MTI Issue 34 by Med-Tech Innovation Magazine

Issue 34 | Nov/Dec 2017

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PLUS Human factors engineering Making packaging smarter

MED-TECH INNOVATION | NEWS MED-TECH

innovation

The disruptive world of the young healthtech pioneer: pages 22-26

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CONTENTS MED-TECH INNOVATION | NEWS

6-7.

Headlines

8-12. Opinions

18-21.

Human factors engineering

22-26.

Startups showcase

29.

Disposables

33.

Packaging

34.

Med-tech Innovation Expo

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

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group editor | lu rahman lu.rahman@rapidnews.com

art | sam hamlyn publisher | duncan wood

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from The editor

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A Kodak moment... pt. II

ast edition saw me issuing a stark warning that the NHS is in danger of embarking on its very own ‘Kodak moment’. For those who didn’t read, or who have forgotten (I won’t be offended), what I meant by this was that photography giant Kodak is famous for having crumbled when it failed to embrace the natural shift of technology. The NHS, it sometimes seems, could very easily fall into the same trap. Though of course, where the NHS is concerned, it’s not a case of resistance to change. It’s just that the stakes are so high, and the money so tight, that it sometimes pays to be risk averse. Nonetheless, the medtech community welcomes the government’s response to Sir Hugh Taylor’s Accelerated Access Report of Innovative Medicines and Medical Technologies (commonly known as the Accelerated Access Review, or AAR). In short, the government is saying that from April 2018, it will back measures to improve routes to market for new medical technology, to the effect that patients could be able to access them up to four years sooner. An ‘Accelerated Access Collaborative’ will also be in place from this year, and this will help formalise the

process of simplifying market access for medtech. What’s more, the government intends to offer £86 million in funding to help innovators access the NHS market and help these products get to patients. All of this is very, very welcome news for medtech innovators. However, optimism is curbed somewhat by the looming prospect of Brexit. In November two major medtech bodies issued foreboding positions on Brexit. Medtech Europe sent out a call for a ‘sensitive’ approach to the process, warning that failure to do so could result in patients on both sides of the channel being unable to access vital, life-saving technology. It could also have a negative impact on competitiveness, warned the group. The association calls for measures that will ensure “the full availability of medical technologies for patients once the Brexit negotiations have come to an end”. Closer to home, Life Sciences Scotland’s chair Dave Tudor penned an open letter to politicians recently, expressing his concerns over the impact of Brexit on the medtech sector. He said: “The sector is of the clear view that UK life sciences

regulation should not diverge from EU regulation and should continue to see continued cooperation with the European Medicines Agency. We would strongly resist creating a new and untried Scottish life sciences regulator when there is a long established global regulatory system.” And, like Medtech Europe, Life Sciences Scotland is concerned about the availability of medtech postBrexit: “Ease of movement of our goods and supplies needs to continue tariff free and there needs to be minimal customs procedures to allow quick and efficient distribution of our products across the EU. As a minimum there needs to be continued mutual recognition for testing and release between the UK/ EU & EU MRA Partners to ensure security of supply to our patients”, reads Tudor’s letter. Despite the challenges thrown up by Brexit, the AAR provides hope that, at least on domestic shores, medtech companies can look forward to better adoption rates in the future. At the time of writing I’m getting ready to head to Compamed and Medica in Düsseldorf. No doubt I will once again be able to see the fast pace of innovation for the medical technologies sector.

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TEN THINGS ...that will change

1. HYBRID CLOSED-LOOP INSULIN DELIVERY Hailed as the ‘world’s first artificial pancreas’, the hybrid closed-loop insulin delivery system helps make Type 1 diabetes more manageable. Approved by the FDA in late 2016, this technology enables direct communication between the continuous glucose monitoring device and insulin pump to stabilise blood glucose. 2. NEUROMODULATION FOR OBSTRUCTIVE SLEEP APNOEA Companies are now marketing an implant that delivers stimulation to open key airway muscles during sleep. Controlled by a remote or wearable patch, the technology acts like a pacemaker, helping to synchronise the intake of air with the action of the tongue using a breathing sensor and a stimulation lead powered by a small battery. 3. GENE THERAPY FOR RETINAL DISEASES In 2018, the FDA is anticipated to approve a new gene therapy for inherited retinal diseases. The ability to deliver a new gene to targeted cells in the body via viral “vectors” is expected to provide visual function improvements in some patients with forms of Leber congenital amaurosis and retinitis pigmentosa. 4. REDUCTION OF LDL CHOLESTEROL New studies reported a 20 percent reduction in the risk of cardiovascular death, myocardial infarction or stroke for patients who took statins combined with a new class of cholesterol-lowering drugs (PCSK9 inhibitors) to reach ultra-low LDL levels. The clinic claims that armed with this information and strategy, doctors may begin to turn the tide on bad cholesterol in 2018. 5. THE EMERGENCE OF ‘DISTANCE HEALTH’ Digital health technologies are also expanding beyond the simple twoway video platform. More patients are now equipped with attachable devices that record and report medical information to doctors to monitor their condition. With momentum building, the clinic believes that the emergence and acceleration of distance health technologies and services are assured in 2018.

According to Cleveland Clinic, these medical developments have the power to transform healthcare next year

NHS ON-TRACK FOR CANCER TECHNOLOGY TARGETS

6. NEXT GENERATION VACCINE PLATFORMS In 2018, Cleveland Clinic says that innovators will be upgrading the entire vaccine infrastructure to support the rapid development of new vaccines, as well as breaking ground on novel mechanisms to deliver new and existing vaccines to vast populations. For example, innovators are perfecting the use of freeze drying vaccines which can allow shipment to more remote locations. Companies are finding faster ways to develop flu vaccines using tobacco plants, insects and nanoparticles. 7. TARGETED BREAST CANCER THERAPIES A variety of new targeted treatments, such as PARP inhibitors for patients with specific mutations in BRCA1 or BRCA2, and novel CD K 4/6 inhibitors for ER-Positive/HER-2-negative breast cancer are having positive outcomes in clinical trials. In addition novel HER2 targeted agents continue to show benefit in this subgroup of HER-2positive patients. 8. ENHANCED RECOVERY AFTER SURGERY Several centers have been developing the concept of “fasttrack” or “enhanced” recovery after surgery. Recent research indicates that an ERAS (“Enhanced Recovery After Surgery”) protocol that permits patients to eat before surgery, limits opioids by prescribing alternate medications, and encourages regular walking reduces complication rates and speeds recovery. These protocols can reduce blood clots, nausea, infection, muscle atrophy, hospital stay and more. 9. CENTRALISED MONITORING Centralised monitoring, in which off-site personnel use advanced equipment, including sensors and high-definition cameras to monitor blood pressure, heart rate, respiration, pulse oximetry and more, is set to make waves in 2018, according to the clinic. Complex data are assimilated to trigger on-site intervention when appropriate while filtering out unimportant alarms. 10. SCALP COOLING TECHNOLOGY The practice of “scalp cooling” – which works by reducing the temperature of the scalp a few degrees immediately before, during and after chemotherapy – has been shown to be highly effective for preserving hair in women receiving chemotherapy for early-stage breast cancer. The scalp cooling system was approved by the FDA in May 2017.

