InterSystems makes your data healthy so it’s accessible, useable, and ready for action.
elcome to the first edition of Med-Tech Innovation News of 2023. As this is landing on your desks in February, I’ll not wish you Happy New Year – it has gone beyond the second week of January, and I think it’s fair to say we are all out of that habit now.
There are many things I could write about in my first editor’s letter since the end of October/ start of November. The current crisis in the NHS, challenging economic conditions for the sector and the hotspots that there are in the regions and nations of the United Kingdom.
But as I pen this I am travelling back from Dubai after attending the first of many shows this year and Arab Health was nothing short of heaving. I can’t remember the last time I’ve had bruises on the top of my feet at a trade show such was the volume of people in the World Trade Centre – particularly across the first three days.
It was the perfect illustration of the appetite there is for great innovation and technology across the world. The UK’s innovation and manufacturing capabilities were noticeable
too – thanks largely because of the presence of ABHI, Medilink and the Department for International Trade – as many UK companies showcased their offering to distributors and buyers in the Middle East. So vast is the potential of companies from the British Isles, it attracted those from politics as parliamentary under secretary of state (minister for exports) Andrew Bowie cut the ribbon to open the ABHI’s UK Pavilion.
The governing party weren’t the only ones to send out political representation. Also on show were the Midlands explaining why it is such a hub for medtech, and the mayor of West Yorkshire Tracey Brabin also made an appearance as the region aimed to illustrate its prowess in life sciences and healthcare developments. Though they’re not the only two regions that are really pushing their cause, it will be interesting to see how these two particular potential hubs for the sector will fair over the course of the year and beyond. With a general election approaching in 2024, devolution and the economy could well be two electoral
issues – so promises of powers for these areas, how they are performing and incentives for the sector will make for interesting viewing.
Though the UK is on course for being the G7 nation with the lowest economic growth – life sciences and medical technology seem to be the leading lights in a difficult time for the UK generally.
Indeed, if you see any economist – or indeed someone in the political arena – pop up on a rolling news channel, they’re more likely than not to highlight life sciences as an area where the UK can develop to be a world leader.
As this issue will show with one particular piece, the UK doesn’t have to look very far when it comes to establishing a successful medtech ecosystem – maybe there are one or two things they can learn from their Irish cousins.
I’m interested to see if 2023 is when medical technology bucks the trend of turbulent economic headwinds we currently face.
Two Artificial Intelligence (AI) assisted, spectral, widedetector CT scanners will be supplied by Canon Medical Systems UK to Craigavon Area Hospital, part of Southern Health and Social Care Trust in Northern Ireland, for a £6.8 million ‘twin’ CT suite development.
The diagnostic imaging systems aim to improve the standard of care delivered to patients by cutting waiting times, expanding the range of local imaging services, and providing enhanced image quality outputs for more certain, first-time clinical interpretations.
The scanning protocols on the new spectral Canon Medical CT scanners will aim to improve stroke, cancer and cardiac imaging services offered to all Southern Health and Social Care Trust’s local catchment area.
The Aquilion ONE / PRISM Edition CT scanners will be capable of rapid and accurate detection of stroke via brain perfusion and AI technologies. Spectral CT scanning will reduce the requirement for follow-up appointments by allowing earlier characterisation of abnormalities which will also help in providing highly efficient cancer work-up.
Billy Erwin, account manager at Canon Medical Systems UK said: “The development of the new twin CT suite with joint control room at Craigavon Area Hospital has been six years in the making. We have been part of the project management team for the new CT facility build, guiding the room design, supporting safety features, and planning delivery access.
This has aimed to reduce the stress on hospital clinical teams by ensuring smooth equipment planning and commissioning logistics. We are looking forward to playing a central role in delivering the CT technology and see it fulfil many clinical and efficiency benefits for the radiology team and patients served.”
Medical and tech experts in Wales have developed a virtual training device which can allow medics to ‘touch’ a patient, even if they are thousands of miles apart.
Mechanical vibrations could help improve our muscles and our balance control, according to research at Aston University.
Researchers in the College of Engineering and Physical Sciences have examined the effect of stimulation on muscle spindles which ‘speak’ to the central nervous system to help keep us upright and walk straight.
Their results provide new perspectives on whole-body vibration applications, paving the way for future research on the interaction between the central nervous system and the peripheral muscles.
The research could be applied to improve balance in older people and help reduce falls, this could be applied through either wearable devices or with a daily session of stimulation.
Hip fractures alone account for 1.8 million hospital bed days and £1.1 billion in hospital costs every year, excluding the high cost of social care.
The goal of the study was to find out if mechanical vibrations
can improve the way our bodies process and react to small body oscillations.
Seventeen young male and female adult volunteers aged between 20 and 28 years old stood individually on platforms, similar to vibrating plates found in gyms, which caused leg muscle contractions. Calf muscles were targeted as the muscles whose action contribute the most to maintaining a stable upright posture.
The researchers stimulated their calves with a frequency of 30Hz and recorded four oneminute trials of undisturbed balance to take a baseline measure and compared the readings to measurements taken after the stimulation. After conducting the experiment, they found that their balance seemed to have improved.
The research, Sensorimotor recalibration of postural control
strategies occurs after whole body vibration, was led by Dr Antonio Fratini, senior lecturer in mechanical, biomedical & design engineering, and PhD student Isotta Rigoni, and has been published in Scientific Reports – Nature.
Dr Fratini said: “Our results indicate that whole body vibration challenges balance at first, triggering a bigger effort to control the upright stance and shifting muscle modulation toward supraspinal control, resulting in a recalibration of muscle recruitment. The neuromuscular system seems to recover from such disruption and regain control over a longer time interval.”
Specialists at the Centre of Excellence in Mobile and Emerging Technologies (CEMET), which is based at the University of South Wales (USW), have been working with Cardiff-based Advanced Medical Simulation Online (AMSO) on developing a proofof-concept for the remote technology.
If it is proved to work successfully, the technology may allow AMSO’s to offer remote training to users across the globe.
Professor Nazar Amso, chief executive of AMSO, said: “The business was established in 2015 to support skills training for healthcare professionals, with many using our resources from across the globe. This included people in the Bahamas, Middle East, Fiji, and New Zealand, who can access the training remotely day and night.
“While we covered the knowledge and were able to assess if they knew what was being taught, we were unable to assess if the ‘handson’ parts of the training has been adequately understood unless the students were able to attend at our simulation centre in Cardiff - which would obviously be costly for students living thousands of miles away.
“This limitation was further accentuated during the COVID-19 pandemic and the impact it had on students accessing clinical training in their own place of work. So, we needed to develop a system which could allow the students to prove their skills through immersive virtual reality.”
Mechanical
strengthen
The presentations were packed and there was clearly a lot of interest. A good and healthy mix of innovators, experts and funders all in one place.
Registration is now open for Med-Tech Innovation Expo 2023, taking place at the NEC in Birmingham on 7th-8th June 2023.
Med-Tech Innovation Expo is firmly established as the UK and Ireland's leading event for medical device manufacturing. In June 2023, this year’s show will connect leaders, engineers, innovators, and manufacturers with all of the technology and innovation they need to facilitate the design and manufacture of life changing medical devices.
