MTI Issue 35 by Med-Tech Innovation Magazine

Issue 35 | Jan/Feb 2018

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PLUS 2018 forecast Innovative materials

MED-TECH INNOVATION | NEWS MED-TECH

innovation

HUMAN TOUCH How MD-TEC is combatting adverse events in medical devices: pages 14-15

ADVANCING HEALTHCARE

M E D I CAL PAC KAG I N G RIVERSIDE

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CONTENTS MED-TECH INNOVATION | NEWS

6-7.

Headlines

9-12.

News and opinion

14-15.

On the cover

16-17.

2018 forecast

19-20.

Med-Tech Innovation Expo

25.

Recruitment

28-29.

Implantables

32.

Public Intellectual 30 THE TEAM editor | dave gray +44 (0) 1244 680 222 david.g@rapidnews.com

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

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

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

art | sam hamlyn publisher | duncan wood

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from The editor

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2018’s greatest medtech challenge?

ne of the greatest challenges facing healthcare systems globally in 2018 is the threat of antimicrobial resistance. It’s a battle that has long been thought of as one belonging to the pharma community. Around the world governments are pressuring the life science industry to work towards a solution to this looming threat. The statistic in most common usage here is that by 2050, superbugs could kill about 10 million people a year. However, the pharma sector has, historically, been hesitant to work on developing new antibiotics. This is largely due to the fact that it is thought that any new classes of antibiotics wouldn’t be prescribed en masse, for fear of repeating the pattern that AMR has already taken. That’s not to say, however, that pharma isn’t doing its bit. Scientists are actively researching ways to modify old antibiotics in order to give them a new lease of life. This, however, is a costly business, not to mention a slow one. So innovation from the pharma world is on the way,

but in the interim, what can medtech do to join the fight against AMR? Some firms are ahead of the curve on this. Last year I visited Med In Ireland, the Enterprise Ireland-organised event in Dublin, and met with SureWash – an Irish firm working on portable devices for healthcare settings which gamify the hand hygiene routine, encouraging good habits amongst hospital staff. Simple as it sounds, hand hygiene remains a key pillar in the strategy for eliminating superbugs in healthcare settings. According to the World Health Organization 7–10% of patients will acquire at least one healthcareassociated infection whilst under treatment, and a large percentage of these would be prevented by improving hand hygiene. And then there are the two devices being exhibited at a special exhibition in London called Superbugs: The Fight For Our Lives. These medical devices have been developed by researchers at the University of Birmingham. One is a device that can perform a test for both bacteria and antibiotic resistance from the same sample. This can be used for

early diagnosis, and to check that the antibiotic prescribed is not one the bacteria are resistant to. The second device tests antibiotic resistance genes in bacteria using a device called Safetube, which uses ‘DNA hybridisation technology’. This is a simple little trick that allows AMR to be detected with a basic colour change test – no need to wait for lab results. I noticed as well that January saw the national press covering a technology for hospitals and healthcare settings that has already been implemented elsewhere in the world – smart door handles that sanitise your hands as you use them. This one is also on display at the Superbugs exhibition in London. In fact, it sounds like it’s worth a visit – maybe there’ll be more medtech for AMR than you might have realised. In any case, as the sector looks out on the year ahead and tries to anticipate the challenges – regulatory changes, Brexit, cybersecurity are all set to feature – don’t forget about AMR – it’s not just a battle for pharma to fight.

you’re a medical device startup

If you’re at the ground floor of a new medical device startup, it’s easy to get caught up in the rush as your company hurtles toward the next product milestone, the next round of investment, and the next steps in getting to market. However, if you’re overlooking the critical details of regulations that permit you to sell your device, you could find yourself swamped in paperwork before you can get to market, or worse, not make it to market at all. Jon Speer, founder and VP of QA/RA at software firm Greenlight Guru, lists five things to start addressing right from the beginning to ensure your regulatory submissions are ready to go at the same time as your product. 1. ESTABLISH A DESIGN HISTORY FILE Design history files are required by law as part of yourfirm’s quality system. A design history file contains all of the documentation that you generate in regards to the design of your product. The following documents should be present: • Design controls - documented procedures that describe your company’s development process; • Product user needs - details of how your product will be used, what problems it solves, and what features it requires; • Design plan - defined responsibilities and milestones for your design process; • Design inputs - a document describing all of the product requirements for your medical device, including physical, functional and performance requirements; this should be based on user needs.

GE AND ROCHE ANNOUNCE ONCOLOGY PARTNERSHIP 2.CREATE A REGULATORY STRATEGY Determine where you intend to sell your medical device and determine its product classification in accordance with local regulations - this will tell you exactly what regulations apply to your device and will inform your regulatory submission process later on. 3. ESTABLISH A RISK MANAGEMENT FILE All regulatory bodies for medical devices are concerned with risk managementand you should be too. Establish risk management procedures, and define and document a risk management plan for your product’s entire life cycle, even through development. Identify any hazards associated with your device, and start a risk assessment -identify any potential harm it could cause, the likelihood of occurrence and what severity could be. Document all of this in a risk management file. 4. BUILD RELATIONSHIPS WITH SUPPLIERS Figure out what materials you’ll need for your new device and establish a system for choosing suppliers. Base it on price requirements as well as quality. Create a list of approved suppliers for the various materials you need, and keep files on suppliers you may wish to work with in the future. It’s important that you fully understand the materials used in your products, and that you trust the companies that sell them to you. 5. ESTABLISH DOCUMENT CONTROLS Document controls may belong at the top of this list. As you create your product, you’ll generate plenty of records, and it’s important to have a system for organising and maintaining them - they’ll later be reviewed by the FDA, ISO, and possibly others toestablish your compliance with medical device regulations. The best way to ensure smooth audits and get to market quickly is to maintain great document controls from the outset. FINAL WORD Getting to market as quickly as possible not only means building agreat product that solved a real medical need safe and effectively, but it also means being quick to establish compliance with the appropriate regulations. You may have the best product in the world, but the FDA wants to see that you’re organised, diligent, and willing to play by the rules before your product makes it to the shelves. Remember we’re building medical devices. If you can address the five items above, you’re off to a great start.

headlines

FIVE THINGS ...to address if

GE Healthcare announced in January that it has now entered into a strategic, long-term partnership with Roche to jointly develop and market digital clinical decision support solutions. The partnership will initially focus on products that accelerate and improve individualised treatment options for cancer and critical care patients. The two companies aim to develop a digital platform using advanced analytics to provide workflow solutions and apps that support clinical decisions. This will allow the seamless integration and analysis of in-vivo and in-vitro data, patient records, medical best practice, real time monitoring and the latest research outcomes. Clinicians will then have the comprehensive decision support for providing the right treatment and quality of care for their patients. For example, oncology care teams with multiple specialists will have a comprehensive data dashboard to review, collaborate and align on treatment decisions for cancer patients at each stage of their disease. In the critical care setting, data from a patient’s hospital monitoring equipment will be integrated with their biomarker, tissue pathology, genomic and sequencing data, helping physicians to identify, or even predict severe complications before they strike.“ This is the first time that two major players in healthcare have combined advanced analytics with in-vivo and in-vitro diagnostics to this degree. We believe this alliance will help accelerate the delivery of data-driven precision health for customers, patients and the healthcare industry,” said Kieran Murphy, President & CEO of GE Healthcare.

TESTING LAB NAMED ‘MEDTECH PARTNER OF THE YEAR’ Anecto was been named the Medtech Partner/Supplier of the Year after winning the accolade at the Irish Medtech Awards at the end of 2017. Anecto is an independent ISO 17025 test laboratory that provides testing, technical support through the product development cycle, compliance guidance, and other technical services to the medtech industry. Clients include many large global medical devicemanufacturers. In a statement congratulating all Anecto staff on the achievement, CEO Donal Devery said: “The Irish Medtech Association represents 200 members which employ over 29,000 people in Ireland. This is a very prestigious award and recognises all the dedication, commitment and support we give to our customers. I was delighted to accept it on all our behalf. Well done to all our team and we look forward to continued success in the future.” The Irish Medtech Awards is a prominent national awards ceremony, hosted by the Irish Medtech Association in partnership with IDA Ireland and Enterprise Ireland, and enjoying its 11th year. The purpose of the event is to promote and reward outstanding performance in the medtech sector.

