MTI Issue 50 by Med-Tech Innovation Magazine

www.med-technews.com Issue 50 | Oct/Nov/Dec 2020

MED-TECH INNOVATION | NEWS MED-TECH

innovation

PLUS Digitisation and medtech â&#x20AC;&#x201C; a threat or opportunity? Med-Tech Innovation Awards 2020 winners

THE HOLY GRAIL: Achieving true volumetric dispensing

ADVANCING HEALTHCARE

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CONTENTS regulars

features

COMMENT

human factors

Ian Bolland examines the challenges for government and industry towards the end of 2020, and the beginning of 2021

making medtech

A round-up of the latest industry news

13.

OPINION

Wilmington Healthcare asks: will improved topic selection make a difference for medtech?

16.

cover story

Intertronics on how to achieve the holy grail in adhesives – volumetric dispensing

32.

digital health

Marks & Clerk asks if the increased digital technology patent filings should be seen as an opportunity or a threat

41.

Real World Medtech

Ian Bolland talks to Manus Neurodynamic about its neuromotor assessment offering

THE TEAM editor | ian bolland ian.bolland@rapidnews.com advertising manager | christine joinson +44 (0)1244 680 222 christine.joinson@rapidnews.com

19.

MED-TECH

Design Partners highlights the projects it has worked on during the COVID-19 pandemic, including VentShare

INNOVATION | NEWS

21.

cleanrooms

Boddingtons explains how you can reap the rewards of good cleanroom investment

25.

contract manufacturing

Tegra on considering a manufacturer’s end-to-end solution

26.

med-tech innovation awards

We announce the 2020 Med-Tech Innovation Award winners

28.

regulation

Dassault Systèmes examine the potential ramifications of the Medicines and Medical Devices Bill

38.

packaging

What impending changes could mean for the industry

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from The editor The choppy waters that lie ahead

[

he end of 2020 and the start of 2021 was always going to bring up some challenges for life sciences. At the start of the year we probably thought it was just going to be all about Brexit following the general election in the UK as the Conservatives won on the promise of an ‘oven ready’ deal. A period of adaptation was expected for the UK regarding its trading relationship with the European Union, and for Ireland as it’s the only country it shares a land border with. Given both the UK and Ireland are major players in the world of medtech, there were bound to be knock-on effects. At the time of writing, we’re not really any wiser as to what the future relationship will look like, or its potential effects on our industry and its supply chains. The MHRA takes on the role as regulator of medical products in the UK that are currently undertaken in the EU system from 1st January. The ABHI recently made a series of proposals of how it should operate. One of its recommendations suggests the UK should become a member of the International Medical Device Regulators Forum (IMDRF), and that any sovereign UK regulation should not contain “unnecessary, costly or burdensome additional requirements.”

Then from earlier on in 2020 we’ve had the COVID-19 pandemic that some foolishly thought would be over in a matter of weeks. We have seen the industry step up to mass produce PPE, ventilators, tests and the pharmaceutical sector continues its search and trial of a vaccine candidate. The pandemic has not only been a public health crisis, but in a less important manner it has been a logistical headache. The enforcement of EU MDR has been delayed until 2021 – meaning there are changes afoot for firms that operate both in the UK and the EU. The extra year of preparation might have been welcome for some, but the two-pronged approach of dealing with an extraordinary global event combined with regulatory changes is bound to have its hurdles. Then there is the inevitable question of trust that is going to come down the line. In a world where conspiracy theories seem to account for a large part of our modern public sphere, life science companies – and government – are responsible for building trust in order to help us get back to normal in 2021. An example of mistrust can be with the recent release of the contact tracing app in the UK – details of its development you can read on our website

– when it comes to people’s perception of freedom. If a breakthrough is made with a vaccine in the near future, then there is going to be a need to counter myths and conspiracies that have been given airtime. Research undertaken by DrugsDisclosed.com illustrates this challenge. It found that 54% of patients in the UK will only take a vaccine after one year of testing and that 74% of patients would not give their children the vaccine unless it has had at least a year of testing. Previous research by the company suggests a “trust deficit” between patients and pharmaceutical companies, contributing to scepticism around a potential vaccine, suggesting 93% of UK patients do not trust advice from pharmaceutical companies about their medication, while 81% do not feel listened to by them. The issue of trust is an important one that needs to be addressed otherwise industry as a whole may be feeling the effects for some time to come. Those at the top of industry – and at the top of government – have got a duty to get the coming months right, or the consequences could be severe.

Making medtech

SURGICAL ROBOT FIRST TO BE USED AT MANCHESTER ROYAL WOZZIE / SHUTTERSTOCK>COM

Scottish product design business becomes employeeowned

roduct design company Shore has announced its transition to employee ownership, with over 30 members of staff given a stake in the business.

MR Surgical’s nextgeneration surgical robotic system, Versius, has become the first ever surgical robot to be used to perform keyhole surgery at Manchester Royal Infirmary (MRI), part of Manchester University NHS Foundation Trust. The robot will initially be used to perform colorectal cancer surgery. Mr Nicholas A. Stylianides, consultant colorectal and general surgeon at Manchester Royal Infirmary, said: “The introduction of Versius at Manchester Royal Infirmary is an exciting step forward and one that will help our team continue to deliver worldleading surgical training and care. Today, more than ever, it is vital that we are able to minimise complications from surgery and help patients recover quickly – keeping them well and out of hospital. Using robotic minimal access surgery more frequently will play an important role in this and Versius will therefore be

Today, more than ever, it is vital that we are able to minimise complications from surgery and help patients recover quickly 6

a critical tool for our surgical teams moving forward.” Versius is portable, modular, and designed to be easily moved between operating theatres. Once in an operating theatre, it takes an average of 15 minutes to set up the system. Mark Slack, chief medical officer at CMR Surgical said: “A main goal when we designed Versius was that we wanted to significantly widen access to minimal access surgery – allowing far more patients to benefit than currently do. The introduction of Versius at Manchester Royal Infirmary is a key part of that journey and we are therefore delighted by the news. The fact that this leading teaching hospital has never had a surgical robot highlights the need for a new approach to surgical robotics and reinforces the value of the defining features of Versius – its portability, versatility and its cost-effectiveness. These are attributes that we believe will open the door to more minimal access surgery across the world improving outcomes for patients, surgeons and hospitals.” In February 2020, Versius was launched in the UK at NHS Lothian’s Western General Hospital in Edinburgh and Milton Keynes University Hospital NHS Trust, with further launches expected to be announced.

The company, based in Leith, Edinburgh, designs, engineers and develops classleading drug delivery products, diagnostic devices and medical training products. Its global customer base features over 80% of its customers in the USA, EU, Switzerland and Japan. Shore was founded in 2003 by current owner and managing director Nick Foley, who wanted to plan for his eventual exit by considering succession options early, therefore allowing for a smooth transition. He wanted a solution that would ensure the business remained independent and retained the company’s strong values and culture. Foley said: “In due course I

Videogames to help rehabilitate stroke patients

game controller helping stroke patients get back hand and arm movement by playing on the computer is set to start tests in a stroke unit. The NeuroBall is shown to help people regain strength and movement in their arms and hands after a stroke by making daily rehab exercises more fun. 1.5 million Brits have a stroke and 70% of them get weakness in their hands and arms, leaving many unable to even make a cup of tea or get dressed. Developers at Brunel University London and UK firm Neurofenix have won £60,000 from The Stroke Association and MedCity to take development to the next level. Dr Richard Francis, head of research awards at the Stroke Association, said: “Neurofenix and Brunel University London

Making medtech

Cognitant Group

Schoolgirl helps develop vaccine education ﬁlm

will want to exit the business, however having founded and developed it into a market leading company over the past 17 years, I didn’t want to sell to a third party and see the team’s hard work absorbed into another organisation with different values or a long-term strategy that might not match ours. “We have developed a strong team ethic and a culture based on collaboration, support and respect. We’re not a group of individuals sharing an office – we are a team. Our people are handpicked for the skills, creativity,

experience and spirit they bring to our company, so it was important to me to give the company, the jobs and the brand the best chance of continued independent existence following my exit. The business should work for the employees, rather than the other way around, so employee ownership was the perfect fit for us.” An Employee Ownership Trust has been formed and will hold a majority of the shares on behalf of the employees. Foley will remain a significant shareholder in the business. The move to employee

ownership comes despite current economic turmoil as a result of the COVID-19 pandemic, with Foley viewing the transition as an effective way to bolster staff morale and maintain engagement and productivity. He added: “The staff are very excited about the transition, so it’s been a very positive experience and they’ve been really engaged in the process. Moving into employee ownership gives the opportunity for continued job security for all staff and enables them to have collective control of their future.”

will explore how this new hand-held console and app could improve the recovery of hand and arm movement at vital, earlier stages of recovery. “They will also look at whether the new technology can be cost-effective for the NHS.” Stroke survivors can play nine themed video games holding the Neuroball console, which uses AI to track arm and hand movements and send feedback to an

app. Developed by the team at Brunel along with Neurofenix and stroke survivors, it’s designed to motivate users to do hundreds of physio reps from home without even realising it. “Our vision is to enable stroke survivors and patients suffering neurological conditions to regain their independence. Brunel University London helped us validate how our technology can aid stroke survivors,” said Neurofenix’s Dimitris Athanasiou. Hospital stroke rehab patients move their arm and hand an average 32 times in a session. But survivors who played videogames with the Neuroball practiced on average 17 hours a week, notching up 15,000 reps over seven weeks, an earlier study showed. Starting in January, the new study will track stroke patients who are in an earlier stage of recovery, first at Hillingdon stroke unit and then their first weeks at home.

