MTI Issue 37

www.med-technews.com Issue 37 | May/June 2018

PLUS

The NHS at 70: medical technology past, present and future

MED-TECH INNOVATION | NEWS MED-TECH

innovation

HOW ZEUS IS CHANGING THE CATHETER GAME — P.17

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CONTENTS MED-TECH

6-7.

INNOVATION | NEWS

Headlines

8-9.

Med-Tech Innovation Expo

Past, present and futu

13.

To celebrate the 70th anniversary of the NHS, we’ve put together this infographic charting a 8history of innovative progress - as well as a glance at the hospital of the future.

ISO 13485

17.

On the cover

18-19.

70 years of NHS technology

2028

20-21.

Q&A: a design for life

18

22-23.2018

Europe: where’s the innovation?

25.

The In Crowd: meet the2010 Healthtech Alliance

29-31.

22

Finance and funding 2000 32 THE TEAM editor | dave gray +44 (0) 1244 680 222 david.g@rapidnews.com reporter | reece armstrong reece.armstrong@rapidnews.com head of content | lu rahman lu.rahman@rapidnews.com brand director | colin martin +44 (0) 1293 710 042 colin.martin@rapidnews.com

1990

ad sales manager | damien challenger +44 (0) 1244 680222 damien.challenger@rapidnews.com senior sales executive | amy miller +44 (0)1244 680222 amy.miller@rapidnews.com

Rapid Medtech Communications Ltd. Carlton House, Sandpiper Way, Chester Business Park, Chester, CH4 9QE SUBSCRIPTION: Med-Tech Innovation is free to qualified readers in the UK and Ireland. Register to receive copies at www. med-technews.com or e-mail: circulation@medtechinnovation.com

1980

head of media sales, plastic & life sciences | lisa montgomery +44 (0)1244 680222 lisa.montgomery@rapidnews.com art | sam hamlyn publisher | duncan wood

The Publisher endeavours to collect

1970

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.

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.

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 herei ©Rapid Medtech Communications Ltd. No part may be reproduced or transmitted in any form without the prior permission of the Publisher.

ISSN 2046-5424

3

from The editor

AI may well be the answer... but there are three things that need fixing first

[

P

rime minister Theresa May delivered an important speech in May, calling for innovators and clinical staff to work closely to make the dream of AI for cancer (and other) diagnoses a full-scale reality.

It was part of the launch of a new government target to get people living healthily for five more years by the year 2035, and it incorporates the prevailing consensus in western medicine at the moment that prevention rather than intervention is the only real way to managing the ageing population. The PM also discussed other aims under the umbrella of the fourth industrial revolution.

Fittingly, the pledge also came at the same time as the UK health sector hits an important milestone - the 70th Anniversary of the NHS. 70 years is a long time in innovative terms, and at the centre of this issue you’ll find a potted history of the technological advances of the NHS through the decades - including a look at what’s to come (and yes, AI/machine learning is on the list).

In our office we have an ongoing debate about AI. Some say it’s over-hyped, and the potential is so far in the distance that it’s almost invisible. Others believe that we are just around the corner from a new age of diagnostics.

4

Personally, I think there are three things that need addressing - and the sooner we do, the sooner we can start predicting cancer and cardiovascular disease before they have chance to do irreversible damage.

The first is adoption. At Med-Tech Innovation Expo in Coventry earlier this year, I spoke with a number of visitors from various backgrounds who told me they still felt that government initiatives like the Accelerated Access Review are still merely paying lip service to the underlying problems of getting technology into the NHS. And, they said, despite the promising name, the Accelerated Access Review is also proving slow to deliver the goods. A common belief is that the NHS, or rather, the policymakers behind the scenes, still place too much emphasis on costeffectiveness, rather than cost-benefit and long-term efficiencies. Implementing AI will take considerable investment - and the government has a duty to make that available if it intends to set targets around AI adoption.

Next, there’s the issue of the data itself. We know that there are already vast amounts of information available, but before it can be translated into useful algorithms, surely it needs to be organised into such a way

that it can be interpreted by a machine. Much of the data we have available at the moment was never obtained with the intention that it would be used to create an algorithm.

As such, there’s some good old-fashioned human work to be done there.

Which leads me on to the third hurdle that needs knocking down: skills.

Thankfully, the government has placed significant emphasis on the need for more education and talent acquisition in the field of data science - part of its futureproofing strategy. There are also accelerators and incentive schemes on offer for those willing to put these skills to good use. But it’s not yet a mature talent pool, and until it is, there may not be enough pairs of hands to implement AI on the scale needed to beat cancer and heart disease.

Despite these (and probably several other) challenges, the good news is that the industry is making good progress. Just two days after the PM’s speech, I received word that Oxford University spinout Ultromics has raised £10 million in series A funding to bring its coronary artery disease diagnosis algorithm into 20 NHS hospitals. Let’s hope that the government will match the efforts of industry in making AI a reality for the NHS.

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EIGHT

YORKSHIRE FIRM SCOOPS TWO AWARDS AT MED-TECH INNOVATION

COMPANIES ...that are winning at medtech

2 – CELLPATH CATEGORY Export Achievement CellPath is a family business based in Powys, Wales, which manufactures and supplies products, consumables and services to the cellular pathology cancer diagnostics market.

6 – 270 VISION CATEGORY Outstanding Achievement 270 Vision is a product design company based in Hampshire, focusing on innovative medical grade wearable technology for the medical and professional sports sectors.

3 – INHEALTHCARE CATEGORY Collaboration with the NHS InHealthcare is a Harrogate 7 – BLUEFROG DESIGN based company whose secure CATEGORY multi-million pound digital Advancing Healthcare Award infrastructure supports remote Bluefrog Design is a Leicesterhealth monitoring for the entire based Product Design UK population. Consultancy providing product, engineering and graphic design expertise to industry.

4 & 5 – NEMAURA PHARMA AND SALTS HEALTHCARE (JOINT WINNERS) CATEGORY Innovation Award Nemaura Pharma is a Leicestershire-based specialist biotech company offering accurate, controllable and minimally invasive skin-based advanced drug delivery systems, and Salts Healthcare is an international medical device manufacturer based in Birmingham, specialising in stoma care devices and associated products.

6

8 – INHEALTHCARE CATEGORY Editor’s Award for Business in Healthtech Inhealthcare scooped its second award of the evening, for its pioneering work in apps and medical technology.

headlines

1 – NUVISION BIOTHERAPIES CATEGORY Start-up award NuVision is a regenerative medicine company based in Nottingham which manufactures and supplies a therapy made from human amnion to effectively treat sightdestroying conditions.

Every year the UK’s medtech sector gathers at Med-Tech Innovation Expo to recognise the pioneers in their field at the Medilink UK Business in Healthcare Awards.

Here’s a brief summary of this year’s champions…

Yorkshire’s Inhealthcare went home with two awards at the national Medilink awards for its work in the UK healthtech sector.

Bryn Sage, chief executive of the digital health specialist, said the event showcased the wider strength of the UK life sciences industry and its ability to create economic prosperity across the country.

Inhealthcare collected the NHS collaboration award, sponsored by the AHSN Network, for its groundbreaking Health Call partnership with trusts in the North East of England.

The company also won the prestigious Editor’s Award, sponsored by the website Digital Health Age. Mr Sage said: “Of course, we are delighted to win these awards. I am very proud of our hard-working team and the digital health services we are delivering with our forwardlooking partners in the NHS. “The more important message though is about the huge growth potential of life sciences in the UK and how, with the right support from government, this industry can rival the City of London and financial services as an engine of jobs and prosperity for the regions.”

The Health Call collaboration in the North East brings together six NHS trusts with an agreement to share successful innovations across an area of 3m people.

The collaboration aims to overcome duplication of efforts and “not invented here syndrome” to accelerate the adoption of proven healthcare technologies at scale.

Health Call is underpinned by Inhealthcare’s secure healthcare platform that supports the remote monitoring of the entire UK population.

MEDICAL DEVICE SALES HIT

BY SKILLS SHORTAGES A new study has revealed that a staggering 63% of professionals in the medical device sector don’t feel they hold the necessary skills to address the challenges presented by today’s sales market. The study is being led by sales and negotiation training group, Huthwaite International.

The research, which investigates medical device sales performance, strategy and delivery across six of Europe’s most prominent trading countries (UK, France, Germany, Switzerland, The Netherlands and Belgium), shows a clear link between the issues facing the market at present, and how they will continue to impact commercial success moving forward.

60% of respondents confessed that existing selling skills and techniques are not effective, with 65% believing this is set to get worse within 10 years’ time. And, whilst the UK and Belgium (80%) admit to struggling the most when it comes to ineffective sales techniques today, it is Switzerland (84%) that shows the greatest concern that selling skills and techniques will fail to be effective by 2028.

The report also revealed concerns with global competition, with three in five respondents stating this is both a challenge now and will be in the future, with 60% believing that another area concern centres on adding greater value for clients.