headlines

healthcare delivery in 2018

The NHS is on-track to transform cancer services in England by 2020/21 according to a report published by NHS England’s National Cancer Programme. The report details the investment the NHS is making in cancer transformation, including £130m over the period 2016/18 in new and upgraded radiotherapy equipment and £200m over the next two years to accelerate rapid diagnosis and enhance patients’ quality of life. The report describes progress across the field including: modernisation of radiotherapy equipment throughout the country; new models of care introduced to ensure cancer is diagnosed earlier and improve survival; establishment of Cancer Alliances across the country to bring together clinical leaders, healthcare workers, patients and charities for better coordination of care. “Achieving World-Class Cancer Outcomes – Progress Report 2016-17” describes the significant advances the National Cancer Programme has made over the past year as it moves towards the full delivery of the NHS five-year national cancer strategy. The strategy was developed in 2015 by an independent cancer taskforce that was asked to deliver the vision set out in the NHS Five Year Forward View.

INAUGURAL UK ‘HEALTH HACK’ A SUCCESS Health Hack is a series of three free events organised by the Medtech Accelerator in partnership with the Eastern AHSN and Health Enterprise East. The first event was supported by the University of East Anglia and IP21. Each event is designed to engage a wide community of stakeholders, focused on delivering innovation within the NHS, through the identification and development of new products and services that have the potential to meet clinical needs and generate commercial benefit. Held at the Earlham Institute in Norwich on Oct 19-20th, the first event focused on rehabilitation from injury and illness and was attended by more than 60 delegates from NHS organisations, academia and the healthcare and technology industries. Participants included clinical stakeholders, subject-matter experts and other NHS staff, software/hardware developers, academics/researchers, regulatory experts/consultants and business/marketing/ strategy consultants. After an open call for innovations, seven individual ideas were shortlisted. Each team or innovator then shaped their idea with selected subject matter experts to refine it ahead of presenting to a panel of judges who then chose the winning pitch.

HEALTHTECH CHALLENGE WINNERS ANNOUNCED Eight researchers have been awarded grants to address long-term health challenges through the development of innovative healthcare technologies. The recipients will share more than £8 million of funding to develop new solutions ranging from next-generation prosthetic hands and endoscopy devices to cancer treatment devices controlled by the body’s electrical signals and optimising surgical interventions in the hip. The funding has been allocated by the Engineering and Physical Sciences Research Council (EPSRC) as part of the second Healthcare Technologies Challenge Awards call. EPSRC Chief Executive, Professor Philip Nelson, said: “EPSRC’s Healthcare Technologies Challenge Awards are designed to equip the next generation of research leaders with the tools they need to tackle current and emerging health challenges facing society. “These awards will help them to develop novel therapies that enhance efficiency and reduce risks to patients; create prostheses and other devices to restore normal function; produce minimally-invasive physical interventions to repair damage or remove disease; and optimise treatment for the individual, improving health outcomes.” Winning innovations include: nanoplasmonic metapixels for multidimensional endoscopy; polymer bioelectronics for high resolution implantable devices; sensorimotor learning for control of prosthetic limbs; and wireless communication with cells towards bioelectronic treatments of the future.

ACCELERATED ACCESS NEWS WELCOMED BY INDUSTRY GROUPS The Association of British Healthcare Industries (ABHI) said the Government’s response to the Accelerated Access Review (AAR) was welcome news. From April 2018, selected technologies will begin a process which could make them available up to four years earlier. The move will significantly speed up the time taken for patients to access lifesaving medtech. ABHI works with key NHS figures and national organisations to bring changes to the adoption landscape. The association led the medtech industry input into the review and the response contains several positive measures for the sector, many of which were the consequence of continued ABHI contributions during the development of the review and its recommendations. Commenting on the review, ABHI CEO Peter Ellingworth said: “ABHI welcomes the Government’s response to the Accelerated Access Review and is pleased to see key MedTech recommendations reflected. Delivering a consistent set of national, regional and local routes to market will support the diverse nature of the MedTech sector and help ensure that NHS patients have improved access to new technologies. Providing greater central alignment through the Accelerated Access Collaborative is an important step to speed innovations through the varied support programs.”

feel the benefit

OPINION

The MDSAP (Medical Device Single Audit Program) program was initiated ten years ago by the IMDRF (International Medical Device Regulators Forum); it is a global approach which is devised to audit and monitor the manufacturing of medical devices, with the objective of improving their safety and effectiveness. The aim of MDSAP is to offer an “all-inone” audit and to provide evidence of compliance with the ISO 13485 standard and the medical device regulations in Canada, Brazil, Japan, Australia and USA. Canada is the only country to enforce MDSAP as mandatory, starting from January 1, 2019. MDSAP typically takes three years from start to

Peter Rose, managing director, Europe at Maetrics offers advice on getting the best out of the MDSAP (Medical Device Single Audit Program).

completion and it includes three different audits, these are: the initial audit, the surveillance audit and the recertification audit. Occasionally, in some unique cases, special audits are conducted by the regulatory authorities and unannounced audits may be conducted. As the regulatory landscape continues to evolve it couldn’t be more important for medical device manufacturers to be up to date with the changes and to keep completely informed, particularly when it comes to making more cost-effective choices. In order to assist with this, we have listed the main benefits and opportunities for manufacturers which can be derived from MDSAP.