16-year-old schoolgirl, in conjunction with healthtech company Cognitant Group, has created an animated video to educate the public about vaccinations. The schoolgirl chose Cognitant for her work experience as she wants to study medicine when she leaves school. With support from Cognitant’s medical writing and clinical advisory team, she wrote, designed and produced the animation as part of this work experience. From essential childhood immunisations like the MMR to the flu vaccination, there are concerns that vaccination uptake will drop in the aftermath of COVID-19, with people being afraid to visit clinics to get routine vaccinations. Dr Mary Ramsay, head of immunisations at Public Health England, has said: “The national immunisation programme remains in place to protect the nation’s health and no-one should be in any doubt of the devastating impact of diseases such as measles, meningitis and pneumonia. During this time, it is important to maintain the best possible vaccine uptake to prevent a resurgence of these infections. “The Department of Health is hoping to extend the flu vaccination programme to all those above 50 (instead of just those above 65-years-old) if vaccine supply allows. It is imperative that we increase flu vaccine uptake. By ensuring that people do not get flu, we are reducing the risk of hospitalisation and death from COVID-19.” For a number of years flu vaccine uptake in the UK has not met targets set by the World Health Organisation which aims for more than 75% of eligible groups to be immunised. Last year (2019/20) flu vaccine uptake was at 70.6%.

MEDILINK

Over 190 individuals from across the healthcare and life sciences sector came together online to celebrate success at the Medilink UK National Awards.

he awards, presented by comedian and freestyle rapper Chris Turner, recognised achievements and outstanding contributions to the life sciences industry. Winning companies from the regional Medilink awards, which were held throughout 2019 and early 2020, were automatically shortlisted for the national titles. The award winners and runners-up for the Medilink UK Awards were as follows: START UP AWARD - For newly established companies (trading for up to three years) in the medical and healthcare sector, that show a promising future, sponsored by HORIBA. Winner: Neuronostics (Exeter) provides diagnostic decision-support tools for neurologists. Its first commercially available clinical indication is a seizure susceptibility technology called BioEP, which enables diagnosis of epilepsy. Highly Commended: Cansense (Swansea) is developing a non-invasive diagnostic for the early detection of cancer using spectroscopy and AI technology on a blood sample. LightOx (Newcastle) is developing light activated drugs for the treatment of oral cancers, with the aim to provide clinicians and patients alternative options to surgery in pre-cancerous and early stage cancer. EXPORT ACHIEVEMENT AWARD - For outstanding performance in international trade, sponsored by Morningside Pharmaceuticals. Winner: Cellpath (Powys, Wales) is a family business specialising in the

AND THE

GOES TO…

manufacture of worldwide supply of products, consumables and services to the cellular pathology cancer diagnostic market. Highly Commended: TissueMed (Leeds) is a company specialising in the development, manufacture and worldwide sales of a surgical sealant technology. Bailey Instruments (Manchester) specialises in the manufacture of medical devices (diagnostics for diabetes and neuropathy) and surgical instruments for podiatry, general surgery, and ENT. Bailey Instruments sells to 35 countries internationally. COLLABORATION WITH THE NHS AWARD - For the development of a collaboration with the NHS that has or will have a major impact or benefit to both business performance and patient care, sponsored by The AHSN Network: Winner: Spirit Health Group (Leicester) has been a partner of the NHS since 2009. Their growing range of products and services empower people to take control of their health, make best use of NHS resources, and use new technology to improve patient outcomes and add value for clinicians. Highly Commended: Cievert (Newcastle) has been providing the NHS

with software to better manage cancer patients from diagnosis to recovery for years. They have cut the waiting times of over 100,000 NHS oncology patients, improved adherence to protocol, and saved clinicians time that is better spent treating patients. Docobo (Leatherhead, Surrey) has digital health solutions which support care to patients with multiple longterm conditions, including cancer, mental health, musculoskeletal and social isolation. INNOVATION AWARD - For the development of an innovative technology, design or process that has produced a major improvement in business performance or end-user benefit, sponsored by Kallik. Winner: Magstim (Whitland, Wales) is a medical device manufacturer and supplier of Transcranial Magnetic Stimulation (TMS) equipment, coils and complete packages used for both Magstim TMS therapy and neuromodulation research. Highly Commended: SurePulse Medical (Nottingham) is a vitalsigns monitoring company. SurePulse VS is a wireless heart rate (HR) monitor for newborn babies that addresses real clinical needs, supporting patient safety in

an entirely new way. PEDAAT (South Tyneside and Sunderland NHS Foundation Trust, Sunderland) The Paediatric Emergency Department Asthma Assessment Tool (PEDAAT) developed by the South Tyneside and Sunderland NHS Foundation Trust’s Paediatric Emergency Department (PED), identifies asthma patients with inadequate routine care or treatment adherence and provides an intervention. OUTSTANDING ACHIEVEMENT AWARD - For an achievement that has had a significant or vital impact on the company, sponsored by Mills and Reeve LLP Winner: Sygnature Discovery (Nottingham) an independent integrated drug discovery and pre-clinical services company. Since 2011, Sygnature have delivered 30 compounds into pre-clinical development, 15 of which have subsequently entered the clinic (Phases I, II and III) in several types of cancer, spinal injury, severe asthma, COPD, dry eye syndrome, Cushing’s syndrome, antiviral, anti-fungal (invasive aspergillosis) and hereditary angioedema. Highly Commended: Kapitex (Wetherby, Yorkshire) is a specialist in airway intelligence and manufactures and distributes medical devices for tracheostomy, laryngectomy and dysphagia management. YourGene Health (Manchester) is an international molecular diagnostics group which develops and commercialises genetic products and services; enabling scientific advances to positively impact human health.

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MEDILINK

How the Midlands has responded to COVID-19 Darren Clark, director of Medilink Midlands, writes about how its service has adapted during the pandemic.

s I sit at home writing this, expecting a Teams call in the next half hour, having reviewed the company risk register to allow staff back to the office at working distances no less than two metres apart and ensuring we’ll have enough hand sanitiser and disinfectant wipes, I’m struck by how ludicrous such an arrangement would have sounded less than a year ago, but now is as normal a consideration as which shirt to wear. The reason for such a change is of course, COVID-19. This is a crisis which has been incredibly disruptive for us all and has forced us to adapt to different ways of working. Whilst I would never say that it’s been plain sailing, the Midlands has ably met the challenges faced over the past six months and adapted accordingly. Fluidity and dynamism are characteristics of Midlands businesses as a whole, and during the COVID-19 crisis, these attributes have shone. During the COVID-19 crisis, connecting businesses has been more important than ever. As a focal point of life science industry in the Midlands, Medilink Midlands has played a pivotal role from the onset; supporting the business community by connecting them with suppliers, distributors, key NHS contacts and other like-minded businesses who were pursuing similar COVIDrelated goals. This led us to set up ‘The Big Ask’ alongside the East and West Midlands’ academic health science networks (AHSNs). The Big Ask started as a central repository of all current needs and wants of life science businesses in the Midlands and to date, we’ve had 111 offers of products and services, from 105 different companies. This has included the manufacture of gowns, gloves, masks and face

shields, COVID-19 testing, remote consultation, mental health services and medical textiles. Alongside this repository, it has grown into a sourcing service, helping our companies find the materials and components needed to meet the unprecedented demand as their traditional supply chains failed. We plan to continue operating The Big Ask for the foreseeable future and will continue to bring companies, clinicians and academics together as part of our mission to help the Midlands life science community to grow and prosper. As well as continuing our support of business, there have also been some exciting developments within Medilink itself, with the ongoing creation of a Medilink Midlands group structure. Prior to COVID-19, Medilink East and West Midlands had been working together under the Medilink Midlands brand when delivering region wide initiatives such as CoDex4SMEs – an Interreg NW Europe project helping develop companion diagnostics and personalised medicine, our work with the Department for International Trade showcasing the Midlands Life Sciences capabilities, and our MOU with the City of Mentor, USA. This evergrowing relationship saw Medilink Midlands and the City of Mentor come together again for the third year running (albeit virtually) in early October, to help Midlands life

science businesses to trade in the American market. The reason why we decided to look to formalise the Medilink Midlands group structure now, of all times, was that we felt that in times of uncertainty and unknown, what businesses need more than anything is reliability and steadfastness. We saw the opportunity to give this to the Midlands life science community by providing a united, Midlandswide front, in the form of Medilink Midlands. This operating model will ensure there is a truly region wide life science network operating under a single governance structure, whilst the delivery of our sub-regional contracts continue. For us here at Medilink Midlands, lockdown and COVID-19 has been an invaluable time to revise and reflect on our current internal processes and capabilities, take stock and adjust our approach to allow us to continue to serve the Midlands life science community, unburdened of current circumstances. I can’t predict all that the time ahead will hold for us all, but we all approach it a little wiser and more experienced. Throughout the entire COVID-19 situation, I have maintained that the Midlands has the skill, ingenuity, and know-how to push through, and by working together we’ll face down any new challenges that stand in our way.