COACHING ACADEMY LAUNCHED FOR ASPIRING NHS INNOVATORS A coaching academy has been launched by the Innovation Agency to help health and social care professionals introduce innovations into the health service. Two programmes are being offered to people working in the NHS, universities, voluntary and other public sector organisations in the North West Coast – Cheshire, Lancashire, Merseyside and South Cumbria. The aim is to improve the spread and adoption of innovation and to create a safe and continuously improving healthcare workplace culture, using the best available strategies and techniques. The Innovation Agency’s associate director for improvement and education, Juliette Kumar said: “Innovation is something new that adds value, this could be shiny new tech or a new approach or system of care; but it isn’t a simple matter to introduce it into a health or care service. “There are well-evidenced tools and strategies for helping staff to adopt innovations and implement changes in their workplaces, we will provide these tools through our new academy, and offer ongoing coaching and support as staff navigate the tricky waters of implementing innovations. “Health and care services don’t always involve a simple transaction between one clinician and one patient; it involves multiple teams and professions and even the best ideas for improvement can fail if teams are not aware of both the technical and interpersonal challenges they will face as they prepare for change.”

MEDTECH FIRMS CITE ASSOCIATED COSTS OF WORKING WITH THE NHS AS SINGLE BIGGEST CHALLENGE Four out of every five medtech companies have seen their costs of serving the NHS increase over the past year, a survey by the Association of British Healthcare Industries reveals. The business survey, compiled by the UK’s medtech trade association, found that the single greatest challenge for companies was selling to the NHS, with 85% experiencing increases due to costly measures such as the eProcurement strategy, credentialing, and added regulatory fees. The industry, which has grown at a rate of 9% in recent years, is now worth over £17bn to the UK economy. However, uncertainty around Brexit has meant over one third of companies have delayed investment decisions. 70% of companies expect their exports to Europe to increase in 2018. This is higher than any other market and highlights the need to manage Brexit correctly, to ensure the trading opportunity that Europe represents is not lost. Commenting on the findings, ABHI CEO Peter Ellingworth said: “The messages from our members are clear. We must get Brexit right to ensure patients have prompt access to products. The current procurement environment is hostile to companies when it focusses purely on the lowest cost. Failure to purchase on the basis of quality and value to the system is not beneficial to the patient, nor does it provide efficiency. Quality is critical to providing safe and effective care, whilst delivering long-term savings to the NHS.” To minimise any disruption to the supply of products to patients, the industry is calling on law makers to adopt the European-wide regulatory model. To maintain and protect the health of both EU and UK citizens, it is also important to ensure that the cross-border movement of goods remains as seamless as possible.

Visit us at Med-Tech Expo 2018 26-27 April Ricoh Arena, Coventry UK Stand E12

PHOTONICS SET TO BE BIG BUSINESS FOR MEDTECH

NEWS

With the National Centre for Healthcare Photonics

Light is playing an increasingly significant role in next-generation products and manufacturing. In the UK in particular, the industry’s growth is more than twice the national average, and in 2017, photonics contributed more than £12.9 billion to the economy. From manufacturing to environmental monitoring, to telecommunications and aerospace, photonics technologies are used across a wide range of applications. However, it is healthcare that is the application of significant interest – thanks to the ability photonics has in delivering non-invasive, costeffective, rapid, and personalised treatment. In healthcare photonics, light is used to diagnose and treat a wide

range of acute and chronic conditions. This ranges from accelerating wound healing, to imaging in cancer care, to diagnosing and monitoring brain injury, and re-correcting vision in cataracts patients. Despite the UK’s research capabilities in healthcare photonics being world-class, many early-stage inventions fail to reach commercial stages due to lack of expertise, or cost associated with product development, manufacturing and commercialisation. With the National Centre for Healthcare Photonics due to open in December 2018, innovators will soon be able to overcome these barriers thanks to a variety of openaccess facilities, including laboratories, equipment and office space, and expert advice services.

In preparation for the new building, activities of the centre, including recruitment in key technical roles, are already underway. Photonics technologies available at the centre will encompass high frequency x-rays, through UV and visible light, to infrared all the way up to the terahertz part of the light spectrum. The National Centre for Healthcare Photonics is beingbuilt as part of the Centre for Process Innovation (CPI), the UK’s technology innovation provider for process manufacturing. The centre will enable small and mediumsized companies to increase their chances of commercialisation, at reduced risk and with increased capital efficiencies. Technology readiness processes will be safeguarded thanks to CPI’s link to the

now under construction in the North East, the region is set to become a global hub for transforming photonics innovations into successful healthcare solutions.

academic, medical and clinical communities, supply and value chain partners, as well as key players within the healthcare innovation ecosystem. Developing healthcare photonics in this assisted environment will help to improve the range and utility of photonic methods available, including biomedical imaging, diagnostic methods and therapies, whilst reducing manufacturing costs. Ultimately, the National Healthcare Photonics Centre will not only place the North East of the UK as a global leader in the field of healthcare photonics, but will dramatically assist modern healthcare in moving away from inconvenient hospitalbased and delivered services, towards more desirable patient care that is local and personalised.

Medical device regulation

OPINION

The medical device sector is in a state of significant uncertainty at the moment as it prepares for the introduction of the new Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) due to be fully applied in 2020 and 2022 respectively. Paul Brooks, executive director at the Regulatory Affairs Professional Society (RAPS) discusses how Notified Bodies are preparing as they transition to the new regulations and the wider impact that this has on the medical device sector. REGULATORY OUTLOOK The new MDR (2017/745) and IVDR (2017/746) will replace the EU’s current Medical Device Directive (MDD) (93/42/EEC) and In Vitro Diagnostics Directive (IVDD)(98/79/EC) to ensure greater confidence in the effective protection of public health and patient safety. The new regulations were officially published in May 2017 and entered into force later that month. They include important improvements to modernise the current system, such as stricter pre-market requirements for higher risk devices, much more prescriptive and demanding criteria for

what’s the impact on Notified Bodies?

designation and processes for oversight of Notified Bodies. They also refer to the inclusion of certain aesthetic devices, improved transparency, reinforcement of rules on clinical evidence and strengthening of postmarket surveillance as well as improved coordination mechanisms between EU countries in the fields of vigilance and market surveillance.1 PREPARATION IS KEY Under the new regulations, stricter requirements will be imposed on Notified Bodies and all existing Notified Bodies will have to apply for and achieve new designations. Consequently, it is essential that they are already preparing themselves to demonstrate compliance with the new requirements and are correctly anticipating the expectations of the European Competent Authorities and European Commission (EC) Medical Device Coordination Group (MDCG). Equally, it is most important that Notified Bodies have thoroughly reviewed the newly proposed product codes and have considered how to demonstrate competence across the codes when submitting applications for Notified Body designation.

From the perspective of EU member states and manufacturers, it is important that a selection of Notified Bodies are able to achieve designation for each and every code (otherwise it will not be possible to get CE marking/market clearance for devices related to those codes). Early designation under the new regulations is also important as it is predicted that during the transition time manufacturers will need to work with the Notified Bodies to calibrate and clarify the interpretation of the expectations. It is in the interest of all stakeholders to ensure the consistent application of the new requirements early on. This will enable a smoother and more efficient transition into regulatory compliance with the new regulations, ensuring minimal disruption to the market access of all legacy and new devices. INCREASED PRESSURES Notified Bodies are required to now demonstrate increased, more granular technical expertise in their scope of designation, as well as improved quality management systems. They will be initially audited jointly by the local Competent Authority, another member state Competent Authority,

and EC representatives. Also, re-audits will occur more frequently and more consistently across all Notified Bodies than currently. All this has put Notified Bodies under additional and appropriate significant pressure and is demonstrative in the decline in the number of active Notified Bodies. Before the publication of the regulations, there were over 83 Notified Bodies under the current MDD, yet as of October 2017 there are already significantly fewer (<52)2 and further reduction in Notified Bodies is expected as the designation process under the MDR proceeds. As of the end of October 2017, there are 23 members of The European Association Medical Notified Bodies (TEAM NB) who have announced their intentions and timelines for applying for Notified Body designation under the new MDR and/or IVDR3. As with all transitions between regulatory updates, there is an element of ambiguity with certain ‘grey areas’ which will require individual interpretation and more guidance before acceptance by all stakeholders is achieved. All these additional

requirements in turn lead to a significant investment of resources not only in the improved quality processes but also in increased employee training in order to meet these more prescriptive and demanding regulations. While it is clear that larger Notified Bodies can support this investment, it’s unclear whether smaller ones will be able to meet all thedemands of the MDR and IVDR. ATTRACTING TALENT With the combination of increasing pressures, it is perhaps becoming much less attractive to enter into the Notified Body business. It has been reported that in an attempt to find new expert staff, some Notified Bodies arecompeting to attract auditors and product experts from each other or from industry. Industry is also looking for replacements for lost knowledgeable staff members and isattracting personnel from Notified Bodies. Competent Authorities and the EC are also looking for more expert staff members. This has the potential to impact the capacity of Notified Body services especially as Notified Bodies now need to hire, train and rampupauditors and staff with higher competence and expertise to ensure they comply with the new MDR and IVDR.4 This in turn makes it a very competitive landscape where Notified Bodies will need to do much more to retain their talent.

