MTI Issue 47 by Med-Tech Innovation Magazine

www.med-technews.com Issue 47 | Mar/Apr 2020

@medtechonline

PLUS

Your guide to the Med-Tech Innovation Expo Packaging 2020 healthtech predictions

MED-TECH INNOVATION | NEWS MED-TECH

innovation

ThinkinG out loud Maucher Jenkins shares its IP expertise for gene therapy inventions MEDICAL DESIGN & MANUFACTURING INSIGHT

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CONTENTS regulars

features

21.

What’s in store at this year’s event

Comment Making medtech

Behind the scenes at Medilink East Midlands and an interview with Kevin Kiely, CEO, Medilink UK

13.

In focus

The start-ups worth watching, plus the Parliament & HealthTech Conference 2020

17.

Opinion

Wilmington Healthcare explores the role of valuebased procurement in the NHS

18.

Cover story

Maucher Jenkins share its expertise on IP strategies and considerations for gene therapy inventions

33.

Digital Health Age

Medtech in the 2020s: what’s in store? Asks Charles Taylor, HeartFlow

48.

MTI Expo: revealed

MED-TECH INNOVATION | NEWS

22.

MTI Expo: Question time

Two of this year’s key speakers discuss the medtech sector now and in the future

30.

Pinnacle of success

What’s behind Olympus’ medtech rise, asks Lu Rahman?

38.

How packaging can be sustainable

ULMA Packaging UK explores packaging challenges faced for the medical industry

40.

Biosimilars and drug delivery: where are the opportunities? Lu Rahman speaks to Owen Mumford

In practise THE TEAM head of content | lu rahman lu.rahman@rapidnews.com web content editor | ian bolland ian.bolland@rapidnews.com brand director | colin martin +44 (0) 1293 710 042 colin.martin@rapidnews.com

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from The editor It’s a deal!

[

t’s no news to anyone that the medtech space continues to innovate on a regular basis. While that innovation doesn’t happen overnight, what is more exciting (well, I think so, anyway) is the way that key players in the sector continue to seek new ways of improving their offering as well as the way that clinicians and patients, receive care. Medtronic recently announced the acquisition of Digital Surgery, an expert in surgical artificial intelligence (AI), data and analytics, and digital education/training. The company’s aims to digitise surgical protocols using computing and to support the delivery of consistent, datadriven and evidence-based surgical care. According to Medtronic, the acquisition will strengthen its robotic-assisted surgery platform, among other benefits. The move should help advance Medtronic’s desire to use AI and data within laparoscopic and robotic-assisted surgery. While you could view this as another big business looking to further its medtech footprint, you might also feel that cases like these highlight how astute the medtech sector is becoming. It’s no secret that the industry – in the UK, Ireland and on a

global level – has enormous economical potential as well as having a hugely positive effective on the health outcomes of millions of people across the world. But moves such as this one from Medtronic show how forwardthinking the sector actually is. By acquiring Digital Surgery, Medtronic now has the ability to use big data to both create benchmarks but also to analyse large numbers of customers. This is highly beneficial to the business of course but on a wider level, the acquisition brings significant benefits to surgeons. They will see better outcomes via real-time technology. This additionally bodes well for patient outcomes too. “Joining Medtronic creates an incredible opportunity to realise the promise of reducing unwarranted variability in surgery,” said Dr. Jean Nehme, surgeon, CEO and co-founder of Digital Surgery. “We have always believed in computational power and data as two central drivers of consistency and quality in surgery. Computational power has impacted our lives in so many ways, and within surgery it is almost absent. By joining forces with Medtronic, we will finally apply computing and AI to surgery on a meaningful scale with a goal of helping more patients in more places benefit from consistently

high-quality surgical care.” This ‘meaningful’ aspect of the sector is fascinating. Through expertise and a desire to better standards of surgery, the effect is a benefit to the likes of me and you. No doubt, companies like Medtronic have a keen eye on the bottom line, but when the outcome of a business deal results in better medical care, who wants to complain? We are also continuing to see a positive role for data in the medtech environment. Issues around security and privacy are ongoing however, thanks to advances in medical devices and the way they collect health data, we have potential to understand illness plus track conditions to help avoid life-threatening outcomes. There’s a lot to think about in Medtronic’s acquisition. In a time that often derides technology, business and data, it’s encouraging to see how these elements can pull together to show promise for patients on a global scale.

Of course, companies like Medtronic have a keen eye on the bottom line, but when the outcome of a business deal results in better medical care, who really wants to complain?

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Making medtech

NEW DATES FOR MED-TECH INNOVATION EXPO

29-30 September 2020

ith global concern regarding the Coronavirus outbreak (COVID-19) escalating, and after monitoring the situation closely over the last few weeks and consulting with exhibitors and partners, Rapid News Group has decided that it is in the best interest of all parties to postpone the Med-Tech Innovation Expo, scheduled for April 1-2 to September 29-30 2020. The latest developments have significantly increased the concerns of participating companies about the health of their employees. Rapid News Group has the same concerns, having health and safety of its exhibitors, visitors, partners and staff as a number one priority.

Therefore working in conjunction with the NEC and in close consultation with exhibitors and partners, Rapid News Group has rescheduled to 29-30 September 2020 and is confident that these new dates will deliver an excellent alternative timing, offering clarity to exhibitors and visitors. Med-Tech Innovation Expo will now run alongside Rapid News Group’s other successful industrial events, Interplas, the plastics show and TCT 3Sixty, 3D printing & additive intelligence.

Duncan Wood, CEO Rapid News Group said: “In unprecedented and extremely fast moving circumstances we have to make a very difficult decision to postpone our event until September. We are aware that this decision will require industry professionals, exhibitors, partners and visitors to reschedule their attendance, which will have an impact on their organisations, as it will for Rapid News Group. We are grateful that given the current situation everyone involved has understood and supported our decision.”

For more information Exhibitor enquiries www.med-techexpo.com Sarah.Orme@rapidnews com

+44 1244 952 247

Neil.Bamford@rapidnews.com

+44 1244 952 374

Making medtech

Med-Tech Innovation Expo features Mediplas Pavilion

he highly specialised area of manufacturing plastic parts for the medical industry is an innovative sector

and the Mediplas Pavilion will return once again in 2020 to focus on the essential aspects of medical device manufacturing.

Organised in conjunction with, and sponsored by Medical Plastics News magazine, this feature zone will enable visitors to quickly identify the

exhibitors showcasing technologies, materials and services relevant to their field. Covering all areas of the medical plastics supply chain including design and prototyping, materials, cleanroom machinery and equipment, process control, contract manufacturing, assembly, testing and regulations, the Mediplas Pavilion will highlight the developments in this sector.

Featuring in the Mediplas Pavilion are: • White Horse Plastics • Wittmann Battenfeld • Intertronics • Mi3 • Primasil Silicones • Biocote • The British Plastics Federation • Carville • Wittenburg Group • MasterFlow UK • RJG Technologies • Laser Lines • Riverside Medical • S&S Plastics • Röchling Engineering Plastics (UK)

Medtech start-up launches campaign for algorithm-based diabetes app

uin, a femalefounded, digital health start-up based in London, has launched a crowdfunding campaign for its AI-driven medical app. The Quin app is set to revolutionise diabetes management by using algorithmic insights to help decide when and how much insulin to take. The campaign aims to raise £600k. Investors across the UK and Europe can invest as little as £10. The funds raised will be used for further app development and product launch. Since its start-up Quin has raised £2 million in grants and angel funding, recruited hundreds of beta testers, and launched

its ML research partnership with the University of Bristol. Accolades include winning the Diabetes Center Berne Start-Up Stage competition, being selected for the Apple Entrepreneur Camp, and being used as a case study by government-funding body, Innovate UK. Quin has also filed two patents and launched the beta programme in five additional European countries. The latest figures from Diabetes UK indicate that 4.7 million people in the UK alone live with diabetes. Of that group, 92% who take insulin are unable to achieve their recommended target blood glucose levels, despite their best

efforts. The number of people experiencing complications from diabetes, such as dehydration and metabolic abnormalities, is rising. Insulin therapy relies heavily on individual judgement to determine the appropriate dosage of insulin. People with diabetes have to figure it out on their own, making hundreds of decisions a day, through trial and error. The Quin app aims to humanise diabetes technology by utilising the experience of people who take insulin to create a more personalised insulin treatment regime. It uses a machine learning (ML) algorithm from existing diabetes-management devices, sensors and

phones to help people decide how much insulin is right for them, and when best to take it. Quin CEO and cofounder, Cyndi Williams, said: “With the funds we hope to raise, we want to help people take back control and find their personal balance by reducing the self-care decisionmaking load. We are therefore opening our doors to those who want to invest in our future growth and invite everyone to become a partner in this noble initiative.”

Behind the scenes at Medilink

LINKING UP

AS PART OF THIS MEDTECH INNOVATION EXPO ISSUE, LU RAHMAN ASKED MEDILINK EAST MIDLANDS TO REVEAL WHAT LIFE IS LIKE AT THIS KEY INDUSTRY ORGANISATION

Medilink East Midlands (EM) is a business support organisation based at BioCity Nottingham which helps East Midlands organisations in the life sciences and healthcare sectors to grow. It helps businesses form partnerships, develop products and services, and share ideas. It also delivers three projects which allow East Midlands businesses to access support and grant funding to help them innovate and grow.

Specialist Networking Grants (SNGs), help SMEs to attend events beneficial to their business. The SNG finances up to 50% of costs for travel, accommodation and event registration to attend an event, or conference, in the UK or internationally.

INSTILS operates in Derbyshire and Nottinghamshire, SoLSTICE operates in Leicester and Leicestershire, and ACTIS operates in the south-east Midlands. All the projects are partfunded by the European Regional Development Fund (ERDF) and the East Midlands Academic Health Science Network. Support and advice is available from sector specialist innovation advisors and grants are available to help overcome innovation barriers.

Medical Technology Trial (MTT) grants, helps SMEs to test and evaluate products and services in a clinical setting. This grant is available to support the costs associated with a clinical trial

Three types of business support grants are available: Innovation Support Grants (ISG), help SMEs bring new and improved products and services to market. Typical types of cost include proof-of-concept through to being ready for manufacture, smaller scale clinical testing and evaluation. It can also include regulatory, quality, and IP. NuVision Biotherapies benefitted from an ISG for the development of its Omnigen treatment, a sightsaving therapy.

SurePulse Medical benefited from an SNG for attendance at the Texas Medical Centre Medical Accelerator Programme.

Sanandco was successful with an MTT grant, which it received for the evaluation of its MonitorMe device. This is a telephone, equipped with sensors to monitor the patient’s vital signs including temperature, heart rate and pulse transit time.

