MTI Issue 57 by Med-Tech Innovation Magazine

www.med-technews.com Issue 57 | Jan/Feb 2022

@medtechonline

MED-TECH INNOVATION | NEWS MED-TECH

PLUS innovation Why companies are targeting Ireland for nanotech Exhibitors explain why they’re returning to Med-Tech Innovation Expo Regulation: How medical device firms can learn from pharma

Adding value

- Trumpf analyses the current state of play with additive manufacturing in medtech

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CONTENTS regulars

COMMENT

Ian Bolland suggests that medtech will be at the forefront of a more proactive approach to healthcare in 2022

MAKING MEDTECH

A round-up of the latest industry news

12.

COVER STORY

Trumpf analyses the potential to explore new technologies within 3D printing and its potential effects on medtech

25.

MED-TECH INNOVATION EXPO

Two exhibitors, Shawpak and ZES, explain why they’re returning to Med-Tech Innovation Expo in June

26.

DIGITAL HEALTH

ORCHA considers whether a government report goes far enough when advocating digital health use

34.

features 11.

IRELAND

MED-TECH

IDA Ireland highlights why the country is a sweet spot for medtech firms wishing to explore nanotech

INNOVATION | NEWS

17.

MICRO & NANOTECH

Accumold explains the uses of micro moulding in microfluidics

21.

DIAGNOSTICS

PBD Biotech asks if phage viruses could be the next big diagnostic tool

22.

REGULATION

Pharmaseal explains how medical device companies can learn from pharma when it comes to getting ahead of the regulatory curve

30.

COMPONENTS

Thomson outlines how miniature linear motion components can help medical device designers meet their requirements

REAL WORLD MEDTECH

GAMA Healthcare explains the uses of its infection prevention offering and its role in increasing isolation capacity

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from The editor The more proactive approach

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owards the end of 2021, and at the start of 2022, it was hard not to recognise something of a shift caused by the events of the last couple of years. During a four-day visit to COMPAMED/MEDICA, I came away from Dusseldorf with my opinion reaffirmed that the approach of developing new medical technologies, or technologies for the medical setting, is now increasingly about prevention rather than reaction. This is not a new thing for those have followed the new developments in this space for some time, but it feels like the events of COVID-19, like with a lot of the changes seen in society and in many other sectors, may have hurried the process along somewhat. Technology has been repurposed. More consumerbased technologies have become accessible as society has become more health conscious while other aspects are branching into different areas of the healthcare setting – whether that is infection control, making procedures easier through better components and devices, and indeed using technology to educate those how to use these devices properly to enhance patient outcomes.

One burning issue for me though, is whether the innovators and innovations from these companies will be able to drive significant strategic change within our health systems. In the UK, there have been several strategy papers and pieces of legislation developed in the last couple of years – The NHS Long Term Plan and The Topol Review to name a couple that have both focused and outlined areas where new technologies can be best used within the NHS. A lot of the focus has been on efficiency and better treatments, using data in a better manner, reducing any burdens on clinical staff, and ensuring the workforce is more digitally literate – all of which are admirable. But it wouldn’t surprise me if 2022 was more about keeping people out of hospital rather than treating them within the healthcare setting – irrespective of the presence of a dangerous airborne virus and as the NHS is currently experiencing record waiting times. We’ve all necessarily become more accustomed to selftesting and monitoring our conditions and there appears to be an appetite for this

to continue. I’ve never met anyone who enjoys going to their doctor, and medtech and more information allows us to keep on top of any symptoms for whatever condition may be manifesting itself. Whenever we need that consultation with our GP, we go in armed with more information and it’s more of a two-way interaction, ultimately leading to a more informed patient journey. Now, one wonders if there is the political will to transform the approach to health with the benefit for these new technologies. Under the previous health secretary, the UK has published a Long Term Plan for the NHS as well as the Health and Care Bill – both of these could be amended and developed to cater for this change in approach, while the main opposition party has started to set out its policy platform – which will surely see more meat on the bones as we get closer to the general election scheduled for just over two years’ time. If either of the two main political parties in the UK really want to take advantage of the innovation potential generated in medtech in recent years, they are going to need to work closely with the industry. It will be fascinating to see what ideas and substance emerges.

Making medtech

Vision Engineering partners with Zeiss to add to microscopy range V

ision Engineering is partnering with Zeiss Industrial Metrology to add an extended depth of focus inspection system to its range of microscopy systems for the first time. DeepFocus 1 combines Vision Engineering’s technical and design expertise with Zeiss’ new Visioner 1 long depth of focus digital microscope head. Featuring MALS Technology, DeepFocus delivers live, realtime extended depth of focus imaging with depth of focus up to 100x greater than that of a conventional microscope, removing the need for post imaging focus stacking by delivering ‘all-in-focus’ images instantly to a depth of up to 69mm. Using a micro-mirror array lens system (MALS) enables DeepFocus 1 to generate “virtual” lenses with different curvatures, thus focus planes. This is achieved by changing the orientation of each individual micro-mirror in an orchestrated way. Re-

shaping the curvature of this “virtual” lens at speed allows ultra-fast focusing and realtime all-in focus imaging and documentation. Three viewing options aid understanding of the subject being inspected. Extended Depth of Focus (EDoF) view shows the topdown view of the subject with all details in focus. Height-map view displays height data from the subject aiding visualisation of monochromatic samples and understanding of height. Topographic view shows a simulated 3D visualisation of the subject which can be rotated and manipulated. Paul Newbatt, Vision Engineering’s group sales and marketing director, said: “We are delighted to partner with Zeiss in adding DeepFocus 1 to our growing innovative microscopy product range, which further cements our position as a leading microscopy solutions provider in the electronics, and precision engineering sectors.”

MolGen opens UK office

olGen B.V., a global solutions provider of innovative DNA / RNA extraction technology, system, products and kits for human and animal diagnostics, pharma and biotech, has recently opened its UK office. The new office is located at Sixth Floor, South Quay Building, 189 Marsh Wall, London, E14 9SH. This expansion will enable the company to meet the increasing demand for costefficient diagnostic services in new markets. The new location will serve as a branch to provide professional laboratories based in London and the UK with access to

MolGen’s extraction DNA / RNA portfolio across diagnostics, pharma and the biotech industry. The opening of this new office comes shortly after MolGen opened its US office in San Diego. Niels Kruize, MolGen CCO, said: “We have been fortunate to experience such rapid growth as a company. Our ability to scale quickly has been a great asset as we continue to strive to meet the growing demand for our innovations. We see this new office as a way to further advance the testing and diagnostics industry and provide solutions as to how the world responds to disease and other life science conditions.”

Making medtech

What makes a Med-Tech Innovation Award winner? E ntries are now open for the Med-Tech Innovation Awards 2022, returning after COVID-enforced hiatus at the Hilton Metropole in Birmingham on 8th June, supporting the Medilink UK Healthcare Business Awards. There are six categories for this year’s edition: 3D printing, Connected Health, Design, Engineering, Materials Innovation, and the all-new Sustainability category. If you’re in two minds about whether you think you’ve got what it takes to win one of the prestigious prizes, here’s a snippet of what our judges had to say makes a good innovation. Alba Gonzalez, senior clinical engineer and MarieCurie Conex+ postdoctoral researcher, simply says: “A good innovation is a better way of solving problem.” Andrew Davies, digital health lead at Association of British HealthTech Industries, said: “A good innovation is one that solves a problem in an elegant, original, cost effective

and practical manner. It helps improve people’s lives, making things easier and more efficient.” Darren Clark, chief executive of Medilink Midlands, who will be keeping a watchful eye on the Medilink UK awards, says: “A good innovation is the successful application of a new idea that improves current processes.” Ashton Harper, head of medical affairs UK & Ireland, Roche Diagnostics, summaries his thoughts, saying: “Innovation is not simply invention. The ultimate goal of a novel medical technology should be to improve the

lives of as many patients as possible. To achieve this the technology (invention) must be thoroughly researched (e.g. proof of effectiveness and safety), be widely adopted and eventually prove its advantages beyond standard care - this is good healthcare innovation.” Do you think your innovation matches our judges definitions? Visit med-techawards.com to enter. Applications close on 9th March!

Engineering couple awarded MBEs

o-founders of Hampshire based manufacturing & innovation company Morgan Innovation & Technology (Morgan IAT), Sue Clarke (chairman) & Howard Clarke (research director) have both been awarded MBEs in the Queen’s 2022 New Year’s Honours list Sue has been awarded her MBE for outstanding services to business and engineering. Howard has received his honour for exceptional services to business and entrepreneurship. On learning of being awarded MBEs, Sue & Howard said: “Both of us are very proud and honoured to have been awarded MBEs. It was a huge surprise and unexpected. What has made it particularly special is the recognition that we are a

team. Everything we have done and achieved, both in business and volunteering, is because we are a team. “However, our work supporting innovation and our work with young people, students, interns and graduates have only been possible because we have always been supported by our family and the people with whom we work.” Sue co-founded Morgan IAT with Howard back in 1987 and served as managing director until February 2018, continuing today as the company’s chairman. Howard is an entrepreneur, inventor & passionate advocate of the next generation of innovators; and provides mentorship and financial support to individuals and fledgling businesses.