Despite the lack of confidence in future sales ability when it comes to skills, global competition and adding value for customers, it seems the sales sector is keen to address these areas, with 64% believing that creating a considered alternative to commercial business models is the solution to ensure sales success. Another area of opportunity appears to lie in meeting the needs of different stakeholders in the sales process, with four in five believing this will be a key strategy required by successful sales teams in the future.

SOFTWARE PARTNERSHIP WILL SPEED UP REGULATORY APPROVALS Software group Qt has announced a new partnership with Emergo, a global medical device regulatory consulting firm, to help Qt’s medical device manufacturer customers accelerate time-to-market for their products.

Bringing a medical device to market takes a significant amount of time, money and resources, with the average time-to-market for a medical device falling between three to seven years.

Qt takes a three-pronged approach to helping its customers navigate medical device industry regulations, consisting of certification of Qt’s own products; full transparency into Qt’s development process, product performance, and internal validation and testing; and access to an experienced and diverse partner ecosystem.

Through the new Emergo partnership, Qt says it is “able to fully support its customers’ regulatory and compliance efforts in order to gain market clearance, including compliance with regulations and standards set by the FDA, EU, ISO and IEC”.

“While Qt, through its software development framework, enables companies to speed up the process of

device development, getting past the regulatory hurdles in countries worldwide is still a challenge and can delay the entry to a specific market,” said Dr. Benjamin Grosse-Siestrup, PhD, Business Development Manager for Emergo. “By partnering with Emergo, Qt is providing a more complete service offering to its customers along the entire product lifecycle, which includes international medical device and IVD market clearances.”

According to a recent survey, more than 84 percent of Qt’s customers report that they are more productive with Qt, and highlight that productivity of projects has as much as doubled through their usage of Qt. “We understand how challenging it is to develop innovative medical devices, and we realise that providing a comprehensive software development framework solves only part of the challenge of getting medical devices to market faster,” said Roger Mazzella, Senior Product Manager for The Qt Company.

“The other part of the challenge is clearing the medical device in markets all over the world. As a result, our goal is to support our customers through the entire innovation and product launch cycle, which includes helping them navigate the critical step of global regulatory market clearance. With our partnership with Emergo, we’re providing our customers with the resources they need get their groundbreaking products to market faster than ever before.”

7

MED-TECH INNOVATION EXPO

M

ed-Tech Innovation Expo, the event for medical device designers, manufacturers and engineers, is on the ascent. On the back of the latest successful edition in April, the organisers, Rapid Medtech Communications (part of the Rapid News Communications Group), announced the show’s relocation to Birmingham for 2019. Following the announcement, MedTech Innovation News’ Holly Delaney sat down with Duncan Wood - Chief Executive of Rapid News Communications Group - to find out more about the future of the event.

8 8

Med-Tech Innovation Expo TO

re-locate and grow HD: WHAT WAS BEHIND THE DECISION TO MOVE MED-TECH INNOVATION EXPO OUT OF THE RICOH ARENA? WHY THE NEC? DW: It’s really simple. Our ambition for the show in terms of size and both national and international impact can only be satisfied by the UK’s premier exhibition venue. When we acquired the show back in late 2016 we always had this move in mind.

Now, with two successful growth years under our belt, it is the time to take this step.

We already have a great relationship with the NEC and have run other group events there such as TCT Show and Interplas for many years. So, between that relationship, the easy accessibility for the venue by road, rail and air, and the opportunities for further growth it was an obvious choice.

HD: HOW HAS NEWS OF THE MOVE BEEN RECEIVED? DW: I think overall the feedback has been positive towards our ambitions. The industry can see that we’re committed to it, and this was important to establish before we made the move.

For sure there is always a little resistance to change, particularly one that is so significant, but it’s our job to understand that and hold hands during the move.

We’re going down a path we know very well; in 2011 we moved TCT Show from the Ricoh Arena to the NEC, and now it is a leading international event with over 10,000 attendees and 300+ exhibitors annually. We know the ground here and have executed a similar transition before very successfully in a much smaller industry.

HD: WHY HOLD THE EVENT IN BIRMINGHAM? DW: Aside from the fact that the NEC is really the only venue that can accommodate our ambition for the event, Birmingham is England’s second city. It’s no more than a three hour journey for 75% of the UK and has an airport that averages 292 domestic and international flights daily - this means Med-Tech Innovation Expo 2019 will be easier to get to for both UK and international visitors which in turn means better return on investment for our exhibitors.

A greater international audience will also allow us to show off the UK’s expertise in this sector and drive the industry forward by making the event a focal point for the sector.

MED-TECH INNOVATION regulation EXPO

The Midlands is a hub of engineering excellence for the UK. A great number of our core attendees - designers, engineers, manufacturers, R&D experts and other professionals involved in the design and manufacture of medical devices – are based here. There are 280,000 people employed in manufacturing in the region and 62,000 in advanced engineering.

HD: HOW DO YOU FEEL THE MOVE WILL BENEFIT ATTENDEES? DW: It’s quite easy to list all the positives the NEC offers.

We’ve already touched on accessibility for both national and international visitors.

Alongside this is a greater choice of onsite hotels, more restaurants and of course the ability we now have to craft a much broader event with more exciting aspects to it. We’ve already confirmed plans to expand the breadth of the event with the addition of four new exhibition zones focused on digital healthtech, medical plastics, pharmaceutical manufacturing technologies and early stage innovations.

Alongside this, a wider content and conference programme will increase the learning opportunities in all areas of the technologies we cover.

Med-Tech Innovation Expo will continue to bring together designers, engineers, innovators and manufacturers from the medical, pharmaceutical and healthcare sectors to source products, explore new ideas, understand emerging technologies and do business with companies representing the entire medical device supply chain from ideation, through design and validation, to manufacture.

The solutions on the show floor will help them design the next generation of medical and pharmaceutical devices.

HD: AND EQUALLY WHAT DOES THE MOVE OFFER FOR YOUR EXHIBITORS? DW: The accessibility, accommodation and eating options hold true for exhibitors too, but the most important news for them is that we’ve been able to reduce our rate card for exhibiting by a significant amount. This immediately saves our exhibitors almost £2,000 on the cost of a 9m² stand.

This is our investment in the industry, allowing more exhibitors to take part and enabling returning exhibitors to consider larger stands. We’re committed to delivering increased ROI reducing exhibition costs and increasing attendance is the simple equation that will deliver this.

HD: THE NEC IS A MUCH LARGER VENUE, WHAT WILL THIS MEAN FOR THE DAY-TO-DAY PRACTICALITIES OF EXHIBITING? DW: The NEC certainly comes with bigger halls and the possibility of multiple events going on at the same time, so there will be a few policies and procedures for exhibitors to adjust to. We know change can be daunting, especially if it means spending more time adhering to policy, but we’ve run events at the NEC for years. We know what to expect and are more than capable of making the set up and break down as easy as possible. Our highly experienced operations team will make sure exhibitors are correctly prepared and given all the guidance they need.

HD: FINALLY, WHAT DOES THE FUTURE LOOK LIKE FOR MED-TECH INNOVATION EXPO? DW: I’m quite confident that 3 years from now, when the expo is where we expect it to be, our exhibitors will be more than happy with the growth the event has provided for their businesses.

There will be very little nostalgia for the days when it was smaller!

We could have stayed at the Ricoh with a smaller show, but this move is about ambition. When you consider the scale of the £27bn UK and Irish medtech industry, it deserves a bigger platform.

We mustn’t be afraid to grow and step onto the world stage.

It’s time the UK had a show commensurate to the size of the market, one that can promote our expertise to the rest of the world.

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

9

how medtech can heal old wounds across the NHS

MORE THAN A STICKING PLASTER

OPINION

Last year Lord Hunt, former Chief Executive of the NHS Confederation, drew attention to the substantial costs and outdated practices related to managing wound care.1 An estimated £5.3bn is spent on treating wounds by the NHS every year, which exceeds the costs of obesity treatment.2 A recent study, led by Professor Julian Guest, found that the average CCG spends in excess of £40m managing wounds every year3. With the prevalence of acute, chronic, and other unspecified wounds increasing at a rate of 9–13% per annum, this figure is predicted to increase year on year.3 Against this background, Lord Hunt has called for innovation and a clear leadership strategy to save costs, but also improve clinical outcomes and quality of life.

Clinically sub-optimal and labour-intensive wound management methods have become embedded within many healthcare providers, which are now struggling to reduce the financial burden of wound care. “Healing takes far too long, diagnosis is not good enough, and

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Innovative new medical devices could revolutionise the way wounds are treated – but the NHS is still using

inadequate commissioning of services by CCGs compounds the problem,” explained Baroness Margaret Wheeler.1 Professor Guest described how wound care delivery appears to be “patchy and disparate”3 at best and promotes a major rethink on the issue, including a greater focus on prevention and active management with the intent of healing wounds.4 Factors driving the cost of wound care are well established. Caroline Dowsett, tissue viability nurse at the East London Foundation Trust said: “Healing time, frequency of dressing change and incidence of complications are the three main cost drivers.”5 Appropriate use of innovative and clinically proven wound management technologies can help to alleviate some of these pressures.