NICE to see you: will improved topic selection make a difference for medtech? Oli Hudson, content director at Wilmington Healthcare, looks at what the latest changes proposed by NICE could mean for industry.

he National Institute for Health and Care Excellence (NICE) has opened a public consultation on its process of new topic selection. This one is not to be confused with the NICE methods consultation (beginning November 2020) or the process consultation (February 2021). What’s on offer here is a welcome consolidation of the topic selection landscape, which as far as medtech is concerned is fairly complex. Healthtech Connect, launched in 2019, offers one starting point, but topics can also be suggested by NHS

England and Improvement. Furthermore, external topic selection panels and committees, or decisionmaking groups involving predominantly health system partners and NICE staff, have been used inconsistently. There are also different topic selection processes for pharma (eg, PharmaScan) and specialist interventions (eg, via the NIHR) – with differing rates of responsiveness and support compared with the medical devices process. NICE proposes that all these processes be simplified into one topic selection ‘manual’ and a single topic selection ‘panel’.

What’s on offer here is a welcome consolidation of the topic selection landscape, which as far as medtech is concerned is fairly complex

The Topic Selection Oversight Panel (TSOP) is slated to replace the three existing topic selection panels to oversee the application of the identification, selection and routing criteria. It will consist of NICE staff, supported where necessary by DHSC, NHSE/I, and, for the first time, lay members. WHY IS THIS HAPPENING? Juggling these various panels and processes has not been easy for NICE, which takes a lot of flak about its speed and scope. Also, new responsibilities have recently been added to its work. For example, the Accelerated Access Review, the Life Sciences Sector Deal 2 and the NHS Long Term Plan all place greater demands on NICE to issue more guidance on more things, more quickly and with a greater degree of implementation support. Then there is the need to adapt the process to new technologies that don’t necessarily fit into existing processes, such as integrated technologies which could include a combination of digital, diagnostic or treatment components. WHAT ARE THE NEW CRITERIA? NICE says topics will be selected if they have benefits that are likely to be highly disruptive or lead to a stepwise change to an established care pathway in the UK and…a systematic assessment of the cost and system impacts is needed.” Such benefits will need to be supported by evidence of effectiveness, information about the expected resource impact of adopting the

technology, advice from experts (such as patients, carers, clinicians and commissioners) that confirms the benefits are desirable, and are likely to be realised when adopted in the UK health and care system. WHAT IS OF NOTE IN THE NEW SYSTEM? Cost has of course always been a huge consideration in the NICE HTA process, but the emphasis here appears to be changing to a fuller consideration of the system impact of an innovation. This will segue into a discussion about system finance, which is being developed over a near parallel timeline. Importantly the new consultation stresses that all new or significantly modified interventional procedures that will protect patient safety will be selected if they are available to the NHS or independent sector, or about to be used outside of formal research, with the press release saying “these proposals will ensure we can continue to meet [our] ambitions at a time of unprecedented change in the healthcare system.” Perhaps there is some ownership here of some truths that have developed over the course of the pandemic – that disruptive changes are costly in themselves, and come with upstream and downstream costs, but what’s important in the final analysis is benefit to the whole system; the significant disruptive innovations need to be adopted at pace; and that patient safety is at a premium. The consultation on the proposals runs until 19 November.

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17.09.20 16:07

It’s already out there! Anne Blackwood, chief executive of Health Enterprise East, explains how using existing technologies or not yet adopted innovations can transform our healthcare.

s healthcare systems, we can be guilty of ‘re-inventing the wheel’ or designing what we believe to be bespoke solutions, when in fact the technology we need already exists. This is due to a number of possible reasons - perhaps we either are not aware of what is already on the market, we do not have a good way of evaluating existing technologies, or we simply believe we can build a better mousetrap that fits our exact requirements. The latter approach can set us off on a costly and timeconsuming exercise when a fully customisable off-theshelf solution would work much better. The global mHealth apps market, projected to be worth over $110 billion by 2025, continues to grow as adoption for mHealth apps tracking both health and vital signs expands further, partly thanks to social distancing measures brought in to control COVID-19. Whether for tracking patient data, enhancing patient education or providing diagnostic and treatment decision making, support mobile apps are here to stay, with a recent report showing that there are now over 165,000 mobile health apps available to download to mobile or tablet devices. As a doctor or medical professional faced with prescribing a mobile app to help improve patient outcomes however, how do you approach selecting the right platform when many of these digital health tools have not gone through the same kind of rigorous testing and evaluation that other medical devices do?

The NHS has responded to this by creating an NHS Apps Library, where health apps and digital tools are assessed against a set of consistent national standards before being accepted into the Library. This ensures that only safe and secure apps that pass a combined assessment of technical stability, interoperability, usability and accessibility, data protection, clinical safety and some evidence of outcomes are published on the Library. The NHS Apps Library provides the confidence commissioners need to prescribe solutions already on market that will help improve outcomes, support care pathways and provide an efficient and safe method of communication between patients and healthcare professionals. There are currently over 90 apps and digital tools in the library, covering everything from cancer to pregnancy and mental health. So, are there equivalent initiatives for medical devices? To some extent, this is covered by the National Institute for Health and Care Excellence (NICE) medical technologies guidance that reviews new medical devices for adoption in the NHS. However, many small medtech companies struggle to generate the evidence required for a full NICE assessment and ‘lighter touch’ reviews are still in demand. Sometimes, in our search for rapid solutions to new and dangerous threats such as COVID-19 help is already at hand. For example, recent clinical trials found that patients

treated with steroids were found to recover quicker compared with patients who were not. The RECOVERY trial, which showcased the UK’s strengths in scientific and clinical collaboration, investigated dexamethasone, a cheap and widely available steroid, and reported to have cut deaths by a third among hospital patients who need ventilation and by a fifth among patients receiving oxygen only. Whilst not a cure, it provided a treatment option in the fight against the virus at a time when clinicians had no specific treatment choices available. Recently, the success of the government’s Ventilator Challenge, to ensure the UK had sufficient stock of ventilators to deal with

the surge in demand from COVID-19 patients, demonstrated the ability of industry and clinicians to come together and produce rapid prototypes based on designs which utilised parts already widely available in the NHS supply chain. Such invention, created from necessity, requires collaboration not just from engineers and doctors, but also from regulators, so these technologies can be safely accelerated through to market and save lives. To respond to today’s pandemic, and tomorrow’s crises, we would do well to consider what we can already procure, evaluate or repurpose to provide affordable, rapid solutions for transforming our healthcare systems.

on the cover

THE HOLY GRAIL

hen dispensing materials like adhesives, coatings and lubricants, manufacturers aim for a process that is both repeatable and accurate to within the specified tolerances. Choosing the right dispensing system is key to achieving this, especially when the requirements are more exacting. Technology manufacturing businesses are demanding ultimate precision in their processes in order to meet the highest quality expectations. But all engineers dislike variability in their production, and that includes the application of materials. In the early 1970â&#x20AC;&#x2122;s, fluid dispensers based on a time/ pressure principle started taking over from techniques like brushing, dabbing or hand syringes. They delivered quality, efficiency and health & safety benefits, and remain ubiquitous in factories around the world to this day. Since then, advances in dispensing technology have been progressing to deliver a true volumetric process; the delivery of exactly the same specified volume of material every time. This is The Holy Grail.

Peter Swanson, managing director at adhesives specialist Intertronics, discusses how manufacturers can achieve true volumetric dispensing.

