MTI Issue 41 by Med-Tech Innovation Magazine

www.med-technews.com Issue 41 | Mar/Apr 2019

@medtechonline

PLUS

Your guide to Med-Tech Innovation Expo

MED-TECH INNOVATION | NEWS MED-TECH

innovation

HEADING FOR THE FUTURE Maucher Jenkins talks IP in the digital health age

ADVANCING HEALTHCARE

CONTENTS 6.

MED-TECH INNOVATION | NEWS

Regional news

Analysis

11.

Design

12.

On the cover

15.

Med-Tech Innovation Expo

26.

Automation & robotics

29.

Digital Health Age

32.

Industry 4.0

44.

STARTR

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

art | matt clarke publisher | duncan wood

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Why I want to see you at Med-Tech Innovation Expo

nd no, it’s not just because I happen to be employed by the organiser. Selfishly, it’s because if you come, it’ll make my job of reporting your news a lot easier. IF YOU’RE AN EXHIBITOR… You should be there anyway! Hopefully if you’re reading this, you’ll be heading to the NEC, and I’ll be coming round to see what’s on your stand. Maybe you’re also appearing on the Introducing Stage, where exhibitors have the opportunity to share their news and promote new launches. IF YOU’RE A VISITOR… It means you’re working on something for the medical sector. I want to know what it is, why you’re doing it, who your partners are, who designed it (if it wasn’t you) and how it will benefit the patient. This is my bread and butter, so get in touch with me and let me know which day you’re planning to attend (seriously!). IF YOU’RE A PRODUCT DESIGNER… You have a really fascinating job, and there are going to be loads of people who want to meet you. The Expo’s visitor profile will include more startups and fresh new innovators than ever

before, largely thanks to the introducing of the new Accelerator Zone. All these people have great concepts and they’re crying out for experts like you to help them make their ideas a reality. IF YOU’RE A STUDENT… You’re part of a growing movement towards closing the UK’s skills gap, and I can assure you, you’ll be met with a warm reception at the show. Who knows, it may even be the start of your career* (*though that’s not a guarantee, don’t hold me to that!) IF YOU’RE AN ENGINEER… You may just find the solution you’ve been missing. It could be equipment, or maybe you need to try a different material. I genuinely believe that for medtech, the Expo is the best opportunity in the UK to try and solve problems and improve processes – but then I would say that.

I didn’t mean for this editorial to turn into an advert for attendance at this year’s Expo – but if you’re working on a medical innovation, I would really love to meet you at the show and find out more about your work. Contact me on david.gray@ rapidnews.com, and let’s meet!

I GENUINELY BELIEVE THAT FOR MEDTECH, THE EXPO IS THE BEST OPPORTUNITY IN THE UK TO TRY AND SOLVE PROBLEMS AND IMPROVE PROCESSES – BUT THEN I WOULD SAY THAT.

IF YOU’RE WITH A MAJOR OEM You’ll be able to attend the UK’s leading clinical and supply chain conference, hear from C-level speakers, get the latest regulatory updates and connect with your peers.

NEWS AND VIEWS FROM HEALTH ENTERPRISE EAST

regional news

NOTES FROM THE EAST R. ANNE BLACKWOOD, CEO AT HEALTH ENTERPRISE EAST ON BALANCING THE GENDER SCALE FOR WOMEN IN MEDTECH.

Over 75% of the NHS workforce is female and yet in our work at Health Enterprise East, only around a third of the clinical entrepreneurs submitting ideas for new medical technologies are female. Females are underrepresented in the start-up sector too, raising just 16% of equity deals in 2018. There is no doubt a gender imbalance in female entrepreneurship in tech, but the reasons are multi-factorial. The percentage of girls and boys studying maths and science at GCSE level is similar, since these subjects are mandatory, but there is a massive drop off in the number of girls studying STEM (science, technology, engineering, mathematical) subjects beyond GCSE. At university, 25% of STEM graduates are women. More must be done to encourage girls to study STEM subjects and see them as an attractive career choice. Once in the workplace, more support for flexible working is needed. Technology enables today’s workforce to be more flexible and productive so management should help their staff achieve a better work-life balance. CEOs must lead on diversity issues too. While I was fortunate in my early working career to develop under leaders

who recognised talent and hard work irrespective of gender, a lot of women still feel a glass ceiling. Within life science companies over the last five years, women have consistently only held 17% of senior management positions and 34% of middle management positions. Having more women in senior management teams and the boardroom will bring new perspectives and insight to the sector. UK Government initiatives, such as Innovate UK’s Women in Innovation awards, are certainly a step in the right direction, providing UK funding and mentoring, coaching and business support to UK business women to develop their ideas. New female led businesses backed by the scheme in 2019 include Virtue Health– a tool to help clinicians assess patient health more efficiently – led by Alex Haslehurst and Run3D, led by Jessica Bruce – which uses 3D gait analysis originally conceived for runners to help older adults and those recovering from surgery to walk pain-free. Women are traditionally not seen as risk takers, so initiatives to create more role models and shine a light on female entrepreneurship in tech are much needed. Fortunately, there is a new breed of female entrepreneur coming through, who took a traditional medical training path but is now applying their clinical knowledge and expertise to innovation. Dr Maryanne Mariyaselvam, a clinical research fellow at Queen Elizabeth Hospital, Kings Lynn, is one such role

model. Maryanne’s research focuses on patient safety and solutions to prevent so called ‘never events’. With Health Enterprise East’s support, Maryanne has developed two safety innovations, Arterial Glucosave, licensed to technology development company Medovate, which prevents inappropriate administration of insulin, and the Non-Injectable Connector (NIC) which helps avoid complications associated with arterial lines. Maryanne is a fellow of the NHS Innovation Accelerator Programme that supports national implementation of saleable innovations. Dr Tamsin Brown, of Cambridgeshire Community Services NHS Trust, developed a headset that uses bone conduction headset technology to help children with long-term glue ear overcome hearing loss. Tamsin, a community paediatrician, based the idea on headsets currently used in sports including cycling. Female medical innovators like Maryanne and Tamsin are being supported by clinical entrepreneur programmes that will equip them with the skills and knowledge needed to deliver the new medical technology innovation the NHS and wider healthcare industry desperately need if we are to deliver safe, effective and efficient care in the next 10 years. There has never been a better time to become a health tech entrepreneur and female led businesses and innovators have a huge role to play.

THE LATEST ANNOUNCEMENTS FROM THE MEDILINK UK COMMUNITY.

LINKING UP

MEDTECH COMPANIES ELIGIBLE FOR CLINICAL EVALUATION FUNDING Medical technology companies in Nottinghamshire and Derbyshire can apply to cover 50% of their clinical evaluation costs, thanks to a project delivered by Medilink East Midlands and part-funded by the European Regional Development Fund (ERDF) and the East Midlands Academic Health Science Network (EMAHSN). Medical Technology Trial (MTT) grants are available to qualifying companies who need to test and evaluate their products and services in a clinical setting. The gathering of this evidence is vital for companies wanting to sell their products and services to the healthcare market – including the NHS. The grants are delivered as part of the Inspiring Networking to Stimulate Technology Innovation in Life Sciences (INSTILS) project, a £7.39 million scheme part-funded by ERDF. INSTILS provides free and impartial support and advice to Derbyshire and Nottinghamshire companies working in, or looking to work in, life sciences; to innovate and create new products and services. The East Midlands Academic Health Science Network (EMAHSN) is one of the project delivery partners and are also part funding the project. The other delivery partners are The University of Nottingham and Nottingham University Hospitals NHS Trust.

FEMTECH PIONEER WINS MEDILINK NORTH AWARD A pelvic floor muscle retrainer from Femeda won the Medilink North “Partnership with Academia Award” at the ceremony which took place in Leeds in February. The device, which was launched into the UK market in October 2018, contains Reactive Pulse Technology (RPT) that offers a solution for a female bladder leakage. This award follows Femeda’s success at the Bionow Awards in 2018 where it won Product of the Year. Professor Jacqueline Oldham, director of Corridor Manchester Health Innovation, said: “Pelviva is the result of pain staking research through academic, clinical and industry collaboration bringing innovation into healthcare. This trail blazing development has the potential to transform the lives of women worldwide.” The product is made of a Body Responsive Foam, which adapts to every woman’s individual shape. The Pelviva RPT delivers a series of intensive reactive pulses every alternate 10 seconds, to stimulate the pelvic floor muscles. MEDILINK UK LAUNCHES MEDICA PAVILION FOR MEMBERS Following feedback from its members, Medilink UK has launched a UK pavilion at Medica 2019. These high quality exhibition stands are on offer to companies around the UK and provide a platform at the world’s largest exhibition in our sector where companies can meet potential partners and clinicians form across the world. Please contact Medilink’s international team to discuss your requirements and eligibility for government backed grants, offsetting the cost of exhibiting: (e): international@medilink. co.uk (t): 0114 232 9292.

UNIVERSITY OF DERBY RECOGNISED FOR LIFE SCIENCES CONTRIBUTION The University of Derby has been recognised for the contribution it makes to life sciences, by becoming the 21st Patron of Medilink East Midlands (EM). Medilink EM works with life science businesses, academic institutions and the NHS across the East Midlands, to help new and existing life science companies to develop and grow. Medilink EM has always offered a membership service to companies, in addition to the business support programmes it helps to deliver. The University of Derby was looking to further develop its life science capabilities and recognised the work of Medilink EM as a key driver of life sciences within the East Midlands. Both organisations have worked closely for a number of years, but the University’s move to expand its life science involvement and offering led to an ongoing discussion between the University and Medilink EM, which resulted in the University of Derby becoming a Medilink EM Patron. 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. Patrons also appreciate the positive contribution that Medilink EM makes to the sector through its business support activities. The University of Derby was one such organisation and joins other leading regional organisations, including fellow academic institutions the University of Leicester, the University of Nottingham, De Montfort University and Nottingham Trent University.