These accolades come at a time of expansion for the Hampshire-based company, having recently opened additional assembly lines for more agile production to meet the changing demands

of the sector. These include lines to accommodate prototyping, box builds, and micro- runs yet still maintain their high-end electronics lines while keeping manufacturing lines open.

Theatre caps provide eco-friendly way to improve communication

iverpool University Hospitals NHS Foundation Trust (LUHFT) is at the forefront of Trusts nationally to introduce eco-friendly theatre caps. A former nurse has launched the project to improve communication in theatres and minimise waste. Danielle Checketts has developed reusable, cloth theatre caps embroidered with names and roles to enable better communication in a theatre environment, whilst reducing disposable waste. The caps have now been rolled out for many theatre staff at the Royal

Liverpool University Hospital, with plans to introduce them Trustwide imminently. Checketts, managing director at Warwick Med, who produce the caps, said: “Having trained and worked at Aintree University Hospital and the Royal Liverpool University Hospital, this Trust and its patients are important to me. I’m a massive advocate for improving patient safety and I wanted to create something that could make a difference. I’ve seen first-hand how access to the right medical advances can change patients’ lives.” In 2020, Checketts identified that because

of COVID-19 and the need for healthcare staff to wear increased levels of personal protective equipment (PPE), it wasn’t as easy for them to recognise each other. Dr Mruga Diwan, consultant anaesthetist, has helped to implement the reusable caps at the Trust. She said: “The use of reusable named theatre caps enables better communication, and since wearing our own personalised caps we have noticed an improvement not only between staff engagement, but also for our patients. “We can all look very similar in our theatre

gowns and personal protective equipment, so patients now know exactly who they are interacting with, which allays any anxiety and improves their experience. The environmental benefits are also a massive bonus for us all.”

MEDILINK

As the caps are reusable, Liverpool University Hospitals is reducing waste. On average, a typical hospital will discard over 100,000 disposable viscose theatre caps per year. With the swap, LUHFT is expected to save the Trust over 1 tonne of clinical waste each year. Photo credit: Medilink Midlands and LUHFT

Inventya completes Academy launched to help innovation ideas grow Cresco merger

nventya Grants has completed a merger with Cresco Innovation. This merger aims to further enhance their combined offering of innovation and growth support to clients via increased grant writing services. With over a decade of grant writing experience, Cresco’s team of bid writers has raised more than £30 million in grant funding for clients in the last three years. Aldo De Leonibus, CEO of Inventya Limited, said: “We are delighted to have completed this merger, as it will allow us to offer our enlarged customer base an enhanced service

to further support our mission to help innovative companies bring their products and services to market in the UK and internationally via funding, finance, R&D tax credits and consultancy.” Jo Derbyshire, of Cresco Innovation Limited, added: “This is a move driven by the collective vision to work proactively on behalf of our clients, drawing on our experience to maximise both bid and tender success with our commitment to support innovative growth and myself along with the team are excited to be joining a larger group to provide a greater range of client services.”

orking with Medilink Midlands, East Midlands Academic Health Science Network (EMAHSN) has launched its first Innovation Academy to bring together all the relevant expertise a person will need to develop their health innovation idea – and it’s free to register. EMAHSN commercial director Tim Robinson said: “The East Midlands AHSN Innovation Academy is open to anyone to register including health and care staff, private and voluntary sector organisations and academic institutions. You do not have to be based in the East Midlands. “Once registered, participants will have access to a range of modules to help them put their idea into practice – whatever level of development it’s at. Each module includes a webinar, live Q&A session with the experts and online resources.”

Darren Clark, CEO of Medilink Midlands, added: “The Midlands is a hotbed of innovation and we have so many inventive and inquisitive companies who are all looking to tackle the life science issues we face. I’m pleased that we are working with the EMAHSN to better enable companies in the region to bring their ideas to reality.” Modules include: Understanding NHS structures and payments systems, understanding stakeholders, budget impacts and business cases, evidence and evaluation, patient involvement and many more. The live Q&A session for the first module Understanding the NHS Structure: Insight from a Commissioning/Trust Perspective – takes place on 10th March at 10am. Visit www.emahsn.org. uk/innovationacademy to register and find out all you need to know to develop your proposition to improve patient care.

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IRELAND

The nanotech racetrack Rachel Shelly, head of medical technologies, IDA Ireland, discusses why global medtech companies are targeting Ireland to help them join the nanotech race.

nnovation and technology are leading to significant breakthroughs in healthcare and the use of nanotechnology particularly is accelerating research into a new realm of medtech products. The most recent predictions suggest that the use of nanotechnology in medical device development is due to reach $20.82 billion with a CAGR of 11.9% from 2020-27. The U.S. currently dominates the market in this area with a prevalence of bigger players driving the research. The growth of the market is currently driven by an ageing population and an increasing prevalence of disease such as cancer, genetic and cardiovascular disease as well as chronic conditions. However, nanotechnology is costly and challenging to develop and needs specific talent to be able to take it forward. Global medtech companies are broadening their sights to find the expert support and sources of talent needed to mitigate the risks of becoming involved in high risk, earlystage research in-house where they would have to place multiple bets on technologies that may or may not work. There are three main reasons why Ireland is proving to be an attractive partner for companies involved in nanotechnology.

A RICH ECOSYSTEM, FUNDING AND SUPPORT PROVIDES THE IDEAL ENVIRONMENT Global medtech companies are already using production sites in Ireland to tap into its track record, rich eco-system, funding supports and talent pool. The Science Foundation Ireland Advanced Materials and Bioengineering Research Centre (AMBER), is currently partnering with some sizeable companies who are using the funding and facilities available for their nanomedicine research projects. For example,

New Jersey-based Integra LifeSciences is teaming with AMBER researchers based in the Royal College of Surgeons of Ireland and Trinity College Dublin to develop biomaterials for the treatment of peripheral nerve injuries, restoring the structural and functional properties of damaged or degenerated tissue via regenerated nerves. Johnson & Johnson too is working on a programme focused on 3D bioprinting of biological cells and biomaterials for promoting bone and tissue regeneration in the treatment of patients with degenerative diseases such as osteoarthritis. SUPPORT FROM WELL ESTABLISHED GLOBAL HUB TO TAKE RISK OUT OF RESEARCH Support from the Irish Government and IDA Ireland is a crucial factor in the reasons why companies are seeing Ireland as an attractive prospect to help them kick-start their nanotechnology potential. IDA Ireland’s focus on supporting research is a big draw, with its 25% R&D tax credit for RD&I expenditure for activities in a wide variety of science and technology fields, in addition to grants and innovation supports for investors. Researching new nanomaterials is an imposing task which presents risks when trying to develop something at scale for industry applications. But the expertise and infrastructure within Ireland’s medtech hub enables companies to get on board with research with skilled scientists. Another challenge for medtech companies, is that research is typically funded by a company itself, which can be a significant undertaking in the case of early-stage research. Under the SFI centre cost-share model, AMBER has the ability to co-fund projects with the collaborating company, which is well suited to early-stage high risk research.

In this scenario any foreground IP will be owned by the University with the company having the option to license. The company can also fully fund the project in which case the foreground IP may be assigned at the end of the project. ACADEMIC RESEARCHERS FROM ACROSS THE GLOBE GIVE COMPANIES SOLID LIFT OFF The nature of nanotechnology is that it is multi-disciplinary and needs to bring together expertise of academic researchers from several different fields, including physics, chemistry, bioengineering and immunology. Traditionally companies will collaborate with a top domestic university lab and use its resources, but this is usually a one-off situation. However, collaborating with AMBER in Ireland means companies have access to the eight different universities that are affiliated with the centre. They can then define the nanotechnology research that they’re interested in exploring and the centre will put together potential academics from its institutional partners who could assist with the project. The resources within these eight institutions include academics from all over the world who come to Ireland because of its reputation for investing in breakthrough research. Thus, it’s not surprising that Ireland is competitive with the world’s top universities, and that AMBER has won a multitude of prestigious European Research Council awards. With such assistance, global firms get a solid lift-off for major research that can then be brought into their company at a more mature stage, and is more likely to translate into a product. Investors in Ireland have access to the many trained graduates produced annually by the universities in Ireland, alongside access to transferable applied nanotechnology research in ICT, biophotonics.

