www.med-technews.com Issue 38 | July/August 2018
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PLUS
The HealthTech Series
A DIGITAL HEALTH SPECIAL
MED-TECH INNOVATION | NEWS MED-TECH
innovation
ROBOTS
HOW THE UK IS TURNING A CORNER WITH INDUSTRY 4.0
ADVANCING HEALTHCARE
5 THINGS TO CONSIDER 5 THINGS TO CONSIDER WHEN MANUFACTURING CONNECTED WHEN MANUFACTURING CONNECTED DRUG DELIVERY DEVICES DRUG DELIVERY DEVICES The estimated number of connected drug delivery devices continues to increase andestimated the impact of this trend could bedrug significant, The number of connected deliveryexplains devicesPhillips-Medisize continues to increase and the impact of this trend could be significant, explains Phillips-Medisize
5 THINGS TO C
WHEN MANUFACTUR DRUG DELIVERY DEV
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While digital connectivity or connected health can improve the coordination and delivery of patient care, original equipment managers needimprove to keepthe these five thingsand in mind when While digital connectivity or connected health can coordination delivery drug delivery devices: ofcreating patientconnected care, original equipment managers need to keep these five things in mind when
creating connected drug delivery devices: 1 Development strategy and design consideration While digital connectivity or connected health can Situation analysis and and patient compliance 12 Development strategy design consideration of patient care, original equipment managers nee Connectivity ecosystem 23 Situation analysis and patient compliance creating connected drug delivery devices: Wireless subsystem 34 Connectivity ecosystem 5 Security of device and information 1 Development strategy and de 4 Wireless subsystem
2 Situation analysis and patient 5 Security of device and information 3 Connectivity ecosystem As the Internet of Things continues to become an integral part of people’s lives, the opportunity 4 Wireless subsystem tothe useInternet it withinof drug delivery devicetoapplications The manufacturers As Things continues become anremains integral promising. part of people’s lives, the opportunity 5 Security of device and inform and device designers must identify, investigate and overcome these challenges so that the to use it within drug delivery device applications remains promising. The manufacturers implementation of wireless and other related smart technologies canchallenges be achieved. When done and device designers must identify, investigate and overcome these soThings that the As the Internet of continues to become an successfully, connected systems enable the patient and caregivers have a 360° view ofdone toto use itachieved. within drugWhen delivery device applications r implementation of wireless and other related smart technologies can be both the patient and the disease – not only to manage adherence, but to improve results by and device designers must identify, investigate a successfully, connected systems enable the patient and caregivers to have a 360° view of implementation of wireless and other related sma understanding of the regimen. both the patientthe andeffect the disease – not only to manage adherence, but to improve results by
understanding the effect of the regimen.
successfully, connected systems enable the patie both the patient and the disease – not only to ma understanding the effect of the regimen.
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CONTENTS 6-7.
MED-TECH
Headlines
INNOVATION | NEWS
8-11. Opinions
13-19.
The HealthTech Series
6
24.
On the cover
28-29.
Outsourcing 13
31.
Quality management
33.
TCT Show 24
34.
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A long, hot summer
[
d
from The editor
L
et’s face it, we’re not geared up for this weather here in Britain. At the time of writing, it’s the day after the hottest day of the year. Knowing my luck, when this hits your desk things will have turned decidedly arctic and this whole comment piece will be irrelevant. We’re not alone though, much of Europe has been sweltering too. Pundits are now edging closer to declaring this summer hotter than the famous heatwave of 1976. It was before my time, but I’m reliably informed by my elders and betters that the last six weeks don’t hold a candle to the summer of ’76. Just as everyone had a story for me last winter about a time when the snow was ‘so much worse’, there are always those with a good tale to tell. In ’76 for instance, I’ve heard it said that the advice of one British doctor was to consume plenty of beer and crisps, to replenish the fluids and salt lost through sweating. Well, it’s one theory.
It got me thinking about what the advice will be in a few years time, when today’s disruptive technology has become the norm. At CES this year, beauty brand L’Oreal launched a wearable UV sensor – something that the firm has been developing for a few years now. It may seem a little gimmicky, but L’Oreal’s Guive Balooch, global vice president of research and innovation technology department says that human-centred design – a key tenet of the medtech world – was put into practise during the development of the product. It sits on the thumbnail and the sensors communicate via NFC with a smartphone app to inform the user about their sun exposure, and issue guidance on any necessary precautions. Apps, too, will likely play a greater role in the next heatwave. I’m not just talking about things that remind you to drink
enough water, or point you in the direction of the nearest beach. As we learn how to properly exploit the proliferation of technology available to us via our smartphones, we will soon be monitoring vital signs in vulnerable populations – particularly infants and the elderly – and will perhaps be able to reduce the strain on A&E when a heatwave strikes. Already some Trusts are reporting record numbers of admissions this summer, with respiratory problems and dehydration among the top causes. Smart buildings and smart clothing have been touted as potential solutions for unpredictable weather. Perhaps this intersection will soon link into digital health, too. It doesn’t seem so futuristic to imagine a world where our very surroundings become the early warning signal that also responds according to our needs. But there again, we still have a little way to go. Crisps anyone?
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FOUR MATERIALS ….which are the future of medtech
2. ELECTRONIC PAPER Intelligent ink has certainly seen increasing usage in medical applications, but that the coming years may also propel advanced printed electronics to the fore of medical device packaging. It’s happening already. The August Faller Group for example recently announced a prototype of a ‘counting device’ – a folding carton for medicine which uses an e-paper display and electronic controls. The user just has to press a button on the display each time he/she takes a pill, and the packaging can track their dose. Another prototype from the firm, currently just called ‘Medical Prescription’ keeps track of the amount of pills and connects to a smartphone app via bluetooth, which in turn sends the signal to order a repeat prescription. All of this is great news for medical device manufacturers. Smart packaging creates added value in the form of a closer bond with the patient – a rapidly emerging trend in the age of digital health. But smart packaging is not without a couple of significant drawbacks. Predictably, cost is the main one. Added value is all well and good, but if it can’t be achieved cheaply, it adds cost that some won’t be able to afford.
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3. SILK It may put you more in mind of luxury evening wear, but silk has been under the microscope in recent years for its potential as an engineering material across a broad range of applications – including medtech. German company Amsilk is using spider silk to create functional biopolymers. One application for these materials is as an implant coating for better biocompatibility and reduced inflammation. The company says its silk polymers can also be used in surgical meshes, wound dressings, and electrical, orthopaedic and dental implants. Across the pond, a group of engineers at Tufts University in Maryland have also come up with a way to use silk to incorporate therapeutics into surgical devices such as screws and rods for healing bone fractures. According to The Engineer, the team experimented with coating the devices with an agent that suppresses the action of proteins that slow down bone growth.
4. SHRILK That’s not the same as saying the word ‘silk’ after a few too many. But, like silk, it is derived from the natural world. Researchers from the Wyss Institute have developed what they claim is a ‘fully degradable bioplastic’ by combining chitosan with silk proteins. Chitosan is found in shrimp cells, and combined with the silk protein, the researchers say it could be used to create “implantable foams, films and scaffolds for surgical closure, wound healing, tissue engineering, and regenerative medicine applications”. It has the right mechanical properties for these applications because chitosan is a form of chitin, a touch polysaccharide which gives crustaceans their strong armour. Aside from medical devices, its creators also say ‘shrilk’ could be used for mass commodity applications, since it is said to boast excellent green credentials versus synthetic plastics. It is claimed that the material rapidly biodegrades when placed in compost, and releases nitrogen-rich nutrient fertiliser.
