being developed; • stock holding at a national level will be increased; and • further information will be provided to industry in September.

In the event of no Brexit deal, the UK would no longer be part of the EU medicines and medical devices regulatory networks.

Sharing of these common systems and the associated exchanges of data between the UK and EU/ EEA countries would cease, and the UK would need to have its own processes and systems to manage UK human medicines and device regulatory activities. The UK Government has said that it is currently developing some new systems for March 2019. However, developing a new framework risks making the UK unattractive for companies because of the extra costs involved. Because the UK’s trade depends so much on EU regulatory activities and networks to make it frictionless, it is difficult to assess how medical devices would continue to be traded when those frictions return. How well the UK rises to these challenges remains to be seen.

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the healthtech series

JUST TRUST US

T

he UK’s medtech sector is well supported and represented by a raft oF organisations and associations.

Each issue, we meet one of the stars of these associationS. This time, Raj Purewal, business development and partnerships director at Trustech, provides an insight into the organisation and how it is flying the flag for healthcare innovation.

Trustech is an NHS organisation that aims to improve health and care through the development of innovative products and services. We were one of the first NHS innovation service providers and have built an enviable wealth of experience in managing and developing innovation in the health and care sectors.

We work with other NHS organisations, companies, and regional, national and international bodies and networks to bring forward new ideas and help to put them into practice. Our innovation management services are available to all NHS providers and commissioners, while our consultancy service is for health and social care companies from anywhere in the world, who want to access the NHS. We also work with universities, local and national governments, local authorities and business support agencies who focus on improving delivery of patient care.

Originally created by the NHS, Trustech is still hosted by one of its biggest trusts in England; Manchester University NHS Foundation Trust. Our peerless connections to the NHS give us in-depth, and upto-date insight into how the institutions work and how the wider NHS is planning to implement changes. With our insight, our clients trust us to give them the best possible advice on how to work with in this area.

After national funding from the Department of Health ended in 2012, many of the other regional innovation

hubs altered their course and became private companies. Trustech has been able to remain as the intermediary for the NHS and the commercial world by establishing a membership model for our trusts and by developing effective innovation support services, such as the Innovation Factor, which helps to stimulate, capture and drive new staff ideas.

We deliver our support services in a number of ways, primarily through either our NHS membership services or commercial consultancy services. For the NHS, the Innovation Factor helps cultivate and capture innovation from the NHS workforce, and we provide bespoke support to them for innovative ideas. This support can include, advice on patents and protection, assistance with funding applications or research, and also relevant innovator (from industry) engagement.

We also help NHS organisations identify innovations for potential adoption and implementation, and this aids the adoption of innovative ideas across hospital and community settings to improve patient care.

For industry, we act as the access and entry point

for UK, EU and global healthcare companies that are seeking to introduce their innovative products and services to the NHS. For academic and commercial clients, we help them understand how the NHS works and what it needs, identify the NHS staff they need to speak with, and facilitate in-situ evaluations of their innovations.

Our day-to-day roles are exciting as we are at the heart of change. Our team helps to qualify, develop and test new technologies, and advise on how they can be adapted or adopted for use in the NHS. The projects themselves range from technologically inventive medtech products to more unique products, such as SAGE & THYME; a training package to help staff always communicate with compassion and objectivity.

With the range of projects Trustech works on, what we do each day can vary from planning and delivering Dragons’ Den style innovation programmes for Clinical Commissioning Groups, to advising an innovative paediatric nurse on how best to develop her innovation for infants. Our goal is always the same; to improve health and care by capturing, supporting and developing innovations.

To discover how innovation can help your NHS organisation progress, or if you have an innovative idea that you would like to launch in the health and social care arena, contact Trustech on 0161 276 5764, email innovations@trustech. org.uk, visit www.trustech. org.uk and follow us on Twitter: @trustech_nhs.

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INNOVATIVE MATERIALS

CONSUMER CHOICE

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eepak Prakash, senior director, global marketing, and Neal Carty, global director, research and development and medical and scientific affairs at Vancive Medical Technologies, discuss material selection in an increasingly consumer-centric healthcare market.

Amid changing care delivery models, disruptive technologies and healthcare’s consumerisation, medical devices must often do more to help providers achieve positive outcomes and meet tougher standards. Those standards aren’t just the ones set by various governing bodies but by patients — the end consumers of care.