Jo Maltby, project leader Innovation, Medilink East Midlands Jo Maltby is one of Medilink EM’s innovation advisers and supports businesses in Derbyshire and Nottinghamshire, as part of the INSTILS project. She joined the Medilink team in June 2019 and has spent over 15 years as a business adviser working across multiple sectors. Each Medilink EM adviser spends time getting to know and understand an organisation, taking a companywide view to see where they can add value and maximise the overall support available. This could be through accessing grant funding, direct advice and support, helping the company to make connections with universities and clinicians and forging connections and partnerships opportunities with businesses. In addition to the 1-1 business support offered by Medilink EM’s innovation advisers, Medilink also offers a series of specialist sector events. Jo Rudzki, project leader events and marketing Rudzki joined Medilink EM in January 2019. She is part of the Medilink EM events team, which is responsible for both Medilink East Midlands events and the management of Medilink EM partner events. Rudzki helps deliver project events which include Special Interest Groups - these are held on subjects such as digital health, infectious diseases, food supplements and medical technologies and systems. Companies which attend these events can hear from industry thought leaders. Medilink EM is also running events in partnership with the East Midlands Academic Health Science Network, to help companies access the NHS. These free courses illustrate different aspects of NHS Market Access. Over the three sessions, companies learn all about NHS structure and process, preparing an NHS business case and creating valid evidence and evaluation. Upcoming NHS market access events will be held throughout 2020.

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Linking up

p o View from the top

KEVIN KIELY, CEO, MEDILINK UK, CHARTS HIS CAREER AT THE ORGANISATION, OUTLINING HIS VIEWS ON THE UK LIFE SCIENCES SECTOR

s a joint founder of Medilink nearly twenty five years ago, I have seen a significant transformation in our health delivery system over this time, with a change in focus from GP and hospital treatment, to early diagnosis, community / home care, self-management of chronic disease and prevention (health & well-being). These changes have only been possible through underpinning technology developments eg. genomic medicine, molecular diagnostics, AI / Machine Learning, regenerative medicine, additive manufacture and robotics, all which further fuel expectations, and create a continuous cycle of innovation in health delivery. The need to enhance connectivity between technologists, clinicians, and businesses to drive the nation’s health and wealth, is as important now as it was when Medilink was formed, bringing together for the first time a regional partnership between academia, clinicians and business, to drive commercially viable innovation. In this model businesses are seen as central in translating clinical need and technology advances into mainstream healthcare solutions, and this is why Medilink UK focuses the majority of its resources on supporting business development. Last year was a challenging year for the life science business community. After what seemed like a lifetime since the referendum on Brexit, and the terrible uncertainty that businesses have had to endure, we are now out of the EU, but I don’t think any of us will be able to the predict what our relationship will be post 31 December. I think it’s perhaps an understatement to say that there will be some difficult negotiations ahead.

As well as uncertainty around Brexit, another major issue our member companies have faced over the past 12 months has been regulation, namely the unrelenting countdown to the implementation of the new European Medical Device Regulations or the MDR on the 26 May of this year. This situation has been exacerbated by the demise of the Notified Body infrastructure, with there currently being only 10 Notified Bodies across the entire of Europe to undertake CE marking audits under the MDR, with only one of these being UK based.

The need to enhance connectivity between technologists, clinicians, and businesses is as important now as it was when Medilink was formed,’ says Kevin Kiely, CEO, Medilink UK

So In addition to Medilink UK’s day to day support for life science companies, region by region, which include services spanning innovation and commercialisation, skills development, PR & marketing, and International, Medilink has tried its best to respond to issues of the day. For example we organised Brexit readiness events and webinars, funded by BEIS, with our Brexit webinar series, covering logistics, legal, IP, regulation etc., now forming a resource library that can be accessed through our website. Our international team is gearing up for the support that companies will need to seize the new international opportunities which will result from Brexit.

19 epidemic, being just one example. I know that I speak on behalf of all the CEOs and chairs of the regional Medilink organisations, when I say that we are all committed to doing our bit, in partnership with other key institutions, to drive health and wealth not only in the UK but globally. I also feel privileged to have the support and encouragement of Medilink UK’s chair, Bill Cruise, who has over 20 years life science commercial experience, latterly as the vice president of 3M Healthcare, Western Europe, and who has been actively engaged in strategic development for the sector, representing industry on the key groups e.g. Ministerial Medical Technology Strategy Group, the Accelerated Access Review Group.

With respect to regulation, Medilink UK was joint partner in a national study on SME preparedness for MDR, commissioned by Innovate UK. The results confirmed initial fears, that life science SMEs were extremely unprepared for the new regulations. In recognition of this fact, Medilink has stepped up its support in this key area and has been working with all of the appropriate government agencies to seek meaningful interventions. There will be many challenges ahead, with the growing Covid

I look forward to meeting with both new and old friends at this year’s Med Tech Innovation Expo in Birmingham.

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IN FOCUS

SINGLED OUT:

THE UK AND IRISH START-UPS TO WATCH MEDTECH IS BOOMING AND THERE ARE MANY START-UPS LOOKING TO TAKE MARKET SHARE FROM ESTABLISHED OEMS. BUT WHICH SECTORS ARE DRIVING THIS GROWTH AND WHICH START-UPS ARE THE ONES TO WATCH, ASKS CHEMIGRAPHIC’S NPI DIRECTOR, JOHN JOHNSTON?

s much as 10% of GDP is spent on healthcare – and around 7.2% of this goes to medical technologies. The European medtech market is worth €110 billion and it’s growing at a significant rate as new ways of delivering health care are developed. • In vitro diagnostics is the largest sector, followed closely by cardiology – with both these areas predicted a 6% CAGR leading up to 2022. • Global oncology spend is forecast to reach $200 billion by 2022. • Imaging diagnostics: in the UK alone, the NHS performs over 45 million procedures annually. The UK’s diagnostic imaging equipment market will reach $2.63 billion in 2020. • Medical wearables: the wearable medical device market is forecast to be worth €24.4bn by 2023. • With real-time imaging available, the global cardiac imaging software market should reach $530 million by 2023.

ENTER THE START-UPS The Office for Life Science calculates that 80% of UK healthtech businesses are SMEs, employing 23% of staff ,generating 10% of turnover. Medtech start-ups are in the top ten of the most profitable small businesses – returning an average net profit margin of 12.1%. The rise of the start-up is facilitated by the agility of small businesses to move fast – and in this they are helped by partnering with experienced EMS partners. When it comes to choosing five British and Irish startups that are going to disrupt the medtech sector there’s no shortage of candidates. We’ve picked one from the five main areas of growth in the sector. ONCOLOGY: KHEIRON MEDICAL TECHNOLOGIES Breast cancer survival in the UK is improving, and has doubled in the past 40 years, but earlier detection and faster diagnosis could improve these figures. This London-based medtech start-up uses machine learning to help radiologists detect early signs of cancer with greater accuracy and faster than ever before. It is the first start-up to receive a CE Mark in deep learning and radiology and is working with the NHS on pilots. Funding has also been secured to scale across the EU. MEDICAL WEARABLES: GIVEVISION London-based GiveVision offers innovative solutions that empower blind or visually impaired people to live independently. It is

developing solutions for people diagnosed with low vision due to central vision loss (eg. AMD, Stargate’s) and conditions affecting the whole visual field (eg albinism, optic neuritis). It has already brought a product to market that powers smart glasses to be used as eyes for blind people. SightPlus converts visual information into audio cues and can magnify visual perspective, allowing eg. the reading of books or finding a seat on a bus. CARDIOLOGY: VIVASURE Vivasure, based in Galway, Ireland, makes polymer implants and delivery systems – primarily for minimally invasive vessel closure in cardiology, interventional radiology and vascular surgery. In 2016, its first European product – a vascular closure device – attracted investors to back it to the value of over €16m. Its lead product is a fully absorbable, patch-based large-bore percutaneous closure device. This device enables closure of large arteriotomies in transcatheter procedures. IMAGING AND DIAGNOSTICS: INCEREB

Based in Dublin, Incereb has developed a range of paediatric, neonatal and foetal sensors for EEG monitoring that can be applied in minutes, with minimal training. Incereb has found a solution to attaching EEGs to a baby’s head to determine brain function without needing a lot of time, trained member or causing discomfort for the baby. The Incereb design has already gained FDA approval, and simplifies the electrode application into an innovative single electrode array which allows nursing staff with minimal training to align the central reference lead to the baby’s scalp. GENERAL MED-TECH: COROFLO Coroflo has developed a breastfeeding shield and monitor, the Coro, which can measure how much breast milk a baby is consuming. The sensor is non-invasive, easy to use, comfortable and tiny: there’s no need for wires or chargers. It connects to your phone to monitor feed volumes, store the data and analyse it.

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IN FOCUS

Parliament & HealthTech Conference 2020: Key takeaways THE HEALTH TECH ALLIANCE HELD ITS INAUGURAL PARLIAMENT & HEALTHTECH CONFERENCE ON 28 JANUARY 2020, GIVING INDUSTRY AN OPPORTUNITY TO ENGAGE WITH DELEGATES FROM ACROSS GOVERNMENT, PARLIAMENT AND THE HEALTH SYSTEM

he conference, hosted by Labour MP Steve McCabe and chaired by Dame Barbara Hakin, the chair of the Health Tech Alliance, heard from a host of speakers, including secretary of state for health, Matt Hancock and Dr Sam Roberts, chief executive of the Accelerated Access Collaborative. Panellists across the board agreed that the future of healthcare is inextricably intertwined with the wider adoption of health technologies, but clear obstacles were also identified. Technologies have to be developed in partnership with the workforce and patients or they risk alienating the people they are seeking to help. Richard Stubbs, chief executive of Yorkshire & Humber AHSN also suggested that workforce issues are arguably the most pressing area in which healthtech can help to make positive changes, while Rachel Power of the Patients Association stressed that patient trust would be integral to driving uptake. The panel also discussed how healthcare services can do their bit to better integrate technologies, with Professor Heather Tierney-Moore OBE of NHS Supply Chain citing the need for the NHS to increase its risk appetite. Delegates were however, reminded of the challenges faced by hospitals, which always have a plethora of metrics of success to consider.

The panels also discussed the practicalities of adoption, with NICE’s Joanne Holden stating that a lack of data-sharing arrangements with healthtech companies made it hard to measure successful uptake. Professor Tim Orchard of Imperial College Healthcare NHS Trust cited the need for greater training of clinicians on issues such as big data and AI, although it was noted that this would add further complexity to their day-to-day roles. Highlights of the conference of course included the two keynotes, Dr Sam Roberts, chair of the Accelerated Access Collaborative, and secretary of state for health, Matt Hancock. Both keynotes spoke passionately about the huge progress that has been made by the government and the health service in prioritising health tech and acknowledged the barriers to adoption. Indeed, Matt Hancock’s announcement of a £140 million AI award at the conference represented further proof of the government’s continued commitment to the UK life sciences sector. It was evident that while there is still much to be done, conferences like these, which bring together so many disparate voices from across the system, are essential to fostering greater collaboration. The input of bodies from across the health service, patients and

Matt Hancock’s announcement of a £140 million AI award at the conference represented proof of the government’s continued commitment to the UK life sciences sector

the workforce are necessary at all stages of product development and implementation to achieve widespread adoption. In working together more closely, stakeholders can agree on metrics of success and understand the challenges of embedding new technologies in care pathways. While different organisations have different priorities, the Parliament & HealthTech Conference demonstrated that we all share a common desire to see more technologies across the health system and are united in our efforts to deliver this. The Health Tech Alliance is a coalition of health technology companies and stakeholders from across the NHS and wider health system.