A new cardiac diagnostic device aimed at helping physicians rule out active ischemia in patients presenting to the emergency department (ED) with chest pain is being trialled at five major research facilities in the United States. The trial will take place across the Mayo Clinic, Rochester, MN; Baylor University, Houston, TX; Vanderbilt University, Nashville, TN; University of Cincinnati, OH; and Wake Forest University, Winston-Salem, NC).
headlines
1. BIOCOMPATIBLE INKS A group of ETH Zürich researchers have developed a biocompatible ink that makes it possible to 3D print living bacteria. This could make it possible to produce biological materials capable of breaking down toxic substances or producing high-purity cellulose for biomedical applications. The ETH researchers’ new printing platform offers numerous potential combinations. In a single pass, the scientists say they can use up to four different inks containing different species of bacteria at different concentrations in order to produce objects exhibiting several properties.The ink is composed of a biocompatible hydrogel that provides structure. The hydrogel itself is composed of hyaluronic acid, longchain sugar molecules, and pyrogenic silica. The culture medium for the bacteria is mixed into the ink so that the bacteria have all the prerequisites for life. Using this hydrogel as a basis, the researchers say they can add bacteria with the desired range of properties and then print any threedimensional structure they like.
UK MEDTECH FIRM IN RECORD-BREAKING US CLINICAL TRIAL
The device, developed by Creavo Medical Technologies, a UK-based medical device company, is a mobile medical magnetometer which can be used at a patient’s bedside to measure and report electromagnetic fluctuations caused by heart activity. Approximately 720 patients will be enrolled throughout the trial, which is the largest magnetocardiography (MCG) trial ever to take place in the United States and is scheduled to be completed by mid-2019. Gregory J. Fermann, MD, Professor, Executive Vice Chairman and Director of the Clinical Trials Centre at the University of Cincinnati said: “The ability to quickly risk stratify and safely discharge emergency department patients presenting with symptoms consistent with chest pain of cardiac origin is critically important to the overall flow of patients through crowded Emergency Departments. This device has the potential to become an essential tool in the rapid evaluation of these patients.”
OOK MEDICAL PUSHING TO EXTEND BREXIT TRANSITION
UK LIFE SCIENCES TO GAIN GREATER MARKET ACCESS ACROSS THE COMMONWEALTH The Northern Health Science Alliance has signed a memorandum of understanding (MOU) with Life Sciences Queensland (LSQ) in Australia and another MOU with Scan Health and World Health Innovation (WIN) in Canada to open the door to working across the Commonwealth countries. These joint working arrangements will benefit UK, Canadian and Australian patients and industry by helping new expertise and research to be shared quickly and effectively across the countries booming life sciences economies. The MOU is designed to open up opportunities for UK companies to expand into Australia which has a £28bn life sciences economy and Canada, which has a £17bn life sciences economy and for their companies to bring the latest health technology and treatment to the North and vice-versa.
Dr Hakim Yadi, CEO of the Northern Health Science Alliance said: “This joint working arrangement means that the life sciences industries in Australia, Canada and the UK will benefit from closer relationships. “There is a real international appetite to work with the North’s health research system – demonstrated by these MOU signings and our recent MoU signing with the leading Singaporean MedTech Accelerator Zicom MedTac Pte Ltd. As a result there are now a number of Singaporean companies conducting research studies in partnership with Northern Universities and Hospitals. “We want to best and brightest companies to come and work in the North of England – and for the best and brightest of our companies to spread their wings internationally.
Cook Medical, which employs more than 850 people in Limerick, has called on the British Government and the EU to push for an extension of the UK’s Brexit transition agreement for medical devices until at least 2025. Extending the post-Brexit transition period would provide the medtech and other highly regulated industries with additional time to meet new UK regulatory arrangements and protect supply chain integrity, as well as ensuring patients and customers do not experience delays in product delivery. “Patient need and wellbeing isn’t at the forefront of conversations about Brexit trade restrictions. The process to acquire regulatory approval for these complex, often lifesaving products is intentionally rigorous to protect patients,” said Emmet Devereux, director of government and regulatory affairs EMEA at Cook Medical. “It will be extremely difficult for medtech companies to ensure that their products meet any new UK regulatory requirements or frameworks by the end of 2020, as so much remains uncertain and undecided.” Mr Devereux continued: “Cook Medical, and every other medtech company
that has traded without restriction in the UK and the rest of Europe, will have to contend with different rules for importing and exporting components and products, and rework existing supply chains under Brexit. “We strongly believe that London and Brussels should push this transition date to 2025, or agree to an exemption for medical devices, so that the medtech industry can ensure its operations and supply chains remain uninterrupted, and that its patients remain unaffected.” Employing over 38,000 people in Ireland, the medtech industry generates approximately 10 percent of all Irish exports, worth €12.6 billion to the economy. A third of the world’s contact lenses and a quarter of its diabetes injection devices are manufactured in Ireland. Medtech is recognised as one of Ireland’s emerging global industries. “Considering the importance of medtech to the Irish economy, we believe it is not only in the industry’s best interests, but ultimately in the interests of patients that the transition agreement is extended to avoid disruption to an integral part of the national economy,” said Mr Devereux.
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The new kid on the block
OPINION
In the United States, aggregators such as Mint. com have already disintermediated banks and now own the ‘last mile’ of the customer banking relationship, disrupting traditional players. Having worked in healthcare technology for the last 20 years, this rings bells for me around the area of ‘patient or citizen relationship management’. By that, I mean the way that health and care organisations interact with citizens and patients. In an ideal world, I would expect them to use the data they have to develop and manage their relationships with citizens and patients. This would focus specifically on improving their health and wellbeing and delivering better outcomes at a reduced cost. You can imagine a scenario where a disruptor such as Apple, Google or Samsung obtains access to someone’s health information by consent, in a similar fashion to ‘open banking’. It would then be able to amalgamate it with information around lifestyle (eating habits, sleeping, exercise), genetic makeup, preferences and health and care details. With this insight, it could help manage longterm conditions, new health problems or just suggest preventative advice. But it could go further. It would have the capacity to monitor
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TAS HIND, DIRECTOR OF TECHNOLOGY AT ESSENTIA TRADING, TAKES A HOLISTIC VIEW OF THE POTENTIAL OF BLOCKCHAIN FOR MEDTECH AND CONSUMER HEALTH OEMS.
how people are doing (blood pressure, heart rate, blood sugar, medications). It would also enable patients to update information and share it with relevant parties. Alerts could be sent, and patients would get help when they needed it. Patients (or citizens) would always be confident that the data is shared securely with their consent and only with the people or organisations that they have approved. It would be easy to see who has accessed the information and to track what has been done to it and by whom. In summary, it is a solution that is central and tailored to patients’/citizens’ needs and they can be confident that it is taking a holistic view when recommending and driving solutions to improve their health and maintain their wellbeing. As in the banking sector, it will only be a matter of time before third party and independent service providers will build the capabilities to enable them to aggregate health and wellbeing information in this way. Such providers will need to support security measures such as encryption, strong client authentication and auditing to keep healthcare transactions and information secure. These solutions will need to be scalable and efficient with high availability and reliability.