Healthcare institutions and their medical device suppliers are responding to consumer expectations when it comes to care protocols and delivery models. After all, why would the same consumer who doesn’t want to be limited by a land telephone line with a spiral cord somehow think it was acceptable to be tethered to a hospital bed by lots of wires and leads? Donning the hat of patient does not mean leaving one’s everyday preferences at the door.

These heightened expectations are driving complex new material requirements upstream for applications ranging from medical wearables to ostomy appliances to advanced wound dressings. Amid the whirl of transformation, as traditional healthcare paradigms shift, there can be some inevitable clashing and clanging of seemingly contradictory requirements.

For example, how do you pack a wearable device with lots of analytical capabilities, make it comfortable, safe, discreet, painless to remove — and economically viable? This is the type of issue device OEMs and their material suppliers ultimately are challenged to creatively solve.

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INNOVATIVE MATERIALS

top of their condition but not have their lives revolve around it. Individuals with ostomies want discretion, freedom of movement and no worries about odour or skin irritation. With such important qualityof-life factors providing the backdrop for device design, OEMs are seeking out new materials that: • conform to different body contours • s tretch for optimal freedom of movement • offer extended wear times • are odourless • are thin and in some cases transparent • manage moisture for comfort • h ave healing or painkilling properties PERFORMANCE/OUTCOMES: Healthcare institutions, clinicians and insurers are very focussed on outcomes for new medical device applications. To have a fighting chance at adoption, new solutions must meet or beat the clinical results of traditional solutions they are designed to replace. The right material innovation can make a big difference in consistent product performance and quality, from concept to prototype to regulatory review to product launch.

BIOCOMPATIBILITY: With R&D happening around the world, global material innovation may become more influenced by localised requirements.

It used to be commonplace for the biocompatibility checklist to focus on ISO 10993 standard tests for cytotoxicity, irritation and sensitivity, which is no small amount of work. But some device developers want to avoid

certain ingredients that would typically not be considered problematic under ISO 10993. They may be catering to localised regulations or specific allergen concerns relative to their device application.

SUSTAINABILITY: The healthcare industry, like many other business sectors, continues to strive towards greener, more eco-friendly practices.

Because the natural environment is so closely linked to human health, sustainability takes on an even greater significance for many hospitals and medical device companies.

Non-profit entities such as the Sustainability Roadmap for Hospitals and Healthcare Without Harm provide guidance on environmentally preferable purchasing (EPP) and other sustainable healthcare practices. Some device developers and healthcare institutions are seeking alternatives to the ethylene oxide (EtO) sterilisation method because of risks for hazardous air pollution and potential employee exposure to carcinogenic substances. Novel methods, such as use of vapourised peracetic acid (VPA), have been approved by different regulatory bodies for some new product applications. As device OEMs explore novel sterilisation methods or sustainable alternatives to various chemicals or ingredients, they need material suppliers to move with agility and skill to support their sustainability objectives.

COST: Last but certainly not least, there is cost. At the end of the day, the healthcare

marketplace will only adopt innovations for which there is a viable economic model. In areas of relatively uncharted territory, such as new digital health solutions, this usually means that device OEMs must aim for a per-unit price point on par with or less than the price of the legacy solution that is the current standard of care. This can be a tall order for all of the aforementioned reasons.

For skin-worn medical applications, the ability to provide long-term wear of devices, such as advanced wound care dressings, diagnostic wearables or drug-delivery patches, makes the economic model more competitive because fewer devices need to be purchased and reimbursed by insurance.

Also, healthcare institutions and insurers are seeking ways to deliver care at the most effective and costefficient point. This bodes well for material and device innovations that enable preventive healthcare, remote monitoring of chronic conditions, automated drug delivery, medication compliance management and other e-health applications. There can be a powerful business case for solutions easily applied or administered at

home or in an outpatient setting, which is much less costly than inpatient care.

In conclusion, times of transformation and disruption, the likes of which the healthcare industry is experiencing today, can be challenging.

But with creative collaboration, R&D ingenuity and rigorous focus on efficient manufacturability, innovative materials will continue to be building blocks for tomorrow’s most advanced healthcare solutions.

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REGULATION

A N INSP E C T O Where a company holds an EC Certificate, but is an OEM producer for another company, unannounced audits still apply, regardless of whether the devices are sold under the manufacturer’s own brand name or as an OEM product. Likewise, an EC Certificate holder which exports products solely to countries outside of the EU will receive unannounced audits, even though the devices are placed on markets outside the EEA.

ow do you prepare for an unannounced audit visit from a notified body?