Take your place at the fastest growing event in medical technology, where you'll find: live demonstrations, advanced technologies, new product launches, a world-class conference programme, cutting-
edge technology zones, industry association pavilions and more! Med-Tech Innovation Expo is a free, must-attend event for anyone who is part of the medtech industry. To register, visit www.med-techexpo.com.
The Med-Tech Innovation Expo will feature two stages of inspirational leaders, innovators and practitioners, offering thought-leadership and insights from the sector.
More than 100 companies will be on the show floor, representing the complete medical device and manufacturing supply chain,
More than 100 companies will be on the show floor, representing the complete medical device and manufacturing supply chain.
with exciting displays from Boddingtons Plastics, Guardtech Cleanrooms, Nelipak Healthcare Packaging, Ox Device, Qosina, Raumedic, Relyence UK, The Sempre Group, Wilmington Healthcare, ZwickRoell and more.
Whether you're looking to invest in the latest technologies, need to improve your manufacturing
processes, source new suppliers, or want to absorb new information, Med-Tech Innovation Expo has everything you need in one place.
Med-Tech Innovation Expo takes place on 7-8 June 2023 at the NEC, Birmingham. For more information, visit www.med-techexpo.com
The deadline to enter this year’s Med-Tech Innovation Awards is fast approaching with applications closing on 1st March.
Submissions are open across six categories, including 3D Printing, Design and Connected Health.
Organisations with groundbreaking success stories can submit their entries today, for a chance to gain recognition from esteemed judges, industry
professionals and peers. The awards are tightly fought, and extremely well regarded across the industry and beyond.
Peter Broom, director at Meryl Medical, 2022 winner of the Sustainability Award, said: “We feel extremely honoured and proud that Meryl Fabrics has received such high-profile industry recognition, and has been presented with two highlycoveted Med-Tech Innovation Awards.”
Other previous winners include Acurable, Birmingham Biotech and Adapttech.
Finalists will be selected by an expert panel of judges and winners will then be announced at the Med-Tech Innovation Awards Ceremony on the 7th of June 2023, at the National Conference Centre Birmingham, complete with celebrity host, JJ Chalmers. This awards ceremony will be held alongside the Medilink UK Healthcare Business Awards.
The six categories for this year’s awards are:
● 3D Printing
● Connected Health
● Design
● Manufacturing Excellence
● Materials Innovation
● Sustainability
For more information about the awards ceremony and to submit your entry, visit www.med-techawards.com.
Med-Tech Innovation Expo 2023 takes place on 7-8 June 2023 at the NEC, Birmingham. For more information, visit www.med-techexpo.com.
AUK Precision Tooling Academy has been launched thanks to a partnership between In-Comm Training and Brandauer.
As the rate of advancements in the medical technology sector continues to accelerate along with increasing demand, the importance and relevance of the world’s largest healthcare exhibition has never been more apparent.
MEDICA 2022 once again proved to be a vital shop window, innovation hub and networking event for the life sciences and healthcare sector, where companies in this dynamic, fast-moving industry can meet, collaborate, and establish relationships to help to meet the evolving needs of the market.
The Medilink UK pavilion located in hall 16 brought significant footfall to exhibitors.
Jack Jakins, senior marketing executive at Team Consulting said: “Medilink had a fantastic stand location within the UK pavilion. We had excellent footfall across each day and many useful conversations.”
2022 saw Medilink UK host its largest ever UK pavilion, accommodating some 60 companies wishing to expand their international presence, and supporting a further 40 companies attending trade missions with the Department for International Trade (DIT) from the North of England and Midlands regions. Their presence has grown year on year over the last two decades, becoming the lead UK Partner of the Messe Düsseldorf.
Medilink’s pavilion included medtech companies focused
on entering new international markets, finding distributors, and establishing new partnerships. Exhibitors included digital health companies, manufacturers of implants and prostheses; producers of medical instruments and consumables; suppliers of diagnostic, treatment, and monitoring systems; and legal, financial, insurance and consulting services.
Before the 2022 show had closed, a record number of repeat bookings were being taken for the 2023 event, from both exhibitors new to the show, and those who are regularly a part of MEDICA.
Lee Kirk, head of sales at LEEC Limited said: “We exhibited at MEDICA a few years ago to launch new products in our range – the success of which helped us to expand as a business. We exhibited again in 2022 to meet new and existing contacts face-to-face following the COVID-19 pandemic, to obtain more global distribution partners. We met with people from as far as the Middle East and Indonesia and will definitely return to exhibit again.”
Medilink UK’s exhibition package includes access to funding for eligible businesses, support throughout the event, including briefings, meetings with DIT advisors, assistance with travel, shipping and accommodation and networking opportunities. It also includes specialist in-market PR support. For many companies this is a vital aspect of their participation.
Peter Carroll, director at Medezine said: “We have worked with Medilink for 15 years on a number of occasions; their exhibition assistance is excellent, with everything from accommodation support to their links with the Department for International Trade for additional opportunities for UK exporters.”
Medilink’s innovation and commercialisation specialists were also on hand to offer market insight and guidance to help increase the probability of commercial success and profitability. Advisors are also available to provide information and help with understanding international healthcare settings including market access and opportunities, market dynamics, assessment criteria, reimbursement policies and regulatory landscapes.
Bookings for this year’s show are now being taken with many exhibitors already signed up, showing that 2023 is set to be another huge, successful event. The Medilink UK pavilion will once again occupy a prominent position in one of the busiest halls. For those wishing to be part of the Medilink UK delegation with associated support and assistance, it’s recommended contacting us as soon as possible to avoid disappointment as space regularly sells out quickly.
To book your space or to find out morebout the event, contact the team on international@medilink. co.uk/0114 232 9272.
Over £1 million has been invested by the two strategic partners to create a commercial toolroom in the training provider’s facility in Aldridge, which will produce complex tooling, as well as acting as a professional training ground for future toolmakers and designers. The Academy will offer companies access to professional toolmaking courses, upskilling opportunities for qualified engineers looking to diversify their skills and a Level 6 Tool Process Design Apprenticeship.
Up to 35 individuals in the first 12 months will learn on live tooling projects and will give Brandauer and other tooling experts the opportunity to reshore more manufacturing projects from Asia, the EU, and the US.
Gareth Jones, managing director at In-Comm Training, said: “We have always placed employers at the heart of our approach to skills and, through our close relationship with Brandauer, identified a real demand to create and upskill engineers into world-class toolmakers.
“Lots of conversations turned into a rough plan to create an advanced training academy that is embedded into a live commercial toolroom. This would serve two purposes: provide the best possible hands-on practical and theoretical training, whilst also giving the precision stamping specialist additional capacity to meet the growing global demand for more UK made tools. A winwin and we’ve both backed it to the tune of £1 million.”
Today, Ireland’s medical device cluster has global significance, punching well above its weight in terms of geographical and population size. This has been the case now for decades. What about the future, though?
After all, today’s world is very different. Technologies we couldn’t imagine 30 years ago are now commonplace, words like digitalisation are driving business strategies, and there is increasing competition from lower cost-based regions of the world.
The medtech industry in Ireland is pivoting and reacting to changing market conditions, while leading the way in innovation and new product development. Ambition in the industry is unquestionable, so the future looks promising.