Healthcare solution providers such as Electronic Health Records (EHRs) will need to offer services that can be consumed by external third parties and think more creatively about how to use such independent services for their own offerings. The blockchain approach, best known as the schema that underpins the Bitcoin ecosystem, might just be the overhaul that healthcare is looking for. It allows digital information to be distributed but not copied and whilst it relies on it being in one location, it is available from different sources. Medrec, for instance, has developed a solution that provides patients with onestop-shop access to their medical history across multiple providers. It uses smart contract data structures that are stored on the blockchain and associate references to disparate medical data. It has developed ownership and viewership permissions and record retrieval location. This provides an immutable datalifecycle log, with complete auditability. It is notable that the raw medical record content is never stored on the blockchain, but rather kept securely in providers’ existing data storage infrastructure. But the blockchain approach will not be achieved overnight. Although there is a great deal of thinking and some
development that has already been done in this sector, there are several steps that will need to be taken before such a vision can be achieved. For instance, the digital maturity of the information held in health and care organisations will need to increase significantly. Mechanisms to integrate and inform data from different sources inside and outside health and care organisations will need to be established. Only then can we imagine a scenario where this information can be augmented with fitbit, wearables, insideables, eating and sleeping habits, physical activity, research, genomes and genetics to build a complete picture of citizens and patients. The final step is to make this information available securely to end users in a way that they gain insights about their condition and lifestyle and offer advice and guidance that can improve their health and wellbeing. It is good news, therefore, that blockchain is being considered as part of solutions to improve the health and wellbeing of patients and citizens, otherwise some ground breaking and revolutionary opportunities could be missed.
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From tiny seeds…
OPINION
ROGER HARCOURT, PARTNER AND HEAD OF HEALTHCARE AT LAW FIRM,
As the healthcare industry becomes increasingly digitised, gaps in the market are leading tech-savvy entrepreneurs to bring new innovations to market. Increased access to health platforms and widespread usage of smartphones, direct patient distribution channels have created an opportunity for innovators but in order to capitalise on this, they must understand how to bring a new product or service to market successfully. There is a plethora of medical devices, utilising cutting edge technology, creeping into mainstream healthcare services, from virtual and augmented reality tools, to digital health management and training platforms. They impact everything from diagnosis of newly-presented conditions through to the self-management of existing ones. Innovation in the sector is not only driven by improving patient outcomes and access to health services but also to relieve pressure on the healthcare system as a whole, in particular the increasingly-squeezed NHS. With the renewed focus on wellness, there is also a desire to increase the focus on prevention. Now, having been promised an extra £20bn annually, the focus will be on getting the most
bang for the tax payers’ buck and new technology in the sector will be central to achieving efficiencies. Attracting investment is one of the main barriers for entrepreneurs. By starting with the end goal in mind, healthcare innovators can focus on where they want to go, how they’re going to get there and what the most efficient and profitable routes to market will be. Simply having a great idea often isn’t enough and breaking down each stage into granular detail will ensure investors know that thorough stress testing and planning have taken place. When bringing a great idea to the market, entrepreneurs must understand their main focus and where appropriate seek support to smooth the route to commercialisation. Innovators may conclude that selling or licensing their idea or technology to a larger business, that already has specialist resources, is the better route to market. Clinical trials or even demonstrating the efficacy of a product or service, can be extremely costly and without the necessary funding, good ideas often grind to a halt. With innovation in the healthcare industry becoming increasingly
SHAKESPEARE MARTINEAU ASKS: WHAT MAKES A SUCCESSFUL MEDTECH SPIN-OUT?
globalised, UK-based entrepreneurs should also consider exploring other markets, such as the US, where funding might be more freely available. Medtech entrepreneurs should also be prepared for failure. Understanding why things haven’t worked can be a valuable process and pave the way for future success. Adopting a ‘fail fast’ attitude will ensure adjustments are made quickly and speed the way to market. Being prepared to pivot and iterate products or services and distribution strategies, without fixating on the original idea, is also often crucial to success. A failure to properly focus on the problem that your product or service is intended to solve, or to understand the distribution channels to market, is surprisingly common – particularly if the entrepreneur is focused on the product. An idea could be pure genius but if it doesn’t solve a problem, which is significant in terms of both health outcome and market size, it is unlikely to attract commercial investment and may have limited viability. A full understanding of the market for a new good, product or service, as well as the customer user experience is crucial.
As noted above, licensing an idea can be a good and flexible way to commercialise it quickly. A well drafted licence agreement will balance risk and reward between the parties; protecting the entrepreneur and helping them to realise value through a royalty stream. Careful scrutiny of agreements is needed to ensure appropriate royalty rates and territorial restrictions are set. Entrepreneurs also need to make sure that the integrity of their intellectual property is secured and that licensees are committed to sufficient levels of sales activity to ensure that the opportunity is properly exploited in a timely fashion. Protecting the intellectual property (IP) of any innovation is important; particularly if an entrepreneur intends to licence it. However, specialist advice should be sought in this area, as rushing to patent a new technology may not be the best way to protect it. Entrepreneurs also need to understand the importance of confidentiality and use non-disclosure agreements where necessary. If a pragmatic approach to commercialisation is adopted, there are huge opportunities for medtech entrepreneurs.
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A feather in one’s app
he medical app market in the US could be about to skyrocket. But Thomas Prock, partner, Marks & Clerk explains why it’s so much harder to patent an app than a device, and why the UK has the potential to get it right.
Apple’s recent announcement that it will be opening its health records application programming interface (API) will be big news for healthcare app developers in the US. The data covers patients at more than 500 hospitals and clinics and it’s hoped that, by making the data available, a new tranche of apps and products will be developed focused on helping patients better manage medications, care plans and long-term conditions. Digital health is a growing field and there is no doubt that better and more sophisticated apps, underpinned by better and
more sophisticated data, have the potential to make a real difference to people’s health outcomes. Alongside technical challenges, developing successful apps also poses significant business challenges such as how to monetise the app and crucially, how to secure the time and money invested in developing it with robust intellectual property (IP). Patents are the best-known means of protecting an invention from imitation. Apps however, as with software in general, are not always easy to patent. The reason for this is that patents are designed to protect technical innovations and not all apps can be considered ‘technical innovation’. Many apps are based upon the presentation of data in novel ways – an app might harvest data from other sources to show you the location of the surgery of a medical practitioner having a desired qualification in your local area for example. While there is no doubt that many successful apps have been based upon such principles, the innovation here is more one of imagination than technical advances.
Where patents aren’t appropriate, IP protection remains vital to locking in the value inherent in the development and launch of an app. In the absence of or in addition to patents, trademarks provide a vital means of protecting software innovation. Over time, as an app develops and grows its user base, its brand will acquire ‘good will’ and a degree of faith in the service it provides. Like any IP, this good will is an asset which can be protected and which is central to the value of an app. Should a third party app undermine this good will, for example by launching a rival product so similar as to confuse consumers, then well protected IP will allow action to be taken. Registering a trademark for an app should be one of the first steps for any developer – especially in the case of healthcare apps, where trust and confidence in functionality, and the ways in which sensitive medical data is being used, is so important.
While the majority of an app’s intellectual property will likely be covered by patents and trademarks, the app may also have an element of design. In this instance, developers might also consider registering designs, which is cheap and quick and also significantly easier for developers in the UK since the UK ratified the Hague Agreement earlier in the spring. Membership of Hague means a design registered in any of the Agreement’s signatory states, is protected in all other signatory states – of which there are more than 60. It will be interesting to see how Apple’s experiment in the US unfolds, and whether we see any similar initiatives in the UK (imagine for a minute how much healthcare data the NHS must be sitting on). The challenge for developers will be to use the data and develop apps which can corner a section of the healthcare market, and develop products patients can trust. Intellectual property will be central to meeting these challenges.
Defining what constitutes technical innovation as far as apps go, and what doesn’t, isn’t always easy, though based on well-established principles. Generally speaking however, the most patentable apps will be those that find technical solutions to the technical challenges of utilising healthcare data. It is expected that machine learning will play a significant role in this.