KEEPING IT SIMPLE MDSAP covers the existing ISO 13485 standard and country specific requirements which means that it is not based on any additional ISO standards or regulatory requirements. This means the normative framework remains unchanged and medical device manufacturers can benefit from the process of standardisation and harmonisation within the QMS, and also in the regulatory submissions.

countries will automatically comply with the requirements of the other four participating countries. Preparing for and responding to audits and inspections within various markets is a time consuming challenge which is significantly reduced by MDSAP. It might seem to some that the initial implementation phase is restrictive but ultimately the benefits that MDSAP will bring will far outweigh the initial constraints.

CO-ORDINATED AUDIT REQUIREMENTS MDSAP is built on multiple regulations from five different countries meaning that any manufacturer who complies with the audit requirements of just one of these

AVAILABLE SUPPORT The FDA website provides guidance to stakeholders by making policies, procedures, templates and forms publicly available. On the websites of the FDA and other regulatory

authorities it is also possible to find links to descriptions of procedures, templates and forms. It is advisable for manufacturers to follow this available guidance in order to ensure compliance with MDSAP is as seamless as possible. LARGER MARKET ACCESS MDSAP allows for the increased acceptance of audit reports through more sharing and extra involvement of various regulators. This means that certain manufacturers may choose to expand their participation to other markets included in the MDSAP program, and in fact, this could be seen as a manufacturer’s commitment to product quality and regulatory compliance. If done

correctly, then it can be used as a promotional tool to create a marketing differentiation. SAVES TIME AND MONEY As MDSAP stipulates that one audit can suffice in the place of five it means the overall number of audits or inspections is reduced for medical device manufacturers and they can optimise the number of resources as well as the amount of time which will ultimately be spent on audit activities. The MDSAP should also have a positive impact on the number of Auditing Organisations (AOs); currently the number of AOs is not as large as expected, but it is possible that MDSAP will eventually provide a broader choice of third

party AOs as other organisations (other than Notified Bodies) will be recognised. ENGAGING WITH EXPERTS There are many MDSAP subject matter experts who can add timely and valuable support to manufacturers going through the MDSAP audit preparation. Many consultancy organisations will engage and collaborate with the best MDSAP experts who are appropriately trained to bring about the maximum amount of compliance and regulatory success to manufacturers.

for the ultimate benefit of the medical device industry. Some stakeholders may be hesitant to embrace this new approach; however, it is quite clear that the benefits of compliance outweigh the initial constraints and risks, and will benefit the medical device industry as a whole.

“Preparing for and responding to audits and inspections is a time consuming challenge”

There are a lot of stakeholders involved in the MDSAP process; however the MDSAP programs aims to consolidate the efforts of the stakeholders in a collaborative effort

step up your game

OPINION

Registration is now open for Trustech’s latest STEP INto Healthcare programme. This intensive and successful programme helps SMEs with innovative products increase their chances of success in the healthcare market, bringing much needed innovation into the health and care system. Technology is impacting us in new ways every single day, changing everything we do - from the way that we access food and travel, to the way that we engage with the world around us. This is equally apparent in healthcare, where innovation and technology is helping us beyond convenience; it is helping save lives. Designed for businesses with aspirations to scale-up, the STEP INto Healthcare programme provides SMEs with access to networks, strategic knowledge and market opportunities, through one-to-one support and a number of workshops with leading industry experts. The programme gives companies with innovative solutions access to NHS leaders and decision makers to help them to refine their

Dr Richard Deed, technology director at NHS innovation firm Trustech

pitches, marketing and product offer. Commenting on the programme and the opportunities for innovators in Greater Manchester, Rowena Burns, executive chair of Health Innovation Manchester said: “There is brilliant innovation out there, but in the past, getting this innovation into the health and care system has been far too slow. This is not just a UK problem, it’s a global issue. One driven by the complexities of a highly regulated, fragmented market, and the challenges for industry in focusing on creating compelling and proven propositions aligned to priority and need. “Greater Manchester, however is unique. Devolution enables joined up decision-making across the entire health and social care spectrum, and Health Innovation Manchester is already capitalising on this to radially simplify the landscape for industry innovators. “Programmes such as Step INto Healthcare, which also address issues on the supply side of the continuum, equipping

explains how it is working with Health Innovation Manchester to deliver a new intensive support programme for SMEs.

SMEs with the skills and knowledge to successfully navigate the market in Manchester and beyond are essential. This is essential to improving outcomes for citizens, the future of health and social care services, and realising the full economic benefit of the regions thriving life sciences sector. “Health Innovation Manchester is delighted to be supporting this programme.” Ian MacArthur, head of sectors for business growth hub, said: “The combination of Manchester’s devolved responsibility for health and social care, world class research assets and intuitively disruptive culture presents a unique opportunity for life science SMEs. The city’s ambition to become an internationally recognised leader in accelerating innovation, at pace and scale to transform our citizens’ health and wellbeing, means there is no better place or time to be an SME with an innovative product or service. “We are delighted to be working with Trustech

and Health Innovation Manchester on the STEP INto Healthcare programme, and encourage SMEs to find out more about this expert insight into gaining access to the NHS and health marketplace.” INSIGHT INTO THE NHS The comprehensive multiday programme covers a range of topics. First and foremost an overview of the NHS landscape is provided. Here the key players from public to private organisations are explained, along with the challenges and opportunities presented by demographic and financial pressures.This is an effective introduction for SMEs which sets the scene for the rest of the programme. There is a support infrastructure available to SMEs targeting the NHS, unfortunately few are aware of the extent of help available, so it’s often a real eye-opener. The next step is to analyse the market opportunities for the individual products or companies.

Most people behind small businesses are confident they have a good grasp on this aspect of their business, however as well as defining the strengths, weaknesses, opportunities and threats, the programme encourages attendees to think about market readiness and willingness to invest and adopt its product. Time is also spent ensuring the delegates have a full understanding of what it takes to create a compelling value and business case, which if completed well, can both provide the best chance of success. UK healthcare law and regulation is also explained - a lack of understanding in this area can break an SME. What’s particularly unique about this programme is that it focuses a great deal on pitching. The elements of a successful pitch are explored, and there is help on hand to construct a concise and engaging story. In addition to a ‘pitching to the NHS coaching session’, which involves one-to-one personalised coaching and feedback, there is also the final pitch. This is what really creates a buzz, as it’s where SMEs can pitch

to real NHS procurers and decision makers; something which many are doing for the first time as a result of this programme. Not only can they receive feedback immediately, this part of programme is an opportunity to create real partnerships. It’s the ideal time to fine tune that pitch! HOW IT HELPS As attendees are able to gain feedback from NHS decision makers specific to their business case, it allows them to refine their proposition to better target relevant NHS needs using NHS language. This may seem like a somewhat trivial skill to acquire, but as we all know, saying the right thing at the right time can have a big impact. And so it was for Corporation Pop, one of the initial cohort of companies that participated in the STEP INto Healthcare programme. Manchesterbased Corporation Pop are design and technology experts who have limited knowledge and experience developing products for the NHS. However, when they started developing an app to help NHS patients they quickly found themselves at the foot of a steep learning curve.

