Page 1

Issue 36 | Mar/Apr 2018


PLUS IP & Patents NEW: The HealthTech Series



N 1 Destination o

Boddingtons returns to Med-Tech Innovation Expo: page 12


Some big ideas need guidance.

MEDICAL advancements are not acheived without experimentation, passion, and patience. At Zeus, our primary mission is to enable you to creatively explore new ideas and utilize the best tools to turn your vision into reality. Five decades of extrusion experience have made us a leader in the medical industry. As we continue our commitment to forming long-lasting partnerships, let’s see what we can develop together. Call for a consultation or visit for free samples and get started today.

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On the cover


Med-tech Innovation Expo



IP & patents



The HealthTech Series


Public intellectual 32 THE TEAM editor | dave gray +44 (0) 1244 680 222

brand director | colin martin +44 (0) 1293 710 042

reporter | reece armstrong

ad sales manager | damien challenger +44 (0) 1244 680222

head of content | lu rahman

art | sam hamlyn publisher | duncan wood

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

for any losses or other damages incurred by readers in reliance on such content. All submissions are handled with care. Every precaution is taken to ensure accuracy, but the Publisher cannot accept responsibility for the accuracy of the information herei ŠRapid Medtech Communications Ltd. No part may be reproduced or transmitted in any form without the prior permission of the Publisher. ISSN 2046-5424


We improve patients’ quality of life Applications in medical technology place high demands on drive components:

Heart pumps

Precision, sterilisability, smooth running as well as low heat build-up in DC and BLDC

Drug delivery

drives. maxon medical specialises in the development and production of microdrives for such applications, strictly in accordance with the medical standard ISO 13485.

Find by by visiting us atus Med-Tech Expo 2018 Findout outmore more visiting at Med-Tech Expo 2018 26-27 Ricoh Arena, Coventry UK Stand E12 25-26April April Ricoh Arena, Coventry UK Stand E12

Surgical robots Hand and leg prosthesis Surgical hand tools

ISO 13485

Contact us to see how we can help. Phone 01189 733 337


maxon medical technology Applications in medical technology place high demands on drive

Heart pumps Drug delivery Surgical robots Hand and leg prosthesis Surgical hand tools

ISO 13485

components: Precision, sterilisability, smooth running as well as low heat build-up in DC and BLDC drives. maxon medical specialises in the development and production of microdrives for such applications, strictly in accordance with the medical standard ISO 13485.

Contact us to see how we can help. Phone 01189 733 337


Visitus usatatMed-Tech Med-Tech Expo Visit Expo 20182018 25-26 April Ricoh Arena, Coventry UK E12 Stand E12 26-27 April Ricoh Arena, Coventry UK Stand

from The editor



Play a new role

his edition of Med-Tech Innovation News features a new regular spot devoted entirely to one of my favourite topics – digital health. The emergence of digital health is leading to a change in what is considered as normal practice in healthcare and the medtech sector. It’s a complicated journey for many stakeholders to go on. The role of the medical device OEM is changing. Patient-centric design may be an old concept, but digital health takes it to the next level. OEMs have the opportunity now to design devices which bring them closer to the patient in many ways – be it via the gathering of patient data, or interactive guidance on using and living with the device. All of this constitutes added value, and for those devices where it is appropriate, it’s an opportunity for medtech firms to interact with patients in a similar way to the consumer business model. At the same time, the role of the patient is also changing. The arrival of connected medtech has given rise to the idea of the empowered patient – a patient that, in theory, is less of a burden on the healthcare system. Our mission here at Med-

Tech Innovation News is to provide content that helps medical device OEMs solve challenges and adapt to the changing demands of the market. The aforementioned changing roles are the reason why we’ll be running a regular digital health update in each issue. Named the Healthtech Series, you’ll find the first instalment on page 29 of this issue, with an overview of the market from my colleague Reece Armstrong – reporter and commentator for our sister title, Digital Health Age. Adopting a patient-first, connected approach is definitely going to be key for many of the sector’s major players in the coming years. Ernst & Young (EY) recently reported that over 75% of life sciences organisations currently included in the Fortune 500 are at risk of falling out of this ranking by 2023. EY believes that to mitigate that risk, medical device firms need to “look beyond devices to provide data-driven health services”. There has been a significant movement from both start-ups and major consumer brands into the healthcare arena. That said, this is not necessarily a sign that market share is going to diminish for those

specialising in certain fields – it just means that there will be more stakeholders in the supply chain. EY says that life science firms now have the opportunity to invest, participate in or build platforms of care, working hand in hand with the new kids on the block. Perhaps the best example of this is Medtronic’s partnership with Fitbit. Under the partnership, Medtronic’s blood glucose monitoring technology can integrate with Fitbit’s activity tracking technology. Via an app, diabetes patients can see how their fitness efforts pay off in terms of managing their condition. Perhaps then, the key to a successful future for any established medical device OEM is not to resist, or compete with the newbies, but instead, seek to form partnerships. After all, the experts in this industry have a wealth of knowledge which will never be redundant, even in the age of wearables and connectivity. It’s knowledge that will form part of the next generation of devices. One place you might make some new partnerships is the Med-Tech Innovation Expo, taking place 25-26 April at the Ricoh Arena, Coventry. I look forward to seeing you there!


EIGHT ways ...that industry 4.0 is


impacting medical device manufacturers

2 – MONITOR AND IMPROVE PERFORMANCE Predictive maintenance technologies can save time and avoid costly breakdowns in the long term – all from a one-off investment in technology. Algorithms and machine learning, such as those used by GE’s Brilliant Manufacturing software, can now anticipate when – and why – a machine is likely to fail. Jennifer Bennett, general manager for GE Digital’s manufacturing software initiatives explained: “Manufacturers are challenged to decide what to build, how to build it, where and when to build it, and how to efficiently maintain it. We believe that the key to optimising the full product life cycle from design to service is through analytics of data that has been traditionally locked inside corporate silos.” 3 – GO PAPERLESS Going paperless could signal an improvement in regulatory conformance. Robert Kavanagh, business development executive at Irish medical device manufacturing specialist Seabrook Technology says: “Taking a look at the recent FDA figures on Non-Compliance Observations, it is clear that production and process controls are a key source of issues. In our experience, over 50% of non conformances are a result of errors on paper, rather than problems with the product.” 4 – TRACK AND TRACE Raumedic is one of the major players in the medical device field to take steps towards going digital with its manufacturing systems. Last year the group selected software provider Guardus Solutions to design a new manufacturing execution system (MES) for its existing machinery as well as future investments. As a result, products from Raumedic can be tracked all the way back to the raw material and can also be crosslinked, managed and documented from the time of their development to their delivery.


5 – BOLDER DESIGNS Design trends like miniaturisation create opportunities for the medical device sector – but they also create challenges for manufacturers. Using advanced scanning and technology processes, manufacturers can produce more complex and intricate designs. 6 – INVENTORY CONTROL Industry 4.0 may be capable of increasing outputs – but more output means more raw materials and supplies coming into the plant. Luckily, technology could hold the key to this as well. Gelston Howell, senior vice president, marketing at medical device manufacturer Sanmina says: “In the past, managing inventory was manually transacted in an enterprise resource planning system, such as Oracle or SAP. With the implementation of industry 4.0 technologies and the use of machine-to-cloud communication, inventory management has moved from manual to automatic transactions, enabling real-time inventory control.” 7 – CUSTOMISATION Personalised medicine could be a game-changer in healthcare delivery – but it will have an impact on those manufacturers who aren’t geared up to deliver on the promise. 3D printing is one option, but older manufacturing methods can also be adapted with advanced product lifecycle management (PLM) software. For example, Siemens now offers a PLM platform that creates an automated image to implant process. 8 – SCALABILITY Adopting Industry 4.0 tech can help future-proof OEMs for future expansion. B. Braun Medical recently made the switch to a digital manufacturing system. Francisco Almada Lobo, CEO of critical manufacturing said of the move: “Critical manufacturing is committed to B. Braun’s success, both in our project execution approach and our flexibility to meet all of their long-term needs. We will use a joint project team to configure our system and build the competence to maintain it for the foreseeable future. We are confident that we will help B. Braun Medical Industries become a global benchmark for advanced and innovative medical manufacturing.”


1 – REDUCING ERRORS Industry 4.0 technologies can be implemented across the whole manufacturing process, but quality control is perhaps the step with the most potential for improvement. Using sensor technology, manufacturers can quickly identify the source of the problem, and thus reduce unplanned downtime.

Is Industry 4.0 really a game-changer for medtech? Here’s eight ways it actually could be.

New research from Coherent Market Insights has found that single-use medical device reprocessing is gaining in popularity as it helps to reduce hospital waste and allows for major cost savings. For instance, US healthcare provider Kaiser Permanente reportedly saves $11 million per annum by reprocessing certain single-use devices. Non-profit environmental group Practice Green Health, is quoted as saying that single-use medical device reprocessing prevented the entry of 10,000 tonnes of medical waste into the waste stream from 1997–2007, via the re-processing of an estimated 50 million devices. Coherent’s research states that hospitals potentially stand to reduce the cost associated with medical devices by 50%. However the findings report that the Asia Pacific, Europe and South America regions have historically been lacking in regulatory standards, which is a restraining factor for the growth of the reprocessing market. The European Union is looking to address the matter, however, and the upcoming European medical device regulations (MDR) set out the minimum requirements for the reprocessing of single-use medical devices. According to a fact sheet issued by the European Union, under the new rules reprocessing may only take place when authorised under national law and in accordance with the provisions of the medical devices regulation. When reprocessing is allowed, the entity that wants to reprocess the device must assume the same obligations as a manufacturer. However, a different regime is applied in the case of reprocessing by health institutions and by third parties on the request of health institutions.