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A serious injection
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he NHS is to receive an almost half a billion pound package to help increase the amount of digital technologies that are available across services within the organisation. Med-Tech Innovation News’ Reece Armstrong reports.
Speaking at the West Suffolk hospital in July, the new secretary for health and social care Matt Hancock (pictured) outlined his plans for the NHS, emphasising the importance of ‘technology-driven health and care’. Hancock announced a total of £475 million worth of funding which will go towards new technology designed for hospitals.
Lodge social care home, blood coagulation machines and Scan4Safety barcode tracking. These technologies have helped link homes with GPs and local hospital to develop preventative pathways, offer better clinical data and safely track patients, their treatments and the effectiveness of equipment respectively.
Discussing the work that is being done at West Suffolk, Hancock said that, “junior doctors and nurses will soon throw away their pagers and install a new smartphone app, removing the need to phone colleagues for details after getting paged – something that a pilot has shown should save nurses more than 20 minutes and doctors almost 50 minutes every shift.”
“More than £400 million will go towards new technology in hospitals which make patients safer, make every pound go further and help more people access health services at home,” Hancock said. “It will be another major step along the road to full provider digitisation. “A further £75 million is available to Trusts to help them put in place state-ofthe-art electronic systems which save money, give clinicians more time to spend on patients and reduce potentially deadly medication errors by up to 50% when compared to the old paper systems.” Hancock referenced a number of initiatives that are taking place across NHS organisations such as the use an electronic planning system at the Bridgeside
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MATT HANCOCK’S FAVOURITE INNOVATIONS SO FAR A quick look at some of the shining examples mentioned in the minister’s speech.
Whilst the extra funding will undoubtedly be welcome news, Hancock mentioned that it is ‘just the start’ and the recently announced £20 billion for the NHS “will be contingent on modern technological transformation”.
“When it was introduced, Scan4Safety was expected to deliver savings of £800 million over seven years. A year after this workstream began, that estimation increased to £1 billion and the true savings could be even higher.
“We will put in place the data standards, and support the workforce to adopt change too. Some of this is about inventing new technology but in lots of places it is about adoption because we know there are places where this technology is working,” Hancock said.
“Not only that, but the ability to track, trace and record critical supplies like surgical implants greatly reduces the risk of errors and improves the possibilities for product recall in an emergency. It also makes it possible to measure the cost of individual procedures, opening the door for true patient-level costing. We hope that the real benefits of this technology, that we helped to introduce to the NHS, can now be adopted by Trusts and patients across the country.”
“In my experience the small part is finding or inventing the technology. The big part is embedding a culture of always looking for the best possible technology and embracing it. I want to drive that culture change. Commenting the recent announcement, Noel O’Hanlon, CEO of Genesis Automation, which has been involved in the Scan4Safety hospital pilots, said: “It’s great to hear that the Department of Health is convinced of the significant cost savings and advances in patient safety that the Scan4Safety initiative have shown so far.
1. SCAN4SAFETY Scan4Safety is a pioneering initiative led by the Department of Health that is improving patient safety, increasing clinical and operational productivity and advancing supply chain efficiency in the NHS through the adoption of international standards. NHS Trusts are encouraged to use barcoding technology in order to adopt these standards across the healthcare system, and numerous suppliers have been involved. Matt Hancock’s predecessor, Jeremy Hunt said of the initiative: “Scan4Safety is a world first in healthcare – and a vital part of this government’s drive to make the NHS the safest and most transparent healthcare system in the world.” 2. REMOTE COAGULOMETERS Roche Diagnostics makes a product called CoaguChek, which allows patients with certain conditions, and those taking Warfarin, to monitor their health and adjust their medication accordingly. Furthermore, in May last year the group launched Coaguchek INRange – possibly the product that Hancock was referring to – which allows patients to test for coagulation (known as an INR test) remotely. Though he mentioned that the results are sent via email, INRange actually uses an app to record the results, which can then be accessed by the healthcare professional. 3. ELECTRONIC PLANNING SYSTEMS Though it’s not clear what system Hancock has seen in action, he did have this to say: “At the Bridgeside Lodge social care home yesterday I saw new technology in action. The home links with GPs, with local hospitals and develops preventative pathways for each patient. Their electronic care planning system – on a phone – uses voice recognition, gives clinical staff better data about what’s happening to each patient, saves costs, and saves each nurse an estimated hour per shift, giving them more time to care.” NHS Digital recently reported that over half of acute Trusts in England have replaced paper GP referrals with the NHS e-Referral Service (e-RS). e-RS is intended the improve the efficiency of the referral management process by reducing the time taken to create and manage referrals. By improving communication between primary and secondary care, the system aims to reduce the number of inappropriate referrals, ensuring patients are seen by the right person.
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WWW.DIGITALHEALTHAGE.COM
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How smart stents could predict narrowing of the arteries
F
or every three individuals who have had a stent implanted to keep clogged arteries open and prevent a heart attack, at least one will experience restenosis — the renewed narrowing of the artery due to plaque buildup or scarring — which can lead to additional complications.
Now, a team led by University of British Columbia electrical and computer engineering professor Kenichi Takahata has developed a type of ‘smart stent’ that monitors even subtle changes in the flow of blood through the artery, detecting the narrowing in its earliest stages and making early diagnosis and treatment possible. “We modified a stent to function as a miniature antenna and added a special micro-sensor that we developed to continuously track blood flow. The data can then be sent wirelessly to an external reader, providing constantly updated information on the artery’s condition,” said Takahata.
The device uses medical-grade stainless steel and looks similar to most commercial stents. Researchers say it’s the first angioplasty-ready smart stent — it can be implanted using current medical procedures without modifications.
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Research collaborator Dr York Hsiang, a UBC professor of surgery and a vascular surgeon at Vancouver General Hospital, noted that monitoring for restenosis is critical in managing heart disease. “X-rays such as CT or diagnostic angiograms, which are the standard tools for diagnosis, can be impractical or inconvenient for the patient,” said Hsiang. “Putting a smart stent in place of a standard one can enable physicians to monitor their patient’s health more easily and offer treatment, if needed, in a timely manner.” The device prototype was successfully tested in the lab and in a swine model. Takahata, who holds patents for the technology, says his team is planning to establish industry partnerships to further refine the device, put it through clinical trials and eventually commercialise it. The research is described in the May issue of Advanced Science and featured on its front cover. Engineering researcher Xing Chen, now a research associate at the Johns Hopkins School of Medicine, and Babak Assadsangabi, a postdoctoral fellow at UBC’s faculty of applied science, also contributed to the study.
www.first-sensor.com 17
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THE healthtech the HEALTHTECH series SERIES
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Hole in one
T
He great and the good of the digital health universe gathered at The Belfry in June for an annual fixture which has become a mustattend for all stakeholders in the sector. MTI managed to scoop an invitation.
