MTI Issue 43 by Med-Tech Innovation Magazine

www.med-technews.com Issue 43 | July/Aug 2019

@medtechonline

PLUS

AC/DC: a look at batteries and power for medical devices

MED-TECH INNOVATION | NEWS MED-TECH

innovation

TO STARTING A STARTUP

MEDICAL DESIGN & MANUFACTURING INSIGHT

MEDICAL DESIGN & MANUFACTURING SERVICES With strong customization capability and experience in medical grade systems, Medical DMS not only deliver qualiied medical computing products to our customers but also act as the strategic & innovative partner for medical customers

Unique Competencies

Why Us?

1. 2. 3. 4. 5. 6.

35 years experience in industrial & medical computing Your partner from beginning to end Long term support (3-5+ year life cycle) Time to Market, Value Engineering Cost Down Capability Own production in Asian and European assembling facilities with ISO 13485:3003 certiication Manufacturing risk control back up plan

Time to Market Longevity Support Customization version Control (Bios, EE, ME) Value Engineering (Cost Down Capability) Manufacturing Risk Control / Back up Plan Extensive Services (Thermal Simulation, Global Logistics, iManager/SUSIAccess)

Sales.AUK@advantech-uk.com | ď&#x201A;&#x2DC; 08704 931 433

YOU DREAM, WE CREATE

CONTENTS regulars 6.

Regional news The latest from Health Enterprise East and Medilink UK

opinion Why tech is still not reaching patients

14.

ON THE COVER What is a cofoundery? And is it right for you?

31.

Digital Health Age

Applying nudge theory to medtech

34.

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

features

MED-TECH

12.

INNOVATION | NEWS

AC/DC

The next generation of medical power solutions

17.

finger on the pulse

Using pulsed lasers for medical device joining

22.

NANOTECH

University scoops major funding for medical research

24.

QA & QC

How MDR will affect your quality management

27.

Innovation

A one-stop-doc-shop

28.

HOLE IN ONE

Med In Ireland returns to Dublin

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

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

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

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

web content editor | ian bolland ian.bolland@rapidnews.com

head of studio & production | sam hamlyn

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

designer | matt clarke junior designer | ellie gaskell publisher | duncan wood

Rapid Medtech Communications Ltd. Carlton House, Sandpiper Way, Chester Business Park, Chester, CH4 9QE MTI PRINT SUBSCRIPTION – QUALIFYING CRITERIA UK & Ireland – Free Europe – £249 ROW – £249

FREE on iOS and Android devices Subscription enquiries to subscriptions@rapidnews.com

The Publisher endeavours to collect and include complete and current information in Med-Tech Innovation, but does not warrant that any or all such information is complete, correct or current. The Publisher does not assume and hereby disclaims any liability to any person or entity for any loss or damage caused by errors or omissions of any kind, whether resulting from negligence accident or any other cause.

All submissions are handled with care. Every precaution is taken to ensure accuracy, but the Publisher cannot accept responsibility for the accuracy of the information here. ©Rapid Medtech Communications Ltd. No part may be reproduced or transmitted in any form without the prior permission of the Publisher. ISSN 2046-5424

Med-Tech Innovation does not verify any claims or other information appearing in the advertisements contained in the publication and cannot take any responsibility for any losses or other damages incurred by readers in reliance on such content.

from The editor Can medtech save the economy if we exit with no deal?

[ ’m a little reluctant to write this editor’s note. It’s all about Brexit, which I thought was timely, as I’m writing it on the day that Boris Johnson has become Prime Minister. As I type, he’s meeting the Queen at Buckingham Palace. The trouble is, by the time this magazine hits your desk in a couple of weeks, who know’s what will be happening with Brexit. For all I know the whole thing might have been called off (though it’s unlikely), or the UK could be barrelling towards a general election (that seems possible), or it could even be a confirmed no deal (please, no). Anyway, what I’m saying is, I’m sorry if this material is redundant by the time it reaches you. I can’t think of any industry that would welcome the uncertainty of leaving without a deal – excepting perhaps the national press. Whatever your political leanings, Boris has presented himself as a game changer for the current crisis facing British firms, and my guess is you can count on him to live up to that reputation. Whether the game changes for better or worse remains to be seen.

Assume for a moment the least palatable option (at least for industry) comes to pass, and the UK crashes out at Halloween with the current contingency plan. At the end of June, the government issued an update to its nodeal planning, to include an ‘express freight service’ to ensure that, from day one, there is no disruption to supply. In addition, regulatory requirements have been clarified to try and reassure manufacturers on both side of the channel. Indeed, in a letter to manufacturers, the government says it will advise local health authorities to avoid excessive stockpiling where possible, playing down the natural concerns over the supply chain. So, preparation is at least under way. But these are only short-term band-aids. And it also seems to me that the government’s attempts to work with UK manufacturers through the Brexit puzzle is more than a little one-sided. I can’t see much being done out there to reassure UK medtech firms currently supplying into Europe in the event of a no-deal Brexit. On a more optimistic note, one of our contributors, Dr Mahiben Maruthappu,

co-founder of the NHS Innovation Accelerator, believes the medtech sector could in fact prop up the UK’s economy post-Brexit. His vision involves the UK, through its current dedication to exponential technologies, becoming a powerhouse in healthcare, rivalling Silicon Valley. He points out too that the NHS has unparalleled health data going back 70 years. He makes a convincing argument for the UK as the destination of choice for tech firms and inward investment after Brexit (you can read his column at med-technews. com). But the sector can only give this kind of productivity in the long run if it can be assured of some degree of stability and protection in the short- to mid-term. How is a no-deal Brexit going to affect you? Email me at david.gray@ rapidnews.com.

SELECTION

REVOLUTIONARY UNIQUE

THREE COMPONENTS

GRANDMASTER NEXT GENERATION

CUSTOMISED ADDITIVE WORLD CLASS AUTOMATION

Flexibility in additive manufacturing! This is what our open freeformer system offers. We have now gone one better – with our new freeformer 300-3X. Like its little brother, it does everything a freeformer needs to be able to do. And even more: larger build chamber, three discharge units – now also for complex yet robust hard/ soft combinations. Once again: unique in the industry! www.arburg.co.uk

NEWS AND VIEWS FROM HEALTH ENTERPRISE EAST

regional news

HLOE MOSS, ANALYST AT HEALTH ENTERPRISE EAST, OFFERS HER ADVICE ON TRANSITIONING ACADEMIC RESEARCH INTO INNOVATION.