TOYOTA TO HOST MEDICAL DEVICES PRODUCTIVITY WORKSHOP Toyota and the Society of Motor Manufacturers & Traders (SMMT Industry Forum) are set to co-host a one-day workshop to examine ways of improving UK manufacturing productivity. Medical device manufacturers are being invited to attend a workshop free-ofcharge that will give an insight into methods to help improve productivity. Taking place on 11th May, the event will be held at the Toyota Engine Plant Deeside, North Wales, and will share lessons learned in automotive manufacturing that are transferable to the medical devices industry. The Industry Forum’s chief executive, Dr. Chris Owen, said: “At a time when we keep hearing how British productivity is lagging behind international competitors, the automotive sector is reaching out to other UK manufacturing sectors to show that productivity doesn’t have to be a puzzle. We are inviting chief executives and managing directors from medical devices manufacturing businesses to gain a deeper understanding of how to deliver productivity improvements by examining their own beliefs and looking at methods underpinning Toyota’s worldclass operational performance.” The workshop will encourage senior executives to examine productivity and the application of knowledge to different productivity scenarios.


Students from Northumberland College have created a 3D printed prosthetic limb that could improve the life of a young person in need. A group of mechanical engineering students are working with Enabling the Future, a global network of volunteers that work with organisations worldwide using 3D printing technology to create prosthetic limbs for young amputees in third world countries. The students, who are the first cohort of engineers to study in the college’s STEM centre, were provided with specific instructions from Enabling the Future to generate an artificial hand to fit a child’s arm. The limb, made of PLA polylactic acid (a biodegradable plastic) has cost £5 to manufacture, including the cost of materials and power. Gordon Crombie, Northumberland College’s STEM centre manager said: “This excellent project highlights all of our rapid prototyping resources and the positive impact of new technologies. “As children grow they need larger prosthetics, which becomes expensive due to technology limitations in developing countries. However for us, it costs just £5 and a little time.” Gordon added: “Our students have been a credit to the College and fully embraced this learning experience. They are doing something fantastic for under privileged children, which has been a pleasure to be part of. “Our aim is to be able to produce future prosthetics to help more vulnerable young people across the world whilst broaden our students life skills.”

‘MYSTERIOUS’ IRISH MEDTECH FIRM RAISES €40M FOR ‘SECRET’ CARDIAC DEVICE Foundry Innovation & Research 1 (FIRE1), recently announced it has secured €40 million in funding for developing remote monitoring solutions for heart failure patients. The news drew the attention of the press, with news website FORA describing the firm as ‘mysterious’ (having previously reported that it was developing the device in ‘stealth mode’); while the Irish Independent described the project as a ‘secret heart gadget’ due to FIRE1’s statements that further details on the project cannot yet be disclosed. Nevertheless, the financing provides FIRE1 with capital to advance its ‘remote monitoring solution to improve outcomes for heart failure patients’. Globally, it is estimated that at least 26 million people suffer from heart failure, and the burden is particularly high for older patients. “This infusion of new capital from these premier investors will enable us to accelerate our progress and deliver on our commitment to help patients with heart failure,” said Conor Hanley, FIRE1 CEO and president. “Heart failure is a life-threatening disease and a significant burden on patients and healthcare systems.  Managing patients at home with novel digital healthenabled solutions will help intercept the trajectory of the disease and reduce the need for hospitalisation.” “Improving outcomes for heart failure patients remains one of the most pressing needs in healthcare,” said Janke Dittmer, partner at Gilde Healthcare.




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knowledge is power


Ahead of this year’s Med-Tech Innovation Expo, Matt Chapman from

In the run-up to this year’s Med-Tech Innovation Expo, we all continue to hear about fantastic innovations in medtech with the potential to impact on our ageing society and on the multitude of health and care challenges that we face. From novel rapid point-of-care diagnostics to robotic surgery to applications of artificial intelligence in healthcare, these stories capture our imagination and show us what can be achieved through the ‘white heat of technology’. In the UK, we have a lot to be proud of. We benefit from a world-class science base, generating a flow of new knowledge which helps to populate a diverse pipeline of medtech R&D. This R&D activity, in turn, is supported by significant public and private investment, with a diverse range of centres of excellence, accelerators and clusters across the nation. Perhaps we don’t emphasise enough the value of the medtech sector to the UK economy. It’s a major employer, more so than the much higher profile pharmaceutical sector, with around 120,000 employees across over 3,000 companies. The sector has shown positive

growth in both employment and turnover since 2011 and exports around £5bn of goods and services each year. And of course, the UK is home to the NHS, the world’s largest singlepayer healthcare system, which affords us all with everyday miracles. As well as providing patient care, the NHS offers huge opportunities to trial and sell new products and services across the UK population, with our unique position of each patient having an NHS number allocated at birth or on entry into the NHS system. SO THE PICTURE LOOKS PRETTY POSITIVE WHAT’S THE BIG DEAL? Well, as we all know, the UK medtech sector faces many challenges. These include being fragmented across multiple segments; being dominated by small and micro companies with limited resources and reach; running a trade deficit while European competitors, including Ireland and Germany, show significant trade surpluses; and addressing a domestic NHS market which is perennially slow to adopt and diffuse innovation, and which faces increasing cost constraints. But this isn’t a counsel of despair. At the Knowledge

the Knowledge Transfer Network tells us why UK medtech firms have plenty to be optimistic about.

Transfer Network (KTN) we continually see examples of great new products and services impacting on the NHS, and there’s a multiplicity of support and funding available to expand on these successes. In recent years, government and industry have come together to tackle wider challenges through the Accelerated Access Review and the Life Sciences Industrial Strategy / Sector Deal, aimed at raising the intensity of R&D in the UK and strengthening the environment for clinical trials and adoption. Developments include the Industrial Strategy Challenge Fund, with opportunities for medtech around the ‘Healthy Ageing’ and ‘Data to early diagnosis and precision medicine’ programmes, plus the Digital Health Technology Catalyst initiative; new funding for the Academic Health Science Networks (AHSNs) to support adoption of innovation by the NHS; and the Accelerated Access Pathway for strategically important innovations. There’s also a wide range of support available from the Innovate UK ‘family’ of organisations. This includes funding from the Biomedical Catalyst; joint funding with the Office for Life Sciences (OLS)

for SMEs to evaluate innovative medtech and to get involved in NHS Test Beds; and Innovation Loans to provide debt funding for late stage innovation. More broadly KTN, as the UK’s innovation network, can help with connections to funding, partners and expertise which can accelerate innovation – this includes our 4Manufacturing programme which helps manufacturing companies to take advantage of digital technologies and systems under Industry 4.0. Our sister network, Enterprise Europe Network (EEN), can help with internationalisation and has an extensive database of market and technology opportunities. And the wide-ranging Catapult network of technology and innovation centres provides access to expert technical capabilities and equipment, taking innovative ideas from concept to reality. So, the landscape for medtech innovation may be complex and challenging but KTN can help medtech SMEs to connect to all of these opportunities. We’re pleased to be a partner in Med-Tech Innovation Expo, as the key annual UK focus for the medtech design and manufacturing community, and look forward to a great event!

1. Strength and Opportunity 2016 [updated Aug 2017] 2 MedTech Europe - The European Medical Technology Industry – in figures / 2018




by the rules Phil Brown, the Association of British Healthcare Industries (ABHI)’s director of technical and regulatory, examines the nature of the new medical device regulation. The Medical Device Regulation (MDR) was published in May 2017. Rather than being an update or an extension to the old Medical Device Directive (MDD), it is considered a new document in its own right. It includes a whole raft of requirements that bring medical device control into the 21st century, whilst ensuring a much greater business integration of quality and technical detail. No longer can the signature on a company ‘declaration of conformity’ that allows for CE marking, be the singular purview of the regulatory or technical department. This legal declaration demands a more robust compliance with elements of quality management, risk management, distribution control, transparency, post-marketing surveillance and training. These elements are without a doubt, now ingrained within the business process, ensuring that


CE marking has a more holistic feel. The influence for example, of post-marketing surveillance on risk management and how this is then communicated through ‘patient transparent’ media will be an ever-increasing necessity for the manufacturer of medical devices. The below highlights some of the more critical business-related processes needed to allow for future CE marking and suggests ways in which companies can prepare for change. TRANSITION PERIOD AND TIMING The MDR has a transition period of three years. Until May 2020, either the new MDR or the old MDD can be applied to medical devices prior to being placed on the European market. Beyond May 2020, all new products must comply with the new MDR. This all sounds reasonable and logical of course, but there are caveats and nuances that impact on these timeframes and that will influence company strategies surrounding their product portfolio. For example: 

A notified body that will certify ‘conformity assessment’ of a product or quality system must apply to be accredited under the new scheme. Only accredited bodies can issue certificates against the new MDR.

This application and accreditation period is underway, with the first notified body accreditation expected towards the beginning of 2019 at the earliest. This does not leave a great deal of time for companies to organise certification and CE Marking against the MDR and requires early dialogue with their notified body. 

Notified body capacity is a constant issue within the CE Marking scheme. The number of bodies has been decreasing steadily over the last two to three years, meaning that timelines for auditing and certification is extending. Again, early discussions with the notified bodies is essential to determine whether delays can be expected and to explore potential mitigations.