on the cover

Adding value (with Additive)-

- MeTAL 3d prInTInG oF sTAndArd deVICes In THe MedICAL IndUsTry

ost medical device manufacturers already have experience with 3D printing, either with metal, plastics, ceramics, or biological materials (such as tissue). You could say that additive manufacturing is not so new anymore. Compared to the vast field of conventional processes, however, it is, and it has yet to prove itself as a serious alternative in many application areas. Nevertheless, it is no longer accurate to see additive manufacturing technologies only in terms of “rapid prototyping”, as the technology has developed quite rapidly into a production solution for final parts within the last decade. This development was driven by early adopters and printing enthusiasts, but also by machine manufacturers like TRUMPF. German laser expert and machine manufacturer TRUMPF entered the additive manufacturing field back in 1999. Since 2014, the company has offered metal 3D printers based on laser powder bed fusion (LPBF) technology with its TruPrint machines. Being familiar with the medical market through its laser marking, laser cutting and laser welding solutions, the company has not only launched machines that meet the needs of medical device manufacturers, but also offers advanced services to help customers with their qualification and validation process. Additive manufacturing is best known for its design freedom, which has made the technology ideal to produce patientspecific devices. But this is not the limit of its potential. Many off-the-shelf devices have proven to be a sufficient and reliable solution for patients all over the world and do not necessarily need to be replaced by a customised solution. Nevertheless, or precisely because of this, the question arises as to how 3D printing can add value to the production of these standard medical devices. The design flexibility afforded by additive manufacturing technology makes it possible to significantly shorten the entire process chain by already integrating the surface modification or component functionality into the printing process step.

Laura Kastenmayer, industry manager medical technology, TRUMPF Additive Manufacturing, analyses current technologies within additive manufacturing and their role in enhancing its capabilities in medtech.

An exemplary case for the mass production of parts with integrated surface design is acetabular cups. These are flagship products for metal additive manufacturing in medtech and have been printed with different surface structure characteristics since 2007.

ON THE COVER

The benefits of the technology are obvious, even if only a fraction of the potential of additive manufacturing has been exploited so far

Meeting the mass production market requires an approach that significantly reduces cost per part and time to market, while maintaining a high level of quality. There are several critical process parameters that impact a reliable and efficient production process, and many of these can be addressed through engineering improvements to the machine. Over the years, TRUMPF has invested heavily in advanced and robust machine designs, focusing on well thought-out gas flow concepts, parameter settings and stable process conditions. The company also equips its machines with state-of-the-art monitoring solutions that help additive manufacturing operators better understand their process and monitor the quality of their parts. One of the technical machine developments is the 500°C preheating option on the TruPrint 5000 machine. This feature raised the limits of production capacity in metal powder bed melting to a new level without the need to add further laser sources. Using the acetabular cups as an example, the effects of 500°C could be optimally exploited by significantly reducing the number of support structures and stacking the components in multiple layers. It is self-explanatory that this process saves material costs and reduces part costs in series production when the system is utilised to the maximum. The use of 500°C preheating for

titanium and advanced parameter setting also ensure that quality is not compromised at maximum production capacity. But it is not only the widely used material titanium for orthopaedic implants that benefits from the advances TRUMPF has made in printing technology in recent years. With the 500°C preheating of the build plate, it is also possible to process high-carbon materials such as hot work tool steels 1.2343 (H11) and 1.2344 (H13). One might think that this is of no interest to medtech, but it is the opposite. Hot work steels, as well as stainless steels such as 1.2709, are often used for mould inserts in plastic injection moulding. Considering the huge amount of disposable plastic products, plastic injection moulding plays an important role in the medical industry. Combined with additive manufacturing, mould inserts can be designed with near-contour cooling to improve cooling rates and plastic quality in ways that would not be possible with conventionally manufactured inserts. Nevertheless, it is rarely the case that additive manufacturing can do without one of the conventional processes. For users, machine suppliers and the manufacturing industry, it is crucial to bring the additive and conventional worlds together in the best possible way. Each technology should be used where it brings the greatest benefit. TRUMPF offers technical solutions in the dental market that take this approach into account and allow individual geometries to be printed on a conventionally manufactured part. This approach is called printing on preform and medical applications such as shoulder or dental implants and surgical instruments can also benefit from this solution in an economical way. From major OEMs in the medical industry to new, emerging contract manufacturing companies, all have recognised the potential of metal 3D printing

for medical device products. The challenge is to use the technology in a profitable way. The initial time spent evaluating the potential of additive manufacturing, as well as the right machine solution and the right machine supplier to support along the way, are key to success. “We worked for two years with IMR [Irish Manufacturing Research], a technology and research organisation, to experience 3D printing and get a feel for what it could do in terms of its capabilities, limitations, advantages and disadvantages,” says Gerard King, director of Smithstown Light Engineering, an Ireland-based company that recently invested in two TruPrint 2000 machines from TRUMPF to manufacture and supply parts to the medical industry.

It is worth investing time and money in the introduction of additive manufacturing first. The benefits of the technology are obvious, even if only a fraction of the potential of additive manufacturing has been exploited so far. Currently, the focus of metal additive manufacturing is on orthopaedic devices and implants, which are primarily made of titanium or CoCr. But the technology offers so much more. Even exotic materials such as copper, tungsten, tantalum, nitinol, precious metals, and amorphous metals have already been successfully processed on TRUMPF printers, opening up future improvements in areas such as cardiology, electrosurgery or imaging and diagnostics. Those who neglect the emerging technology of additive manufacturing could lose touch with the market and the competition in the medium to long term.

MED-TECH INNOVATION

8-9 JUNE 2022 NEC | BIRMINGHAM | UK

Co-located Shows

Medical Device Supply Chain Intelligence

3D PRINTING

3D printing innovation and patent protection during the pandemic Robert S. Jacobson and Kate Nuehring Su, associates at Marshall, Gerstein & Borun, discuss key IP considerations for patenting 3D printed medical supplies and devices, and how the COVID-19 pandemic could shape innovations over the next few years.

nnovators have sought to address the urgent challenges and supply shortages created by the COVID-19 pandemic by harnessing 3D printing technologies to develop and improve various medical devices. For example, when supply chain problems caused a critical shortage of nasal swabs, a team at the University of South Florida (USF) developed a 3D printed swab that uses nubs instead of a traditional polyester flocked head to collect tissue. The team provided the files to hospitals and healthcare systems worldwide, and over 70 million swabs using their design have been printed. What might be surprising is that, in addition to freely distributing the files for their swab design, the USF team also filed a provisional patent application. Patents are valuable tools that let manufacturers of 3D printed medical supplies and devices protect their innovations from being made, sold, or used by others. To obtain a patent, the innovation must at least be novel and non-obvious. “Obvious” is not understood in the colloquial sense; rather, obvious is a legal term that involves a rigorous analysis. In 3D printing, this may mean that simply replacing a conventionally manufactured part with a 3D printed equivalent is not sufficient to obtain a patent. Instead, one should focus on the particular differences between conventional parts and 3D printed parts. For example, does the 3D printed part (e.g., the USF nasal swab) have a more detailed geometry than a conventionally manufactured part? Does the 3D printing process allow for multiple parts to be integrated into a single 3D printed part? Is

there a unique way of printing the part as compared to other 3D printed parts? These are among the considerations that are important in assessing whether an innovation is best protected via patents.

containing, and treating COVID-19. The Open COVID licenses last until one year after the World Health Organisation declared the COVID-19 pandemic to have ended but, in any event, not beyond January 1, 2023.

Another important consideration is understanding the specific protection afforded by a patent. Take, for example, a patent for a physical dental implant that is printed based upon a scan of a patient. Now imagine that a competitor was to scan the patient and send the patient a CAD file for printing at home or via a 3D printing service. The company that scanned the patient and sold the CAD file did not make, sell, or use the physical dental implant. Accordingly, the patent owner may have to rely on more complicated doctrines of indirect infringement or seek damages from the patient. As such, it is important to ensure that the patent protection is crafted such that the business model surrounding the innovation is also protected.

In that time, some of the pledged 3D printing technology that might be freely commercialised includes:

The patent system is intended to reward the effort put into innovation but asserting a patent on a necessary technology amid a global pandemic runs counter to the very purpose driving many inventors: to help those in need. To balance these competing priorities, an international group of researchers, scientists, academics, and lawyers developed the Open COVID Pledge. The Open COVID Pledge involves making one’s intellectual property free of charge for use in ending the COVID-19 pandemic. By making the Open COVID Pledge, an IP owner grants everyone a royaltyfree license to make, use, sell, or import the pledged patent for the purpose of diagnosing, preventing,

• 3D Printed Customised Medication: IBM pledged U.S. Pat. Pub. No. 2021/0008869A1, which is directed to a method for printing customised 3D medication using a patient’s medical records. • 3D Printing of Biologically Derived Materials: NASA pledged U.S. Pat. No. 10,815,474B1, which “combines 3D printing technology with artificially modified cells for production of nonliving biomaterials.” • 3D Printed Model for Surgical Planning: IBM also pledged U.S. Pat. Pub. No. 2020/0015893A1, which describes a method for making a three-dimensional model of a patient’s organ for purposes of pre-surgical planning. While there is uncertainty and legal risks in how it will play out, the Open COVID Pledge is an encouraging example of how companies are able to work together to mitigate legal hurdles that would otherwise hinder collaborative solutions to global problems. The lessons from setting up the legal framework to fight COVID-19 in a decentralised manner will provide the confidence that open and collaborative approaches are viable and that new sources of innovation are possible.