NOTES FROM THE EAST BACK TO SCHOOL The NHS is crying out for innovation: Matt Hancock has rarely missed an opportunity to highlight the ever-growing demand for advances in medical technology, and this need for innovation in healthcare is also referenced in the NHS Long-Term Plan. Thankfully, in the UK we have world-class researchers working on some of the latest technology innovations to help improve and transform the NHS. Unfortunately, too many of these potentially transformative ideas wither on the vine, as innovators fall at the one of the many hurdles in translating a medtech solution from bench to bedside. THINK LIKE A BUSINESS, NOT AN ACADEMIC Adopting a business mindset that hones in on the true value a new product is critical to large-scale adoption. This means innovators going beyond simply highlighting the technical advances offered by their new product, and instead providing data on the wider commercial value of that technology, such as the size of the market, the costbenefit of the solution as well as any hidden costs (e.g. will staff need to be re-trained before using a new medtech device? Are there storage and maintenance considerations?). This approach will ensure academics are well-placed to make a commercial case for adoption to NHS procurement teams. Moreover, healthcare systems increasingly insist on health economics data to evidence an innovation’s clinical effectiveness and associated cost-savings. Undertaking a careful assessment of economic factors during early-stage development, will help inform both innovators and future

customers what the potential impact of the product is, based on empirical data and statistics. TAPPING INTO INDUSTRY EXPERTISE Academics can be reluctant to engage with industry about their innovations, with many concerned that they could lose control over their projects. This is a common misconception. The reality is that early engagement with ‘industry’ – which includes a wide range of private companies not limited to just pharmaceutical companies but also the regional and national innovation hubs and not-for-profit agencies, specifically designed to support innovators. These sorts of industrial partners can be extremely helpful not only when developing a clear commercial strategy and business plan, but also when seeking new funding channels. Dialogue with industry could also help secure early buy-in from industry champions and provide insights from experts on navigating often complex regulatory requirements. SECURING FUNDING Going it alone, when it comes to funding, can be tricky. There are a wide range of publicly funded grants available, but it can be difficult to work out which funding source is most appropriate. Many funding schemes, including the Medical Research Council (MRC), are increasingly placing emphasis on translational research, including funding streams which fund drug discovery clinical trials. Government-funded initiatives are also accelerating innovation by funding and facilitating cross-disciplinary development. The National Institute for Health Research (NIHR), for example, has substantial funding from the

government’s Department of Health and Social Care, and alongside the Academic Health Science Network (AHSN), has access to funds to help innovators develop their technologies to help improve NHS services outside of the traditional hospital environment. HOW TO FIND THE PERFECT PARTNER If you are working an in university, an excellent first port of call is the University Technology Transfer Office (TTO). TTOs are designed to facilitate scientific translation and advise on intellectual property and spin-out options. If you are a clinician then there are research teams, commercial advisors and experts within most hospital trusts. Similarly, consultancies such as Health Enterprise East work with and alongside countless clinicians and academics to develop their innovations into a tangible medtech solution. Another useful route is via the Academic Health Science Network (AHSNs), which specialises in bridging the gap between academics, clinicians and industry. AHSNs can help signpost innovators towards the most appropriate industry leads for the project and offer guidance on funding sources. FROM ACADEMIA TO INNOVATION Academic research lies at the forefront of delivering innovation, but without an understanding of the innovation pathway and of the wider resources available, turning medtech ideas into practical solutions can be challenging. The key is to collaborate with the industry, and to start those discussions as early as possible during product development to ensure you can navigate the path to success.

THE LATEST ANNOUNCEMENTS FROM THE MEDILINK UK COMMUNITY

LINKING UP

EAST MIDLANDS INNOVATION DAY RETURNS TO A PACKED ROOM On Thursday, 4 July, over 200 representatives from life science companies - from multinationals to micro-businesses and medtech to pharmaceuticals - came together to celebrate Medilink EM Innovation Day. As well as the wide variety of speakers covering a vast array of topics, there was also an opportunity for Innovation Day delegates to meet with over 30 life science companies who exhibited at the conference. Medilink EM CEO Darren Clark formally launched the Medilink EM Annual Report for 2018/19 and delegates also had the opportunity to attend the Medilink EM Summer Networking, which took place after the day’s events, featuring a talk on the Growing Rehabilitation Industries Project (GRIP). GRIP is a University project between the Universities of Loughborough, Leicester and Nottingham Trent, with Medilink EM supporting the project as a key industry partner, to help develop the Medical Technology and Rehabilitation sectors in Nottingham, Loughborough and Leicester. Speakers at the event included: Professor Chas Bountra OBE, pro-vice chancellor for innovation, University of Oxford; Professor Dan Clark, head of clinical engineering at Nottingham University Hospital NHS Trust; and Laura Boyd, deputy director, NHS Innovation Accelerator.

HEALTH ECONOMICS CONSULTANCY OPENS GLOBAL HQ, INDICATING GROWTH IN UNCERTAIN TIMES BresMed’s new global HQ, at Steel City House in Sheffield, is the heart of the company’s worldwide operation. Commenting on the move CEO Nic Brereton said, “I am so proud to be expanding BresMed to these premium premises in the city. The building very much fits with our brand – it’s iconic with a quirky feel and, like us, it dares to be different.” BresMed supports pharmaceutical companies and medical device manufacturers to identify, evaluate and demonstrate the clinical and economic value of their products to governments and other healthcare payers and providers. In July, employees joined health economics experts and business leaders at the grand opening. PURE DRUG SAFETY NAMED MEDILINK PATRON Pure Drug Safety has been recognised for the contribution it makes to life sciences, by becoming the newest Patron of Medilink East Midlands (EM). Medilink EM Patronage is offered to organisations because of their prominence within the East Midlands and their recognition of the importance of life sciences in the region. Darren Clark, Chief Executive of Medilink East Midlands, said: “I look forward to working with Pure Drug Safety as one of our Patrons. I know that they share our passion for driving life sciences in the region and I believe that they will add a lot of value to Medilink East Midlands’ mission going forward.” Carol Kingstone, Managing Director of Pure Drug Safety, said: “Having worked closely with Medilink East Midlands for a number of years, we’re committed to growth and we understand the value of having a well-placed, wellinformed and effective network.”

HUNTLEIGH HEALTHCARE AWARDED QUEEN’S AWARD FOR INNOVATION Cardiff based-company and MediWales member Huntleigh Healthcare has been awarded a Queen’s Award for Innovation in recognition for its new range of Digital Handheld Dopplers. Peter Cashin, managing director, said of the new product: “Features we have introduced such as the high resolution colour display represent a first for handheld Dopplers. This allows clinicians to clearly see vascular waveforms as well as hear digital audio sounds. In the Fetal Heart Rate (FHR) version the FHR data is displayed in high visibility large numbers and recorded digitally as a waveform for archiving and review.” The Cardiff facility provides a Global Centre of Excellence for a range of Arjo (the group’s parent company) and Huntleigh products. Employing more than 60 engineering staff the centre provides a stable platform for further innovations in the future. Joacim Lindhoff, President & CEO of Arjo said: “We are both honoured and proud of this recognition. This marks a significant achievement for our team in Cardiff and confirms that we are developing innovative products that offer our customers an excellent experience, through both performance, functional benefits and a desirable design.”

Innovative solutions. Engineered to your specific requirements. Realize your vision. Partner with the most innovative team in the industry. MicroLumen.com

Why tech is failing to reach patients Michael Branagan-Harris, CEO, Device Access UK writes.

t has been said that it takes an average of 4.6 years and millions of pounds to get a technology through R&D, regulatory, manufacturing, and clinical research to launch. That’s a very long lead time and thousands of hours of hard work too. The global regulatory approvals landscape has always had its changes and challenges for all countries. But far too many medtech companies believe that compliance is enough to pitch to hospitals and clinicians to get their medtech products paid for and adopted. NICE was originally set up as a filter between the manufacturers of medical devices and the NHS, as a screening process to ensure that devices were safe for patients, effective and value for money. Like most healthcare systems, there exists a very strong directive to look at pricing and cost effectiveness. So why are so many manufacturers using archaic and failed methods to reach a justifiable sales price for a new technology, when it has impacts for patients, providers of care and payers of care? Most device companies work on the same principles that