Conformity assessment certificates against the old MDD issued during the transition period, will have their own inherent ‘shelf-life’, which will extend their usefulness beyond the end of the new MDR transition period. Products therefore, may still be placed on the EU market using these certificates, potentially four years after May 2020.


It should be noted however, that this implies no significant technology changes may be made to these products beyond May 2020. If this is the case, then the new MDR will apply post May 2020. These added complications are being used by some as an opportunity to re-assess current product portfolios and to reconsider product life-cycle management processes. With all issues comes opportunities. QUALITY MANAGEMENT One of the guiding principles of the ‘new legislative framework’, to which the new MDR forms part, is the presumption of conformity afforded by the application of mandated standards – those standards harmonised through a European process. One such standard is EN ISO 13485, which controls the quality management system of a manufacturer. Quality management considers all aspects of the manufacturers activities, from product conformity to management responsibilities and actions. Application of standards however, should always be considered as voluntary, rather than a legal requirement. For aspects of manufacturing control therefore, a manufacturer can cite EN ISO 13485 or not, depending on circumstance. If the standard has not been followed however, a satisfactory reason for this deviation must be provided. In all cases, application of a mandated standard is considered a route to compliance. Unlike the MDD, the new regulation includes aspects of quality management within its legal text. As a result, although application of the EN ISO 13485

standard is recommended, there is a certain degree of legal necessity. For example, the regulation demands details of quality objectives, organisation of the business, design and development, as well as details on postmarketing plans and activities. The ‘declaration of conformity’ therefore, which is the legal document stating that a given product is compliant with the regulation, demands that aspects of management review and business practice are carried out, and that these aspects are audited by the notified body. The signatory to the ‘declaration’ must be cogniscent of such processes to be assured that compliance requirements are met. DISTRIBUTION CHAIN The MDR now requires that a manufacturer has greater control over the distribution of their products. All ‘economic operators’, which includes the manufacturer, authorised representative, warehouses, importers and distributors, have defined roles and responsibilities. Indeed, all have a responsibility for ensuring that only products that are MDR compliant are placed on the EU market. The underlying reason behind such tight distribution control is twofold:  The need to ensure

appropriate post-marketing surveillance and; The need to ensure that only regulatory conforming product reaches the enduser.

Manufacturers must have complete transparency of their distribution network, including sub-distributors. In addition, the authorised representatives must have a ‘person responsible for regulatory compliance’, who effectively releases only conforming products onto the EU market. Therefore, manufacturers need appropriate contracts in place with their distribution chain, to ensure that responsibilities are understood and carried out. This may also need an auditing process to ensure compliance is maintained. POST MARKETING SURVEILLANCE Post marketing surveillance is considered as both reactive and pro-active, in that it covers vigilance and adverse effects, as well as continual monitoring of products in use. Both are critical to understanding how a product performs and how product ‘risk’ changes. The MDR requires that these processes are audited by the notified body, as they form part of the legal text rather than part of European guidelines. A company must also have plans for conducting post-marketing clinical follow-ups either to verify or enhance product performance. Although these processes are

also part of the MDD, they are considerably enhanced within the new regulation. Combined with the additional requirements for the initial establishment of clinical performance, they represent a broader and more systematic challenge to companies in monitoring use of the product once made available to the patient. A company can organise these post-marketing surveillance programmes depending on the risk of the product and perhaps the amount of time that the product has already been made available. For example, a wound dressing that has been available and used safely for the last twenty years, would need less post marketing data than a newly developed hip stem. The mechanisms for obtaining data may also vary from one product to the next and may include interactions from many stakeholders such as marketers, sales teams, endusers, surgeons, nurses, quality representatives and so on. SUMMARY Rather than being specifically aimed at controlling products, the MDR includes several aspects that will exercise not only the regulatory professional, but the chief executive. Can regulatory and quality now be considered part of the strategic thinking within companies? Is the regulatory department still to be known as the ‘sales prevention team’? These new requirements would suggest not.


cover story


No1 Destination

ward-winning plastics injection moulding manufacturer, Boddingtons, is coming back to Med-Tech Innovation Expo in April for the third year running – and it has plenty of new developments to share with visitors. The firm will be presenting the features and benefits of its new manufacturing operations. Class 7 cleanrooms, and expert testing and inspection services are just part of a new £4.6m investment now reaping rewards for the UK-based company. Boddingtons is certified to ISO13485 and ISO9001 quality management systems requirements and is also compliant with FDA 21 CFR Part 820. Jay Cheema, who heads up the growing quality management function at the company, explained the background to the recent investment: “Quality of people is the biggest part of our company recipe – and is absolutely essential in medical device manufacturing in order to fulfil ever-increasing global regulatory requirements and obligations. “Our ‘everything is possible’ approach has combined with significant investment in co-ordinate measuring machine systems and metrology in order to assure a very bright future for customers of Class 1 and 2 medical devices.” Boddingtons says the new cleanrooms are also essential to growing its customer base in the medtech sector. The company is now using video to communicate the features and benefits of its Class 7 cleanroom manufacturing environment to customers. The cleanroom is now full, with further expansion planned in 2019.


The firm says it is also expanding its geographical reach. In early February Boddingtons CEO Andy Tibbs took video content demonstrating the cleanroom in operation to several purchasers and OEM visitors at MD&M West in Anaheim California. Tibbs said: “It’s a pleasure to be able to show our Boddingtons Class 7 clean room services in some detail. Our capabilities for the manufacture of Class 1 and Class 2 medical devices are second to none, and our FDA compliance puts us in the running for several important opportunities in the USA.” Tibbs added: “The current international business climate — via the strong dollar — is currently weighted in favour of qualified UK manufacturers supplying the US medtech supply chain. Naturally Boddingtons is presenting a very strong business case.” Regulatory affairs is another area the company will be looking to discuss with visitors at Med-Tech Innovation Expo. Shimaa Elsaway, regulatory affairs manager at the group, said: “We work closely with our business partners - particularly at the early stages of new medical device development. Taking care of compliance matters at the very outset helps launch the customer’s product into the market with confidence and within an optimum time frame.” The company is also continuing its investments in testing and inspection with the purchase of a second non-contact co-ordinate measuring machine. This equipment will be commissioned in the coming months and will assist with validation work and in-process control measurements caused by increased demand from the marketplace. Tibbs concluded: “Investment in metrology equipment is critical, since there is little point producing precise mouldings if we cannot measure the parts accurately.”

Visit Boddingtons on stand E2 at Med-Tech Innovation Expo

med-tech innovation expo

s s e n i s for bu


From 25-26 April, Med-Tech Innovation Expo returns to the Ricoh Arena in Coventry to showcase the very best of the UK & Ireland’s medical technology sector. Reece Armstrong explains.

LEARN SOMETHING NEW Med-Tech Innovation Expo will bring together a world-class speaker line-up across its two stages. In advance of the event, Med-Tech Innovation News editor Dave Gray sat down with a handful of speakers from both stages to discuss the challenges of working in the sector, plus the many opportunities. MED-TECH INNOVATION CONFERENCE STAGE in association with Medilink UK This year, the conference looks into the future and will examine the ways in which technology and social media are expected to influence healthcare and life sciences in the years to come. Karen Taylor, research director at the Centre for Health Solutions, Deloitte UK, is kicking off the conference by predicting what the healthcare and life sciences sectors will look like in 2022. Also speaking about where technology is taking healthcare is Debbie Chinn, director of solutions assurance at NHS Digital, who will discuss the current and future trends of clinical risk management for health informatics. Later in the day, Dr Chris Subbe, consultant physician and senior clinical lecturer will examine the lessons we can learn from social media when it comes to making hospitals safe. For Subbe, innovation in healthcare is increasingly a consumer concern: “Integration of medical technology with consumer technology is the area where I see the greatest scope for immediate innovation. “It is not by accident that Apple is increasingly active in this field. Knowledge about what ‘normal’ and ‘well’ looks like for individual patients is crucial to understand what ‘unwell’ and ‘at risk’ looks like. And in patients with chronic illnesses this can only be delivered by collected data while patients don’t feel as ‘patients’,” said Subbe.