Micro and Nanotech

LASER SHARP Lincoln-based manufacturing firm Micrometric outlines how it feels it leads the way in micro laser manufacturing.

icrometric produces fine parts and precision components for a range of customers in the UK and international markets, specialising in services including cutting, etching, drilling, and welding as well as tube cutting and precision component machining. Fine parts are used in a variety of industries: gas turbines, filter applications including aircraft hydraulics, scientific instrumentation including instrumentation for analysing gases and military applications.

Commercial director Chris Waters said: “At Micrometric we have built up a reputation for taking a personal approach to fully understanding every customer’s laser cutting requirements to optimise the production process and achieve the best results.” The company is AS9100 qualified and can supply process sheets, certification, first article inspection reports or similar inspection regimes to clients, as required. It also has micro laser cutting capabilities that allows small parts to be cut to tight tolerances +/-0.05mm to +/-0.02mm across materials including stainless steel, titanium, copper, brass, and ceramic. The smallest part

Micrometric has produced is a washer with a diameter of 0.5mm. The company can cut extremely thin materials down to 0.05mm thickness, which is about three times thicker than household kitchen foil.

companies which produce aerospace filters, automated injection needles, endoscopy components and MRI scanning equipment as well as producing finer, precise parts for other sectors.

Not only are parts laser cut using precision lasers, but additional operations are carried out using the wire erosion machine, surface grinder and Haas CNC miller achieving even finer tolerances.

Speaking about medical sector work, Waters said: “The equipment produced for the medical sector is often extremely small and intricate and as these devices are used to save lives, it is imperative that the processes used to make them from beginning to end assure their quality and reliability.”

Parts are cut on fine lasers, which have collection trays underneath, so that parts can be cut without leaving a pip. All parts are then also cleaned via a suitable method including acid cleaning, ultrasonic cleaning, tumbling, and flattening. A variety of measuring equipment enables measurement of even the finest features. Waters continued: “We use several CO2 and state-ofthe-art fibre laser cutting systems which precisely cut materials with minimal heat and excellent edge quality to produce components quickly, efficiently and cost-effectively. “In 2018, we invested in the Coherent StarCut Tube machine which is fully automated and is designed to laser cut, drill and mark tubular or flat metal components and is traditionally used by subcontract manufacturers to produce exclusive medical instruments with extremely high precision.” Since investing in this equipment, Micrometric’s workforce has used the machine to cut, assemble and weld complex medical and aerospace components for

To manufacture medical parts, the company uses tube cutting to create small windows, slots, holes, and spirals for different pieces of equipment such as cannulas. The laser machines offer high resolution cutting to ensure high speed dimensional accuracy, precision and stability which is required when producing medical tube components economically. Micrometric understands the importance of having full traceability when massproducing for this sector and can laser mark medical products with clear Unique Device Identification (UDI) codes to ensure that every part can be tracked back to its source.

Waters added: “We can also weld autogenously or with wire feed. Depending on the metallurgy of the parts, it is possible to add different alloys as wire to adjust the weldability of the component. The wire feed can be fully automated within the welding machine. For some welds, such as titanium, a helium atmosphere is required, and an enclosed helium welding system is used.

“A variety of materials can be laser welded dependent on the metal composition and design of the product. We have experience in welding a variety of different tube sizes for different applications including medical, aerospace and other industrial applications.”

The company has several lasers, and its experts can weld a range of parts to form high-quality solutions. Laser welding offers the benefit of welding while minimising heat input which is critical when welding components with temperaturesensitive items inside them or minimising any distortion due to heat.

Micrometric is also a member of TWI so can access expert advice, knowhow and safety assurance related to engineering technologies.

Micro and Nanotech

COMPLEXITY IN MICRO MOULDING – A FOCUS ON MICROFLUIDICS

Aaron Johnson, VP marketing & customer strategy, Accumold, analyses the use of micro moulding in microfluidic devices.

here are few applications that are as exacting as the manufacture of microfluidic devices. Not only is there a requirement for ultra-precise and ultra-small features that need to be manufactured repeatably, but it requires a laser-like focus on the area of design for micro moulding (DfMM). When looking at the micronlevel of precision inherent in a microfluidic device, it is necessary to understand that the rules of injection moulding and the behaviour of plastics change. One area that also requires detailed attention is flatness. A microfluidic device usually needs to be completely flat, as any curvature will compromise the required sealing of channels through which gases or liquids need to pass. Traditionally, injection moulding is characterised by such issues as deflection, warpage, and shrinkage which can all compromise the integrity of the finished device, so your chosen micro moulder must have the knowledge and experience to work round such potential problems, and this may require the moving or modification of features. When looking at microfluidics, we are not dealing with devices that afford a lot of room for manoeuvre, and there are often a lot of interconnected features and geometries, movement, or redesign of one potentially altering another. With all this in mind, a micro moulder will necessarily place a disproportionate focus on up-front design reviews involving representatives from all phases of the product development process. Key among these are representatives from the micro-tooling team. Tooling for micro moulding projects does not require an extrapolation of the rules governing tooling in traditional injection moulding. Features in micro moulded parts often exceed the allowable

tolerances in traditional injection moulding, and similar issues are confronted in the areas of venting and tooling mismatch. Other tooling issues specific to micro moulding are requirements for an understanding of polishing for micro-mould cavities, and the heating and cooling implications when dealing with extremely thin steel inserts that can be negatively affected by temperatures involved in many moulding applications. In addition, as many micro moulding applications use high temperature or high performance materials, such as liquid crystal polymers and PEEK, it is necessary to use and understand the nature of tooling materials such as stainless steel rather than traditional tool steels which may not be able to withstand the high temperatures necessary, and can corrode. It is vital to consider the likely stresses and strains that a specific microfluidic device design may impart on the necessary micro tool to make it. Very often microfluidic devices are characterised by extremely small micron-level distances between features, and this implies that the tool will have very thin regions that are prone to wear and tear. Such a tool if not designed correctly may well be appropriate for only low quantity production but would be troublesome when looking at high volume mass production, and then the cost and time implications of mould maintenance become an issue. Catching such problems before a design is locked down is extremely important, as it means that the time and cost of design re-iterations and revisions can be avoided.

When working with your chosen micro moulder, it should all be about reviewing and a total focus on DfMM and design for micro assembly (DfMA) when producing microfluidic devices. Standard mould flow analysis does not always work when looking at micro tools and working at micron tolerances, so it is about the knowledge and experience of the micro moulder. Microfluidic devices require tooling that will allow the production of parts that see the correct depth and length of features is replicated sometimes millions of times perfectly and repeatably. When looking at the micro features in such tools, your chosen micro moulder needs to have a detailed knowledge of the different material flow, viscosity, and solidification characteristics of the materials being used to ensure that feature integrity is maintained. Quite often such devices are used in safety critical applications, so failure is not an option. As so often is the case, the micro moulder that will be able to navigate the intricacies of the design and manufacture of highly complex microfluidic devices is one that will combine access to in-house technologies that push the envelope in terms of what it is possible to manufacture (the kit), with the knowledge and understanding of all the different aspects of a product development process from design to mass volume production and assembly (the experience). The emphasis must also, as always, be on the nature of the relationship that is forged between customer and micro moulder. The discussion of the huge importance of DfMM and DfMA above in respect of the manufacture of microfluidics involves a true partnership ideally from the point of product conception to achieve optimised goals as quickly and costeffectively as possible.