An estimated two million people are living with a chronic wound across Europe and an estimated 15% of all chronic wounds remain unresolved after a year of

treatment6. This falls well below best practice when there is technology designed to improve healing rates, overall cost, and prevent or reduce complications readily available, but not adopted because of the current procurement strategy based on cost-per-unit.

Procurement practice relating to wound care often adopts a narrow, cost-per-unit focus which promotes dressing selection based on cost rather than patient need.

Whilst this may reduce the supply cost, it may have an adverse effect on the total cost of care, if it results in sub-optimal treatment choices. Adopting a total cost of care approach to procurement is likely to result in more appropriate use of advanced treatment options with proven effectiveness where these can deliver better outcomes and reduce the frequency of nurse visits and expensive complications.

There is a growing body of evidence to support the use of ‘care pathways’ incorporating criteria for the use of innovative wound technologies that have been shown to deliver improved

a cost-per-unit approach to procurement.

Paul Trueman, VP market access at Smith & Nephew, argues a performancebased strategy would cut costs in the longterm.

outcomes at lower total treatment costs.5 Take, for example, surgical site complications; infections and dehiscence (re-opening of the wound) often occur post-discharge and create a significant burden on community nursing services.7 A study has suggested that around 40% of wounds treated by community nursing are acute, such as surgical, wounds.3 Where complications occur, this results in extended treatment costs and excess morbidity for patients8. Evidence indicates that many of these complications could be avoided through improved management of the surgical wound in the immediate post-operative period.9,10 Studies of PICO, a single-use negative pressure wound therapy device, illustrate a potential 50% reduction in surgical site complications.10 Despite this, adoption of this pioneering, single-use negative pressure wound therapy device remains limited, largely due to concerns over the unit cost compared to standard care.

The fact that it has been shown to deliver improved

outcomes and reduce the total costs of care may not be adequately taken into account in the procurement process.

Infections are a common recurring theme of longerterm chronic wounds too, extending the duration of the wound and increasing the potential risk of hospitalisation.5,11 Detection of infection largely relies on clinical judgement. Given that the majority of wounds are treated by non-specialist nurses (as opposed to dedicated tissue viability nurses) there can be inconsistencies in judgement. Innovative technologies, such as MolecuLight i:X, a handheld device that measures the surface area of a wound and visualises the presence and distribution of fluorescent bacteria, can contribute to earlier and more consistent detection of wounds at risk of infection.12,13 More accurate detection of infection may lead to more appropriate use of antimicrobial dressings, which at present are often restricted from use in community nursing settings due to concerns over their cost and inappropriate use. Furthermore, accurate diagnosis can also contribute to improved stewardship of antimicrobials and antibiotics thereby reducing concerns about resistance.

It has been estimated that there are 400,000 pressure ulcers per annum in the UK, at an estimated cost to the NHS of £1.82.6bn.2,4 Standard care with regards prevention requires considerable nursing input, in the form of active monitoring and regular re-positioning of

patients. Recent evidence has indicated that implementing a multi-layer silicone adhesive foam dressing in pressure ulcer prevention, as part of a pressure ulcer prevention protocol, is an effective strategy.14 Such dressings are a relatively inexpensive intervention and require only modest nurse training, meaning that they can easily be integrated into existing workflows. Despite this, a number of wound care formularies continue to limit the use of such dressings for prevention.

These examples illustrate how the narrow cost per unit focus of procurement may restrict access to innovative treatments and increase the total costs of wound care. Focusing on the need to find the lowest priced intervention reduces the clinician’s access to more advanced therapies, even where evidence exists to show that they can deliver improved outcomes and efficiency. Care pathways and protocols that provide clear guidance on the appropriate use of advanced technologies offer real potential to improve outcomes and reduce the costs of wound management.

As Baroness Jolly, Liberal Democrat Lords spokesperson for health, said, “There are many voices and players in this discussion: the clinicians, the commissioners, industry, those who are trying to improve performance and save money by rationalising systems and processes, and of course the patients too.”1 ​ All of these stakeholders have the common

interest of delivering improved outcomes and cost effective wound care, incorporating the appropriate use of innovative technology. With an ageing population and ever-increasing demands on community nurses, it is vital that a national strategy is put in place to address the burden of wound care.

Procurement practices need to embrace the potential of technology to disrupt the inefficiencies of current practice and enable sustainable care pathways that reduce the burdens on patients and the NHS. REFERENCES 1.

Lords House, “NHS: Wound Care,” London, 22 November 2017.

2.

J. Guest, N. Ayoub and T. McIlwraith, “Health economic burden that wounds impose on the National Health Service in the UK,” BMJ Open, vol. 5, no. 12, 2015.

3.

J. Guest, K. Vowden and P. Vowden, “The health economic burden that acute and chronic wounds impose on an average clinical commissioning group/health board in the UK.,” Journal of Wound Care, vol. 26, no. 6, 2017.

4.

J. Guest, N. Ayoub and T. McIlwraith, “Health economic burden that different wound types impose on the UK’s National Health Service,” International Wound Journal, vol. 14, no. 2, 2016.

5.

C. Dowsett, J. Hampton, D. Myers and T. Styche, “Use of PICO to improve clinical and economic outcomes in hardto-heal wounds,” Wounds International, vol. 8, no. 2, 2017.

6.

C. Lindholm and R. Searle , “Wound management for the 21st century: combining effectiveness and efficiency.,” International Wound Journal, vol. Jul, no. 13, 2016.

7.

Woelber, E., Schrick, E. J., Gessner, B. D., & Evans, H. L.

(2016). Proportion of surgical site infections occurring after hospital discharge: a systematic review. Surgical infections, 17(5), 510-519.

8.

Stephen-Haynes, J., Bielby, A., & Searle, R. (2011). Putting patients first: reducing the human and economic costs of wounds. Wounds UK, 7(3), 47-55.

9.

Hyldig, N., Birke‐Sorensen, H., Kruse, M., Vinter, C., Joergensen, J. S., Sorensen, J. A., ... & Bille, C. (2016). Meta‐analysis of negative‐pressure wound therapy for closed surgical incisions. British Journal of Surgery, 103(5), 477-486.

10.

V. Strugala, “Scientific and medical affairs PICO evidence summary,” Surgical Infections, November 2016.

11.

World Union of Wound Healing Societies. (2008).

Wound infection in clinical practice. An international consensus. International Wound Journal, 5(Suppl 3), 1-11.

12.

MolecuLight Inc., “MolecuLight i:X User Manual”.

13.

R. DaCosta, “Point-of-care autofluorescence imaging for real-time sampling and treatment guidance of bioburden in chronic wounds: first-in-human results.,” PLoS ONE, vol. 19, no. 10, 2015.

14.

Forni C, D’Alessandro F, Gallerani P, et al.

Effectiveness of using a new poly-urethane foam multi-layer dressing in the sacral area to prevent the onset of pressure ulcer in the elderly with hip fractures: A pragmatic randomised con-trolled trial. Int Wound J. 2018;1–8.

11

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23/05/2018 11:47

ISO 13485:2016

g n i k c a r C the code

T

he update to ISO 13485 doesn’t exactly make for light reading – which is why MedTech Innovation News asked Richard Poate, senior manager at notified body Tüv Süd for help in deciphering the revised standard.

WHAT ARE THE REQUIREMENTS? ISO 13485:2016 addresses the development, implementation and maintenance of a quality management system for medical device manufacturers and suppliers. The standard details how customer specifications and relevant regulatory requirements should be incorporated within an organisation’s quality management system.

Published on 1st March 2016, ISO 13485:2016 has a three year transition period for device manufacturers and other organisations, after which old ISO 13485:2003 certificates will expire on February 28, 2019.

WHAT’S NEW? There are significant changes in a number of important areas: QUALITY MANAGEMENT SYSTEM (CLAUSE 4) All processes that are part of a manufacturer’s quality management system will now need to be developed using a risk-based approach.

This represents a significant expansion from ISO 13485:2003, in which only product design controls and product realisation processes were subject to risk management requirements. In addition to this important change, processes that are outsourced must also apply a riskbased thinking approach.

This section also states that any software used as part of the quality system must be validated and documented. In addition, the revised standard requires the maintenance of a comprehensive technical file for each manufactured device that includes a description of the device along with all relevant specifications and records.

MANAGEMENT RESPONSIBILITY (CLAUSE 5) Changes to this section primarily involve clarifications of existing requirements regarding quality management system planning, responsibility and authority, management representation and management review.

RESOURCE MANAGEMENT (CLAUSE 6) Device manufacturers will be obliged to define the specific skills and experience required for personnel involved in the maintenance of the quality management system. ISO 13485 certified organisations will also have to maintain

systems for ensuring that personnel maintain the requisite knowledge through ongoing training, as well as assess the effectiveness of such training.