Rounding out the day will be a talk on patient safety and quality of care from Janet Monkman, CEO at the Academy for Healthcare Sciences. Monkman will give a talk on the Life Sciences Industry Credentialing Register - the implications for any company accessing any NHS site, and how the register can benefit patient care and advance the healthcare science workforce. The UK’s medtech sector faces considerable challenges on home turf. This is especially true in terms of access to the NHS. In recent years the government has started responding to these concerns. Alan Sumner head of public affairs, healthcare development and strategic services at Roche Diagnostics will open day two with a look at the government’s Accelerated Access Review. Sumner explained the need for the AAR to succeed: “The Commonwealth Fund ranks our healthcare system number one out of 11 healthcare systems including the US, Canada, Nordic countries, France and Germany. However, our outcomes don’t fare as well as these other countries. Can the AAR deliver for patients by accelerating access to new technology and treatments - and really improve outcomes for patients?” Liz Ashall-Payne is the founder and CEO of ORCHA – an organisation which reviews apps in the healthcare space. At the Med-Tech Innovation Conference, she will discuss the mHealth landscape; one in which regulation continues to evolve. “Those of us who are concerned with proactively managing our health are increasingly turning to mobile (or ‘mHealth’), and the use of unregulated apps”, explained Ashall-Payne. “The widespread availability of mobile health solutions presents an accessible, affordable and inviting opportunity. Yet there was little regulation within this growing industry. My idea was to provide a review system, which would guarantee quality to the


med-tech innovation expo

end user, and to provide health and care systems with a vehicle which would enable them to get the best apps to their patients and citizens.” Visitors can also attend a number of inspiring stories of success from family-run businesses including, Forte Medical and Salts Healthcare. Giovanna Forte, chief executive, Forte Medical and Philip Salt, chief executive, Salts Healthcare will be sharing their experiences of transforming a family business into a global success. Dr Ian Campbell, director of health and life sciences, Innovate UK, will provide an update on industrial strategy and the industrial strategy challenge fund, while John Wilkinson, director of devices, Medicines and Healthcare Products Regulatory Agency will be discussing the new Medical Device Regulation – and the actions companies need to be taking. Continuing with the futuristic theme, Joel Haspel, partner, GE Healthcare Finnamore will be giving a talk on partnering for artificial intelligence development and delivery. Unsurprisingly, innovation will be a key theme at this year’s conference. Professor Mike Hannay, chair, National Network of Academic Health and Science Networks (AHSNs), will talk about the adoption and spread of Innovation in the NHS, and the role of AHSNs in addressing some of the biggest health challenges facing the UK. Mirren Mandalia, senior director, new ventures & transactions (medical devices), Johnson & Johnson Innovation, will share his experience of advising healthcare startups and leading investments that J&J Innovation makes in exciting early-stage medical devices. Speaking about the conference, Bill Cruise, chair at Medilink UK, said: “Given the high calibre of speakers from such a wide range of backgrounds, we’re certain that this year’s conference will be a great asset to the Expo, and will be of great value to all who attend.”


HEALTHTECH STAGE Major changes are on the horizon with the implementation of the new European Medical Device Regulations (MDR), and as such regulation will be at the forefront of discussion for medtech OEMs at this year’s expo. Alan Johnson, technical director at product design group Tactiq, is set to talk about the design challenges of wearable devices on the HealthTech Stage. “An immediate impact will be on devices for which the classification changes. This will

particularly impact IVDs (in-vitro diagnostics) and software-only medical devices. Work will be needed to bring existing devices into compliance and some devices may be withdrawn”, said Johnson. “Another issue at the moment is that the notified bodies are overloaded, and this is a problem particularly for new businesses.” Medical device manufacturers have a wealth of opportunity in the years to come. Industry 4.0 holds masses of potential, particularly where compliance and quality control are concerned. But the manufacturing supply chain is changing shape in other ways, too. Jim Reed, vice president, business development and marketing at Minnetronix will be discussing virtual development partnerships across the medtech supply chain. He believes that sourcing partners from around the globe for specialist manufacturing requirements is increasingly important for British firms to stay competitive. “The industry has evolved to the point where highly specialised companies exist for nearly all kinds of manufacturing processes or technologies, component expertise, or development domain. In fact, it has become extremely difficult for traditional medical device companies operating as generalist organisations to compete with outside firms in their areas of specialisation, in terms of cost, quality and capability. “Expertise rather than co-location is what matters and virtual organisations leverage the specialised skill set from each firm to improve business objectives. “This macro trend is very positive for the UK and Ireland, where the specialist infrastructure is not as well-established as medical device hubs like Boston, the Bay Area, and Minneapolis. Minneapolis, for example, has sixty years of cumulative medical device expertise, talent pools, infrastructure, and vendor base density in a fifty mile radius.” Inevitably, Brexit is set to feature throughout the agenda with uncertainty still present in industry generally.   Professor Alexander Seifalian from NanoRegMed will be discussing the development of medical devices using graphene nanomaterials in his presentation on the HealthTech stage. He was happy to talk Brexit though, and has a balanced view on the transition which will directly impact his work:   “The negative side is that we have been doing lots of collaboration with SMEs as well as academics throughout the EU, including testing the medical device under GLP (good laboratory practice) in EU countries. This is significantly cheaper for us.   “However, Brexit may bring new opportunities. This could include a closer direct link to North America and Asian countries. It could make it easier, simpler and less costly to obtain permits for medical devices through the UK’s regulatory bodies.” The HealthTech Stage will showcase the best and brightest from the Med-Tech Innovation Expo show floor, as well as technical know-how from across the industry, making it a feature not to be missed.

med-tech innovation expo



xhibitor Blue Frog Design (stand C8) will be showing off its latest innovation, highlighting how the company used 3D printing to help a patient with an ongoing skin condition. The company worked alongside Medilink East Midlands to help a patient who suffered from paraesthesia – a skin condition in which tingling, tickling, numbness or burning sensations occur with no apparent physical cause. In this case, the patient was experiencing a prickling sensation from the rib cage to the collar bone when his clothes touched his body. Blue Frog Design was able to 3D print a structure that stopped the patient’s clothes from touching his upper body, removing the irritation and improving his quality of life. The company took a scan of the patient to identify the desensitised parts of his body on which the device could be placed. The scan provided Blue Frog with the precise data it needed to design the product. Blue Frog was able to produce a device that followed the contours of the patient’s body in a minimally invasive way. The company used

medical-grade material to 3D print the device, which is lightweight thanks to its lattice based design. The design also provides ventilation as air can flow through the device, the clothes and the body, helping to keep the patient cool. Blue Frog believes that the product is an example of how useful 3D printing can be for the design and prototyping of medical devices. As a key area of its business, 3D printing allows Blue Frog to produce products which traditional manufacturing processes can’t produce as quickly or economically. Furthermore, 3D printing lets Blue Frog make any required modifications to prototypes during the design process - something which would be technically challenging if using injection moulding, as it would require frequent and costly modifications. Speaking about the Med-Tech Innovation Expo, a spokesperson for the company said: “For anyone attending this years Med-Tech Innovation Expo we will be exhibiting this product giving you the chance to see it in the flesh. We will also have with us various other medical products we have developed for clients.”

SOMETHING TO CELEBRATE Hosted by TV’s Dr Phil Hammond, The Medilink UK Healthcare Business Awards and gala is set to bring visitors and exhibitors together on the first evening of the show to celebrate outstanding achievements from across the industry. A new addition to the awards this year is the Editor’s Award for Business in Healthtech, which has been conceived by the editorial team behind news brands Digital Health Age and MedTech Innovation. Created to recognise achievements in business, the team will take into account the impact on unmet clinical needs, company growth and scale, as well as market share. The Medilink UK Healthcare Business Awards have attracted sponsors from some of the UK’s leading government, academic and business organisations, including the AHSN Network, HGF and GovGrant. Mike Hannay, chair of the AHSN Network, said: “We’re really pleased be sponsoring the ‘Collaboration with the NHS’ category at this year’s Medilink UK Awards. It’s the shared ambition of England’s 15 AHSNs to create the right environment for companies to work with the healthcare system for both patient benefit and to generate economic growth. We are keen to support innovative collaborations between the NHS and the medtech sector, and I look forward to the Medilink UK Awards as an important opportunity to celebrate some the fantastic partnership working that is taking place in this extremely vibrant sector.”


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Chief commercial officer at GovGrant, Luke Hamm, added: “GovGrant is delighted to sponsor the Innovation category of the Medilink Awards. We should always recognise and celebrate the tireless efforts of companies who are continuing to achieve medical advances and bring new solutions to the market. We work with many companies to ensure that they recognise their full entitlement to government support when overcoming technical challenges or achieving scientific advances and the medtech community are always one of the most well deserving.” At the time of writing, a limited number of tickets are still available for this prestigious and entertaining evening – head to to book. ON THE SHOW FLOOR A range of companies are returning to Med-Tech Innovation Expo, representing the diversity and breadth of the medtech industry. This year, exhibitors will demonstrate a wealth of products, with many being shown or previewed for the first time. Here’s a brief look at what visitors can expect to see at the show this year. ALL PART OF THE SERVICE From design support through to legal considerations, the expo will showcase multiple firms offering services for medical device OEMS. For example, product design consultancy, Renfrew Group International (stand B21), is back once again, with its latest products for medical device design and development. The company will be showcasing a number of products it has helped create across many fields, including prototypes of an artificial pancreas and

a home dialysis system developed by medical device company Lucenxia. Covering the product liability market is IHN Insurance Brokers (stand C8), which is on hand to discuss its knowledge of the technology sector, as well as its risk management and tailored insurance solutions for medical technology companies. And if you’ve ever wanted to know about human factors engineering in the medtech sector, then visit Medical Device Usability on stand D11. The company will have specialists onhand to discuss any requirements visitors may have about their medical device products. Richard Featherstone, managing director of Medical Device Usability, said: “We are looking forward to attending the Med-Tech Innovation Expo in April and meeting other exhibitors and attendees.” ALL THE COMPONENT PARTS A good medical device is only the sum of its parts. That’s why a variety of components manufacturers and suppliers will be on hand throughout the show to help solve medical device challenges. One such firm is global supplier of stock OEM components, Qosina, which is returning to the expo for the fourth consecutive year. Ken Wolcott, director of marketing and product development at Qosina, spoke about the importance of Med-Tech Innovation Expo as it “affords us the opportunity to meet with our customers in person.” “We take full advantage of engaging with them to help us understand their unique market requirements and how we can better serve their needs as they respond to ever-evolving changes in the medtech industry. “Stop by stand E8 and chat with our knowledgeable sales team about how Qosina can help you with your current or future project. You can also pick up a copy of our 2018 product catalogue, which features more than 150 new products.” Wolcott concluded. Meanwhile, family-run business Mintdale Engineering will be showcasing its automated production services for the medical device industry at stand G29. The company will be highlighting how it can produce components for a range of industries without the complex jigs and fixtures which can add to the cost and lead time. And with over 40 years of experience specialising in the design and supply of fluid components to medical and scientific markets, West Group is returning to Med-Tech Innovation Expo once again. Speaking about the show, Anita Netherton from West’s marketing department, said: “West is a loyal supporter of Med-Tech Innovation Expo which we have found it to be the perfect place to showcase new products and touch base with existing customers. Come and see us on stand F2.” While newcomer to the show, Maxon Motors (stand E12), is “looking forward to showcasing Maxon medical products as well as meeting