Dom Raban, managing director said, “At Corporation Pop we’ve spent the last couple of years developing an app that helps child patients navigate the healthcare system. I realised early on that if our app was to be a success then we needed to be able to clearly articulate the benefits to the NHS. Ironically, as we formulated our business case, it became clear that navigating the healthcare system was going to be more difficult than we first thought. “After 12 weeks taking part in the first cohort of STEP INto Healthcare I’m now a lot clearer about our value proposition, the complexities of NHS procurement, the minefield of CE certification and the drivers for NHS purchasing decisions. Whilst I know it’s not going to be easy, this course has equipped me with the confidence and tools to take our product to market. I thoroughly recommend it to anyone who sees the NHS as a potential customer.” What’s apparent is that the programme provides inside knowledge to the NHS which is often difficult for SMEs to obtain under normal circumstances.

Equally, procurement professionals find it useful to understand the new products that are being brought to market; it is the best way for the NHS to engage with the commercial medtech sector. ACHIEVEMENTS SO FAR The first cohort of 12 companies have progressed through the STEP INto Healthcare programme over the last few months. During this time, they have been exposed to a number of industry opinion leaders and specialists from inside and out of the NHS. These specialists have provided support and expertise around developing a business case, developing the value proposition, understanding the regulatory landscape that companies have to navigate, working with NICE, and also helping to understand the decisionmaking process within the NHS. Programmes like these are invaluable, so if you’re an SME looking to break into the NHS, one of the future rounds of the STEP INto Healthcare programme may be just the ticket.

TECH-TALK: DR TOM CLUTTON-BROCK

OPINION

MTI: What are the major barriers to getting medical devices taken up into the NHS, and how can these be overcome? TCB: There are numerous barriers to getting medical devices taken up into the NHS. The NHS, through commissioning, funds services and not technology, making it very difficult for NHS Trusts to recover any additional costs associated with using new devices. For medicines, large amounts of clinical research evidence are required before regulatory approval; the same is not true for devices and so industry faces a huge task to collect evidence of sufficient quality and quantity to satisfy Health Technology Appraisal Bodies. Academics, clinicians and research support staff are much more used to undertaking medicines research than device research. Applying the rules around medicines to devices slows down both the regulatory and evidence gathering processes. The whole funding of device SMEs is a problem, with over 29,000 medical device SMEs in Europe alone; with an average employment of two people it is hardly surprising that one company is estimated to fold financially every 11 minutes.

Dr Tom Clutton-Brock is the clinical director of the new Medical Devices Testing and Evaluation Centre (MD-TEC), based in the

MTI: Why is the new Medical Devices Testing and Evaluation Centre (MD-TEC), supported by the European Regional Development Fund, so important to the Life Sciences Economy? TCB: There is a mass of evidence to support the view that the majority of device related adverse incidents are user related. The latest publications both from the Medicines and Healthcare products Regulatory Agency (MHRA) and the FDA highlight the importance of including usability testing in a device’s technical file. Many devices undergo significant re-design loops after introduction into clinical practice, which is very costly to the life sciences industry. The MD-TEC provides a dedicated test facility for med tech companies to test the usability of their technology in a realistic environment, using real clinical staff but without placing patients at risk. MTI: How will the facility change how medical device companies approach product development and design? TCB: The key factor here is engaging with clinical staff at a much earlier stage in product design

Institute of Translational Medicine (ITM) in Birmingham. He was also recently named as one of the “100 most influential drivers of the health technology revolution, globally”. MTI finds out more about his work and MD-TEC.

and development than at present. Feedback from realistic testing sessions will be available well before the regulatory step allowing for much reduced development costs. MTI: As a clinician, what developmental errors are most avoidable? How would you approach medical device design? TCB: User interface errors are very common and can lead to serious errors. We don’t need a new driving lesson each time we buy a new car, why should we need an extensive training programme each time we use a new device? MTI: Human factors and usability engineering is becoming a bigger part of requirements for effective design of medical devices, how do you see this changing over the coming years? TCB: I think it will be increasingly difficult to get a new device through the regulations without demonstrating that an effective usabilitytesting programme has been undertaken and has influenced device design. I believe that not to do so

will require an extensive explanation. MTI: If you could offer a piece of advice to any company developing within the med tech arena what would it be? TCB: Come and talk to us as early as possible – or email: MDTEC@uhn.nhs.uk. A modest investment up front could save you a fortune in later re-design loops. For some SMEs we even have funded support available (eligibility criteria applies). MTI: How is the industry changing to facilitate the use of more medical devices in healthcare? How are UK SMEs being supported nationally to facilitate this growing sector? TCB: Industry is getting better at seeking help and advice at an earlier stage. The UK government, the NHS, the MHRA as the regulator and NICE all have programmes to facilitate the uptake of new device technology. Bodies such as the NIHR Healthcare Technology Cooperatives (Med Tech Cooperatives from January 2018) and the MDTEC have all been created to help UK and other SMEs, make use of them.

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case study

edical device company ITL Group recently teamed up with fellow engineers at Physik Instrumente (PI) to integrate an xyz stage into a fluorescence microscopy platform offering complete automation of an innovative molecular diagnostics test.