TIME/PRESSURE FLUID DISPENSERS These popular machines work by applying a pulse of air to a syringe barrel, which forces liquid out through a needle or nozzle. Control of the process relies on the applied pressure, the time of the air pulse and the diameter of the needle. These work reasonably reliably but without the accuracy that more sophisticated assembly demands. Variations in output come from changes in material viscosity â&#x20AC;&#x201D; caused by changes in ambient temperature or the curing occurring with mixed two-part materials, for example. In addition, as the syringe barrel empties and the material is replaced by air, each air pulse to the syringe delivers progressively less material; air is compressible and liquid is not, and an increasing volume of air needs to be compressed by each pulse before pushing out the liquid.

adhesives

These effects which limit accuracy can be somewhat mitigated by the use of a dispensing valve. For industrial applications like adhesive dispensing, these valves are usually pneumatically controlled. The advantage is being able to turn the material on and off like a tap, with the inherent improved control. There are many types of dispensing valve on the market, including needle valves, spool valves, and diaphragm valves. Valves which produce a spray pattern instead of dots or beads are also available. Valve choice is based on material chemistry and cure mechanism, and size and geometry of output. Pneumatic dispensing valves are popular, robust, and provide increased dispensing control, often at modest cost. But they are still based on time/pressure principles, and the variable results based on factors like viscosity change may not be acceptable for more critical applications. The precise control of a pressurised flow of material will always be susceptible to changes in the material rheology. In consequence, industrial dispensing technologies have been developed based around a positive displacement concept. An amount of material is physically established in the pump or valve, which is then ejected or displaced — generating a reproducible volume. Volumetric dispensing is achieved in a number of ways. POSITIVE DISPLACEMENT Dispensing valves are available designed around an auger screw in a metal tube. Material is fed

under pressure into the tube and is propelled by the motor-driven screw. These are more effective for higher viscosity materials like filled epoxies; low viscosity materials can just fall through the valve, and can be affected by the supply pressure, with the resultant loss of control. In contrast, low viscosity materials may be dispensed using peristaltic pumps. The fluid is contained in a flexible tube fitted inside a circular pump casing. Rollers or wipers are fitted to a rotor and they process along the inside circumference of the casing as the rotor turns, pinching the tubing and pushing the material along. The tubing is subject to wear and needs regular replacement to avoid failure and the output from a peristaltic pump is pulsed, especially at low speeds and volumes. In both scenarios, increasing the motor speed will increase the flow of material. They can both be seen as positive displacement methodologies but are limited by viscosity and deposit size. JETTING VALVES In this positive displacement technology, a small cavity in the valve body is filled with material, which is then ejected from the valve by a tappet. The tappet is driven pneumatically or by piezo, and can be activated at very high rates — so whilst the amounts dispensed are small, and can be in the nanolitre range, the dispensed shots can occur at hundreds of times per second, building up dots or beads. Jetting valves like the Vermes MDS 1560 find uses in very small deposit applications, high speed

Manufacturers can now achieve true positive displacement dispensing and dosing by opting for technology based on the progressive cavity pump principle

manufacture, or where complex part geometry benefits from its non-contact nature — for example, the application of an annular ring of lubricant inside a cylinder. PROGRESSIVE CAVITY PUMP Manufacturers can now achieve true positive displacement dispensing and dosing by opting for technology based on the progressive cavity pump principle. Typically, a progressive cavity pump consists of a single-helix metal rotor and a double-helix hole in an elastomeric stator. The rotor seals against the stator, forming a series of spaces or pockets, which translate along as the rotor rotates, keeping their form and volume. The pumped material is moved inside the pockets. The pockets are shaped such that they taper and overlap; the output is continuous, even and non-pulsing. The flow rate is directly proportional to the rate of rotation (which can be reversed), and the volumetric output of the pump is directly proportional to the number of rotations. Due to the rotor/stator seal, input pressure has no effect on the pump. It is able to pump at very low rates, and low levels of shear are applied to the pumped fluid. Vitally, the output is viscosity independent — the material rheology changes caused by ambient temperature variations, for example, have no effect. One example of this technology is the preeflow eco-PEN, which uses a progressive cavity pump principle to dispense a wide range of material viscosities with absolute control, achieving a volumetric dispensing process with an accuracy of ±1%, >99% of the time. These pumps are capable of precise, stable doses as small as 1 µl and applications include electronics, medical devices, laboratories and more. The preeflow eco-PEN can be integrated into a robotic system for an automated dispensing process. The delivery of exactly the same specified volume of material every time, requires a volumetric approach. Progressive cavity pumps, such as the preeflow ecoPEN, give manufacturers more control over their dispensing process than ever before.

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Med-Tech Innovation News is delighted to announce the

of this year’s 2020 awards.

ollowing on from the nominations announced in the previous issue, our expert panel of judges have been able to pick our winners in a competitive field across our five categories. Here are the 2020 winners.

“The design freedom we were able to get by using 3D printing to manufacture our devices let us do some really interesting things such as having joints inbuilt into the prosthetic, which is something we wouldn’t be able to do with traditional manufacturing.” Highly Commended: FabRX Ltd – its M3dimaker 3D printer prints solid oral medicine enabling personalised doses of medicine to meet specific health and therapeutic requirements in one pill.

3D PRINTING WINNER – ExpHand Prosthetics ExpHand develops 3D printed prosthetics for children aged three to ten, with an adjustable universal socket that can be fitted at home by parents. Kate Walker, who founded the business during her final year at university, was inspired by meeting a little girl called Zoey who was born missing her left arm below the elbow and hadn’t been offered a prosthetic before. The company’s research found that existing prosthetics were expensive, custom fit and children tended to grow out of them quickly. Walker said: “When we first started developing the ExpHand we were looking for a quick and easy way to prototype our design and test out new ideas and 3D printing was a great way to make that happen. We had access to a lab full of machines and so we could make design changes on a Monday and have a part ready for testing on a Tuesday which really helped us move forward with our development at a fast pace.

monitoring of a range of other neuropathologies.” Highly Commended: The London Ambulance Service NHS Trust’s online Point of Care Testing (POCT) service enables en route pathological testing with results available online for the destination hospital.

CONNECTED HEALTH WINNER – Ainostics Ltd Ainostics has developed an AI analysis engine which uses multimodal patient data to perform diagnosis and prognosis for early dementia. Explaining a bit more about the company and the solution it offers, the company told MedTech Innovation News: “Our purpose is to advance medicine and healthcare by turning data into clinically meaningful information. We develop integrated technologies that aim to improve and optimise every stage of the clinical care pathway for such conditions, as well as pharma trials for dementia therapeutics, and we continue to invest in infrastructure and innovation to support our ambitious vision.

DESIGN AWARD WINNER – Charco Neurotech (formerly TheMoment) TheMoment, recently rebranded as Charco Neurotech, sees its CUE1 device win the Design Award. The non-invasive wearable device uses pulsed cueing and focussed vibrotactile stimulation to ease the symptoms of Parkinson’s.

“What we are developing at Ainostics is an array of platform technologies that aside from dementia, can be utilised for the diagnosis, prognosis and

“With our early prototypes, we worked together with our volunteers with Parkinson’s to adjust and tweak the stimulation and positioning of the device to produce the optimum effect. The usability of the device was also a very important part of our journey: keeping in mind the challenges our users faced with their movement, we designed the device closely with them to make it desirable, easy to use, and effective.”

Hojjat Azadbakht, CEO and founder, Ainostics

Lucy Jung, chief executive and founder of the company, explained the factors the company had to consider when developing the device.

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Highly Commended: Oxford VR has developed a virtual reality therapy platform with a computer-generated virtual coach for personalised treatment of mental health conditions – and has been adopted in four NHS Trusts. ENGINEERING WINNER – Biovation Orthopaedic Solutions Ltd

Biovation redesigned an instrument kit used to perform cartilage replacement implant surgery for big toe arthritis to eliminate pre-operative lead times, reduce manufacturing costs and lead times, and to allow more accurate surgery. Matthew Marsden, technical manager, explained that the reusable kit was originally made from stainless steel and converting into plastic components was one of the big challenges but provided surgeons with greater visibility during procedures.

metatarsal drill that had a stop collar for precise depth of cavity. The improved surgical accuracy of delivering the implant helps provide patients with a successful outcome. “With plastics being more malleable, having lower yield strength and being more brittle than metals, the newly proposed plastic components had to be engineered to be as strong and reliable as their metal predecessors. We also had to consider how were going to sterilise the instrument set. The reusable predecessor was steam sterilised, which was not a viable means of sterilising the single use instrument set due to the new plastic components having a lower melting point than metals.” Highly Commended: Marsden’s Patient Transfer Scale is a transfer board with an inbuilt weighing scale to enable immobile and time critical patients to be weighed instantly to allow for administering of drug doses and treatment. MATERIALS INNOVATION – Spyras Spyras has developed a paperbased wearable device for continuous real-time breathing analysis in hospitals. The device is designed to automatically alert clinicians to early signs of patient deterioration.