CHALLENGES FOR NOTIFIED BODIES The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has estimated that there may be more than half a million different devices currently CE marked under the directives that must transition to fully comply with the new regulations. This clearly has an impact on not only the workload of Notified Bodies, but also their capacity to complete all the necessary conformity assessments now required for compliance with the MDR. Under the MDR, there is much greater emphasis on a higher number and more thorough reviews by Notified Bodies to confirm manufacturers are fully compliant and devices are fully supported by adequate data and technical documentation. Under the IVDR the workload compared to the IVDD increases many fold hence the longer transition period. There is the potential for significant backlogs toward the end of the transition period so waiting too long could be a particularly risky strategy for a manufacturer.

not to apply for the designationwhich again has many repercussions for the future of the medical devices sectors. Even if a Notified Body decides it is ready to apply for designation under the new regulations in applications, it is estimated that no designations will be confirmed for a further six to nine months, pushing Notified Body MDR designations well into 2018 andfurtherreducingthe transition period available before May 2020. It’s also important to note that the uncertainty and unknown future following the outcome of the EU referendum in the UK has added to the stresses of UK Notified Bodies. This is encouraging them to consider contingency plans so that they are able to continue to work in the event that the current UK negotiations with the EU fail to reach agreements. The British Standards Institution (BSI), for example, has already established a Dutch Notified Body unit in the Netherlands just in case it is unable to continue to operate fully from within the current UKHQ. Final thought

Advanced preparation and early action will be key to ensuring a smooth transition to the new requirements. It’s evident that there is a much greater level of communication taking place in the industry between the relevant Authorities and all stakeholders, with industry training sessions taking place throughout the EU as well as workshops that aim to educate the industry and allow for a much clearer adoption of the new regulations. REFERENCES 1 http://ec.europa.eu/ growth/sectors/medicaldevices/regulatoryframework_en 2 http://ec.europa. eu/growth/toolsdatabases/nando/index. cfm?fuseaction=na.main 3 http://www.teamnb.org/wp-content/ uploads/2017/10/ Team-NB-MDR-IVDRApplication-20171030.pdf 4 https://www.medical-risk. com/news/item/71-2017

As already discussed, redesignation is an important part of the new regulations for Notified Bodies to continue to operate. However, many currently designated under the MDD may not achieve designation under the MDR, or may decide

UDI posing a challenge?

NEWS

ONE-DAY EVENT IN MARCH AIMS TO SUPPORT MEDICAL DEVICE MANUFACTURERS THROUGH THE IMPLEMENTATION.

Since the introduction of UDI by the US FDA, a demanding series of requirements have been laid down for manufacturers of medical devices. There is, however, still some ambiguity relating to the implementation of product labelling. Manufacturers must not only make their products UDI compliant, legible and securely traceable, they also have to adapt and validate their manufacturing processes at the same time. To aid medical device manufacturers navigate the many challenges presented by UDI, Bromsgrove based TLM Laser has announced a symposium which will discuss the quality management and technical implementation requirements, and provide expert advice on what a UDI compliant solution should look like.

This one-day event, to be held on the 21st March 2018 at the South Court Hotel, Limerick, Ireland, will spotlight the issues around UDI and cover topics such as risk classes, deadlines for compliance, impacts on quality management, together with advice on the technical implementation of UDI marking in production processes. There will also be a presentation on best practice examples of UDI in production. Speakers at the event will include TLM Laser director Andy Toms and representatives from laser marking experts Alltec and Foba Laser Marking + Engraving. In addition to the presentations, there will be a practical demonstration on how vision-aided laser systems can help build a more robust and cost effective UDI marking process. A Foba M2000-P laser marking system with IMP (Intelligent Mark

Positioning) will demonstrate part validation, pre-mark verification, automatic mark alignment, mark verification and OCV and 2D code validation. The event will be of specific interest to manufacturing and quality engineers from medical sector manufacturing companies within the UK and Ireland. TLM Laser is the UK and Ireland distributor for Alpha Laser and Foba Laser and offers a comprehensive range of laser welding and marking machines and systems.

MD&M WEST

Medical Design & Manufacturing (MD&M) West, America’s largest medical

design and manufacturing event, has announced new features for the 2018 event.

CALIFORNIA DREAMIN’

ew features include attendeeto-exhibitor matchmaking, a 3D printing focus and product showcases from leading exhibitors in the field. The event allows medtech suppliers and connect with over 20,000 design and manufacturing professionals who attend the event. “The primary goals of MD&M West are to display the most groundbreaking innovations from the industries we support and to nurture business and networking opportunities for our attendees and exhibitors,” said Nina Brown, vice president of events, UBM. “This year’s attendee-to-exhibitor matchmaking and 3D printing focus strongly align with this emphasis, and both features truly complement our already robust slate of education and activities at the show.” New for 2018 is the attendee-toexhibitor matchmaking platform, which will aid attendees and exhibitors in making successful business and networking connections during the event. Attendees will have the opportunity to meet with over 100 participating companies across the three-day event for focussed,

one-on-one meetings tailored to specific areas of interest and products offered. Attendee-toexhibitor matchmaking will take place in the connection corner, located in Hall E of the Anaheim Convention Center. MD&M West will also highlight 3D printing during the 2018 event. According to a Global Market Insights report, the healthcare 3D printing market will be worth $2.2 billion by 2024. Many 3D printing focussed exhibitors will be exhibiting on the show floor in 2018, including 3D Systems, Forecast 3D, OnShape, Protolabs, Purple Platypus and Stratasys. Steven Pollack of Carbon will discuss how 3D printing has opened new doors in medical treatment as it can provide customised care and parts for individual patients. Pollack will also cover medical implications of 3D printing and how it will impact the medical field in the future.

In addition, Chris Wiltz from UBM and DesignNews will lead a guided tour of the most innovative 3D printing companies on the expo floor. This tour will cover the new materials and design techniques that are advancing 3D printing. Finally, the 3D Printing Innovation Summit will run across two days, and will include presentations about biomaterials, bioprinting and beyond prototyping. MD&M West runs alongside four other events, including Automation Technology Expo (ATX) West, Pacific Design & Manufacturing, Plastec West and WestPack. The event takes place February 6-8, 2018 at the Anaheim Convention Center.

on the cover

USE ERROR

IT’S EVERYONE’S RESPONSIBILITY

MANUFACTURER

END USER

During the medical device development, the manufacturer is expected to perform risk analysis and understand the severity of the potential harm3 that comes from the failure of the medical device, especially in actual use scenarios. Two options are acceptable when aiming to eliminate adverse events:

the predicted error does not occur as another process is in place to prevent the error from happening, or the error can occur, but it is mitigated so that it does not lead to an adverse event. Moreover, one should not omit the importance of well-defined processes in healthcare institutions, such as standard operating procedures (SOP) for medical device operation, medical device maintenance as well as errorreporting mechanisms4. Human factors is also addressed in relation to health and safety, the reason for which various hospital departments diverged from Health and Safety and Continuous Improvement working towards both employee and patient safety.

HEALTHCARE PROVIDER

inziana Popescu, research fellow from Aston University is heavily involved in medical products development, human factors and usability engineering and commercialisation at Birmingham’s MD-TEC (medical device testing and evaluation centre). Here, she explains what the centre is doing to help combat adverse incidents in medical devices.

very year about 98,000 people die in hospitals in the United States and 11,859 in England due to medical errors1, many of which are due to incorrect medical device utilisation by the human operator. These are known in the speciality literature as use errors, being commonly triggered by mistakes (lack of knowledge or training) or skillbased (within automated routines) errors. Interestingly, in spite of the improved access to technology and the booming medical innovations, the UK has seen an increase in the number of adverse incident reports for medical devices2. Human factors engineering (HFE) in healthcare entails more than the ergonomics aspects as it is essential to ensure that the design of the device is safe and suitable for lay users, healthcare professionals or patients. The need for more effective HFE has been echoed with moves from the Food and Drug Administration (FDA) and Europe to encourage medical device companies to complete this type of testing with documented guidance published in the last two years (FDA guidance document for applying human factors & usability engineering to medical device and IEC 62366-1:2015 application of usability engineering to medical devices). While the manufacturer is in reality the responsible and accountable party for use errors, a collaborative effort is necessary in order to minimise the occurrence and severity of healthcare errors.