Your technical experts for plastic injection moulding

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Sensors and Electronics

AT THE HEART OF CHANGE: How sensors have become the centre of an RPM revolution

Nick Delmonico,, founder and CEO of Strados Labs, examines the role of sensors in remote patient monitoring (RPM).

ver the past several years, the medtech industry has seen incredible technological advancements and opportunities to provide patient care in lower cost care settings like the home. Medical smart sensors, devices capable of collecting clinical-grade biometrics from patients and connecting to software applications like EHRs or telehealth applications, are increasing in stakeholder demand. In the last three years alone, wearable use with patients has risen from about 35% to nearly 45%. In reality, over 45% of people today are monitoring their health in some way with wearable technologies, and of the new users in the last five years, about 2/3 of those are using it to manage their chronic condition. Over 15% of clinical trials include wearables today and according to Kaiser Associates and Intel, 70% of clinical trials will incorporate sensors by 2025. REMOTE AND TELEHEALTH CAPABILITIES Remote patient monitoring (RPM) is the ability to collect data from a patient after they leave a doctor’s office, hospital, or skilled nursing facility and get meaningful insights that you wouldn’t otherwise have access to outside of one of the aforementioned facilities. Armed with this information, as a clinician you can either decide to change management, treatment, or recommend

the patient seek care locally. Reimbursement for RPM in 2022 can be between $70-$150 per patient over the course of 30 days of management and provides significant ROI to providers when complex patients can avoid the ER or a hospital admission as a result. Patients don’t always have convenient access to specialists like pulmonologists or cardiologists in their area, making it difficult to see the doctor without taking time off from work. RPM & telehealth provides a way to engage with the clinician via text messages and through a patient portal where you can ask questions and easily sync and provide critical physiological data from your wearable sensor, all without having to commute and take time off from work. Strados for example has developed an FDA cleared technology called RESP, a lung sound measurement device that connects to a mobile and web application to aid in clinical assessment of a patient’s respiratory status. RESP is worn by a patient and collects recordings of lung sounds daily, for review by a clinician via its web platform. It detects and measures wheezing, coughing, rales, rhonchi, all of these different

lung sound abnormalities that may not otherwise be reported by the patient subjectively. This may help doctors, nurses or therapists make treatment decisions for the patient and avoid hospital visits. MITIGATING CHALLENGES WITH DECENTRALISED CLINICAL TRIALS Clinical trials are the cornerstone of medical advancements, but due to geographic and financial barriers, they are not accessible to all patients. Trials typically require that participating patients travel to a study site for data collection including biomarkers, creating challenges with recruitment and retention. In December, the FDA introduced a new strategic framework to advance the use of realworld evidence to support the development of drugs and biologics. Using wearable devices to collect biomarkers and electronic outcomes assessment (eCOA) like blood pressure, cough rate, activity remotely enables decentralised and hybrid trials to be successful. REDUCING PATIENT BURDEN TO INCREASE RETENTION Study sites are not always conveniently located to the general population, which can make participation

impossible for patients who do not have the means to travel. These barriers can impact the diversity of patient populations, recruitment, data collection and ultimately the trial results. Leveraging connected medical sensors and digital health applications means researchers can collect all the study data required like questionnaires, point of care diagnostics, and physiological data wherever the participant is, significantly reducing the patient burden and increasing the likelihood that they will remain enrolled. Digital biomarkers collected from wearables and sensors also help researchers effectively define the recruitment criteria and enrich enrolment of a patient subgroup who are more likely to respond to a novel therapeutic in Phase ⅔ clinical trials. What is most exciting for the future of smart sensors and wearables in clinical trials and remote care is the rapid adoption of mobile technology and infrastructure that is now in place, pushed over the edge by COVID-19. Firms and patients are now fully enabled by telehealth and remote platforms. The integration of the right smart sensors to capture key insights into biomarkers and vitals is the clear next step.

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Diagnostics

PHAGE VIRUSES – THE NEXT TOOL IN THE DIAGNOSTIC BOX?

Med-Tech Innovation News spoke to Dr Tomas Richardson, a specialist in DNA replication and molecular diagnostics, who has joined PBD Biotech to set up a dedicated R&D laboratory and head up the research team, as the company looks to develop a series of diagnostics for tuberculosis (TB) and related diseases. First, tell us about phage, and how they can be used in diagnostics? Well, phage (or bacteriophage) are viruses that infect and replicate within bacteria as part of their natural lifecycle. During that process, the bacterial cell is destroyed, and its DNA is released. From a diagnostics perspective, that’s useful as the DNA can be used as a target for detection, for example by using PCRbased methods. What makes phage useful though is that they infect only viable bacteria. That means they can be used to identify only live, disease-causing bacteria from clinical samples. Traditional PCR-based methods do not discriminate between live and dead targets. As such, they can generate false positives due to the detection of genetic material that has been shed during clearance of an infection, or that may have originated from a vaccine, for example. PBD Biotech has developed a technology that uses bacteriophage to improve the molecular diagnosis of TB. I’m not aware of any comparable approaches that are currently commercially available. 1.5 million people died worldwide from TB in 2020. Many of these deaths could have been prevented with better diagnostic tools. Having recently joined PBD Biotech, how do you plan to use phage to develop future innovations? One of the things that most impresses me about PBD Biotech is the high level of scientific expertise within the company. Two of the company founders, Professor Cath Rees and Dr Ben Swift, have successful academic research careers and conduct fundamental research on how phage and bacteria behave. By improving our understanding of the basic science that underlies how phage interact with their hosts, we’re in a much stronger position to be able to apply that knowledge in making better diagnostics.

When applying that knowledge in future innovations, I think defining and even adapting the host-range of different phage will enable the Actiphage assay to be applied in different contexts. Employing phage that can infect and lyse dormant mycobacteria, for example, would be very exciting, as it would potentially enable identification of latent TB infections. Although perhaps less exciting, I think there are also lots of small, stepwise improvements that could be made to the existing assay. For example, by continuing to optimise the storage conditions of the phage and other reagents, we should be able to improve the stability and shelf life of the product, which is important for deploying the assay to where it’s most needed. How do you see phage being used in antimicrobials, and other areas? It’s no secret that antibiotic resistance is one of the major threats to modern medicine and food security. It has been suggested that many common medical procedures, like organ transplants or caesarean sections, could one day become impractical, or at least extremely dangerous, if our current arsenal of antibiotics becomes ineffective. Bacteriophage represent a powerful, alternative weapon in that fight. Due to the practicalities of identifying, preparing, and distributing phage for use as antibacterial treatments, I don’t necessarily envisage a future where they’re used in the same way that chemical antibiotics currently are. That kind of biological control approach to treating routine infections would ultimately lead to bacteriophage resistance, in the same way that we’ve seen with chemical antibiotics. What I think is more likely is that in very specific cases a suitable bacteriophage will be identified and adapted by specialists for use against chronic bacterial infections where chemical antibiotics have failed. Currently, that

sort of approach isn’t licensed for use in most territories, but it has been shown to work and we’re starting to see permissions granted as an option of last resort. Speaking more generally, I think phage- and virus-mediated technologies are having a bit of a ‘moment’ now as researchers start to realise their potential. Increasingly, they’re being used in a variety of different contexts. We’ve seen their application in COVID-19 vaccine development, as viral vectors. Viruses are also a rich source of components in the field of synthetic biology where they can be used to engineer orthologous circuits and systems in living cells. Phage have been proposed as a potential way for achieving tailored engineering of the gut microbiome. You’ve described how bacteriophage are currently used in TB diagnosis – could it be used to detect other conditions? Absolutely. The principals that underlie the Actiphage assay apply equally to the detection of other bacterial pathogens. The assay is already being used to detect another mycobacterial disease in cattle, known as Johne’s disease, which is caused by the bacterium, Mycobacterium aviumsubspecies paratuberculosis (MAP).

REGULATION

EU Medical Device Directive compliance woes? Just take a leaf out of pharma’s eClinical book

Ricky Lakhani, director of product management, Pharmaseal, explains how medical device companies can learn from biopharma firms to stay ahead of the regulatory curve.

dvances in technology are stretching the definition and utility of medical devices to ever new lengths – and the regulations are following suit. Since May 2021, organisations working in the space have been expected to comply with the new EU MDD, which subjects devices to similar clinical trial standards to their biopharmaceutical cousins. The need for CE marks and greater pre- and post-marketing scrutiny is fundamentally changing the way companies operate. Luckily, there is no need to start from scratch. Adopting the processes and technologies that biopharma has been using – and refining – for years will allow medical device businesses to stay ahead of the curve, and ensure products are safe, effective, and compliant, both now and in the future. Traditionally, medical device companies have operated with a lower level of regulation around clinical trials than their biopharmaceutical counterparts. The introduction of the EU MDD changed all that, placing greater scrutiny on pre- and post-marketing procedures, and fundamentally changing the way companies operate. Far from being an insurmountable challenge, however, this paradigm shift could be a huge opportunity to future proof business. Medical device organisations are in the perfect position to learn from their drug developer counterparts and embrace the advanced clinical

trial technologies biotech and pharma have been using and refining for years. With their ability to unify disparate systems to provide global data oversight, modern SaaS technologies provide a tried and tested, cost-effective approach to compliant trial management. In short, it’s time for the medical device industry to be bold. Because by taking the leap and adopting these technologies, companies can get ahead of current regulatory requirements and equip themselves for a future in which data will be central to everything they do. According to the European Commission, the EU MDR brings EU legislation into line with “technical advances, changes in medical science, and progress in law making” and places “more emphasis on a life-cycle approach to safety, backed up by clinical data.” As well as changing the classification of many devices, it significantly alters the obligations of manufacturers in their quest for a CE mark. For example, it stipulates manufacturers have systems for risk and quality management, that they conduct clinical evaluations, compile technical documentation, and apply conformity assessment procedures.