ANALYSIS

Assistant of clinical editor Ian experience; and Bolland spoke Paul Brown, to Peter Brady, chief executive CEO of digital of Suffolk service agency Primary Care Orbital Media; following the Dr Simon publication of Rudland, a the NHS Long GP with more Term Plan. than 20 years

Roundtable on: the NHS IS THERE RENEWED PRESSURE ON MEDTECH FIRMS TO MAKE THE LONG TERM PLAN WORKABLE? Paul Brown: There is certainly an opportunity for medtech firms to rise up to the challenges facing the NHS. For the long term plan to succeed, it will require an effective partnership and synergy between clinicians, technology and patients. WHAT KIND OF ADDITIONAL OPPORTUNITIES DO YOU ENVISAGE WORKING WITH THE NHS? Simon Rudland: We need to be focusing on the opportunities to transform care pathways, particularly for patients with long term conditions, at a primary care level. GP groupings through Federations or Super partnerships offer exciting opportunities for collaboration and research with medtech companies. WHAT KINDS OF TECHNOLOGIES NEED TO BE USED MORE TO MAKE THE AMBITION WITHIN THE PLAN A REALITY? Peter Brady: We are potentially living in a golden age of innovation within healthcare. The convergence of technologies such as artificial intelligence (AI), block chain, robotics, virtual reality and augmented reality, are offering almost limitless opportunities to improve healthcare outcomes. If you had to pinpoint one technology that will have the biggest impact on delivery of the Long Term Plan, I would put my money on AI. Its influence on every aspect of healthcare will be profound. CAN TECHNOLOGICAL SOLUTIONS REALLY REDUCE BUREAUCRACY, OR IS JUST A CASE OF MAKING IT MORE MANAGEABLE? Simon Rudland: This could go either way! We don’t want more information as GPs – we want the right information at the right time! We don’t want worried well patients either. It’s very important that we empower patients whilst ensuring that the technology they’re using is properly validated so patients are actually accurately measuring biological

parameters. An example would be concern over the accuracy of wrist blood pressure assessment compared to brachial blood pressure. WHAT AFFORDABLE SOLUTIONS ARE AVAILABLE AND WHAT CAN MEDTECH COMPANIES DO TO MAKE THEM MORE MAINSTREAM? Paul Brown: Affordability is perhaps the single largest barrier for the adoption of medtech. In primary care budgets are limited and cases highlighting the benefits of medtech such as resources saved is often lacking or over emphasised. To make medtech more mainstream it needs to be cheaper or have clearer benefits. DO YOU THINK THE ‘DIGITAL FIRST PRIMARY CARE OFFER’ BY 2022/3 OUTLINED IN THE LONG TERM PLAN IS ACHIEVABLE? Peter Brady: With the right framework, support and engagement, anything is achievable. Paul Brown: Of course it is possible, however it is likely you will see some early adopters achieving the desired aim and other areas not. Simon Rudland: It’s a big ask however if the adoption is properly funded and the products have a meaningful impact in general practice, then undoubtedly general practice can do this. General practice, if incentivised, is one of the most adaptable innovative areas within health. HOW CAN THE INDUSTRY HELP SUPPORT THE NHS IN PROVIDING MORE SOLUTIONS THAT SUPPORT GOOD MENTAL HEALTH AND IMPROVE RECOVERY? Simon Rudland: Digital health has the ability to impart patience and help to make better choices, food, alcohol, or exercise. To make good choices, you may need to be motivated and feel well enough to do this in the first place, which is where the big challenge lies in promoting wellness to patients with mental

health problems. Despite this, there are lots of opportunities to improve compliance with drugs, improve monitoring by offering near patient testing for things like ECGs where there are QT interval concerns. WHAT KIND OF ADVANCES IN MEDICAL SOFTWARE AND HARDWARE DO YOU ENVISAGE COULD HAVE A PROFOUND IMPACT ON THE NHS IN THE NEXT 10 YEARS? Peter Brady: A single clinical patient record accessible to health clinicians as and when required would have a profound and positive impact on the NHS.

DR. SIMON RUDLAND, GP AT STOWHEALTH

PETER BRADY, CEO ORBITAL MEDIA

PAUL BROWN, CHIEF EXECUTIVE SUFFOLK PRIMARY CARE

Long Term Plan HOW CAN THE INDUSTRY ASSIST IN EDUCATING THE NHS WORKFORCE TO MAKE SURE ANY TECHNOLOGICAL TRANSITION IS AS SMOOTH AS POSSIBLE? Peter Brady: Firstly, too little attention is paid to optimising user experience and user interface design. Getting these aspects right is critical to securing a smooth technological transition. Secondly, tools such as virtual reality, augmented reality and AI will

revolutionise the speed and effectiveness of training provided to the NHS work force. As an example of this from another industry, EDF has used virtual reality to deliver nuclear reactor health and safety training that is producing significantly superior results in terms of user recall, whilst reducing training costs by 90%.

We are there when reliability is of top priority. Our innovative sensor solutions make medical devices even safer and more efficient.

You can read the full-length round-table on www.med-technews.com

DO YOU THINK THE ‘DIGITAL FIRST PRIMARY CARE OFFER’ BY 2022/3 OUTLINED IN THE LONG TERM PLAN IS ACHIEVABLE? IS THERE RENEWED PRESSURE ON MEDTECH FIRMS TO MAKE THE LONG TERM PLAN WORKABLE?

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CLINICAL MONITORING

LIFE SCIENCES & MEDICAL INSTRUMENTATION

HEALTH, WELLNESS & FITNESS

IMAGING

VISIT US AT STAND

J29

It’s important to recognise value of simulation, say Jessica James

and Rebekah Dixon of design group Synopsys.

design

SIM CITY

atient-specific modelling provides a number of opportunities and challenges for medical device design. Using the image data from MRI and CT scans to build the models enables anatomical accuracy, capturing each patients’ unique features. This image data can then be used during the design stage for medical devices to integrate CAD models of components with anatomies and simulate performance. When used to complement experimental testing, simulation using techniques like finite element analysis (FEA) increases choice when optimizing and validating design decisions. Computational modelling of this kind is increasingly being recognised by medical device manufacturers and healthcare regulators. These methods also tie into industry 4.0 trends for smart manufacturing, partial automation of tasks like presurgical planning, technological customization, and improved human and technology interactions. However, there remains some key hurdles for using image-based modelling, including, accessibility for learning software, data availability, and avoiding obsolescence. FUTURE PROOFING ANATOMICAL SIMULATIONS Several solutions are in place for improving decision-making at the design stage for medical devices, with the goal of reducing risk and making it easier to tailor new technologies to improve the quality of the final implant. These approaches are particularly aimed at increasing understanding of human-implant design, where patient-specific optimization of hip implants, pacemakers, stents, and other devices can improve outcomes. For example, Simpleware ScanIP from Synopsys is a well-established software that converts image data taken from MRI and CT into 3D models. These are suitable for examining

how devices interact with the human body. Image processing tools enable segmentation of anatomical regions of interest, measurement and statistical quantification of anatomies, and the integration of CADdesigned implants. The benefit of using these virtual models is that multiple device designs can be studied to decide on optimal placement, as well as for understanding key factors like wear and movement after surgery. A key push in software development is to reduce the number of workflow steps needed between patient scan and completed model, as well as to improve communications between different teams through the manufacturing lifecycle. One such workflow is to use Simpleware software to create a 3D model from image data and export it directly to a simulation tool for carrying out FEA of how the implant will perform within the body. An important part of this process is to ‘future-proof’ the technology to prevent obsolescence and apply trusted techniques to new patient datasets and more powerful simulations. This process can be scaled up to account for multiple implant designs and simulation requirements. For medical device designers, routes from 3D images to models can be extended to exporting files for 3D printing of implants, suitable for visualising and planning procedures. AUTOMATING PRE-SURGICAL WORKFLOWS One of the more recent innovations in medical device design has involved semiautomating pre-clinical guides to quickly and accurately deliver models to surgeons and other medical professionals. For example, Corin Group in Australia have developed an Optimized Positioning System (OPS) technology that uses Simpleware

software tools to help plan total hip replacements. 3D scans of patients are obtained from CT data and X-ray tomography, and imported to Simpleware software to segment and incorporate CADdesigned implant models. Corin Group’s OPS tool then analysed different types of movement to understand the optimal position of cups, and translate the results into 3D printed surgical guides. Scripting tools are used to speed up this process, with the end-goal of improving the options available to clinicians when planning an operation. CONCLUSIONS The future of medical device technology and the design of better implants will depend on the availability, quality, and reliability of software solutions. Patientspecific planning from imaging data offers multiple strengths for researchers and clinicians, including being able to tailor treatment to individual anatomies. Simulation allows researchers and medical device manufacturers to carry out more exhaustive testing of designs before they reach the market, reducing the risk of later failures which may have significant impact on the patient’s health.

on the cover

Digital health is a rapidly evolving industry which shows great potential for improving the quality and accessibility of healthcare services that will be available to patients in the future.Â

Digital health is being driven by two main factors: (1) the increasing use of mobile technology; and (2) the large demands that are being placed on the healthcare industry, for example, due to an ageing population. Digital health covers the use of data to assist in diagnosis, treatment, prevention and monitoring of diseases and other conditions, as well as providing support for healthcare practitioners. Thus, the development of digital health technology is expected to lead to lower health care costs, personalised treatments and quicker diagnosis, resulting in better patient outcomes. The rapid development and evolution of digital health technology means that businesses will need to carefully consider use of Intellectual Property to protect innovations. In contrast to some other healthcare industries which are often developed over a slower period of time, product life cycles in the digital health industryÂ are typically much shorter. Thus, digital health businesses need to develop and regularly revise their IP strategy.