Explaining the use of paper when it comes to respiratory monitoring, George Winfield, CEO & founder, said: “The paper you are reading this article from in adsorbing water from the environment without you noticing. By exploiting this hygroscopic nature of paper and the changes of moisture difference of exhaled and inhaled breath paired with a conductive electrode pairing on the papers surface to measure the conductivity changes of this cyclic change, gave an affordable, highly accurate and disposable sensor. The use of a paper sensor for respiratory monitoring was something not previously seen before.” Highly Commended: Stratasys – Digital materials have been developed to allow the Stratasys Digital Anatomy Platform to replicate human anatomy which has the same biomechanical properties as native bone and tissue for realistic anatomical models.

“The single use introducer component (used to compress the implant for implantation) is manufactured from transparent polycarbonate to provide surgeons clear visibility throughout the procedure. The new introducer component was also redesigned to feature a nose that fit inside the drilled cavity. This provided anchorage and stability during implantation. The drilled cavity was created by a

regulation

A NEW MODEL FOR UK LIFE SCIENCES? Richard Coxon, director, life sciences, Dassault SystĂ¨mes, examines the potential ramifications of the UKâ&#x20AC;&#x2122;s Medicines and Medical Devices bill.

arly in September 2020, the Medicines and Medical Devices bill entered its second reading in the House of Lords. The bill addresses safety, the pace of innovation and the regulation of medical devices and medicines for the future in post-Brexit UK. These laws will govern the UK life sciences sector and establish a framework for innovation and early adoption of new therapeutics, attracting new investment and global interest in the UK while retaining the focus on safety and striving for excellent, patient centric health outcomes. A NEW HOPE? Once the formality of the new bill has completed, the UK life sciences sector has the opportunity to take advantage of the benefits that technology promises; and leap forward with virtual technology instead of doing everything in the real world. There is rising pressure from patients, the healthcare industry and policy makers for personalised healthcare with the patient at the centre. There is a strong need to lower the cost of medicines, have faster access

and approval of new therapeutics, while at the same time reducing waste production and energy usage and of course ensuring safety first by complying with stringent regulations. The technology landscape in life sciences is generally slower to change than in other sectors, this is in part because of the burden of this stringent regulatory compliance. However, with health technology innovating at pace and a fresh focus on the UK regulatory compliance framework, are we seeing the start of a change to embrace this innovation and technology and welcome a sea change in life sciences? SHIFTING FROM THE REAL TO THE VIRTUAL WORLD Take a look at other regulated industries and the impact of digital transformation over recent decades. For example, the aerospace sector has undergone a huge period of digital transformation, going from time consuming and high cost physical prototyping to full product development in the virtual world. The time and

cost savings are enormous, and safety is maintained, despite the increasing complexity of aircrafts. Not to mention the reduction in waste and energy. Imagine a life sciences sector where most of the development (clinical trials) is performed in the virtual world? Using virtual patients? With a wealth of technology at our fingertips, including advanced simulation, 3D design and virtual twin experience technology, the life sciences sector is in a place to overhaul how we think about therapeutic product development, and welcome in personalised medicine and devices. Technology such as computational modelling and simulation, could enable the use of virtual models to benchmark the performance of a medical device, evaluate how each part interacts and performs and how the overall device is predicted to respond in real world circumstances. Such advances in virtual twin technologies have already reached the patient,

regulation

world by helping people lead healthier lives and ultimately save lives.

we can experience true to life virtual models of the human heart, brain and more to help model medical device performance. Information from these virtual models can help the entire manufacturing chain assess how to design, create and deliver the device so that it can provide the best performance at the lowest possible cost to the right patient. The regulatory bodies, such as the FDA, are already exploring this new virtual “clinical” evidence of the safety and benefits of medical devices. As we increase our focus on implementing this virtual experience technology into life sciences, it will vastly accelerate all product development time, significantly reduce costs, and impact the real

BREAKING DOWN THE SILOS When you take a holistic look at the sector, there are many key stakeholders involved to create a therapeutic product. From policymakers, to researchers, doctors and patients, they all play a vital role in the improvements and the health of patients, but unfortunately they often work in silos. Product Lifecycle Management (PLM) can help to bridge gaps between the silos and help increase collaboration. PLM brings together research, development, testing, therapeutic delivery, commercials and reimbursement, and all other vital elements into a single digital environment. A joined-up flow of processes, communications and data will undoubtedly reduce time to market and the cost of development. A well-implemented PLM solution also allows an organisation to streamline its decision-making, using past knowledge and knowhow, together with a means to manage product innovation and quickly evaluate options to design, manufacture and supply the therapeutic product. This is also key in helping to manage globally distributed and geographically separated teams – something we need more than ever in the current COVID-19 climate.

ENHANCING THE PATIENT EXPERIENCE COVID-19 has also brought to light the power and speed possible through innovation. From the NHS Nightingale hospitals that took mere weeks to build, to having potential vaccines in development for the virus in a matter of months, we have proven we have the capabilities to transform better patient outcomes given sufficient urgency. The recent bill highlighted that “availability and attractiveness are the twin pillars of the government’s strategy on medicines and medical devices, and the key themes of this Bill.” This means the UK wants to make new treatments available as early as possible to UK citizens, and for the UK to be the most attractive place for new treatments to be tested, rolled out and adopted. Getting this right will enable the UK to become a global centre of life sciences investment, thereby enabling the UK to lead the industry by adopting virtual and simulation technology to innovate the human experience, governed by a flexible and fully safe regulatory framework. This innovation and virtualisation of therapeutic development will help deliver personalised medicine and medical devices, and achieve a more patient centric healthcare system; one that is focussed on accelerating better health outcomes and longer lives for every UK citizen.

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A REMOTE HEALTHCARE

REVOLUTION

Malin Johansson, vice president Europe, HealthBeacon, discusses how its care management system assists patients and healthcare professionals managing chronic care treatment.

he COVID-19 pandemic has brought widespread impact to healthcare services worldwide and with it, significantly increased the need for patients and healthcare providers to assess and utilise innovative ways of interacting to optimising care in a new, ever changing health landscape. To meet the pandemic challenges for patients and healthcare systems, HealthBeacon introduced the HealthBeacon Injection Care Management System and, for us, it has become an essential companion for patients during the pandemic, supporting patients remotely managing medication schedules and allowing virtual injection training support. It is an effective alternative for patients requiring remote care during lockdown and ‘at risk’ phases, and as we enter a new era of healthcare. Many patients that manage self-injecting medication for chronic conditions belong to COVID-19 high risk groups. It is essential to limit the contamination risk for these individuals and at the same time, more important than ever to follow treatment schedules to avoid unnecessary disease complications. One of the major challenges for people self-injecting medication is adhering to treatment schedules. Non adherence causes both significant loss to patient health and a rapidly escalating financial burden on state health care systems across the globe. Evidence shows that on average patients comply with their chronic medicine schedules only 50-60% of the time. However 80% - 90% compliance can be achieved when medicines are connected with adherence support solutions – which is where HealthBeacon steps in.

HealthBeacon’s Injection Care Management System removes the challenge for the patient to remember complicated treatment schedules. Now healthcare professionals can follow their patients in ‘real time’ and get immediate alerts if the patient struggles with adherence to the medication schedule or any other complication related to the treatment. HealthBeacon provides a personalised and effective support opportunity for the healthcare system by targeting the ‘high risk’ individuals that are in most need of support. This alone provides greater control and increases health outcomes for patients. HealthBeacon´s vision is connecting people to better health through sustainable, digitally-enabled solutions. Together with healthcare providers and suppliers we help patient’s to better manage their chronic illnesses. We give patients’ insights to help them better understand their treatment and more frequently connect with their healthcare providers By identifying, measuring data and understanding adherence patterns across multiple therapeutic areas and medicines, we enable preventative support models that identifies patients at risk, expands remote monitoring capabilities, increases patient-to-HCP interactions and touchpoints to improve delivery of care.

In direct response to the pandemic we have seen a spike in demand globally for remote support services from healthcare providers, highlighting the importance of remotely connected patient support. The service, has to date, been adopted by pharmaceutical companies, governments, health insurance companies and individual healthcare providers. We support patients across 14 different markets globally and most recently we were appointed as an official NHS supplier to provide remote monitoring technology platforms.