are used in the world of fastmoving consumer goods, based on the manufacturing cost price plus a healthy margin. Some go to lengths of finding out what they could sell their devices for by conducting interviews with clinicians - but are clinicians really qualified in understanding the value and benefit of a great new technology beyond their part in using or implanting them? And how do they justify the investment up the line to their managers for purchasing? This traditional mechanism of pricing often leads to disappointing results. It can result in adoption failure, as the benefit of a given technology to patients, providers and payers has not been researched and therefore cannot be communicated scientifically. This approach will have an effect on the selling price, which should be optimised for the benefit of the device manufacturer, so the technology reaches the largest, most needy and most appropriate patient cohort. So, is there something to learn here from the pharmaceutical industry? Can you imagine the pharma industry using these interview and guessselling price principles? No. The investment cost of a new

drug taking years to invent, test, manufacture, and get approved needs to be fully justified, and for that they work backwards and understand scientific pricing before they start the process – let alone to get funding and investment to do so. But what is the right approach, and when is the right time to consider value when inventing a new technology? For that, let’s take a look at the most common principles used by the medtech industry. These are often the principles of marketing, a process designed back in the 1960s. Marketing decisions tend to fall into four categories: product, place, price, and promotion. They are referred to as four ‘controllable’ categories. They are ‘controllable’ because manufacturers’ efforts affect them or their outcomes. Policies, rules and regulations on the other hand, are ‘uncontrollable’ categories. Manufacturers’ need to learn to influence them, and understand this as early as possible in the process. It’s not just about regulatory approval, either. Manufacturers must also focus on the value proposition scientifically, and to engage with organisations, like NICE, to assist them in a

national strategy for adoption. In my experience over the last nine years of engaging with hundreds of manufacturers of medical devices, the term ‘market access’ is often used. But what is market access, and what does it mean? For this we describe the ‘four principles of market access’ to help manufacturers think differently, scientifically and strategically to bring great technologies so patients ultimately get them sooner: • • • •

Benefits to patients Benefits to care providers Benefits to payers of care Benefits to the product

BENEFITS TO PATIENTS First and foremost, and quite rightly, new products are focussed on improving patient’s lives and outcomes. Less invasive, less pain, faster recovery and return to normal life with minimal risk to life. This has a far wider cost effect on welfare and if the existing treatment fails, this has an effect on the patient’s life and their dependence on the provider of care. The patient voice around existing therapies and excitement around the new techniques are today very strong due to social media, and form part of the very important feedback required.

Why tech is failing to reach patients BENEFITS TO PROVIDERS OF CARE Many manufacturers here default to the fast-moving consumer goods principles, the most common (and hardly scientific) conversation being “it’s cheaper” and “it’s better”. Other words that now have little effect are “innovative”, which doesn’t really help hospital decision makers. If what they are buying is not going to help deal with the big issues in a hospital, then it’s often easier by default to use the same old existing proven technology with predictable outcomes, which the clinicians are used to. The very worst outcome here is that the conversation between the salesperson selling a new device ends up with a hospital procurement manager becoming the ultimate decision maker. It’s no wonder these conversations often end with downward pricing negotiations, and profit/value erosion, often when the salesperson has failed to demonstrate the value and benefit to the right

people higher up in the hospital organisation. But are the medtech salespeople of today equipped with the science and the knowledge to do so? So, this is where understanding the bigger picture is so valuable. Let’s take the NHS again, where up to 45% of inpatient admissions and 25% of outpatient referrals are now, due to a growing and ageing population, and where demand for elective and cancer treatments is growing year on year. Despite increased funding, patients are being let down by the NHS’ failure to meet deadlines for waiting times. The percentage of patients treated within waiting times standards continues to get worse for both elective (non-urgent care) and cancer treatment. Less than half of NHS hospitals meet the 18-week waiting times standard for elective treatment, and only 38% meet the 62day standard from referral to treatment for cancer patients.

NHS Hospitals now routinely operate with a bed occupancy rate of more than 90%.

care episodes, and funding the treatments and medical technology.

This of course affects elective patient care as patients may have their treatment postponed because beds are needed for emergency admissions, resulting in delays to treatment and poorer patients.

The pharmaceutical industry, particularly in the UK, has had the privilege and benefit of knowing very detailed information on the prescriptive use of drugs and subsequent disease states down to the pharmacy provider, by post code accuracy. This makes it relatively easy for the clinical commissioning group spend and activity.

This all due to bottlenecks in the hospital system, and is precisely the area where technology can help save valuable bed days with less invasive treatments and improving care pathways. But without the sales persons knowledge of what really is happening, and how the technology can help solve the hospital issue around productivity, the default language of “cheaper and innovative” is really not helping. BENEFITS TO PAYERS OF CARE The payers of care hold the money to fund the providers of care – the hospitals for the

This information on usage really helps pharma to have far better value and benefit conversations with the payers. The UK medtech industry often does not even engage with the payers, and if they managed to, they would need to really raise their game in terms of understanding the populations they treat. The ultimate benefit communication should be around getting the right treatment for the right patients, and real justification

for adoption. The payer doesnâ&#x20AC;&#x2122;t like treatments that fail or result in costly unelected emergency readmission. BENEFITS TO THE MANUFACTURER OF PRODUCTS This is where manufacturers can really optimise their sales price and design devices around a more scientific budget and price. Starting with understanding the economics of the patient pathway, the outcomes and benefits for providers of care and payers, they can truly start to understand how to optimise their product price and not use the old 1960s principles of marketing and margin for their technology. For the UK, despite growing needs and demands for the population, NHS England treated 400,000 more elective patients last year, and 362,000 more emergency patients too. So the market and need for

great transformative medical technology is growing globally, the patients are better informed and want it, the providers need it to deliver great care and get paid, and the payers want value for money and better outcomes. If the medtech industry engaged at a higher level as consultative and collaborative problem solvers, instead of being afraid to use organisations like NICE to validate and support their story, products would reach patients faster, providers and payers would benefit, and ultimately the medtech industry would be more sustainable and profitable. Since 2010, Device Access UK has supported over 30 medtech companies through NICE processes and approvals. It holds access to NHS Englandâ&#x20AC;&#x2122;s patient episode database and is able to understand patient care and treatment pathways, outcomes and costs.

ELECTRONICS AND POWER

hane Callanan, director of engineering technology, Advanced Energy Industries, reflects on the evolution of medical device power supplies – and the new requirements shaping their future. According to the New England Society of Medical Engineering, up to 10,000 people per year were electrocuted in American hospitals during the late 1960s and early 1970s as a result of leakage current from defective electronic medical equipment. Defined as the flow of electric current in an unwanted conductive path under normal operating conditions, leakage current is a direct function of the line-to-ground capacitance value. As long as the equipment is grounded, these currents will flow in the ground circuit and present no hazard. If the ground circuit is faulty, however, the current flows through other paths such as the human body. With staggering statistics prompting the healthcare industry to conduct a wide range of studies to examine the risk of ventricular fibrillation by electric shock, researchers eventually determined that as little as three micro amps (0.000003 amps) of voltage applied directly to a portion of the heart during a critical part of the cardiac cycle could cause lethal arrhythmia. It is a small amount, considering a lightning strike – which many