There have been many factors over the years that have contributed to the success of Ireland’s medtech industry. One of the main drivers is the wellestablished medtech ecosystem.
It comprises a broad range of organisations and stakeholders, including multinational corporations, SMEs, indigenous Irish companies, investors, thirdlevel education institutions, and the Irish government through organisations like the IDA, Enterprise Ireland, and Skillnet.
This ecosystem encourages, facilitates, and supports the key ingredients for success:
● Innovation mindset, particularly through the growth of medtech R&D in Ireland to complement manufacturing.
● Collaborative approach, such as through strong connections between medical device companies and the universities that are educating tomorrow's workforce.
● Convergence potential between medtech, technology, and pharmaceuticals given Ireland also has strong tech and pharma industries. This convergence potential is leading to innovations in areas like digital health and combination devices.
● Talent base for Irish medtech professionals in addition to an ever-growing number of people born outside the country who now call Ireland home.
Looking to the future, it is clear healthcare is changing in several significant areas. Populations are ageing in many parts of the world, and there are growing pressures on healthcare provision. Patient and user expectations are also changing, as are the regulations that govern medtech.
Technologies are driving change, too, with an increasing use of data and technologies that utilise the Industrial Internet of Things (IIoT).
There are also areas of transformational change on the horizon. This includes Industry 4.0 technologies and the digitalisation of workflows, and the growing trend towards the personalisation of healthcare, where parts of the industry could transition from mass production to mass customisation.
Ireland’s medtech sector is acutely aware of the above changes taking place in healthcare and is at the forefront of shaping the industry’s future in many areas.
There are also challenges to manufacturing sustainability in Ireland from low-cost countries.
The introduction of the new EU MDR is also a challenge although some relief could be provided on this due to the recent publication of a proposal to amend the MDR and to extend its transition period until full compliance of the marketed devices with the MDR is required by the European Commission. This proposal was published on 6 January 2023 and is under review by the stakeholders.
A lot of the success enjoyed in Ireland, particularly in the strong growth period during the 1990s, came from foreign direct investment by US-based multinationals. They came to Europe because products could be approved and launched faster than in the US, and they came to Ireland because of its low-cost base. These benefits no longer exist.
There are strong indications that Ireland is successfully adapting to both changes and challenges, while continuing to innovate and build on its strengths.
We can look to recent investment announcements as examples of a continued commitment to Ireland as a global hub for the medical device industry:
● Abbott Ireland is investing $450 million in a new site in Kilkenny that will employ an additional 1,000 people, increasing its workforce to 6,000.
● Boston Scientific is investing $100 million to expand its Galway operations and increase its workforce by 300.
Leaders in the industry are also looking to maintain Ireland’s growth through a strategic approach. For example, The Irish MedTech Association’s 2022 report The Global MedTech Hub 2025 outlined four strategic pillars that will facilitate continued growth:
● Innovation with impact
● Talent to thrive
● Excellence through collaboration
● Competitiveness of the ecosystem
Innovation, R&D, and new product development are going to be the key drivers of growth in the industry as Ireland looks to continue to diversify across the entire medical device value chain. After all, the typical lifecycle of a medical device product is 18-24 months after which it is replaced by an improved version. There is no time to stand still.
Again, there are strong indications that Ireland is moving in the right direction in this key strategic area. For example, per capita, Ireland ranks fifth in the world for medical patents.
The focus over the coming years must be a continuation of this effort, where innovation is fostered, encouraged, and supported by all stakeholders, including the government.
executive officer of Avem, comments on the latest developments in the sector in Ireland and how it can retain and expand its presence going forward.
SPONSORED
Irish medtech industry. 42,000 – the number of people employed in the Irish medtech industry.
Largest – Ireland is Europe's largest
per capita employer of medical device
professionals. Second largest – Ireland is Europe’s second-largest exporter of medical device
products. 90% – nine of the world's top 10 medical
device companies have operations
in Ireland.€12.6 billion – the value of Ireland’s
annual medtech exports. Over 100 – the number of countries
Ireland exports medical devices to.
80% – the number of stents used across
the world that are manufactured
in Ireland.50% – the number of ventilators used
in the world's acute hospitals that are
manufactured in Ireland. Number one – Ireland is the world’s BY
number one exporter of contact lenses.
DMC Medical has developed a comprehensive range of color coded, Latex Free Polycarbonate Syringes available in 94 variations. Crystal clear barrels with a secure luer lock tip are available in 1ml, 3ml, 6ml, 10ml, 20ml & 30ml. DMC also offers a pre-printed custom syringe range in similar sizes and colors. Supplied bulk non-sterile. Our Polycarbonate Syringes are FDA 510k approved and manufactured in accordance with ISO 13485.
NuGen™ - DMC Medical also manufactures a similar range in a BPA free Copolyester with advanced chemical and lipid resistance, suitable for both EtO & Gamma sterilization.
1ml3ml6ml10ml20ml30ml
FD -1017NSFD -1021NSFD -1025NSFD -1026NSFD -1031NSFD -1035NS
FD -1018NSFD -1022NSFD -1069NSFD -1027NSFD -1032NSFD -1036NS
FD -1110NSFD -1096NSFD -1100NSFD -1071NSFD -1103NSFD -1073NS
FD -1020NSFD -1024NSFD -1070NSFD -1029NSFD -1034NSFD -1106NS
FD -1019NSFD -1023NSFD -1099NSFD -1028NSFD -1033NSFD -1107NS
FD -1094NSFD -1097NSFD -1101NSFD -1030NSFD -1104NSFD -1108NS
FD -1095NSFD -1098NSFD -1102NSFD -1072NSFD -1105NSFD -1109NS
Available Colors for Pre-Printed Syringes
Oli Hudson, content director at Wilmington Healthcare, explores some key themes and developments in the NHS for 2023.
The NHS seems to go from crisis to crisis. My last article for MedTech Innovation News in October explored this in depth – and the problems seem more acute since then.
Issues in capacity, workforce, finance, and integration are creating a perfect storm, causing unprecedented numbers of patients to experience suboptimal care: a backlog in screening, diagnosis, treatment and care, extensive waits and issues with access and equitable services.
The NHS is trying to address these issues by policies intended to improve activity levels, enhance collaboration, and maximise efficiencies.
However, the struggles are plain to see and the impact on industry is wideranging. Here, we highlight four areas of change and how medtech should react.
This is throwing up new networks of decision-makers and stakeholders which exist in unfamiliar groupings, including clinical networks, provider collaboratives, and place-based partnerships, whom medtech needs to understand and access, and with whom they must build new relationships to ease access for innovation.
For companies seeking to partner with the NHS on patient identification or pathway change, other roles may need to be sought such as transformation leads. If your innovation depends on digital technology, you may need to work with a programme lead for digital at integrated care system level.
Outsourced procurement management seems to be coming to an end at a national level with NHS Supply Chain to take in the majority of medical procurement and clinical supply in-house.
“We are now operating in a more challenging economic environment, and we need to simplify how we operate and partner more expertly with our stakeholders,” it explained.
In this financial climate, more
efficiencies are likely to be needed from procurement and more will be asked of suppliers to improve their offer on sustainability – including on long-term viability of NHS services.