DIGITAL HEALTH

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DIGITISATION AND MEDTECH –

THREAT OR OPPORTUNITY? Matthew Jefferies – senior associate, Marks & Clerk LLP, examines data from the European Patent Office (EPO), and analyses what it means for medtech manufacturers.

ecessity is often the mother of invention and, whilst COVID-19 has been a significant challenge for the medtech sector, it has also put a spotlight on medtech innovation. As global demand for ventilators grew and supply chains failed, medtech manufacturers worked together to 3D print ventilator parts quickly, giving a lifeline to numerous intensive care units. This served to highlight the power of 3D printing and other ‘Industry 4.0’ technologies to the medtech sector. These technologies will be of increasing importance to medtech in coming years and this episode demonstrates how companies embracing these technologies can have an edge over those that do not. Industry 4.0 aims to merge physical production with smart digital technology to improve efficiency. It involves an increased reliance on computing systems to improve automation within manufacturing, supply chain logistics and industrial practices. The increased centrality of these digital technologies to innovation is reflected in recent statistics published by the European Patent Office. Whilst medtech has for a number of years been the largest single category for patent filing at the EPO, in the last 12 months for which full data is available it was overtaken by patent filings in the category of ‘digital communications.’ This was off the back of an

impressive 20% increase in patent filings for innovations in digital communications (relative to a 1% increase for medtech). Computer technology also saw patent applications up more than 10%. This recent surge in patent filings for digital technology reflects the overall movement of most industries to embrace digitisation and, in particular, advances in machine learning. In fact, many of the patents filed for digital communications technology will likely find applications in other technical fields, ranging from medtech to aerospace. Accordingly, the latest figures do not necessarily represent a slowing in medtech innovation, but rather the increasingly important role of, for example, AI programmes in making medtech and other technical fields smarter and more responsive. The risk posed by this increase in digital innovation is that traditional medtech companies may lose out to ‘tech first’ software companies. Many industries that have previously relied heavily on manufacturing innovation alone have seen increased competition from data driven technology companies. For instance, in the automotive sector, the next major technical milestone is arguably selfdriving vehicles. This is likely to be one of the key developments in the next 10-20 years, but many of the companies that appear to be leading this space are software companies, rather

than traditional automotive manufacturers. Traditional medtech companies will need to be aware of the threat of innovation from primarily digital technology companies to avoid being left behind. Another key development over the last decade is the increased availability and decreased cost of additive manufacturing, which can allow the manufacture of a wider array of shapes, reducing assembly and reducing material wastage associated with traditional manufacture. Whilst additive manufacturing offers new opportunities for innovation, it also offers competitors a simple means for producing counterfeit products. With recent reductions in the cost of 3D printers, there is a reduced barrier to entry for manufacture. Where traditional manufacturing may have required specialised tooling and manufacturing expertise, additive manufacturing allows products to be produced effectively “at the push of a button.” Digital models of products can be

easily obtained through 3D scanners, allowing counterfeiters the opportunity to easily backwards-engineer mechanical products. In an increasingly digitised world, digital security and effective IP protection is paramount. The recent EPO statistics show that innovations in the digital sector are outpacing other fields. Traditional medtech research and development strategies that revolve solely around mechanical innovation may be at risk of falling behind digital competitors. Furthermore, IP protection aimed solely at traditional manufacture may be at risk of being easily circumvented through the use of more “digital” methods, such as additive manufacturing. Nevertheless, whilst increased digitisation will pose a challenge to some more traditional manufacturers, the potential rewards for those that can successfully adapt will be great. Using intellectual property strategically, to get ahead of these issues, will be key to success.

DIGITAL HEALTH

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AI: THE FUTURE F PAIN ASSESSMENT Professor Jeff Hughes, chief scientific officer at PainChek, explains how artificial intelligence (AI) and smart automation has the potential to revolutionise pain assessment in patients with dementia who struggle to communicate. THE NEED FOR ACCURATE PAIN ASSESSMENT Dementia currently affects around 850,000 people. Around 70% of residents in the UK’s 18,000 care homes have some form of dementia, 80% of whom suffer pain at any one time, and 50% experience persistent pain. It is a daily challenge for carers and healthcare professionals to assess pain in people living with dementia or other cognitive impairments. Often pain goes undetected or untreated, which often leads to unnecessary prescribing, behavioural and psychological issues and

PainChek uses AI-powered unique facial analysis technology to assist in the identification of pain in dementia and cognitively impaired patients who struggle to communicate.

decreased quality of life for residents. PainChek was developed as an effective solution to this problem. Its unique combination of automated facial-analysis technology and smart automation enables carers and healthcare professionals to identify the presence of pain when pain isn’t obvious, to quantify the severity of pain and monitor the impact of treatment to optimise and evidence overall quality of care. RESEARCH AND DEVELOPMENT PainChek emerged from research carried out at Curtin University in Western Australia. Initially, we looked at automating the ‘Face of Pain Scale,’ but our research led us to identify the merits of a multidimensional pain tool, incorporating AI and smart automation. A unique 42-item observation pain assessment tool was conceptualised, based around the American Geriatric Society’s most commonly seen pain-related behaviours in people with cognitive impairment and the Facial Action Coding System (FACS). Research funding was secured in 2012, and a prototype app delivered in 2013, which first underwent validation testing in communicative people with chronic pain, and then in residents of aged care facilities who had moderate to severe dementia and could not self-report their pain. Performance of the app was compared with the Abbey

Pain Scale, a paper-based validated pain assessment measurement. These initial studies demonstrated the validity and reliability of the tool, and the data was used to support regulatory clearance for PainChek as a Class 1 medical device in Australia and Europe, which was granted in 2017. BEHIND THE TECHNOLOGY PainChek uses facial analysis to detect the presence of facial microexpressions (action units or AUs) indicative of the presence of pain. Utilising the computation power and the built-in cameras of smart devices, the app uses technology which detects the presence of a face, maps the facial features, and applies a series of algorithms to detect pain-related AUs in real-time from images from a short three-second video. This data is then combined with non-facial features observed by the app user and input via a series of digital checklists, which together allows automatic calculation of a total pain score and the assignment of a pain intensity level. The system allows pointof-care assessment of pain using the app on either iOS or Android mobile devices, without the need for internet connection, meaning it can be used across a broad range of clinical settings. Data synchronisation to a cloudbased repository takes place when the device is connected to the internet, providing data security and data sharing across multiple users linked

to the same software licence. OPPORTUNITIES FOR HEALTHCARE Tools that increase accuracy of assessments and reduce the time to eﬀectively evaluate pain are crucial. Technology that overcomes the gap in pain documentation equips care providers with the means to better plan and treat pain according to evidence-based pain management practices, which ultimately, improves the quality of care. The opportunities AI offers to the global healthcare sectors, from hospitals and primary care, to aged care facilities and home care, are vast. AI can be used to automate patient assessment and remove assessor bias. It can evaluate patient risk, such as of a patient developing a particular disease or suffering a particular adverse event, diagnose disease, for example, by interpreting ECG results and X-ray images, select the optimal treatment based on a patient’s clinical history and the results of clinical trials, and monitor disease and detect early warning signs of deterioration. The use of AI in healthcare will be driven by the availability of big data on which to train predictive algorithms, which assist (rather than replace) human decision-making, facilitate curiosity-based thinking, enable collaboration and remove mundane tasks, enhancing patient care as a result.

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How biocompatible 3D printing

IS CHANGING HEALTHCARE Gaurav Manchanda, director of healthcare at Formlabs, explains why the future of medicine relies on a responsive, flexible, and agile healthcare system, and how biocompatible materials help get us there.

ver the past six months, 3D printing proved its value by producing in-demand medical supplies like PPE and COVID-19 test swabs. The responsiveness of the industry alleviated some of the major shortages the healthcare community faced in the fight against COVID-19. The scalability and versatility of the technology will continue to serve the healthcare industry long after the pandemic ends. Part of the long-term staying power of the technology is its ability to print with biocompatible materials - plastics that can interact safely with the human body. Resins that are produced in ISO 13485 certified and FDA-registered facilities, and tested for biocompatibility and sterilisation compatibility can enable hospitals to reduce risk and increase agility in the medical supply chain while improving patient care for years to come. HOW BIOCOMPATIBLE MATERIALS ARE BEING USED TODAY � Implant Moulds: Surgeons and radiologists at University of Michigan printed sterilisable 3D printed moulds to customise the shape of commercially available absorbable orbital implants. Surgical repair of an isolated orbital fracture requires anatomically accurate implant shape and placement. The researchers found that use of the 3D printed moulds reduced operating room time by almost 50%. • Implant Sizing: Mayo Clinic surgeons utilised a 3D printed fixation tray to confirm adequate fit and orientation of reconstructive segments prior to surgery. The tray was printed to exact patient specifications using biocompatible resin. The tray aided in alignment and stabilisation of the fibular segments while also providing patient-specific anatomic references for indexing of bony and soft tissue components. • Cut / Drill Guides: Researchers have found that patient-specific guides printed with biocompatible resin can significantly improve the accuracy of glenoid pin placement compared with the standard guides for total shoulder arthroplasty.