DC people survive – contains a minimum of 5,000,000,000 micro amps (5000 amps). But for patients with compromised health, even the smallest voltage can be fatal. Medical devices, which require a consistent and safe power supply, have some of the tightest leakage current requirements of any industry. And it is understandable, given the high risk involved and a history of tragic outcomes. Up until the 1970s, when the switch mode power supply (SMPS) began gaining popularity, the backbone of power conversion was the linear DC (direct current) power supply, a design requiring a large transformer to raise or lower the AC (alternating current) voltage and produce a clean DC voltage. Because the transformer size is indirectly proportional to the frequency of operation, the power supply is typically large and heavy but best for sensitive analog circuitry. Alternatively, a SMPS not only converts the AC line power directly into a DC voltage without a transformer but also converts raw DC voltage into a higher frequency AC signal that is used in the regulator circuit to produce the desired voltage and current. The result is a transformer that is considerably smaller and lighter than a linear power supply—by as much as 80 percent—and best suited for portable devices. Generating less heat, the SMPS is often more efficient than linear but transient response times can be up to 100 times slower, which presents challenges— and the need for expertise—in manufacturing. Particularly as medical devices increasingly use

sensitive analogue electronics, wireless technologies and microprocessors, it is imperative that during the manufacturing process, power supplies meet customer needs as well as essential standards, including electromagnetic compatibility (EMC) compliance. For example, health professionals performing cosmetic procedures with medical-grade lasers want and need high-power density and reliability incorporated into a portable power supply that has longevity, black box recording capabilities, seamless connectivity and firmware that is easy to upgrade. With the amount of allowable leakage current specified to ensure that direct contact between a patient and any medical equipment is highly unlikely to result in electrical shock, manufacturers must deliver a power supply that not only meets design specification, but also includes appropriate isolation barriers, to minimize leakage current and ensure the safety of both patient and clinician. Even with the challenges of design and compliance ever present, as new equipment can take years to develop and refine before reaching the market, advances in power supplies have enabled remarkable improvements in surgical procedures alone. Common knee replacement surgeries, the first of which were performed in 1968, are one of the most successful medical procedures today. Many well-equipped surgeons are now operating with the help of 3D models, which are fed into the power supply. In the event the surgeon tries to remove too much or too little of the knee in respect to the 3D model, the power

THE ORIGINAL MEDICAL PUSH-PULL CONNECTOR

supply shuts off immediately to avoid any errors. The impact of this new approach has been tremendous, with success rates jumping from approximately 50 percent to 90 percent or higher. Advanced power supplies have also enabled life-saving thermal solutions. Among the many applications utilising heating and cooling therapies, doctors are using helmets with automatic and interval temperature adjustment capabilities designed to prevent brain damage in newborns. Though invisible, energy is ubiquitous in every facet of life and nowhere more critical than the field of healthcare, where research is accelerating, and more advanced devices and equipment are launching to market at a rapid pace. Driven by a gradual shift in focus to patient care and speed of recovery,

the need for more accuracy in terms of treatment requires new diversity in supply, from radio frequency (RF) amplifiers that power ultrasonic equipment to thermal solutions for heating and cooling. While change has been slow and significant progress achieved only in the last ten years, advanced power supplies have undoubtedly provided the medical industry with scalable solutions enabling smaller, more reliable and powerful devices that reduce cost, complexity and human error while heralding a new era in medical innovation.

REDEL SP • 4 to 22 contacts • Patented Push-Pull system • Grey, black or white outershell • Solder, crimp and print contacts • 100% scoop proof

REDEL P • Self-latching plastic connectors • Sterilization • Fibre optic, fluidic, coaxial or high voltage contacts • 2 to 32 contacts

BioCompatic® Cable Visit us on Stand No. 7 Ground Floor Galway Racecourse 25th – 26th Sept 2019

• USP class VI cable • Medical cable • Cable assembly service

LEMO UK LTD Worthing, United Kingdom Phone: +44 (0) 1903 234 543 uksales@lemo.com High and Cables High Quality QualityConnectors Connectors and Cables

facebook.com/lemoconnectors linkedin.com/company/lemo-sa

Contact your local partner on www.lemo.com/contact

start-ups

ifferent from an accelerator and different from an incubator. That’s how Nova sees itself. It works with people who come with a problem and helps them find their solution. Nova co-founds businesses with individuals or groups and works with them as 50-50 partners. Those behind the idea don’t have to provide any capital up front, as is the norm in accelerators or incubators, with Nova allowing people to develop their idea alongside their day job – acting as mentors. Paul Dodd, Nova’s head of marketing, explains: “Until you’ve reached a point where you’ve actually proven that business model, proven that it works within the market and actually got market traction to that point where it’s safe enough to jump across – what we say is that we’ll support you until you get to that stage with our resource.

TO STARTING A STARTUP

“We have investment partners that we work with and we say ‘you can come to us with a great idea, you don’t know how to move it forward or you don’t have the time, skill or gumption to move it forward at this stage, but we can allow you to do that. We will mentor you and bring you to the stage where we put you in front of our investors and when that investment is received that then goes to support our resource of the team here, and essentially we end up as partners in the business.’” Dodd acknowledged the high failure rate of tech startups, with Nova quoting figures for the industry to be around 90%. With Nova, it’s lower at 50% - significantly lower by comparison. In the last financial year, Nova managed to found 36 startups, and this year it’s aiming for 50.

Med-Tech Innovation’s Ian Bolland and Dave Gray went along to Box Studios and Sensor City in Liverpool to meet the people behind Nova – a cofoundery which works with start-ups at the early stage of their development.

This involves a presentation and then an intense cross-examination from investors who provide the capital to fund these ideas. In fact, we were invited to sit in on a pitch. It’s all very Dragon’s Den (sans the dramatic music and weird lighting). While at Nova’s HQ, we met Rebecca Taylor, the MD and founder of Aquarate. Rebecca said she had an interest in medical engineering and did some research surrounding kidney health and hydration. From this, along with Nova, she developed the idea of a hydration monitoring system for the care setting.

start-ups

open to it. I think it’s just about being clever about how we engage with them and making sure there’s not too many meetings, making sure people feel engaged and they’re making a difference with the work they’re doing.” Up to 40 people work across the health startups at Nova – some based at the Box Studios HQ, some offshore, while others work at Sensor City – which builds, engineers and develops some of the ideas that come through Nova. Dr John Kenny, chief engineer at Nova, who previously worked at Sensor City, explained: “It is a relatively new initiative and the whole point of it is that it’s an innovation hub. “Nova not only has the engineers to build those prototypes but has the funding streams, product managers, the start-up consultants, and the business managers. It has the full support of those new businesses and it certainly does put contacts in for mass manufacturing and things like that. It can take a product right from nothing, something coming in with no money, no resources, nothing but a problem.” The facility has 3D printers, protolasers, microscopes which have 5000X magnification, and a virtual reality suite. There are also close relationships with both the University of Liverpool and Liverpool John Moores University – based walking distance from both of the main campus sites.

She met with cofoundery in June 2017 at a Hackathon event run by the Innovation Agency, and has been working with a design house called Design Reality, which has had a role in working on the electronics side of the product. The system is a smart cup and mug that tracks what patients are drinking and provides clinicians data – digitalising the process – but there are ideas to further develop the device. The product itself can also be used in a dishwasher. The product has been tested in the care setting at Liverpool Royal Hospital, Southampton Hospital and Aintree Hospital – with studies taking place on renal, geriatric and cardiac wards. “Clinical staff are desperate for a tool that can stop preventable hydrationrelated illness, so they’ve been pretty

Different from an accelerator and different from an incubator. That’s how Nova sees itself. It works with people who come with a problem and helps them find their solution.

Andy Davidson, Nova’s CEO, said: “I believe we’re at a really fascinating phase of technological adoption across the health industries: one where the real value and possibilities of the successful application of technology are being realised, and the momentum of change is gathering pace. “For a long time, this hasn’t been the case. A lack of support for entrepreneurial people within these industries has made change difficult, frustrating and slow, and contributed to a startup failure rate within the health industry of over 90%. To see the green shoots of change, with some of our founders and their products making a real impact and being adopted in the industry, is really exciting for us.”