HSJ reports that NHS trusts will have to receive Cabinet Office approval for any clinical and non-clinical spending over £10 million. NHS England in London will introduce the new controls first and then roll out to the other regions over the next two years.
This will apply to NHS and foundation trusts, shared procurement services and procurement hubs, and subsidiaries where the majority shareholder is a trust. It will cover framework call-offs and agreements, contract changes or extensions, and collaborative trust procurements awarding to a single supplier.
All expenditure over £10 million will be in scope, including new or replacement contracts or call-offs from frameworks, contract changes or extensions, framework agreements themselves, and collaborative procurement between multiple trusts with a single supplier.
For high value procurements this is going to present another set of criteria to deal with in contracting and tenders for industry.
In the planning guidance released in December 2022, NHS England states a core priority is for systems to break even by year-end.
This is a tall order when the majority of trusts are in the red and much resource is being taken up dealing with emergency services, hiring agency staff and attempting to deal with elective backlog.
Some payment for trusts is now being carried out on a payment-byresults basis, intended to encourage activity and this could change some trusts’ focus on how much work they do in certain clinical areas.
Wherever medtech does engage, value for the NHS will become ever more important. The value proposition will need to be honed to establish how
your device can create efficiencies across the whole system, with all the costs of a pathway or service line considered. Staff time, theatre time, the mix of HCPs required to operate, and length of stay will become relevant to the sell as delayed discharge takes over some systems and leaves hospitals unable to operate at full capacity.
The planning guidance also prioritises service transformation. This could involve digital technologies and virtual services, preventive care models, new care settings such as community care models, and self-referral and selfmanagement.
Unfortunately, the stress on the system means there is little time for improvement and learning from best practice when enormous effort must be expended by NHS staff just to keep basic services going.
This means medtech must try to build projects locally where there are the opportunities, drawing on what has worked and where there is real-world evidence to suggest change could benefit other parts of the NHS.
Industry can help by engaging with four key areas:
1. Developing meaningful multilevel partnerships with the right stakeholders – understanding the who’s who of your clinical area
2. Investing time in developing a multidimensional value proposition –covering sustainability, accessibility and efficiency
3. Developing pathways for cost and clinical effectiveness, building in quality improvement with a focus on improving outcomes, and
4. Assisting the NHS to develop new delivery models that disrupt traditional ways of thinking, allowing us to rethink our current way of delivery.
Success in these areas will make a company stand out, as we go into a most uncertain year for the NHS.
After the first day of Med-Tech Innovation Expo at the NEC in Birmingham, the evening will see the National Conference Centre host the Medilink UK Healthcare Business Awards in association with Med-Tech Innovation.
This year’s ceremony takes place on 7th June 2023 at the National Conference Centre in Birmingham, a short ride away from the NEC. Here we provide a brief overview of what to expect from the gala evening.
The Medilink UK Awards finalists will be made up of the winners from the regional Medilink Awards from the Midlands, North of England, Wales, South West and South East; and will span seven categories which are:
■ Advances in Digital Healthcare: Awarded to the company who demonstrate how digital technologies were employed to enhance current service delivery or create new ways of delivering healthcare. Last year’s winner was Spirit Health – a digital health company which empowers people to take control of their own health with remote patient monitoring and virtual wards.
■ Delivering Innovation into Health and Care: For the development of a collaboration with the NHS that has or will have a major impact or benefit to both business performance and patient care. In 2022, TUTUM Medical took home the prize. The company is spun out from TBG Solutions – an engineering company providing test capability on manufactured products to large corporate companies.
■ Export Achievement: For outstanding performance in international trade. After being recognised by the World Health Organization for its benefits of helping people recover from COVID-19, POWERbreathe was shown to help to lower blood-pressure, reducing heart attack risk as well as boosting cognitive & physical performance; and now has over 30 distributors worldwide.
■ Innovation: For the development of an innovative technology, design or process that has produced a major improvement in business performance or end-user benefit. EarSwitch Ltd has developed a sensor that detects motion through the movement of one of the smallest muscles in the body. The company’s central ethos is to provide communication devices, and control of assistive devices (such as prosthetic arms for people with amputation, and arm exoskeletons for people with paralysis or stroke).
With the 1st March deadline for entries to the Med-Tech Innovation Awards fast approaching, here we give a rundown of what the awards night will entail, and give you some inspiration with a round-up of the 2022 winners.
■ Outstanding Achievement:
For an achievement that has had a significant or vital impact on the company and the sector. Paxman, a manufacturer of scalp cooling systems to minimise chemotherapy-induced alopecia, received the accolade in 2022. The company has an 80% share of the global scalp-cooling market.
■ Partnership between Academia & Business: Awarded to the company who demonstrates how the collaboration / partnership has or will enhance current service delivery or create new ways of delivering healthcare. Last year was Somnus Scientific and the University of the West of England who were the winners, as its collaboration has resulted in the development of personalised sedation and anaesthesia which is safer for patients and better for the environment than anaesthetic gases.
■ Start-Up: For newly established companies (trading for up to three years) in the medical and healthcare sector, that show a promising future. Drill Surgeries is developing technology to reduce the excessive amounts of radiation used in operations which use a metallic rod to bind broken bones. Drill Surgeries has created Artificial intelligence to provide a precision guide allowing surgeons to place everything in the right place, first time – and were the 2022 startup award winners.
There is a slight change to this year’s line-up for the Med-Tech Innovation Awards. Last year saw QuantuMDx recognised for its Q-POC in a special recognition award in response to COVID-19, while the Engineering category has been substituted for Manufacturing Excellence. Here is the rundown of this year’s categories:
■ 3D printing: This award is for those who have shown how using 3D printing has enhanced or fundamentally improved the design or manufacture of medical devices. Lucid Implants were the 2022 winners having developed custom implants and cutting guides to improved surgical accuracy, resulting in a 53% decrease in hospital stay, a 73% decrease in OT time, and an 88% decrease in recovery cost.
■ Connected Health: Given to those who have developed or manufactured a cuttingedge medical device, whether through supplying miniaturised sensors or conductive materials; or involvement on the digital and software side of things. Acurable’s AcuPebble took home last year's prize. This wearable acoustic sensor became the first medical device to obtain the CE mark for the automated diagnosis of obstructive sleep apnoea in 2020 and has since gained FDA clearance for home sleep apnoea testing in the USA.
■ Design: Focused on the design or redesign of a medical device, what clinical need was identified, and how this need was met through the innovative use of unique design developments. This prize went to Lightpoint Medical in 2022, who developed a miniaturised robotic gamma probe designed to significantly widen the field of minimally invasive radioguided surgery, providing real-time, intra-operative cancer detection.
■ Manufacturing Excellence: Focusing on the manufacture of a medical device, entrants should detail an innovation in the manufacturing process or technique which improved the product outcome. Last year’s Engineering award went to Adapttech's INSIGHT for lower limb amputee socket replication and pressure distribution evaluation within the patient socket. With CAD/CAM export & integration abilities, INSIGHT shortens the number fitting appointments and enables a more accurate fit.