REGULATIONS

Especially in the case of portable or home-use devices, it is in the patient’s best interest to understand and correctly use the recommended medical devices; this is increasingly becoming common place. With increased emphasis on community care identified in the NHS Five Year Forward View and Sustainability and Transformation Partnerships (STPs), the need for easily usable devices is becoming more apparent. While the manufacturer must ensure that the instruction manual is adequate for the average user, the healthcare service provider tends to introduce a Code of Professional Conduct for the

employees to adhere to. Lastly but not least, healthcare professionals and carers also have a moral duty to report faults or misuses of the medical device. Moreover, regulatory bodies are trying to promote a common approach for manufacturers in the development of medical devices. With the imposed medical device guidelines (essential requirements) and post-market surveillance systems, the manufacturers are legally required to report safety and performance issues. Usability testing is key to HFE strategy and it involves representative end users performing, step by step, the tasks required for medical device utilisation in order to reveal strengths and weaknesses of the design. Usability tests can be performed at any design stage development (formative study) and validation (summative study) - as it enables the device improvement for the intended users, use and environments. The medical device users can be protected from harm only via a robust and reliable user interface, comprising displays, controls, labels, packaging and instructions for use. The profile of human factors in medical device development has significantly increased with change in regulations and expectations to improve the healthcare services. Previously sidelined in favour of technological advancement and health and safety, the benefits of usability engineering are now being realised and the implementation of HFE processes can lead to the advantages outlined above5:

USER

SAFETY

• Improve clinical effectiveness of device use

• Promote improved safe use of a device

• Improve efficiency of device use

• Reduce incidents associated with use error

• Improve user satisfaction with device

• Reduce litigation which can result from poor device production

• Reduce poor compliance / non-use and abandonment of a device

BUSINESS • Reduce potential for product recall and furtherpost production design iterations • Positively impact brand loyalty • Provide added user value to device • Increase purchasing power and revenue from device sales

Despite the clear need for improved HFE with medical devices there is currently little support outside of the USA, which can be utilised to realise the advantages of engaging end users in medical device development.

offers similar support and expertise in this area to deliver improved outcomes for healthcare, patients and industry. For further information visit our website www.md-tec.com or email us on mdtec@uhb.nhs.uk *Eligibility criteria apply.

Medical Devices Testing and Evaluation Centre (MD-TEC) supported through funding from the European Regional Development Fund 2014-2020, aims to facilitate the commercialisation process for small and medium sized Life Sciences companies* in the Midlands region. Offering access to the Usability / Simulation Suite and R&D expertise, manufacturers can evaluate medical device user interfaces in representative use environments, such as the operating theatre and wards. The implementation of usability into medical products is mutually beneficial to all involved parties, leading to use(r) optimisation and a competitive advantage. In addition, the National Institute for Health Research (NIHR) Trauma Management MedTech Cooperative

REFERENCES: 1 - http://threecircles.eu/tag/mhra/ 2 - Medicines and Healthcare products Regulatory Agency Annual Report and Accounts 2015/16 3 - CDRH, Applying human factors and usability engineering to medical devices, Guidance for industry and food and drug administration staff, 2016 4 - Z. Robinson Wolf, R. G. Hughes, Chapter 35: Error Reporting and Disclosure, Patient Safety and Quality: An Evidence-Based Handbook for Nurses, 2008 5 - E. Taylor, S. Hignett,, A. Joseph, The environment of safe care: considering building design as one facet of safety, in Proceedings of the International Symposium on Human Factors and Ergonomics in Health Care, pp.123-127, 2014

IMPROVED QUALITY OF CARE OPTIMISED MEDICAL DEVICE DESIGN PATIENT SAFETY

NOVEL MEDICAL TECHNOLOGIES

SIMULATION SUITE ASSESSMENT

2018:

2018 Forecast

EVOLUTIONARY OR

In November 2017 Deloitte launched its report -‘The future awakens: life sciences and healthcare predictions 2022’-which provides an overview of six predictions that the group believes will transform health care. Here though, Karen Taylor, director, Centre for Health Solutions at Deloitte LLP, tells MTI about the key medical technology innovations that the firm believes will impact healthcare in 2018.

t is vital that we envisage the innovation that could deliver improvements in healthcare. Especially given the growing imbalance between demand for and availability of affordable health and social care. This will require new approaches to accessing and delivering care to improve the efficiency and cost-effectiveness of services and help bridge that gap. Our assessment is underpinned by the evidence available today that enables us to say, with some confidence, what tomorrow might look like. Inevitably, some of these predictions will happen sooner than we think, while others may never happen. THE SIZE AND SCALE OF THE MEDTECH MARKET Global medtech sales are estimated to be worth $425.1 billion (USD) in 2018 and are forecast to reach $521.9 billion by 2022 (a compound annual growth rate (CAGR) of 5.1 percent). In vitro diagnostics is expected to remain the largest medtech segment with annual sales of $70 billion by 2022, cardiology ranks second and is expected to reach $62 billion in sales by 2022, followed by diagnostic imaging at $48 billion, and orthopaedics at $44 billion.1 Exponential advances in technology have made medtech ripe for innovation. Whilst the industry still lags behind other industries, in the past few years there has been an increase in device innovations aimed at tackling some of the most intractable healthcare challenges. The following assessment, derived from our six predictions, highlights some key examples occurring in 2018.

THE RISE OF THE QUANTIFIED SELF In 2018 individuals will have unprecedented access to technology, advice and support to enable them to be better informed about their own health status and future health risks. An increasing number of people will opt to obtain their genetic profiling. While many others will use health apps and wearables to provide improved monitoring of their vital signs, fitness and nutrition. The adoption of technology is helping people remain connected and active and should ultimately help to reduce the cost of healthcare. For example: • Bio-telemetry, using wireless technology such as smart watches, and electroluminescent clothing, is collecting meaningful data and using analytics to monitor variability in vital signs. 2018 will likely be a landmark year for wearable technologyas sleek design improvements and enhanced usability make these innovations more integrated than ever before. • Gamification is coming in to its own as a healthcare tool - the 2016 worldwide phenomenon, Pokemon Go, showed how a game can encourage people to get outside and become more active, leading to new video games being developed to impact people’s behaviours and actions, including rehabilitation exercises.

SMART HEALTHCARE CAN DELIVER MORE COST-EFFECTIVE PATIENTCENTRED CARE In 2018, patients with complex and acute inpatient needs will increasingly be monitored using near patient digital monitoringand radiofrequency identification (RFID) technology, enabling the location of patients, staff and equipmentto be tracked. More providers will adopt data-driven, real-time understanding of patient flows and acuity, with digital devices helping staff optimise care delivery, patient experience, and the management of back office services, there byreducing costs and improving outcomes. Examples include: • Increased use of 3D visualisation and augmented reality for surgeryenabling surgeonsto operate more effectively and efficiently while also giving medical trainees a clear picture of what they’re doing-use casesinclude ophthalmology and neurology; • Demand for surgical, rehabilitation, and hospital robots will continue in 2018 -driven by declining costs, labour shortages, and successful pilot projects. Healthcare robots will increasingly be deployed in surgery, hospital logistics, disinfection, nursing, exoskeletal rehabilitation and prosthetic limbs.2

WE ALWAYS OVERESTIMATE THE CHANGE THAT WILL OCCUR IN THE NEXT TWO YEARS AND UNDERESTIMATE THE CHANGE THAT WILL OCCUR IN THE NEXT 10. Bill Gates from his book, “The Road Ahead”, published in 1996

REVOLUTIONARY? MADE TO ORDER MEDICAL DEVICES ARE HELPING IMPROVE HEALTH OUTCOMES In 2018, an increasing mnumber of medical devices will be ‘made to order’ based on specific patient geometry, using technologies such as additive manufacturing (3D printing). Over the past decade around 200 3D printed devices, including surgical instruments and devices implanted into patients, have been approved. One example is the revolution in the production of hearing aids, reducing the manufacturing process from nine to three steps - more than an estimated 10 million hearing aids have been manufactured using such technologies. The total size of the 3D-printed health care market is estimated to be between $1.2 billion and $2.3 billion by 2020.3 ARTIFICIAL INTELLIGENCE AND BLOCK CHAIN TECHNOLOGY UNLOCKING VALUE IN HEALTH DATA The Internet of Things means the physical and digital worlds are increasingly connected and are collecting massive amounts of data, faster and more detailed than ever before (the world’s data volume is expected to grow by 40 percent a year). Innovations include: • AI will continue to gain ground in 2018-mining medical records, designing treatment plans, speeding up medical imaging and drug creation; • Blockchain technology pilots - to bridge traditional data silos, increase IT and organisational efficiencies, keep medical data secure, and streamline patients’ access to data - has the potential to help overcome the limitations of large scale sharing of health data that is currently holding back innovation. Block chain

technology will likely see its first real-world tests in healthcare in 2018; • Cybersecurity technology which will remain a critical priority.4

NEW APPROACHES TO DIAGNOSTICS WILL TRANSFORM HEALTH OUTCOMES One area where medtech will come into its own is in diagnostics, with advances in the field accelerating in 2018. These include: • Liquid biopsies to improve cancer detection and measurement of treatment responses; • Increased understanding of the interaction between people and their microbiome with many biotech companies increasing their investment in the microbiome’s potential to develop newdiagnostics andtherapies; • Point-of-care (POC) diagnostics will accelerate in 2018 as the growth of boundaryless hospitals and community care increases the need for rapid results outside of clinical settings.