DR. FIONA KELLAS AND REUBEN JACOB, PARTNERS AT MAUCHER JENKINS, WRITE FOR MED-TECH INNOVATION NEWS

HEADING FOR THE FUTURE 12

In addition, businesses should ensure that contracts are put in place when working with any third parties, and that procedures are set up to establish ownership of any IP that may arise during development of a digital health product. Potential inventions should be treated as confidential until the IP situation is understood and any patent and/ or design application relating to the invention are filed. In addition, when developing a product, it may be beneficial to carry out a freedom to operate analysis to check that there are no existing IP rights that relate to the same invention. Various aspects of a digital health product may be protected using IP, such as the hardware, the software and any associated data analytics. Each of the IP rights that may apply to digital health will be discussed in greater detail below.

on the cover

Despite these challenges, many successful digital health companies havebeen able to secure patent protection for their inventions. PATENTS Mechanical, chemical and/ or electrical components of a digital health product may be patentable if they are new and inventive. Methods and protocols associated with using the digital health product may also be patentable. However, digital health products often comprise software and/or a computerbased element which may be difficult to protect using patents. In Europe, in order for a patent to be granted for a computer implemented invention, a technical problem needs to be solved in a new and inventive manner. Thus, when considering patent protection in Europe, it is necessary to demonstrate that the software component of the digital health product has a technical effect. Advantageously, digital health software innovations may be able to overcome this problem since the software is often integrated into a hardware device or used directly by patients, such that they may be considered to have a technical effect. Recent case law developments in the US have made it more difficult to protect innovations where the underlying software or technology is built on abstract ideas or laws of nature (Alice v CLS Bank International 134 S. Ct. 2347 (2014)). As a result, it is important for digital health companies to think more strategically about how to acquire patent protection. Despite the above challenges, many successful digital health companies have been able to secure patent protection for their inventions. DESIGNS It may be important to protect aspects of the appearance of a digital health device (such as the shape and/ or colour of the device), especially in light of the competitive nature of the digital health industry. As a result, design protection should be considered if there are aspects of the appearance of the digital health device that may be important in driving sales of the device. TRADE MARKS Trade marks may be important in protecting the brand of the product, for example, where a user associates the product with its name. COPYRIGHT AND DATABASE RIGHT Copyright may exist in the programs and algorithms used by the digital health device. Software is considered to be a literary work which may be protected by copyright. However, a problem may arise if the code of the software is slightly altered but the function remains the same, since this may allow third parties to slightly change the code of the software

without infringing the copyright. Due to the fact that many inventions in the area of digital health will involve at least some elements of software, technology providers will need to think carefully about their IP strategy. Digital health devices may be linked to a database in which the data is collected and stored. Database Rights are defined in Directive 96/9/EC. A database is defined as “a collection of independent works, data or other materials which are arranged in a systematic or methodical way and are individually accessible by electronic or other means”. The data stored in a database may be protected: (1) under the law of copyright and the rules that apply in relation to databases; and (2) under the UK Copyright and Rights in Databases Regulations 1997. Since the copyright owner is the creator of the database, digital health companies need to be careful when using a contractor to create a database. This is because the contractor is likely to be the owner of the copyright in the database. Therefore, if a company wants to own the copyright, it must enter into an agreement with the contractor which contains an assignment of the copyright. Digital health devices often collect and store data which may be transmitted to a healthcare professional or a hospital. Patients often own their own data and medical records. However, consolidated and anonymised data often belongs to the NHS. In addition, data sets that are licensed from third parties will be subject to the terms of those licenses and the restrictions of any copyright that may apply. Furthermore, companies operating in the area of digital health will need to be aware of the obligations imposed under data protection legislation for the storage of data and aware of the concerns relating to patient privacy. The development of digital health products and services may involve a number of different parties. It is therefore important to assess any contracts and licences that may apply and to be clear about the ownership of any IP that may arise. CONCLUSION Digital health is a rapidly developing area which is expected to grow significantly over the next decade. Due to the competitive nature of development in this area, the use of IP to protect innovations relating to digital health is important. A number of IP rights may be used in parallel to protect various aspects of a digital health device and associated software and technology.

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Innovation in Miniature

med-tech innovation expo

LET THE SHOW BEGIN Med-Tech Innovation Expo is back for 2019, bigger and more diverse than ever before. The medical technology sector is changing, and with those changes come new requirements on engineering. This year’s Expo will demonstrate the best-in-class solutions to address these new challenges. A NEW HOME Reflecting the current surge in interest in medical technologies, the event has seen growth on all sides in recent years. That’s why, for 2019, the Expo is relocating from its previous venue in Coventry, to the NEC in Birmingham. This year promises to be more international than ever before, with trade delegations expected from around the world, taking advantage of the central transport links into Birmingham International. Duncan Wood, chief executive of Rapid News Group, the organiser of the event, had this to say: “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.” WHO YOU’LL SEE The West Group, on stand F1, will be a crucial stop for anyone with miniature fluid control requirements. The group is a specialist outsourcing partner in this field, and combines component supply with services like cleanroom production. First-timer Jet Press will also be exhibiting at the show, bringing its fasteners and components range. Just last year Jet Press was appointed as an official European Distributor for Heyco Cable and Hose Management. Since 2001 Jet Press has been working closely with Accuride, a specialist in high-quality drawer slides and linear motion solutions. These engineered drawer slides have multiple functions ideal for medical applications, such as trolleys and storage cupboards.

Jet Press will also present its own trim panel and hose clip range, produced in the UK. This range was recently extended and includes valuable solutions for building machines. Besides this exciting range Jet Press says it is able to design bespoke parts using rapid prototyping and 3D printing, along with part assembly of components. The group will be on stand J58. Meanwhile on the Medilink Pavillion, Midas Pattern Company will be showcasing a selection of high-quality polyurethane RIM mouldings, for medical device enclosures. The group says that from the initial discussion, it can turn around a project in a matter of days to support with time-to-market. A full roundup of exhibitor news can be found in the What’s On guide included with this edition. CRUCIAL CONFERENCE SESSIONS Across three stages and over two days, a stellar line-up of international speakers will discuss challenges and opportunities for medical device manufacturers of all kinds. On the HealthTech Stage, Sarah Trenfield, director of innovation at FabRx will explain how 3D printing can revolutionise the healthcare sector by enabling the production of personalised medicines. The talk will also assess the latest research and technological developments in this emerging field, and evaluate the implications for the future. On day two, Leanne Taylor, head of content at Rapid Plastics Media will be joined by Dr Artemis Stamboulis, senior lecturer in biomaterials and nanomaterials at the University of Birmingham, and Helena Flowers, owner and managing director at Andel Plastics, for a panel discussion on the role of women in healthtech and engineering.

This year promises to be more international than ever before, with trade delegations expected from around the world, taking advantage of the central transport links into Birmingham International.

med-tech innovation expo

THREE SIMPLE QUESTIONS

We set some of our speakers from across the three stages at this year’s expo a task – to answer three crucial questions. Their responses demonstrate the broad cross-section of stakeholders attending this year’s Expo.

WHAT ARE THE CURRENT CHALLENGES IN MEDTECH? Alistair Walker, owner and consultant, Lorit Consultancy: One of the biggest challenges the sector faces is companies keeping up to date with the massive framework of international standards, as well as directives from different markets, in order to ensure their products are compliant with safety regulations. The lack of standardisation internationally is a huge burden on medical device companies and navigating the regulatory landscape can be very complex. This can even be prohibitive when it comes to international expansion as different markets have different standards you must adhere to should you want to trade in that geography. Michael Branagan-Harris, CEO, Device Access UK: The NHS is under enormous strain and device manufacturers really need to present their device differently as a solution for the patients and hospital in a way that’s beyond using the words “saving money” or “innovative” which does not work, as does pointless downward price negotiation with procurement. Steve Cox, 3D tech consultant, Amfori Consulting: I think the challenges are similar to those facing most other sectors in that people are expecting more solutions, they are expecting better solutions, but we need to be delivering those solutions somehow with less. I work as a consultant with Autodesk and “More, Better, Less” is a strapline that they have adopted as a challenge that they want to meet with the software and solutions that they offer in the design and manufacturing sector. Oli Hudson, content director, Wilmigton Healthcare: Aggregating procurement, value pricing, transparency, the burden of proof on outcomes, and demonstrating a whole-system benefit. Michael Kipping, Innovation Lead, InnovateUK: The Medical Device Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR) usher in important changes to the EU regulatory environment and increase the requirements on companies. Challenges for medtech companies include: how to assess regulatory gaps in current product portfolios, finding a Notified Body that will accept them as a client, where to seek regulatory advice from and evaluating whether it is commercially viable to re-certify to MDR/IVDR, lack of awareness of the need to comply e.g. digital technologies, combination products etc. WHAT ARE THE OPPORTUNITIES? Michael Branagan-Harris: The NHS have never needed technological innovation as much as they do now. In 2014 The King’s

Fund advised NHS England to build 22 x 800 bed hospitals before 2022 to meet current demand, and the building work has not started yet. New technologies that reduce length of stay, reduce complications and readmissions, treat and diagnose patients faster with greater accuracy with less staff are things that the system needs like never before. Alistair Walker: There is an opportunity to learn from other high risk, highly regulated sectors such as automotive, rail and aviation. We tap into knowledge of different industries to support the guidance we give to clients as there is great benefit in taking this approach. While other sectors have their own unique challenges, they are far more standardised than the medtech sector; currently the medtech sector can even find different definitions of commonly used words across standards causing a lot of confusion and inefficiencies. Steve Cox: New digital technologies and 3D capabilities are providing new tools for use in the sector, and those solutions are able to deliver more effective, and in some cases, more bespoke solutions but at an economic cost Michael Kipping: Drawing together the fragmented support mechanisms in the UK and supporting SMEs to comply with new regulations and develop opportunities in nonUK markets. Oli Hudson: I’d say the big opportunities lie within innovation tariffs, faster evaluation under NICE, investment in technology under the longterm plan, and the medtech funding mandate.