Europe at the forefront of global healthcare regulation Driving innovation through convergent approaches in medicines, devices and veterinary regulatory affairs TOPRA – The Association for Professionals in Regulatory Affairs is the professional membership organisation for individuals engaged in regulatory affairs for human and veterinary medicines and for medical devices around the world.

The Medical Devices/IVDs Symposium will include topics such as:

The TOPRA Annual Symposium is the first-choice key event in the European regulatory affairs calendar for anyone working in, or alongside, regulatory professionals. This large annual event brings together the latest developments in the healthcare regulatory sector while providing participants with access to insights directly from regulators, key opinion leaders and innovators.

• Updates on progress and preparation for the MDR and IVDR

• Medical devices used to deliver medicinal products – new regulatory processes from May 2020

• Convergence with HTA - the effects on development and regulatory processes • Disruptive technologies challenges and opportunities

Register now – www.topra.org/mti-mdsym 30 September–2 October 2019 Clayton Hotel, Burlington Road, Dublin, Ireland www.topra.org/mti-mdsym | meetings@topra.org

TOPRA Symposium 2019

DUBLIN

In cooperation with the Health Products Regulatory Authority, Ireland

ANDY TOMS, DIRECTOR AT TLM LASER, DISCUSSES THE BENEFITS THAT PULSED LASERS BRING TO WELDING AND JOINING APPLICATIONS WITHIN MEDICAL DEVICE MANUFACTURING.

WELDING AND JOINING

hen it comes to welding and joining metal components, lasers offer distinct advantages over other more traditional processes such as TIG (tungsten inert gas) or micro TIG welding, however those considering laser technology have yet another choice to make, a decision between a CW (continuous wave) laser or a pulsed laser. Manufacturing processes continue to evolve year on year and as a result, we generally see the introduction of a new technology or process being adopted by forward thinking manufacturing sectors, before the technology becomes mainstream as others realise the benefits it can bring. This scenario is certainly true of the original transition from conventional TIG and Micro TIG welding to that of laser by medical device manufacturers. Laser welding offered a wide range of benefits including greater precision, and by comparison, a muchreduced heat

affected zone, and the fact that the process could be performed with more consistency with less skilled operatives. Today manufacturers have another choice, that of adopting the latest generation Nd:YAG or pulsed fibre lasers as opposed to using CW lasers. Lasers are

able to achieve greater penetration in CW mode than when pulsed welding because they are emitting light continuously. However whilst this might be a valuable attribute in some applications, within medical device manufacturing many components are delicate, and welding in CW mode may still generate too much heat and therefore a larger heat affected zone. As the name suggests, pulsed lasers produce a series of short pulses at a certain width and frequency. A pulsed laser is capable of producing a peak power that is significantly greater than its average power due to the laser energy being stored prior to release. The pulsed welding process can take just a fraction of a millisecond to complete; and a pulsed laser is capable of producing several pulses per second. When deciding whether to purchase pulsed laser technology, either an Nd:YAG laser or a fibre laser, there are also several factors which potential users may wish to consider. Currently Nd:YAG lasers produce higher levels of peak pulse power when compared to fibre lasers. As an example a 200W Nd:YAG laser from Alpha Laser will generate a peak pulse power of 9kW, by comparison a 300W fibre laser from the same manufacturer produces just 3kW of peak pulsed power. Fibre lasers do offer a number of benefits. The prime advantage is the greater process consistency which the technology offers, together with the fact that there is no loss of quality in the beam over time, a characteristic common with Nd;YAG lasers as the lamps deteriorate. Fibre lasers also deliver

better wall plug efficiency and can also easily switch between Pulsed mode and CW mode, if the latter is required for greater levels of penetration when welding. Due to the very short duration of the pulse from either technology, typically just a few milliseconds in duration, heat entering the part is kept to a minimum, making pulsed laser welding the ideal solution for heat sensitive components or very thin-walled materials. Pulsed laser welding also tends to work well with reflective metals due to the high amounts of energy being delivered at the onset of the pulse. This intense power at the beginning of the pulse cycle only lasts for a fraction of the total pulse duration. However, it is powerful enough to penetrate the reflective surface of materials such as aluminium and copper, whilst keeping the average power low and in turn reducing heat input. By comparison, a laser operating in CW mode would have to deliver a lot of energy to break through the reflective metal, with the resultant heat potentially causing damage to the part, or in the case of very thin walled items, even destroying the part. Pulsed laser welding is also the perfect solution for applications where sensitive components, such as electronics are either in close proximity to or encapsulated within a metal enclosure. The very small heat affected zone produced during the pulsed welding process keeps these delicate parts safe. TLM Laser is the UK distributor for Alpha Laser, manufacturer of both Nd:YAG and fibre laser systems for metalworking applications.

X-Ray & Automation Solutions for Medical Device Manufacturing

Analytical X-ray

Automation Solutions

Ultrasonic Coating System

Automated X-ray Inspection

Find Us - Booth 88, Ground Floor @ 25-26 September 2019, Galway Racecourse, Ireland

Book a meeting via email: sales@quiptech.com

www.Quiptech.com

MEDICAL TECHNOLOGY IRELAND RETURNS TO GALWAY RACECOURSE ON 25-26 SEPTEMBER 2019.

MEDICAL TECHNOLOGY IRELAND

A day at the Races WITH OVER 200 GLOBAL SUPPLIERS EXHIBITING AND A CONFERENCE PROGRAMME FEATURING THE START-UP & INNOVATION ACADEMY AND THE WOMEN IN MEDTECH FORUM, MEDICAL TECHNOLOGY IRELAND 2019 IS KEY EVENT IN THE 2020 CALENDAR.

WHAT’S ON DISPLAY? One of the firms taking centre stage will be Arburg, one of the leaders in injection moulding and plastics technology in the medical space. Colin Tirel, managing director at Arburg Ltd., explained: “We will show a Freeformer 200-3X additive manufacturing system, this will allow us to offer the visitors a live demonstration of our application expertise and the versatility of the Arburg Plastic Freeforming (APF) process, which can produce one off or small volumes of fully functional components from standard plastics granulate.” The group is planning to show the potential of the Freeformer, not just for the medtech industry, but potentially also the pharma sector. Tirel added: “At the exhibition, the Freeformer 2003X will produce a very innovative

medical product: a pill with several active ingredients in one capsule. The use of conventional manufacturing methods to produce such products is a multistage, time-consuming and costly process. Additive manufacturing provides the flexibility required to provide integrated, complex microstructures to integrate different drugs into different parts of a pill. In addition, additive manufacturing makes it easy to adjust the respective dose to the relevant patient. The dose is released in a controlled manner, resulting in an optimal therapeutic effect over the period of 24 hours.” The project, in collaboration with the School of Pharmacy, Faculty of Science, University of East Anglia, Norwich, focuses on the use of the Freeformer for the production of pills with multiactive ingredients and functional geometry, which control and facilitate the release of the active substance.

Another firm bringing something new to the sector is ODU-UK Ltd, which will be showcasing several new innovations in its range of push-pull connectors, developed specifically for medical equipment. What’s more, the group recently published a whitepaper on smart Connectors with integrated EEPROMs (electrically erasable programmable read-only memory). Based on some customer-specific projects, ODU now offers an off-the-shelf solution to system designers. Electronic identification via microchips is a well-established process, however the integration of EEPROM technology inside the connector provides many advantages for both the OEM and users. ODU’s smart connectors offer some interesting potential solutions for medical equipment manufacturers and these are outlined in the new whitepaper (you can read the full document

TECHNOLOGIES THAT SAVE LIVES

FIRST-CLASS CONNECTORS FOR MEDICAL APPLICATIONS ODU connector solutions fulfill the most demanding requirements for medical applications. ODU has the right connectors that withstand even the most stringent requirements of these applications. They include systems such as heartlung machines, mobile ECG measurements, operating table systems or magnetic resonance imaging (MRI). ODU offers also complete cable assembly integrated solutions.