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Value-based procurement: could it become a reality? Oli Hudson, content director at Wilmington Healthcare, looks at value-based procurement and its place in procurement in the emerging NHS landscape.

he NHS is increasingly requesting that medical technology companies work with them in closer partnership. With focus shifting from unit price to measures of performance, safety and patient outcomes, how can industry demonstrate the short, medium and long-term value it brings to the NHS? There’s much talk in the NHS of value-based procurement, which even has an official definition designated by the NHS Supply Chain: “Value-based procurement is an approach that delivers tangible, measurable financial benefit to the health system over and above a reduction in purchase price; and/or a tangible and measurable, improved patient outcome derived through the process of procurement (tendering, contracting, clinical engagement and supplier relationship management).” Brian Mangan is the Value Based Procurement project lead at the NHS Supply Chain. He says that valuebased procurement is about looking at procurement from a different angle, to maximise savings opportunities across the patient pathway, and improve patient outcomes. “Value Based Procurement is all about whole life costing. This involves facilitating a paradigm shift from traditional buyer supplier relationships, to a position where healthcare and industry operate in an environment based on trust, aligned objectives, mutual benefits and success.” It’s a nice sentiment, but

is there more to it than a mission statement? NHS Supply Chain has given this some thought and Mangan gives an example: “If we assume that the current price of a knee implant is £1,000, if procurement saves 10% that’s a saving of £100. However, if they save 10% on the pathway costs, through improved theatre efficiency or reduced length of stay for example, and this equates to 10% of the pathway cost (perhaps £5,000) then procurement have the potential to quadruple the savings opportunity to £500.” So here are two product hooks that go ‘beyond unit price’ – theatre efficiency and reduced length of stay. WHAT IT COULD ENTAIL A team at North West Procurement Development says that such value propositions have four basic categories – quality, innovation, financial and productivity/efficiency. Quality could mean product quality, such as a low percentage of returns and defects, or service quality, such as a high response speed for patients / clinicians. Innovation can cover new products but new ways of engagement with process, such as during trials and evaluations, and participation in improvement activities such as category panels. Financial could be a reduction of whole life costs or simply improving invoice accuracy; and productivity offers levers that can have a direct improvement on the pathway, like Mangan’s examples, but also including

reducing waiting times or waste, or improving sustainability. Historically, it has been difficult to find evidence for such product claims. It is therefore welcome news that NHS Supply Chain is engaging with NHS suppliers and clinical, financial, commercial and industry stakeholders on about a dozen pilot projects. The aim is to look at system benefits leading to sustainable procurement and savings efficiencies, focusing on areas which can demonstrate a relationship between product adoption and measurable benefits that can be achieved across the pathway. A project to deliver a bed management contract at a North West NHS Trust used value-based thinking to mark a step change in procuring pressure care mattresses and associated products and services. The outcome reduced costs and incidents of pressure ulcers for patients, with knock-on savings, plus potential for meeting hospital targets. CONCLUSION NHS Supply Chain, in its new contracting process – which governs the work of the category towers and framework agreements – is trying to move from “a tightly managed, highly specified input contract into a looser outputs - and outcomes driven environment”. This is a change from effectively ‘microcommissioning’, where the payers define the services/ product and the nature and

Value-based procurement is an approach that delivers tangible, measurable financial benefit to the health system over and above a reduction in purchase price location of delivery – which has proved an inflexible, organisation-based approach - to prescribing “outputs and core metrics”, which need to be met, measured and understood with flexibility as to how these are achieved. Some companies more comfortable with the traditional model perceive a risk in the change in contracting away from fee for service or goods to more nebulous notions of outcome and value. This has resulted in some legal challenges or referrals to national regulators from suppliers. However, engagement is key and there seems to be a movement to make procurement more agile, smart and responsive to patient, system and pathway needs. Data and analytics to provide a picture of wholelife and pathway costs, as well as engagement with clinicians, will be crucial. But one of the other principal ideas in the NHS Supply Chain’s definition is ‘supplier relationship management’ – a sign it sees success as a partnership with industry, and that value-based procurement will only succeed with industry buy-in.

COVER STORY

ThinkinG out loud REUBEN JACOB AND FIONA KELLAS, MAUCHER JENKINS SHARE THEIR EXPERTISE ON IP STRATEGIES AND CONSIDERATIONS FOR GENE THERAPY INVENTIONS

ene therapy enables the treatment of a disorder or disease through the insertion of a gene into a patient’s cells instead of using drugs or surgery. This technique involves the introduction of genetic material into cells to compensate for abnormal genes in the patient or to make protein that will be beneficial to the patient. As an example, if a mutated gene causes a protein that is necessary for the correct functioning of cells to be faulty or missing, gene therapy may be able to introduce a normal copy of the gene to restore the function of the protein. Gene therapy is understood to be useful in the treatment of a range of conditions such as cancer, cystic fibrosis, muscular dystrophy and Alzheimer’s disease. UK ROLE IN GENE THERAPY TECH R&D Gene therapy is considered to be very important to the future of medicine and as such, many companies are focussing their research and development into gene therapy technologies. The UK is a growing industry for research in these areas and it is anticipated that by 2035 the UK industry around cell and gene therapy technologies will be worth in the region of £10 billion. Gene therapy research is still at an early stage. Due to the length of time and the associated costs involved

in developing an effective gene therapy and taking it through to approval, it will be important for companies working in this area to put into place an effective IP strategy that will provide protection for their inventions. In addition, the competitive nature of the gene therapy industry means that it will be important for a company to obtain patent protection for inventions being developed, as well as reviewing the patent landscape to check that the company is free to operate in their chosen area. WHAT MAKES SOMETHING PATENTABLE? In order for an invention to be patentable, it must be new, inventive and capable of industrial application. In addition to the above, it is also important that the invention does not contain subject matter that is excluded from patentability. One of the challenges associated with obtaining patent protection for gene therapy inventions is that the European and US patent systems include a number of exceptions to patentability that are relevant to biological material and natural products. In Europe, it is not possible to obtain patent protection for a method of treatment or surgery of the human body. Thus, the removal of cells from a patient would not be considered to be patentable

in Europe. In addition, inventions relating to stem cells that are derived from the destruction of human embryos are not patentable in Europe. In the US, recent case law (Association for Molecular Pathology v Myriad Genetics, Inc, 2013) has meant that inventions relating to natural phenomena and natural products must show characteristics that are different to their natural counterpart(s). However, despite the above challenges, there are a number of aspects of gene therapy technology that may be eligible for patent protection. Typically, the gene therapy procedure can involve performing a modification procedure on cells that have been removed from a patient before reintroducing the cells into a subject to produce their modified effect. The process of modifying the cells may be patentable if it fulfils the above requirements of patentability. In addition, it may be possible to obtain protection for the methods that are used to culture, manipulate or modify the cells that are used for gene therapy. At Maucher Jenkins, we have a team of attorneys who can provide IP advice and assistance in the area of patenting inventions involving gene therapy, molecular biology and biochemistry.

COVER STORY

THERE ARE A NUMBER OF ASPECTS OF THE GENE THERAPY TECHNOLOGY THAT MAY BE ELIGIBLE FOR PATENT PROTECTION

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MAKING MEDTECH

In for a win: Med-Tech Innovation Awards 2020: finalists announced The finalists for the Med-Tech Innovation Awards 2020 have been announced, with a total of 23 entries shortlisted across five categories.

his year saw some inspiring entries recognising areas of innovation across the life science and healthcare technology sectors.

3D PRINTING AWARD Axial 3D - Axial 3D’s surgical model service uses machine learning algorithms to help convert patient scan data to 3D anatomical models, reducing lead times. ExpHand Prosthetics ExpHand has developed affordable, expandable, customisable 3D printed prosthetics for children. FabRx - The M3dimaker 3D printer prints solid oral medicine, enabling personalised doses for specific therapeutic requirements. MedScan 3D - MedScan 3D offers a 3D printed surgical model service, which produces anatomically accurate silicone test simulators for medical devices. University of Liverpool A digital electronic imaging system has been developed to enhance the quality control of the EBAM additive manufacturing process, to improve reliability in the manufacture of bespoke orthopaedic implants. CONNECTED HEALTH AWARD Ainostics - Ainostics has developed an AI analysis engine which uses multi-modal patient data to perform accurate

diagnosis and prognosis for early dementia. FeelTect – Tight Alright is a connected wearable device for measuring and monitoring subbandage pressure during compression therapy, reducing healing times and improving quality of life. Game Doctor - Game Doctor has developed a healthcare analytics platform using mobile gaming, to map and predict health behaviours. The London Ambulance Service NHS Trust An online Point of Care Testing (POCT) service for the London Ambulance Service (LAS) enables en-route pathological testing with results available online for the destination hospital. Nemaura Medical SugarBEAT is a noninvasive continuous glucose monitor and lifestyle app for diabetes, providing a personalised and progressive behaviour change app to manage and prevent type 2 diabetes. DESIGN AWARD Nemera - Safe’n’spray is a smart drug delivery device, with a reusable child-resistant locking unit and fingerprint identifier, to monitor drug delivery and prevent overdosing. Oxford VR - A virtual reality therapy platform with a computergenerated virtual

coach for personalised treatment of phobias and mental health. Adopted in four NHS trusts.

delivery device to improve quality control and reduce inspection costs.

wearable devices which offer water resistance, breathability, elasticity and long wear times.

SleepAngel - This patented medical barrier bedding allows the bedding to breathe while being a 100% barrier to allergens and pathogens, reducing hospital-acquired infections.

Emerson - Emerson has developed a micro solenoid valve for use in portable oxygen concentrators, which is light and compact with a significantly higher flow rate than competitor valves, enhancing the quality of life of the user.

Paxxus - StreamOneR is an ultra-high barrier, hermetically sealable medical packaging solution for the number one polyester recycling stream, providing a sustainable alternative to polypropylene medical packaging.

Freudenberg Medical Helix iMC technology measures the inner geometry of silicone tubes during extrusion, to improve product quality and productivity as well as reducing waste and time to market.

Spyras - Spyras has developed an affordable, disposable, paper-based wearable device for continuous real-time breathing analysis in hospitals. It automatically alert clinicians of early signs of patient deterioration.

TheMoment - M-co is a non-invasive wearable device using pulsed cueing and focused vibrotactile stimulation to ease the symptoms of Parkinson’s disease. ENGINEERING AWARD Biovation Orthopaedic Solutions - A kit used to perform cartilage replacement implant surgery, for big toe arthritis, has been redesigned to eliminate pre-operative lead-times, reduce manufacturing costs and allow for more accurate surgery. Carclo Technical Plastics - Specialist intool process control and monitoring equipment has been introduced to the injection moulding process of a drug

Marsden - The Patient Transfer Scale is a transfer board with an in-built weighing scale to enable immobile and time-critical patients to be weighed instantly for precise drug dosing. MATERIALS INNOVATION AWARD 3M Medical Materials and Technologies The 3M Extended Wear Medical Transfer Adhesives is a set of solutions for stick-to-skin

Stratasys - Specialist digital materials have been developed to allow the Stratasys Digital Anatomy Platform to replicate human anatomy which has the same biomechanical properties as native bone and tissue for realistic anatomical models.