Richard Poate, medical health services business line manager at product testing and certification organisation Tüv Süd Product Service gives his thoughts.

COPING WITH MEDICAL UNANNOUNCED AUDITS The European Union (EU) has a mandatory requirement for notified bodies to conduct unannounced audit visits, at least once in every third year, to all manufacturers certified under one of the European medical device directives. This not only applies to legal manufacturers located in Europe, but to all EC Certificate holders, regardless of whether the manufacturer resides in Europe or outside the European Economic Area (EEA).

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suspends the certification in question.

VERIFY YOUR AUDITOR Verification and authentication of the auditor is a very important step that manufacturers must take in order to safeguard themselves. The responsibility lies with the manufacturer to ensure that the auditors are genuine.

As an example, Tüv Süd has a very clear process for verifying and authenticating the auditors: • upon arrival of the audit team The scope of unannounced on the manufacturer’s site, an audits is considerably different authentication letter is handed from routine surveillance to the manufacturer by the and recertification audits. audit team; Unannounced audits are much • the manufacturer can contact shorter as they focus on a their local Tüv Süd contact particular product, at the facility person/office and ask for a where it is manufactured, with verification of the unannounced the aim of assuring day-to-day audit, based on the three compliance of the product itself, provided in the authentication while surveillance audits are focused on quality management letter; • upon request, a copy of the systems. Therefore, the authentication letter can be European Commission decided faxed or emailed to the client. that unannounced audits should be conducted in addition to the regular auditing programme.

WHAT HAPPENS DURING AN This process therefore requires UNANNOUNCED AUDIT? additional investment, both time Unannounced audits are and money, from manufacturers. performed to verify the Given this, manufacturers should effective implementation of a factor the additional costs Quality Management System, related to unannounced audits in based on a randomly selected their budgets. representative product. If needed, this can be more than There will be no prior notice one product, in order to assess for any unannounced audits. if it has been manufactured If the auditor is not allowed to in accordance with the enter the company, this will be technical documentation. documented in the audit report As unannounced audits are and a recommendation made conducted at the facility in which that the certification board a product is manufactured,

if a company has several product lines and/or several manufacturing sites, all products and sites will be subjected to an unannounced audit.

A team of two auditors will be on site for a minimum of one full day, but it may last multiple days. Mandatory elements for all unannounced audits include: • Conformity of selected device with the technical documentation and with legal requirements; • traceability of all critical components and materials; • traceability system; • conformity of the following with legal requirements; • manufacturing activity ongoing at the time of the unannounced audit;

REGULATION

T OR CALLS • manufacturer’s documentation relevant for the manufacturing activity.

Key processes, including design control, establishment of material specifications, purchasing and control of incoming material and components, assembling, sterilisation, batch release, packaging, and product quality control will be carefully examined. This list is not an exhaustive list and other relevant processes may be examined as well.

Manufacturers are asked to categorise their product portfolio of all CE-certified models into device types. A definition for each device type must be available and include the following information:

• The complete range of models (product codes) included in the device type; • the criteria applied to include this range of models in a device category; • a description of how the models are constructed; • a list of components; • a list of subassemblies; • information on critical suppliers / outsourced processes, in particular testing.

Once the audit has been completed, the manufacturer will receive a confidential audit report and, if applicable, an audit finding list which details any major non-compliances that were detected during the unannounced audit.

NOTIFIED BODIES Across the EU, all unannounced audits have to be performed by all notified bodies for manufacturers of devices under the new Medical Device Regulation (MDR), which came into force in May 2017 and will replace the current Medical Device Directive (93/42/EEC) and the Directive on active implantable medical devices (90/385/EEC) on 26th May 2020).

The European

Commission expects notified bodies to perform unannounced audits as a separate function to product assessments and quality system assessments.

For quality management related certificates, sample testing is not mandatory. However, it may occur if the unannounced audit team has reasonable doubts about the conformity of the device type(s). In this case, a product sample will be chosen for further inspection and testing, and if critical processes are subcontracted or critical parts are purchased from a supplier, the notified body may also conduct an unannounced audit of an OEM’s facilities.

Testing a product sample onsite, with the notified body auditor as a witness may be possible. Other options include the testing of samples by the notified body’s laboratory, or by qualified personnel under one of the following: • Under notified body observation on their premises; • on the manufacturer’s premises; • on the premises of the manufacturer’s OEM; • in qualified external laboratories.