Organised by software systems provider Intersystems, Joined Up Health and Care was held at the world-famous golf course and resort. It was the start of the Great Heatwave of 2018 and a glorious day for golf. Our man on the ground claims he saw a Bentley with the license plate ‘TIGER’ pass him by during lunch. Could it be? Regardless, the sporting theme continued during the all-day conference. Delegates were greeted by four-time Olympic gold medallist Sir Matthew Pinsent, whose duty it was to deliver the keynote address. Comparing the challenges he and his team faced during his Olympic days to the current uphill battles ahead of the NHS, Pinsent explained: “We knew that if all we did was to carry on doing what we were doing, we would end up between two and four seconds behind the mark. “The number of variables that go into that performance are astronomical. You try and persuade yourself that you are in control of all of them, but you aren’t.” The challenge: “How do we empower people in our
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Credit: drawnalism.com
^ InterSystems vice president Don Woodlock took to the stage to give examples of how the firm’s technology is being used to “unify the health multiverse”. system, in our crew, to say ‘we know we must change, how are we going to do it?’ You have got to come up with metrics about how you are going to show improvement.” Ahead of the conference, Downing Street pledged an additional £20bn in NHS funding by 2023. But with growing demands inevitably set to accompany new funds, the need for continuous, incremental and measured improvement, echoed throughout the conference after Sir Matthew sat down. For the uninitiated, InterSystems vice president Don Woodlock took to the stage to give examples of
how the firm’s technology is being used to “unify the health multiverse” – thinking far beyond the acute environment. The NHS Coordinate My Care service, for instance, uses InterSystems HealthShare platform to build an online care plan for urgent and end of life care patients, changing the patient experience, preventing inappropriate hospital admissions and informing actions for emergency and out-of-hours responders across London. On the other side of the Atlantic in New York City, Woodlock recalled how Healthix, the country’s largest health information exchange, had connected information for more than 600 organisations and 16 million patients.
the healthtech series
WWW.DIGITALHEALTHAGE.COM
A NEW MODEL FOR PAEDIATRICS? Philip Graham, digital programme lead at Healthier Lancashire and South Cumbria, gave an example of local and national working together to this end. Supported by HealthShare, he detailed how a project in his locality is helping to progress a national programme around transforming the flow of information for the care and wellbeing of children for the first years of their life. Part of the task was to deliver 70,000 e-redbooks by March 2019. “The key to the programme is to know where every child is, how healthy they are and what we are doing about it. This needs to permeate everything – it doesn’t just work in Lancashire or London, we have to interoperate information wherever a child might have a vaccination, or a development check. That’s not just healthcare – that is schools and social care as well.”
But effective engagement is still seen as vital to avoid informaticians developing a “digital version of the paper process”, he said. Similarly, Jason Hess, executive vice president for strategy at KLAS Research revealed that his organisation had found that fewer than 7% of providers were getting feedback from their clinicians on satisfaction of their electronic medical records. THE MISSION Intersystems as a business is analysing the NHS, identifying the challenges and the opportunities. There is clearly much to be done, as was highlighted at the event. But at the
same time, the discussion illustrated that in many areas technology is being adopted at a faster rate than the general public might perceive. Mark Palmer, country manager for the UK and Ireland summarised: “I walk into many of my customers’ environments day in day out, and I am struck by the operational challenges. The NHS sees 1 million patients every 36 hours and delivers 10 million procedures a year. That is a huge operational challenge, and when you are trying to deliver digital technology to improve the delivery of care, it is like changing the engines while you are flying the plane.”
^
Intersystems says that such scale would now be of value for the UK’s vision. Malcolm Senior, NHS Digital’s programme director for integrating care, told the audience: “What we are trying to do with national interoperability is to build things at scale. That really does mean everybody pulling together. There is no room on that boat for passengers.”
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An artist was on hand during the event to illustrate the presentations. Philip Graham, digital programme lead at Healthier Lancashire and South Cumbria, explained how a project in his locality is helping to progress a national programme around transforming the flow of information for the care and wellbeing of children for the first years of their life.
CLINICIAN ENGAGEMENT WITH TECHNOLOGY Later, Mike Green, chief clinical information officer at South Devon and Torbay NHS Foundation Trust, spoke of the limits of the attention span of clinicians for technology.
Credit: drawnalism.com
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COMPONENTS
I
ELECTRIC While surface-mounted devices are the most common solution for miniaturisation, chip-on-board technologies are become more prevalent.
“Companies need to completely re-design their products in order to stay competitive”, said von Meiss as he talked the crowd through the many challenges of selecting and using electronic components in an increasingly miniaturised world.
“The way to reduce the risk for electronic boards is to work on the feasibility stage first. We [Valtronic] work first on the functions that we feel are risky. We try to make a proof of concept of those risky functions. We have a risk management system right from the beginning of the project. And we use the verification and validation methodology, which is usually used in software.”
But challenges like miniaturisation of the device are compounded by the need to retain standard costs - and this can hold manufacturers back. Other obstacles include optimised security, efficient power management and supply chain management (including the risk of components becoming obsolete over time). He gave the example of a cochlear implant. The components inside such devices sometimes need to last as long as 70 years, he said. But, maintaining a simple dialogue with components suppliers can be a pro-active way to manage risk around parts becoming obsolete.
explored the many evolving challenges of using electronics in medical devices in front of an audience of OEMs. MTI’s Dave Gray writes.
FEEL
n an industry which has been disrupted at scale by connected technologies, electronics are driving new waves of innovation in medical devices.
The trends driving the need for electronics in medical devices include minimising patient trauma, more cost-effective therapy, more functionality, reduced size, portability, ease of use and connectivity, he said.
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Smart health was centre stage at MedTech Europe this year. Patrick von Meiss, head of sales at Swiss contract manufacturer Valtronic
The next example from von Meiss was a deep brain stimulation unit, which is just 20mm long and 8mm wide and yet uses 13 components connected with gold wires. “The central unit needs to be very close to the brain, so this created many different challenges in
reducing the size.” The group achieved this using high-tech miniaturisation methods but without adding additional costs. Finally, the group’s otoscope (a consumer device for assessing the health of the eardrum) is something which the group is developing. “First of all we needed to acquire some video images. So we brought a temparature sensor, added a camera, and tried to take some video [as the feasibility study,] he explained. “We made several prototypes before going to clinical trials. There are four cameras in the device, which allow you to choose which is the right one to examine the ear.” Again, with a combination of feasibility studies and low-cost miniaturisation techniques, the group was able to create a device which houses all four cameras but still fits inside the ear. “Innovation today is mainly driven by electronics. Very often OEMs will need to add intelligence and communication skills to their products. What they need to do is choose a partner specialised in electronics. Also, choose a partner specialised in miniaturisation. To achieve both of these things together, find someone with R&D and production at the same location. That way you can test the product immediately,” von Meiss concluded.
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DESIGN
WORKING OR HARDLY HARD, WORKING?
M
ark Costello, head of design at Synecco explains what a ‘hard working’ medical device really means, and how to achieve perfection through design.
WHAT DOES A “HARD WORKING” PRODUCT LOOK LIKE? • It is efficient to develop • It has built-in defendable IP so that it can fend off impersonators • Its aesthetics differentiate it from the competition and enhance your brand • It is intuitive, minimising the risk of use errors • It delights by identifying the true user and meeting their real-world needs • Its desirability maximises market share and margin • It has been built to be reliable and is demonstrably effective in its intended use • It has been developed along the regulatory path of least resistance • It is efficient to manufacture at volumes to optimise unit cost • Its features are informed by a lifecycle strategy including plans to develop hardworking successors
Your products are your ambassadors in the field. Controlling how hard these products work for you is key to driving growth and achieving a sustainable ROI across the product’s lifecycle. But how do we control whether these products are hard working or lazy? Hard working products are the result of a balanced product development approach underpinned by the strategic interaction of design thinking and multidisciplinary teams. So how does design thinking improve your products? By weaving a design thinking model into the development process you empower the development team to think holistically and to challenge false assumptions. Design thinking objectivity probes the product’s viability from a business perspective, feasibility from a technology perspective and desirability from a user perspective. Adhering to this simple mantra ensures that the development program is balanced during all phases and that the user’s needs are considered with the same level of respect that we give to the harder edged considerations of technology, business and compliance. This balanced approach may seem obvious, but the reality is that we all arrive at NPD (new product development) programs with our
own biases so we need to actively manage these biases. For marketing teams and industrial designers this can be an emphasis on user desirability at the expense of all else resulting in the progression of lazy products that on the surface appear hardworking. An engineering bias can come in the form of an over attachment to the core technology, whether it is appropriate to the market or not. Clinician inventors can be too close to the perfect clinical solution and too far from the commercial realities. Financial controllers can have the opposite problem, with the optimal solution lying somewhere in between. So how do we make “harder working products” a reality? Most importantly we need to put in place multidisciplinary teams that collaborate from the very outset of the project. For managers of the process it is critical to develop an awareness of the interaction of these disciplines over time. Each team member needs to continue to bring their own values to the table, but this should be tempered by an appreciation of the need for a holistic solution by always seeking to balance the design thinking model. In the medical device industry’s understandable focus on science, technology and quality, the importance of singling out the designer from the engineer can be overlooked.