High reliability Autoclavable Non-magnetic

25. â&#x20AC;&#x201C; 26. SEPTEMBER 2019CE UR GALWAY RACECO

Reliable touch protection High mating cycles

Booth 42

Cable assembly integrated solutions MEDICAL MILITARY AND SECURITY

TEST AND MEASUREMENT

INDUSTRIAL

ODU-UK Ltd. tel.: +44 (0)330 002 0640 sales@odu-uk.co.uk www.odu-uk.co.uk

ENERGY

EMOBILITY

MEDICAL TECHNOLOGY IRELAND

at www.odu-uk.co.uk/downloads/ whitepapers/). Also hoping to make a connection at the show is LEMO, which will be highlighting its latest range of medical interconnect solutions. The group will bring its range of industry-leading electrical and fibre optic interconnect solutions to share with the Irish medtech community. Products on display will include the Redel SP range of connectors which will give both existing customers as well as potentially, new design engineers, the opportunity to view some of the latest innovations and discuss their specific requirements with the LEMO team. For coding and marking, TLM Laser will showcase FOBA’s fixtureless marking technology – MOSAIC and IMP (Intelligent Mark Positioning) with a FOBA M1000 system.

The MOSAIC concept uses the camera to capture multiple small images and then arranges them into a single large image, just like a mosaic. This image is then used for system training, job setup, part validation, pre-mark verification and mark alignment. As long as the parts are placed anywhere within the marking field, the system will determine the position and orientation prior to accurately producing the mark required. Punters will also want to check out the Nordson Dage Explorer One, which Quiptech plans to launch in Ireland on the first day of the event. This high resolution, super compact X-ray system identifies defects as small as 2 µm with QuadraNT¬ X-ray tube technology. While powerful automated inspection routines save significant time for batches of boards, program a routine once, then simply click to go.

THE IRISH MARKET The local market is jostling with many of the major medical device OEM brands, and as such, the supply chain itself thrives in Ireland. Nick Harper, MD at ODUUK explained: “Once again we are pleased to be exhibiting at Medical Technology Ireland. Just as medical equipment manufacture and export is of considerable importance to the economy of Ireland, it is likewise a most important market for ODU.” Arburg’s Colin Tirel added: “We have always considered Ireland to be a very important market for Arburg. We have been dealing with the Irish market for injection moulding machines and associated technologies for over forty years. The market is heavily focused on the pharmaceutical and medical sector.

The local market is jostling with many of the major medical device OEM brands, and as such, the supply chain itself thrives in Ireland.

MEDICAL TECHNOLOGY IRELAND

“Over the years we have been successful in working closely with many customers, large and small in order to meet their requirements on an ongoing basis through our technology portfolio. We have now entered a completely different sector within additive manufacturing with the Freeformer”. The regional industry isn’t just focussed on medtech either. As Andy Toms, director at TLM Laser explained: “There is also a healthy semiconductor, electronics, aerospace, tool and die and automotive sector that we supply into. Ireland represents about 30% of our turnover so is an important part of what we do. We would like to see this percentage grow. “Ireland has a mass of overseas investors and this enables us to break into companies that normally we would have to trade through the USA to do business with. The result of this is the volume of smaller second and third tier suppliers that have established themselves, and grown into large entities which all need similar or the same laser processing equipment.” And why Galway, specifically? It has been said that while Dublin has an enviable cluster of medtech firms, Galway has more in the way of digital tech and advanced materials. Céline Laget, general manager at silicon specialist Sterne said: “From our point of view, Ireland and particularly Galway seems to be one of the main regions where multinational companies pool together in medical and biomedical sector, with smaller companies revolving around.

Thus, regarding our core business and expertise in medical and biomedical sector, Galway appears as a potential target and a strategic location to offer our services.” Sterne is specialised in the design, development and manufacturing of custom silicon parts, with its core business being in medtech. Its French facility includes cleanrooms to ISO 6, ISO 7 and ISO 8 standards, and our quality management system is established under ISO 9001:2015 & ISO 13485:2016. On the subject of standards, staying ahead of the regulatory curve is one of the reasons Irish, and Irish-based OEMs seem to succeed. Donal Murnane, Global Sales Director at Quiptech explained: “Medical devices make up almost 10% of all Irish exports, making Ireland a significant manufacturing territory globally for the sector. To maintain this position in the global market, there is an increased need for companies to automate the assembly and inspection processes.”

Researchers from the University of Liverpool’s Department of Molecular and Clinical Pharmacology have been awarded more than £645K of funding for a nanotechnology research project that aims to revolutionise drug delivery for prevention and treatment.

£645K BOOST

unds have been awarded to the University, for a project led by Dr Marco Siccardi in collaboration with Dr Neill Liptrott, as part of the SAFE-N-MEDTECH consortium, a European H2020 NMBP (Nanotechnologies, Advanced Materials, Biotechnology and Advanced Manufacturing and Processing) project involving researchers from the University of Liverpool in addition to 27 other organisations around Europe. Nano-enabled medical technologies can be applied in nearly every medical area, with a major presence and increased importance in cancer, regenerative medicine, advanced therapies, neurology, cardiology, orthopaedics, and dentistry. However, there remains a number of questions about their development and the mitigation of risks relating to their efficacy and safety due to their complexity in design and application.

nanotechnology

FOR MEDICAL NANOTECH RESEARCH As part of the project the researchers will examine the bio distribution and safety of Nanoenabled medical technologies in health as they relate to their use in humans. The aim of the SAFE-N-MEDTECH project is to build an, innovative, open access platform providing reference laboratories that have capabilities, expertise, experience, networks and services that are required for developing medical technologies. Specifically, this relates to the testing, evaluation, optimisation and marketing of nanotechnology enabled diagnostic medical devices throughout the products’ entire lifecycle. This platform enables developers and stakeholders such as Pharmaceutical companies, SMEs, healthcare providers and industries to access a, multi-

disciplinary, platform dedicated to understanding the materials, properties, and applications in the medical technology sector. Dr Siccardi, said: “The open access platform that will be developed is unique and will support the development of innovative nano-enabled medical technologies for prevention and treatment with potential benefits for both patients and the NHS. The project is based on exciting collaborative network in Europe, providing exceptional opportunities for future collaborations, through the application of cutting-edge research strategies. ”

project, as well as more broadly across the University, will facilitate the translation of these novel technologies to clinical studies and beyond.” The SAFE-N-MEDTECH project is part of the Open Innovation Test Bed (OITB) initiative from the European Commission, a new and challenging approach towards upscaling the use of nanotechnologies in Europe and abroad and seeks to address these issues. It represents an investment of £15.8m over four years.

Dr Liptrott, said “Nanotechnology offers great promise for the diagnosis and treatment of a number of clinical conditions. The work we are doing within this

Richard Poate, medical health services manager at global

QA & QC

product testing and certification organisation TÜV SÜD.