TL Group specialises in the design, development and manufacture of life-saving medical technology, diagnostic devices and analytical instruments. Martin Foxley, project manager at ITL, describes how the company approaches new projects: “Customers wanting to design a product typically come to us with a concept, and our R&D department’s multidisciplinary team – including mechanical, electronics, firmware, software and systems design engineers – fleshes out a requirement specification. This then leads on to a conviction kit, engineering breadboard or prototype, and will sometimes result in a pilot instrument, before going on to manufacturing.” In one recent example, a client approached ITL for the production of a highly specialised fluorescence microscope system offering complete automation of an innovative genetic screening technique. Martin explained: “The client’s technology is based on a proprietary method that ‘combs’ DNA to spread it across the surface of a coverslip for interrogation with fluorescent probes. At only 170 microns thick, coverslips are very difficult to work with; they are extremely delicate and, unsupported, are too flexible for microscopy.” “When the client approached us, there had already been some early proof-of-concept and singlesample prototyping work performed by another company, and initially they wanted a technical audit that would lead on to the development and eventual production of the automated system. Unfortunately, this process required a fair degree of redesigning around the principles of the original idea, as well as the development of a disposable device to clamp and support the coverslips. This was essential for automation of a multi-sample device, as individual coverslips are far too delicate to be reliably handled by an autoloader.”

pla er

team

ayers

case study

Another important aspect of the design was the xyz stage used to position the coverslips for image acquisition. Foxley continued: “Analysis of each sample involves scanning a 20 by 20 mm area at 0.4 mm intervals to generate a composite image. This takes around one hour per sample, and the resulting images are extremely high resolution – the sample produces over 5 GB of data. This requires a stage that offers very high resolution – down to the nanometre scale – to ensure accurate alignment of the individual image acquisitions.” “The prototype instrument design used a z-axis drive from PI, paired with a bespoke xy drive. When developing IVD instruments, it is essential that you can prove the reliability and performance of all components to ensure regulatory approval, and so we wanted to move away from the use of these bespoke drives towards off-the-shelf components. This not only simplifies approvals – as the component manufacturer can supply the relevant performance data – it also accelerates timelines considerably compared to developing, manufacturing and validating all the components in house. The timescale of this project was a real challenge, and so using pre-existing mechanisms would help to save time and costs. We were impressed with the design of the PI z-axis module, and so we contacted the company about supplying a complete xyz stage.” The ITL and PI teams worked closely on what was required. “A key challenge was sample loading,” Martin explained. “The microscope

stage needed to offer nanometre resolution for scanning, but also needed to be able to travel a long way from the optics to allow the autoloader to access the disposable devices containing the sample coverslips. Using off-the-shelf products from its catalogue, PI was able to put together a complete xyz stage that combined this fine positioning control with a large range of travel.” “For this particular application, it is crucial that the axes are fitted orthogonally, to allow correct alignment of the composite images. The x and y drives are mounted within two arcseconds of one another, with the z mechanism bolted on one side, and the whole unit was supplied to us as a complete module. PI also supplies an integrated PCI card with the stage, rather than a separate control unit, ensuring exceptional control of positional accuracy and resolution, while simplifying integration with the rest of the system. This provides seamless interaction between the 160-position sample loader and the stage, allowing secure and reliable transfer of the proprietary disposables and coverslips between the stage and the magazine.” There were a few issues along the way but the two companies say they formed an excellent relationship and, with direct contact and assistance from PI engineers in Germany and the UK, everything was resolved. The overall result was an xyz positioning mechanism, as part of the final product, a flexible, 160-sample autoloading, research instrument now in manufacture.

catheters, stents and tubing

THE NEXT GENERATION

“ D

Healthcare giant Abbott has announced receipt of a CE Mark for Xience Sierra, the next iteration of the company’s Xience everolimus-eluting coronary stent system.

octors tell us they need better tools to treat increasingly challenging cases, which involve multiple, or totally blocked arteries and complications such as diabetes,” said Chuck Brynelsen, senior vice president of Abbott’s vascular business. “We designed Xience Sierra with the goal of helping more people with coronary artery disease regain their health and return to their daily lives as quickly as possible.” Xience Sierra was designed to make it easier for cardiologists to access and unblock difficult-toreach lesions. New features include a thinner profile, increased flexibility, longer lengths, and small-diameters. “Xience Sierra can help cardiologists be even more

precise when implanting the stent, which is important for efficacy and safety,” said Charles Simonton, chief medical officer of Abbott’s vascular business. “Its design, range of sizes, and increased flexibility mean doctors don’t have to use as much force when they implant a Xience Sierra stent compared to other stents.” More than eight million people worldwide have received a Xience stent since its initial regulatory approval. Abbott says it “is the most commonly used stent in Europe” and has been studied in over 100 clinical trials and in ten years of global real-world experience. Abbott has also submitted an application to the US FDA for Xience Sierra approval in the United States.

seal the deal Freudenberg Medical has launched a new hemostasis valve range which has been designed for medical device companies looking to accelerate time to market.

he new hemostasis valve family adds the HyperSeal and CertuSeal valves to the existing FlexSeal valve launched last year. Hemostasis valves are used to minimise blood loss and can facilitate minimally invasive, catheterbased medical procedures. Also being introduced is the new HyperSeal Introducer Sheath with Hydrophilic Coating which joins the FlexSeal Introducer Sheath as a white label device solution for large bore procedures. Introduced at the Transcatheter Cardiovascular Therapeutics Conference (TCT) in Colorado, these hemostasis valves can be incorporated into therapeutic catheter development projects in order to provide new design options, shorten development time, and lower costs, according to Freudenberg. “Freudenberg Medical’s hemostasis valves provide a wide range of innovative features designed to greatly improve hemostasis and procedural performance when integrated into next generation catheters and delivery systems,” said Bernie Kaeferlein, director of portfolio management at Freudenberg Medical. “As a partner for innovation, we are committed to proactively addressing unmet clinical needs and offering our medical device customers a growing portfolio of finished device, design, and process solutions to help improve efficiency and accelerate their time to market.”