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automation & robotics
do the W robot
e entered the fourth age of the industrial revolution – dubbed Industry 4.0 – some time ago and manufacturers have become aware of the range of digital technologies that Industry 4.0 encompasses. One of the biggest technologies currently used in industrial manufacturing is robotics. Europe represents the second largest market for industrial robot sales and in 2016 there was a 12% increase in the number of sales made to various industries using the technology.
Whilst it’s difficult to gauge the uptake of robotics within the medical manufacturing industry, figures do show that robot sales to the electronics industry, which includes medical devices, have risen significantly since 2013.
The factory of the future is everywhere. The UK has lagged behind other countries, but we may be about to turn a corner. Med-Tech Innovation News reporter Reece Armstrong investigates.
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The reason for this uptake? Quite simply, robotics offer manufacturers a way to streamline production lines, helping to increase productivity and optimise workflows. Within the medical manufacturing industry, robots are being used across the entire production line, from assembly to inspection and packaging. Due to the strict regulations that try to ensure devices’ safety, manufacturers are under a lot of pressure to reproduce the same product, under the same stringent conditions time and time again, with little downtime. To keep up with the pace of innovation, medical manufacturers must be able to change manufacturing lines when new products are needing to be developed. Robotics and automation are able to help manufacturers by offering modular systems that promote efficiency and workflow. Motion control systems help production lines assemble and move medical devices in a flexible workspace; meanwhile control sensing and visionguided systems can help manufacturers not only pick-and-place devices but ensure product safety by scanning and verifying barcodes.
automation & robotics
Take for example Kuka’s KR Agilus six-axis robot. Designed for highworking speeds in confined spaces, Agilus is able to be installed on the floor, ceiling or wall, enabling manufacturers to maximise their workspaces whilst also reducing cycle times and increasing production quality. To be used within a number of sectors including cleanrooms, Agilus ensures continuous productivity by never needing a change of lubricant. Looking towards the realms of human and robot collaboration, Festo has designed a workstation that combines self-learning systems with artificial intelligence (AI) and robot-based automation. The company’s BionicWorkplace enables humans to work alongside a bionic robotic arm in a fully customisable workspace. Workers are supported through a range of systems and peripheral devices which help to relieve them of tiring or hazardous tasks. Unlike other robotic systems, which entirely replace the human element, BionicWorkplace is made for those industries in which the human worker cannot be replaced. The system is able to learn from every action initiated from its base and can therefore optimise itself to become consistent in its production. Better yet, the system’s processes and skill can be transferred to other BionicWorkplace’s and in the future, Festo anticipates it will be possible to integrate multiple systems in a global network in which orders are placed and carried out autonomously by the machinery. Sterility can be a key consideration for some medical devices manufacturers. Neal Welch, business manager for life science at Mitsubishi Electric, explains: “Automation has always lent itself to the manufacture of mass produced disposable medical devices and the bulk processing of samples - for two main reasons; initially for speed and repeatability, and then because human presence poses one of
the biggest contamination risks in a clean production or processing environment.” Derby-based Riverside Medical Packaging is using robotics to increase productivity. The company turned to Mitsubishi Electric to help it develop its Shawpak thermoforming sealing machines. The machine, which is designed for cleanroom environments, uses an innovative forming, packing and sealing process which is now carried-out on a drum, rather than a linear conveyor system. Production benefits come from the fact that the machines start at only 1.5 metres and can occupy less than 2m2, representing a reduction of up to 95% compared to traditional form fill sealing (FFS) machines. Ivor Rowe, technical manager at Riverside Medical said: “A comparable FFS machine can be anywhere from seven to 20 metres in length depending on the packaging process requirements, occupying a working space of up to 40 square metres. As a result, a given cleanroom space can fit six times more packing machines with a Shawpak design, increasing both productivity and throughput.” Nevertheless, a government report last year showed that the UK is lagging behind international manufacturing competitors in terms of adopting robot technology. The Made Smarter Review states that for every 10,000 employees the UK only has 33 robots. Compare this to 93 in the US and 170 in Germany and it’s easy to see why the UK is below other countries in terms of productivity. Indeed, a survey by Protolabs of 301 senior business decision makers in the UK manufacturing industry showed that automation isn’t having that much of an impact on organisations’ business models. The survey showed that 15% of respondents said they have no
automation in their manufacturing services, and one in 10 (9.7%) expect no or only a little (15%) increase in automation in their business over the next five years. The statistics are worrying, especially when you consider the technological advances being made to benefit manufacturers. However, initiatives in the UK such as LCR 4.0 are aiming to help companies utilise Industry 4.0 technologies to modernise manufacturing lines. The project, which is part-funded by the European Regional Development Fund (EDRF), aims to place Liverpool City as a modern and collaborative hub for manufacturing by connecting SMEs with other businesses and offering access to practical support through a dedicated LCR 4.0 team. Currently operating on a local level within Liverpool, the initiative is expected to create 60 news jobs in supported businesses; deliver fully subsidised support to 300 SMEs in Liverpool and enable collaborations between 200 businesses and partners. Last year, it was announced that LCR 4.0 has already delivered support to almost 100 businesses in Liverpool and is being touted as one of the most important projects in the UK for helping to promote Industry 4.0 to manufacturers. Mentioned in the Made Smarter Review in 2017, LCR 4.0 still needs to do more ‘to integrate districts from all corners of the Liverpool City Region,’ according to Simon Reid, sector manager for advanced manufacturing at the Liverpool City Region LEP. With LCR 4.0 already showing signs of success, a similar nation-wide initiative might be the next logical step if the UK wants to boost its manufacturing production and reach targets set out in its Industrial Strategy. (Continued overleaf).
Automation has always lent itself to the manufacture of mass produced disposable medical devices
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automation & robotics
When it comes to Industry 4.0, German-based Siemens is a big advocate of the need to push towards more modern methods of manufacturing. Despite a number of barriers (digital skills, collaboration, cyber-security) currently preventing a successful transition to Industry 4.0, Siemens’ believes that manufacturers must adopt digital practices if they are to stay relevant and competitive.
These technologies are enabling manufacturers to capture more data, access systems remotely, view online diagnostics and add production data behind devices that are being built.
Through the company’s Process Industries and Drives Division, Siemens has helped companies including Evonik, Covestro and even Dulux increase their digitisation capabilities. Siemens realises that the vast amount of data that companies now generate needs to be utilised if businesses are to optimise not only production lines, but entire operating plants. Indeed, Siemens now offers its services to businesses, stating it can create a ‘digital twin’ of manufacturers’ plants that can be used to map and optimise product lifecycles. And of course, with robotics and automation systems starting to be implemented across manufacturing sites, Siemens offers companies modular production capabilities through which they can quickly adapt to constantly changing requirements.