How MDR impacts your quality management system

he global medical device market is governed by a broad range of national and international regulations and standards, and medical device manufacturers must meet certification and testing requirements to legally place products on each market. As the regulatory requirements are complex and vary between regions, manufacturers are faced with increased product development costs and time to markets challenges. There are further complications as medical device manufacturers will soon be confronted with major changes in the European Union’s decades-old regulatory framework which governs market access to the EU. The new Medical Device Regulation (MDR) replaces the EU’s current Medical Device Directive MDD (93/42/ EEC), and the active implantable medical device directive AIMDD (90/385/EEC). This represents a major restructure to the medical device regulatory framework, with the MDR coming into force on 25 May 2017 and ending its transition period on 26 May 2020.

In order to evaluate the compliance of their device against the Essential Requirements of the MDD/AIMDD or General Safety Performance Requirements of the MDR, a manufacturer’s product and quality management system must undergo a conformity assessment process, with the involvement of a Notified Body in most of the cases. They must also write technical documentation, as well as establish a quality management system that meets the relevant and applicable requirements. A Notified Body is an organisation that has been designated by an EU member state and notified by the EU Commission to assess whether manufacturers and their medical devices meet the requirements set out in legislation. Manufacturers can apply to any EU Notified Body and, following an appropriate assessment, the Notified Body will issue relevant certification decision. This allows

manufacturers to add the CE marking on to their products so that they can be sold anywhere in the EU market. ROLE OF THE NOTIFIED BODY A Notified Body’s tasks will vary depending on the classification of the products concerned and the conformity assessment route a manufacturer has chosen. Typical activities that can be undertaken by a Notified Body include: •

•

Full quality assurance – the Notified Body will carry out an assessment of the manufacturer’s quality system, including design. They will also sample across the range of products and processes to ensure that the requirements are being met. Examination of the design – to ensure that products meet requirements, the Notified Body will assess the full technical documentation. Type examination – the Notified Body will assess the full technical information relating to each type of product and carry out appropriate testing of a representative production

QA & QC

•

sample, to ensure that it meets the requirements. Verification – before the manufacturer can place products onto the market, the Notified Body will either test every unit or every batch of product to ensure that they meet requirements. Production and product quality assurance – the Notified Body will carry out an assessment of either the manufacturer’s quality system covering production and inspection (production quality assurance) or final inspection (product quality assurance). The Notified Body will also sample across the range of products to ensure that relevant technical files are available, as well as ensuring that the relevant processes being undertaken meet the requirements Conduct unannounced audits of manufacturers – it is now mandatory for Notified Bodies to conduct unannounced audits of manufacturers.

WHAT PRODUCTS REQUIRE A NOTIFIED BODY? Notified Body involvement is not required for Class I devices which are not sterile, do not include a measurement function and are not reusable surgical instruments. This means that manufacturers can add the CE marking in the normal way and self-certify that their product meets the requirements.

Class Is, Im, Ir, IIa, IIb and III devices do need a Notified Body to be involved, so this means that it is important for manufacturers to plan ahead from the start of the product development process as any delays in the certification process could disrupt time to market.

the product development lifecycle – to verify that products meet legislative requirements. A Notified Body audit is then bolted on top of that at the final stage of product development – to gain certification, with both discreet activities done by two separate organisations.

Class IIa Devices are generally low to medium risk and are mainly devices installed within the body in the short term, for only between 60 minutes and 30 days. Class IIb Devices are slightly more complex and are generally considered medium to high risk, as these will often be installed within the body for periods of 30 days or longer. While they have an identical compliance route to Class IIa devices, there is the added requirement of a device type examination by a Notified Body. Class III medical devices are usually those that sustain or support life, are implanted, or present potential unreasonable risk of illness or injury, for example implantable pacemakers and breast implants.

To streamline the time to market process as much as possible, manufacturers should take a step back and a more pragmatic, joined-up approach. From the start of the process, a device manufacturer should establish what the regulatory expectations will be for both the final product and the test process that goes alongside it. If you understand this from the start and engage with a Notified Body at this point, you can ensure that you meet all of the Notified Body’s expectations and requirements at the final certification stage. Also, internally at a device manufacturer, the regulatory affairs team, which deal with certifications/audits and the CE Marking process, and R&D engineers are often very separate teams. So, they need to work more closely to expedite the process.

STREAMLINING THE PROCESS However, while medical device manufacturers are faced by such challenges, they may not realise that they have an opportunity to streamline this process. There is often a presumption that because product testing and Notified Body auditing are discreet activities, that they must be undertaken by two separate entities i.e. a test lab and a Notified Body. Testing is done first, usually throughout

Also, think about your target markets from the start and how you can streamline this process, so that the entire process is geared towards your end goal – to sell a medical device to particular and multiple markets.

+44(0)1527 959 099 PUL S ED FIBE R L A S E R S Y S T E M S FOR MEDICAL DEVICE MANUFACTURING Inject a pulse into your medical device welding operations with ALPHA LASER technology from TLM

• Flexiblity • Precision • Performance

Custom HMI Solutions - Suitable for medical environments - ISO 9001 and ISO 13485 certified - Certified EMC compliance - Easy to use and clean

Agents & Distributors For:

www.tlm-laser.com | sales@tlm-laser.com

uksales@schurter.co.uk +44 1296 319 001 schurter.co.uk

Latching advert_THE LEEDERS AD 03/08/2015 18:22 Page 1

Miniature Latching Solenoid Valve ● Low Power Consumption ● Magnetically Latched ● Light Weight: - less than 2.5 grams ● Ultra Compact Size ● Plug-In and Face Mount Style ● Operating Pressure Range: Vac – 45 psig (10 psid) The Lee Company’s ultra-miniature 2-port normally closed solenoid valve is now available in a magnetically latched design. Optimized for applications that demand ultra-low power, low heat and small size, this design is ideal for compact, battery powered instruments.

For more information visit www.leeproducts.co.uk Tel: 01753 886664

Fax: 01753 889588

email: sales@leeproducts.co.uk

Lee Products Limited, 3 High Street, Chalfont St Peter, Gerrards Cross, Bucks. SL9 9QE

Innovation in Miniature

At Med-Tech Innovation, we’re all about medtech engineering. But every now and then we get the offer to test out some cutting edge medical devices. The electro

interstitial scan (EIS) sensor analyser promised so much, regular contributor Reece Armstrong couldn’t resist going to check it out.

innovation

A ONE-STOP-DOC-SHOP?

harmacies in many ways have been part of the old guard of healthcare services, handing out prescriptions and occasional pieces of advice to patients but failing to keep up with the digitisation of modern life. So when I received an invitation to try out a new holistic healthcare service at the John Bell & Croyden pharmacy in London, I jumped at the chance. Not only because it would give me a (hopefully) stress-reducing snapshot of my health but also to see how this luxury pharmacy was adapting to modern times. The pharmacy’s Nutri-Clinic is described as a bespoke personalised nutritional assessment, during which a detailed account of a person’s history of health concerns is taken by a doctor. This ‘detailed account’ is achieved using a class II medical device known as an Electro Interstitial Scan (EIS) Sensor Analyser developed by Minerva Research Labs. The machine consists of six electrodes which were placed onto my feet, hands and forehead to the measure the fluid between the cells throughout my body. The idea is that by measuring this interstitial fluid, the doctor can then perceive a person’s current vitamin, mineral and hormonal imbalances within your body. The scan takes around three minutes (of a 90-minute appointment) after which I was taken through an outlook of my health, with the doctor