A new clause in this section also addresses contamination control issues for sterile medical devices, and includes requirements related to the validation of processes intended to ensure the integrity and effectiveness of sterile device manufacturing.

PRODUCT REALISATION (CLAUSE 7) Clause 7 addresses specific requirements within each of the areas defined within this enlarged scope of product realisation. Medical device manufacturers will also be expected to incorporate risk management principles in determining the application of these requirements. New sub-clauses have been added in design and development for transfer of design, as well as development outputs to manufacturing and maintaining a design and development file.

MEASUREMENT, ANALYSIS AND IMPROVEMENT (CLAUSE 8) Device manufacturers will be expected to formalise their processes for obtaining feedback from both production and postproduction activities, and to develop sound methods for incorporating that feedback into its risk management programme.

Requirements regarding the investigation and control of nonconforming products, as well as those related to corrective and preventative actions, have been strengthened. New subclauses have also been created in monitoring and measurement for complaint handling and reporting to regulatory authorities.

HOW CAN MANUFACTURERS PREPARE? Given the extent of the changes, transitioning to the new requirements is likely to take a considerable investment of time and resources. Therefore, medical device manufacturers and other ISO 13485:2003 certified organisations are advised to promptly begin the process of evaluating the application of the standard’s updates against their existing quality management system, in order to determine the scope of required changes and the time that will be needed to implement them.

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the healthtech series

www.digitalhealthage.com

YOU CAN TEAcH an old dog new tricks

H

ow do you turn an established medtech business into a digital health pioneer? Mitch Beaumont, Prashanth Prasad, Ulrica Sehlstedt and Mandeep Dhillon, from management consultancy Arthur D. Little explain.

Recent advances in technology, along with changes in healthcare reimbursement models and care delivery pathways, have created opportunities for digital products and services to play an important role in healthcare. The benefits of digital, such as lowering costs, increasing patient engagement, and improving outcomes, have been discussed extensively. Many new entrants and start-ups are taking advantage of the opportunity and challenging established healthcare companies, hoping to get a share of an industry that makes up about 10 percent of the global economy. These organisations employ newer, more agile working models that are better aligned with being digital. A further advantage is emerging: regulators that have not been friendly to software products in the past have started to embrace new iterative development approaches to accommodate the growth of digital health.

In contrast, established medical technology companies face a different picture. Their operational and cultural DNA has been steeped in rigid company processes that were created to minimise the risk of noncompliance with regulatory requirements such as FDA guidance. For many of them, results have been elusive as going digital has strained their current ways of doing business.

In fact, being successful with digital products and services requires established companies to rethink their business models and the underlying operational models. This can be seen with some recent examples of established medical technology companies that have found levels of success.

RETHINKING MODELS – ROCHE DIAGNOSTICS Roche Diagnostics saw insufficient outcomes from diabetes treatments and decided a more holistic approach was needed to manage diabetes. To that end, it adopted an ecosystem approach to connect and offer integrated digital solutions to all stakeholders involved in the diabetes management cycle, in order to optimise care processes and improve prevention.

Before the ecosystem was created, Roche’s main value proposition was offering its diabetes management systems, such as glucose meters and insulin pumps.

With the ecosystem, Roche could expand its value proposition for patients and enable “more time in range”, leading to fewer hospitalisations. Roche became a partner to patients,

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helping them manage their conditions, rather than just being a manufacturer of products. Operationally, Roche separated Roche Diabetes Care into a subsidiary with its own operating model to facilitate the creation of a worldleading big-data ecosystem for diabetes management.

A new, global hub with the required digital and IT capabilities was created in Barcelona, and co-promotion and distribution partnerships were set up with a number of complementary companies, including Medtronic, mySugr and Senseonics.

With this successful digital transformation, Roche went from only treating sick people in acute care settings to enabling treatment in chronic care and remote settings. In addition, it increased patient engagement to proactively assist in prevention by improving patient lifestyles.

A FRAMEWORK TO GUIDE THE DIGITAL TRANSFORMATION Based on our experience, and from assessing examples such as Roche, we have identified two sets of primary levers that executives can use to impact the changes to their companies’ business and operational models that are necessary to support a digital business. The specific levers used, and the degree to which they are “pulled”, will be unique to each company’s environment and its ultimate goals for digital. Most medical technology companies, including the examples cited above, will focus more on two or three of these levers, with more minor changes in the others happening.

the healthtech regulation series

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BUSINESS MODEL LEVERS • Value proposition. Digital products and services can enhance or shift a medical technology company’s value proposition in the market. For example, it can extend its products to provide remote-monitoring capabilities that improve care and reduce costs.

Or it can offer tools such as applications and reminders to increase patient engagement and improve adherence.

Typically, a digital business will want to build upon the company’s existing core value proposition, rather than creating a completely new one.

• Value extraction. Most medical technology companies have focused on selling devices, or generating revenue per unit. However, monetisation of value can take on alternative forms with digital, such as service-oriented models, e.g., selling hours of operation for a home health device versus the device itself, and datacentric models, e.g., selling the data generated by the devices. These new models may require working with government payers and insurance companies to gain support for reimbursement.

• Markets served. Digital can enable a company to shift or expand the markets it serves to open up new business opportunities. For example, digitally enabled products and services can be marketed to caregivers of the elderly or children who are willing to pay for access to data on activity or medication adherence to give them peace of mind. Alternatively, companies may be able to create new business relationships with other value-chain players,

such as home health companies, by providing information that improves the effectiveness and efficiency of in-home care delivery.

OPERATING MODEL LEVERS • Process/methods.

Going digital requires new ways of working.

Software development cycle times are faster, and will be more effectively enabled by agile methods, which are fundamentally different from existing linear or phase-gate approaches employed by most medical technology companies. Robust technology and portfolio management methods are needed to keep up with the faster pace of technology change and ensure R&D resources are invested in the right areas.

• Delivery network.

Becoming digital can create opportunities for medical technology companies to engage with a broader ecosystem to develop offers and reach the market. The complexity and systemlike nature of many digitalcentric solutions creates attractive opportunities to engage development and/ or delivery partners.

• Capabilities/footprint.

Adding digital elements to a portfolio will require new capabilities in areas such as application development, data

management and security.

In addition, medical technology companies will require capabilities in areas such as consumer insight and behavioral economics to ensure their digital-health solutions meet patient/user needs and expectations. The organisational footprint should also be an important consideration to help gain technical talent or local market knowledge and access.

HOW TO GET STARTED There is a clear set of initial steps an established, analogue-native medical technology organisation should take to get started on a digital transformation.

Even if an organisation has jumped into creating digital elements or dabbled in deploying a digital service, it will pay dividends to go through the steps to ensure there is a strategic alignment between what the market needs and what the company does.

• Get a firm understanding of stakeholder needs, especially latent needs, of patients, users, and other relevant players independent of the application of digital.

• Develop ideas into solution concepts, often with multiple ideas brought

together into one.

• Evaluate the implications to the business model and underlying operating models for each prioritised solution concept.

• Only once the implications for the business model and operating model are understood can an organisation set its strategy and plan for going digital.

CONCLUSION There is significant value to be captured with digital products and services in the healthcare industry.

Many new entrants are well positioned to compete because their models are oriented towards software development – more so than existing, analognative medical technology companies, which are organised to comply with regulations. For these companies, going digital will require significant businessand operational-model changes.

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MED-TECH INNOVATION | NEWS

SUBSCRIBE TODAY MED-TECH INNOVATION NEWS IS THE UK AND IRELAND’S LEADING PUBLICATION FOR MEDICAL DEVICE DESIGN AND MANUFACTURING TECHNOLOGY If you work in medical devices, this is your companion for daily news, technical content, analysis, case studies and high profile interviews with industry experts and thought leaders.

A subscription to Med-Tech Innovation News gives you access to the latest guidance for the design and manufacture of class I, II and III medical devices.

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ON THE COVER

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As the number of minimally invasive surgeries continues to grow, healthcare professionals continue to seek new and better tools to deliver the best care for their patients. Leading development in this area is a keen interest in smaller or microcatheter designs for endovascular catheterisation procedures, as Kevin J. Bigham, PhD., technical writer for Zeus explains.

nhancements in miniaturised devices can lead to improved efficiency and effectiveness and reduced trauma for patients.

Microcatheters address a broad portion of endovascular disorders including peripheral artery disease (PAD) and neurovascular disease because of their ability to access smaller vasculatures.

Access to these small vessels presents obvious size limitations for the device but also for intraluminal catheter technologies such as intravascular ultrasound (IVUS), atherectomy devices, cameras, and fibre optics. Recently, Zeus Industrial Products, Inc., (headquartered in Orangeburg, SC, USA) has developed an extremely thin-walled PTFE catheter base liner to address microcatheter design and vascular access. This product features a maximum liner wall thickness of 0.01905 mm (0.00075′′) and is the thinnest catheter base liner made to date. With such extremely small dimensions, this PTFE catheter liner creates greater lumen potential and allows for a smaller overall finished catheter device.