CONFORMITY TESTING If sampling at the manufacturer’s premises is not feasible, notified bodies should take samples from the market if necessary (with support by the competent authorities), or should perform testing on a device installed at a customer location.

If it is possible to perform tests on raw

materials, intermediates, components or unfinished products, these tests will take place instead of destructive tests on final devices. However, the device acquisition and its testing must be financed by the manufacturer.

To ensure a correct testing procedure and reliable results, the following information and documentation must be provided by the manufacturer: • Complete product specification(s); • final batch testing report(s) of the selected samples; • test protocols and results from design verification and design validation (or type examination); • test description and instructions, and related forms if applicable.

When testing is performed on the manufacturer’s own site, the manufacturer will use its own personnel and laboratory test equipment, with the notified body’s personnel supervising the tests.

FINDING NONCONFORMITIES The unannounced audit plays an important role in maintaining certification of a manufacturer regarding the European Medical Device Directives. Therefore, it is possible that certification can be suspended, if the audit result is inadequate, and products could not be placed on the European market until the certification is deemed valid again by the notified body. If major nonconformities are detected during an unannounced audit, the manufacturer will receive an audit finding list and will be given a maximum of 60 days to respond to the nonconformities and present the root cause analysis, correction and corrective action plan or implementation.

21

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for over 80% of the market, with many manufacturers requiring third-party certification for the first time. Other requirements have been significantly changed, and new requirements added, each creating significant additional work; new requirements for performance evaluation and clinical evidence throughout the product lifecycle is just one example.

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• Expertise – our diverse and experienced team brings in-depth knowledge and understanding of complex medical devices • Global presence – we operate in over 180 countries and offer market access services for many regulatory schemes • Confidence – our stringent review process combines experience, integrity, independence and predictability

Preparation is key Success will ultimately arise from understanding, planning for and implementing the Regulation. Ensure that you’re ready by creating robust transition plans, attaining buy-in from key stakeholders, and understanding and implementing the

For more information on the IVDR, to access complementary resources or to find out more about BSI, visit: bsigroup.com/IVDR-UK

CATHETERS, STENTS AND TUBING

Translucency is critical, says Foster Corp

Latest catheter tech heads east Tekni-Plex business, Dunn Industries presented its latest tubing solutions for endovascular catheters at Medtec China in September.

T

he Chinese market is currently after solutions from tubing suppliers to develop diagnostic and interventional devices used in endovascular procedures.

Endovascular catheters rely upon unique properties of select thermoplastics and thermoplastic elastomers (TPEs) to produce high strength and flexibility thin-wall catheter tubing.

These include thermoplastic urethanes (TPUs), polyether block amides (PEBA), polyamides, and polyolefins.

“Medical device companies are designing catheters with smaller dimensions and tighter tolerances, and requesting quick turnaround

on prototypes to accelerate time-to-market. Fast lead times on precision extrusions and the ability to quickly scale to production quantities are hallmarks of our service offering,” said Dan Lazas, Tekni-Plex senior director of medical components.

Endovascular surgery, which is performed within the blood vessels, is commonly used to treat aneurysms, narrowing areas and blockages, whilst also being used to deliver replacement heart vales and more.

Procedures involve catheters being inserted into femoral or radial arteries and moved to the required vascular site using x-ray imaging.

Foster Corporation has launched its newest technology for the catheter tubing market, in response to greater demand for translucent materials.

D

ubbed ProPell T, the new material is said to offer low lubricity and translucency in medical device components when added to lower durometer TPU and Pebax. polyamide elastomer compounds.

Foster says that ProPell T offers reduced coefficient of friction while maintaining critical mechanical properties, and improved manufacturing and handling of medical catheter tubing. In addition ProPell T offers a proprietary surface enhancing additive that also provides translucency.

Translucency is critical in medical applications that require close visual monitoring. “Medical personnel can not only see the substance that is being transported through the tubing, but can also easily detect any defects in the device,” explains Larry Johnson, Vice President of

Business Development for Foster Corporation.

The ProPell T technology reduces tackiness and friction in medical device components, especially soft, flexible polymers such as low durometer TPU, commonly used in central venous catheters (CVC), and Pebax polyamide polymers that are used in interventional vascular catheters.

“The use of ProPell T in catheters benefits medical practitioners by offering easier deployment and control of the device by enabling the catheter to move faster and smoother through the vascular system,” Johnson comments further.