MEDILINK UK Medilink UK is the UK’s largest network of life science and health technology organisations, with a total of 1,600 members and a database of 48,000 contacts. We encourage innovation in the sector and nurture collaboration between academics, clinicians and industry. With eight offices based across the UK, members of Medilink UK have access to opportunities and events on both a national and a regional level. Our experts can provide specialist support in: ●

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new product development and market research selecting and reaching your target market, whether it’s in the UK or abroad

●

Clinical research and NHS procurement

●

Sourcing funding and finance

To find out more about joining the largest UK network for Life Sciences, visit www.medilinkuk.com

human factors engineering

WWW.MEDICALDEVICEUSABILITY.COM Cambridgebased Medical Device Usability recently embarked on

Injecting a little colour

he science of human factors has only relatively recently been applied with any rigour to medical devices. Of course, everyone wants to develop a product that meets the needs of its users. In the old days an odd focus group here or there, and getting your favourite medics to try it would just about do it. And the marketing campaign would boldly state that their new product is ‘easy to use’, without actually providing any evidence to back up the claim. But, like any science, the knowledge base expands, practitioners apply a more rigorous approach, and of course the regulators take a keener interest. So it is with human factors. In large part driven by the FDA, manufacturers are struggling to get up-to-speed with the requirements. What doesn’t help is that there is, sadly, very little published usability data

a research project to analyse the design fundamentals of autoinjectors. In this article, managing director Richard Featherstone explains the background to the project.

on medical devices. Manufacturers have understandable concerns about commercial confidentiality, given that most usability work is carried out during the pre-market product development phase. In contrast to their clinical studies, most pharma companies do not publish their human factors data. Whilst this protects their intellectual property, it has the effect of creating a void. Anyone who wants to develop a new device, for example an autoinjector, has almost to start from scratch, answering such fundamental questions as how large should the device be? Should it feature a button? What is the best colour to use in the dose indicator window? Should it click once or twice (the answer is twice by the way). We at MDU are uniquely placed to gather usability data from across a wide range of

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YOUNG ONES 3. CAN YOU AFFORD TO PROTECT IT? CAN YOU AFFORD NOT TO? An important part of protecting your innovation is cost. Can you afford to spend the money needed to get patent protection? Getting an application prepared and filed, and dealing with the application for the first year after filing, can cost several thousand pounds, and costs will typically rise further after this. Make sure you have the budget to do this, and have a clear plan of what you intend to do with your application, bearing in mind that it might not be granted as a patent for two or more years. Are you going to be able to start making money in that time? Once you have filed a patent application you will be faced with strict deadlines that have to be met, with fees that have to be paid, otherwise your application will fail.

4. DONâ&#x20AC;&#x2122;T OVER-REACH A common mistake is to assume that protection in as many countries as possible is the thing to do. This is not necessarily a sensible move, as it can result in spending huge amounts of money for little added benefit. If you are a big pharmaceutical company with a blockbuster drug, patenting everywhere there is a market for the drug might make sense. If, however, you are a small startup with a new type of medical device, be practical about what countries you go for and budget accordingly. Remember that the costs of patenting increase with every country you add to your list, and to justify the costs of a patent in any country there has to be a plan for making money from the invention in that country.

Think also about what the consequences would be of not applying for a patent. How easy would it be for someone else to copy your invention? Would it be possible to reproduce the invention by seeing what you have put on the market? Are there any hurdles that others would have to overcome to get a competing product on the market? In the medtech area, regulatory hurdles can be substantial, so the first to get an approved product can often have a useful lead over the competition. A patent, however, can give you protection for up to 20 years.

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investment firm Z-Cube tells MTI what it’s like finding investment and mentoring in the lifescience start-up scene

Off to A good start

n aging population and the prevalence of chronic and communicable diseases is expected to fuel growth in the life sciences sector. It is estimated that in the UK, life sciences contributed £30.4 billion to the UK economy in 2015 and reports show that the global life science sector is set to grow to the value of $447.5 billion by 2020. The future success of the sector is reliant on the successful development of new treatments and technology and today’s researchers will drive a positive contribution in the future, when their developments reach the marketplace. Investment and commitment in earlystage life science start-ups is therefore crucial. However, securing funding is complex. In the UK alone roughly 60

new life science start-ups are formed each year with University spin-offs accounting for 34% of these. This finding highlights that start-ups in life sciences are very often composed and set up by visionary academics who, unfortunately, would probably not hesitate to describe themselves as inexperienced with the practicalities of setting up a business such as composing a robust business plan, sourcing a reliable supply chain, managing partners, tax and staffing issues. Yet all these key business activities need to be fleshed out and accounted for if early stage companies wish to impress investors and secure funding. A recent report by MindMetre Research confirms that a lack of key skills is a turn-off for investors as it found that Private Equity houses believe that some key business skills such as IT management and marketing are generally sub-par in the businesses they acquire. The European life science start-up panorama is in fact blighted by a critical inconsistency: businesses typically tend to get funding when they have reached relative maturity, and yet they are unable to reach maturity without significant funding. To solve this, many businesses are going public too early by commentators’ standards at the risk of undervaluing their business. This environment, which sees earlystage often academic start-ups struggling to get funding, translates into a Catch-22 situation, where the only people knowledgeable enough

to innovate are denied access to funding because they lack business experience and only firms that have already received funding are able to access more. Such an environment is damaging to the whole life science sector as it stifles innovation, discourages entrepreneurial initiative and ultimately suppresses important developments that could improve patient health. Life science early-stage start-ups should, therefore, consider wisely what type of support is offered by different types of investors, being careful not to underestimate the importance of access to mentors and advisors that can show them the ropes when it comes to the practicalities of setting up a business. So, while the initial draw to a particular accelerator programme might be the availability of funding, not all programmes are set up to provide structured growth opportunities and counsel. With data showing that 90% of all startups fail within the first year, securing the exposure to key figures in your industry and investors that understand your business is critically important. Getting in front of the right people at the right time can be the make-orbreak for a business. Taking part in an accelerator that helps enable that key exposure and provides opportunity to connect with advisors and peers that understand your business can place your business on the fast-track for growth.

pharmapack europe

Pharmapack Europe 2018 is taking place on 7–8 February at Paris Expo Porte de Versailles, Paris.