HOW ARE CHANGES TO THE REGULATORY LANDSCAPE AFFECTING THE SECTOR? Michael Kipping: The softening of the stance by FDA combined with the increased requirements of the EU MDR/IVDR mean that some companies are now looking to the US first for regulatory approval rather than the EU. Alistair Walker: There has been a lot of talk regarding MDR, however this is not saying anything new. It is purely tidying up what was already available and presenting it in one large document. From a regulatory point of view this is a positive step forward however in reality when you scratch beneath the surface there is nothing new – just a different format and more rigour as a result. Michael Branagan-Harris: Over regulation stifles innovation. If the EU Government continues to move the goalposts, then sadly technology research and trials will end up in other parts of the world which have easier regulations, like South America, and we won’t have them first.

med-tech innovation expo

MEET THE SPEAKER Under the steerage of CEO Andy Tibbs, Boddingtons has come to the fore as a leading contractor to today’s global med-tech industries. His presentation on day 1 will address what it means to become the ‘finished article’ as a medtech manufacturing supplier. Here, he elaborates on his plans for this year’s Expo. Boddingtons is looking forward immensely to this year’s Med-Tech Innovation Expo. Not only will we launching our biggest ever exhibition presence – an 8m x 4m medtech technology space - I shall also be sharing Boddingtons views about industrial best practice in the medtech industries. INVEST IN FACILITIES In recent years Boddingtons took the decision to back our medtech aspirations with hard investment. We undertook the design and build of a purpose built £4.6m facility, including a modular Class 7 cleanroom capable of making Class 1 and Class 2 medical devices. Why did we do this? The medical world is one of the most highly regulated sectors on the planet and its demands are largely fixed. Production methods – and audits of the same – are highly structured, highly regulated and costly. The price of admittance in time and money can be extremely high. Paradoxically, the rigidity of medical manufacturing protocols makes it all the more important for suppliers like ourselves to put a high premium on creativity, innovation and doing things a little differently. After all, when everyone else has invested in a similar fashion, what makes the difference? You will need to invest – but money alone will not win you business. Remember that much of the medical sector is innovating and creating devices that have never been manufactured before. You therefore need engineering skills and creativity to make new products and you need production skills and a wealth of experience to create these products efficiently and at a profit. In some ways this is the antithesis of capital intensive and fixed manufacturing lines. Our design-for-manufacturing ethos might have us create and build a six or seven workstation array within our Class 7 clean room. This cell might include injection moulding, automation, welding, hand assembly, QA Vision inspection systems; packaging and printing services before despatch. MAKE IT EASY FOR THE CLIENT - INVEST IN SYSTEMS As a general rule, try to include all possible manufacturing, commercial and technical services for your client. Typically, your

medical client needs to devote nearly all of their energies to needs of the marketplaces, letting you take care of all the manufacturing concerns. And if you can also provide support with many of the regulatory and administrative services that the medical sector demands then you are likely to retain and increase your business. Boddingtons offers these services; in many cases becoming the legal manufacturer in the supply chain in order to relieve clients of the burden. Qualifications ISO 9001, BS 13485, FDA compliance and now, MDSAP, are all mandatory for the successful and global medtech supplier. The client will invariably be new to such protocols, and will often view them as obstacles to success. The more you can remove them in your supply arrangements the better the overall business will be. At Boddingtons we generally aim to take on the management of all regulatory, standards and ‘red tape’ work for our clients, together with all technical evolvement of designs and prototypes. TREAT ALL CLIENTS THE SAME It may sound strange to note – but treating all clients in the same way, regardless of size, scope or budget, is generally the best possible policy. When medtech solutions are right for their time this can be an extremely fast-moving and high volume world. It therefore helps to view all of your inventors and your first-time projects as blue chip OEMs in the making. YOUR MAIN EXPERTISE – SHARPEN THE SAW Our medical marketplace success is based upon our fundamental excellence as an injection moulder. In all that we do, day to day, we are mindful not to forget these fundamentals and to periodically renew our expertise and our facilities with the best-inclass options that we can find. In terms of our shareholders and stakeholders our job at Boddingtons is to strategize and shaping our contract manufacturing services in order to deliver improved performance, unparalleled customer satisfaction resulting in expanded sales and profit margins.

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DISPLAYS

This year’s Medilink UK Healthcare Business awards, once again taking place alongside Med-Tech

Innovation Expo, will celebrate the best-inclass talent and innovation from across the sector.

med-tech innovation expo

A NIGHT TO REMEMBER THE HOST Adam Kay is an award-winning comedian, TV writer, and Sunday Times best-selling author. This is Going to Hurt, his “hilarious and heartbreaking” (Charlie Brooker), “blisteringly funny” (Jo Brand) memoirs from his former career as a junior doctor was published by Picador in September 2017. It received across-theboard critical acclaim and entered the Sunday Times best-seller list at number three. TV and film rights for the book have been sold and the book is being translated into eight languages. THE CATEGORIES MEDILINK UK HEALTHCARE BUSINESS AWARD CATEGORIES Collaboration with the NHS Award For the development of a collaboration with the NHS that has or will have a major impact or benefit to both business performance and patient care. Sponsored by:

Export Achievement Award For outstanding performance in international trade.

Start Up Award For newly established companies (trading for up to 3 years) in the medical and healthcare sector, that show a promising future. MED-TECH INNOVATION CATEGORIES Connected Health Award The winner will have played a part in the design or manufacture of a cutting edge connected medical device. Design Award Awarded to the entrant who has used design principles to create a futuristic solution to meet a clinical need.

Innovation Award For the development of an innovative technology, design or process that has produced a major improvement in business performance or end-user benefit. Sponsored by:

Engineering Award Celebrating the use of engineering skills and savvy thinking to solve a design or manufacturing challenge.

Outstanding Achievement Award For an achievement that has had a significant or vital impact on the company.

Industry 4.0 Award How smart manufacturing techniques and systems can result in productivity gains, and efficiencies of scale.

Materials Innovation Award Awarded to an entrant who can demonstrate an application which was made possible by material choice.

THE JUDGES MEDILINK UK HEALTHCARE BUSINESS AWARD CATEGORIES Laura Hughes, Editor, Medical Plastics News Laura is the Editor of both the European and North American issues of the Medical Plastics News magazine. She has spent her entire career to date working within medical publishing. Sue Dunkerton, Interim CEO, Knowledge Transfer Network Sue has been involved in knowledge transfer since 2002 through Faraday Partnerships, the forerunners to what is now the Knowledge Transfer Network. She received an OBE in the Queen’s New Year Honours in 2014 in recognition of her championing of and contribution to the engineering industry. Professor Mike Hannay, Chair of the AHSN Network Mike has more than 25 years’ experience of working in the pharmaceutical industry, with an excellent track record of building collaboration with healthcare and academia. He joined EMAHSN in July 2016 from ThermoFisher Scientific, where he had worked since 2013 as Vice President for the UK BioPharma Services Division.

THE JUDGES MED-TECH INNOVATION AWARD CATEGORIES Ana Avaliani, Head of Enterprise, Royal Academy of Engineering Ana heads up the Enterprise Hub team at the Royal Academy of Engineering supporting technology entrepreneurs on their journey of setting up and growing innovative engineering companies. Dr Tom Beale, CPhys, Commercial Development Manager - Med-Tech, The Centre for Process Innovation (CPI) Prior to joining CPI, Tom worked in the NHS developing medical devices for commercial exploitation, working on multiple projects from point-of-care diagnostic devices, to implantable brain simulators. Mark McIntyre, Senior Director of Health Economics and Government Aﬀairs, Boston Scientiﬁc, EMEA Having worked for more than 10 years in NHS procurement at local and regional level, Mark became executive for e-commerce at the Department of Health (PaSA). He joined Boston Scientific in 2003 with responsibilities that included relations with Government and Opposition, the DoH, NICE, patient advocacy groups, clinical professional groups and the media, to promote the benefits of minimally invasive medicine. Dr Darren Clark, Chief Executive, Medilink East Midlands Darren has been with Medilink East Midlands, since 2004. In his role as Chief Executive, he has successfully overseen the development of the company into one of the key players in the Medilink UK network. David Gray, Group Editor, Rapid Life Sciences Since 2014, David has served the pharmaceuticals, medical devices and digital healthcare markets, creating and sharing content across the life science community. Leigh Cornock, Director of R&D, RDT, A Philips company Leigh has a PhD in Electronic System Engineering from the University of Essex and has been working in industry on electronic product research and development for 15 years, with over 13 years focused on medical device development.

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med-tech innovation expo

PHOTO OPPORTUNITY The Centre for Process Innovation (CPI), which is returning to Med-Tech Innovation Expo this year, officially opened the doors recently on the National Healthcare Photonics Centre at NetPark in Sedgefield. Assistant editor Ian Bolland went along to the launch to have a look at the new facility.

art of the function of the new facility will be to offer advice and assistance to companies who have designed and developed medical devices, and so they can be piloted. From the ideas stage of sketching out how one would like a device to look and function, the new centre will offer companies guidance on the road to commercialisation. Tom Beale, commercial development manager, medtech told Med-Tech Innovation News: “What CPI can do that is possibly unique is not only help businesses from a technical sense but help them grow as well. We can offer them business advice in terms of where they are in their life cycle and what they need to look out for. “There’s companies that we’ve supported within our other facilities where they’ve been working with us for five, six, seven years and they’ve actually grown as a company. “They start up with us as one or two people, they grow and work within our labs but they take up another building within NetPark and they grow in that space as well. We help them grow and develop but we maintain that relationship with them.” The new facility, which CEO Nigel Perry said he was ‘overwhelmed and gobsmacked’ by during his remarks at the opening, offers small companies the opportunity to work within the labs of the new centre. On a tour of the facility, one room for manufacturing and assembly has the ability to work on up to four different products at a time – a room for a ‘mini-manufacturing line’. There is the opportunity for medtech firms that have just started out with one or two employees to oversee development from the offices in Sedgefield.

Beale was keen to mention that CPI can draw on resources away from the newly-built Photonics Centre before continuing its development at its new facility – citing conformable electronics for a wearable device, or for a drug delivery system there is the opportunity to work with CPI’s biologics facility in Darlington. “We can pull from all of the different aspects of CPI, pull that all together to offer something fairly unique in terms of medtech and what we can supply. “This facility is specifically developed for medtech development. We have other sites which are designed for other aspects. “What we can do here is bring in what we’re able to do at other sites and bring that in to satisfy the demands of medtech in healthcare industries. One unique thing we have in healthcare photonics we don’t have in other parts of the CPI is our certified quality system to ISO 13485. “What we are able to do within this facility is draw in expertise from other parts of the company as well.” An example of a company that CPI has worked with across the facilities is HP1 Technologies. Its technology is designed to make sure equipment is fit for use and not compromised by damage which they believe in the short term is the best way to reduce injury, and that data generated in the longer term could prove valuable to medical research around head injury. Beale added: “Using our printable electronics facility they’ve been printing pressure sensors in order to do this but all CPI were able to offer was the ability to print the pressure sensors. What we can now do in healthcare photonics that we couldn’t do before is integrate that into a product so we can now offer our 3D design and development facilities. “That is of much bigger value and a much bigger benefit to that company.” The Centre for Process Innovation will be exhibiting on stand J6.

med-tech innovation expo

IT’S NICE TO GO DIGITAL — BUT YOU NEED THE RIGHT TOOLS Jeanette Kusel, director for NICE scientific advice discusses the launch of a new digital health module of the Medtech Early Technical Assessment (META) tool, which will be evaluated during this year’s Expo on the Introducing Stage.