■ Materials Innovation: Showing how a new or repurposed material was pivotal in the creation of a medical device. Birmingham Biotech’s anti-viral nasal spray was last year’s winner, as a patented blend of natural ingredients to help slow or prevent viral infection called Norazite, coats the nasal cavity, creating a protective barrier to physically trap viruses.
■ Sustainability: For demonstrating how innovation in design or manufacture has reduced the environmental footprint of a medical device. Meryl Medical was recognised in 2022 for its antimicrobial fabrics, which are fully recyclable with zero microplastic pollution through the innovative use of hydrogen bonding to create strong molecular chains that seal all microfibres into the filaments.
The evening will be compered by the familiar face of presenter, speaker, and Invictus Games Medallist JJ Chalmers. Chalmers is also an ambassador for the Invictus Games as well as Help for Heroes. For those familiar with their sport, Chalmers’ face will be a recognisable one as he has hosted coverage for several sporting events including the Olympic and Paralympic Games, the London Marathon and Commonwealth Games.
For more details on this year’s Medilink UK Healthcare Business Awards, and to enter to the Med-Tech Innovation Awards, visit www.med-techawards.com
Thomas Averre, founder of specialist public relations consultancy Tarleton Communications, provides a small preview of his seminar at Med-Tech Innovation Expo as he discusses how start-ups can go about securing investment.
Raising investment is one of the most important objectives for a start-up, not least because of the vast expense involved in R&D, patenting and conducting trials. Yet many founders and CEOs find raising investment difficult and struggle to connect with investor audiences.
They are therefore surprised to discover that investors also struggle to find companies to invest in and spend considerable time seeking out promising medtech start-ups.
One senior investment manager I spoke to at a mid-sized venture capital firm told me he receives hundreds of pitches a week and just doesn’t have time to read them all. Unless he has already heard of the company or has been personally referred to them, emails often go unanswered.
This paradox – companies struggling to find investors, while investors struggle to find companies - is the result of huge amounts of ‘noise’ in the market. Thousands of startups are claiming to be innovative and tackling multi-million-pound problems, making it hard for investors to differentiate between them and know which to shortlist. Investors either use referrals or ‘signals’ to help them decide which businesses to investigate further.
These ‘signals’ include visibility and credibility. Many start-ups don’t demonstrate either, and very few demonstrate both, so businesses that can skilfully create and articulate these stand out.
So, where does this leave a promising start-up and how can they show investors that they are different?
Tactically, I advise clients to explore profile raising through PR, to create authoritative content, and to develop a digital presence that reflects their offline reputation. The best methods vary from business to business and depend on factors like whether the business is in medtech or biotech, how much it is looking to raise and its commercial pipeline. The ‘what to do’ isn’t the important bit. How is.
A press release or two isn’t going to suddenly solve the investment riddle. Management teams and boards need to think broadly about external communications and consider brand building as a serious strategy for growth that helps to attract investors, build pipelines, and create shareholder value. Some leaders get this, but others reject it immediately.
I can understand why. There is a misconception that brand building is about lots of marketing, new logos, expensive campaigns, and brochure redesigns. It’s not. It’s about being distinctive and memorable, and demonstrating how your innovation is different and how you are uniquely placed to commercialise it. This can be done on a budget, but it needs to be strategic and executed by someone who really understands the sector.
I handle the public relations activity for some genuinely cuttingedge medical device, pharma, and digital health start-ups, and advise them on how to attract investment through brand building and investor communications. I recommend focusing on two things - creating visibility and demonstrating credibility.
On visibility, the target audience needs to read, hear, and see the business regularly in print, online and in person. This isn’t about an investment manager reading one article and calling them up, but about building and refreshing memory structures so that they start to recognise and remember the business. It’s also part of the due diligence process – when someone researches the business, what will they find? By securing industry, national and business media coverage for clients, I help them prove to investors that others take them seriously and that they have momentum behind them.
In healthcare, credibility matters much more than it does in other industries because of the scale of many claims. It is established gradually and over time helps to build a powerful reputation. Tactically, this might be done through thought leadership, speaker opportunities or white papers but in essence, involves showing investors how knowledgeable and sophisticated the team are, without just saying ‘we’re experts’.
After all, which start-up isn’t claiming to have a revolutionary innovation with an expert team?
Join me at Med-Tech Innovation Expo 2023, where I am delighted to be speaking on why a brand is important and how medtech and life science businesses can stand out and avoid failing at the early due diligence stages. I’ll also be giving practical advice on how start-ups can develop the momentum that piques investor interest, whether you’re on your first round or third.
When locating a specialist micro moulder, it is important to find one with not just the wherewithal to achieve exacting micron tolerances, but one that has expertise at the design, tooling, manufacture, assembly, validation, and measurement stages of the micro product and component development process. This will ensure that the requirement for lengthy and costly design reiterations will be minimised, and so micron tolerances can be achieved cost-effectively and in a timely fashion.
It is vital that micro moulders have the business culture, personnel, and equipment in place to provide the service necessary to ensure a successful project outcome. Micro moulding for OEMs from a variety of industry sectors requires the ability to cater for low, medium, and high volume runs in a variety of different materials, all requiring different levels of validation. Micro moulders must also have expertise in handling, storing, and processing often extremely expensive and sensitive materials that in many instances will be used in safety critical applications.
The transition from injection moulding machines that can effectively produce “small” parts, and machines that can produce “micro” parts and features is important, and micro moulders must be able to utilise state-ofthe-art equipment designed for exacting micro applications.
The necessity for the degree of control and repeatability needed in micro manufacturing requires the moulding press to be equipped for such precision. Traditional machines tend to struggle to maintain accuracy the smaller the part dimensions often adding additional processing struggles. So, saying, micro injection moulding machines — which may be manufacturing parts with weights less than 0.005g — can not only handle much smaller geometries and tolerances, but have a positive effect on material usage, residence time, and consequent material degradation common on larger presses.
It is in tooling for micro moulded parts that time and money can be wasted if the micro moulder does not have the expertise required. 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. Micro moulders must be able to employ an array of moulding technologies, including the latest CNC machining technologies, and — as is often required — EDM.
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, high performance materials, such as bio-resorbables, 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.
Process parameters in micro moulding are different in many ways from traditional injection moulding, but key is an understanding of the balance between melt temperature, injection pressure, and injection velocity and their effect on dimensional accuracy. Also, attention must be focused on micro moulds that in many instances require mould alignment to less than 5 microns, and with gate diameters that are typically anything from 60 to 200 microns. Proper venting and runner design are critical steps for the process to be as efficient as possible.
Due to the often critical nature of some micro moulded parts and products, it is often necessary to manufacture under cleanroom conditions. With extremely exacting quality and traceability systems, complete control of the entire manufacturing process is required,
Due to the often critical nature of some micro moulded parts and products, it is often necessary to manufacture under cleanroom conditions. With extremely exacting quality and traceability systems, complete control of the entire manufacturing process is required.
and adherence to the parameters set out in ISO 9001 and ISO 13485 can be hugely important, setting out the requirements for a comprehensive quality management system for the design and manufacture of safety critical components.