NEW ENTRANTS AND PARTNERSHIPS ARE DISRUPTING HEALTH CARE Non-traditional healthcare companies areusing their brand, engineering expertise and knowledge of customers to disrupt the healthcare landscape. These new entrants are partnering with traditional providers to deliver a more customer-focussed experience based on new business models and operating strategies. For example, telehealth companies are bringing healthcare to people’s doorsteps or workplaces. 2018 will see an increase in demand for tech enabled services such as telehealth and telemedicine toovercome geographical boundaries to provide access to

services in remote areas or to tackle shortages of healthcare professionals. CONCLUSION At the start of 2018, the future of health is more challenging and the possibilities more exciting than ever before - including the need for strategies and judgement on how best to shape healthcare. While predicting the future is by its nature challenging, one thing all the above predictions have in common is that the developments are made possible by the advances in technology and the emergence of new collaborations and partnerships. In 2018 the medtech industry is well placed to build on and expand innovative developments and create new opportunities to deliver solutions that diagnose needs and inform care decisions, improve care delivery and enable more comprehensive care management. REFERENCES 1 2018 Life Sciences Global Outlook report. Deloitte DTTL, January 2018. 2 The future awakens: life sciences and health care predictions 2022, Deloitte, November 2017. 3 3D Printing: The contribution of 3D printing in improving health outcomes. Deloitte Centre for Health Solutions blog, May 2017. See also: http://blogs.deloitte.co.uk/ health/2017/05/3d-printing-thecontribution-of-3d-printing-inimproving-health-outcomes. html42018 Life Sciences Global Outlook report. Deloitte DTTL, January 2018

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Med-Tech Innovation Expo is just around the corner, and this year we’re planning to put on a show that’s bigger and better than ever before. Next issue will include our full guide to the show, but in the meantime, here’s the key info for planning your visit.

MED-TECH INNOVATION | expo

WHEN & WHERE

RICOH ARENA, COVENTRY, UK

25-26 APRIL 2018

KEY STATS

MED-TECH INNOVATION EXPO

LET THE SHOW BEGIN

In association with Medilink UK, the Med-Tech Innovation conference has come to be regarded as a crucial forum for those in the sector to access thought leadership and guidance all in one place. This year’s line-up is looking better than ever, with the following names already confirmed…

200+ EXHIBITORS FROM ACROSS THE MEDICAL DEVICE SUPPLY CHAIN

2,500+ VISITORS

VISITOR REGISTRATION

UP FOUR TIMES ON THE PREVIOUS YEAR (AS OF JAN ’18)

EXPO

At the heart of the twoday event, the exhibition brings together experts in packaging, medical electronics, medical grade plastics, design, sterilisation, components, regulation and manufacturing equipment. For start-ups with a new idea for transforming healthcare, this is the go-to event to meet the suppliers and consultants you’ll need along the way. Equally, for established medtech OEMs, the challenges of working in this market are well-known. The expo floor is the place you’ll find all the answers.

CONFERENCE

REPRESENTING THE ENTIRE MEDTECH COMMUNITY KAREN TAYLOR, DIRECTOR, CENTRE FOR HEALTH SOLUTIONS, DELOITTE UK The future awakens: life sciences and healthcare predictions 2022

PROFESSOR MIKE HANNAY, CHAIR, NATIONAL NETWORK OF AHSNS (ACADEMIC HEALTH SCIENCE NETWORKS) The Role of the AHSNs in the adoption and spread of innovation in the NHS

JOEL HASPEL, PARTNER, GE HEALTHCARE FINNAMORE Partnering for AI development and delivery JOHN WILKINSON, DIRECTOR OF DEVICES AT MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY (MHRA) The new MDR/IVDR from words to action

JANET MONKMAN, CEO, ACADEMY FOR HEALTHCARE SCIENCE Life Sciences Industry Register - what this means for you ALAN SUMNER, HEAD OF PUBLIC AFFAIRS, ROCHE DIAGNOSTICS, UK & IRELAND The accelerated access review - how can it best serve patients? IAN CAMPBELL, DIRECTOR OF HEALTH & LIFE SCIENCES, INNOVATE UK Update on Industrial Strategy and Industrial Strategy Challenge Fund (ISCF)

HEALTH TECH STAGE As well as two days of engaging conversation on the main stage, this year Med-Tech Innovation Expo brings you the HealthTech Stage – a place for technical know-how and supply chain expertise. Highlights for 2018 include: KEN BLOCK, KEN BLOCK ASSOCIATES Meeting the newest FDA expectations for innovative software JIM REED, MINNETRONIX Successful virtual development partnerships PROFESSOR ALEXANDER M. SEIFALIAN, THE LONDON BIOSCIENCE INNOVATION CENTRE The development of medical devices using graphene nanomaterials

LIZ ASHALL-PAYNE, CEO & FOUNDER, ORCHA Understanding the mHealth landscape: global, the UK and the NHS MIRREN MADALI, SENIOR DIRECTOR, NEW VENTURES & TRANSACTIONS (MEDICAL DEVICES) J&J INNOVATION A great idea can come from anywhere

MED-TECH INNOVATION EXPO

Holly Delaney, visitor marketing manager for UK Events at Rapid News Communications Group, (the organiser of MedTech Innovation Expo) spoke with a selection of Medilink UK Pavilion exhibitors recently, learning about their expectations for the sector in 2018 and beyond.

HD: Firstly, what do you see as the major trends for the medtech sector in the coming year? HARRISON LAW, account executive at IHN, an independent chartered insurance brokers with medtech expertise: With Technology advancing at an incredible rate I can see the NHS outsourcing more and more contracts. I envisage some fantastic opportunities throughout the sector, be it App developers in the Tech space or Manufacturing, all benefitting from advancing technology. KATE PYM, managing director of Pym’s Consultancy which oﬀers support to companies to commercialise health and social care innovations/ technologies and gain access to both UK and international markets: A government-led focus on internal and investment into the UK Med Tech industry, with greater impact and support from Higher Education Institutions to lead the development of innovation.

WHY BREXIT, REGULATIONS AND INVESTMENT ARE VITAL FOR

UK MEDTECH ADNAN ASHFAQ, consultant director at Pharmi Med, a consultancy specialising in supporting medical technology businesses with compliance for ever-changing regulations: In 2018 we see major challenges, as ISO 13485: 2016 goes through its final year of transition in which all companies must have received certification of the revision by 28th February 2019. In addition to this the MDR and IVDR released in May 2017 also enforces another timer, in which companies selling in the EU market must have transition by 2020 and 2022, respectively. HD: How do you plan to take advantage of these opportunities? KP: We are already working with several university Technology Transfer and Commercial teams, and will be expanding our customer base in higher education, using the recently published UK Industrial Strategy, Deal for Life Sciences and Higher Education Knowledge Transfer strategies to provide strong support and thought leadership for SME spin-outs and licencing of med-tech innovation.

AA: Pharmi Med Ltd are staying in tune with industry changes so we can be certain that we are ready to serve the industry by ensuring they comply. We will be networking and making our presence known by marketing but mainly through good industry connections and a brilliant track record. HD: Give us your view on Brexit and how you feel it will impact the medtech market. HL: With the UK being at the forefront of the sector in terms of Research and Development, Compliance and Regulation, it will give UK companies a fantastic opportunity to expand their customer base in new markets be it the USA, Asia or Africa to name a few. KP: Brexit will have a tremendously positive effect on the UK med tech industry, a key area for future development highlighted in the industrial strategy. The cost of exporting has fallen considerably, and investment in med tech is set to grow significantly. The rest of the world look to the UK for med tech innovation, and Brexit will provide a real opportunity for the UK to develop. AA: We believe that Brexit will not impact the new regulations otherwise this will mean a new set of regulations for

UK alone which makes no sense. However, what will potentially impact is the falling of the pound sterling against the Euro - this could make manufacture in the UK cheaper than the rest of Europe. If the pound were to fare better than the Euro we may be less competitive than our European counterparts, forcing manufacture out of UK. Either way, the Far East (particularly China and India) have already started to take up a lot of manufacture for UK companies. This will make us more of a developer than a producer, focusing on innovation, R&D and prototyping. HD: Finally, why Med-Tech Innovation Expo? Why are you exhibiting and why you would encourage people to visit the event? HL: The Expo meets everyone’s needs including great networking opportunities with suppliers and peers. The Expo also showcases new products, technology and ideas to help expand and develop your own. Whether you’re looking for financing or improvements to supply chain, this is the event to attend. KP: We had a very positive response to our stand last year, and met many of our current associates and customers there for the first time. It provided excellent information, presentation and networking opportunities, certainly an event that we wouldn’t want to miss. AA: It’s the main UK event for medical technology so businesses, start up or established, should come just to network and see how we can work together to make us more competitive, more innovative and more successful as a nation.