Go to www.medtechexpo to get tickets

Med-Tech Innovation Expo

LU RAHMAN QUIZZES TWO OF THIS YEARâ&#x20AC;&#x2122;S KEY SPEAKERS ABOUT THEIR VIEWS ON THE MEDTECH INDUSTRY. NADINE MILES, SPIRIT HEALTH AND HILARY THOMAS, KPMG, OFFER INSIGHT AND INDUSTRY INTELLIGENCE TO PROVIDE A FASCINATING VIEW OF THE MEDTECH SECTOR NOW AND IN THE FUTURE

QUESTION TIME

Med-Tech Innovation Expo

What do you see as the major challenges facing the medtech sector at present? Hilary Thomas: Across the world healthcare systems are stretched – there aren’t enough people to staff them and there are spiralling costs which make staff unaffordable. Outmoded models of care drive patients to hospitals which are not always the right setting of care. And this can only get worse. Nadine Miles: One of the significant challenges we collectively face is adoption within local clinical pathways. There is no shortage of proven medtech solutions, but the challenges of healthcare delivery are local, specific and complex. Addressing each one requires a tailored response based on a holistic view of a CCG’s current patient pathways and dynamics. What would you like to see happen to overcome them? Is there anything government could do? Hilary Thomas: To overcome the challenges we need to reinvent healthcare – engage patients more actively in their care so that they stay well longer and take ownership. We know activated patients are cheaper for healthcare systems. We also need to move towards prevention – which is ultimately cheaper but requires a more long-term view which governments are often reluctant to support. So governments need to be more mature, think about their legacy, and invest for the long term. Nadine Miles: There are two ways in which we can overcome this challenge. The first is to build, share and evolve the evidencebase for strategies that have succeeded elsewhere - so CCGs can ‘self-select’ solutions that would seem to fit. The second is then to make it easier for healthcare decision-makers to access, procure and effectively implement these proven med-tech solutions into

their local pathways, which is where government ‘kitemarking’ or ‘preaccreditation’ would help. Where are the opportunities in the sector? Hilary Thomas: There are opportunities to use digital, as well as data and analytics, to be more evidence based; create more cost-effective pathways and improve automation and self-care so that the staff that we do have and can afford are able to operate as effectively as possible. Nadine Miles: We see a huge drive towards proactive medicine and preventative healthcare, so clinicians are supporting people to make better decisions. A great example of this is the incorporation of air quality data into our CliniTouch Vie platform, empowering patients with information about satellite-based, realtime air quality data. This technology, in combination with the growing adoption of digital solutions, such as remote monitoring for long term conditions, enables patients to collaborate with clinicians for proactive disease prevention and to reduce unplanned hospital admissions. How easy is it for medtech companies to find skilled staff and what advice would you give potential recruits? Hilary Thomas: There is huge competition for capable people – a true talent war in healthcare and medtech companies face the same challenges. The skills of the future will not be those required in the past so organisations need to consider how they future proof themselves. However potential recruits are likely to join an industry which is changing fast and has demonstrated its adaptability so a career should be stimulating and rewarding. Nadine Miles: Finding brilliant people that have appropriate skills along with healthcare experience is not easy. Spirit Health Group has

the great advantage of being able to offer recruits the opportunity to work within an ethical business whose mission is to make health easy for service providers and patients, where we make lives better. How is regulation affecting business? Hilary Thomas: Given the exponential advances in technology and the growing pace of change it is hard for regulation to keep up. This means that regulation may act as an unforeseen brake. Consequently organisations need to work with regulators, to educate them about changes which are happening and enable them to foster and support progress. Nadine Miles: Regulation is essential, but in the healthcare context, we also have to work within medical, technology and governance regulation. We have to be careful that this doesn’t stifle innovation. What will the medtech landscape look like this time next year? Hilary Thomas: Although change is happening faster than ever before – and there are more potential disruptors of the industry as well as increasing convergence between healthcare and life sciences companies and more widely in reality changes from year to year are mostly incremental. However this pace and convergence will encourage innovation and so we may see some new market entrants from surprising places and the adoption of technology from outside the sector. I would anticipate more partnerships between academia, industry, the third sector and others as well. Nadine Miles: As well as the wider use of AI and machine learning within healthcare, the trend of utilising integrated smart technologies will be more prevalent, including those that incorporate population health aspects, such as air quality monitoring.

BIOGRAPHIES Nadine Miles is director of market development, Spirit Health Group. Miles graduated with a Business Studies degree in Birmingham and in her early career worked in banking, retail and in the public sector. Since then she has held roles in healthcare, both within the NHS and the independent sector, including operational and service development roles in community services, mental health, acute, and primary care. This experience has landed her ‘the best job in the world’ working with the rapidly growing ‘Sunday Times Fast Track 100’ company Spirit Health Group as director of market development. She gets to work across Spirit’s six businesses, alongside a team who are focused on making health easy for patients and clinicians. Hilary Thomas is KPMG’s chief medical adviser and works in the life sciences practice. She spent 23 years in the NHS where her last roles were as professor of oncology at the University of Surrey and medical director of the Royal Surrey County Hospital. After two years as group medical director of CareUK, she joined KPMG in 2009, initially in the healthcare team. Here she led KPMG’s global health proposition, Care System Redesign, working across regional health ecosystems to redesign inter-organisational patient pathways and shift provision of care to more appropriate settings. She moved into the life sciences team six years ago. Here, alongside the strategy team, she has developed a proposition entitled Quality of Care which enables life sciences companies to become partners in healthcare ecosystems and improve the way care is delivered and move towards different contracting models.

Ultrapolymers â&#x20AC;&#x201C; Your Healthcare Partner from Design to Production Ultrapolymers is a pan-European polymer distributor based in over 25 countries throughout Europe. Our experienced team, based in multiple locations, act as a partner to IP owners, designers and converters in a wide range of industries with a significant focus on Healthcare. A dedicated Healthcare team within Ultrapolymers support projects from concept to consumer. We can assist you through the design stage with material selection, design for manufacturing optimisation, tooling advice through to component production for the life of the project. We are proud supporters of innovation in MedTech and Healthcare applications with the knowledge and range to help bring your product to market. With the complexity and long term nature of Healthcare projects, partnership between all invested parties is critical. When everyone is working together and communicating the objectives this ensures success for the life of the project In the early stages of a project Ultrapolymers can offer support in designing your part to make it as easy to produce whether it be through injection moulding, extrusion, blow moulding or additive manufacturing. With our broad portfolio of materials from market leading suppliers such as LyondellBasell, Ineos Styrolution, BASF and many more weâ&#x20AC;&#x2122;ll be able to propose the right polymer type and grade for you. To further support your project Ultrapolymers offer Moldex3D, Moldflow as well as FEA analysis which our team can run and analyse locally to offer swift feedback. These tools coupled with the experience of our Business Development Team make Ultrapolymers the ideal partner for your component design.

The regulatory environment is continuously evolving. In particular with the introduction of the MDR, we are seeing an increasing number of customer requests regarding approvals and guidance on how to navigate this evolving landscape.The Ultrapolymers team have experience with current and upcoming compliance regulations and can offer guidance on how to navigate these changes. Ultrapolymers supply a wide range of polymers into a broad range of sectors including, but not limited to, drug delivery, diagnostics, primary and secondary packaging and medical devices. Ultrapolymers wider experience outside of healthcare can help us provide a different perspective with innovative solutions to challenges you may face.

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Med-Tech Innovation Expo

Meet the speaker: ALY KING-SMITH, CLEARWORKS

Clearworks was founded in 2013 by Aly King-Smith who is a principal consultant, writer and speaker operating in the world of smart STEM leaders. She has built a team of experts with specialist skills to deliver robust, measurable impact on behaviours, conversations and leadership capability in this sector

magine what could happen to fast-growing medtech or biotech organisations if they had inspirational leadership confidence and courage across the board. Imagine how much more effective conversations, decisions and plans could become if everyone belonged to a truly high performing team. After a lifetime celebrating correctness, accuracy and specific knowledge, it’s a tough ask for smart technical experts and scientists to move to a more intuitive, whole-hearted, wholeself leadership style. And heaven knows, we need more wholehearted leaders globally at the moment, right? This is the sweet spot for the Clearworks team, on a mission to be consistently the best in class for developing exceptional leaders in this sector. After more than 15 years working as an executive coach and boardroom facilitator across many sectors, founder of Clearworks, Aly King-Smith, became fascinated with the challenges of this fast-paced world which is so critical and life-changing for patients. What if she could build an organisation that specifically focused on accelerating progress in this sector, by developing exceptional leaders

and teams more quickly? KingSmith started her career as a surgical physiotherapist, and moved into commercial roles in the pharmaceutical and vaccine industries in the 90s, before her move into organisational & people development. She became compelled by the need to accelerate progress in this sector. Since 2013, King-Smith has been gathering specialist executive coaches and lead team facilitators to deliver specifically in the STEM, biotech and pharma sectors. Aware of the growing amount of unregulated coaching flooding the market, she focuses on the ‘curated’ team of experts - known and trusted, assessed, insured, qualified, developed - all of whom deliver specific expertise for this sector. The team now delivers diagnostics, coaching, training and facilitation across the UK and Europe, individually and for lead teams and groups. This is the first time Clearworks has attended the Med-Tech Innovation Expo and the company is excited to meet visitors and fellow exhibitors King-Smith will be on the Introducing Stage to outline a case study of one of Clearworks’ flagship programmes, the Clearworks Coaching Circles. The affordable Clearworks Coaching Circles bring executive coaching to more leaders more quickly. Brave behaviour change is accelerated by small groups of leaders working with the same executive coach for a term of six or twelve months. The Circles build accountability, drive and connection, building positive,

courageous conversations as a norm. Organisations use them to push for more progress in focus areas, such as ‘retaining top talent’ or ‘women in leadership’. They’re also highly effective for aspiring leaders: ‘readiness for leadership’; such a key gap in the science sector, where accidental heroes are common...be a great scientist and suddenly you’re head of department...! The groups that King-Smith will describe at the expo were commissioned by a biotech that was losing women in senior leadership. They had no idea why. The groups led to an increase in retention and promotion, as well as the unexpected benefit of driving a coaching culture and improving the skills of the leaders with their own people. Circles focusses on one’s own personal and leadership style. This is where the magic of the Clearworks Circle lies, as senior leaders work together on their own ‘stuff’ and behaviours, in an accountable group. After hosting a year of Circles as a pilot, the organisation has now commissioned further groups, as they make the programme a permanent part of the curriculum, and previous members take a multiplier role in embedding changes across their teams. Big consultancy coaching without the big consultancy price tag. Every organisation has its own unique leadership challenges, and the Clearworks team is established, innovative and courageous.