The 0.01905 mm (0.00075′′) maximum wall liner is an improvement over earlier generations of this extrusion technology. Previously, thin-walled PTFE extrusions used as catheter liners were generally limited to walls no thinner than 0.025 mm (0.001′′) and lacked certain mechanical consistencies for very-fine-tuned or precision applications.

In addition to a proprietary process, the new 0.01905 mm (0.00075′′) liner, called StreamLinerXT by Zeus (part of the Zeus StreamnLiner series), achieves a consistent wall thickness by stretching or drawing down the liner after it is placed over the mandrel during catheter construction. The drawdown process fits the liner snugly over the mandrel for secure and repeatable construction. Furthermore, and through the manufacturer’s exclusive technology, the 0.01905 mm (0.00075′′) wall liner possesses significant strength and toughness despite its extremely thin nature. For catheters made with this

new liner, mechanical attributes such as torsional response, flexibility, and stiffness appear to meet the criteria necessary for use with fine vascular procedures.

There are other benefits to using PTFE when it can be extruded to meet such microcatheter requirements.

PTFE has an extremely low surface friction – a highly desirable trait for a catheter lumen. The low surface friction is also more uniform because it is an extrusion followed by a manual draw-down. Low surface friction of the catheter lumen reduces the deployment force (minimises resistance) for various intraluminal catheter technologies like those cited earlier. For more delicate catheter-deployed devices such as stents, the lower and uniform lumen wall friction minimises the potential for collapse of the stent before reaching its destination. On the whole, this highly lubricious thin-wall extruded lumen presents many attractive features over existing similar technologies and products.

Finally, there are the salient advantages of using a smaller device.

Minimally invasive surgical procedures (MISPs) are almost always preferred versus open surgeries because MISPs significantly reduce trauma to patients.

Reduced trauma speeds healing for patients, reduces hospital stays, and reduces the overall healthcare burden for that patient. Considering the prevalence of chronic endovascular diseases in nearly all modern societies, technologies that reduce trauma further still, such as the 0.01905 mm (0.00075′′) liner appears poised to do, are always in demand. Moreover, the ability to produce ever smaller microcatheters allows access to the smallest vasculatures, even those approaching the smallest neurovascular networks.

With greater access come expanded options for MISPs versus open surgeries.

These smallest micro-devices also lay the groundwork for possibilities of innovative catheter technologies which have yet to be conceived.

PUSHING THE

ENVELOPE 17

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2000

2010

2018

2028

To celebrate the 70th anniversary of the NHS, we’ve put together this infographic charting a history of innovative progress - as well as a glance at the hospital of the future.

In 1998, NHS Direct was launched as a way to provide convenient alternatives to GP services.

NHS Direct grew to become the biggest single e-health service in the world and was only disbanded in 2014 to make way for the NHS 111 service.

The next ten years will see digital technologies start to become more widespread. In 2014, both My NHS and NHS 111 are launched to better utilise data and smart technologies. NHS 111 Online helps direct patients to the right point of care and My NHS aims to let the public compare the performance of health services.

Paperless: Plans for the entire of the NHS to be paperless by 2018 are now looking unlikely and even an extended deadline of 2020 is disputed in the Watcher Review on NHS IT. The review states that instead, all NHS Trusts should be largely digitised by 2023 - still a positive step forward for a more modern health service.

Additive manufacturing: The development of bioprinting research will bring the possibility of 3D printed organs closer to reality.

Machine Learning: The creation of machine learning will benefit a whole range of NHS services. AI will help doctors diagnose diseases quicker, algorithms will sift through medical data in search of new treatments and patients are benefitting from AI chatbots.

Robot-assisted surgery: This will become the norm in healthcare. Surgeons willl be assisted by robots which can use advanced sensors and imaging to highlight important parts of the body.

VR and AR: Surgeonswill be able to gain assistance from healthcare professionals anywhere in the world.

Past, present and future

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1950

1960

1970

1980

1990

Shortly after the Second World War, founder of the NHS, Aneurin Bevan, opened the NHS at Park Hospital (now known as Trafford General) as the result of an ambitious plan to make healthcare an essential right to all UK citizens.

Perhaps the biggest healthcare discovery to come in the next 10 years is research revealing the structure of DNA. Discovered by Cambridge University scientists, James D Watson and Francis Crick, DNA is opens up the possibilities of further research into diseases caused by defective genes.

The next decade saw a range of treatments becoming available to patients, including the first British heart transplant which took place in London. Other advances included the increased use of endoscope and kidney dialysis, and the advent of whole body CAT scans.

In 1980 two major advances were made to healthcare. The introduction of MRI scanners provided doctors with clearer information into the body, making it particularly useful for finding tumours. Keyhole surgery was also used for the first time to remove a gallbladder and has since become one of the most useful procedures.

In 1988, breast screening units were introduced to help reduce the number of breast cancer deaths in women over 50. The programme, alongside improved drug therapies helped reduce the number of deaths by over 20%, making it an important milestone in the battle against cancer.

DESIGN

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Healthtech and wellness tech are two fields which are increasingly overlapping – and one thing they have in common: design credentials.

Orrb is a wellness device that could have major implications for healthcare delivery. MedTech Innovation News editor Dave Gray met with its designer, Lee McCormack, at Clerkenwell Design Week.

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design for life

With medical devices and wellness products taking an increasingly consumer-centric design, how is the design process evolving for those in the field? Lee McCormack’s Orrb has been through that process and has undergone several iterations along the way. His journey saw him form partnerships with McLaren F1 as well as Disney, to name just two.

The product dates back to 1997, when McCormack was finishing his degree in design at Goldsmiths, having spent the previous few years travelling through India and Nepal learning techniques in mindfulness and meditation.

He tells me he was fascinated by the role of psychology and anthropology in the creative process – an interest he gained from his experiences in remote communities.

“I was interested in social cohesion and social tensions, the interplay between those things, and how that manifests in the environments the people operate in,” he explains.

At the same time, the late nineties were a time of technological – and aesthetic – evolution.

“The architecture was starting to shift from cubicle

format into open-plan format.

I asked: what impact was this having on people’s wellbeing, and the interplay between leisure and work?”

Workspaces were going open-plan, and to match that in the digital world, mobile technologies and social networks were also breaking down the barriers to communication.

McCormack recalls how “people would plan where to place water coolers in the office for maximum interaction between employees who wouldn’t normally interact.”

He studied this shift, and concluded that people working in the city would soon need some respite from all the openness.

“The outcome in the West of the proliferation of technology was an increased ability to be connected, but also an increased ability to keep on working and to do more work. Privacy was diminishing, the barriers between work and play were diminishing.

It seemed obvious to me that over time there would be consequences from this insatiable drive towards openness and connectivity.

And sure enough, the outcome has been increased levels of stress and the inability for people to focus on particular tasks,” he explains.

That’s when, in 1997, he began working on a space that would enable a person to feel safe, and secure, allowing them to recuperate and recover from stress.

“As a product designer you start to create a brief around the requirements for delivering this solution.

You have to look at spatial constraints, ergonomic restraints and manufacturing challenges. We ended up with a very small footprint. I made the first prototype in 2002, but

even now the actual form has never changed. It’s expanded and contracted a little, but through specialist techniques I was able to bring the footprint right down while keeping the size the same inside.

“The whole body is actually supported in a reclined position. Once I’d determined the optimum position I wanted to place them in, the form of the device was wrapped around that.”

Lots has changed in the 20+ years of Orrb’s development, not least in the technology space. This means that there’s a need for a lot of modularity. All of the so-called ‘touchpoints’ included in Orrb are interchangeable, allowing for a degree of futureproofing, without needing to change the overall form of the product.

I asked McCormack about the process of finding and working with industry partners to design Orrb.

“The partners I worked with have always been a mix of my own handpicked teams, mostly mechanical engineers.

“Most of the companies I worked with were using the product as a marketing tool.

So that’s how I was able to keep the vision alive. Disney ordered 25 of the pods and used them to market some of their movies.

We are there when reliability is of top priority.

Disney had seen an early prototype of Orrb in a window in Selfridges – part of an exhibition showcasing young designers. One of the producers for the Disney sci-fi film Hitchhikers’ Guide to the Galaxy asked if he’d be happy to loan them the product which was to be featured within the ‘Heart of Gold’ spaceship at the centre of the film.

Disney executives became aware of the product during filming and approached him again to enquire about purchasing 500 units. At the time, he’d only produced a few prototypes and wasn’t geared up for production on that scale. He eventually agreed to supply 25 units within their 12 week lead time.

“At the same time I formed a partnership with McLaren to engineer a new version of the product. They brought a lot of expertise, especially in terms of materials, which helped me take the product to a new level.

“In fact, I developed a couple of versions of the product with them. The kind of thing they learn in F1 is around materials science. Each team has an applied technologies division, and each of those divisions will try and devise other commercial uses from those technologies which evolve from racing cars.”

The 25 units were distributed worldwide in advance of the film release, with five in the UK, seven in the US and the rest across Europe and Brazil.