How women manage poor bladder control associated with urinary incontinence (UI) varies immensely. Despite global UI fast becoming the single largest condition affecting women’s health1, current solutions and interventions only help to alleviate symptoms rather than to treat the underlying cause – weak Pelvic Floor muscles. This lack of market innovation has led Femeda Ltd to develop their ground-breaking medical device, Pelviva® due to be launched in the UK in April 2018. “Current solutions and interventions include incontinence pads, panty liners, mechanical devices and pessaries, which focus on alleviating symptoms rather than providing a treatment. Other solutions include drug treatments, all with side effects, and surgery, the last resort for many females,” says Femeda CEO, Andrew Tasker. “Pelviva® is a life-changing breakthrough that provides women with a clinically effective and discrete treatment for poor bladder control, which if ignored can severely impact quality of life.2,3” Pelviva® is a single-use, disposable intra-vaginal Pelvic Floor muscle re-trainer. Each device contains a unique microprocessor that delivers Reactive Pulse Technology (RPT) to the Pelvic Floor muscles. The Pelviva® reactive pulse mimics the way the body works naturally, causing the Pelvic Floor muscles to contract. This helps restore speed and strength to the power fibres, to prevent bladder leakage when women cough, laugh, sneeze or exercise. It also retrains the endurance fibres to hold on when the body urgently needs the toilet and reduces the number of trips to the toilet.4 It is made of a patented Dynamic CRC (coated reversibly compressible) – Body Responsive Foam, which adapts to every women’s individual shape.1 The unique Pelviva® RPT delivers a series of intensive reactive pulses every alternative 10 seconds, to stimulate the Pelvic Floor muscles. Each 30-minute treatment using the Pelviva® innovative stimulation programme, delivers up to 25% greater penetration of the deep pelvic muscle than conventional stimulation.5,6

Pelviva® is supported by a comprehensive package of clinical data. In a 12-week randomised single blinded clinical study involving 123 women, 84% of the women using Pelviva® reported improvement in bladder control. Women who used Pelviva® also reported a four times greater improvement in quality of life versus women who followed an unsupervised pelvic floor muscle exercise program alone.7

TME

Global patents and regulatory approvals are in place for Pelviva®. A Class IIa medical device status has been achieved in Europe, and initial positive meetings have been held with the FDA. There are 26 granted patents across four patented groups with extensive Geographical Coverage to 2035. Femeda has forecast significant market penetration for Pelviva® and has identified a potential 698 million women worldwide who may be suitable for treatment.1 “The global UI market is worth approximately $13.6bn8 and we are forecasting significant market penetration in the UK” says Andrew. “Direct model, retail and out licensing, per country discussions are already in progress for 2019 to scale the business to meet its potential as a $1bn+ global opportunity.” Pelviva® has been developed keeping ease of use in mind and to help women take back control of their pelvic health and regain their bladder control. For more information on the clinical effectiveness of Pelviva® visit: www.femeda.com

REFERENCES: 1.

Femeda – Data on File 2017.

Harriet Vogt Research & Planning May 2015.

Sinclair A. J. and Ramsay, I. N. The Obstetrician & Gynaecologist 2011;13:143–148.

Kidd G, Oldham J. Clinical Rehabilitation 1988; 2:22-33.

Binder-Macleod S. et al. J Neurophysiol. 1998 Apr; 79(4):1858-68.

Chang Y and Shields R. Neurorehabil Neural Repair. 2011 Jun; 25(5): 423–432.

Oldham J, et al. Neurourol Urodyn. 2013; 32(5): 460-466.

Artikel-Presse.de. Neurology Devices Market Size to Reach US$13.6 Billion by 2019. https://www. artikel-presse.de/tag/neurology-devices-market/ (Last accessed January 2018).

AL RI O RT VE AD

FEMEDA’S LIFE-CHANGING TECHNOLOGICAL BREAKTHROUGH, PELVIVA® DEVELOPED TO IMPROVE THE LIVES OF MILLIONS OF WOMEN

INNOVATIVE MATERIALS

If pharmaceuticals and biologics could be successfully loaded into fibres, it could make for

raditional melt extrusion processes used to manufacture fibres destroys the viability of most drugs and biologics, given that melt extrusion must occur at temperatures often exceeding 200 degrees celsius. Today, emerging technologies such as electrospinning and wet-extrusion processes occur at room temperature, greatly expanding the range of pharmaceuticals and biologics that can be incorporated into implantable medical devices and therapies. These low temperature processes potentially allow a broader variety of drugs and biologics to be loaded into fibres compared to melt extrusion; however, this benefit comes at a price. In these low temperature processes solvent exposure is accepted in exchange for heat exposure.

an entirely new approach to nerve regeneration, as well as advanced drug delivery and tissue engineering. Dr. Kevin Nelson, founder and CSO, TissueGen explains.

During the wet spinning process, a polymer is dissolved in a solvent, and this solution is injected under pressure through a spinneret into a coagulating bath. The coagulating bath is comprised of a solution that is highly miscible with the solvent used to dissolve the polymer, yet is a non-solvent for the polymer. As the polymer solution stream enters the coagulating bath, the solvent diffuses from the polymer solution stream into the coagulating bath, locally increasing the polymer concentration. At the same time, the polymer stream is exposed to the non-solvent of the coagulation bath. This combined effect causes the polymer molecules to precipitate out of the solution, forming a solid fibre. The polymer fibre is then pulled from the coagulation bath and taken through several draw stations where the fibre

IT TAKES SOME NERVE 22

is stretched and heated, but at typically much lower temperatures than possible with melt extrusion because the residual solvents (and non-solvents from the coagulating bath), rather than heat, provide the molecular mobility required to allow the polymer chains to align and create entanglement sites that provide high mechanical properties to the fibre. Providers of these low temperature processes must now create a means whereby the drugs are protected from the frequently harsh solvents associated with electrospinning or wet extrusion. These protection processes now become the heart of the intellectual property of these manufacturers. When successful, the biological activity of incorporated sensitive growth factors and biologically-based agents can now be preserved so that a wide range of pharmaceuticals and biologics remain viable when loaded to biodegradable fibre. These electrospun or wet-extruded fibres are ideal for use in current and next-generation implantable medical devices, regenerative medicine, and as pharmaceutical depots for slowcontrolled release. The localised pharmaceutical delivery capability of these fibresmay even allowmedical device designers to locally alter the body’s response to the device. The controlled release of wet extruded fibrebased systems is well-suited for a variety of medical applications, including meshes and weaves for current textile applications, sutures, ligatures and scaffolding. The fibres are also strong enough to potentially be used to create biodegradable, self-expanding, pharmaceuticalloaded cardiovascular stents. Using this proprietary technology, even viral particles have been successfully loaded into fibres, implanted into immune compromised animals, and have shown extremely efficient transfection. With wet extrusion, sensitive growth factors such as Nerve Growth Factor (NGF), Vascular Endothelial Growth Factor (VEGF), and other sensitive biological molecules including immune proteins and enzymes such as IgG and even live adenoviruses can be loaded and delivered via fibres.

Fibres loaded with such biologics and incorporated into implantable medical devices may find use in severalregenerative applications, including: • • • •

Nerve regeneration Solid tumor remediation Spinal cord repair Dermal wound healing

One specific example of how this technology may be applied is the repair of the nervous system. During embryonic development, growing nerves are known to follow growth factor concentration gradients; and this also true in wound-healing for adults. Therefore, it is speculated that if it were possible to create a concentration gradient of the right growth factors in an adult wound-healing situation that it may be possible to induce accelerated, focused regeneration of axons. Using these same growth factors loaded into a fibre, it may be possible to create a conduit containing a variable-pitched, growth factor-loaded coil, meaning the loops of the coil are much closer together at one end than the other. This gives an opportunity to create a concentration gradient moving down the center of the coil as there will be more growth factor where the loops are closer, and less growth factor where they are further apart. This drug-loaded fibre-based coil may then be a key component to creating nerve regeneration across long gaps in humans. This technology may also prove beneficial to other areas of nerve repair both in the peripheral and central nervous systems. By preforming extrusion at or near room temperature, the limitations to drug viability that have impeded how pharmaceuticals and biologics can be delivered via implantable medical textiles can finally be overcome. Extrusion processes that occur at room temperature enable loadinga wide range of pharmaceutical and biological agents into biodegradable implantable devices thereby enabling localised delivery within the body which mayfacilitate breakthroughsin medical applications such as nerve generation, spinal cords injury repair, tissue engineering and even vascular grafts. This technology has the potential to be particularly well-suited for the repair of the nervous system, as nerve cells are known to follow growth factor concentration gradients during development and after injury.