med-tech innovation expo

existing customers and developing new relationships” according to Matt Dean, sales engineer. Supplier of pouches, lidding, rollstock, and mounting cards for the global healthcare industry, Oliver Healthcare Packaging (stand D43), says it is continuing an exciting 2018 with the show in April. Anneke Willems, customer care representative at the firm, said: “2018 is already off to an exciting start for Oliver Healthcare Packaging, and we have a lot to share with you. Visit our team at stand D43 to learn more about our new technology centre, unique educational opportunities, and the latest in sterile barrier packaging.” Manufacturer and developer of complex serial parts in steel and high-grade alloys, Parmaco Metal Injection Mouding AG, will be displaying its products over on stand C39. Since 1992, Parmaco has developed its products for the medical, automotive and many other industries. Meanwhile Carville (stand G4) will be showcasing its range of high accuracy diffusion bonded fluidic manifolds at the expo. Used widely in medical, life sciences and industrial applications, these products can reportedly help reduce manufacturing costs, assembly time and servicing requirements by incorporating system complexity into a single component. And Craig Thompson, commercial manager of component and finished product manufacturer Penlon, says the event is an important one for showcasing its products: “Med-Tech Innovation is the ideal opportunity for us to meet companies looking for the reassurance of working with an established UK partner. Penlon has 75 years of experience manufacturing medical devices and an in-depth understanding of the sector, including the regulatory requirements. You will find us on stand C44 and we look forward to seeing you at the Ricoh Arena.” SIMPLY SOFTWARE How do you get your process to run smoothly with repeatable quality? Head over to stand F41, where Vivaldi Software will be previewing its latest quality management software. Used within a range of industries including life sciences, biotech and medical devices, Vivaldi 6 features “the latest web technologies”, according to the group.


The new software can be used across any device and is intended to make work easier, save time and help users prepare for upcoming audits and manage documents and other essential information. If you’re interested in moulding simulation, FlowHow will be demonstrating the latest capabilities of its Moldex3D software at stand G41. The group explains that its software is designed to provide professional injection moulding simulation to guide customers through design process.

FUTURISTIC FACTORIES It’s important to prepare for the manufacturing models of the future. That’s why process automation group Festo (stand E38), will be showcasing a new technology which aims to bring Industry 4.0 to medical device manufacturing. The company’s new Festo VTEM Motion Terminal reportedly turns automation tech into ‘Industry 4.0’ tech. Users can see the components working as a connected system communicating to the cloud. Additive manufacturing group Laser Proto (stand F10) is displaying its latest samples produced on metal sintering machines. Laser Proto believes that metal sintering is fast becoming the preferred manufacturing method for custom implants (created exactly for an individual) and surgical guides, allowing the design, development and manufacture of parts and devices which are beneficial to practitioners and patients alike. PLASTICS PARTY With the international market for medical plastics being estimated to reach $33 billion by 2022, it’s no surprise that Med-Tech Innovation Expo will feature a number of the sector’s leading companies. This year, Raumedic (stand C52) will be presenting a range of products made from thermoplastics and silicone. The company’s portfolio includes products made from extruded parts, to more complex solutions such as catheters and single-use cartridges for wearable patch pumps. Area sales manager of Raumedic, Conor Ward, said: “Raumedic is not only a supplier, but a real development partner for the medical technology and pharmaceutical industries. That is why the polymer specialist supports its customers from product concept to design, from prototype construction to series production taking over all key processes of product lifecycle management.” HTE Engineering Services says it will be aiming

med-tech innovation expo

to solve medical device joining problems at this year’s expo. As a newcomer to the show, the company will be bringing its PulseStaking process to help medical device manufacturers join their polymer components. The process is used for joining components to plastic parts and reportedly offers advantages when compared to other joining methods. The company will be demonstrating its handheld PulseStaker on stand G21 - a product for low volume production and product prototyping. Meanwhile, on stand C21, Albis Plastics is participating at the expo to showcase its distribution portfolio of plastics for use in the healthcare sector. The company says it has recently positioned itself to take advantage of the rapidly changing regulatory environment for medical devices. Primasil Silicones will be celebrating 40 years in business at the 2018 expo, and plans on displaying its portfolio of silicone products. The company’s team will be available to discuss any new silicone projects customers have and technical experts will be on-hand at stand B10. Finally, plastic injection moulding manufacturer, Boddingtons will make another appearance at Med-Tech Innovation Expo. Boddingtons (stand E2) has recently expanded its production with a new plant offering expandable class 7 cleanrooms, thirty injection moulding machines and customer benefits such as disaster recovery safeguards. Speaking about the expo, Boddingtons CEO Andy Tibbs said: “Once again, we are really looking forward to the Med-Tech show and welcome OEMs, designers, product developers and brand managers to our stand to discuss new or existing opportunities.” AN INSPECTOR CALLS With the important roles medical devices play in patient care, they must be thoroughly checked so as to adhere to strict regulatory standards. This is where companies such as Industrial Vision Systems (stand E27) come in to provide inspection equipment, specifically designed for the medical device industry. Director of sales at Industrial Vision Systems, Earl Yardley spoke about what the company will have on show at Med-Tech Innovation Expo this year.

“At the Med-Tech Innovation Expo, Industrial Vision Systems will be showcasing the latest inspection vision systems specifically designed for the medical device industry. These latest fully validated vision inspection technologies provide high-speed quality checking of medical device products at up to 500 parts per minute and can be fitted to existing production lines as well as new machine builds.” In addition to this, Industrial Vision Systems will be demonstrating a robot inspection system capable of quality checking across multiple criteria. On stand F20, Zwick Roell will demonstrate its latest technology in parenteral drug-syringe testing equipment. In a Med-Tech Innovation Expo exclusive, Zwick Roell will demonstrate how drug delivery syringes are tested in accordance with stringent standards to ensure safe use. The company’s machine measures the breakaway and glide forces of a syringe important factors as syringes are often used by patients to safely self-administer parenteral drugs.

KEEPING IT CLEAN At this year’s expo, visitors to the show floor can find out about how medtech companies are helping to keep components sterile for end-use. Exhibiting at the expo are Connect 2 Cleanrooms, Monmouth Scientific, Steris AST and Guardtech Cleanrooms. All of these companies represent a market which is estimated to reach $5 billion by 2023. Steris recently released its latest financial revenue for its sterilisation technologies, reporting a 13% increase compared to last year. The increase in revenue was primarily due to the company’s core medical device customers, Steris stated. Speaking about Med-Tech Innovation Expo, Sean Fryers, marketing manager at Connect 2 Cleanrooms, said: “The Med-Tech Innovation Expo gives us the opportunity to have valuable conversations with companies in the medical design and manufacturing technology sectors.” Connect 2 Cleanrooms will be exhibiting on stand F28, Steris can be found on Stand D41, Monmouth Scientific on Stand G47, and


med-tech innovation expo

The tool works by assessing applications’ source codes within a short time and producing a comprehensive report detailing relevant metrics and any potential vulnerabilities. Check out IntelliQA’s latest software at stand C18.

Guardtech Cleanrooms will be on Stand E43. Lastly, on stand F44, Turbex will be promoting its highly controllable cleaning equipment for washing and drying medical instruments, prosthetics and consumables. SECURITY SHIFT In 2017, the WannaCry attacks on the NHS proved to the UK that its healthcare industry wasn’t immune to attacks from cyber-criminals. IntelliQA is highlighting the paramount importance of data security at Med-Tech Innovation Expo, in an era where healthcare is shifting toward further digitisation. The company is presenting its software security testing tool, Micro Focus Fortify on Demand. The tool addresses application security rapidly and without the need for infrastructure investments on security staff.

BACK TO SCHOOL Academia is at the heart of so many medical device innovations. That’s why a team of researchers from the University of Leicester will be at Med-Tech Innovation Expo, discussing how clinicians and scientists are using near-patient and remote sensing technologies to analyse breath samples to better diagnose cardiorespiratory disease. On stand B8, members of the East Midlands Breathomics Pathology Node (EMBER) team will be discussing their work. DON’T FORGET THE COMPETITIONS First timers to the show, mould and press toolmakers, ND Precision Products, will be offering a chance to win a crate of champagne at their stand (A21). In addition visitors to medical tube tip specialist Polyflon’s stand (D39), can enter a short price incentive survey throughout the show. Speaking about the expo, managing director for ND Precision Products, Nick Squire, said: “ND Precision Products has never exhibited at Med-Tech Innovation Expo before and we are excited to see what the show has to offer. As well as this we will be running a free prize draw for the chance to win a crate of bubbly! To enter is easy, simply place a business card into the clear Perspex box on our stand to be in with the chance of winning.”