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Med-Tech Innovation Expo

Meet the speaker: DAVE EASTON, ZES

David Easton is director and principal validation consultant of Zener Engineering Services. His experience has been predominantly gained by working for world-class pharmaceutical and medical device manufacturers, as well as healthcare providers. Easton’s presentation will highlight and discusses a number of GMP project mishaps. “The team at Zener Engineering Services (ZES) is looking forward to exhibiting at the Med-Tech Innovation Expo, our first time exhibiting at a trade event. My talk, ‘Have You Ever Wondered Why a Project Was Not a Resounding Success, but Were Too Afraid to Ask?’ Benefitting from over 25 years’ experience of GMP project management of up to £20m, I decided to share those experiences and examine why some projects flounder. There are an infinite number of scenarios which have the potential to produce a GMP project mishap, but most of these can be controlled to reduce risk. In floundering projects, we have found common problems and issues, which should be addressed to help towards project success. My presentation aims to address some of the most common GMP project issues and I expect that the audience, will find the illustrated examples very revealing. ISO 13485:2016 With the publication of ISO 13485:2016, there is a realisation that the validation requirements for medical devices are more comprehensive and overall more akin to the detailed requirements of pharmaceutical manufacturing. Enquiries regarding software validation and cyber security, for example, are becoming more and more frequent.

WHY YOU SHOULD CHOOSE ZES We started as a small engineering company specialising in quality engineering, focused on pharmaceutical and medical device manufacturing compliance to FDA and MHRA regulatory requirements. Over the years, we have evolved into an all-round service provider and consultancy, dedicated to health and life sciences. Founded on the principles of being innovative and providing world-class solutions, ZES is building a reputation for quality and excellence. Key personnel have worked in highly regulated industries, bringing a wealth of expertise to the service we provide. Members of our management team have substantial qualifications and experience in the sectors in which we operate. QUALITY AND RELIABILITY We provide a first-class comprehensive engineering service, covering a range of pharmaceutical and medical device manufacturing operations, and healthcare provider services. We provide a specialist engineering service for projects, maintenance and consultancy, enabling engineering tasks (large or small) to be outsourced to a single point of contact. GMP quality and reliability are at the centre of everything we do. SPEED AND FLEXIBILITY We provide speed and flexibility whilst responding to the changing needs of our clients, from small single drawings, to project management of large capital projects.

Our business model allows us to operate all over the UK and Europe, whilst being able to promptly deliver a first-class quality engineering service. All aspects of pharmaceutical and medical device manufacturing are covered, to the highest of standards. FDA / MHRA experience ZES personnel have worked with former FDA inspectors and have fronted FDA and MHRA inspections. We have striven to ensure a successful inspection outcome. Inspection preparation and remediation are areas where we have significant experience. VALUE FOR MONEY We deliver by utilising handson approaches, drawing on the professional experience of our consultants, to provide our customers with a flexible and value-for-money partner. Through careful use of resources, we can deliver the same level of service as provided by much larger companies, more quickly, whilst delivering a better service. Our business model allows us to pass on savings. JUST GXP ENGINEERS We only utilise GxP engineers who hold relevant qualifications and possess hands-on experience in engineering or science. Our clients also enjoy complimentary access to our senior management team, on an ad-hoc basis, during the engagement. All our engineers have proven experience. We don’t utilise dedicated salespersons, recruitment agencies or other non-engineering bodies. We utilise our network of over 150 experienced GMP engineers.”

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IN FOCUS

Medtech show offers springboard for start-ups T4M IS AT THE FOREFRONT OF MEDICAL TECHNOLOGY. TAKING PLACE ON 5-7 MAY IN STUTTGART, THIS YEAR’S EVENT IS THE IDEAL PLACE FOR INDUSTRY PIONEERS AND START-UPS

uturologist Sven Gábor Jánszky summed up the T4M 2019 premiere well: “There is more and more going on in the medical technology industry every year, so it is vital not to miss the boat. T4M represents the culmination of industry discussions.” Many companies that play a pioneering role in the medical technology industry will once again come to Stuttgart in 2020 to take part in T4M – Technology for Medical Devices. This upand-coming trade fair in southern Germany is the ideal place for intensive networking and dialogue, providing the basis for developing and implementing new ideas. Moreover, T4M – with its clearly defined key exhibition areas of production engineering, the production environment, services, and components and materials – provides visitors with the opportunity to meet

key players so they can nurture promising business relationships. “Successful companies involve suppliers, universities and research institutes in their value chains, incorporating them into the innovation process,” says T4M project manager Tanja Wendling. “As one of the key regions for medical technology in Europe, Stuttgart is the perfect place for the industry to meet, create valuable connections and tap into the innovation potential on offer.” SPRINGBOARD FOR START-UPS AND YOUNG COMPANIES T4M provides attractive offers to companies that are new to the industry in order to encourage innovation. One of these initiatives is T4M Start-up World, a joint venture between Messe Stuttgart and Medtech Zwo. It provides a professional stage for founders to showcase promising medical technology solutions as well as opportunities for dialogue with industry giants and investors. Start-ups can also use the Pitching Stage at T4M to present their innovative products to an outstanding trade audience. As of this year, the German Federal Ministry for Economic Affairs and Energy (BMWi) is also supporting T4M as part of its commitment to innovative companies. Through its sponsorship of a group stand, upand-coming German businesses have the opportunity to present at the trade fair at a subsidised price,

T4M provides attractive offers to companies that are new to the industry in order to encourage innovation allowing them to make a name for themselves on the global medical technology market. CREATING MOMENTUM THROUGH NETWORKING As new ideas originate primarily from collaboration, exhibitors and visitors are given ample opportunity to engage in professional discussions and intensive networking at T4M. Wendling puts it like this: “The trade fair and the accompanying programme are all under one roof at T4M, so it is quick and easy to make contacts. You can also network at events specially organised for this purpose and at group stands, which act as central information hubs.” With its comprehensive accompanying programme, T4M is also shoring up the transfer of knowledge within the medical technology industry. Exhibitors and visitors can get inspiration from specialist forums, workshops and keynote speeches, while also finding out about the trends that are currently driving the industry.

T4M project manager Tanja Wendling says: “As one of the key regions for medical technology in Europe, Stuttgart is the perfect place for the industry to meet, create valuable connections and tap into the innovation potential on offer.”

IN PROFILE

Pinnacle of success: Why Olympus has become a medtech pioneer

OLYMPUS IS GLOBALLY RECOGNISED FOR ITS OPTICAL AND DIGITAL PRECISION TECHNOLOGY. LU RAHMAN SPEAKS TO FRANCIS WHITE, DIRECTOR OF MEDICAL & SURGICAL BUSINESS, OLYMPUS KEYMED TO FIND OUT MORE ABOUT THE COMPANY’S MEDTECH EXPERTISE AND ITS FAR-REACHING MEDICAL GOALS

R: Olympus Medical Systems has been innovating for 65 years. Tell us about some of the company’s latest medical innovations FW: Olympus was founded in 1919 and launched its first gastro-camera in the 1950s. Since then we’ve been medtech leaders, especially in the field of endoscopy. We have developed and released a range of innovative products, culminating in our flagship technologies, the Evis Exera III and Lucera endoscopic video systems. Most recently, we have launched PowerSpiral; the world’s first motorised endoscope. These innovations have been developed in close consultation with the healthcare professionals who use them, listening to their needs and striving to deliver solutions that enhance clinical care. Olympus plans to remain at the forefront of medtech development and we will continue to seek out innovative ways to meet the healthcare demands of the future. LR: Tell me about Thunderbeat… FW: Thunderbeat is the world’s only energy system that delivers the two most-established forms of

energy to tissue simultaneously. These are ultrasonic energy for superior dissection and fast tissuecutting capability, and advanced bipolar energy for fast and secure haemostasis for vessels up to and including 7mm in diameter This system allows for sharp and blunt tissue dissection, even in hard-to-reach places such as deep pelvic areas. User feedback to date, has been extremely positive and we hope to see it continue to be that vital tool for surgeons in clinical practice. LR: What would you say has contributed to the company’s longterm success? FW: There are many elements to this, but some factors stand out. We have shown a commitment to innovation in the research and development of optical and digital precision technology – especially in the field of medtech. We listen to our customers and support them with a field team which earns their trust. Other factors include cooperation and partnerships with healthcare professionals to develop innovative product solutions to address clinical challenges. We ensure that we invest in professional training. We have a bold purpose that unites all employees – to make people’s lives around the world healthier, safer and more fulfilling. And of course, we possess a strong vision in the core business, medical endoscopy: to put colorectal cancer (CRC) into the history books

LR: You have a 70% global share of the gastrointestinal market – how does the business sustain this competitive edge? What are your main drivers and challenges? FW: We are incredibly proud of the partnerships we have established with our customers and the continued trust they put in us to develop and deliver innovative, safe and reliable products. What drives us in our daily business is our vision to one day make CRC history. One of our biggest challenges is that while we continue to strive for technological excellence which can undoubtedly support healthcare professionals in saving lives - this alone will not be enough and we are only able to improve the overall standard of CRC screening with the participation of all other stakeholders – such as hospitals, healthcare systems and health authorities. We need to find new, compelling ways to engage and activate these key groups. LR: You are listed as one of the top 100 Global Innovator Companies. What does this mean to the business and what makes you so innovative? FW: We have close relationships with our customers and we have a regular

“What drives us in our daily business is our vision to one day make CRC history,” says Francis White, Olympus

IN PROFILE

dialogue with them to understand what they need in order to achieve positive healthcare outcomes for their patients. We also have a wealth of experience from our 100-year heritage, but at the same time fully embrace new approaches. For example, we recently initiated a partnership with an emerging industry newcomer, an AI technology company named AI4GI. We believe this partnership will help us build for the future by incorporating cutting edge technology into our core business, medical endoscopy and beyond. We also always consider the clinical impact of our decisionmaking process and take a longterm view of societal challenges, which we feel sets us apart from companies that tend to prioritise short-term business goals. For example, we are committed to finding ways to help make CRC a thing of the past. LR: The healthcare sector has changed significantly in the time that Olympus has been supplying its solutions. Today, we hear about the effect digital solutions will have on healthcare. How has the company addressed this and how do you see these types of technologies transforming the industry? FW: The world in which we operate has certainly evolved over the last 100 years and the opportunity that we now have to accelerate positive change is incredibly exciting. As we mentioned, we are already moving in to the AI space to support physicians with detection and characterisation tools that aim to improve their daily

work. From a broader perspective we are also seeing digital optimisation of clinical workflows in gastroenterology departments, resulting in shorter patient waiting lists and accelerating turnaround times for patients. LR: We hear a lot of talk about the importance of collaboration between manufacturers and healthcare professionals. Is this approach important to the business and if so, why? FW: Yes, it’s indispensable. Healthcare professionals can give us a unique perspective on what is really needed and what their challenges are. As with the movement toward digital and AI approaches, we are focusing more and more on the younger generations of gastroenterologists, as their needs sometimes differ from those of established experts. Investing in round-table discussions to learn about new clinical trends is also a key to success. And, of course, the promotion and implementation of training and education initiatives is crucial. All with the shared goal of extending the limits of endoscopy and, one day, making our vision come true by making CRC history. LR: Your website states that you are ‘committed to conducting partnerships between industry, healthcare professionals and HCOs’. Why is this significant to you? FW: Building partnerships with our healthcare professional customers is one our top priorities. However, the cooperation with healthcare organisations (HCOs), especially the associations of medical specialties, is no less crucial as it is their guidelines that allow the adoption and integration of new evidence-based technologies.