RECRUITMENT

New year is a busy time for most people, but for final year undergrads, it’s around this time when they really begin to think about

potential employers. Samantha Blythe-Moore, founder and director of specialist recruitment firm Medical Engineers writes

New year, new start

he ‘first appointment’ after graduation can really define a career path: the breadth of opportunity currently available and the type of graduate programme will certainly give those graduates a flavour of what the medtech market can offer in terms of a challenging and exciting career. So where to begin? Well, let’s work backwards: what is it that you want? If you’ve already decided what area you want to specialise in, then is there really any point in completing a two-year graduate scheme, where you spend three to four months in various departments? On the flip side, if you’ve no idea yet what your specialism will be-you just know you love medical devices-then this could be the perfect solution for you. Another option is to go for a graduate specialist role, for example a graduate design engineer role in a smaller company. Here you will get to specialise, but you will work closely with all the other departments in the business and get a really good understanding of the product development lifecycle and all the influencing factors which affect the design of the product. Whatever your strategy, make sure to properly target your choice of companies within medtech. Explore all elements, from IVD to surgical robots, keep your options open. RESEARCH, RESEARCH If you really want to secure a role with your employer of choice you need to invest some time now. All companies will have a website. Now, you can follow the crowd and register your interest via these websites. But even better, why not

engage with your target employers through social media? It has never been more prevalent as a job search tool, providing immediate access to talent acquisition teams and recruiting managers directly - what’s not to love? Remember that anybody can rattle off a few statistics about profits, number of employees or key products. In addition, therefore, try to really understand the target organisation and, above all, how you can add value to it. Show insight and commitment. Look at the latest news, trade press and competitors to comprehend the key challenges and opportunities they face. Work out how your experience and expertise will help tackle these challenges. NETWORK, NETWORK Companies recognise that to secure the best of future talent they need to be engaging with candidates across all social media channels. So get ‘talking’ or stalking your target companies, follow Twitter feeds, join Facebook groups. Check out company alumni, especially those on LinkedIn. Connect and message with these people where appropriate and start getting the inside track. In summary, it has never been easier to get in front of decision makers - all from the comfort of your phone, laptop or tablet. You can use your own network to find information about the interviewer and possibly the team you may be working in. Use LinkedIn and other networking sites to gather all the intelligence you can. It’s never too early to start engaging skilfully and get yourself known - in a good

way. Competition is fierce. A recent graduate recruitment campaign for a blue chip international medical device company yielded over 400 applicants for two available roles. You need to stand out. In the coming weeks and months Medical Engineers will be visiting UK universities to speak with undergrads about how they can optimise their CVs for medical engineering roles and engage with target companies professionally and effectively. We always ensure we have plenty of time, so please do come and speak to us after our presentation. We are passionate about keeping STEM graduates in our industry. Medical Engineers allows any medtech company, regardless of whether they’re a client or not, to advertise graduate roles and internships on its website and we will forward on all applicants directly at no cost to the recruiting company. Remember also that the medical device and diagnostic industry within the UK is at the forefront of some of the most innovative and technological advancements in the world. And so when the time is right, you may seek the value of a third party chat and assessment. And we are here to help candidates at all levels and ages – whether broadening or deepening your career in medical device development, be that within biotech, pharmaceutical, diagnostics (IVD), medical electronics, robotics, orthopaedics, surgical instruments, wound care, drug delivery, research and development or consultancy.

PLM & SOFTWARE

Paradigm shift:

the impact of industry 4.0 on Class III medical device manufacturing

As the pace of innovation accelerates for Class III medical devices, medical OEMs are designing complex products such as pacemakers and other implantables in smaller form factors. In order to manufacture these types of Class III devices in high volumes, OEMs are leveraging the expertise of electronic manufacturing services (EMS) companies forboth automation and manufacturing systems that assist with day-to-day regulatory compliance.

Gelston Howell, Sanmina Corporation writes.

Consider for example, the challenge of manufacturing 10 million Class III devices a year, with an assembly and test process having 50 steps, using dozens of components, some of which are too small to be handled by a human. Both the devices and the processes must meet regulatory requirements for component traceability and verification, storage and access to device history records (DHR), and process compliance. In addition, with thousands of kits of material required per week, inventory control on the production floor poses

additional challenges. With the level of complexity involved in producing a Class III device in these volumes, automated production and advanced manufacturing systems area necessity. Industry 4.0 technologies — including cloud computing, machine-to-machine communication and cyberphysical systems — are enabling advanced automation that help overcome these production challenges. The increased connectivity and data-gathering provided by these technologies make it possible to build highvolume, regulatory compliant manufacturing processes with efficient inventory and production management. Here are some examples of how industry 4.0 technologies are being deployed to produce and assist with regulatory compliance, for Class III devices in high volumes. DHR, DMR, MEDICAL REGULATORY COMPLIANCE, AND MACHINE-TO-CLOUD COMMUNICATION Recording a device history

record (DHR) for each Class III device is a regulatory requirement. The DHR establishes that the device has been manufactured according to the bill of materials, approved manufacturer list, procedures and instructions in the DMR (Device Master Record). The DHR records component and device part numbers, unique serial numbers, date codes, date of manufacture and the results of any tests or inspections. Not only is it a requirement to record the data, the data must also be retrievable in a timely manner. Scanners located in manufacturing equipment communicate with Manufacturing Execution Systems (MES) in the cloud to ensure that only components specified in the DMR are assembled into products. The scanners upload the part number, serial number, and date code information to an electronic DHR. Machines and scanners record the device’s progress through the manufacturing and test process. Results of optical inspections, pass/fail data, and parameters measured during test processes are uploaded from machines to the cloud MES system. All of this data in the electronic DHR is stored in the cloud MES or sent to the PLM (product lifecycle management) system and can be retrieved with a simple query. This technology and these methods are in production today at a Sanmina factory for high volume class III medical devices, helping ensure day to day regulatory compliance.

PROCESS COMPLIANCE, FORCED ROUTINGS, AND THE CYBER PHYSICAL FACTORY For a Class III device with 50 process steps, 10-15 will involve inspection, calibration or testing. If the product fails an inspection or a test, it is routed out of the main process flow for diagnosis and possibly rework. Following rework, products are reinserted in-line at the point just before the failure occurred. This practice ensures that each repaired product passes the test it originally failed. Assuming, for this example, 10 million devices manufactured each year (a device produced every 1–2 seconds), the number of permutations of valid process paths that could occur as a result of pass/fail results at 10 test or inspection steps is substantial. In such an environment, it is challenging to confirm that each product is manufactured using the defined process, but industry 4.0 technologies and techniques can help manage that challenge. For example, the defined physical manufacturing and test process flow is replicated using a virtual factory in the cloud MES. Rules are established in the MES system for valid process flows. At every step of the manufacturing process, each product is scanned, and the MES forces it through the defined process flow, ensuring process compliance. DEVICE CALIBRATION AND PROGRAMMING AT A RATE OF ONE DEVICE PER SECOND Many electronic products are built with storage components such as EEPROMs. These devices store the software programs required to make the product function (firmware), part numbers and serial

numbers. In some cases they also store calibration and component data. Part numbers and serial numbers are critical traceability records for the DHR. Calibration requires measurements of analog and digital parameters such as voltage and current to be taken and adjustments made to data stored to ensure that the device will operate within acceptable control limits. Each EEPROM stores both static data including the firmware, part number and serial number as well as dynamic data calculated as a result of calibration procedures. Writing data into an EEPROM takes time. Measuring and calibrating the device takes more time and is a complex mathematical process. Regulatory compliance requires that the static and dynamic data recorded in the EEPROM is also stored in the DHR. The process of selecting the correct firmware, part number and serial number to write into the EEPROM, calibrating the device and recording the calibration data is complex. Producing ten million devices per year means that a device must be completed every one to two seconds. Volume and manufacturing cycle time adds to the technology and regulatory complexity. Connecting multiple manufacturing machines and test systemsbto the cloud based MES enables real time parametric data analytics, calibration and EEPROM programming in a very high volume medical manufacturing environment. REAL-TIME INVENTORY CONTROL AND MACHINE-TOCLOUD COMMUNICATION On any given day, thousands of parts are transferred from the warehouse and placed on the factory floor in varying quantities. These components must be replenished from the warehouse, increasing component inventory on the production floor. As components are consumed and built into products, inventory is adjusted by reducing component inventory and increasing sub-assemblies

or finished products. In the past, managing inventory was manually transacted in an ERP 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 realtime inventory control. For example, an automatic optical inspection machine, having determined that an electronic PCBA is correctly assembled, communicates with the ERP system, directing it to consume the individual components and reducing the quantity located on the production floor while increasing the number of PCBAs produced by one. This practice improves inventory accuracy in real-time and makes the process highly efficient. These industry 4.0 technologies, including machine-to-machine communication, automation, and cyber-physical systems integrated to a cloud MES, are being applied to drive efficiencies and automate production. In the case of high-volume Class III medical device manufacturing, these techniques also are providing solutions to the challenges of regulatory compliance to create the DHR, ensure DMR compliance, and solve business problems like inventory management in highvolume manufacturing. Implementation of this vision requires advanced technology; the examples described here required machine-tomachine and machine-to-cloud interoperability among more than 20 different types of machines. It’s a daunting task for a high-volume manufacturing facility to connect dozens of production and test systems to the cloud. Industry 4.0 concepts and cloud technology are now enabling real innovationand the results —in terms of compliance, efficiency, control, and manufacturing precision — are transforming manufacturing operations.