It also makes manufacturers responsible for their devices after release, meaning post-marketing monitoring becomes essential, and states each organisation have a named person responsible for regulatory compliance. The regulation significantly increases pre-market scrutiny. It requires all applicable devices to undergo additional assessment and validation from notified bodies before being awarded a CE mark and eliminates “grandfathering” meaning all existing devices reaching a certification renewal date must be compliant with the new rules.

REGULATION

While these changes may appear daunting at first glance but in many cases, they simply bring device regulations into line with those applied to biopharmaceutical companies in their own journeys towards market approval – journeys that have been expedited and simplified using eClinical solutions. ADAPT AND THRIVE For medical device companies, complying with these new rules requires more pre- and post-market surveillance and active monitoring of device performance than ever before, increasing the time to market for many products. Attempting to make that move using traditional processes, or legacy, standalone technologies will put organisations behind the curve. Luckily, there is no need to reinvent the wheel, as businesses can follow the lessons of their biopharmaceutical cousins, who fully understand this additional focus on safety measures, risk management, post-market surveillance, and data collection and exchange. The drug development sector has been refining the processes and technologies needed to run safe

While the processes and terminology are slightly different in the medical device and pharmaceutical arenas, they share the same goals – to bring novel innovations that improve people’s lives to market as quickly and as safely as possible and effective clinical trials for years. In that time, they have learnt that data is king, and that deploying single-use technologies to solve singular problems only leads to a tangle of disparate systems that require complex and costly integrations. The result is today’s advanced clinical trial technology, which provides flexible solutions that simplify workflows and unify processes, boosting productivity and reducing the overheads associated with using multiple platforms. Medical device organisations stand to benefit from this learning curve. But to do so they need to take a more structured approach – they need to plan, secure management buy-in, and provide the training required to ensure the right skills and budget are in place to automate processes to embrace digital transformation. TECHNOLOGICAL SOLUTIONS As the biopharma industry now knows, consolidating Clinical Trial Management Systems (CTMS) and electronic Trial Master File (eTMF) offers a range of benefits – benefits that, under the EU MDD, are just as pertinent to the medical device sector. The approach eliminates the need to invest in multiple systems, while reducing the risks associated with information fragmentation, and the cost and complexity of integrating disparate platforms.

Allowing for interoperability across eClinical applications unifies information and processes, streamlining study management processes into one, end-to-end, compliant, collaborative technology. And by increasing the visibility and transparency of information across studies and devices, it can provide actionable insights to drive proactive decision making. This global view of operations creates a closed-loop process that improves strategic planning, and is vital for the faster, safer, more efficient conduct of compliant studies. This approach consolidates key data within one system. It provides a single source for master data, providing fully compliant access to the entire audit history, without the risk of data loss, or the burden of reconciliation. SHARING BEST PRACTICE To date, the medical device sector has been underserved by eClinical solutions that have been designed specifically for biopharmaceutical organisations. But today’s SaaS systems are easily adapted to the space, come with low overhead and maintenance costs, and relieve the pressures of running trials. Importantly, embracing digital transformation and striving for more connected trials – from initial safety studies to post-marketing real-world data collection – will give companies access to the data they need to stay compliant in this new landscape. While the processes and terminology are slightly different in the medical device and pharmaceutical arenas, they share the same goals – to bring novel innovations that improve people’s lives to market as quickly and as safely as possible – and integrated eClinical solutions are key to doing just that.

Med-Tech Innovation Expo

BACK FOR MORE Lucie Markgraf from Shawpak and Dave Easton from Zener Engineering Services (ZES) explain why they are returning to Med-Tech Innovation Expo in June. SHAWPAK: First, how was being at MedTech Innovation Expo 2021? Attending Med-Tech Innovation was really exciting, it was our first time exhibiting at the event. It was very well organised and even though there were a few obstacles in the way due to COVID and travel issues it went well with a good turnout. It’s a great opportunity to showcase our thermoforming packaging machines at Med-Tech Innovation and show people face-to-face what we do. What’s making you come back for more in June? We wanted to come back and exhibit because it’s local and having a medical oriented show in the UK really helps us to connect face-to-face with new customers. You’re going to have a bit more of a presence in 2022, what may we see in June that we didn’t see in 2021? We have decided to expand our exhibition space for 2022, it means we can look at exhibiting more machines including our brand new four Side Seal Pouch machine. Following on from that, what can visitors to the show expect from Shawpak? Visitors can expect to see some of our range of thermoforming packaging machinery, we have three different size machines and a brand new four Side Seal Pouch machine.

ZES: Our machinery is compact and flexible, and this is so important to medical device manufacturers when cleanroom space is so expensive! What can you tell us about the plans that you have as a company between now and the show? Other than attending various medical packaging shows in Germany and the USA we are currently designing another piece of equipment to join our range of Shawpak machines. We are continuously expanding our team as orders increase and have plans to open a European office in the short future. Anything else that you would like to highlight? Shawpak has a short-term aim of developing a broad range of medical device packaging equipment. We see a global need for a machinery supplier who can offer all forms of packaging equipment designed specifically for the medical device industry. We have our revolutionary rotary thermoform machine which has been a huge success and have recently released our new three and four side seal machine for pouch manufacturing. This year will see the development of more unique and versatile packaging equipment that will give our customers full flexibility for their medical device packaging needs.

You were at the show in September 2021, what made you want to come back for more in June 2022? ZES is returning for a couple of reasons. Firstly, the 2021 show was organised to an extremely high standard during the COVID pandemic, with our needs being taken into account every step of the way. ZES didn’t feel like just another exhibitor! Secondly, ZES representatives met very prominent leaders from the medical device industry, whose interest in compliance, particularly around software validation, was refreshing. What can visitors expect in June from Zener? Visitors can expect to meet our experts and chat about medical device compliance and any concerns and issues they may have. Also, visitors will have the opportunity once again to enter our champagne prize draw, which ZES hopes will prove to be very popular again in 2022. You specialise in engineering validation services covering life sciences, what issues can you can address? Medical Device Software Validation is a regulatory requirement, which is a specialist area of concern, in which ZES is very experienced. ZES can also manage large projects and provide leading experts in the field to ensure that medical devices and their manufacturing processes comply with regulatory requirements and are safe for patients. Predominantly, ZES acts on behalf of the medical device owner to ensure that they receive what is expected, from a regulatory engineering perspective.

MED-TECH INNOVATION | expo

What experience do you have of working with medical device companies to ensure their innovations are compliant? ZES has worked with both blue-chip medical device companies on large projects to ensure regulatory compliance of large manufacturing operations and very small start-ups providing ad-hoc consultancy. ZES is very flexible in its approaches and provides bespoke solutions matched to each client’s needs. ZES doesn’t just provide validation services. We also provide a wide range of other services, including: • Project Management (up to £20 million) • Bespoke Training • Medical Device Decontamination Expertise • Regulatory Inspection Preparation/Remediation • Supplier Audits • Ad-hoc Consultancy (e.g. 1 Day upwards) • Cloud-Based Solution Advice and Validation • Data Integrity Advice and Validation Who are you keen to talk to in June? Any Life Science company who has compliance, and the safety of their patients, at the forefront of their mindset and operation. Compliance is not just an after-thought!

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DIGITAL HEALTH

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HARNESSING AI TO HELP THE NHS TACKLE CANCER BACKLOGS Orlando Agrippa, CEO and founder of RwHealth, explains how AI can be key to tackling cancer backlogs.

s COVID-19 becomes better controlled by vaccines, medicines, and other measures, cancer is reemerging as the UK public’s top health priority. The effect of the pandemic on cancer treatment has been profound. From patients putting off medical appointments to the ongoing bed shortage, disruptions to cancer diagnosis and treatment continue to threaten the lives and wellbeing of hundreds of thousands of people. With half of the population expected to be diagnosed with cancer at some point in their lives, it’s crucial to restore pre-pandemic levels of research, prevention, medical and social care as quickly as possible. Achieving success when health services are still battling with fundamental capacity constraints requires us to harness new technologies aimed at better identifying and treating cancer. So, what are these technologies and how do we support them to deliver the improvements that are so urgently required? ENSURING EARLY DIAGNOSIS AND BETTER TREATMENT PATHWAYS Speed is crucial when diagnosing and treating cancer. Early diagnosis leads to more effective therapeutic intervention and, ultimately, better outcomes – and here is where clinicians recognise Artificial Intelligence (AI) as a game-changing technology.