Med-Tech Innovation Expo is free to attend and takes place 25-26 April at the Ricoh Arena, Coventry, UK.


Thomas Prock, Partner at Marks and Clerk, looks at the EU’s new ‘wildcard’

initiative, which will back high-risk medical device ideas.

ip & patents

moonshot medtech —

making it work

SO, WHAT CAN MEDTECH INNOVATORS & ENTREPRENEURS DO TO MAKE WILDCARD IDEAS AND INVENTIONS INVESTABLE? Underpinning all successful innovation is intellectual property (IP). IP takes many forms, ranging from the wellknown such as patents and trade marks, to the less well known, such as know-how and database rights. One thing investors will be looking for when considering the potential of a new product, will be reassurance that those behind the product have a developed sense of how their IP portfolio and strategy will continue to support the business as it develops. The strategic use of IP protection can give a company a competitive edge, helping de-risk the business in the eyes of investors.


ertain health problems bring with them a level of risk and complexity that can make investment in their solutions difficult. These problems require blue sky thinking and public/private cooperation. Recent examples of such initiatives include former US President Barack Obama’s ‘cancer moonshot’ and Google’s significant investment in medtech aimed at making life easier for those with type 1 diabetes. In a similar vein EIT Health, an offshoot of the European Institute of Innovation and Technology, recently announced that it would make €4 million of funding available for ‘wildcard’ medtech ideas which utilise emerging technologies like AI and big data or tackle urgent health challenges including antimicrobial resistance. 

IP will also prevent third party imitation of your products, thus preserving your market and preventing competition from third parties. Beyond this, and especially in cases where an invention truly fits the description of ‘wildcard’, the lack of prior art (pre-existing knowledge that might limit the scope of a patent in a more established industry) means that well drafted IP might confer not just protection for your invention, but also the opportunity to licence your innovation to others, creating lucrative revenue streams and enabling access to new markets.  DEMONSTRATING IP AWARENESS Having an effective IP strategy is critical for companies of all sizes, even if – in the case of preinvestment companies – it can only be implemented at some future time. Demonstrating an understanding of the opportunities offered by IP and prioritising the IP that needs to be protected first, will be key to attracting investment. For example, is brand a big aspect of your business? If so, trademarks will be key in protecting that brand in the public space, ensuring trust

is maintained in your services and products and the value in your brand is protected. If, on the other hand, your business is focused on technological innovation, then patent protection will be critical in stopping copycats producing cheap imitations. Another key question for emerging medtech companies and entrepreneurs will be, who in the company owns the knowledge inherent in the business? Most of the knowledge and skill within small companies is concentrated within the memories of the small number of individuals who founded the business. This is both a blessing and a curse. The upside is that corporate knowledge is easily accessible and admin is minimised. As companies grow however, a lack of clear policies and documentation can lead to disputes. For example, if a founder member of the team leaves, he or she might take their knowledge with them unless there is some agreement to the contrary. Decide early on who should own the IP, the individuals within the business or the business itself, and ensure secret know-how is secured, preventing disclosures of information which could be disadvantageous. Alongside ensuring IP around products and services is robust then, it is also important to ensure that IP ownership and procedures within the company are clear and well defined. This is most easily achieved early on, while all parties involved are on good terms. There’s no one size fits all approach to IP and developing the right portfolio and strategy is a bespoke process. Engaging in this process early on however will put an emerging enterprise on sure footing, and make wildcard innovations all the more investable.







n a sector such as healthcare, where entry to market is often delayed by the need to overcome regulatory hurdles, any increase in the period of market exclusivity is clearly beneficial. Unlike medicinal products, most medical devices will not be eligible for patent term-extending supplementary protection certificates (SPCs). Despite this, there is still scope for extending market exclusivity in respect of medical devices. Given that the development of a medical device often starts with the conception of a fundamental idea, one or more initial patent applications may be directed towards that broad concept. Surprisingly, this is where IP strategy begins and ends for many medical device companies, and commercial opportunities are being missed as a result. Following the initial conception of the fundamental idea, it is likely that research and development work

will continue, and this period presents opportunities for filing secondary patent applications. These secondary patents might relate to optimisations of the device which are realised when technical problems are encountered and solved during development, or in response to an evolving market need. For example, optimisations may relate to improvements in the reliability, safety or ease of manufacture of the device, and each may represent a patentable invention that may be made the subject of a secondary patent application that complements the core patents. The 20-year term of these secondary patents will expire after that of the core patents, thereby extending the overall exclusivity period of the final device and presenting further obstacles to competitors seeking to enter the same market. With its specialist medical devices team, HGF is well placed to assist healthcare companies in identifying opportunities for protecting their medical devices and formulating an effective IP strategy that complements their commercial ambitions.

ip & patents



ed-Tech Innovation editor Dave Gray caught up with Dr David Pearce, patent attorney and partner at Barker Brettell, to examine medical device patents – and how to get the best out of the investment.

DG: SO, WHERE DO YOU START IN PLANNING FOR PATENTING? DP: The most important first step is to make sure the invention is kept confidential, because any non-confidential disclosure can be used against you and stop you from getting a patent. The next most important thing to do is to put together a viable business plan for making money from the invention. Then go and find a patent attorney and discuss your invention with them. DG: WHAT MAKES A GOOD IP STRATEGY? DP: Pragmatism is always a good way of approaching your IP strategy. Do not be too protective of your patent applications. If it looks like an application is not going to be commercially useful, don’t fall prey to the sunk cost fallacy and hold on to it just because you have spent money getting it to that point. Instead, think at every stage where your money can be best spent. Weigh up the costs and benefits of each application, and be ruthless about letting go of those that are not paying their way or do not have strong commercial prospects. A strong, broadly defined, patent may be nice to have, but if there is no commercial product it covers the patent is fairly useless. A more narrowly defined patent that covers a specific product, however, can be much more valuable and worth protecting. DG: DO YOU ALWAYS NEED TO PATENT? DP: No. Sometimes it is simply not possible to patent something, such as a new business method. Even if something is patentable, there may sometimes be more value in being the first to get to market, particularly if there is a lot of confidential know-how involved in the product. Not patenting though can be risky, as others might be able to work out how your product is made and create their own version to undercut yours. Where an invention is, for example, a new way of making something, you should weigh up the benefits of getting a patent versus the downsides of having to make the process public when your application is published and the difficulties of enforcing the patent if it does get granted. Sometimes therefore, if it is possible to keep a manufacturing process secret, this can be the best way of protecting it.

DG: IT’S AN EXPENSIVE THING TO DO – SO HOW DO YOU MAKE SURE YOU’RE MAXIMISING ON YOUR INVESTMENT? DP: Figuring out which invention will make money is, of course, impossible. What is possible, however, is to maximise any potential benefit by staying realistic and flexible about your investment in IP. View your patenting strategy as a process that needs to be fed with new developments as well as having a clear out occasionally. Stay flexible with how far you reach with your patent applications, and don’t ask for the earth. Patenting in every possible country may give you plenty of opportunities but will very rapidly consume your budget, so be realistic about where and how you are actually going to be making money from your inventions. DG: WHAT WILL A PATENT ATTORNEY ACTUALLY DO FOR YOU? DP: At the outset, a patent attorney will prepare and file a patent application based on your invention that should give it the best prospect of being granted. If there is something in your invention that is patentable, your patent attorney should be able to identify it and write an application that will be able to capture it in a way that will make it harder for others to copy without infringing your patent. During the application process, your patent attorney will explain to you what the search and examination reports mean, and advise you on what you might be able to do to get over any objections from the patent examiner. DG: FINALLY, WHAT DO YOU DO IF YOU’VE TRIED AND FAILED TO PATENT YOUR PRODUCT ONCE? DP: If at first you don’t succeed, try and try again. Often the first attempt is part of a learning process, and a subsequent development that comes during developing a product turns out to be the invention that is the more commercially important one. Don’t think of the patenting process as “fire and forget”. Instead, it is important to think about all further developments as potentially adding to a portfolio that grows and refines over time. While some may be pruned or kept in a limited form, others may become more significant and be allowed to grow further. Trying, and sometimes failing, is all part of the process.


human factors engineering packaging

‘Smart packaging’ – it’s a buzzword that’s popped up in multiple industries recently –

consumer, food – and yes, even medtech. Med-Tech Innovation’s Dave Gray examines this hot new trend.

what’s so smart

about medical device packaging The group has been working on a new concept which would use audio messaging to communicate instructions – with the prompts being triggered by touch-sensitive paper technology. The group says that there’s a real clinical need for this, because poorly understood instructions can lead to drugs and devices being misused, potentially endangering the patient.


irst of all, let’s look at what smart packaging is not. After all, in the age of marketing jargon, it’s easy to oversell (and under-sell) these things. For example, it’s a lot more than just sticking a QR code on the box which takes the user through to some safety documentation and a page of disclaimers that didn’t fit on the physical literature. Equally, it’s not augmented or virtual reality. True, some brands are using that technology for promotional efforts in packaging – but that’s one for the consumer world. I think it’s unlikely that we’ll see such indulgences in medical device packaging for some time. So, no QR, no AR and no VR. What is it then? Cambridge Consultants, which operates out of one of the UK’s leading medtech clusters, is a good place to start.