McCormack worked with Disney’s creative team and produced an interactive user experience that was used to engage the public in the buildup to the film’s release in each country.

Disney then went on to use them for a number of other films including Pirates of the Carribbean; The Curse of the Black Pearl, and its sequel, Dead Man’s Chest, amongst others.

Major brands were now using Orrb as a marketing tool, but McCormack

still wanted to see it used as a wellness product. Unfortunately around that time, the financial crisis hit, and ideas like this became seen as non-essential in the office space.

McCormack’s vision has always involved developing a platform into which different technologies could be employed to help an individual with their wellbeing, through diagnostics, or even treatment.

Now launched into the workplace wellness sector, he’s getting ready to take on medtech.

“In 2018 we see a plethora of telemedicine, eHealth, online diagnostics. There’s loads of companies specialised in designing medical equipment into ever-smaller packages. The medical industry has started to fall in love with the ergonomics of design.

“There’s applications built into Orrb now like guided meditation, breathing exercises, and mindfulness. These things teach people resilience and techniques for reducing stress. But other technologies have evolved to the point where we can start to look at how they are delivered and design-in those technologies. This could include diagnosis, or even writing prescriptions.

The aim is to take away as many of the tasks as possible that people go to see a GP for. I’m thinking of this as a microclinic, with the incorporation of the best medical technologies that are available to us.”

Our innovative sensor solutions make medical devices even safer and more efficient.

www.first-sensor.com

InNOVATION

HOT SPOTS

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With its medical technology market estimated to be at around €110 billion, Europe can be viewed as one of the most vibrant and diverse locations for developments in the medtech sector.

Second only to the US, Europe’s medtech market accounts for almost a third of the world market and it has been growing on average by 4.4% Med-Tech since 2009. Figures from the European Innovation Patent Office are encouraging – showing that patents filed for News medical technologies were higher reporter than any other technology sector; beating digital communications and Reece computer technologies by over 1,000 Armstrong applications.

Indeed, tech giants such as Apple asks: where and Amazon are jumping on the does the opportunities that medical technology offers. Apple’s recent partnership innovation with AliveCor made the company’s come from in medical-grade ECG device available to Apple Watch owners across Europe? the world. The move highlighted the potential democratisation of healthcare that consumer medical devices offer and further emphasised Apple’s intent to enter the healthcare market.

UNITED KINGDOM With the third largest medical technology market in Europe, the UK has a lot to offer, even with the uncertainty of Brexit looming.

One of the UK’s major clusters for medtech innovation is Cambridge, where over 50 SMEs are based alongside leading universities, science parks and medical training institutions.

Cambridge Science Park for instance, hosts over 100 companies, including major players such as AstraZeneca and Philips.

In fact, research commissioned by AstraZeneca estimates that the Cambridge life sciences cluster could generate an extra £1 billion to the UK’s economy by 2032.

Andy Williams, vice president for Cambridge Strategy and Operations at AstraZeneca, said: “A strong science base is one of the jewels in the UK’s crown. Life sciences clusters such as Cambridge, where our global corporate headquarters have been located since May 2016, enable the scientific community to break down traditional boundaries to drive innovation.”

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One of the companies operating from Cambridge Science Park is Owlstone Medical, which has developed a Breath Biopsy device, to be used for the early detection of cancer and within precision medicine. The company has recently raised £11 million to support the commercialisation of its platform and is working alongside companies such as AstraZeneca and GlaxoSmithKline to study disease drivers in respiratory conditions.

It’s not just areas in and around London that are attractive to upcoming medtech companies though. The ‘Golden Triangle’ for instance, named for the innovative companies operating between Oxford, Cambridge and London, attracted over £1 billion of US investment last year. Since 2011, life sciences companies within the Golden Triangle have seen £472 million of investment and medical technology companies have taken in £207 million of investment from the US. Manchester is another city that has a thriving medical technology sector.

Manchester Science Partnerships’ (MSP) is perhaps the city’s biggest incubator for businesses operating within the life sciences sector. Over 300 life sciences companies operate within MSP’s campuses, and it is responsible for initiatives such as Mi-Idea; a post accelerator centre that is helping digital technology startups connect with businesses, academia and the government in the North of England.

One success story to have come out of MSP is Elucigene Diagnostics, a market-leading molecular diagnostics company developing products for the rapid detection of genetic diseases such as cystic fibrosis.

The company has grown from five to 30 employees over the past four years and is demonstrating growth both in the UK and overseas.

In fact, this year the company was awarded the Queen’s Award for Enterprise for its success in international trade. The company relies on its exports to overseas markets, and over 80% of its £3.7 million annual sales come from those made outside of the UK. When asked why Manchester is such a good location for the company, Dr Mark Street-Docherty, chief executive of Elucigene Diagnostics, said: “For us, Manchester and Citylabs is a fantastic location for our business. Citylabs 1.0 is based on Europe’s largest clinical academic campus, meaning we have unrivalled access to talent, world class research in precision medicine, and also to the NHS.”

GERMANY As Europe’s biggest market for medical technology, Germany has over 1,000 medical device manufacturers (most of which are SMEs)and the country benefits from collaborations with its academic and scientific communities. A high rate (44%) of students studying subjects relevant to the medical technology industry means that Germany will likely continue as an industry leader.

Certain regions of the country boast large clusters of medical companies. Tuttlingen for instance, located in the south of the Germany, claims to be the world centre for medical technology and is home to over 400 medtech companies. The region is mainly known for its high volume of surgical tool makers, but medical device manufacturers such as Stryker, and orthopaedic implant specialists, Emerging Implant Technologies, give weight to Tuttlingen’s claim as the world centre of medical technology.

But Germany’s medtech market isn’t localised to one region and the industry stretches across the entire country. Acting as a hub for partnerships throughout Europe is EIT (the European Institute of Innovation & Technology). Within Germany, EIT has offices in Mannheim and Heidelberg, with biotech giant Roche Diagnostics acting as host to the offices. A regional collection of 150 SMEs contributes to the strong innovation ecosystem that exists around Heidelberg and Mannheim.

IRELAND Sitting right next to the UK, Ireland has perhaps one of the most exciting medtech sectors in Europe and is recognised as an emerging hub across the world. Impressively, the country exports €12.6 billion worth of medical products every year to over 100 countries around the globe.

More so, Ireland is the largest medtech employer per capita across Europe and boasts an industrial workforce of 29,000. The impressive stats don’t stop there. With 18 of the world’s top 25 medtech firms operating in Ireland and 234 home-grown companies, Ireland offers a mix of global and local organisations operating across the entire spectrum of medical technologies.

In April, Galway-based Kite Medical received €1.5 million to help develop its non-invasive device to detect kidney reflux in children with urinary tract infections (UTIs).

The device uses wearable technology to monitor changes in the kidneys and monitor symptoms of kidney reflux. The device was developed to replace the current diagnostic test for kidney reflux, which can be distressing for children as it requires a catheter, the bladder to be force-filled and exposure to radiation.

Ireland’s strong medtech sector benefits from a range of collaborative initiatives that help to promote the development of innovative healthcare solutions. Health Innovation Hub Ireland (HHIB) for instance, was launched in 2016 to help start-ups and expanding healthcare companies gain easy interaction with hospitals and primary care centres.

Other organisations such as Enterprise Ireland are helping to bolster the country’s reputation as a global hub for innovation. Whilst Ireland is home to major OEMs such as Medtronic, Becton Dickinson and Boston Scientific, Enterprise Ireland is placing bets on both the country’s academic research institutions, and the abundance of start-ups that are currently active. In fact, last year Enterprise Ireland supported 181 start-ups investing €31 million through its High Potential Start-up and Competitive Start Fund.

Speaking about the importance of EU funding, Carlos Moedas, European Commissioner for Research, Science and Innovation, said: “The ERC’s Advanced Grant scheme has supported outstanding and established research leaders since 2007. It provides a great example of how EU funding can help expand the frontiers of scientific knowledge, providing the resources necessary to continue ground-breaking, highrisk projects, and ensure Europe’s global competitiveness.”