One thing that makes micro moulding supplier choice a key concern in the design to manufacturing cycle is the increased pressure in quality control. Quality control and high-quality requirements are characteristic of many industrial sectors today. This is a direct reflection of the fact that micro manufactured components in numerous industrial applications are now performing critical functions, and so failure rates — even in high volume mass manufacture — must be zero. This not only requires painstaking attention to manufacturing process control, but also demands that focus is maintained on quality control procedures and validation.
It is unsurprising that industry should take advantage of the possibilities that exist through the judicious use of micro manufacturing technologies and techniques today. Micro injection moulding, for example, facilitates the cost-effective and repeatable manufacture of small or micro products to extremely tight specifications, or larger parts with tiny features. In general, where possible, moulded products are replacing machined components. The primary advantage of micro injection moulding over micromachining being cost, micro injection moulding taking no time at all to mould components in relatively low-cost materials compared to machining.
Micro moulding also facilitates the manufacture of extremely complex geometries and represents a dimensionally stable production process with no particle contamination, and
often a better surface finish. For OEMs seeking to take advantage of the possibilities that exist today for the manufacture of small to micro plastic parts, partner selection is vital. As well as assessing the nature of the equipment that a micro manufacturing partner has in-house (this including not just processing equipment but handling, assembly, and inspection equipment as well), of paramount importance is finding a supplier with an intimate knowledge of the process and the specific requirements of different industrial sectors. Accumold's expertise with small and micro-sized injection moulding is a fit for industrial sectors that require precision thermoplastic components with dimensional stability.
Accumold’s pre-eminence in micro mould tool design and fabrication is also extremely important, as this is the key stumbling block as OEMs attempt to enter the micro moulding arena. Accumold has in-house mould building capabilities, with cross-functional teams of designers and toolmakers working together to fabricate tools that can produce production-ready parts the first time. This reduces the likelihood of multiple and costly design iterations and tool redesign.
In its 40th anniversary year, component manufacturer and laser processing specialist Micrometric is reflecting on the changes the company has faced, and the evolution of the services it provides in the medical sector.
Founded by Maurice Gates and Neil Main, Lincolnbased Micrometric began by cutting sheet metal using CO2 lasers in January 1983. In its first month, Micrometric had a small turnover of around £50, but that soon started growing.
Several requests for laser cutting other materials led Micrometric to consider new ways of cutting silicon, alumina, and more exotic metals. It was also asked to make difficult plastic parts and achieved precision and highly complex computer control. As demand for specialist work grew, so did the business.
Neil Main, managing director of Micrometric, remembers contracts that changed the services provided by Micrometric: “We were asked by the Atomic Energy Research Establishment at Harwell if we could make radiation sensors for detecting alpha radiation. They had produced a new plastic that reacted to radiation and a way of using electro etching to create lines that could be counted with a microscope.
“They needed small rectangles cutting and each to have a letter and number and error code that was different on each. At that time our competitors were not able to do this, so we rose to the challenge. I programmed the large CO2 laser (DE), and a local computer expert programmed the new BBC Micro which successfully drilled the identity and output the required parts.
“After some time, we needed to speed things up and we purchased the HK Fiber Laser cutting machine. It changed the way we worked! We
approached potential jobs with flexibility and openmindedness which allowed us to offer new and innovative services. In fact, we still do this job!”
Continuous development was a key strategy for the company and in 1985 Micrometric was contacted about cutting silicon. Its customer had a contract to make a particular semiconductor, but it needed special silicon and a particular set of discs. After the CO2 laser did not perform to the standard required Micrometric purchased the Nd:Yag laser from Switzerland, which produced around 1.5 million semiconductors over about 18 months.
The volume of the silicon meant Micrometric needed to invest in another laser; a JK Laser which was made in Rugby. The company was also cutting silicon for other companies in Europe including Finland, Germany, and Italy. By 1990, Micrometric Techniques was a precision laser processor, and several industries were asking the team to make parts. Most of the medical items were for instrumentation but Micrometric was asked to
make one part for a prostate cancer remover. It was a long, thin, laser-cut stainless tube with laser-welded parts on it. This meant the team could improve their laser welding techniques and enabled the process to become more controlled.
In 1994 the company moved into a new purpose-built factory in Lincoln, allowing further expansion. With more space the company invested in new lasers including its first Bystronic.
Neil Main recalls when Gates tried to sell the business: “I still have potential contracts from some of the companies that failed to buy Micrometric Techniques. Most were interested in just one of our wide ranges of production and all did not want ‘the rest of it’.
“I then purchased the company from Maurice in 2004 and at that time we had a good turnover and large number of employees. I changed the company name from Micrometric Techniques to Micrometric, since this was the name the company was known as by customers.”
After purchasing Micrometric Neil faced a great challenge: the biggest customer which
accounted for around 25% of turnover in Micrometric’s portfolio bought its own laser. The company’s revenue declined, and it resulted in redundancies.
Recovery took a while before the company was able to invest in new equipment but technological advances meant the new lasers when purchased were state-of-theart, resulting in better quality components more quickly with a higher-skilled workforce.
The last five years has seen strong growth and further investments to meet the demand for precision components, including the Coherent Starcut tube cutting machine for exclusive medical instruments with high precision, and a new Lasercube machine for quality, precision, speed, and efficiency. The company feels these developments will allow the team to continue producing high-quality precision components for the medical sector.
When looking into the future Main is positive: “Most things develop out of a need, and we have seen so much change in just the last three years, but customers are still asking for new parts and processes.
“A customer has recently asked us to laser cut and weld components for insertion into human bodies, which we can produce, but they also need medical deep cleaning, disinfection and medical packaging solutions which is not our area of expertise. We are always looking for new ways of expanding our services so there is huge potential for growth into the medical industry.”
William Mason, managing director of motor and drive specialist maxon UK and Ireland, discusses how small motors are driving innovation across one of maxon’s fastest growing sectors: medical.
The trend for miniaturisation continues to be relevant as many industries are driven to reducing weights and footprints to save space and improve user experience. Modern surgical tools, for example, are being made smaller and lighter to improve precision while enhancing user comfort and safety.
Medical devices vary greatly in size and weight, from active implants, weighing between 20 and 50 grams, to larger, heavier surgical tools. Because of this, each device will have its own motor requirements. For example, active implants must withstand the high salt concentrations inside the human body. Meanwhile, surgical tools need motors with high-power densities and without gears, to limit vibration and noise.
Despite these differences, one thing remains the same: the need for small motors. In fact, it is now possible to manufacture motor
controllers smaller than a postage stamp, adding extra control modules where necessary to enhance the capabilities and precision.
In something as small as an active implant, reducing weight seems obvious because the device is embedded somewhere in the body. But, for something bigger like a surgical drill, miniaturisation is just as important.
This was apparent when maxon supplied a configurable DCX direct drive to a Dublin-based hair replacement clinic who wanted to create a hair follicle extractor drill to replace its existing bulky and cumbersome device. Because hair replacement procedures can take between three and four hours, depending on how many hairs are grafted, a lightweight device was needed to reduce user fatigue and optimise precision. The resulting drill offered high power density and torque in a compact footprint, the nose measuring just 0.8 millimetres in width.
Small motors are also needed in myoelectrics, a technology that uses sensors to recognise and measure muscle contractions in prosthetic limbs. This was demonstrated when Massachusetts-based Myomo needed several small motors and controllers to manage multiple features simultaneously in the elbow, hand, and fingers of its motorised arm brace, the MyoPro 2+.