examining everything from my calcium levels, to a past trauma highlighted by my neurological functions. Thankfully, all my body’s essential minerals were at the correct levels and my gut’s health too was optimum thanks to an alkaline pH balance. Importantly, the health information I gained during the visit was detailed enough for me to know if I needed to either make changes to my lifestyle or to follow up with a doctor for any concerns I might have. Overall though it was an affirming experience to know that I’m a fairly healthy individual, an outcome I’ve never really gained from visiting a GP or a pharmacy prior to this. *Note that this service isn’t for diagnostic purposes, but simply a guideline to a healthier lifestyle and to see if you may need follow up appointments with a GP. The full Nutri-Clinic service doesn’t end with the scan like my appointment did. Customers will be taken through an entire lifestyle assessment, during which they will find out what kinds of foods they should be eating and even what supplements they can take to counter any imbalances. My only worry was that, as a pharmacy that sells many

premium supplements, customers will only be recommended John Bell & Croyden products, making the service rather predatory in regard to patient care. However, when following up with Dr Vidhi Patel – the doctor in charge of the new service – she assured me that her patients’ health and indeed trust was her first and only priority, regardless of the service being offered by a prestigious pharmacy. Some might balk at the price tag of £180 but – as my colleague pointed out – you’d pay the same for your car’s MOT so why not for a service which can indicate whether or not you need to follow up with your doctor. More importantly, services like this, and other in-house offerings, get consumers off of the streets and into the pharmacy. With the emergence of electronic prescription services and digital appointments, pharmacies need to offer ways in which customers feel the benefit there and then. Whether it’s a holistic checkup from John Bell & Croyden or getting a suspicious-looking mole examined, pharmacies can be the first stop for patients worried about any ailments. For those lucky enough to be sent on their way without anything to worry about, GPs and other NHS departments may just avoid another unnecessary appointment; a small but vital time-saving for an already overstretched service.

2019 may well be remembered as a brilliant year for Irish golf, but it’s

med in ireland

ore than 800 executives from the global medical technology and healthcare sectors will attend the one-day event this October. Once again it’s invite-only, but open to expressions of interest, and includes a full day’s conference with presentations from top executives and key opinion leaders from around the world. It provides an opportunity for international visitors to experience the future of medtech, in a country acknowledged as a global medtech hub. For many visitors, the primary attraction is the chance to participate in a tailored programme of visits to some of Ireland’s most innovative medtech and healthcare companies, organised by Enterprise Ireland, the trade and innovation agency, for introductions to potential research, innovation and manufacturing partners. Med in Ireland is a unique opportunity to meet with Ireland’s existing and emerging leaders across medical devices, diagnostics and digital health, as well as its world-class component part engineers and manufacturers. It provides a chance for visitors to experience at first hand Ireland’s highly innovative medtech sector and to understand how a small country on the western periphery of Europe is producing so many groundbreaking medtech companies. The future of medtech is emerging from a unique ecosystem In a rapidly growing market, a glimpse into the future of medtech is invaluable. Medtech sales worldwide are forecast to reach €530 billion

by 2024. It’s the most innovative sector in Europe, resulting in 13,795 patents filed with the European Patent Office. Digital health alone is forecast to have sales of €15.7 billion by 2024. Irish companies will make a significant contribution to this growth, helping to define the future of healthcare globally. The country hosts almost 300 homegrown medtech businesses supported by IDA Ireland and Enterprise Ireland, the biggest seed investor of start-ups in Europe. In addition to established companies, Ireland has a vibrant medtech start-up ecosystem. These young companies are among the world’s best in terms of new technology, processes and services. SUPPORTING MEDTECH START-UPS The commercialisation agenda is very important to Enterprise Ireland’s support of medtech startups. It is the leading agency for the commercialisation of research out of third-level institutions and its Commercialisation Fund gives innovative teams in academic institutions and clinical communities funding to validate the technical and commercial viability of ideas and products supporting the creation of new technology start-ups. Enterprise Ireland co-funds Bioinnovate Ireland, a national programme that supports innovation and “design thinking” in the medtech sector. A significant number of alumni Bioinnovate Fellows of the have been successful in creating new high potential start-ups from research in recent years. The agency also supports Health Innovation Hub Ireland, a government-backed collaboration between business and the Irish healthcare system.

also the year that Med In Ireland returns to Dublin.

Ireland’s medtech ecosystem is further supported by bodies such as BioExel, the country’s medtech accelerator; Irish Manufacturing Research (IMR) Technology Centre an independent not-for-profit research organisation, funded by Enterprise Ireland and IDA Ireland, which provides applied research solutions and advanced manufacturing expertise, technology transfer and training to the country’s manufacturing sector, and CeADAR, a marketfocused technology centre for innovation and applied research in AI, machine learning and data analytics across. INNOVATION IS IRELAND’S MEDTECH DIFFERENTIATOR Ireland’s geography helps too. It is a strategic location of choice, not only for global medtech, but also as a base for companies looking to tap into the second biggest global medtech market, Europe, which accounts for 27% of the world market, at €115 billion. “Med in Ireland is an opportunity for us to fly in top international customers from around the world, so that they can see the medtech industry we have in Ireland, and for Enterprise Ireland’s client companies to do business across diagnostics, medical devices, digital health and the subsupply of precision engineering and component manufacturing,” says Deirdre Glenn, director of life sciences at Enterprise Ireland (pictured). It’s also an opportunity for Ireland’s medtech sector to show what sets it apart – innovation. “The differentiator for Irish medtech is not just about being top quality and price sensitive, because those things are a given, it’s about the fact that Ireland is highly innovative,” she says.

med in ireland

agenda. Enterprise Ireland helps companies to access clinicians, academics and researchers, plugging them into the very highly integrated ecosystem we have here.” Healthcare costs are spiralling globally, she acknowledges, pointing out that Irish medtech companies succeed by helping their clients to regain control. They lead the way in relation to value-based healthcare by helping, not just to design innovative solutions, but by also clearly articulating the ultimate impact of their products and services in terms of savings. “Irish medtech companies are working on a collaborative basis, listening to clients’ needs and developing products and services to suit. It is market-led, customerled, innovation,” says Glenn. The funding Enterprise Ireland makes available to support its medtech sector is a unique enabler of this.

KEY FACTS Ireland…

• …is home to 9 of the world’s top 10 medtech businesses • …is location of choice for the world’s top 10 biopharma companies • …is one of the world’s top five global medtech hubs • …is Europe’s greatest per capita employer of medtech professionals • …has 40,000 people working in medtech* • …expects 4,000 new medtech jobs by the end of 2020 • …hosts 10 of the top 10 tech companies in the world • …has the world’s seventh most competitive economy. Source: Enterprise Ireland

Ireland, already a trusted advanced manufacturing base, succeeds by helping its clients solve their problems through innovation. “The Irish medtech sector acts as strategic partners rather than just suppliers to each of their customers,” says Glenn. HOW ENTERPRISE IRELAND HELPS “Med in Ireland is not just about showcasing the most innovative of our companies. It’s also about showing the supports we have here in Ireland, designed to support companies in their innovation agenda and in their competitiveness

“Certainly there is more available to companies here in terms of supporting their research, development and innovation than elsewhere. It’s why Ireland is considered an emerging global hub for medtech in terms of the whole innovation agenda,” says Glenn. The importance of innovation for Ireland cannot be overstated, she says: “We are a tiny nation which punches way above its weight in medtech. We know that to compete globally, we need to innovate. That we succeed in this is proven time and again by the best in class companies we have that are selling all over the world.” Med in Ireland takes place at Dublin’s RDS on Thursday 19th October, 2019.

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

Our experts can provide specialist support in: ●

●

We encourage innovation in the sector and nurture collaboration between academics, clinicians and industry. With offices based across the UK, members of Medilink UK have access to opportunities and events on both a national and a regional level.

●

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

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

DIGITAL HEALTH AGE