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NORTH AMERICA EVENT CALENDAR

Joining forces

JUN 12–14, 2018 // NEW YORK, NY

JAN 29-31, 2019 // SANTA CLARA, CA

JACOB K. JAVITS CONVENTION CENTER

SANTA CLARA CONVENTION CENTER

Atlantic Design & Manufacturing, ATX East, EastPack, MD&M East, PLASTEC East, Quality Expo

DesignCon

SEP 11–13, 2018 // NOVI, MI SUBURBAN COLLECTION SHOWPLACE

The Battery Show, Electric & Hybrid Vehicle Technology Expo, Critical Power Expo

OCT 31–NOV 1, 2018 // MINNEAPOLIS, MN MINNEAPOLIS CONVENTION CENTER

ATX Minneapolis, Design & Manufacturing Minneapolis, ESC, MD&M Minneapolis, MinnPack, PLASTEC Minneapolis

NOV 14–15, 2018 // MONTRÉAL, QUÉBEC PALAIS DES CONGRÈS DE MONTRÉAL

FEB 5-7, 2019 // ANAHEIM, CA ANAHEIM CONVENTION CENTER

ATX West, MD&M West, Pacific Design & Manufacturing, PLASTEC West, WestPack

MAR 13-14, 2019 // CLEVELAND, OH HUNTINGTON CONVENTION CENTER OF CLEVELAND

Advanced Design & Manufacturing Expo featuring ATX, Design & Manufacturing, MD&M, Pack, PLASTEC

MAY 15-16, 2019 // BOSTON, MA BOSTON CONVENTION & EXHIBITION CENTER

BIOMEDevice Boston, Design & Manufacturing New England, ESC

Advanced Design & Manufacturing Expo featuring ATX Montréal, Design & Manufacturing JUN 4-6, 2019 // TORONTO, ON Montréal, Expoplast, Montréal Powder & Bulk TORONTO CONGRESS CENTRE Solids, PACKEX Montréal PACKEX Toronto, PLAST-EX, ATX Canada, Design & Manufacturing Canada, Toronto Powder & Bulk Solids DEC 5–6, 2018 // SAN JOSE, CA SAN JOSE CONVENTION CENTER

BIOMEDevice San Jose

APR 28–30, 2020 // ROSEMONT, IL DONALD E. STEPHENS CONVENTION CENTER

International Powder & Bulk Solids

For more information please e-mail us at: amgpartners@ubm.com

THE IN CROWD

Joining forces The Health Tech Alliance is an informal coalition of medical technology companies, working with the NHS and other key stakeholders to raise the profile of medical technologies, devices and diagnostics and drive up their adoption throughout the health service. We provide an informal platform for companies both small and large to get involved in strengthening the voice of their sector.

T

hroughout the first half of 2018, Med-Tech Innovation News met with a selection of Industry associations to find out what each one offers.

This first report is from Dame Barbara Hakin, chair of the Health Tech Alliance.

We asked Dame Barbara what the alliance stands for, and how measures such as the Accelerated Access Review can be put into practise.

The Alliance believes that the UK’s thriving medtech sector holds enormous potential in alleviating pressures on clinical staff, enabling greater self-care among patients and reducing bed days – all of which benefit both patient outcomes as well as the overstretched health service itself. It is therefore our mission to ensure that patients can access the wealth of innovation currently developing within the medical technology sector by alleviating the market access and reimbursement obstacles that currently affect the sector.

We do this by working as collaboratively as possible. Changes to wider health policy can have a profound effect in shaping the business environment for individual companies and it is therefore necessary to engage with government departments, health bodies and politicians in ensuring that the voice of medtech is considered – something we do on behalf of our members, while keeping them updated through timely intelligence on key industry and political developments that can affect their business.

Our regular members’ meetings allow them to engage directly with stakeholders such as those from NICE, NHS England, the AHSN network and the Office of Life Sciences. They also provide a space for them to share best practice with industry peers and explore opportunities for further collaboration with leading market access experts and other members.

There have been recent policy announcements that do demonstrate an encouraging commitment from the Government in ensuring that important

innovations are given the chance to deliver greater efficiencies within the NHS. The Government’s response to the Accelerated Access Review in November 2017 pledged £86 million of Government support to drive the uptake, adoption and diffusion of health technologies along with the introduction of an Accelerated Access Pathway for up to five transformative protects a year. We’ve also seen the announcement of a Life Science’s ‘Sector Deal’ that outlines a series of commitments and investments from Government to drive both growth and productivity within the life sciences sector.

These measures do set a high-level of ambition and I hope, on behalf of our members and the wider industry, that this is a first-step towards the Accelerated Access Pathway expanding in the future so that a greater number of lifechanging medical technologies reach patients sooner. However, we the Alliance believe that for medtech companies to truly benefit from measures such as the Accelerated Access Review, industry voices must be working with policy makers to inform decisions and have a role in implementation.

The Health Tech Alliance offers members the chance to do so, in intimate, informal settings. To get the most out of joining the Alliance, we need members to not just engage but engage constructively with other bodies. The NHS faces huge challenges and the industry needs to work together and with the NHS to find viable solutions to these challenges.

We aim to facilitate this problem-solving approach by encouraging collaboration between member companies and senior stakeholders and the numerous organisations that make up the health system. We believe this is vital to ensure patients get the best possible treatments and the best possible outcomes.

For more information on the Health Tech Alliance, visit www.healthtechalliance.uk or contact the Secretariat at secretariat@ healthtechalliance.uk

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CATHETERS, STENTS AND TUBING

Be my eyes and ears About 10% of the western population will, at a certain stage in their life, be taken to a catheterisation laboratory for angioplasty surgery (stent placement), treatment of an arrhythmia or a heart valve replacement.

This ikautxo Medical percentage is increasing OEM explains with an aging why more population. customers Fortunately, most of these are seeking interventions catheters can be carried with sensor out using minimally technology invasive built-in, and procedures that are how this has assisted by impacted smart imaging production. and sensing catheters that are the ‘eyes and ears’ of the surgeon directly at the point of intervention.

The growing number of cables in the cath lab is rapidly becoming a problem. The interventionist increasingly has to deal with instruments that have electrical cables connected to them. These cables hamper the workflow, and can result in dangerous situations eg, when a cable hooks behind the rotating x-ray c-arm, or during an electrical cardioversion.

Sensing smart catheters are consequently more and more demanded in the cath lab.

C

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‘SENSING’ TRENDS IN CATHETERS To improve the success rate of the most important cardiovascular diseases but also for other type of surgeries, catheter manufacturers have started to add electronic sensing functionality to the instruments resulting in what is referred to as ‘sensing’ catheters. Here, different examples of catheters are distinguished based on their

application disease. Some of the ongoing applications today are: UROLOGY: Foley catheter temperature sensors enable clinicians to accurately monitor urinary output and bladder temperature in addition to facilitating urine drainage.

Commonly used also to monitor a patient’s body temperature during surgery.

VASCULAR: vascular catheters with blood glucose measurement have the potential to become a standard of care for the management of blood glucose levels in the critical care units of the hospital. The near-continuous glucose measurements automatically transfer whole blood from a radial artery, peripheral vein, or central venous catheter to an external flow-through glucose sensor. A vascular catheter with this type of sensor acquires a fresh blood sample every five to 15 minutes, measures the concentration of blood glucose, and then flushes the sample back into the bloodstream using flush solution. Standardisation of blood sample acquisition, analysis, and calibration will increase the accuracy and precision of the blood glucose measurement, a major advantage of those catheters compared to routine clinical methods.

ON-GOING THERAPY: a whole new class of implantable devices is being developed with the purpose of delivering local and on-going therapy. These ‘electroceuticals’ stimulate or block nerves directly addressing organs.

The ‘sensing’ catheters are contributing to industry 4.0, Where the internet of things (iot) will also conquer the internet of medical devices (imd).

MANUFACTURING ‘SENSING’ CATHETERS “Customers are increasingly demanding sensor integration in our oem catheter manufacturing activity. We are embedding different types of sensors, from the most common ones like temperature or pressure sensors, up to the most difficult ones, like position systems.

“Sensors are very fragile components that need to be carefully manipulated during the assembly in the catheter. Intensive tests are also made to validate the correct sensing functionality after the product final assembly.

“Our sensor r&d centre, ikerlan, located only a few miles from our cleanroom facilities, means we stay on top of the latest technologies in sensors, so we can help our customers to select the most appropriate solution for their needs,” said iker principe, ceo, Cikautxo Medical OEM.

TESTING & INSPECTION

Inclusive design in recent years has become more and more popular, due mainly to an increasing aged population and a desire to create a product that is suitable for all.

Sometimes this type of product testing involves the use of empathy tools, or simulation tools. But Venetia Dickinson, Medical Device Usability asks: can they keep up with real world evidence?

Time for a little

EMPATHY

I

t is a greatly important design principle not only to broaden the target market available but to produce a product that is more sustainable for the business and environment.

Inclusiveness is a philosophy medical device companies have had to think about from the start given that in most cases the medical device could be used by a variety of people and user types each with different physical capabilities and needs.

With an increase in inclusive design, there has become an increase in empathy tools designed to simulate certain conditions such as aged hands or rheumatoid arthritis by restricting motion and function. Empathy tools are intended to help develop empathy with users as well as an understanding of their capabilities. The simulation tools are advertised to be used throughout the design process from understanding the customer needs through to testing the concept and verifying the usability of the device2.

THE DESIGN OF MAINSTREAM PRODUCTS AND/ OR SERVICES THAT ARE ACCESSIBLE TO, AND USABLE BY, AS MANY PEOPLE AS REASONABLY POSSIBLE ...

WITHOUT THE NEED FOR SPECIAL ADAPTATION OR SPECIALISED DESIGN. 1

But can simulation tools really compare to actual users? Can you determine the usability of a product just through physical limitations?