For someone who has lost the use of an arm from a stroke or traumatic brain injury, regaining as much function as possible is vital to improving their quality of life. If a brace is cumbersome to lift, the functions of the device will be limited and users may be at a higher risk of further injury, like repetitive strain on the shoulder or neck. This is why the
MyoPro 2+ had to be as lightweight as possible, allowing it to feel like a natural extension of the body, rather than a medical device.
To achieve this, the company used a miniature maxon DCX19 motor in the elbow joint, and a RE13 with an integrated planetary gearhead for the hand operations. Both motor ranges offer higher power density in smaller footprints, usually between 6–35 mm depending on the application. Multiple miniature motors are used for this brace in different areas, in an aim to improve its functionality, and to allow users to comfortably perform normal daily activities.
It’s safe to say that the need for smaller motors will increase substantially as companies across the medical industry continue to miniaturise their designs. With 60-years’ experience and global R+D capacity, maxon is well positioned to provide specialist, lightweight motors to be integrated into small devices.
Denis Pasero, product commercialisation manager at Ilika, outlines the role micro batteries will have on implantable medical devices going forward.
It is no exaggeration to say that we are set to experience change in the design of implantable medical devices. Over the course of the next decade, a wave of new products will alter how we look at implants, as a range of miniature devices become available that can be implanted close to the target organs.
The ability to manufacture smaller devices also creates new opportunities. For example, a device can be designed into a replacement joint to provide realtime information on the condition of the joint itself, the patient’s overall health and irregularities such as misalignment and abnormal bone growth. This means that remedial treatment is possible sooner, while the issue is less serious. In the future, data gained from techniques like this will allow the design of better joint replacements. Similar techniques could be applied to orthodontics, where devices will be embedded in dental wearables to monitor the patient’s saliva for diagnostic purposes, while simultaneously observing the wearable for effectiveness and usage data. Smart contact lenses could measure patient metrics such as glucose levels and intra-ocular pressure. They could one day be used to implement sight correction, and even further integrate AR/VR features.
In the short term at least, the area that offers the greatest impact for these new devices is neuromodulation, where electrical impulses are used to provide targeted stimulus to the nervous system of the patient. The treatment is well understood and very effective for many ailments, including chronic neuropathic pain, epilepsy, pelvic disorders, gastrointestinal disorders, and angina. At present, the downside of neuromodulation is the actual provision of the treatment. In some cases, treatment is performed in medical facilities, in others it is provided through relatively bulky implants. Tomorrow’s medical devices will improve the implantation process by providing less complex surgery with a quicker recovery time, fewer complications for the patient and easier battery replacement, while expanding the range of treatments available. As the devices are implanted close to the targeted organs (nerves, near the brain or spinal cord), there will be further benefits for patients, such as lower doses of medicine required and greater control over treatments.
Most of the ingredients that will enable this new wave of implantable medical devices have been in place for some time. A sophisticated microcontroller takes only a few square millimetres on a Printed Circuit Board, is less than a millimetre high, uses negligible power in standby and only a little more in
operation. Other components, such as the communications chip and sensors, have similar dimensions and power requirements.
The only component that has so far resisted real miniaturisation is the power source - normally a battery - 75% of life-critical implanted devices use large, nonrechargeable batteries. Some non-life critical applications use rechargeable batteries, such as lithium-ion (LiB), which are similar to households batteries but with thicker casing making them ultrasafe so there’s no leakage. Even if made smaller, the need for a casing means it is almost impossible to get their height under 2mm. Reducing the size of LiB batteries means that they may not be able to supply the necessary peak current to power the circuit during operation.
Smaller, safer, and more powerful batteries are key to new implantable medical devices, and these are now becoming available in the form of solid-state batteries. In addition to their small size, solid-state batteries use a solid electrolyte that can’t leak.
Practical examples of solid-state batteries for medical applications can be found in Ilika’s Stereax range. The Stereax M300 battery has a capacity of 0.3 mAh and comes in a 3.6 mm x 5.6 mm x 1 mm package. It has a pulse rating of 3 mA, which is sufficient for most medical applications and communications. A manufacturing and commercialisation partnership with Cirtec Medical will bring the Stereax battery technology to market enabling medical implantable devices to have micro battery power that has low leakage and can be used with energy harvesting circuits. In the future, wireless charging from outside the patient’s body will also be possible, meaning that they will last almost indefinitely inside the human body in many use cases.
Chris Whitehouse, an expert on medical technology policy at Whitehouse Communications updates readers on changes to the timelines for implementation of the EU’s Medical Devices Regulation and highlights the need for the sector to engage with European institutions to avoid regulatory crises.
Acrisis was fomenting in terms of European regulation of medical devices, but it seems last minute action can yet see it averted and manufacturers can breathe a sigh of relief.
The EU has never been renowned for quick decisionmaking, and the long-awaited implementation of its new Medical Devices Regulation, first enacted back in 2017 but not yet fully implemented, is no exception. The question is whether its provisions are still fit for purpose when assessed against the background of a global pandemic the like of which the EU has never previously seen, and which wasn’t anticipated back when the details of the regulation were agreed.
But, regulators, lawmakers and manufacturers all broadly accept that the new regulation is indeed fit for purpose not only to guarantee safety but also to facilitate innovation. The EU Medical Devices Regulation (MDR) is intended to meet that test. The problem that has come crashing to the fore postpandemic, however, is that regulators and the third-party organisations that handle medical device assessment under the provisions of the regulation lack the capacity to meet the demand. Delay in implementation has, therefore,
come as something of a relief across the sector.
A three-year transitional period was originally planned for the implementation of the key provisions of the MDR, but, last month, the Commission listened to manufacturer concerns and proposed an extension. Understanding the current state of play and future timeline for change are key for medtech developers’ and manufacturers’ future planning.
The MDR replaces the EU Medical Device Directive (MDD). Changes introduced by the new legislation include enhanced safety and performance requirements, technical documentation, and clinical data and evaluation requirements. The legislative change required all medical devices certified under the MDD to be re-certified based on MDR by 26th May 2024.
Yet, the substantial shortage of capacity in the “notified bodies” set to undertake this work presented a roadblock to progress which needed urgently to be addressed.
Notified bodies have to date received 8,120 applications from manufacturers and have issued only 1,990 certificates under the MDR. The number of MDR certificates expected to have been issued by May
2024 may still only reach around 7,000 if the current rate of certificate issuance continues with no changes to current conditions – well short of the 22,793 certificates issued under the MDD. The shortfall is massive and rightly set alarm bells ringing.
The Commission has now proposed to extend the transitional period for the certification of medical devices with staggered deadlines depending on the risk class of the device: 2027 for class III and class IIb devices (devices in higher risk categories) and 2028 for class IIa and class I devices (lower risk devices) that need the involvement of a notified body in the conformity assessment.
Fortunately, the Commission’s proposal was supported by European Council members at the Employment, Social Policy, Health and Consumer Affairs’ (EPSCO) session held on 9th December. In terms of next steps, the Commission aims imminently to provide the legislative proposal to the Council and the European Parliament to consider. This needs to happen fast.