Here, too, we see ourselves as a strong partner to jointly advance clinical progress. LR: Where do you see the medtech sector heading in the next ten years? FW: We see digitalisation as a major focus in medtech. Clinical workflows in particular are becoming increasingly automated and today’s medtech devices will have to interact with each other to an increasing extent. Patient records will be digital and ideally all medtech devices will be able to process and share medical records in a secure, direct and automated way. We also believe that AI will become an established and integral part of the medtech sector. This may feel revolutionary to many areas of the healthcare system, but we are sure AI will find its place as a trusted tool for healthcare professionals – and for the health of patients. Naturally at Olympus we aim to play an active role in shaping this process. LR: What advice would you give younger companies entering or thinking about entering this market? FW: You must understand the needs of healthcare professionals and the patients that they treat. Without their crucial input you will never fully understand how to support them. Patient health and safety has to be your highest priority; any technologies that are created must work perfectly. Every. Single. Time. Finally, regulatory requirements should not be seen as a hurdle – they are there for a reason. Work with regulators as a collaborative and inclusive partner. All this requires an uncompromising approach to meeting the very highest standards of product and service quality.

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WHY TRUST IS THE KEYWORD IN AI

ark Hitchman, Canon Medical Systems UK, discusses why trust and business values will be the cornerstones to defining AI ethics.

Just as clinicians take a Hippocratic Oath, medical technology innovators need to be guided by a moral and ethical compass, says Mark Hitchman, Canon Medical Systems UK

There’s no doubt Artificial Intelligence (AI) has a place in modern healthcare. But as the pace of innovation and adoption into health organisations accelerates, there will be the prejudices and voices of caution. The concerns surrounding its capacity to replace people seem to be abating as understanding grows around its supporting role to workforces and how it will co-pilot clinical diagnoses. However, the key to garnering a warmer embrace by end-user stakeholders is to inspire confidence through trust and sound governance. Just as clinicians take a Hippocratic Oath, medical technology innovators also need to be guided by a moral and ethical compass. Everyone’s vision for AI in healthcare is the application of deep learning techniques with rich medical datasets to positively impact patient outcomes. It’s exciting, inspiring and most importantly, it promises solutions to some of the very big challenges facing UK healthcare today. But with the AI hype, there also comes caution. Can we trust AI? Where is

Innovation and trust go hand in hand.

the data coming from to build the algorithms? Is data diverse enough to represent our health populations? AI WILL SUPPORT MODERN HEALTHCARE The 2020s will be a decade of health innovations led mainly by the deep learningbased technologies that are fuelling the AI evolution. The early pilots and entry-level machine-learning case examples are providing benefits for many process, clinical and operational efficiencies in our over-stretched health services. Examples include its use as a second-layer checking tool of breast cancer screening scans, as automated assistants in routine surgery, or to improve the diagnostic quality of CT scans whilst keeping patient dose low. Continuous innovation in developing algorithms that drive healthcare technologies is the quest of all the major players. Working in collaboration with global academics, innovators and clinical luminaries is a common theme. So too is the issuing of ethics charters, or guidelines, that set out how AI will benefit and support health establishments, patients and society. Business values are the cornerstone of AI ethics The way a company does business is

the cornerstone to gaining trust in Artificial Intelligence. This portrays its overall ethical stance and values. This can help define answers to all the key ethical questions around where data is coming from to build algorithms and ensuring AI is representative of all the health demographics it is going to serve. The business of ethics goes far beyond the statutory requirements of a commercial organisation - it’s about discretionary decisions and behaviours guided by core corporate values. Business values influence how we interact with employees, suppliers and customers. They govern accountancy practices and indeed inject a commercial consciousness. Examples of the business of ethics can define the authenticity of a company over the long-term. Does it have a strong corporate social responsibility (CSR) pedigree with deep altruistic charity links? Does it have an opinion on the key macroenvironmental issues of our time? Is it doing something concrete to make a difference to climate change, world poverty or race/gender inequality? Often the wider ‘personality’ of a medtech innovator illustrates the values behind its ethics and ethos. Its culture and

philosophy for its own people and society beyond tell a story about the leadership and innovations it builds. You don’t need to be a tech leader like Bill Gates to roll out initiatives for the greater good. Philanthropy woven into business leadership can champion a higher level of trust in the brand, the business and ultimately the AI advancements that are being developed. Relationships are always governed by trust Innovation and trust go hand in hand. Especially where the lives of patients depend on it. So in this early stage of AI evolution and collaborations it is crucial that we all act transparently to build a trustworthy foundation. Individuals and companies that undermine integrity, by fast-tracking developments or gathering data from unvalidated repositories, risk setting back the reputation of the whole of the industry. Let’s hang on to the excitement of AI to boost medtech innovation, drive the ethics of transparency and good governance, and look forward to the rewards. AI without shock and awe will ensure a steady and supported adoption of this inspiring innovation. Championing trust and working with businesses with ethics is vital to deliver the greatest rewards.

Packaging

How packaging can be sustainable without loss of quality ALASTAIR COOK, ULMA PACKAGING UK, EXPLORES THE SPECIFIC LEGISLATIVE PACKAGING CHALLENGES FACED BY THE MEDICAL INDUSTRY AND HOW PROCESSORS CAN SIMULTANEOUSLY REDUCE PACK WASTE

ith McKinsey calculating that the demand for plastic packaging will double in the next 20 years, in addition to increased demand from consumers to reduce plastic packaging, there have been more efforts made in recent years to redouble sustainability efforts. For the medical industry, where product integrity and consumer safety are paramount, reducing the overall environmental impact of plastic packaging, all while ensuring that strict legislative requirements are met, will require no small amount of innovation from packaging machinery providers.

STRICT LEGISLATION Though contamination remains a concern regardless of industry, ensuring a contaminant-free packaging process and hygienic hermetic seal, to keep medicines safe, is especially important in the medical sector. For this reason,

strict regulations exist to ensure product safety is always prioritised. When choosing a packaging machinery provider, it is important to check that any machinery can meet the regulations required. The main standard for packaging equipment in the medical sector is ISO 11607, which governs packaging requirements for terminally sterilised medical devices, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility until the point of use. As well as ISO 11607, further legislation has been introduced to tighten product safety throughout the entire supply chain. The new Falsified Medicines Directive (FMD), introduced by the European Union in February 2019, is designed to improve product protection and preserve the tough sterilisation conditions in the healthcare sector. For

packaging, the FMD establishes two mandatory safety demands on packs of medical products. This includes a unique identifier barcode to ensure full traceability, and tamper-evident features so patients have peace of mind that their medicines have not been interfered with. Indeed, many medical products manufacturers actually go beyond even the heightened scrutiny specified in current legislation to provide quality control assurance, achieving compliance with regulations such as Part 11 of Title 21 of the Code of Federal Regulations, otherwise known as Title 21 CFR Part 11, or Part 11 for short. Though part of the USAâ&#x20AC;&#x2122;s Food and Drug Administration (FDA) regulations, a number of UK organisations have implemented practices set down in Part 11. Its criteria look to ensure electronic

Packaging

Even when using materials like film and plastics, there are ways to reduce waste when sustainable materials can’t be used

or Tyvek® flash spun high-density polyethylene; porous materials, gas and steam can pass through for sterilisation purposes. Certain substrates of this paper can be recycled and, in the case of Tyvek, discarded packaging can be absorbed back into the broader circular economy to minimise waste. These materials can then be repurposed into construction, protective garments, graphics, tags and labels, or even back into medical packaging again.

records in the healthcare, biotech and biologic fields can be considered as trustworthy as equivalent paper records. Put into practice, this translates into implementing controls such as audits, system validations, audit trails, electronic signatures and the documentation for software and systems involved in processing electronic data. KNOWING THE RISKS The risks of contamination in medical packaging cannot be overstated, as it can impair the packaging process, and any adverse effects could lead to potential fines, reputational damage, and, most seriously, jeopardise consumer health. Only by choosing a reputable packaging machinery provider can any healthcare product be trusted once it leaves the factory floor. With the right packaging machinery equipment design however, medical products can meet the discerning standards required and even be sustainable too. PACKAGING SOLUTIONS A number of packaging solution providers can and have taken steps to improve sustainability in the medical packaging industry. For example, ULMA Packaging UK has traysealing and thermoforming packaging machinery solutions that can be used with medical-grade paper

Further avenues for improving sustainability include using thinner gauge materials in rigid medical packs, such as pre-formed trays in traysealing applications. Certain thermoforming packaging methods like positive forming can also allow medical device manufacturers to save on material. This is because in contrast to traditional negative forming, where the packaging shape is formed by a vacuum under the mould sheet, the formed cavity achieved by positive forming is more robust. As a result, it is possible to securely package certain items on a case-by-case basis using less materials. FINDING EFFICIENCIES Even when using materials like film and plastics, there are ways to reduce waste when sustainable materials can’t be used. It can make a great difference given that even a small amount of lost raw material over time can become a significant amount of waste in the long run. This situation is compounded when the logistics and costs of waste removal are factored in too. ULMA Packaging UK’s thermoforming solutions are also compatible with reduced scrap solutions developed by Sealed Air, which can help manufacturers markedly reduce material waste and disposal costs. These machines use a narrower reel of film than standard, allowing for pronounced waste reduction, and, when combined with machine automation capabilities, enhanced

productivity. Furthermore, because of the design of thermoformer machinery, a finished package arrives fully-formed having been created on-demand from a roll of stock materials. As a result, manufacturers opting for such a solution can make efficiency gains and cost savings while improving the sustainability of their operations. By offering a one-stop packaging solution, with no further transportation of products to the manufacturing facility required, companies like ULMA Packaging UK can help manufacturers avoid the logistical challenges associated with transporting materials, reducing overall carbon footprint. Situating all packaging processes in one place gives these manufacturers the chance to use lighter gauge materials, providing excellent product protection alongside further material savings. In conclusion, reducing materials waste and creating more sustainable medical packaging is now more pressing than ever. The ‘Blue Planet’ effect has rightly put packaging under the spotlight, and medical manufacturers installing new packaging lines will need to be mindful of the potential for future sustainability measures on packaging. Indeed, with consumers attitudes shifting and the packaging industry accounting for 40% of plastic processed every year, it is clear that, if possible, sustainable solutions that minimise waste should be implemented.