In addition to improving manufacturing and application performance in extruded components such as catheter tubing, ProPell T also reduces tackiness in injection moulded devices as well, the firm states.

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IMPLANTS

A

HOW THE HUMBLE TOMATO COULD PREVENT COUNTERFEIT BREAST IMPLANTS

research team at the Fraunhofer Institute for Applied Polymer Research have developed a way to use DNA sequences from tomatoes as permanent markeRs to identify any implants that have been illegally tampered with.

Counterfeit medical products have become a major concern not only for manufacturers but also for consumers. Fake medical products tend to be inferior to the original and can put patients’ lives at risk.

In 2010, a French company blended unapproved silicones with its breast implants as a way to cut production costs.

Illegal manipulation such as this can be very difficult to detect, requiring elaborate analyses to see if products have been tampered with.

To combat this, the team at the Fraunhofer Institute developed a method which involves using tomato DNA as a way to positively identify implants.

“We isolated genomic DNA (gDNA) from tomato leaves and embedded it in the silicone matrix. We used approved siloxanes, which are building blocks for silicone products, to manufacture breast implants,” says Dr. Joachim Storsberg, a scientist at the Fraunhofer IAP in Potsdam and a witness in court cases centred on breast implants.

The team managed to prove that the extracted DNA’s temperature remained stable throughout pilot experiments.

The method should be desirable to manufacturers: tomato DNA is inexpensive and is suitable as a counterfeit-proof marker for many polymer-based implants.

“Breast implants are made up of components; that is, several silicone polymers that cross-link to form a gel. The components’ manufacturer now has the option of marking silicones with the encapsulated tomato DNA sequence during the production process. He alone knows the type and concentration of the DNA used. The components are marked first, and then sold to the implant manufacturer.

The PCR method can detect if the manufacturer stretched components with inferior materials or used a lower concentration. “This works much like a paternity test,” explained Storsberg.

Throughout history, researchers have experimented with a host of surprising materials in an attempt to modify the properties of breast implants.

According to the Journal of Plastic Surgery, the first half of the 20th Century saw scientists attempting to manufacture breast implants using ivory balls, glass balls, vegetable oils, mineral oil, lanolin, beeswax, shellac, silk fabric, epoxy resin, ground rubber, ox cartilage, sponges, sacs, rubber, goat’s milk, Teflon, soybean and peanut oil, and glazier’s putty.

More recently, implants have been made available which make use of the lightweight properties of borosilicate – a material more commonly associated with Nasa.

According to The Mirror, the implants, which are made by an Israeli firm, have a standard gel filling containing tiny hollow microspheres made from borosilicate.

Borosilicate glass was used in the heat shield that protected Nasa’s space shuttle during reentry to Earth.

The tomato-based procedure developed by Storsberg and his team – which includes Marina Volkert from Berlin’s Beuth University of Applied Sciences – has already been patented and is published in the Plastische Chirurgie journal.

25

compamed

How to get the best

COMPAMED 2018

W

ith so much to see inside the many halls and corridors of Messe Düsseldorf, here’s editor Dave Gray’s guide to everything you’ll need at this year’s Compamed.

COMPAMED – IT’S ALL ABOUT IMPLANTS Every year Messe Düsseldorf and the IVAM Microtechnology Network team up at a spring convention to forecast key trends for the event. This year the conversation was dominated by talk of new and futuristic implants.

implants on the supply chain: “The new combinations of types of technology and the integration of electronics, smaller and smaller components, high frequency and wireless technology as well as monitoring, recording and control systems are market drivers for implants at the moment.”

New materials, innovative procedures and the combined application of electronics and microsystem technology are set to be fundamental themes at Compamed this year.

Horst Giesen, global portfolio director for health & medical technologies at Messe Düsseldorf said in a statement ahead of this year’s show: “Exciting trends are currently setting the pace. For quite some time now, ‘dematerialisation’ and ‘digitalisation’ and ‘networking’ have been buzzwords that quite fittingly describe the events Researchers from the International Trade Administration around medical technological product development and are and BCC Research have valued still extremely current.” the sales volume of medical implants at €30-60 billion, of which ‘active’ implants constitute Giesen added: “Providers are around €15 billion. ‘Active’ refers turning to suppliers to seek ever more delicate, lighter and at to any implant that is fitted with the same time more advanced an energy supply, typically a components such as sensors, battery. chips, wireless modules and even accompanying energy Dick Molin, medical market segment manager for Compamed savers or information savers. exhibitor Specialty Coating “These then can be installed in Systems (SCS) explains the wearables used for diagnostics impact of the trend of vital signs. These devices towards active

26

are in high demand. Another large application is the field of active implants. Participants in this year’s Compamed Spring Convention have already learned why these are among the most technically sophisticated medical products with particularly high research, development, production and approval requirements and which are currently the most interesting innovations in this area.”