P.A. R.I S T

The organisers are calling for new applications for its Start-up Hub platform as well as the Pharmapack Awards.

is always a good idea

he 2018 Start-up Hub will identify young companies who are deemed to be amongst the most innovative in the industry. Companies in the Start-up Hub will benefit from increased access to potential customers, partners and investors at Pharmapack 2018 from which to forge new and lasting relationships. Start-ups in the inaugural 2017 initiative spanned the breadth of the industry; from functional inks that incorporate electronic applications into packaging, to needle-free medicine delivery, to an app that scans packages to provide product information. For 2018, start-ups developing patientcentric packaging or drug delivery solutions in line with connected health and anticounterfeiting measures are encouraged to apply. The Pharmapack Awards will also return in 2018. The awards consist of two categories: the

Exhibitor Innovation category and, for non-exhibitors, the Health Product category. Exhibitor Innovation winners in 2017 provided new approaches to some of the biggest challenges, including reducing vial overfill and intuitive packaging that increases adherence. The Health Product category distinguishes innovative packaging of new health products or improved packaging of an existing health product (for human or veterinary use) that has created a tangible benefit for users and administrators. The 2017 award winners used innovative packaging design to improve patient compliance and reduce environmental footprint, respectively. The organisers are also encouraging entries from companies that are making packaging and drug delivery devices more sustainable,

smarter, more effective, and more valuable to users. “Pharmapack Europe occupies a unique place in the industry’s conference calendar. As Europe’s dedicated pharmaceutical packaging and drug delivery event, Pharmapack offers a series of unique platforms that bring companies together to network and collaborate in driving business and the quality of products forward,” said Anne Schumacher, brand director, Pharmapack Europe. “Pharmapack Europe is dedicated to innovation, and the Pharmapack Awards had an exceptionally high standard of entries last year while the Startup Hub has quickly established itself as an attendee favourite. We recommend submitting applications early for the 2018 Pharmapack Awards and Startup Hub as the slots are limited and the Innovation Gallery was fully booked in 2017.”

27 27

DISPOSABLES

A US electronics firm was picked by Qualcomm to design and manufacture

sensors for a pioneering new singleuse biometric wearable for gathering health data

ONLY WORN ONCE

ualcomm Life, the technology group’s healthcare division, developed breakthrough reference designs for the connected and medical-grade biometric patches that will enable a multitude of intelligent care models, from perioperative care to assessing the impact of therapeutic interventions. Designed to allow healthcare professionals to monitor patients across the care continuum with access to near real-time data, the patches measure a variety of biometric parameters, including clinical thermometry and sophisticated motion measurements. Benchmark Electronics, a provider of integrated electronics manufacturing, design and engineering services, will license the reference designs and serve as the device design and manufacturer of record with the FDA for those sensors.

As a part of the collaboration, Qualcomm and Benchmark entered into a Healthcare Product License Agreement, which allows Benchmark to license reference designs for Qualcomm Life’s biometric patches. Clinical validation is currently underway, and the patches are slated to be commercially available through Benchmark in 2018.

“This wearable patch technology will be transformative in its ability to provide timely and accurate data to enable care providers to make better-informed decisions,” said James Mault, chief medical officer, Qualcomm Life. “Utilising Qualcomm’s 30 years of leadership in inventing new connected “things,” this lowpower, cost-effective, single-use design will fuel new, scalable care models as we transition as an industry from episodic, reactive care to more continuous, proactive, intelligent care.”

The patches were developed on Qualcomm Life’s 2net Design platform, a reference design platform for electronics modules which power connected medical devices, including disposable drug delivery devices and disposable diagnostic devices. 2net Design is intended for creating reference designs for wireless, power-efficient, small-integrated modules to create smarter, more affordable and intuitive medical devices.

“We are thrilled to work with Qualcomm Life, a global leader in inventing revolutionary connected technologies, to create a new packaged sensor offering for health care companies that is economical, secure and user friendly,” said Paul Tufano, CEO, Benchmark Electronics. “This collaboration aligns with our mission to deliver high-value solutions and innovative technology for our customers.”

CLEANING

IT’S A GAS

s medical components become smaller and more intricate it can be challenging to find an effective cleaning method that works consistently. Contamination varies widely and can range from general handling soils to inorganic contamination from manufacturing and insoluble particulates from a machining process. All of these can have serious implications on the end-product including the risk of bioburden. The processes used in the development and manufacture of medical components has no room for error. Since nearly all devices require some measure of cleaning during manufacturing, the challenge is to specify a cleaning process that is (a) suitable for a variety of materials including delicate plastic injection-moulded parts, stainlesssteel microtubing, or complex mechanical assemblies, (b) reliable and consistent, and (c) affordable and safe. It’s a complex decision.

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DISPLAYS

One of the most effective critical cleaning methods is vapour degreasing. This process makes it easy to clean small components with complex geometries. The process also successfully satisfies the performance requirements needed within the medical device industry and the regulatory regimes in different countries. Recent advances in solvent technology have generated environmentally progressive, low-temperature cleaning options that greatly minimise the bioburden and economic issues. A SIMPLE PROCESS Vapour degreasing is a relatively simple machine and a very simple thermodynamic process. Typically, the systems consist of two chambers filled with a nonflammable solvent. The “boil sump” heats the solvent to a low-temperature boil (typically around 40˚C) which generates a vapour cloud (“steam”) that rises upwards in the machine. As the vapours rise, they contact cooling coils which are arrayed around the inner walls of the machine. The cooling coils condense the vapours back to their liquid state. This distilled solvent then is directed back to the “rinse sump” where the parts are rinsed as the final step in the cleaning process. When filled with solvent, the rinse sump overflows back into the boil sump to complete the recycling loop. This closed-loop system has few moving parts and ensures that the solvent is reliably clean for ongoing cleaning needs. Cleaning is fast and easy with a vapour degreaser. A basket containing the contaminated components is lowered through the vapours and into the boil sump for their first cleaning. After a few minutes, the parts then are moved into the rinse sump. The rinse sump always contains pure, clean solvent that has been distilled from the solvent vapours so rinsing is highly effective. Ultrasonics in the rinse sump can further ensure residue-free parts. This process is easily programmable and allows for excellent process control and repeatability. Components come out clean, dry, at room temperature and immediately ready for packaging or further processing. The benefits of using a vapour degreaser are clear. It delivers very high levels of cleanliness to ensure patient safety and product performance. It also is a safe, environmentally-friendly and affordable process. The systems are small, use little electricity and never use any water. A well-engineered solvent cleaning system is easy to validate and will simplify device sterilisation by removing sources of bioburden from the finished products.

Mike Jones, from cleaning specialist MicroCare, makes the case

for vapour degreasing as the most efficient way to clean medical components and eliminate bioburden risk.