“In the future, these core technologies combined with adaptable automation and agile workflows will provide opportunities to achieve high volume batch production costs for low volume batch manufacturing bringing personalised devices and products ever nearer to the consumer.” Kendall said.
Paul Kendall, industry sector manager at Festo agrees that Industry 4.0 and the technology it encompasses are vital to the future of manufacturing. Whilst robots have been around to years, Kendall says that the ‘latest innovations and deployed solutions are now adding more value than ever’. “Based on the core elements of Industry 4.0, modern automation systems are providing more benefits and added value through digitalisation, connectivity and the use of cyber physical systems,” Kendall says.
In addition to this, ‘new technologies entering into the manufacturing space are adding value far beyond the physical automation itself,’ Kendall says.
Neal Welch, business manager for life science at Mitsubishi Electric, believes that the Industrial internet of Things (IIoT) and Industry 4.0 are the logical next steps for manufacturers. “The next stage is the integration of IIoT and Industry 4.0 style solutions where robots and machines are interconnected in a way the transcends their physical location. Mitsubishi Electric for example, is already using Edge Computing and various forms of AI such as the IBM Watson online AI service, builtin machine learning and physical teaching functions for establishing complex processes quickly without having to hard code routines and parameters as we have done in the past. This level of digitalisation has already allowed us to create interactive safety glasses with augmented reality displays for routine servicing and voice activation for robot function control, so it’s safe to assume that in the future, we will be looking at our robots in a different way and talking to them about what they are doing,” Welch said.
1. https://ifr.org/downloads/press/Executive_Summary_WR_2017_Industrial_Robots.pdf 2. https://www.robots.com/articles/medical-manufacturing-automation 3. http://www.dmaeuropa.com/Clients/MitsubishiElectricUK/About/tabid/3591/Default.aspx 4. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_ data/file/655570/20171027_MadeSmarter_FINAL_DIGITAL.pdf 5. https://www.medicalplasticsnews.com/news/technology/industry-4-0-not-impactingmanufacturing-as-expected-new-res/ 6. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_ data/file/655570/20171027_MadeSmarter_FINAL_DIGITAL.pdf
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Find solutions for common testing challenges faced by pharmaceutical and medical device industries on Instron’s all-new BIOMEDICAL TESTING WEBSITE: go.instron.com/bio
VISIT US AT MEDICAL TECHNOLOGY IRELAND 26-27 September | Stand #62
5 THINGS…
OUTSOURCING: DATAART
E
What makes a successful outsourcing partnership? Vladimir Timashov, Healthcare & Life Sciences, DataArt writes.
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ven in traditionally conservative sectors, technology demand grows ever larger, in the relentless drive towards effective digitalisation. Smart medical devices and enhanced medical software products, such as Embody’s preoperative planning software or Bigfoot’s insulin pump use new technologies such as AI and VR to produce a better user experience, a reduced level of risk, and a reduction in the cost of diagnosis. Many medical device companies are now at the beginning of their digitalisation journey. Some of these manufacturers historically have no software technology capabilities inhouse. Likewise, there are also niche startups in the industry, often founded by
doctors whose expertise lies elsewhere, struggling with software development proficiency and resources. Of course, one option is to build an in-house technology department. However, this approach requires significant upfront investment and can create significant drag on time-to-market. Finding a technology partner is one viable solution that, if chosen carefully, will offer the required expertise and resources for the long-term journey towards digitalisation. According to ISO 9000 and ISO 13485 standards, a manufacturer should control the outsourced processes and remain responsible for them. So, if you are the CIO of a medical device manufacturer and you’re just
starting out on the journey of software technology partner selection, you will need to perform due diligence on companies you consider working with. It goes without saying that any company on your shortlist should have the necessary technological expertise and have produced cost estimates to suit. But these alone are not enough. Who you choose is likely to be a large part of the difference between success and failure in the path to excellent digitalisation. It is not a choice to be taken lightly. Here are the five additional makeor-break considerations when choosing that crucial technology partnership:
OUTSOURCING: DATAART
…TO REMEMBER WHEN CHOOSING A TECHNOLOGY PARTNER
1.
3.
FLEXIBILITY – CAN THEY ADJUST TO YOUR NEEDS?
A great supplier should be flexible and able to adapt to your product development life cycle. Flexibility makes adaptation possible throughout the entire journey. Each particular Medical Device has specific risk factors and intended use, alongside compliance with the company’s standard procedures. Therefore, you may not necessarily need a black-box software solution, but rather a service to make it possible to implement a software component for your medical devices in close collaboration with your company’s guidelines, as a step-by-step approach. A supplier should be capable of developing and adjusting their procedures and fit to the manufacturer’s QMS needs.
4.
ARE THEY A GOOD FIT?
Remember, you will be working very closely with the technology partner. The supplier should fit your culture. The corporate culture of both parties will play a significant role in building a relationship. It’s helpful to keep in mind that shared values, operational routines and management styles make it possible to avoid conflicts, help align priorities easily and significantly speed up the overall process.
ARE THEY GROWN-UPS?
2.
EXPERIENCE – DO THEY KNOW MEDICAL DEVICE SOFTWARE DEVELOPMENT – OR WILL THIS BE A FIRST FOR THEM?
The supplier you choose should be mature enough to help plan and set up quality controls. You will walk handin-hand through planning, solution design, risk assessment, development and validation with the supplier you select. Therefore, it’s important to make sure your future partner has the ability, knowledge and resources to support you throughout the journey. Bringing the technology experts in at the early stages of the planning will help identify and mitigate possible risks related to technology and outline your technology strategy.
Flexibility doesn’t mean the absence of control or avoiding necessary routines. Being a highly regulated industry, medical device development requires thorough approaches when it comes to design controls. Partnering with a technology provider that has all the required knowledge and experience in place makes it possible for the software development lifecycle to be built properly from the very start of the journey and ensures that no important steps are missed.
5.
RE-EVALUATE A LONG THE WAY
Due diligence when selecting a supplier is a crucial step in the whole journey. But don’t stop there. The initial selection of the supplier is still just the first step. It is vital to re-visit, revise and re-evaluate as you go along, regularly asking yourself whether your current supplier still mirrors your goals and adds value. Not only is this required by the standard, it also allows you to make sure the partnership remains meaningful in the long run.
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a
company
Medical Device Design Synecco Studio is an award-winning, IP generating team of researchers, usability experts, industrial designers and engineers who are passionate about how great products deliver commercial success. Our goal is to help visionary clients deliver sustainable success by creating product solutions that work harder for you in an increasingly competitive world. Synecco Studio combines with Synecco Contract Manufacturing to provide seamless end to end design, development, manufacturing and supply chain services to the medical device industry.
CONTACT US TODAY: Block 8, Galway Technology Park, Parkmore, Co Galway, Ireland, H91 YF29 T: +353 91 577978 E: info@synecco.com www.synecco.com
Research & Strategy
Usability Engineering
Industrial Design
Creative engineering
Visit us at stand 72, Medical Technology Ireland, 26-27 September, Galway Racecourse, Ireland
Before even a single product has been sold, hundreds of different records are needed to demonstrate a
QUALITY MANAGEMENT
medical device is fit for purpose. Kate Armitage, head of quality at Qualsys, tackles this complex challenge.