A MATERIAL WORLD While miniaturisation and digital tech are both key trends expected at Compamed this year, more conventional materials are also set to feature.

German chemical giant Henkel, for example, will be showing a new collection of products including LED curing adhesives for flexible medical devices, a range of advanced pressure sensitive adhesives for plasters and functional patches as well as conductive inks for smart health devices.

While these new materials may only really be new iterations of existing technologies, Henkel also believes that new trends are changing the game.

The firm says that the spotlight will be on new acrylic adhesives developed for use on flexible applications made of thermoplastic elastomers (TPE) and thermoplastic polyurethanes (TPU), two substrates increasingly specified by device manufacturers.

compamed

out of As low-viscosity, LED curable and high-flexibility adhesives, they feature tack-free curing and combine high elongation (>200%) with good bond strength also on polycarbonate, acrylic and other rigid plastics used in medical devices.

“Using LED curing saves costs, thanks to the fact that it can be switched on/off instantly.

Additionally, the narrow spectrum of light wavelength without infrared light emissions helps manufacturers save energy consumption and minimises the generation of heat that must be dissipated, especially in cleanroom bonding applications,” said Andrés Bultó, business development and key account manager, medical at Henkel.

If digital health is more your thing, there’s plenty of cuttingedge tech on display at Medica, but what about the tech behind the tech? Henkel says this year it is targetting smart health devices, such as disposable moisture sensors for incontinence management and comfortable on-body health patches for real-time wireless patient monitoring using novel dry-electrode materials.

IT’S ALL ABOUT THE SERVICE While many players like Henkel will be pushing new product lines at Compamed, others will have other developments to share.

Materials group Eastman, for example, has opened a brand new European Technology Center in Ghent, Belgium in the time since the last edition of the show.

Device manufacturers can use the show as an opportunity to find out what’s on offer at the new facility.

In a sneak preview,

Eastman revealed that the facility is based at Ghent University’s technology park, and its staff work with customers from design conception to implementation, as well as helping to address production challenges as quickly as possible. Onsite medical plastics experts are also working closely with Eastman’s other R&D centres across to globe to accelerate the development of future-forward technologies, including performance compound technology and biobased alternatives, the firm said.

“We offer the right plastic now, to enable customers in the medical sector to succeed today. We are also continuously investing in more sustainable business solutions that will help them perform tomorrow. Innovation lies at the heart of our offering,” said Cedric Perben, Eastman Technology.

Another firm with news of an expansion (or, rather, multiple expansions) is Carclo Technical Plastics. Carclo has recently expanded its medical operations in its US, UK, Czech Republic, China and India facilities as it continues its strategy of increasing its contract manufacturing business globally. Underpinned by its EN13485 accreditation, the firm says it has won significant new business in the healthcare, medical diagnostics and eyecare fields during 2017/18, and will be planning on sharing its new capabilities with visitors to the

show.

Commenting on the growth, divisional chief executive officer Robert Stutzman said: “Carclo Technical Plastics has aggressive plans to continue developing our medical business, supported by Carclo’s engineering skills, global footprint and financial stability.

Compamed, co-located with the renowned Medica tradeshow, is one of our prime marketing activities and we invite all customers and prospective customers to meet with us during the week.”

HIT PRINT 3D printing remains a hot topic at Compamed. According to a forecast by market research company Markets and Markets, global 3D printing for medical products is expected to increase from 840 million US dollars in 2017 to around 1.9 billion dollars by 2022, a yearly growth rate of 17.5 percent.

Last year, Compamed’s seminar “3D fab+print” went down a storm. For 2018, it will be followed up with an allday conference on the subject – possibly Messe Düsseldorf’s most significant

foray into the field. Among the companies presenting is Evonik, which has been systematically working on improved materials for orthopaedic surgery in their project house Medical Devices since 2014.

“We are developing new solutions that help prevent operations or accelerate the healing process,” said project house manager Balaji Prabhu.