AI algorithms can extract clinically useful knowledge from vast amounts of data from biology, chemistry, pharmacology, structural biology, cellular networks, and clinical annotations. They recognise patterns and identify complex features and characteristics – such as how a disease may progress – that can’t be processed by the human brain. This means a precise diagnosis can be made more quickly, with the subsequent treatment plan easier to define. Beyond speed and complexity, AI can remove a huge administration burden, freeing up healthcare professionals to dedicate more time to tasks where human judgement is critical. Data from recent clinical trials shows that AI has the potential to reduce the workload of mammography readers by more than 88%, allowing radiologists to examine more images. Ultimately, even once waiting lists have been reduced, we know that the human touch should never be replaced in cancer care. AI gives these healthcare professionals more time for providing care. GETTING THE BASICS RIGHTS At its most sophisticated, AI can help diagnose the rarest of cancers and lead to new treatments. But on an everyday level, the technology can also improve the basic accessibility of the information systems involved in cancer treatment.

Currently, most systems are anything but intuitive, with medical teams grappling with Excel spreadsheets, or forced to use complex software that requires intense, specialised training. By bringing AIbased data analysis to bear on patient records, initial prognoses, and clinical pathways – and making that information available via an easy-to-use interface – it’s possible for patients to be dealt with more quickly and effectively because the healthcare professionals are no longer being hindered by their own tools. PREDICTING SURGES IN DEMAND AI has a significant role in diagnostics and in cutting administrative burden. But there are further benefits in using AI to predict demand and learn what is likely to be needed, and when. Hospitals that use AI for a more data-driven approach to their operations can also better manage patient volume and bed capacity as well as mitigate potential impacts on the supply chain and other critical areas. UNLOCKING THE VALUE OF DATASETS The accuracy of any AI technology always depends on the quality of the data and the way the system is trained. In the case of healthcare and cancer diagnosis, it’s both quantity and diversity of data which is important. For example, if an image database is limited to white males over the age of 45, then the information gathered by the AI system will only be useful to that demographic. In cancer care,

what works for one group of patients may not work for another, and it’s the ability to compare likefor-like cases that will ultimately determine the speed of prognosis and treatment. The good news is that much of this data is already being recorded by healthcare providers. There are vast quantities of relevant information in GP and hospital databases that are currently only being used discreetly, if at all. More work is needed to extract the data, so that AI can then be deployed to unlock its potential. THE FUNDING IMPERATIVE As spending is reviewed and policy makers set budgets for tech provision in healthcare, investing in AI, data extraction tools, and other supportive systems and processes should be top of the priority list if we want to reduce the current backlog of cancer patients. There are already several AI-based technologies being trialled within the NHS, but it’s what we do next to further its use and hone its effectiveness that will really count in the post-COVID catch-up. If cancer treatment is our number one priority in the UK, then clinicians must have the technology to match it.

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Meet the start-up

MEET THE START P:

REMOVING HEALTHCARE BARRIERS WITH 3D PRINTING Cyrille Lecroq, CEO of WeMed, spoke to Med-Tech Innovation News about how it developed the world’s first additively manufactured connected stethoscope. First, tell us a bit about WeMed and how you started? We are a French start-up that specialises in designing devices for telemedicine. WeMed was created with the goal of ensuring that every person receives access to healthcare, by developing telemedical devices that enable healthcare advice and treatment, even when hospitals and doctors’ surgeries are at capacity. My wife is a nurse who has been working on the front-line throughout the pandemic. She told me first-hand how difficult it has been for healthcare workers to keep up with their patients, which means some patients are being sent home without the possibility of a medical follow-up.

The SKOP is a universal device for both healthcare workers and the general public. It works on all tablets and phones, as well as communication platforms such as WhatsApp and Zoom. Its ease of use means that it is intuitive and available for everyone, ranging from isolated families, and retirees, to various at-risk groups. We have also made it affordable to the wider population, and therefore produced it at low-cost.

How is this device different to what’s already out there? The SKOP is the first cardiopulmonary auscultation medical device intended for both healthcare professionals and the general public, as well as the first connected stethoscope to be 3D printed. The device’s acoustic quality is made possible using cochlear technology, inspired by the human ear using biomimicry design concepts.

3D printing reseller Hava3D introduced Third to Nexa3D’s products as the solution. Third then brought Nexa3D into the project, so we could benefit from the advantages of the NXE 400 — printing on an industrial scale at a sufficiently low production cost. The printer also offers a very high print fineness, which is essential to the acoustic quality of the device. Scale up costs were eliminated, as we procured 20 NXE 400 printers for our partner Third to manufacture the SKOP, bringing greater return on investment. What are WeMed’s future plans? WeMed’s mission is to make the SKOP international. SKOP is now CEcertified and has obtained marketing authorisation in Canada. We are currently in the process of obtaining authorisation from the USA.

We knew that something needed to change to ensure that everyone was receiving the necessary care in an unprecedented time, and WeMed was born. What kind of devices have you developed? We’ve since developed our first device, the SKOP, a stethoscope that allows truly remote medical diagnosis, acting as a substitute for a visit to the doctor’s office. The SKOP responds to a global issue concerning access to medical care and its availability helps individuals gain access to remote healthcare particularly during crises such as the COVID-19 pandemic, where healthcare facilities are overwhelmed.

effectively. However, lots of 3D printing technology on the market that offers high-volume also carry a very high cost.

Why did you opt for 3D printing in developing SKOP? The SKOP needed to be produced at high volumes and speeds to quickly relieve pressure on healthcare facilities, while maintaining its high quality, precision, and reproducibility. We worked with contract manufacturer Third to leverage its expertise in additive manufacturing. 3D printing offered many benefits to this project — it meant we could produce a complex geometry quickly and cost-

Remote access to healthcare will ensure everyone receives the level of care they deserve, as well as increased patient satisfaction. We are now working on several medical devices with a philosophy similar to SKOP and plan to use Nexa3D’s ultrafast technology in the future.

Components

How miniature linear motion components help maximise space efficiency Thomson discusses medical sector miniaturisation trends and how linear motion components can assist designers in meeting even the most stringent space requirements for today’s medical equipment.

he rising demand for more space-efficient laboratory technology combined with laboratory process innovation is challenging motion control application designers to deliver small-scale systems without compromising performance. Luckily, select motion control component manufacturers are helping meet this demand by offering standard parts in smaller sizes, hybrid assemblies that eliminate the need for certain components and extensive customisation capabilities.

SCALING DOWN Laboratory instruments are getting smaller. Analytical instruments that once required a room of their own now sit on the benchtop. The trend toward miniaturisation is especially welcome among laboratory managers and diagnosticians seeking to make the most cost-efficient use of floor and benchtop space. It also fasttracks testing by eliminating the need to send samples out to a lab and wait for results. Complementing the miniaturisation trend are space-efficient process innovations such as cartridges that enable multiple reagent tests at a single point; a high density of well plates that can handle multiple assays and specialised instruments dedicated to small batch assays. Much of the move towards miniaturisation and process efficiency involves automation, which challenges motion control system designers to scale these systems down while achieving the same or better performance.

SOURCING OPTIONS Designers developing motion control systems to fit into smaller spaces have three primary options: they can use smaller components, those that do not require external support, or work with manufacturers to develop custom solutions. DESIGNING WITH SMALLER COMPONENTS Once a designer knows how much space they have to work with, they are better equipped to meet customer requirements with standard components. The miniaturisation of laboratory systems has been going on for at least 10 years, during which time increased demand has resulted in wider market availability of smaller components, including size 8 stepper motors and 3mm Ball Bushing bearings. Blood diagnostic and treatment systems, for example, are getting smaller and smaller. An equipment designer was redesigning a large standalone blood-cleansing device to fit on a desktop. The system used UV light to kill pathogens and required motion control to keep the sample constantly agitated for maximum UV exposure. Reducing the width was the primary need. They accomplished this with miniature profile rail assemblies, which enabled them to reduce the height as well. The designer also specified motorised lead screws, which could be tucked behind other components rather than extending outward in any direction, enabling an even more compact design.

Miniaturised innovations such as these are also being applied to “point-of-care” diagnostics, which would bring blood test results right to the doctor’s office or even portable devices that could be used in the home. With smallerscale testing instruments, lab diagnostics could be available in a matter of minutes instead of days. This level of improved speed and accessibility of testing has the potential to save countless lives. ELIMINATING THE NEED FOR EXTERNAL LINEAR SUPPORT For space-constrained, forcesensitive applications requiring shorter strokes that must be repeated with high precision, such as vertically positioning a pipette over a test tube array, designers can economise space using a motorised lead screw actuator (MLA). Doing so with conventional basic stepper motor and lead screw assemblies would require designing costly external linear guidance systems for anti-rotation of the nut, and guidance of the system. The hybrid approach, however, eliminates the need for external linear guidance by surrounding the shaft with an aluminium cover tube with moulded internal splines that lock onto the nut to keep it from turning and provide linear guidance. Eliminating the need for an external guidance component gives the designer more flexibility to reduce the size of the axis, which helps reduce the overall footprint of the instrument.