The concept, dubbed AudioPack, delivers instructions via an avatar named Ana, who guides the patient through step-by-step use of their medical device – particularly useful for devices like autoinjectors. Cambridge Consultants also says that there’s potential here for use amongst patients who have cognitive difficulties as a result of their condition. This, of course, would bring some time and efficiency savings in healthcare settings, where clinicians are required to instruct patients. The whole thing is reminiscent of the trend towards voice-assistants in the smart homes sector. Perhaps the next iteration of smart packaging will take this concept further into interactivity, whereby the patient could conceivably ask for guidance on using the product, or advice on side-effects, and receive a clinically-sound response. Then there’s the story of Gautam and Kanupriya Goel – a husband and wife team based in the US. They pioneered self-expiring packaging, which is not the same as those fantastic self-destructing envelopes in Mission: Impossible. Instead of catching fire whenever your preventer inhaler goes out of date, the Goels’ product uses a dual layer of ink – with the bottom layer only becoming visible as the expiry date approaches. Intelligent ink has certainly seen

increasing usage in medical applications, but I expect that the coming years will propel advanced printed electronics to the fore of medical device packaging. It’s happening already. The August Faller Group for example recently announced a prototype of a ‘counting device’ – a folding carton for medicine which uses an e-paper display and electronic controls. The user just has to press a button on the display each time he/she takes a pill, and the packaging can track their dose. Another prototype from the firm, currently just called ‘Medical Prescription’ keeps track of the amount of pills and connects to a smartphone app via bluetooth, which in turn sends the signal to order a repeat prescription. All of this is great news for medical device manufacturers. Smart packaging creates added value in the form of a closer bond with the patient – a rapidly emerging trend in the age of digital health. But smart packaging is not without a couple of significant drawbacks. Predictably, cost is the main one. Added value is all well and good, but if it can’t be achieved cheaply, it adds cost that some won’t be able to afford. What’s more, smart packaging, as it evolves, will likely incorporate more and more elements, with increasing levels of functionality being added in. This means more components, more adhesives, more inks – all of which detract from the green credentials of the packaging in question. It’s not a huge problem at the moment – printed electronics don’t currently add too much foreign material into the waste stream. But it’s a key thing to consider as our ideas about smart packaging continue to evolve.

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3d printing + additive manufacturing

IMPERIAL COLLEGE ENGINEER TAKES IMPLANT TECH STATESIDE Dr. Jonathan Jeffers of Imperial College London, recently presented data from an ongoing project investigating the development of load bearing lattice structures for orthopaedic implants.  The project is funded by the UK government and engineering firm Renishaw. By incorporating a lattice, implants can provide a scaffold structure for new bone tissue to grow into. The spacing and strut thickness of the lattice can be optimised to match the stiffness of surrounding bone. It may be possible to create a strain gradient on the bone which can accelerate growth. 


magnificent 3(D)


“The partnership between Imperial College London and Renishaw is creating really exciting data on new materials that can control the way bone repairs itself. These materials could change the way orthopaedic implants are designed in the future, and certainly provide an opportunity to improve patient outcomes by repairing the musculoskeletal system with materials that can invoke a desired response in bone”, said Jeffers.

Renishaw’s additive manufacturing systems produce implants using a process known as laser powder bed fusion (LPBF). During the process, lasers are used to melt metal powder in layers as thin as 30 microns. As the powder melts a solid product is formed. This method allows complex, customised designs to be manufactured quickly and with little waste.  


two of engineering’s key players have joined forces with a young innovator to help get 3D printed prosthetics to children.

Major 3D printing player Stratasys has teamed with engineering group Dassault Systèmes and industry innovator Easton LaChappelle to form the new initiative dubbed Unlimited Tomorrow. LaChappelle (pictured here with a young patient) has made the headlines in recent years for developing functional prosthetics since he was 14 – using Lego bricks, fishing wire and electrical tubing. The new brand will make use of Stratasys’ capabilities in the research, development and production of prosthetics.

Traditional prosthetic models are often heavy, cumbersome and expensive. Developing them for children is also complicated, because many young patients will quickly outgrow models and thus require entirely new devices. Unlimited Tomorrow says its mission will be to target the ‘common pain points’ — customisation, weight and cost. The organisation aims to build intuitive, scalable models to engineer custom devices from start to finish. Unlimited Tomorrow also taps into digital, scanning and 3D printing technologies to streamline development and reduce multiple fittings – minimising the impact to each patient. “We view 3D printing as a catalyst for healthcare innovation to enable better patient care, streamline procedures, and improve

learning. One of the most visible impacts is in creation of prosthetics. That’s why a main component of our Corporate Social Responsibility program is focused on accessibility of devices – driving true change, improving qualityof-life, and advancing recipients’ self-esteem,” said Arita Mattsoff, Vice President, Corporate Social Responsibility at Stratasys. The new organisation has chosen Indiegogo’s platform for current equity fundraising efforts. Jonathan Cohen, chief enterprise solutions officer at Indiegogo said: “We applaud Unlimited Tomorrow for their commitment to listen to the “crowd” in crowdfunding for their latest innovation. Indiegogo’s Enterprise offering will allow Unlimited Tomorrow to capture interest and validation while receiving investment from consumers.”


RenAM 500M, for a new era of medical device manufacturing Renishaw’s new metal powder bed fusion additive manufacturing system for industrial production, RenAM 500M, features increased emphasis on automation and reduced operator intervention. The system is the first to be designed and manufactured in-house by Renishaw, applying over 40 years of cross-sector engineering excellence that spans electrical, mechanical and optical technologies. Highlights include: • Renishaw designed and engineered optical system with 500 W laser • Automated powder sieving and recirculation with SafeChange™ dual filter system • RESOLUTE™ linear position encoder on Z-axis for high accuracy operation

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MD&M East—now in its 34th year—is the largest medtech event on the East Coast, connecting you with thousands of engineers and executives, as well as hundreds of leading suppliers. Find the medtech solutions, innovations, and inspiration you need to solve your toughest challenges, while staying on top of the latest advancements across the industry. This year the show floor spotlights two industry mega-trends—3D printing and smart manufacturing—with a dedicated 3D Printing Zone, plus the latest in collaborative robots and robotics on display from the world’s top suppliers.

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the healthtech series




this new regular supplement Reece Armstrong, reporter on our sister title, Digital Health Age will examine the impact that digital technologies are having on healthcare and covers the sector’s latest and most important developments.


igital world Digital health encompasses a range of technologies and data that can be utilised to address the health challenges faced by populations around the world. From commercial devices such as Fitbits and Apple Watches to the medical records the NHS uses, digital health is poised to change the way healthcare is delivered. Whilst certain technologies fail to conjure up meaningful change, the ubiquitous nature of a connected world means that digital health could factor into almost every aspect of our lives. Devices that can monitor our steps, sleep, and heart rate are abundant across the wearables market, but these technologies are simply the beginning of a long list of products that have been designed to improve our health. Due to a vast array of technologies that digital health covers, the market for it is great and is only expected to grow. By 2025, the global digital health market is estimated to be worth over $500 billion. This upward trajectory makes sense when you consider the range of connected and smart health devices that are currently on offer to consumers and healthcare professionals. Everyday consumers now have access to a number of devices that can help them monitor their fitness, vital signs and nutrition, whilst healthcare professionals are using digital technology to take better care of their patients. And whereas wearables and smartwatches are prevalent throughout the consumer high street, it’s the healthcare industry that takes most of the digital health market share. We can split up the digital health market into four segments – telehealth; mhealth; health analytics and digitised health systems. Of these, mhealth is the only segment that caters to consumers, consisting of wearables, medical and fitness apps and digital applications. The rest of the market enables healthcare professionals to treat patients and operate within a digital ecosystem. Digital patient records for example help the NHS access information quickly and reduce admin time, whereas online consultations can potentially reduce the strain on GP practices.

The market for digital health in the UK is not as impressive as in other regions; it currently sits at £2.9 billion and is estimated to hold a global market share of 7% due to strong worldwide competition. Despite this, digital technologies are slowly, yet steadily making their way into NHS organisations, improving patient care and reducing costs for providers. The benefits that digital technologies offer to healthcare are numerous, though there are concerns about its implementation. For instance, the NHS has long been an advocate of digital health, but has been hindered by its existing technology frameworks and the change required to implement digital solutions across such a large organisation. Furthermore, as many digital health solutions require patient data to inform users and healthcare professionals about their condition, issues of privacy and consent become apparent. Consider the backlash against the NHS and Google’s AI subsidiary, Deepmind, when the records of 1.6 million patients were inappropriately shared between the companies. That said, this year sees the introduction of the General Data Protection Regulation (GDPR) which should hopefully safeguard the use of patient data. Patients must be explicitly informed if their data is intended to be used and they should be able to easily consent to the use of it. One of the many discussions surrounding digital health is its ability to provide new models of care to patients; this is highlighted by companies such as Apple and Amazon entering the market, predicating a change is on its way. The latest news of Apple’s AC Wellness centre - which will treat its staff and test its growing portfolio of health services and products – is one such example of the changing health landscape. In 2018, we will be able to see just how close we are to a connected world of health. In the UK, the NHS intends to release an app that lets patients access their medical records, book appointments with their GP, receive online consultations and order repeat prescriptions. With two winters of intense pressure on the NHS, and the organisation burdened by an ageing population and a lack of funding, digital health may be the solution we all need to take better care of ourselves.


the healthtech series



Signs of promise

for medical device interoperability


igital health has huge potential for both medical device and pharmaceutical clinical trials. But interoperability – the way that data is exchanged between connected devices and platforms – remains a hurdle. Nonetheless, Joe Dustin, principle of mobile health at medical device software firm Medidata, says recent developments look promising.