There are no studies currently that verify the actual effectiveness of the devices at simulating specific capabilities such as aged hands. Though cited as a useful tool for inclusive design, no papers

could be found that compared simulation devices against normative characteristic data and further to this there are no studies that compare the various empathy tools against each other and so no qualitative data to determine which tool is best.

It’s an intriguing concept to ‘wear a user’s disability’ and be able to create a specific scenario with any one from the general population however until theses simulation devices have been proven to effectively simulate the necessary capabilities of a desired user group, regulations agencies are unlikely to accept the devices as a validation method for usability. Although they may be a useful tool for a designer to understand their customers’ capabilities,for the moment let’s keep usability to the users.

REFERENCES

British Standards Institute, “Design management systems –Managing inclusive design,” BS 7000-6:2005, 2005.

2 Woodhouse Publishing Series, Integrating the Packaging and Product Experience in Food and Beverages, 1st ed. Elsevier, 2016.

1

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Enabling Life Science companies to bring products to market quickly, at less cost and with reduced risk

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Medical Devices Testing and Evaluation Centre (MD-TEC) provides access to the latest state-of-the art simulation, usability and testing facilities for medical technology and life science companies. MD-TEC features a fully equipped replica operating theatre, intensive care, trauma and ward bed areas; alongside state of the art bio and chemical engineering laboratories with research focus around innovative bio-materials and testing new medical devices.

FINANCE AND FUNDING

e h T g n i r Sha

LOVE

C

hristopher Murray, relationship director, Barclays shares how the bank’s Eagle Labs initiative helped Irish startup Neurovalens break into the US market.

Exporting for the first time can be a risky business. That’s why choosing to take the plunge and break into international markets requires financial support and serious amounts of self-confidence. Connecting with the right people, accessing capital, and navigating a new culture can make the integration process daunting. But that’s just what Neurovalens, a neuroscience and technology start-up from Belfast, has succeeded in doing when exporting its headset, Modius.

NEUROVALENS’ ROOTS Neurovalens is a Northern Ireland company dedicated to improving the lives of millions of people around the world using neuroscience and technology. Its lightweight headset has proven that when worn for an hour a day for two to three months it helps wearers to lose excess weight. The startup is helping people on their weight-loss journey - and evidence suggests they’re succeeding.

Neurovalens was co-founded in 2013 by Jason McKeown and Paul McGeoch – neuroscientists and doctors from Northern Ireland and Scotland. Jason holds a Bachelor of Medicine, Bachelor of Surgery and Bachelor of Obstetrics from Queen’s University, Belfast, while Paul gained his primary medical degree from the University of Aberdeen. He was subsequently awarded the higher degree of Doctor of Medicine by examination for his clinical research on vestibular stimulation at the University of California San Diego.

Applying neuroscience to weight-loss There are more than two billion people globally who are classified as obese, and many of these people will try to solve their weight issues with some form of calorierestricting diet. While some individuals will

lose weight this way, the vast majority will find that it eventually creeps back on.

Modius is designed for people who want to lead a healthy lifestyle. This means supplementing the headset regime with regular exercise and a healthy diet. It is described as ‘less of a killer-diet and more a fad diet-killer.’ The product uses electric pulses to gently and non-invasively stimulate the part of the brain known to control fat storage, metabolism and appetite, called the hypothalamus. This a crucial area in how the brain maintains stable internal physiological processes within the body. The low-level pulses received from Modius are interpreted by the brain as a signal to become leaner.

INITIAL SUPPORT FROM BARCLAYS EAGLE LABS IN BELFAST Barclays Eagle Labs are co-working spaces that were set up to help start-ups and scale up businesses innovate and grow. Residents have the opportunity to network and share knowledge with like-minded entrepreneurs, as well as access mentoring and funding. There are 15 Barclays Eagle Labs across the UK where the residents can develop their digital skills, and take their small business to the next step. Neurovalens was a member of one of these – the Belfast Eagle Lab. Prior to their introduction to the Belfast Eagle Lab, the co-founders of Neurovalens were relatively new to the business world and wanted to build a support network that could help them grow their business. This included obtaining funding advice, as well as building up their wider network to benefit from knowledge sharing.

Neuro-tech is still quite a new area of medicine for many people, so Modius needed to overcome scepticism, demystify its nascent technology and build trust and credibility

29

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All of our courses are available as public training, or as in-house, customisable courses that can be delivered at your own premises at a date and time that suits you.

• MDR & IVDR Training From introduction to implementation courses, our training is designed to benefit professionals who require to understand and prepare for the changes within the MDR and IVDR. • ISO 13485:2016 Courses As the deadline for transitioning to the revised ISO 13485:2016 is less than a year away, LR offers courses for medical device manufacturers who are planning to transition in the near future or looking to add to their existing knowledge of their quality management system.

• MDSAP Training The MDSAP implementation course is relevant to professionals involved with an ISO 13485:2016 management system and plan to continue placing devices on the medical market in Australia, Brazil, Canada, Japan and the US.

0800 328 6543 lrqatraining@lrqa.com lrqa.co.uk/medical-devices

FINANCE AND FUNDING

with a financial audience. As residents of the Belfast Barclays Eagle Lab they were introduced to other entrepreneurs, many of whom have experience in overcoming similar challenges associated with starting a business and whose expertise would prove invaluable.

The co-founders were able to meet with other high-growth start-ups and gain greater knowledge on how to expand the business.

The combination of business incubation, development workshops, mentoring and co-working opportunities were an important platform for expansion and exposure. Since the start of 2017, Neurovalens has grown from a team of three – Jason, Paul, and their chief marketing officer Tony Wilcox – to a team of over 20.

FUNDING ACCESS A Barclays customer since 2015 we spotted the potential in Neurovalens and identified the company as a high-growth prospect from its time spent at the Barclays Eagle Lab. This direct insight into the business and on-going relationship with Neurovalens has enabled us to assist the company as they have grown – connecting them to the people able to add the value and provide appropriate support.

Through the networks Neurovalens was able to access at Belfast Eagle Labs, the company has raised £1.5m in a seed round in 2017 from Angel investors and local Northern Irish Venture Capitalists (VCs). Following this, it launched a successful Indiegogo crowdfunding campaign, which raised nearly £1.4m in October last year.

CRACKING AMERICA It’s estimated that the weight loss market is worth a staggering $66bn in America. This made the US market a priority for Modius, and now the majority of headsets are sold here. But how did a three-man start up from Northern Ireland manage to secure customers over the pond?

As newcomers to the start-up community, the Neurovalens team did not have any prior business background connecting them with VCs or investors. The co-founders required advice to maximise impact on the US market, and we played a key role in introducing the start-up to a series of investors in order to continue its growth and access to finance – as well as identifying potential VCs ahead of further rounds of funding. Neurovalens is currently in the midst of a $10m ‘Series A’ round which it will close in late summer 2018; introducing them to VCs helped add value to this, and bolster their long-term growth prospects.

As Neurovalens grew their global footprint we provided expert advice and support along the way, including multi-currency accounts, FX strategy and international trade guidance.

Next, the firm has aims to target new markets – particularly across Europe and Asia – and is also looking to develop a new version of Modius targeted at people who are clinically obese.

THE FUTURE OF NEUROVALENS Neurovalens remains a small business but is experiencing rapid growth. Currently, it has sold around 6,000 headsets, and has started to see some significant and compelling results from users’ feedback. Already, eight out of 10 people have become leaner with an average of over seven lbs lost in the first two months of use – with the maximum weight lost by a user so far being 23 lbs.

This year alone, Modius has been in the final three of Last Gadget Standing at the Consumer Electronics Show (CES) in Las Vegas; shortlisted in the Best Innovation category at the Sports Technology Awards in London; and been a finalist in the Irish leg of the Med-Tech Awards. We see the huge potential of this product to disrupt the health and weight-loss industry – and can’t wait to see what happens next.

31

PUBLIC

INTELLECTUAL The team at specialist legal firm Barker Brettell take readers’ questions on the intellectual property matters that affect the medtech community.

This time, David Combes, patent attorney and associate does the honours.

Q ?

?A UESTION

My star inventor is leaving to work with a competitor. What can I do?

NSWER

?

Review your IP portfolio to check that no assignments or other documentation (e.g. declarations for USA) are outstanding from the inventor - it may be hard to get a signature from the inventor after they have left. Check that the employee understands the law, both on the ownership of intellectual property developed during the course of their

employment, and the law in relation to confidential information. If they understand their obligations, they are less likely to breach them.

Their contract of employment may put obligations on them about confidential information or there may be implied terms of confidentiality.

Remind the employee

what company information is confidential and should not be disclosed to their new employer.

Get a patent filed covering what they have been working on up to now, even if this is at a relatively early stage. Pick their brains on what they have been doing and cover as much of this ground as possible with the patent filing (or filings).

If the inventor is uncooperative, then talk to colleagues that are familiar with their work.

There is no need for any of this to be confrontational - try to stay on amicable terms with the inventor if possible.

You never know what the future may hold – the grass may not be greener after all.

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