The ‘Blue Planet’ effect has rightly put packaging under the spotlight, and medical manufacturers installing new packaging lines need to be mindful of sustainability measures in packaging

DRUG DELIVERY

LU RAHMAN SPEAKS TO OWEN MUMFORD ABOUT THE FINDINGS OF ITS RECENT REPORT SCOPING THE NEAR-TERM COMPETITIVE BIOSIMILARS MARKET IN THE USA AND EUROPE, AND ITS IMPACT ON DRUG DELIVERY DEVICE DESIGN

Biosimilars and drug delivery: where are the opportunities?

he available market for biosimilar manufacturers seeking to compete with original reference biologics coming off patent between late 2018 and 2023 in the USA and Europe, is considerable. However, says Owen Mumford, even where clinicians encourage the use of biosimilars for the patient, there remain some key considerations to overcome. This includes clinical confidence in the biosimilar; competitive pricing of drugs through greater competition; and patient confidence in the drug delivery device. Owen Mumford’s study reveals the size of the nearterm opportunity in competitive biosimilars markets for biologics coming off patent 2018-2023, and offers evidence that device design is a key differentiator in addressing patient adoption. In Europe, the estimated market opportunity for this five year cohort of patent expiries (factoring in competitive discounts and based on 50% market share) for biosimilar manufacturers is $3.12 billion per year based on current revenues; the equivalent market opportunity in the USA comes to $5.24 billion per year. To maximise on this opportunity, biosimilar manufacturers need to think seriously about drug delivery. Molecular size and viscosity create issues around the volume of drug being delivered, as well as potentially causing pain upon administration. We are seeing an increase in self-administration across the globe. As a result, precision dosing, ease of use, comfort, and convenience – all reliant on drug delivery device design – have become key in ensuring patient adherence. Familiarity and comfort with a particular delivery device also has to be taken into account as it can hinder switching from treatment despite the advice of healthcare professionals.

George I’ons, head of product strategy and insights, Owen Mumford Pharmaceutical Services says: “This latest paper highlights some important issues concerning the key role of design for ‘combination products’ where delivery device and drug are seen as single entity by regulators. This highlights the supporting role of device design in ensuring that drugs, especially newly booming biosimilars, enter the market competitively.” LR: Why is device design for biosimilars so important in relation to patient adoption and what are the main considerations in drug delivery design for biosimilars compared with other drugs? GI: The device component is increasingly seen as integral to the therapy as a whole with biologics rather than a secondary consideration, especially since the design of the delivery device may have an impact on patient adherence. Testament to this is the position the FDA has taken by creating a specific category for approval of combination products i.e. the device and drug. Biologics and biosimilars present specific challenges with respect to formulation development due to the nature of the molecular structure as these types of treatments are typically administered subcutaneously. Typical considerations are the trade-offs between medication volume, viscosity and injection frequency, and delivery time. Higher viscosity formulations may allow less frequent dosing for the patient but increase the complexity of device design. Higher volume injections may mean looking at different options in prefilled syringe and autoinjector design or even considering wearables as alternatives. Injection time, ease

of use, lack of pain and needle protection are all key drivers for increased patient acceptance. It is now widely accepted that the design of a drug delivery device – typically an auto-injector or prefilled syringe device – is a crucial consideration. When switching to a new biosimilar, patients may experience difficulties if they are using a different device that is too unfamiliar. On the other hand, improvements in design and ease of use may be a persuasive factor. LR: How can drug delivery designers and manufacturers seize upon the opportunities available in this market? GI: A key element in device design is a thorough and robust human factors (HF) program. The HF process will test user acceptance of a new device and importantly determine the level of risk associated with each step in its use. Results from formative HF studies can provide key insights as to how device design can be modified to create more usercentric product features. Also important for device manufacturers is the ability to be able to offer flexibility in design so that different sizes and configurations of primary containers can be accommodated to allow for varying drug volumes and viscosities. With low volumes typical of biologics the device also needs to ensure that the full dose is delivered to the patient and that the residual volume in the device is as low as possible. Another key consideration is the requirement to ensure that device designs comply with sharps injury prevention regulations and incorporate safety features that prevent needlestick injury and reuse. With many pharma companies creating different doses and formulations of the same molecule, as part of lifecycle management, the ability

DRUG DELIVERY

to have a platform device that can be used for all these variations with minimal design changes is a key factor. LR: Is it important for device companies to collaborate with drug manufacturers and how easy is this process? GI: The collaboration between pharma and device manufacturers is essential to developing and bringing a successful combination product to market. This relationship is key throughout the drug development process with horizon scanning for devices often taking place well before initiation of clinical studies. Most large pharma companies employ dedicated device teams who work closely with other internal departments such as formulation chemistry, clinical, sales and marketing as well as creating a close working relationship with the device suppliers. Smaller pharma companies without device teams often need additional technical support and guidance throughout the process so good collaboration - whether large or small - is central to a smooth launch.

dominate the pre-filled market, with three in every four devices offering safety mechanisms. If we look at the market data for safety syringes specifically, an analysis of a range of key research sources reveals that the global pre-filled syringes market was estimated to be worth over $772 million in 2018, rising to some $1.137 billion in 2023: this amounts to a significant growth rate of 8.1%. LR: Are there any differences between the US and UK markets? GI: Approval of biosimilars is far more progressed in Europe compared with the US with over 60 approved by the European Medicines Agency to date compared to 25 approved in the US by the FDA. Both US and EU markets have well established regulations in place concerning the requirement for employers to provide safety devices designed to prevent needlestick injury. These regulations

apply to the employees regardless of the place of work and so cover acute and home settings. The US FDA has a specific combination product approval process for drug and device combinations. This has yet to be established in Europe and as such in this market the device still requires a CE mark for approval; however the process will change with the introduction of the Medical Device Regulation (Regulation (EU) 2017/745) in May 2020. For Europe the drug is also regulated separately and a marketing authorisation application (MAA) is reviewed and granted by the European Medicines Agency.

LR: You highlight selfadministration devices - how important is this market and what are the future opportunities? GI: Weâ&#x20AC;&#x2122;re seeing selfadministration become increasingly important across the world. There are many drivers of this trend: in particular, selfadministration helps to ease the burden on hospitals and makes treatment more convenient for patients. This is creating opportunities for manufacturers to favour the production of devices which prioritise ease of use and safety features. There is a growing demand for pre-filled syringes while safetyengineered devices can be seen to

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Coatings

It’s a wrap VENESIA HURTUBISE, MICROCARE MEDICAL, OUTLINES TEN THINGS TO CONSIDER WHEN CHOOSING A MEDICAL DEVICE COATING

hen disposable medical equipment manufacturers design precision mechanical devices, friction between moving parts can be difficult to manage. Engineers typically use medical grade lubricants or coatings including oils, greases or dry powders to smooth the delicate movements of parts. The coatings reduce the friction and sticking of parts that slide, shear, twist, rock or pivot. They resolve the ‘stiction’ problems commonly found in disposable medical devices such as catheters, cutting tools, staplers, hypo tubes and other ‘surface to surface’ assemblies. Lubricating coatings can reduce the coefficient of friction on treated parts to as low as 0.06. This typically translates into a 25-30% reduction in actuation forces, greatly improving the part performance. Many of today’s complex medical devices would not be commercially viable without the aid of a lubricating coating. In addition, lubricating coatings are also used on the manufacturing equipment and assembly fixtures themselves to help speed the

Wafer cleanroom: A non-migrating lubricant coating is essential in a clean room environment.

production of plastic and metal components. They are used on chains and pulleys, metal extrusions, machine window guides and door tracks, chutes and slides, conveyors and almost any other surface or assembly that requires a clean, durable, slick coating for optimum performance. Lubricating coatings are also used to release plastic parts from their injection mould die cavities. However, not all coatings are the same. Here are some key factors to consider when choosing a lubricating coating for medical device assembly. Good solubility and low viscosity: Lubricating coatings are typically applied via dipping, spraying or wiping. The carrier fluid, or fluid used to disperse the coating, should be engineered to either dissolve or disperse the coating so that when the carrier fluid evaporates, it leaves a very thin, uniform layer on the surface of the treated part. It should also have low viscosity to wet and conform to the treated parts’ surface geometry, ensuring highlyconsistent surface coating. Hostile to bioburden: Device makers should choose a lubricating coating with a non-aqueous carrier fluid to prevent bacterial growth and other biologic contamination. In addition to being pyrogenicallyinert, it should be compatible with all commercially used EtO (Ethylene Oxide) and radiation sterilization processes. Nonflammable: The lubricating coating should be nonflammable to reduce the risk of fire as it is applied. This is especially important for high-volume, highspeed production facilities. Many mechanical assembly operations are prone to static discharge, so nonflammability for safety in both storage and use is essential. Good materials compatibility: Lubricating coatings should have excellent materials compatibility. They should be safe to use on materials including metal, glass, plastic and ceramic parts.

Easy to apply: The lubricating coating should be easy enough to apply during the in-house assembly process. By not outsourcing the coating process, device manufacturers save both time and money by validating a process where they always maintain custody of parts being treated. Fast drying and low odour: Device manufacturers should look for a coating with a carrier that evaporates quickly, has a low odour and leaves no residue (other than the coating being deposited on the substrate). Durable and attractive: A good coating dries into a finish that will last the service life of the device. It should maintain a uniform finish without any staining or unsightly clumps, drips or runs. Non-migrating: The coating should not migrate or transfer to the packaging or other untreated surfaces. The lubricating coating should stay where it is applied. This feature is an essential attribute when the coating is applied in a cleanroom environment. Safe for workers and the environment: Device makers should choose a lubricating coating with a higher worker exposure limit. Eg, one with an 8-hour time weighted average of 200ppm or more. Medical grade: Ensure the coating is ISO 10993 tested and certified as medical-grade. It should also be cleanroom compatible. This helps ensure a faster and easier validation process for both the coating and the associated device. Conclusion: There are many lubricating coatings available to disposable medical device makers. When specifying a coating, manufacturers should look for a supplier that can provide expert advice to help them simplify the selection process. This includes individualised consulting, in-lab testing, and the ability to provide both off-the-shelf and customized formulations to ensure the right coating for their specific needs.

COATINGS

Wearing it well MPN EDITOR LAURA HUGHES SAT DOWN WITH ARJUN LUTHRA, BIOINTERACTIONS, TO LEARN MORE ABOUT THE COMPANY’S NEW ANTIMICROBIAL WHICH DOESN’T RELEASE TOXINS INTO THE BODY.