JEANETTE KUSEL, DIRECTOR FOR NICE SCIENTIFIC ADVICE

ll around us a new generation of technologies are changing our lives, from the everyday use of satnavs and smartphones through to the profound understanding in the ability of genomics to help us develop personalised medicines for individual patients. The proliferation of digital health technologies, including mobile health apps and wearable sensors, holds great promise for improving the health of the population. As with other new health technologies, demonstrating evidence of their benefits and costs is a fundamental requirement of the health system and a potentially limiting first step to adoption into clinical practice. The UK has the chance to lead the world on healthtech. We already have some of the world’s foremost healthtech companies bringing new innovations and advancing the international reputation of our excellent science and research base. In the NHS, we have the world’s largest health institution and in NICE we have one of the world’s most respected health technology assessment bodies. Working collaboratively, we have the opportunity to build an ecosystem that continually creates, develops and adopts the best healthtech. NICE EVIDENCE STANDARDS FRAMEWORK TO SUPPORT DIGITAL HEALTH TECHNOLOGY UPTAKE As digital health innovations have developed at an increasing pace, it has been a challenge to identify which are clinically effective and offer economic value for patients and the healthcare system.

To help address this issue, the National Institute for Health and Care Excellence (NICE) has recently published a new evidence standards framework for digital health technologies. The project was led by NHS England and the NICE framework was developed in partnership with other healthcare organisations, including MedCity and DigitalHealth London, with input from commissioners, industry and academia.

These evidence standards are leading the way in providing both developers and commissioners with an understanding of what good levels of evidence look like for digital health technologies according to the type of technology and the level of risk to patients and to the health budget impact. The standards cover both the clinical and economic impact of the new technology and outline what evidence is needed to develop a case for their adoption and use by the health and care system. THE NICE SCIENTIFIC ADVICE META TOOL In 2017, NICE’s scientific advice service launched an online tool to help developers of medical devices, diagnostics and digital health technologies understand and generate the evidence needed to show their products are clinically and cost effective. The Medtech Early Technical Assessment (META) tool has been developed in partnership with Greater Manchester Academic Health Science Network. The tool aims to help companies identify what evidence they have and what gaps need to be filled to satisfy payer requirements. This should help companies prepare for a dialogue with health technology assessment organisations and payers to potentially speed up time to market. It is an affordable service aimed at, but not limited to, small and medium sized companies. The META tool can be licensed for use by facilitating organisations working with medtech companies. This broad accessibility will allow NICE to maximise the META tool’s potential, to support the medtech industry, and make it available to companies not just in the UK but also internationally. ADAPTATION OF THE META TOOL TO FURTHER MEET THE NEEDS OF THE UK DIGITAL HEALTH TECHNOLOGY SECTOR The META tool offers a tested platform for delivering tangible value to those developing novel and innovative health technologies. A new module of the META tool incorporating the digital evidence standards framework will be available to help to align the tool with the fastevolving digital health technology landscape by adapting to meet the needs of companies developing exciting new digital products. NICE will be talking about the new launch on the Introducing Stage at 1pm during Med-Tech Innovation Expo.

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motion control

How motion control tech enabled robotic neurosurgery n neurosurgery, an error of a few hundred microns can result in irreversible brain damage. The risk has led to growing focus on minimally invasive surgery. Surgeons perform procedures using increasingly sophisticated robots rather than scalpels and lasers. In the EU-funded EDEN2020 project, for example, researchers are developing a robotically steered catheter that can precisely deliver anticancer drugs directly to a brain tumor in situ. The system is only as good as its ability to position the needle as commanded, however. When it came time to specify the motion controller and drives for the four-axis robotic system that steered the catheter, researchers wanted compact, low-EMI, highperformance components. They turned to Elmo Motion Control for a solution. A STEERABLE NEEDLE The EDEN2020 system is based on the Programmable Bevel-tip Needle (PBN), a flexible needle that is capable of advancing through the brain along a precisely-defined route that minimises tissue damage. The goal is for the robotic motion system to reference preoperative MRI scans and intraoperative ultrasound imagery during the procedure to generate path commands. When the PBN arrives at the tumour, it delivers a chemotherapy payload to the tissue.

The PBN consists of four interlocking longitudinal plastic segments nested together, each of which incorporates a drug delivery channel. The channel also contains a fiber-optic cable used for shape sensing. Each segment is driven at its distal end by an ironless motor. By pushing one segment or another forward so that it slides over the others, the system can cause the tip of the needle to curve by a specific amount. This process enables the needle to be gently navigated through the structures of the brain to reach even deeply embedded tumours. It is an ambitious program with high performance demands. The task of controlling the robotic, steerable catheter through the brain is no simple matter. The four-axis system requires high synchronisation and high precision, as any errors could cause irreparable harm. At the low-level control range, the system needs to operate with an accuracy of 10 μm.

Twitter (G-TWI) servo drive. Just 35 mm x 30 mm, the compact Gold Twitter drive is essential for minimising the overall footprint of the portable surgery station. In addition, the servo drive’s extremely low EMI, resulting from a highly efficient pulse-width modulation (PWM) switching process, proved vital in this critical medical application. In an environment in which safety is a primary concern, the Gold Twitter, the smallest STO (SIL-3) certified drive available on the market, offers a huge advantage. Guiding the PBN requires the system to analyse the MRI and ultrasound data, then independently drive the four segments of the needle to direct the payload to the tumour. This needs to happen accurately, precisely, reliably, and at very high speeds. For a controller solution, the Imperial College team chose the Platinum Maestro (P-MAS) multi-axis motion controller.

Performance is only one part of the challenge. Space is always at a premium in an operating theatre. The components used in the PBN need to be as small as possible. They also need to be quiet, both in terms of audible noise and EMI. Operating rooms are packed with instrumentation. The robot cannot interfere with imagery or the signal of a crucial instrument.

The Platinum Maestro incorporates a multi-core processor and advanced multiaxis features, making it effective for highly synchronised systems. It includes a library of motion algorithms to simplify the implementation and control of machines and robots that need to be both fast and accurate. The Platinum Maestro features enhanced fieldbus support, including EtherCAT, cycling at a rate of 250 μs in the Imperial project.

DRIVES AND CONTROLLERS The PBN features four motors, each of which requires a drive. In addition, the overall system requires a high-performance motion controller to perform path planning based on closed-loop feedback and input from the MRI and ultrasound units. For a drive, the Imperial College team selected the Elmo Gold-

The Platinum Maestro includes a number of features for ease of use. “In addition to the core benefits of the Elmo Motion Control technology, a key factor in our choice of control solution for the project was the reduced development time,” said Eloise Matheson, PhD candidate at the Mechatronics in Medicine Laboratory.

Compact automation products from Mitsubishi Electric have helped create a new space-

automation & robotics

saving thermopackaging machine for UK-based Riverside Medical.

itsubishi Electric provided Riverside Medical Packaging with a highly compact integrated control solution based on the company’s diminutive L-Series PLC supplied with servo control and safety modules, HMIs and an optional Melfa articulated arm robot. The new Shawpak branded cleanroom thermoforming packaging machines can now replace a packing line that may stretch out to 20m with a unit that is under 2m in length. The cost advantages for operators is significant, as the opportunity to increase production or re-purpose existing floor space is considerable. “The high cost of maintaining a clean room production environment increases the benefits and reduces the ROI when using one of our machines” said David Shaw, CEO at Riverside Medical. “The company has been involved in contract manufacturing and machine development on behalf of the medical industry for over 40 years, so we knew the market for a solution was there. Having developed the initial concept, we then turned to Mitsubishi Electric to help us develop our vision of a super compact design into a fast, efficient, robust and reliable machine.”

The product to be packed is loaded on-top of the drum and ejected into a discharge conveyor underneath. The webs of packaging material, e.g. PET or polyethylene sheets, plus the forming, sealing and cutting stations are positioned around the drum. Thanks to the rotary format Shawpak machines start at only 1.5m long and can occupy less than 2m2 of floorspace. This represents a reduction of up to 95% in the space occupied by a traditional form fill sealing (FFS) machine. Ivor Rowe, technical manager at Riverside Medical confirms “a comparable FFS machine can be anywhere from seven to 20 metres in length depending on the packaging process requirements, occupying a working space of up to 40 square metres. As a result, a given cleanroom space can fit 6 times more packing machines with a Shawpak design, increasing both productivity and throughput.” The innovative rotary design of Shawpak also increases versatility and flexibility

isn’t everything

The resultant Shawpak models are compact thermoforming sealing machines that can be loaded manually, or for additional speed and efficiency using an integrated Mitsubishi Electric

robot. The main innovation is the forming, packing and sealing process which is now carried-out on a drum, rather than a linear conveyor system. The rotary motion of the drum, along with the sealing film is indexed using precision servo control while the product and package manipulation uses suction.

automation on&the robotics cover

during packaging operations. Different forming drums with cavities of various dimensions are available. These can be easily removed and replaced in order to pack objects of different sizes and shapes on the same machine. In addition, the new concept ensures that every piece of packaging material is used, reducing the amount of waste from cut packaging material experienced by other designs. It is possible to further improve productivity on the factory floor as well as maintaining a controlled environment in the cleanroom more easily by adding a robotic arm for loading. Ivor Rowe adds: “The traditional form fill sealing machines used in medical device packaging industries do not fit the modern requirements of plant flexibility, process optimisation and throughput. We believe our novel approach is a gamechanger that can revolutionise the sector.”