• Emergency Response: The COVID-19 pandemic exposed risks in medical supply chains that were disrupted for much of the spring and may be at greater risk if the pandemic worsens as predicted this winter. 3D printing emerged as a critical tool in the pandemic because the materials needed to create PPE components, test swabs, ventilator components, and other items in short supply could be designed and produced locally. Biocompatible materials enabled these materials to be developed, tested, validated, and used on patients quickly. DIVERSIFYING BIOCOMPATIBLE MATERIALS - WHY IT MATTERS Diversifying the medical resins available to the medical community enables researchers, surgeons, radiologists, and beyond to provide patients with personalised, precision healthcare. Having access to a variety of materials that are capable of being used for patient contact provides medical users with greater versatility when creating devices that move healthcare forward. Formlabs recently introduced new materials specifically for the healthcare community: BioMed Clear and BioMed Amber. Both are biocompatible, sterilisable using several sterilisation modalities, and made in a controlled, ISO 13485 certified facility. BioMed Clear Resin is a strong, hard resin for biocompatible applications requiring long-term skin, mucosal membrane, or breathing gas pathway contact. BioMed Amber Resin is a rigid material for biocompatible applications requiring longterm skin or short-term mucosal membrane contact. Both of these materials can be

used for surgical planning and implant sizing tools, implant guides and drilling templates, and research and development. LOOKING FORWARD The future of medicine in this new era relies on a responsive, flexible, and agile medical supply network that can respond to emerging crises with minimal disruption and also provide enhanced, personalised, efficient care during “normal” times. A health system or hospital equipped with 3D printers that utilise an assortment of biocompatible materials would empower this kind of innovation on a meaningful scale. From patient-specific surgical guides to emergency response items like PPE, 3D printers with biocompatible resins enable a range of innovative applications, enabling solutions-oriented healthcare leaders to improve clinical outcomes, personalise medical treatments, and mitigate unnecessary costs.

packaging

THE RIGHT STUFF: What thermoforming offers as a packaging solution Todd McDonald, director of sales & marketing at TEQ, examines the benefits thermoforming offers in packaging.

s the world grows ever more technologically advanced, the importance of protecting that technology has become more vital. Improvements to packaging design are now a necessity. At the same time, there is a demand to deliver products in a packaging solution that adheres to strict specifications while using less production energy and material as well as faster production times. SO, WHAT IS THERMOFORMING? Cleanroom thermoforming is widely used for the production and packaging of pharmaceuticals and medical equipment. This method of thermoforming is carried out in an ISO certified cleanroom meaning any particulates circulating in the air are kept to a minimum. Thermoform packaging is extensively used to safeguard sterile instruments and implants. This packaging method permits the use of lightweight, clear plastic enclosures that stop microbial and dust particles from contaminating the sterile item. They also make possible the product’s secure storage for lengthy periods whilst maintaining the sterile environment. THE BENEFITS OF THERMOFORMING This advanced technology has established itself as a preferred option for many industries and applications, including medical devices, with the main benefit of this packaging solution the clear cost efficiency it offers. The stiffness of this type of packaging material also allows for the creation of smaller units and space-saving benefits. The stiff packaging also offers a barrier to odours and resistance to oil and grease. Packaging from cleanroom thermoforming also has the capacity to offer advanced protection of medical devices

and the importance of this cannot be underestimated as the packaging of medical devices is as important as the product itself. Once the packaging’s integrity is compromised, sterility is lost and the device is ruined. This is why thermoforming is an ideal solution.

The stiffness of this type of packaging material also allows for the creation of smaller units and space-saving benefits

Thermoformed plastic packaging can offer several other advantages including: • Product Orientation: A nurse may need to quickly confirm a product’s orientation and how to grab it. With a thermoformed tray, a nurse can be sure that the medical device stays securely in place in the intended location so he/she can remove it swiftly and confidently. • Handling Assurance: To ensure a device doesn’t compromise sterility, a nurse needs to control the movement of a device as its package is opened. A thermoformed package is more likely to ensure there is no unnecessary rotation or accidental removal. • Clarity: A nurse can find it beneficial to see and identify the product clearly so he/she can better present the device or see any potential defects. • Consistent Opening Experience: Incorporating a good peal area in the package design can allow a nurse an easy access point for pealing the lidding back from the package. • Additional protection: With rigid plastic, a medical device is protected in sensitive device areas. For example, a package can be designed so a syringe will not get depressed. • More ergonomic: A pouch can require both wrists to twist to open, putting repetitive strain on both of the nurse’s wrists. With a sealed thermoformed tray, only one hand is opening the seal while the other is holding the tray in place.

packaging

The importance of container closure integrity Fran DeGrazio, chief scientific officer, West Pharmaceutical Services, discusses container closure integrity (CCI), and how it’s a fundamental requirement of sterile packaging.

ontainer closure integrity (CCI) is a fundamental requirement of every sterile package regardless of whether the package holds a drug product or a medical device.

There should be documented criteria supporting why a particular method is chosen to assure integrity, especially since selection of the wrong methodology could result in a risk to patient safety.

There are several common standards used by industry for characterising acceptable package integrity for sterile barrier packaging systems commonly used for medical devices, such as: • ASTM F1929 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration; and • ASTM F2096 Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurisation (Bubble Test).

USP <1207> strongly endorses the use of deterministic methods whenever possible (e.g., tracer gas leak detection, high-voltage leak detection, laser-based headspace analysis). Additionally, CCI testing throughout the product lifecycle is recommended. Historic test methods, such as blue dye, are seen as probabilistic and, although they may have their use in certain circumstances, are not recommended for characterising the integrity of a drug packaging system from a best practice standpoint.

Proving container closure integrity of a drug package, however, is not as simple as following some historic standards when proving the integrity of a drug container. Several years ago, a new standard was introduced into the United States Pharmacopeia (USP), entitled, Chapter <1207> Packaging Integrity Evaluation-Sterile Products. (1) This chapter introduces the concept that container closure integrity is proven when a package meets its specific maximum allowable leakage limit (MALL) established to maintain product quality attributes for sterility and physiochemical stability throughout expiry. (2) The most common sterile drug package formats are vial systems and prefilled syringe/ cartridge systems. Proving integrity of these systems is more complex than often expected. An understanding of the MALL as a starting point and choosing the appropriate test method for the application are critical.

Even standard test methods may require optimisation for each drug product package to ensure that the selected leak test method is able to meet all relevant leak detection performance criteria specific for the test product-package system. Validation of the final

methods is also required to demonstrate test method detection and precision along with other relevant criteria. Optimisation of the packaging system for integrity is not only dependent on choosing the right test method but understanding all the various risks that could have an impact on CCI. Critical to this understanding is the form, fit and function of the components that comprise the system being used. Not all components are co-designed to fit together in an integral fashion, whether speaking of a vial, syringe, or cartridge primary package. An understanding of the component’s characteristics, drug filling and sealing factors along with the intricacies of the test methods themselves are necessary. The primary package may also be paired with a medical device to form a drug device combination product. This leads to a more complex challenge in meeting the regulatory expectation that

the use of the device with the drug primary package has no negative effect on the integrity of the system. Container closure package integrity is a complex yet necessary requirement to assure patient safety. Manufacturers should collaborate with experts in this field to minimise risks from regulatory and clinical perspectives.

REFERENCES 1. United States Pharmacopeia and National Formulary. Rockville, MD: United States Pharmacopeial Convention; 2016. https://www. uspnf.com/ Accessed August 25, 2020. 2. DeGrazio FL. Holistic Considerations in Optimizing a Sterile Product Package to Ensure Container Closure Integrity. PDA J Pharm Sci Technol. 2018;72(1):15-34. doi:10.5731/pdajpst.2017.007658

packaging

TRACK AND TRACE Jeff Jones, coding and tracking business manager at Sewtec Automation, explains the historic use of Unique Device Identifiers (UDIs) and what changes set to come into effect next year are likely to mean for the production and packaging of the industry’s products.