H: Please tell me about your organisation, BioInteractions. AL: BioInteractions innovates high-performance, biocompatible coating technologies for the medical device industry. We have spent over 25 years in the industry tackling the variety of biocompatible challenges seen by medical device manufacturers. Our range of products aims to provide innovative and effective solutions to improve antithrombogenicity, device related infections and tissue damage at the device-body interface. We have also improved our ability to support our customers’ developments through our Commitment to Care (C2C) services. We are able to provide an optimised coating process for a specific device, in-house testing procedures and to provide supporting data and experience with regulatory submissions. We believe the pairing of our innovative coating technology with our C2C services is the complete coating service for our customers. LH: Which materials are you able to coat? AL: Our technology works on a wide range of substrates and we have multiple techniques to improve the interaction between the substrate and the coating. Our application techniques enable us to coat a wider range of materials in order to ensure a consistent coating applied to the device to give longterm efficacy on the device. LH: You have developed a new antimicrobial which doesn’t release toxins into

the body. How does this coating work? AL: AvertPlus Antimicrobial is a non-leaching coating that eliminates bacteria and helps to reduce biofilm formation. The coating targets a broad spectrum of bacteria, without harming the patient’s cells. The coating works by using a combination of components to provide a contact-kill mechanism. This multi-faceted approach significantly reduces the ability of bacteria to remain on the surface and colonise. This gives the coating significant advantages over alternatives for tackling device related infections. LH: Can you tell me more about the antithrombogenic coating you have developed which is able to mimic the endothelial layer? AL: The Astute Antithrombogenic Coating is a non-leaching coating that actively improves the haemocompatibility of a device by mimicking the natural endothelial layer. Astute enables a device to perform its intended function by preventing formation of a thrombus and reduces the risks of further complications from occurring in a patient. Astute Antithrombogenic coating uses a multi-faceted approach to prevent thrombus formation and helps the device maintain its position for therapy. The coating interrupts the blood cascade mechanism as well as prevents blood components from interacting and depositing onto the surface. This innovative approach provides superior haemocompatibility to the surface and reduces significant risks of the device to improve the patient’s well-being. LH: What do you think are the main challenges when developing coatings for manufacturers? AL: Our customers face a variety of challenges whilst they are

‘The coating targets a broad spectrum of bacteria, without harming the patient’s cells,’ says Arjun Luthra, BioInteractions

developing their final product for the market. A significant change in the industry has come from the regulatory changes, such as MDR. This has had a significant impact on the way devices are being regulated and has impacted the pathways certain devices are able to take. BioInteractions have followed these changes closely and are able to assist our customers with their regulatory submission. LH: In the next five years, what are the key changes you predict within the coatings sector? AL: The medical device regulations have been through significant changes recently. Therefore, the technologies will follow suit and have to catch up with these new regulations. This will take a significant amount of time but will also help to improve the overall quality of innovations and medical devices available. In addition to this, there is a clear intent to introduce computer software and systems into more therapies. This will certainly change the way we are able to provide the therapies and the amount of data we are able to receive. This will in turn improve the therapies available to patients. BioInteractions are committed to innovating and maintaining the highest standards for our customers in order to help provide innovative and effective medical devices for patients.

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Manufacturing technology

Part of the process INDUSTRY 4.0 AND AUTOMATION & ROBOTICS HAVE GROWN IN IMPORTANCE IN TODAYâ&#x20AC;&#x2122;S MANUFACTURING LANDSCAPE. WHAT ROLE DO THESE TECHNOLOGIES HAVE IN IMPROVING PROCESS EFFICIENCY AND CAPACITY?

hris Parsons, Critical Manufacturing, explains how manufacturing execution systems (MES) can improve process capacity The latest, future-ready MES, based around Industry 4.0 technology, is set to help medical device manufacturers increase production efficiency, enhance quality, facilitate compliance and meet demands for medical devices. New technologies and advances in medical care are changing the medical device market, creating opportunities for manufacturers but also presenting them with challenges. Increasingly sophisticated devices; small batch, high-mix orders, and demands for improved quality all sit alongside pricing pressures and the need for competitive edge. The Industry 4.0 (I4.0) manufacturing model offers a way for businesses to meet these demands, increase production efficiency and improve process capacity. The backbone of this model and pathway to a smart factory is a modern manufacturing execution system (MES) that can error-proof and future-proof medical device manufacturers against quality issues, regulatory pressure and constant change. I4.0 adds intelligence to materials, products and machines. Rather than travelling linearly through a production line, waiting for any bottlenecks to clear, smart materials and products can negotiate the most efficient route to get the services they need. This minimizes the impact of machine maintenance, calibration or breakdown, as the product takes an alternative, more efficient route without operator intervention. A new breed of MES is the backbone of the I4.0 production model. It brings visibility and control across the shopfloor

and into the wider supply chain. To handle the distributed intelligence within a smart factory, this new MES is based on decentralised logic and can handle vast quantities of data. It also integrates wider production and logistic processes, enforcing procedures to ensure compliance with industry standards and company procedures. It can check that machinery is certified and calibrated, that operators have the correct certification, and that processes are operating within acceptable control tolerances. Any deviation can be raised in realtime and actioned. This adds to efficiency, lowers costs and helps reduce errors. A modern MES should also measure and help improve overall equipment efficiency (OEE) and yield, reduce cycle-time and increase delivery fulfilment. It contains complete and accurate data about the entire production process and so inherently provides a complete electronic device history record (eDHR). Having this integral record will reduce the time and pain of audit processes as well as reducing the risk of regulatory violations. This can free resources that would normally be dealing with exceptions or prolonged audit processes, to concentrate on innovation both in terms of product and process enhancements â&#x20AC;&#x201C; further adding to levels of efficiency and competitive advantage. GETTING PERSONAL Having a smart shop floor whereby products find the most efficient route through production not only increases production efficiency and capacity, but also offers a way to easily produce small batch or personalized products. Traditionally such orders would need considerable manual input. Adding

intelligence to the products, however, means they can navigate their way through the services they require without operator intervention. This significantly reduces production cost and shortens delivery timescales. Controlled by the automated process is also less prone to human errors and, once again, higher levels of quality, efficiency and consistency can be expected. THE POWER OF DIGITALISATION The Industrial Internet of Things (IIoT) and I4.0 technologies have revolutionised the ways in which real-time data can be used to optimise production. If the MES offers a completely integrated digital twin, new possibilities are created whereby augmented reality (AR) scenarios can be used to further increase operational efficiency. AR arms operators and technicians with a clear and comprehensive picture of everything they need to complete required tasks or resolve issues efficiently. Having this information immediately available reduces the potential for errors, particularly in setup and maintenance operations. Even the most complex tasks, such as assembly operations can be completed quickly and confidently with the guidance of native, realtime AR within the MES. With a new era in medical device production comes the dawn of a new type of MES. These systems take plant monitoring, control, guidance and optimization to new levels. Their intelligence and ability to analyze vast quantities of real-time data mean they can respond quickly to dynamic changes on the shop floor and help optimise the use of materials, machines and human resources to improve overall process capacity.

Manufacturing technology

Irish automation in the spotlight

utomation and robotics are a key part of many manufacturing processes. This type of technology is growing in popularity in the medtech sector with many companies looking to take advantage of the process benefits it creates. According to IDA Ireland, eight of the top 10 industrial automation companies have operations in Ireland, including Siemens, ABB, and Emerson. Modular Automation supplies automation solutions for medtech multinationals. At the end of last year it announced plans to create 100 new jobs by 2023, supported by Enterprise Ireland. The company also plans to expand its facility in Shannon, Co. Clare with the acquisition of land for development and ready-to-go production space to support immediate capacity requirements. Modular Automation is dedicated to the medtech manufacturing sector and has over 25 years’ experience in this highly regulated space. The company believes that the

expansion and job growth supports a growing demand for advanced automation solutions for the global medtech sector. The company is well regarded by its customer base including Johnson and Johnson, Stryker and Boston Scientific. Ireland is the second-largest exporter of medical devices in Europe and nine of the 10 worlds’ top medtech companies are based there which means Modular is perfectly placed to serve their automation needs. “Our team has doubled in the past five years to over 170 employees and due to growing demand, we now plan to create another 100 jobs over the next 3 years. We are also investing to substantially expand our facility to give us the capacity to deliver more for our customers both at home and across the US,” said Vivian Farrell, CEO, Modular Automation. Modular has also opened a subsidiary in Jacksonville, Florida, allowing the company to expand its reach in North America and be located closer to its customers. “This investment enables us to grow our technology and innovation programs focused

around the development and implementation of advanced automation technologies. These are key enablers for our medtech customers to advance their manufacturing processes and systems,”commented Shane Cooke, engineering director. The expansion will also include an Innovation Lab to demonstrate and develop the latest automation technologies which will facilitate their new and existing customers to remain competitive. Stephen Creaner, executive director, Enterprise Ireland said: “ Enterprise Ireland has worked closely with Modular Automation, both in Ireland and internationally since its establishment. It is a great example of an Irish company, headquartered in Shannon with a clear global ambition that is building its scale and expanding its reach internationally and growing its base of new highquality jobs in Ireland. Through its commitment and investment in innovation, the company has successfully positioned itself to be a global leader in automation solutions for the growing medtech sector.”

Got your back

AN BOLLAND SPEAKS TO CHONGSU LEE, FOUNDER AND CEO OF EDINBURGHBASED START-UP PACLA, WHICH HAS DEVELOPED BACK HUG, A PRODUCT THAT AIMS TO IMPROVE THE WELLBEING OF PEOPLE IN THE WORKPLACE

In practise After working as an engineer for Hyundai in Seoul, Lee’s interest in the human body saw him move to Edinburgh to study physiotherapy in 2006. Following his studies, he set up a clinic in the Scottish capital and developed his own technique to treat back pain – ultimately developing Back Hug. Explaining the tri-component nature of the product, Lee said: “When people lie down on their back, 24 robotic fingers stimulate the centre of the back. The back of the device comprises motors, plastic, metal, electronics such as PCB’s as well as some upholstery.” Accompanying that is a private cubicle so people are treated in private. Their treatments can be selected via the Back Hug app on a smartphone. The plan is for users to be treated away from their desks, as Lee states that any treatment while sat up working at a desk is counterintuitive. “One of the key principles in Back Hug is people see a lot more benefits when they lie down and then get a proper treatment in the centre of the back. All of the stress and the tension building around the neck and the back is a lot to do with continuous and persistent sitting.”

How the device works relates to the business model being operated with Back Hug. Currently a cubicle is being installed in offices which have at least 100 employees on site free of charge – with Lee citing government buildings as organisations undertaking the practice. It is installed free of charge and after a user has had a complimentary session, they are then charged via sessions booked on their smartphone. “Rather than asking people to come to a particular clinic or places we install devices where they work – either in GP practices or offices, even in public spaces. So, there is great accessibility. One of the persistent issues people have is cost. The resources are either

All of the stress and tension building around the neck and back is a lot to do with sitting 48

too expensive, or in the NHS the resources are not really available, they are quite scarce. “Most of the public bodies’ offices we’ve approached, they encourage their staff and visitors to use so that they become back pain free and encourage their productivity.” As far as where Lee would like to see Back Hug adopted, he feels there is scope for them to be adopted in GP practices – making it easier for patients rather than referring them to a specialist clinic to receive treatment. “One of the areas we’re really keen to explore is GP practices. GPs see people with aches and pains and even stress. There are probably lots of people who would be able to benefit from back hug because it is very accessible and affordable. If Back Hug can be available for GPs with free installation and they can refer the people to use Back Hug.”

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