In January, Apple released the Health Records feature in IOS 11.3 (beta) that allows users to aggregate their own health data from disparate electronic health records (EHR) on their iPhone. This not only has the potential to change the way patients are involved in their own care, it could also fundamentally change the way research is conducted in regulated clinical trials. My view is that with health records, Apple doesn’t want user data, but rather it wants to provide the platform to use data in a secure manner to unlock value through easy and informative user experiences. By comparison, Microsoft recently announced it was discontinuing the HealthVault Insights app. It was a smart move on Microsoft’s part, because Apple just enabled the same thing, but on every single iPhone as a core component of iOS. Hopefully what will follow will be an Android equivalent for true global adoption perhaps from Google Fit or Samsung, though it’s clear they will be playing catch-up. Why does this matter to medtech? Every clinical development industry event tries to address EHR

integration in their agendas. If consumers, patients and people can now aggregate their own health data, they will share it. Very soon, the systems used to run clinical trials will be able to consume eSource data directly from patients inherently bypassing the need for an enterprisestyle, costly EHR integration. Patients would also have an easier way to get their data back from procedures performed on them in a clinical trial, a key request by patient advocacy groups for years. Apple Health Records could also enhance patient recruitment in clinical trials. Patients are rarely informed about clinical trials even when they could be a good fit. Our industry struggles with this problem, and finding the right people to participate could be made easier by Apple Health Records. Once the feature is utilised by more people who share their data with third-party services, new apps, or even patient communities around a specific disease, it will enable a direct connection to patients and allow for solicited outreach to the right people at the right time. Apple Health Records could be used to match people with clinical trials in a much faster and cost-effective manner than any solution on the market today, which in many cases is only based on past experience and retrospective databases. We’re seeing signs that clinical trials are becoming more virtual as new mobile applications are created to recruit, enroll, engage and receive data from patients with less burden on their everyday life. We have seen virtual clinical trials pave the

way for a future that is quickly evolving. GlaxoSmithKline’s Parade study launched in 2016 was a virtual research study and the very first ResearchKit application released by a major pharmaceutical company. This app had an enrollment and registration step in the patient onboarding workflow to ingest data from Apple’s HealthKit, which included simple demographics. Now, the next time a research app is released, people will have the option to share their health records data as another source inside HealthKit. This opens possibilities for researchers, medtech and pharmaceutical companies that want to improve the patient user experience, which has the potential to attract more participation in clinical trials. In a technology-agnostic example, the Patient Centered Outcomes Research Institute (PCORI) funded the Adaptable study, which uses EHR/EMR data to identify potential study participants through five cardiovascular phenotypic indicators. Eligible patients are invited to join the study remotely and share health and lifestyle related data in a central study database, with individual patient data being reported back to the healthcare provider for possible inclusion in the EHR/ EMR records. Even five years ago, interoperability was nothing more than a good talking point, but efforts like these signal a shift toward a new way of thinking about health data integration.

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Innovation in Miniature

the healthtech series



How digital health could

improve cancer care


igital health isn’t solely limited to smartwatches and wearables. It has real potential to help diagnose and treat a range of serious conditions – cancer being amongst these.

Helping to find the technologies that could transform how cancer is looked at clinically is the Cancer Innovation Challenge. Launched in March 2017, the Cancer Innovation Challenge is a project designed to encourage the development of innovations across Scotland to help care for people with the disease. So far, five projects have been selected by the Cancer Innovation Challenge, all of which are utilising digital technology solutions in their approaches to help clinicians tackle the disease. The five projects were awarded between £35,000 to £100,000 to further develop and demonstrate the feasibility of their technologies. THE FAB FIVE Amongst the projects is an app developed by Px HealthCare to encourage breast cancer patients to notify the Cancer Treatment Helpline when certain symptoms occur. The OWise app provides clinicians with a real-time view of patient reported outcomes and integrates with NHS Scotland’s patient management system, TrakCare. My Clinical Outcomes (MCO) is a web-based platform that has patients take regular assessments to see what impact their condition is having on their life. The tool is being piloted at NHS Ayrshire and Arran and is tailored for patients in Scotland with any cancer type. Clinicians can use the information from MCO to see how


effective treatments are and to inform ongoing clinical decisions. Both projects record “Patient-Reported Outcome Measures” (PROMs) and “Patient-Report Experience Measures (PREMs). The hope is that by allowing cancer patients to record symptoms such as pain, nausea or tiredness when they experience them, doctors can gain a more accurate understanding of what treatments work best and how patients respond to them. Digital tools such as those that Px HealthCare and MCO are using have been shown to extend cancer patients’ lives by up to five months. By sharing symptoms as they occur, it is thought that doctors can find a treatment that works. Scotland’s chief medicine officer, Dr Catherine Calderwood said: “Ensuring that the person receiving care is at the centre of medical decision making it crucial. Getting accurate information from patients about their symptoms at the time they are experiencing them is core to this. This is particularly pertinent for people with cancer. How they feel really matters.” The other three winners of the Challenge are specifically focused on utilising data to improve patient outcomes. Edinburgh-based Canon Medical Research is working with NHS Greater Glasgow and Clyde on a project aimed at building a robust assessment tool for malignant pleural mesothelioma (MPM), an asbestos related cancer with a high incidence rate in Scotland. The second winner, Jayex Technology is working with NHS

Lothian on a proof of concept focusing on haematology cancers. With a shortfall of this data, Jayex is hoping to standardise and migrate existing data, from over 30 years of clinical legacy systems, to a new platform. Lastly, Sharpe Analytics will use machine learning to generate tools for the prediction of outcomes for Scottish cancer patients. The project will start with prognosis modelling for patients with renal cell carcinoma using routinely collected data recorded in repositories such as the Scottish Cancer Registry. This will help increase the accuracy of its models by incorporating additional variables, such as genetic markers influencing the likelihood of tumour development. With projects such as these being implemented across the UK, it will be interesting to see how effective the digital tools used are at helping clinicians treat cancer patients. Speaking about the developments taking place across Scotland, minister for Business, Innovation and Energy, Paul Wheelhouse said: “We are committed to developing Scotland as a centre for innovation, life sciences and world-class clinical research. The £1 million Cancer Innovation Challenge Fund plays a key role in supporting entrepreneurship and new approaches in this crucial area of medicine. This funding will allow these companies to take the next step towards developing new approaches to the diagnosis and treatment of blood, kidney and tissue cancers, using advances in machine learning and automation to deliver better outcomes for patients.”



START UP AWARD Sponsored By The winner will be a newly established business who demonstrates exceptional promise for the future EXPORT ACHIEVEMENT AWARD For businesses with outstanding overseas trading performance

As the winners of each of the regional Medilink awards are announced throughout the year in the lead up to the event, the esteemed list of finalists for the UK grand final grows. Taking place on the evening of the 25th April 2018, the awards gala dinner represents the culmination of this year-long competition. On the night, the very best of the UK’s Life Sciences and Healthcare Technology sector will be crowned.


The 2018 awards and gala dinner will be bigger and better than ever. More than a celebration, the evening will be your opportunity to network with peers, join together as a community, share your pride in the industry and passion for advancing healthcare.

For the company who has developed the most innovative technology, design or process which produces major improvements in business performance or end-user benefits

Sponsored By Awarded to the organisation whose collaboration with the NHS will have the greatest impact on business performance and patient care INNOVATION AWARD Sponsored By

OUTSTANDING ACHIEVEMENT AWARD The winner’s achievements will have had a significant or vital impact on both the company, and the sector as a whole

YOUR PRESENTER FOR THE EVENING, DR PHIL HAMMOND! Phil is ‘one of the most entertainingly subversive people on the planet’ according to The Guardian. A practising GP, he is better known as a comedy writer, author and broadcaster so get ready for a private consultation bristling with humour! In addition to his writing and doctoring duties, Phil has toured the country with his one-man shows including 59 Minutes to Save the NHS and Games To Play With Your Doctor. Phil’s numerous TV appearances include Have I Got News for You, Countdown, Question Time and The One Show plus his own series’ Trust Me, I’m a Doctor and Scream - A History of Anaesthetics.


INTELLECTUAL The team at specialist legal firm Barker Brettell take readers’ questions on the intellectual property matters that affect the medtech community. This time, lucy walker, trade mark attorney and partner does the honours.

Q ?


We want to work together with another party — but who owns the IP?



It’s true what they say; two heads are better than one, especially when you are looking to find a solution to a problem. Collaboration is a fantastic way to help drive improvements and bring big ideas to the markets. But who owns the IP when two parties collaborate? No two sets of circumstances are the same and who owns the IP will depend on how you negotiate the terms

of the collaboration agreement. For example, you could agree that any IP owned prior to the agreement stays with the original owner but any IP created through the collaboration, is jointly owned by all collaborators. Or, if the collaboration is commissioned by a backer, will the backer want to own the IP on the basis without their funds, there would be no developments?

If you have the strongest bargaining position in the collaboration, could you negotiate that you own the IP but you will then provide your collaborators with a licence to use the IP. Once you know who is going to own the IP, you need to make sure a complete collaboration agreement is drafted to address the consequences and mechanics of

the IP i.e. who pays for it, who maintains it, who decides where to protect it etc.; the list goes on. Don’t be put off by the thought of negotiating the terms of a collaboration agreement before you even get a chance to work together. Getting it right from the outset is hugely important and can save you a real headache in the long run.

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Profile for MTI Magazine

MTI Issue 36  

MTI Issue 36