Components

Market demand for immediacy, space contraints and pandemicinduced health concerns will likely continue to drive the need for increasingly smaller medical equipment CUSTOMISATION If a designer cannot get the motion they need with standard components, they will have to work with manufacturers to create custom solutions. In most cases, however, the customisation process does not involve starting from scratch but modifying existing standard components to overcome limitations. Ball nuts, for example, are often designed for use with screws of different diameters. This design choice reduces the cost but does require a slightly larger nut. To save space on an application using a smaller diameter screw, a smaller nut could be developed.

desktop, a designer needed linear motion components to be as compact as possible. They selected a single miniature profile rail assembly to guide the lenses of the spectrophotometer into position. The miniature rail enabled not only a compact profile but also a high load capacity and whisper-quiet movement. Along with compactness, however, high rigidity was critical in this application. Achieving that required attaching the miniature profile rail to another component within the machine instead of a separate mounting surface. This feat required a customised counterbore of the standard mounting holes of the profile rail assembly.

Sometimes, it is just a matter of modifying the mounting. For example, when working on a new spectrophotometer to highly analyse colour samples on the

Another factor to consider in customisation is the supply chain. Whether it be sub-components, plating, materials, engineering

services or other contributors, manufacturers often depend upon external part sources. These must also be evaluated based on whether their standard products are suitable for smallerscale designs. SMALLER TECHNOLOGY; BIGGER DIFFERENCE Market demand for immediacy, space constraints and pandemicinduced health concerns will likely continue to drive the need for increasingly smaller medical equipment. Motion control components can make up a substantial portion of medical machinery footprint, and manufacturers are actively innovating to deliver full functionality in smaller spaces. The likely result is lower healthcare costs and better outcomes for patients.

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Innovation in Miniature

Why the backlog will be the NHS’s biggest issue of 2022 - and why it matters to medtech Oli Hudson, content director at Wilmington Healthcare, explores the NHS’s gravest challenge for 2022 – the elective care backlog – and how it affects industry.

At least 5.8 million patients are now part of the NHS’s elective care backlog. Of these, 300,000 have been waiting more than a year and 12,000 more than two years. December’s report from the Health and Social Care Select Committee highlights how unmanageable a challenge the backlog had the potential to be. Health secretary Sajid Javid said in July that, when taking into account all “unknown” patients, this figure could rise to 13 million – placing something like one fifth of the population on a waiting list for treatment. Government has announced financial support to tackle the backlog, including an extra £5.4 billion over the six months from September 2021 to support the NHS response to COVID-19 and help tackle waiting lists this year, and a further £36 billion in health and social care over the next three years funded by a Health and Social Care Levy to be introduced from April 2022. Questions remain over whether this will be enough. Meanwhile, it remains the number one issue for medtech’s NHS customer. Industry engagement with the

NHS is currently fraught with time-poor staff. That’s why it’s important that medtech takes on board the depth of all this when presenting its value proposition. Here are some ways the backlog is causing issues. CHALLENGES FOR THE WHOLE HEALTHCARE SECTOR The backlog is causing people to die before their time, with 86% of clinicians surveyed by the one association agreeing that some patients are now terminally ill due to either a late diagnosis or treatment delays. The most immediate thought one has about the backlog is that it is a secondary care issue – and it is true that issues there are grave. The Government-mandated catch-up process has resulted in unsustainable patient numbers for staff and total numbers of beds occupied, as well as endless and constant pressure on theatres, on inpatient wards, on numbers recovering in hospital. The backlog is rightly seen as an issue creating problems for secondary care, but it is one that challenges every sector of health and social care.

Firstly, it puts pressure on primary care, who must manage this ever-increasing queue of patients out-ofhospital, with increasingly exacerbating conditions in many cases. Secondly, upon social care, who must do likewise with the limited help of primary and community care staff and have an additional burden of extra residents discharged from hospital to ease capacity in acute care. Thirdly, on emergency care, who pick up the extra emergencies caused by the exacerbated patients and those who, left untreated, have developed complications or even new morbidities. Fourthly, on mental health services, who will address the obvious and concomitant mental health need of those waiting to be treated for a lifeaffecting condition. Finally, on community care because of an upsurge in demand for certain community services intended to help keep patients out of hospital. For a sense of the scale of the challenge it’s instructive to read the Community services prioritisation framework published in January. The framework tells leaders and clinicians in some 61 services in the community: ‘Capacity in community services will need to be extended to enable supporting discharge pathways and urgent community response provision, mobilising virtual wards and supporting end-oflife care at home.’ It also states that many services should be completely paused if they might create extra hospital admissions.

Other services will introduce a prioritisation and rationing policy. WHAT THIS MEANS FOR MEDTECH The backlog is going to be front and centre of every NHS clinical customer’s priorities. Industry support on this will be instrumental in opening doors for engagement and providing possible solutions. These can include products that reduce time spent in hospital, whether through improved outcomes, faster recovery, faster patient throughput and less theatre time, fewer complications and fewer revisions needed. But products that shift the healthcare settings or pathway from hospital treatment can also assist. Trusts now have a new urgency, with HSJ reporting senior financial leaders demanding ‘a strong return to payment by results’ to accelerate activity on the backlog. While the proposed 2022/23 payment system – currently under consultation - seeks to develop a blended approach whereby trusts are paid a fixed amount as well as local incentives to achieve various outcomes – at the moment activity is the key driver. The decisions financial and clinical leaders currently make will have ‘how will this affect admissions and patient numbers’ all over them. Normal service has not yet resumed in the NHS, and the backlog numbers suggest it won’t for quite some time. Medtech should consider this and place assistance with tackling the backlog at the centre of its offering, wherever possible.

Within the tent: Increasing isolation capacity

At MEDICA, Ian Bolland caught up with Guy Braverman, joint CEO and co-founder of GAMA Healthcare, to discuss its infection control products, in particular the Rediroom isolation unit.

nevitably since the COVID-19 outbreak, being able to control the spread of infection and allow healthcare settings to maximise capacity has been a massive factor around the world. One of GAMA’s main products on show at MEDICA was Rediroom, an isolation unit that can be erected around a patient within five minutes, allowing hospitals to increase isolation capacity. Braverman explained that the idea behind the product originally came about when MRSA started to hit hospitals – and was developed by two Australians who developed a prototype over six years before working with GAMA. “One of their wives is a nurse in A&E and she recalled that there weren’t enough isolation rooms for patients with infections,” says Braverman. “The product was designed for contact and droplet precautions – the idea is in a multi-bedded bay when someone has, for example, MRSA you should isolate them but often in hospitals there are not enough isolation rooms. “The idea was if you are a multibedded bay and have an infection you need a side room but if there isn’t one, you’re going to pass on the infection

to other patients in the bay. This can be put around a patient within five minutes while the patient is in bed. We developed it, COVID hit, and then there was the big demand.” As the world was grappling with a new virus, there was a lot of emphasis on isolation as question marks remained over COVID-19’s transmission. Though it has since proven to be airborne, demand is still high for GAMA’s offering, as Braverman points out other conditions haven’t gone away. “All the other hospital acquired infections, the multi-drug resistant bacteria and C. Diff, they’re all still there so there is still demand. Now the big worry is for norovirus and flu, which are much more contact and droplet transmission than airborne, so this room is much more suitable for those. “If you’re in a multi-bedded bay and have diarrhoea and vomiting and should be put in a side room and there isn’t one then you can infect everyone in the bay. We can put this around the patient in five minutes. “It gives increased flexibility to hospitals to have more isolation spaces. That’s what people are looking for, it’s that flexibility. If they don’t have enough side rooms, they have to take some patients out and judge which infection

is worse. Having isolation space is becoming a very big headache and this gives them more isolation capacity.” The product comes in two parts with a reusable trolley and single-use tent, containing windows and Velcro, which is disposed after patient use for infection control purposes. The singleuse element does bring about the inevitable question of sustainability, but Braverman indicates there are avenues being looked at to make the product more sustainable, as well as preserving its infection control properties. “If you did re-use, you would have to do a very deep clean and it would be very difficult to clean. There’s also evidence of if you were in a room where the patient had an infection, you’re up to five times more likely to get that infection because it is very difficult to clean the room. So, the safest infection prevention is to dispose of it. “What we’re working on now is developing a plastic-free version and use all the materials that are plasticfree and more sustainable. The next versions are going to be much more sustainable and we’re going to be working towards having a plastic-free tent that you dispose of.”

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