Such a revolutionary, automated piece of equipment needed state-of-theart technologies to support it and, for Riverside Medical, Mitsubishi Electric’s automation solutions were the obvious choice. David Shaw explains: “We relied heavily on Mitsubishi Electric to realise this project. As this was a completely new concept for us, we needed an automation solution provider that could deliver on the PLC, servo and indexing aspects, as well as providing a costeffective robot integration package.” Mitsubishi Electric has been involved in the development of Shawpak since the initial planning stages, developing the strategy and addressing the project’s challenges. The main one being the extended functionality required versus the restricted space available. Stephen Thornton, Key Account Manager at Mitsubishi Electric, commented: “The size of the control panel in Shawpak is not only much smaller than in a traditional FFS machines, but outright one of the most compact we have seen. Hence the reason we suggested using the latest MELSEC-L Series PLC to provide a compact solution with optimal performance. While there isn’t lots of IO to manage, (the components are connected via a CC-Link open control network) the PLC connects the Mitsubishi Electric’s GOT2000 HMI operator terminal, MELSEC-WS safety system, MELSEC-L series simple motion

IMAGES: MITSUBISHI ELECTRIC EUROPE B.V.

module, the pneumatic valves, as well as controlling the six-axis MELFA RV-F series robotic arm. MEDICAL DEVICE PACKAGING IS ONLY THE FIRST STEP While Shawpak was initially developed for the packaging of medical products, other packaging industries can benefit from the solution, Ivor Rowe explains: “We believe Shawpak could have a big impact on the food and beverage sector, electronic service components or anywhere else with stringent hygienic requirements.” “The creation of such an innovative new FFS machine would have not been possible without the support from Mitsubishi Electric and its range of industry leading automation solutions. We look forward to continuing to work together on Shawpak and future projects that will provide cutting-edge solutions for the packaging industry.”

It is possible to further improve productivity on the factory floor as well as maintaining a controlled environment in the cleanroom more easily by adding a robotic arm for loading.

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AN INTERNET OF THINGS

atherine Booth, a partner in the Manchester office of IP firm Mathys & Squire looks at the new challenges emerging from the Internet of Medical Things (IoMT).

Nobody can fail to notice the ever-increasing presence of the internet in almost all aspects of daily life, with seemingly everything now having some level of connectivity. Medtech is clearly no exception and in fact, is one of the technology sectors to most embrace the opportunities that IoT brings – with the interconnection of devices and systems via the internet (IoMT). However, innovating in the IoMT world may involve stepping into other areas of technology that are different to those with which the medtech community are familiar, bringing new challenges, new competitors, and the need for a new way of thinking, especially with regards to your Intellectual Property (IP) Strategy. In recent years, medtech companies have been developing ways to enhance products using the IoT. Just a few examples are wearable monitors that send data to a connected device or to a healthcare provider; smart medications that record how and when they are used and provide feedback for improving efficacy; data tags in manufacturing and packaging to monitor batch quality, shelflife, shipping and returns, etc. Each of these, and the many other applications being developed, requires transfer of data between devices. A mistake I have often seen made in the medtech sector, even by otherwise IP savvy companies, is incorporating known communications technologies into devices without checking whether this is covered by existing IP. Whilst it may seem surprising, there is often problematic IP held not only by known competitors (whose own IP strategy you may be comfortable with), but more frequently by companies with whom you previously did not compete, since many big-name IT companies are now moving into the medtech space, and they may have a very different

approach to IP. Should they enforce their IP rights, it can be very costly and damaging to a business, to the point you may have to remove your product from the market, and the accompanying compensation payable to them may be significant. Therefore, it is important to rethink and modify your IP strategy if you want to take advantage of the IoT. One of the biggest changes I recommend is to consider the IP landscape at the earliest stage in development and as frequently as possible, since the technology sector is very fastpaced (compared with MedTech) and new IP can arise even when you think you have cleared a product. Tech companies are extremely prolific when filing IP, so it can often seem like there is a huge amount of IP covering what you want to do and no way through it. However, much of this IP is speculative and unlikely to be valid in broad terms, so its existence does not necessarily prevent you from doing what you want, but you will need clear, practical advice to help you make strategic decisions. Another aspect that is quite often neglected by medtech companies is filing your own IP. MedTech is generally a very innovative sector, with developments that stand out as being inventions. Therefore, it’s common for MedTech companies to see communications technologies

as not adding anything particularly innovative to a product and to not seek protection for the new IoMT device. You are missing out on valuable protection that not only can be used to stop competing products, but can also be a bargaining and commercial tool should you find yourself within the IP protection of another company and in need of a licence for example. Another area that must be considered is data protection, especially with the recent legislation changes such as the EU General Data Protection Regulation (GDPR) which came into force in 2018. How you implement GDPR may lead to IP opportunities and again, commercial opportunities with regards to licensing. Timely and appropriate IP advice throughout your development cycle is essential. You can spend large amounts and still not avoid the pitfalls, whereas getting it right from the very start can save costs over time. As you are moving into another sector, with big name players that are typically more aggressive with their IP, and whilst it can be daunting, the rewards can be significant. As Facebook’s Mark Zuckerberg said, “In a world that’s changing really quickly, the only strategy that is guaranteed to fail is not taking risks”. Mathys & Squire is exhibiting on stand F58 at Med-Tech Innovation Expo.

industry 4.0

etherlands-based Promolding recently challenged UK firm Connect 2 Cleanrooms (C2C) to provide an intelligent cleanroom solution to protect a medical device manufacturing contract that is due to run until 2032.

Under the Effective contamination control is critical, as Promolding is producing optical manifolds for an eye surgery machine. Designed to keep pressure on an eye during surgery when the eye lens is removed, these precision parts feature intricate veins and diaphragms. Over nine months, they collaboratively developed a reliable and intelligent cleanroom solution, which works in harmony with Promolding’s Engel machines and robots. The cleanroom is now safeguarding a long term investment, so design features have been optimised to guarantee cleanroom performance for years to come THE PROCESS One shot injection moulding machine (80 tonne) produces one plastics component Two shot injection moulding machine (300 tonne) produces the second component, made up of two plastics (injected, rotated then injected again) Robots pick up moulded parts, drop them onto the motorised conveyor and transport them into the main environment The two parts are then assembled and welded, then they progress to packaging THE SOLUTION Each moulding machine has one fixed and one actuated, HEPA filtered, overhead canopy. The automated, sliding HEPA-lite canopies provide overhead access for tool changes. They are driven by an

actuator with two linear guides, one master and one slave. These drive the filter system to an open or closed position. The canopies feature effective safety mechanisms, sending infra-red signals across the actuators. If the signals are interrupted, for instance by the robot or by operative’s hands, the canopy will deactivate movement, preventing any accidents. The canopies feed into the main cleanroom area, which houses assembly, the plastic welder and packaging. INDUSTRY 4.0 Industry 4.0 is the fourth industrial revolution - the digital transformation. It is a term used to cover the use of automation, smart factories, digital systems, sensors and robotics, data and remote operations - with the goal of increasing manufacturing productivity, improving planning and forecasting, or giving a competitive edge. Here, C2C applied Industry 4.0 techniques and designed a cleanroom with automated canopies to work in cooperation with Promolding’s robotics. These reduce the risk of human error and improve the quality and consistency of the end product. The cleanroom features an intelligent digital system, in the form of C2C’s ECO control system. It is designed to ensure that the cleanroom operates at optimum effectiveness by constantly monitoring the operating conditions, in real time within the critical environment, raising

industry 4.0

canopy alarms if any of these parameters vary beyond a user specified threshold. All relevant control parameters for each three zones are graphically displayed on a HMI touch screen interface, allowing users full control and to locate faults and run diagnostics. All system performance data is logged and is downloadable. The intelligent moulding machine recognises faults with a product and drops affected products into stainless steel drop drawers for inspection. The personnel door is interlocked with the moulding machine during manufacture. The sample drawers are accessible from outside the HEPA-lite, meaning the faulty parts or samples can be safely removed without interrupting manufacture. There are plans to have all the processes within the main cleanroom area to be fully automated in the future. The main cleanroom area was installed under a mezzanine, so the ceiling was fixed to the walkway above it and suspended via 56 drop rods. This secured the roof and ensured that no internal legs were needed to support the room keeping an open plan layout. C2C worked with a structural engineer, to develop the structural system. The 4 existing pillars supporting the building were used to feed the cleanroom’s utilities - i.e. sockets, compressed air. The HEPA-lite canopy system and main cleanroom area have been designed

to accept two more injection moulding machines to feed into the main cleanroom as demand grows. There was an effective collaboration with ENGEL allowing C2C to integrate the HEPA-lite with the injection moulding machines, so it wasn’t necessary to use floor supports. Support legs would have obstructed access compartments and the regular re-calibrations, so full access to the machine is hugely beneficial. Rubber mounts were used to absorb movement, so it doesn’t affect the canopy. Despite being a precision build, the main room was constructed in 4 week and the HEPA-lite canopies were constructed in 2 weeks. • ISO 14644-1:2015 Class 7 • Overall footprint: 279.42m² (19.27m x 14.5m x 2.825m). Internal clearance of 2.5m • Internal change area: 13.86m² (6.860m x 2.02m) • 99no. air changes per hour at an air speed of 0.45m/s in the Main Area • 70no. 20W LED light fittings (6500K light temperature) to match the current lighting used within Promolding’s building • 42no. variable speed controlled HEPA ceiling fan filters • 4no. transaction drawers next to conveyor inlets • 1no. roller door for goods in/out • ECO Control System with automated sliding hatches on HEPA-lite units • 2no. automated HEPA-lite canopies to

• •

•

supply clean air at the critical point of production and reduce contamination by significantly limiting exposure to the external environment during tooling changes. The cleanrooms which house the ENGEL machines and HEPA-lite canopies are 4.7m in height. The grey lid to the filter system houses cables, providing a cleanable surface and looks in keeping with the factory Pendant stations control each automated HEPA-lite on the injection moulding machines. Each have manual overrides for safety reasons Proximity switches to the side of the HEPA-lite have LED lights to give a visual indication when the HEPA-lite canopies are in situ. The canopies also feature a safety mechanism which deactivates actuators if the canopy is obstructed

Connect 2 Cleanrooms is exhibiting on stand D6 at Med-Tech Innovation Expo.

Darren Kaye, business development director at MP+H Packaging, explains how a medical contract led to the

coatings

r e f a s It’s e insid

s an independent business, in our field of supply, we constantly look for new technologies and innovations to try and keep at the forefront of our field. To this end, we often look at a ‘problem and solution’ proposition to facilitate the business growth. This ideally helps our client base to adopt new innovations in material and coating technologies to reduce cost, improve efficiencies or enhance products. Some time ago, working on a new proposal for sachets in to the medical sector, we met with one of our suppliers and discussed the possibilities of producing an antibacterial coating system to add to our portfolio of products. The problem was the need to ensure that the coated sachet reached the end user, through the supply chain, to deliver a product that is safer than anything else yet in the marketplace. Ultimately any packaging that is handled multiple times presents a risk of cross contamination, and the ability to reduce this risk is paramount to infection prevention control, especially within the medical sector at the point of care. This presented many issues to work through, but ensuring we hit the protocols set out to us and after speaking to industry bodies, we set out a roadmap to success. Fortunately, testing proved to be somewhat easier than the initial development of the coating, and on the second batch of testing we achieved our goal of a four log reduction at 99.99%.

development of a coating that protects the product from crosscontamination throughout the supply chain.