IMPLANTABLES

Wearable and implantable technology could give hope to some three million people living with COPD, but there remain key questions around safety, reliability and cost. This is why more clinical research studies are crucial, write Prof Guang-Zhong Yang and Dr Anthony De Soyza.

earable technologies could well be the next wave of technology after smartphones that transform our society and daily life. The new generation of wearable technologies may no longer be wristbands or glasses, and instead be fabrics, patches or even tattoo papers. And, it’s expected that wearable products will soon be widely adopted by the health care services. For the three million people living in the UK with chronic obstructive pulmonary disease (COPD) this can’t come soon enough. Implantable and wearable devices – set out in anew reportby the National Institute for Health Research (NIHR) in collaboration with the Hamlyn Centre, Imperial College London – could hand greater control to patients and their carers, and empower them to better manage what can be such a debilitating condition. COPD describes a group of lung conditions that make it difficult to empty air out of the lungs because the airways have been narrowed. The main symptoms are breathlessness, frequent chest infections, a stubborn chesty cough and persistent wheezing. In the UK alone 1.2 million people live with diagnosed COPD yet millions of people still remain undiagnosed – the ‘missing millions’ range between 1.8–2 million in the UK alone. The potential for technology to improve the quality of a patient’s life is huge but more tech doesn’t necessarily mean better care.

Impla tec

off

There are still key challenges around safety, long-term reliability and device cost before these technologies can be more widely translated into clinical use. COPD can’t be cured or reversed. But for many people the right treatment can help keep it under control, so it doesn’t severely stop them from going about their daily lives. This is where wearable technology can help. COPD patients experience episodic flare-ups, a common worsening of the condition. These are caused by triggers such as bacteria, viruses and pollutants which inflame the airways. A simple portable device could allow patients to identify when their condition is worsening and receive treatment at home. The benefits are obvious in that patients are supported to self manage their condition with the device alerting patients to changes much more than the usual day to day variation in symptoms.

Wearable technologies have been widely used in medical and healthcare applications for many decades. The Holter monitor, first introduced in 1970s, is still being used as a main medical device to assess condition of cardiac patients. But these early wearable healthcare devices tended to be bulky. It’s only the recent advances in the semiconductor and wireless technologies that have allowed for the miniaturisation of devices. And this is key.

lant ech

offers new hope for treatment

In the case of smart textiles, where vests or t-shirt have circuits and sensors weaved into the fabric, recent studies have proposed the use of textile sensing to estimate the amount of air inhaled, exhaled and stored within the lungs at any given time for patients with COPD. Any changes in the amount could help spot an imminent flareup, alerting patients or carers that an emergency medication pack, consisting of steroids and antibiotics, may be needed. Further new technologies are being developed as implantables. Endobronchial valves and coils now being used offer better lung mechanics and improve a patient’s symptoms. These are inserted into the lungs via flexible bronchoscope (an instrument that is threaded through the nose or mouth and down the throat to reach the lungs), often without the need for a full anaesthetic. The benefit? They remove the effect of trapped air in ineffective lungs, without the need for highly invasive surgery. Implantable and wearable medical devices for monitoring the condition could see patients treated earlier at home, reducing the decline in their lung function and improving their quality of life, and cutting the cost of hospital stays. COPD is one of the most costly inpatient conditions that the NHS treats, with a direct healthcare cost of COPD estimated at over £800 million a year.

In order to maximise their clinical potential and impact, COPD medical devices need to be comfortable to wear, easy to use and cost effective. They also need to be reliable and provide relevant and accurate information that improves diagnosis and treatment.Then there is the issue of compliance. Medical devices have to conform to rigorous FDA and EU regulations and must have the CEmark wto base clinical decisions on their measurements. Some critical challenges in translating these technologies include safety aspects, long-term reliability and stability of device performance, minimising follow-up calibration and maintenance, as well as cost of device production and of the surgical procedure (in the case of implantable devices). It is clear that implantable and wearable medical devices are the future of medicine. Yet concrete evidence of patient benefit remains a major hurdle. If we are to reap the rewards of emerging technology, more patient research iscrucial: improving the health of COPD patients and saving the NHS money depend on it. Professor Guang-Zhong Yang, CBE, is Director of the Hamlyn Centre, Imperial College London Dr. Anthony De Soyza is NIHR National Specialty Lead for Respiratory DisordersThe report‘Implantable and Wearable Medical Devices for Chronic Obstructive Pulmonary Disease’was produced by the National Institute for Health Research (NIHR) in collaboration with the Hamlyn Centre, Imperial College London.

21.3” Ultra-wide, Superfine TFT Display Designed for Medical Applications Available from RDS is the new NL204153AC21-25, a 21.3” ultra-wide viewing angle display (IPS/SFT). Developed specifically for medical applications it has a high brightness of 800cd/m², high contrast ratio of 1,400:1 and long-life backlight with built in LED driver. Plus, it’s surface is anti-glare. Features include: • High luminance 800cd/m² • Wide colour gamut • High contrast ratio 1,400:1 • Resolution 2048 x 1536 pixels • Active Display area 433.152 (H) x324.864(V) • 16.77M colours • LVDS Interface 4 port • LED Driver is built in • Wide Viewing Angles 176°/176° (IPS/SFT) For more information on this and other displays go to:

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UK TRIO TEAM UP ON

LIFE-SAVING BABY DEVICE Three members of Medilink East Midlands (EM) have joined together in the creation of an innovative baby health product that could save millions of lives.

Outsourcing and CRO s

he project came about as a result of the Medilink EM Instils support programme, which is part-funded by the European Regional Development Fund (ERDF). SurePulse Medical is a joint venture between The University of Nottingham and Tioga, a contract electronic manufacturer based in Derby. Established in September 2014, SurePulse has developed a platform for monitoring heart rates in new-born babies. The SurePulse VS (Vital Sign) product is a heart rate monitor comprising a cap which integrates a sensor and a wireless display. The cap, which has been purpose-designed to be rapidly applied to the baby, hasbeen manufactured by Capatex, a Nottingham company which manufactures and supplies technical textiles to a wide range of industries. Approximately 10% of newborn babies require some form of resuscitation at birth. In the event of a baby requiring resuscitation, the VS provides a continuous hands-free heart rate allowing hospital staff to swiftly and effectively provide medical support, without the need for a stethoscope. SurePulse Medical, Tioga and

Capatex are all East Midlands-based companies and members of Medilink EM, the life science business support organisation. It’s as a result of the networking and signposting opportunities Medilink EM provides that companies such as these can come together and collaborate, leading to the development of new products and technologies. Medilink EM has also provided financial support through the Instils programme, which is partfunded by ERDF. Over £9k was awarded to SurePulse Medical in August 2017 which allowed rigorous safety testing to be carried out on the VS product. Dr Darren Clark, chief executive of Medilink EM said: “It’s great to see our members coming together and creating groundbreaking advances in new-born resuscitation, particularly as this is an area which has seen little improvement in recent years. The success of this product and the innovative collaboration between organisations demonstrates once again that Medilink EM remains at the heart of the region’s Life Sciences sector.”

PUBLIC

INTELLECTUAL The team at specialist legal firm Barker Brettell take readersâ&#x20AC;&#x2122; questions on the intellectual property matters that affect the medtech community. This time, David Pearce, patent attorney and partner does the honours.

Q ?

?A UESTION

I canâ&#x20AC;&#x2122;t see anything similar to my invention on the market. Can I get a patent?

NSWER

? 32

Maybe. If your invention is different to, or an improvement on, something already on the market, this is a good sign that you might have something worth patenting but you need to look a lot wider than that. To get a patent, your invention has to be new and not obvious over everything that has ever been publicly known.

This is not just limited to what things are available on the market now, but also anything that has been made available to the public. This can include patent publications, books, articles in scientific or trade journals or newspapers and even verbal disclosures. A good place to start looking for what is already known is through freely available patent databases, because patent publications

are a great source of information, much of which is not available anywhere else, on what has been previously invented. Try using Google Patents with a few keywords as a starting point and, as you become more familiar with searching and how patents are classified into subject areas, try using the official patent database Espacenet. Once you have found something that is

the closest to your invention, identify what feature yours has that makes it different and how this feature makes your invention better. You should then go and speak to a patent attorney with everything you have found out and they will be able to guide you through the process of getting a patent.

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