Don’t risk it
T
he very nature of bringing a new medical device to market is extremely iterative. Equipment, materials, suppliers, competency of staff will change multiple times throughout the design control processes. Most procedures are out of date before there is even time to finish typing them up. A common mistake medical device companies make when planning their quality management system is to manage processes in silos. Standard operating procedures, policies and risks are all managed in various locations by different people. While this is sustainable when there is just one quality manager to update just a handful of documents, most medical device companies will grow from 20-200 employees in just two to three years. A lack of integration causes multiple issues when the company needs to manage the entire product life cycle. The first issue is managing communication and collaboration across various departments when a change is made. For example, if the design engineers update the product specification document, there needs
to be a process to demonstrate the product is still fit for purpose. A single change can wreak havoc if there is not an integrated, transparent management system. The second issue is that feedback is not always provided where it is needed. When there is a lack of transparency, it’s much more difficult to capture issues, ideas and insights from subject matter experts across the business. Employees get confused, there is a lack of control, everything becomes more chaotic.
which will enable you to manage risk holistically, not as a silo. The medical device quality management software system by Qualsys is an advanced solution which enables you to associate documents, issues, products, jobs, audits, and any other information with each risk. Audit trails make demonstrating compliance a natural and seamless process.
The final issue is the challenge identifying, measuring and managing risk. In all Standards and Regulations, such as the FDA, MHRA, ISO 13485 AND iso 14971, we are reminded of the importance of effective risk management. However, many medical device companies still look at risk management as a separate, adhoc function. Risk-based thinking needs to be enforced throughout every process. It needs to be everyone’s responsibility. There are many different quality management software solutions available on the market
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International exhibition and conference on the next generation of manufacturing technologies Frankfurt, Germany, 13 – 16 November 2018 formnext.com
Discover the future of manufacturing at formnext! Is your head full of ingenious ideas? Are you looking for innovative partners to realize them using additive manufacturing and the latest manufacturing technologies? We provide the ideal platform.
Where ideas take shape. Offical event hashtag #formnext
25-27 Sept
T ’ N O D … S S I M W 2018
TCT SHOW
ptember 25-27 Se am Birmingh the NEC, g will brin TCT Show ting rin the 3D p ther ity toge n u m m o c We ne roof. under o an D up with caught f r, head o O’Conno up , TCT Gro t n e t n o c ’s ut what to find o r the fo in store n. io 2018 edit
O H S T C ...T
MTI: The TCT brand has gone from strength to strength in recent years, seeing expansion around the world. What have been the drivers for this success? DOC: TCT has grown in parallel with the industry. When TCT started out life as a university newsletter in the early 90s, the number of machine manufacturers was in single figures, and we counted industry revenues in thousands. Today we count machine manufacturers in their hundreds and, according to trusted sources, the market is worth over seven billion US dollars. From that university newsletter, the TCT Group now has four regional editions of the magazine, runs six conferences and five global trade shows. MTI: What trends are emerging in the AM space? DOC: A common misconception about additive manufacturing is that it will eliminate traditional manufacturing methods, but the truth is that many manufacturers are now applying the technologies to augment current workflows. The foundry industry, for instance, is using AM for the investment casting of previously impossible shapes. By 3D printing geometrically complex patterns in a sacrificial material like wax, a foundry can then switch to the materials and the processes it has expertise in to complete jobs they may have previously turned away. We’re also beginning to see SMEs get to grips with the technology and competing with the larger companies by being agile in their usage. MTI: What can medical device manufacturers look forward to at this year’s show? DOC: A recent report found that 16 of the top 20 hospitals in the US now have a point-of-care manufacturing solution. The primary in-house use is the 3D printing of anatomically correct models, often taken from CT scans, which assist in pre-surgery preparation. At this year’s TCT Show, there’s plenty on show for medical device manufacturers. With the likes of Materialise’s FDA approved Mimics inPrint software,
H.C. Starck’s Bio-compatible refractory metal alloys for patient-specific orthopaedics, and 3D Systems’ new on-demand service for 3D printed medical models, visitors can see the complete materials, software and hardware trifecta. The Main Stage is the place where we showcase the most critical research and applications in our fields. The keynote session will kick off each morning giving delegates an inspirational kick for the topics to come. The Healthcare session on day two includes a talk from trauma and orthopaedic surgeon, Dr Brendan Gallagher of Belfast Health and Social Care Trust, Royal Victoria Hospital on “Deploying automated, elastic and cost-effective 3D printing in the NHS to reduce costs and improve care”. MTI: TCT has a history of supporting young talent. Can you tell us more about that? DOC: A recent report from AM UK on the National Additive Manufacturing Strategy said that by 2020 the UK will need to fulfil 60,000 AM specific jobs, the skills gap for engineering is expected to be ten times that. If we want to sustain the additive manufacturing expertise we have developed in the UK, we need to inspire the next batch. Over the past decade we have run an educational programme now known as Inspired Minds. The 2018 edition of Inspired Minds in partnership with CREATE Education, Autodesk and Bloodhound Education, will see hundreds of schoolchildren attend the show. In the training hub located in amongst the multitude of technologies on the show floor, the class of 2018 will learn how to design a part for Bloodhound’s Supersonic Car.
33 33
STARTR Our guide to the latest young up-starts in medtech
TAKE IT HOME
There are now probably hundreds of solutions for monitoring well-known conditions like diabetes at home. So perhaps its time someone came on the scene with a remote monitoring system for a lesser known ailment. Kalium Diagnostics, based in Cambridge, is currently developing a home testing kit for patients with unstable potassium levels. Low potassium can cause heart palpitations, fainting, abdominal cramping and even depression.
GAME CHANGER
Premature ejaculation is estimated to affect about 30% of men, and can become a contributing factor to relationship problems, avoidance of sex, anxiety and depression. Now, a start-up called Morari (the Latin word ‘Mora’ means ‘delay’) has developed a transdermal device which uses neuromodulation as a means of inhibiting the nerves of the penis, thereby delaying an ejaculation.
EYE SEE YOU
Many of us will require cataract surgery as we grow older – in fact it’s one of the most common procedures. But after the surgery, many patients suffer complications, including infections and a proliferation of new cells over the artificial replacement lens. Typical treatments to combat this include eye drops and laser eye surgery. But London-based VisusNano has come up with a drug-eluting intraocular lens implant which could solve this problem for good.
STOMACH THIS
This is another device for mitigating postoperative risks which could soon be on the market. American newcomer Noleus Technologies is developing a medical device designed to improve patient recovery following abdominal surgery. The Noleus device prevents post-operative bowel swelling, speeding patient recovery.
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MED-TECH INNOVATION EXPO
15 - 16 MAY 2019 NEC | BIRMINGHAM | UK medtech | digital healthtech | medical plastics | manufacturing software | inspection and metrology | regulation | design early stage innovations | pharmaceutical manufacturing
MAKE
SALES AT #MEDTECHEXPO
of exhibitors surveyed said they made sales at Med-Tech Innovation Expo or would as a result of exhibiting.
CAN YOU AFFORD TO MISS OUT? OVER 4,000
ATTENDEES ARE WAITING TO MEET YOU BOOK YOUR STAND AT WWW.MED-TECHEXPO.COM
In partnership with
Want up to £7,000 to grow and diversify your business? Keele University’s Business Bridge Innovation Vouchers can pay for specialist support, including: support for market access product design, prototyping and testing CE marking and other regulatory advice Open to Staffordshire businesses operating in or around healthcare and medical markets, particularly: manufacturing
materials
engineering
electronics
digital
and many other sectors
For further information about how the Business Bridge programme can benefit your business, please contact Kylie Salmon, Project Manager, on 01782 734467 or email k.salmon@keele.ac.uk. This programme (no. 32R16P00713) is partfunded through the European Regional Development Fund (ERDF) as part of the England 2014 to 2020 European Structural and Investment Funds (ESIF) Growth Programme.
For details about Keele University’s other business support programmes, please visit keele.ac.uk/business.