Evonik is well-placed to talk on the subject, having been responsible for developing a composite that consists of the polylactic acid ‘Resomer’, and a synthetic hydroxylapatite filler. Hydroxylapatite is the most common bio-mineral in the human body, resulting in mechanical characteristics that are very similar to those of natural bones. Resomer is completely degraded into carbon dioxide and water in the body, does not cause inflammatory reactions and is completely non-toxic.

Compamed takes place from 12-15 November 2018 at Messe Düsseldorf, Germany.

27

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MTI’S REECE ARMSTRONG EXAMINES THE REASONS WHY IRELAND IS A MEDTECH

HOTSPOT AND LOOKS AT WHAT TO EXPECT FROM THE COUNTRY IN THE FUTURE.

IRELAND

Welcome to the island distance of each other. Major players such as Medtronic, Boston Scientific and Creganna all operate within Galway, alongside the 8,333 medtech employees that work within the city.

reland is one of the world’s major medtech hubs, hosting 18 of the world’s top 25 medtech firms and exporting over €12 billion of medical products every year. To many, this country represents a blazoning example of forward thinking and growth in a competitive market.

Ireland’s medtech origins can be traced to a number of different points but perhaps the most important is the development of IDA Ireland, a government body designed to stimulate export-led business throughout the country.

A major win for medtech in Ireland came from IDA securing a contract with global firm Schering-Plough to deliver biotechnology-derived pharmaceutical products; a fundamental moment in Ireland’s medtech history.

Now, as the second largest exporter of medical technologies in the world, Ireland is an established medtech hub. But who are its major players, where are they, and what can we expect from Ireland in the future?

THE HUBS It’s no surprise that medtech companies have flocked to Ireland. Through the country’s EU membership, companies have access to a European market consisting of over 500 million potential customers. And Ireland’s commitment to invest over €5 billion in science and technology

With the West of Ireland accounting for 39% of all medical device employees in the country, Galway has played a strong role in developing its medtech cluster.

As the second largest hub for medtech in Ireland, Galway is home to both major medtech companies, exciting start-ups and the Cúram, Centre for Research in Medical Devices; touted as Ireland’s ‘super centre’ for developing the next generation of smart medical devices.

research in Ireland by 2020 shows a country dedicated to the sector.

It’s not just Ireland’s homegrown companies that are finding success. A partnership between Enterprise Ireland and Mayo Clinic launched in 2014 was designed to commercialise 20 US medtech products whilst also creating 10 spin-out companies in Ireland.

Inform BioScience was one of the first spin-outs to benefit from the partnership and in 2014, the firm signed a license agreement with the Mayo Clinic so it could develop a urine test to detect preeclampsia in pregnant women.

Ireland has a diverse set of locations from which medtech companies are operating. Whilst Dublin is home to a large number of medtech players, many companies are opting to base themselves in regions outside of the capital.

Galway’s medtech scene shows a web of companies all within striking

Cúram has been active in many areas of medtech and throughout the past two years has managed to develop a potential new treatment for lower back pain; formalise a partnership with the Korean Institute of Industrial Technology for education in biomedical manufacturing and scoop up Ibec’s ‘Academic Contribution to Medtech Award’.

Only just this year, manufacturer of rapid diagnostic testing solution, Quidel, announced the creation of a Business Service Centre in Galway. The centre is set to create 75 jobs over the next five years; a small but essential contribution to the 4,000 extra medtech jobs being targeted by business lobby group Ibec , by 2020.

For Creganna, TE Connectivity, Ireland offers a location in which it can easily connect with other medtech companies, as well as potential customers.

“As a medical device outsourcing partner, Ireland offers the benefits of co-location with leading medical

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technology companies.

This close proximity benefits Creganna, TE Connectivity and our customers through regular local access and expedited support for design, development and manufacturing programs,” the company’s director, commercial, Jeff Stanton said.

But what is it specifically that attracts medtech companies to Galway? Well it could be the talented employees that are flocking to the city away from Dublin. Since 2015, a 70% increase in Dublin-based tech workers looking at jobs in Galway has been noted.

And according to Sheila O’Loughlin, senior market adviser for Enterprise Ireland, Galway, “where a third of Ireland’s medtech employees are based, is undoubtedly the epicentre of activity and home to the BioExel Medtech Accelerator, the first of its kind in Ireland to focus solely on the medical technology sector,” she explains.

Designed to attract the best medical technologies currently being developed, BioExel offers €95,000 in seed funding to help applicants build and bring their products to market.

Galway is an ideal location for collaboration with other businesses, but more importantly, Ireland as a whole has a “dynamic ecosystem where academia, industry, clinicians and government work together closely, enabling Ireland to flourish on the global stage,” according to O’Loughlin.