he serialisation of medical devices will be a familiar concept to any manufacturer, but proposed changes to mandatory regulations look set to further increase the traceability of its products. For a number of years now, Unique Device Identifiers (UDIs) have been closely associated with the production and distribution of medtech products in Europe and the US. Since 2013, the Food and Drug Administration (FDA) has mandated the inclusion of UDIs on products marketed in the US, and with many suppliers of products into North America also distributing to the UK and Ireland, coded identifiers are also a common sight this side of the Atlantic. HISTORIC USE OF UDIS UDI regulations essentially require the primary packaging for every medical device to carry a code displaying the product’s serial number and information relating to the manufacture of the device. Under the current regulations, serial numbers are

applied in a generic manner, meaning the serial number will be the same for every unit of a specific manufactured product. With all of this data stored in a centralised government database, this system enables the end user – whether a pharmacist or a consumer – to access key information about a product should they need to. The second major benefit of the UDI regulations is that they provide authentication that a product is legitimate, rather than counterfeit. Back in 2010, the World Health Organisation (WHO) reported that 8% of all medical devices were known to be fake, with many suspecting that the actual numbers are likely to be much higher. While regulators and manufacturers have been striving to drive that

percentage down over the last decade, the industry is conscious of the room for improvement that remains. The main drawback of the FDA’s UDI regulation is that the system does not enable a product to be tracked through the whole supply chain. However, thanks to a new set of proposals put forward by the European Union (EU), that is about to change, bringing with it a much more comprehensive set of track and trace requirements for manufacturers. INTRODUCING THE NEW EUROPEAN MEDICAL DEVICE REGULATIONS 2017/745 First proposed in 2017, the new EU Medical Device Regulations (MDR) 2017/745 proposes a new type of serialisation comprising of a UDI for every product pack,

packaging

For the first time, it is made possible for a product to be tracked at every step of its journey from manufacture to consumer transaction

which is then aggregated at every stage of the supply chain. Under these new requirements, all UDIs will be stored on a centralised European database, which is set to be created and controlled by the European Database on Medical Devices (EUDAMED). The key difference here is the aggregation. For the first time, it is made possible for a product to be tracked at every step of

its journey from manufacture to consumer transaction. For example, it may be that a primary pack is placed within a shelf display carton before being packed within a case and then onto a pallet. Under previous regulations, it would have been impossible to check how far along the supply chain the product was unless you had the identification of the pallet or case. Under the new proposals, however, it is possible to track any product to its most recent process. The proposals may initially appear to add complexity to the supply chain and demand greater sophistication from packaging lines, However, these complexities also bring with them a number of benefits. Firstly, the drive to suppress counterfeit products remains high on the industry’s agenda and this will be bolstered by greater traceability. Secondly – and arguably of greater direct benefit to a manufacturer’s bottom line – the new regulations aim to simplify the product recall process. Should there ever be an issue with a specific batch of medical devices, for example, the new system will make it easier to pinpoint the specific batch affected rather than requiring the manufacturer to recall all stock. Naturally, recalling a batch of a given product is much more costeffective for a manufacturer than having to recall every product unit known to be in circulation. OPPORTUNITY TO UPGRADE Such a significant change to legislation presents an opportunity for manufacturers to

review their existing processes and consider how they may be able to enhance existing manufacturing and packaging lines to aid their compliance. Not only that, but an audit of existing lines may also present an opening to improve operational efficiency at the same time. For track and trace within the medical device industry, opting for a bespoke system which has been invented and manufactured to meet the requirements of a manufacturer’s specific production line can bring with it a host of major advantages. As well as ensuring product aggregation is made more effective and reliable, a purposebuilt packaging line also has the potential to enhance the efficiency levels of the entire system and improve its overall equipment effectiveness (OEE). MDR 2017/745 was originally set to come into force on 26 May 2020 but has been delayed until May 2021 in light of the Coronavirus pandemic. As the industry readies itself for the introduction of the new regulations, it is certain that manufacturers need to prepare to offer a greater level of serialisation and aggregation than they may have done previously. Conducting an indepth review of any existing packaging and labelling lines to establish their level of compliance with the new requirements is certainly a worthwhile first step to take for those manufacturers yet to have their processes reviewed.

compmed/medical

Virtual becomes reality Like everything else this year, trade shows have faced disruption thanks to the COVID-19 pandemic.

ompamed and Medica is no different, and has decided to go virtual in 2020, but it could potentially bring about lasting change to trade shows and how the life science industry, and others, do business going forward. Though the organisers will hope its international audience will return in numbers to the Messe Düsseldorf in November next year, it was announced a hybrid event would take place in 2021 – combining online platforms with visitors to the trade centre. After the announcement for ‘virtual.MEDICA and ‘virtual.COMPAMED’ was made, Horst Giesen, global portfolio director for health & medical technologies at Messe Düsseldorf, said: “Over the past few years, we have

constantly expanded our digital offers and therefore have established internetbased industry platforms in the form of our Medica and Compamed web portals. We can now implement these in order to offer our customers the appropriate tools for networking and facilitating the valuable transfer of knowledge, even in these challenging times. “On the dates of Medica 2020 and Compamed 2020, we will seek out the best elements for streaming from the 600 previously planned sessions for the specialist forums and conferences, working together with our cooperating associations and partners. Participants can expect to see highlights with high relevance to Coronavirus in particular in these virtual

formats. In addition, there will be diverse web presentations from exhibitors on their innovations and an online matchmaking area for making valuable business contacts, including a video web meeting function.”

Compamed High-Tech Forum and the Compamed Suppliers Forum. The virtual experience will also include a Conference Area, an Exhibition Space for exhibitors and product innovations, and a Networking Plaza.

In recent years, over 80% of Compamed and Medica’s exhibitors have come from abroad, from around 70 different nations, with visitors from 170 nations, putting the proportion of international visitors at 70%.

Wolfram Diener, chairman and CEO of Messe Düsseldorf, said: “Our hygiene and infection protection plan was positively received by the exhibitors and the successive relaxations of the international travel rules in early summer meant that we had realistic hopes that both trade fairs would be able to be held successfully and safely. The development of the global pandemic must now, however, be re-evaluated. Against the backdrop of a multitude of travel limitations and considering the very international demographic of Medica and Compamed in terms of both exhibitors and visitors, we must now focus solely on the virtual format this year.

Online visitors to this year’s show will be able to access the Medica forums including: the Medica Connected Healthcare Forum, the Medica Health IT Forum, the Medica Labmed Forum, the Medica Tech Forum, the Medica Econ Forum and the

“The essence of the Medica and Compamed brand is global broadcasting for exhibitors and visitors. This central core is still present this year, just not in the form of an event that demands physical presence, due to the pandemic. With the annual rotation of Medica and Compamed, we are now staying in touch with our customers by creating a comprehensive virtual and globally accessible marketplace for the community with a high-profile programme. This is a good starting point for the joint launch in the trade show year 2021, when we will again offer the successful combination of live platforms for trade visitors at the Düsseldorf Exhibition Centre and digital offerings.”

Pen Power

Ian Bolland spoke to Dr Rutger Zietsma, CEO of Manus Neurodynamica about the company’s offering in neuromotor assessment devices.

he Edinburgh-based firm’s flagship product is the NeuroMotor Pen, a diagnostic system which combines sensor technologies built into a digital pen with associated analytical software to capture and analyse minute limb and hand movements – with the measurements providing objective information about movement abnormalities. As a result, it can support the diagnosis and monitoring of Parkinson’s and other neurological diseases. The company has sold the system to hospitals, including NHS Northumbria, having completed successful clinical trials with the NHS in the North East of England and in Scotland. Explaining more about who is using the technology, Dr Zietsma said: “Most of our early adopters are clinicians with a research interest and use it at the point of care level. These are doctors who run their everyday clinical practice and assess and diagnose patients and also conduct research at the point of care.” Earlier this year the company signed a five-year manufacturing and supply agreement with STABILO to supply the pen. Dr Zietsma explained the pen itself is only one aspect of the technology. There is also an app with UI on a tablet that presents tasks for the patient to complete, along with the analytical software component.

“The hardware comprises of the pen device along with the tablet PC. The tablet PC is ‘locked down’, so has a Manus-specific operating system and has an app installed which presents tasks for the patient to complete. These are quite simply activities like tracing or copying figures such as spirals or circles. “Our device measures the movement of the pen in three dimensions, it also measures the interaction between the hand and the pen. “The software component is really the clever bit. Even if competitors would try to do some reverse engineering and tried to design and manufacture their own pen, they would have a hard time developing the software because the development and clinical validation is a very complex and time-consuming exercise. “It requires a lot of specific expertise in signal processing and movement disorders. The pen and analytics provide digital biomarkers for movement disorders, based on a number of algorithms that extract useful information from the pen signals.” In the eyes of Dr Zietsma, the product stands out from similar devices in the field because it has been developed with a particular intended use, compared to those developed alongside smartphones that monitor conditions and situations rather than supporting a diagnosis. “I think our device stands out because it’s fit for purpose, it’s been developed from the ground up with a specific intended use in mind, measuring fine motor skills clinically to different between neurodegenerative disorders.” But can it work in other areas? Dr Zietsma touched upon using it in helping to diagnose Alzheimer’s and quantifying the effects of medications on patients.

“The word ‘siagnosis’ in clinical practice always refers to making a differential diagnosis and the challenge is distinguishing between different impairments by ruling in or out the likelihood of the patient suffering from a specific disorder. “We are aware of particular patterns in our data that very much look like for example essential tremor or like an enhanced physiological tremor or slower movement due to health ageing. So far, the focus has been on Parkinson’s disease because there is a need, but at this time in the development of the company, we are diversifying into other disease areas. One area that we think is very important is measuring the side effects of anti-psychotic medication.”

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