All testing is independently contracted against ISO22196:2011, as we quickly found that there have been numerous examples of how adding various additives to products can show a reduction in microbial growth. The testing protocols in laboratory conditions (where the bacteria is cultured, in conditions that moisture and nutrients have been manipulated), have not been reliable when attempted during many production processes and masterbatches. We overcame this issue by producing a 100% solid top coated UV coating to encapsulate the product. We also had to fully consider the Biocidal Products Regulation (BPR, Regulation (EU) 528/2012). This concerns the placing on the market and use of biocidal products, which are used to protect humans, animals, materials or articles against harmful

organisms like pests or bacteria, by the action of the active substances contained in the biocidal product. The specially formulated liquid coating has provided a solution for pharmaceutical, medical and healthcare packaging, to prevent cross contamination, and control bacterial activity on both the inside and outside of the product. As our business produces ‘reel fed’ materials, the outside of the material is wound in contact with the inside of the material, up to the point of manufacturing of the filled product. This leaves the window for potential contamination to the inside very low, and this is prior to the product being sterilised by any medium. We often ask the question “how many times is the pack handled prior to being used?” Seldom do people have an answer or test the pack at this stage. The technology has now been fully integrated in to our business as a ‘cost neutral’ option on any product line supplied – sachets, base and top webs, and labels. We are also currently trialling the product in to the blister foil market sector. At IPC2019 London we further released a new product that we have trademarked as Touchpoint. This simple, cost effective and visible technology places the 100% solid top coating on to a substrate that then adheres to many differing items, and protects the product for 90 days. Currently the technology is being implemented in schools, colleges, residential care homes and the workplace (including medical packers, food blenders and food packers). After the launch, and further to running out of samples at the exhibition, we now have sampling taking place in numerous NHS Trusts. Touchpoint is currently available to cover many products, we have manufactured door entry control points, door push plates, door handle wraps and touchscreen products. Touchscreen products have an increased benefit with the technology as the silver ions actually increase the conductivity and sensitivity of the touchscreen, whilst still giving a protection level of 99.99% for 90 days continuously. MP+H Packaging is exhibiting on stand F10C at Med-Tech Innovation Expo.

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Brian Reilly, business development director, biomaterials for NuSil, highlights

the options for reducing friction when using silicone elastomers.

coatings

No need for friction

ilicone has a long and proven history of use with medical devices and can provide many benefits, from flexibility to cushioning. However, silicones can present challenges due to an inherent surface tack. The surface of cured silicone elastomers is sometimes characterized by a high coefficient of friction (CoF), some degree of tackiness and a tendency for blocking (sticking to itself by virtue of chemical affinity). These characteristics may need to be addressed in applications that require a moulded or extruded silicone component to move or slide with minimal friction. As medical device designers account for friction, one solution is self-lubricating liquid silicone rubber (LSR), which eliminates an extra step to apply lubrication. Another solution is the use of a low CoF silicone coating applied to the surface and then cured to chemically bond the coating to the substrate for a non-tacky surface.

SELF-LUBRICATING SILICONE ELASTOMERS CAN REDUCE THE NUMBER OF PROCESSING STEPS REQUIRED. THE ELASTOMER CAN ALSO BE SPECIFIED WITH THE PHYSICAL PROPERTIES AND LEVEL OF LUBRICATION NEEDED FOR THE APPLICATION.

SELF-LUBRICATING LSRS The traditional solution to these friction challenges requires medical device manufacturers to apply a silicone lubricant onto the moulded part as a separate manufacturing step, however, self-lubricating LSRs are now available. The lubricity is built into the silicone elastomer system which yields a lubricious surface on the moulded component. The elastomer system is formulated with a proprietary additive that elutes out over time after vulcanisation. The performance of many medical devices depends upon minimising friction at the interfaces between various components, and self-lubricating LSRs provide the basis on which to produce effective results. Potential uses for selflubricating silicone elastomers include balloons, valves, stoppers, O-rings, silicone devices with moving or sliding parts and parts that require assembly. LOW COF SILICONE COATINGS Other methods to overcome the high degree of surface tack and blocking with silicone elastomers include cured silicone coatings. When applied to the surface of the part and cured to chemically bond to the substrate, the coating mimics the mechanical properties of the underlying substrate. The outcome is a â&#x20AC;&#x153;dryâ&#x20AC;? lubricity that reduces the CoF on the surface of silicone parts and eliminates concerns about migration, leaking or rubbing off that are commonly associated with traditional lubricants. Coating options differ in how they are designed to cure e.g heat cure (HTV) or room temperature vulcanisation (RTV). With approximately the consistency of water, the coatings can be applied by dipping, but spraying is recommended. It achieves a smooth finish that results in more than a 50% decrease in the CoF when compared to a non-coated silicone. NuSil technology experts recently conducted a study to evaluate the static and kinetic

A LOW COEFFICIENT OF FRICTION COATING (LEFT) CAN REDUCE FRICTION ON THE SURFACE OF SILICONE PARTS WHILE ELIMINATING CONCERNS ABOUT MIGRATION, LEAKING OR RUBBING OFF THAT ARE COMMONLY ASSOCIATED WITH TRADITIONAL LUBRICANTS

CoF of coated vs. non-coated silicone surfaces. The force it takes to initiate movement between the silicone rubber and a steel panel (static CoF) was measured, as well as the force needed to keep the silicone rubber moving against a steel panel (kinetic CoF). Both a 70 shore A durometer liquid silicone rubber and 50 shore A durometer high-consistency rubber were tested according to ASTM D 1894 at ambient conditions. During the test, samples were placed on a stainless-steel panel with a mirror finish. On average, the coated samples demonstrated up to 74% reduction in static CoF, and up to 59% reduction in kinetic CoF depending on the silicone rubber substrate. Both lubrication options provide advantages for the healthcare industry. Low CoF coatings are ideal, not only for their performance relative to friction reduction and regulatory concerns, but also because they achieve critical performance goals with negligible impact on the mechanical properties of the silicone substrates they coat. Therefore, a silicone device that must bend, twist, elongate, etc., can handle this movement, coated or uncoated, without cracking, flaking or peeling. Selflubricating silicone elastomers may be chosen to reduce the number of processing steps required; the elastomer can also be specified with the physical properties and level of lubrication needed for the application. NuSil will exhibit on stand G30 at Med-Tech Innovation Expo.

Queen’s University Belfast has invested in a 3D bioprinter from GeSiM for research

3d printing

the small print

nalytik, a company that provides cutting-edge scientific instrumentation, have announced the recent installation of GeSiM 3D bioprinter at Queen’s University Belfast. It will be used in the development of new processes including the manufacture of medical and drug delivery devices. The company claim, ‘L3D printing could revolutionise personalised medicine’ by creating complex devices tailored to the individual patient through precise control of device geometry, materials and internal architecture. Instrumentation such as the family of modern 3D printers from GeSiM are being used to advance the development of new biodevices. The GeSiM BioScaffolder 3.2 is a flexible 3D bioprinter with a unique piezoelectric micropipetting system for pico- and nano-litre spotting of cells and biomolecules, as well as pneumatically-actuated cartridges for precise printing of highly viscous materials (e.g. molten thermoplastic polymers) on definable coordinates within a scaffold structure or on flat surfaces. This combination of both technologies is unique and not available on competitor 3D printers.

PROFESSOR RYAN DONNELLY WITH THE GESIM BIOSCAFFOLDER 3D BIOPRINTER

The BioScaffolder can print polymers at temperatures up to 250 °C, while cells and biomolecules (e.g. enzymes, proteins) can be maintained at 37 °C or chilled to enhance stability. This innovative approach allows struts of mechanicallystiff materials to be combined with cell-friendly materials (e.g. hydrogels) containing suspended cells in novel regenerative medicine approaches. The instrument automatically aligns print tools of different dimensions by means of a 3-axis light barrier. Struts of up to three different materials can be combined, even in a single layer. Individual cells, cell suspensions and aqueous polymer solutions can be printed onto substrates for applications in single-cell analyses, biosensing and drug delivery. Importantly, the BioScaffolder can be interfaced with existing analytical equipment, with individual cells or minutevolume solutions accurately printed directly into multi-well plates, or onto microfluidic chips or biosensor substrates. GeSiM have recently added melt electrospinning for fibre production and UV-curing capabilities, while a new coreshell tool allows precise printing of tubes, with either a hollow bore or soft internal material, further extending utility. Professor Ryan Donnelly holds the Chair in Pharmaceutical Technology in the School of Pharmacy at Queen’s University Belfast. His research is focused on the design and physicochemical characterisation of advanced polymeric drug delivery systems for transdermal and topical applications. He describes the

plans for his recently installed bioprinter which was funded by a Wellcome Trust Multi-use Equipment grant. “Our overall aim is to, for the first time, extend the utility of 3D bioprinting from applications in regenerative medicine into reproducible manufacture of micron-scale drug delivery devices, biosensor production, single cell analyses and enhanced understanding of tumour microenvironments. These novel uses of 3D bioprinting have the potential to make a significant and far-reaching impact, in improving health and therapeutic outcomes for patients. “This is the first 3D bioprinter in our university and, to our knowledge, is the first instrument with the unique capabilities of the BioScaffolder in Ireland. Together with my colleagues, we plan to follow the Wellcome Trust’s strategy on improving health for all, in that it will accelerate the application of research to improve health and drive forward development of new healthcare products, devices and technologies and promote clinical translation of research advances from bench to clinic.” Product Specialist, Hiran Vegad, says, “Working with Professor Donnelly and his group at Queen’s is already proving extremely exciting. Their broad focus will impact on the prevention of disease, antimicrobial resistance, improved diagnoses, better treatments and enhancing understanding of cancer and inflammatory diseases to the benefit of patients worldwide. As suppliers, we at Analytik look forward to playing an active role in this program over the coming years.”

into the manufacture of medical devices and drug delivery systems.

events

Medtec Live 2019

T4M

MEDTEC LIVE EXHIBITION ANTICIPATES AROUND 400 EXHIBITORS FOR THE EVENT IN MAY THIS YEAR.