REMOVE THE BIOBURDEN RISK Bioburden can be a huge issue within the cleaning process, especially if the cleaning method uses aqueous technologies. Using aqueous-based cleaning systems not only instigates a bioburden risk, but it also generates a waste water stream that requires expensive treatment. Higher temperatures also are required for effective cleaning, which means more energy is used which can have a significant effect only on the environment and also on the pocketbook. There are many conditions that can cause bioburden, but water is a primary growth medium for bacteria. Even trace amounts of moisture in hard-to-reach locations can encourage the growth of bacteria, compromising the ability to properly sterilise the device. Therefore, it is important to remove water from the cleaning process to minimise this threat. If it is not properly addressed it can result in increased complications during the validation of the product. A solvent-based cleaning process is a nonpyrogenic environment. This feature alone significantly reduces the risk of bioburden. Solvents dry very quickly and completely leaving no residues on parts after they exit the vapour degreaser. Solvents also do not require additional mechanical action (high pressure sprays or air knives) or increased temperatures to be effective. The process offers an easy way for engineers to validate bioburden issues out of the manufacturing process. Lastly, solvent cleaning has very high throughput because the cleaning is fast and the finished devices are ready for processing immediately after cleaning. The low viscosity and surface tension ratings of solvents, combined with their volatility, allow them to clean very effectively, even in small gaps and areas that water in aqueous systems cannot easily penetrate. Medical device manufacturers can be sure that all surfaces of the finished product will be effectively cleaned and safe for the patient. As medical devices are evolving into more compact and complex components, cleaning becomes more and more difficult. Perfecting and validating a cleaning method that works effectively on the intricate parts of medical components is vital to ensure patient safety. Vapour degreasing offers a simple, proven and reliable answer to cleaning processes within the medical manufacturing industry.

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packaging

The Centre for Process Innovation (CPI), the UK’s technology innovation provider

for process manufacturing, has begun the first phase of its ‘Medicines Smart Packaging’ project.

DRESS UP SMART

his phase of the North East Local Enterprise Partnership (LEP) funded project, known as SmartMed, will begin the process of crystallising the needs for innovation in the smart packaging of medicines and medical devices leading to the creation of an innovation capability. The healthcare sector is in the midst of change, driven by multiple factors including longer life expectancies, a rise in chronic disease and a shift in the pharmaceutical industry towards advanced and personalised therapies. There is also an increasing number of people taking multiple medicines, putting pressure on the NHS to be able to track exactly where drugs and delivery devices are going and when patients are using them. With secretary of state for health Jeremy Hunt’s target for digital-led NHS treatment by 2018, there is increasing expectation on the sector to use technology, such as smart packaging, to address these issues. Using smart packaging can also benefit distribution companies, who can track and monitor devices throughout the supply chain, as well as pharmaceutical companies who could use sensors to monitor environmental conditions during storage and delivery including temperature, humidity and damage, to ensure that medicines are effective when they reach the patient. Smart packaging for medicines and devices could feature printed sensors that can also be used to help with patient compliance. This is a major issue for healthcare, because patients that do not take their medicines as prescribed not only risk their health, but also contribute to significant economic losses for healthcare providers such as the NHS in the UK.

“From manufacture to clinical supply to patients, digital technologies and new types of material have the potential to revolutionise the way in medicines are packaged and therapies of all kinds are delivered. Innovation in this area can help to improve both the effectiveness and experience of treatments for patients,” says Richard Baker, Head of Policy and Strategy at the North East LEP. “The North East has established strengths in technologies like printable electronics, product formulation and digital application which, if brought together, could make a step change in medicines delivery and also develop approaches of value to other industries such as food and consumer products. We’re delighted to be working with CPI and other partners on this project which will aim to ensure that the North East takes a leading role in this area.” The Medicines Manufacturing Industry Partnership (MMIP), a partnership between the UK government and industry, has endorsed the creation of a national centre of excellence in packaging for medicines. This will support the development of the next generation of packaging technology and the associated smart devices required for new and novel medicines, including specialist packaging needed throughout the manufacturing supply chain. The proposed world-class centre of excellence would allow medicine manufacturing and medical technology companies to build their niche capabilities and differentiate themselves in the global marketplace, securing activity and creating jobs. CPI will be hosting a series of workshops to speak to the industry, distribution companies, NHS, and patient groups to assess their need for these innovations and the proposed capability creation.

33 33

MTI EXPO

THE DOORS ARE OPEN...

ree-to-attend, this exciting event will bring together the medical engineering and manufacturing community; more than 200 companies from all areas of the medical device supply chain engaging with 2,500+ visitors across two action-packed days. The only event serving the whole of the £27bn UK and Irish medical technology sector, MedTech Innovation Expo presents a unique platform for medical device design and manufacturing professionals to meet with peers, gain valuable market information and do business face-to-face. At this year’s event, visitors will see the entire spectrum of advanced technology, materials and solutions displayed alongside two conference stages and a whole host of engaging show features designed to educate and entertain. As in previous years, the centrepiece MedTech Innovation Conference will address key industry issues in a purpose-built auditorium at the heart of the show floor. With presentations from Samsung Healthcare, the Academy for Healthcare Science, NHS Digital and more, the packed conference programme will continue to set the agenda for debate in the medical technology sector.

“As a team, we exist on the cutting-edge of innovation in medical technology.” said Holly Delaney, Visitor Marketing Manager at Med-Tech Innovation Expo; “Striving to advance healthcare,

Here at MTI, we have to blow our own trumpet once in a while…

which is why we’re excited to announce that registration for Med-Tech Innovation Expo is now open!

we have once again partnered with Medilink UK to produce a world-class conference programme that will deliver insight and intelligence from a wide range of blue-chip users, government officials and industry experts.” Returning after a successful introduction at last year’s event, the HealthTech Stage (previously known as the Introducing Stage) will see exhibitors and start-ups showcasing the very innovations that will shape the future of medical technology. The open-sided auditorium will once again allow visitors to drop in and out of presentations in line with their needs and interests. With 200+ exhibitors and just two days to meet them all, the HealthTech Stage will be the easiest and most convenient way to get up to date on all the latest industry developments. In addition to the conference and seminar programme, visitors to Med-Tech Innovation Expo will experience exciting show floor features including the Medilink UK Pavilion where experts from Medilink member businesses will present solutions to industry challenges, Inspex (a focus on providers of inspection, measurement and testing hardware, software and services) and much more. Med-Tech Innovation Expo 2018 will be held at the Ricoh Arena, Coventry, UK, from 25th to 26th April 2018. Attendance is completely free, find out more at www.med-techexpo.com

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