Take for instance, the employment opportunities that are being made by medtech companies. Ireland’s employment rates for graduates recently returned to levels last seen during the economic boon

and 60% of graduates go on to work somewhere within Ireland .

In Limerick, Becton Dickinson announced that it will hire an additional 85 staff for its R&D centre, where as further north, Abbott will hire 500 staff to help expand its operations for developing devices to treat and manage diabetes.

Considering that the total number of people living with diabetes in Ireland is estimated to be over 200,000 Ireland offers a major market for companies operating in this space .

The reason for Ireland’s successful medtech industry can be put down to a range of factors.

According to IDA Ireland’s head of medtech, Rachel Shelly, the industry has been “underpinned by the strong skills based and access to talent; technical competency; and Design for Manufacture capability. As a result, Ireland is the largest medtech employer per capita across Europe.”

What can’t be ignored are the financial incentives offered to companies conducting R&D throughout Ireland. The 25% R&D tax credit makes Ireland attractive to medtech companies, which are largely dependent upon innovation and pushing boundaries of science and technology. More so, Ireland’s corporate tax rate of 12.5% is one of the lowest in the OECD and the country also offers incentives for companies carrying out academic collaborations.

And according to Creganna’s Jeff Stanton, the very fundamentals of Ireland’s medtech industry are what helps drive the sector forward.

“Innovation, investment in R&D and continued expansion of manufacturing capability continues apace, enabled by a talent pool with deep industry and

global experience. The industry fundamentals in Ireland pave the way for continued growth of the sector into the future.”

NORTHERN IRELAND Northern Ireland’s medtech market also shows highly promising signs of growth.

Ulster University is one of the region’s major hubs for medtech and a recent €7 million laboratory will see it offering equipment and expertise for companies developing prototypes within the biomedical sector.

More so, the University’s €8.2 million Eastern Corridor Medical Engineering Centre (ECME) was launched earlier this year to develop smart wearable technologies for cardiovascular patients. The centre of research has partners in Republic of Ireland and Scotland, highlighting the cross collaboration that is going on across the UK and Ireland .

Indeed, Northern Ireland-based company Neurovalens – which has developed a fat burning wearable – is a medtech success story, raising over $1.5 million in funding from a goal of $50,000.

THE IRELAND INITIATIVE Initiatives throughout Ireland are aimed at helping companies advance their technologies and now might more than ever be the best time to be a medtech start-up. The Irish government has just announced a €500 million Disruptive Technologies Fund that aims to help companies develop and commercialise their innovations.

Indeed the fund recognises the latest technologies that are beginning to change how industries operate and the government has set out a specific focus on things like augmented and virtual reality, health and wellbeing, advanced and smart manufacturing and artificial intelligence.

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

ALIVE AND KICKING

HAVE HEART

CorFigo is a startup which has recently launched its first product, Heartpad - a device intended for ablation of cardiac tissue from an epicardial (outer surface of the heart) location, while simultaneously protecting adjacent structures from unintentional ablation injury.

Designed for minimally invasive ablation, the proprietary technology utilises potent cryothermal energy coupled with sophisticated sensor technology. The intended result of the Heartpad design is the efficient ablation of broad areas of cardiac tissue.

TEST IT OUT

Cambridge-based Inivata has developed a simple blood test which allows for ctDNA analysis - a way for oncologists to detect cancer, stratify patients, and monitor individual response to treatment.

The non-invasive liquid biopsy could change the way that cancer is detected and monitored, providing the potential for frequent tumour profiling and personalised treatment.

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Freefoot is a real kicker of a new product.

This new foot brace is a dynamic Ankle Foot Orthotic (AFO) that allows dorsiflexion (upwards movements of the foot) using spring resistance. The brace assists the user in raising and lowering their foot for a comfortable and natural walking motion, while providing ankle stability and foot support to keep from tripping or falling. Its maker says that it stands apart from alternatives on the market due to its substantially lower cost and its discreet design.

JUST LIKE THE REAL THING

Medical-X is a young company specialising in the manufacture and sale of high-fidelity patient simulators. The group opened its new factory just last year, and since then has been producing a variety of models, including Adam-X – a male patient simulator designed for practicing skills and providing medical assistance in case of emergency. He may not have a human brain, but Adam comes with a wireless computer, which allows the instructor to monitor and make adjustments in the course of the training.

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