Stuttgart’s new medical technology trade fair titled T4M (Technology for Medical Devices) is taking place 7-9 May 2019.

The medical technology value chain will be represented at the Nuremberg Exhibition Centre for the international MedtecLive exhibition and the MedTech Summit Congress from 21-23 May this year.

T4M (Technology for Medical Devices) encourages the exchange between company founders, established Small and Medium Enterprises (SMEs) and investors.

This event is expected to attract around 400 exhibitors, with two exhibition halls and a lecture programme. “From a standing start, MedtecLive will launch as an international networking platform based in southern Germany, and also as Europe’s secondlargest exhibition for medical technology,” comments Alexander Stein, director MedtecLive at NürnbergMesse. Half of the exhibition area at the event in May will be taken up by companies in the fields of processing, manufacturing and mechanical engineering, whilst the other half will be split evenly between all other fields. “The entire sector hopes to contribute to the success of MedtecLive and definitely wants to be a part of the innovation platform when it launches in spring,” says Stein.

The free industry forums in the exhibition halls offer knowledge and practical tips. Many partner entities will also be there with their expertise and will cover topics of current interest, from cyber security to the latest developments on all aspects of the European Medical Device Regulation (MDR), from hygienic design to artificial intelligence, recruiting skilled employees, and access to the international market. On the second day of the exhibition, the industry’s next generation will gather at the annual meeting of Young Professionals at Medtech, organized by the Association of German Engineers (VDI) as part of MedtecLive. This day will also include an intensive programme of lectures and workshops focusing on extremely popular forwardlooking topics such as bioelectronics and artificial intelligence, which will appear on the agenda alongside regulatory issues relating to the MDR and requirements of clinical studies, and how to develop a career in medical technology. VDI is also actively involved in the latest industry topics in the exhibition forums.

T4M is also launching a feature called ‘Start-up World’, which aims to provide a professional platform for company founders to present their promising medical technology solutions, as well as providing the opportunity to engage with other industry representatives and investors. The event is also aiming to provide new opportunities for a cooperation between established SMEs and start-ups. Sixty start-ups from the medical technology sector will have the chance to introduce themselves at T4M, the new medical technology trade fair in Stuttgart. The T4M Start-up World feature will also include a pitching stage, on which startups from the medical technology sector can present their ideas to an expert jury of investors, medical technology industry representatives and business experts. There will also be a “Networking & Partnering” common area where visitors can lay the foundations for a new cooperation and partnership. Taking place over three days, the event will cover the most important industry segments for medical technology. It will aim to address key aspects such as prevention, inpatient care, outpatient care, rehabilitation, care and production/manufacture.

“T4M Start-up World is the perfect event for anyone fascinated by the medicine of the future,” explained Sandra Wirsching, director of business development at Biocom AG, which publishes the Medtech Zwo journal. The long-term concept is focused on bridging the gap between start-ups and SMEs. Medtech founders receive tips and tricks regarding the implementation of new business ideas, information about accelerators, incubators, as well as access to possible cooperation partners within the sector. Established companies can also expect to find concise information about the various new medical technology trends, external financing options and opportunities for cooperation.

“T4M Start-up World is the perfect event for anyone fascinated by the medicine of the future”

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2019

MAY

REGULATORY UPDATE

The road well-travelled

There are lessons to be learned from big pharma as medical device manufacturers respond to new reporting rigour. Amplexor’s David Gwyn collates some practical advice from those that have already been down this road

While the medical device industry often looks to distance itself from big pharma, it could learn a thing or two from across the divide when it comes to rigorous reporting standards. With MDR and equivalent international standards now being introduced, to increase traceability and improve patient safety, device producers have got a steep learning curve ahead. The regulatory climate for medical device manufacturers is on the brink of a major shift, intended to raise patient safety and make companies more accountable for tracking the impact of their products in the real world. The high-profile PIP breast implant scandal is among the cases that have led to the formal steps being taken, first in Europe then globally in the coming years. The new regulatory requirements pose some fundamental challenges with echoes of where pharmaceutical companies were some 14 years ago – when EMA and other regional authorities around the world began to usher through new information submission standards. HISTORY REPEATING ITSELF After a huge amount of pain and cost, drugs companies have come a long way – their most recent effort being to create a more definitive, consistent and reliable picture of their products from a regulatory perspective, in anticipation of new ISO IDMP requirements. Here, through an internationally harmonised approach to identifying and describing medicinal products, the industry aims to bolster pharmacovigilance activities, make it easier to locate and exchange product and substance information globally; promote reuse of data across different procedures and regulators; and generally streamline regulatory processes.

Until now, medical device manufacturers have been mere observers of the developments. While quality and safety have always ranked highly for reputable players, efforts have largely been concentrated on the manufacturing shop floor in terms of product lifecycle information management. But this will need to change in the run-up to the European Commission’s new medical device regulation (MDR), applicable from May 2020, and the equivalent in vitro diagnostic medical device regulation (IVDR), due for introduction in May 2022. One of the most critical areas of focus of these new regulations is post-marketing surveillance. Once the new regulations are active, device manufacturers will be expected to formally monitor the long-term safety of their products and provide evidence of their follow-up findings in periodic safety update reports. GATHERING EVIDENCE So, first off, companies need to be able to capture post-market safety data. MDR demands a detailed summary of safety and clinical performance information, which must be updated and reported at regular intervals with postmarket clinic follow-up findings – a combination of formal studies, incoming feedback from patients and GPs, and potentially commentary captured via public online patient forums and social media platforms. The new post-market surveillance requirements will apply to every category of medical device, too, creating a lot of work for manufacturers. The implications of falling short of authorities’ expectations could be significant, ranging from multi-million-dollar fines and products being taken off the market, to lasting reputational damage.

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REGULATORY UPDATE

The increased rigour won’t be confined to Europe, either. In the US, more than 1.7 million injuries and almost 83,000 deaths may have been linked to medical devices, based on reports to the FDA over a 10year period. The International Medical Device Regulators Forum (IMDRF) has a keen interest in MDR and IVDR, too, which could result in countries in Asia and South as well as North America adopting their own variations on the requirements in the coming years. INSIGHTS FROM BIG PHARMA With little more than a year to go until the first new requirements come into force in Europe, there is a growing sense of urgency for medical device manufacturers to put in place strategies, processes and systems for managing all of their new reporting responsibilities. So what can they learn from their counterparts in the pharmaceutical sector, to save them from repeating early mistakes? The first takeaway is not to see the coming changes as a single event that manufacturers can plan for with a definitive, one-stop project. If pharma has learnt one lesson above all, it is that the global regulatory climate is continuously evolving, so trying to pin down all requirements up front, or waiting until all the final variables are known before getting going, is not a practical approach. Similarly, regulators’ hunger for information is seemingly insatiable, so selecting a series of best-of-breed applications that each handle a finite set of parameters, has been found to be be a false economy. When pharma companies did this, many ended up with 20 or more different systems from different vendors, all of which needed to be supported and updated, and many of which did not integrate and share data very easily with each other. This caused firms to fall back on manual processes and spreadsheets for managing all of the contributing information,

reintroducing inefficiency, potentially introducing errors and undermining their considerable investments. LAYING FUTUREPROOF FOUNDATIONS Through more than a little pain, pharma companies have learnt that it is far more practical to create a more fluid, end-toend information management capability which can be adapted to a range of different needs. The ideal many firms are now working towards is the creation of a single, complete, master set of data about their products and their evolving status – one that spans R&D, approvals, and post-marketing follow-up, and which can be applied as needed for each different use case. Having a clear line of sight across a definitive single set of complete information offers companies all sorts of advantages, not least the scope to reduce repetitive data re-entry or document creation, and the opportunity to automate preliminary information checking and content building processes. In pharma, companies have been able to do away with huge teams of temporary staff who had been drafted in to review and edit regulatory documents ad infinitum. With strong, authenticated master data to draw on in support of multiple use cases, they were able to automate much of this work.

regulatory data offers medical device manufacturers a host of potential advantages, and a chance to skip to the point that many pharmaceutical companies are only just getting to now. With the first deadlines for the new regulatory compliance bearing down, medical device manufacturers now need to press ahead with their plans. One of the first discussions may need to be about moving extended product data management off the shop floor into a regulatory lifecycle/regulatory information management (RIM) environment, overseen by those tasked with matters of safety and compliance. Certainly, as post-marketing surveillance activities grow in prominence, the role of Regulatory Affairs teams will become more critical in the medical device sector, with a likelihood that relevant skills will be in high demand. It’s a further reason why manufacturers should start acting now.

STAYING PREPARED Looking for broader efficiency gains will also serve medical device manufacturers well as they are required to provide better information directly to patients – for instance, online advice about the lifespan of a product, or guidelines about airport safety for users of pacemakers. That’s in addition to the immediate benefits of being able to call up a product’s status information in a couple of clicks, to verify where it is currently approved, or what has been the latest correspondence with a particular authority. Working towards a comprehensive, global master resource of product

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

PUTTING IT TO THE TEST

Clinical Design has developed a urine testing system which is designed to improve the process from receiving the sample and recording the results to analysis in the laboratory. The system launches this year and has recently been recognised with a Red Dot Award for its design.

GETTING COMFY

Aergo is developing a device to aid the comfort and posture of wheelchair users. The device is built into the chair where movement is monitored and air cells are automatically inflated and deflated to ensure better comfort for the user. Aergoâ&#x20AC;&#x2122;s founder Sheana Yu, recently received a Women in Innovation Award.

MAKING SENSE

Galway-based EnteraSense recently secured â&#x201A;Ź3.5 million worth of backing from EU horizon grants and investment from physicians after developing a capsule to detect gastrointestinal tract bleeding. The capsule can either be attached or swallowed, and is hoped to be commercial by mid-2020.

TO BE PRECISE

Focussing predominantly on the elderly, Feebris has developed an AI-engine to deliver precision diagnosis away from the hospital. It takes measurements from point-of-care devices and scans them for a wide range of disease markers. It then combines these markers to identify the presence of a disease or a complication.

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