The Commission’s Medical Device Coordination Group (MDCG) also published a position paper aiming to achieve a common understanding of and a
uniform approach to the application of Article 97 of the MDR. This article foresees that competent authorities can temporarily allow devices that do not comply with the MDR to continue to be placed on the market if they do not present an unacceptable risk to the health or safety of individuals or to public health.
The position paper suggests that Member States apply the safety valve of article 97 in cases where manufacturers make reasonable efforts to obtain certification under the MDR but the conformity assessment by a notified body has not been concluded it time.
With the whole EU, and indeed the wider world, wanting to see more rapid and effective medical device regulation, action was clearly essential to avoid the sector grinding to a halt. But businesses cannot afford to take their eyes off the ball.
Regulators and lawmakers had several years to see this crisis coming, but, whilst it is perhaps at the 11th hour, at least engagement has on this occasion ensured that the crisis can be averted.
Questions about or comments upon this article can be addressed to the author at chris.whitehouse@ whitehousecomms.com.
Paul S Weston, review & accreditations director at ORCHA, the organisation for the review of care and health apps writes about the mandatory Digital Health Assessment Criteria which new products must pass ahead of being commissioned by the NHS.
Introduced in early 2021, the NHS England Digital Technology Assessment Criteria for health and social care (DTAC) is a benchmark which all digital health products or health apps must reach if they are to be commissioned by NHS England.
The DTAC is a coming together of certificates and standards which the NHS have been using for several years, so adopting this at a national level and with a national mandate has been a welcome step towards best practice. However, one year on from launch the DTAC is still feeling very new to many digital health innovators and healthcare providers.
In short, the DTAC ensures a digital health product or health app is fit for purpose. Its objective is to ensure this new generation of
digital tools is safe, secure, and usable. It tests products for usability and accessibility plus technical security and robustness. It also considers clinical safety and risk, medical device regulations, data protection and interoperability, amongst many other factors, depending on the nature of the product.
When developers do take their products through the DTAC process, we are finding some common pitfalls. What can be done to avoid these?
Many developers overlook mandatory Clinical Safety Officer training in clinical risk management. This training is essential to demonstrate an understanding of the principles of safety, risk management and risk mitigation. The course is just a day long and can be done online through NHS Digital as well as third party providers (Clinical Risk
Many developers overlook mandatory clinical safety o cer training in clinical risk management. This training is essential to demonstrate an understanding of the principles of safety, risk management and risk mitigation.
Management TrainingNHS Digital). The developer’s clinical safety officer needs to make time to attend.
Next, we often find that penetration and security testing is out of date for a digital product or has not been carried out to a required specification. This testing is expensive, so it is often put off. It can also be challenging to find suitably qualified professionals to carry out the testing. But the summary reports are essential, and the common vulnerability scores
the product is given will indicate whether it will meet key DTAC criteria. The testing explores the top things hackers will look for, scrutinising the robustness and the code behind a product. The test must have been carried out within the last 12 months and achieve a vulnerability metrics (CVSS) score of 7.0 or above against the Open Web Application Security Project (OWASP) top 10 vulnerabilities. More information and links to approved testers can be found at Penetration TestingNCSC.GOV.UK .
The following pointers should also help to make your DTAC assessment a smooth ride:
● Adopt an exam technique to all the paperwork. It helps to organise your documentation against the specific requirements – and only include relevant information. Some sort of indexing system or evidence tracker will be immensely helpful, given all the paperwork.
● Be aware of differing lead times for any evidence which must be externally validated and ensure the evidence is indeed still valid and not outside of expiry dates.
● Expect the initial DTAC process to take two to three months. If it has taken longer than six months, that should be a warning bell that certain aspects are not in place.
● Then view the process – and the compliance it achieves - as a moving beast. Your digital product is being benchmarked against many regulations, which may change, and you may update your product or documents might expire and need to be re-submitted.
Finally – a simple bit of admin, but one which often causes delays in the DTAC process. Anybody who has access to administrative features, including the software developers, must be able to demonstrate multi-factor authentication. This involves having two separate pieces of identification logged.
Shortly after the launch of the DTAC, ORCHA was commissioned by developer Wellmind Health to achieve certification for two of its products – Pathway Through Pain and Be Mindful.
Commercial director Sarah Germaney said: “We were looking for something that
would differentiate the quality of our apps, so that we could demonstrate that they had been assessed against accessibility, usability and data security.”
The Wellmind Health team had some background in NHS requirements as their products had featured on the NHS app library before the library was taken down. However, whilst they had many aspects covered, the DTAC brought in more requirements, particularly relating to privacy and quality, data sharing and cyber security. A cyber essentials assessment was required, and a data protection impact assessment.
Germaney said: “This was a real partnership with ORCHA, with much back and forth over several months. There are a lot of processes you have to have in place which rely on other factors.
“Overall, I would say to developers that this process is tough – it isn’t easy –because there’s a very robust examination of all your processes. They may be proved compliant, but many details still require thorough scrutiny. Our rationale for going through this was that
we wanted anyone in the NHS to be confident that our products met all their criteria.”
As the Wellmind Health team has reflected, the DTAC gives valuable third-party validation, and this should give confidence when speaking with individual NHS organisations and reduce potential delays in the demonstrating compliance.
Getting through the process will take staying power but there are numerous support offerings available to digital health suppliers. These range from substantial offers where third-party organisations assume responsibility for certain sections of the DTAC to external quality assurance programmes which offer unlimited re-reviews aligned to your product roadmap. In all instances, do your homework and ensure that the solution you opt for is right for your business and reflective of your skills and competences.
Peter Swanson, managing director of adhesives specialist Intertronics, discusses the considerations for manufacturers bonding RFID sensors to surgical instruments.
Atypical hospital uses hundreds of medical instruments across its operating theatres and emergency rooms each day. Hospital teams must therefore manage a precise assortment of tools during procedures to keep track of equipment, to ensure none are misplaced and to keep patients safe. Historically, monitoring the availability and location of tools was performed manually by hospital teams, who would record serial numbers or scan barcodes. However, this is a time-consuming task that is prone to human error. As regulations become more stringent, the assigning of unique identifiers to medical instruments that enable their management has become more important, as has the improvement of the systems used to management.
To improve how surgical tools are managed, many hospitals are now opting for digital surgical instrument tracking systems, such as those based on RFID. These systems can improve patient safety, as well as uplift hospital efficiency, by streamlining surgical processes and ensuring the correct tools are available. An RFID system enables surgical teams to monitor instrument availability, check sterilisation status, and better manage inventory. They are easier and quicker to scan than barcode tagged devices, as the user does not have to exactly align the tag with the reader.
According to Fact. MR and reported in Bloomberg, the
global surgical instrument tracking market is expected to reach $1,294.89 million in 2023, exhibiting a CAGR of 18% from 2022 to 2032. As the market grows, many manufacturers are looking to start RFID tagging their instruments, or scale up their production of RFID tagged instruments. This can bring some design and manufacturing challenges.
The adhesive used to bond RFID chips must form extremely strong bonds to stainless steel and other materials that instruments are made from, to ensure the tag remains in place throughout the product’s lifetime. It is critical the materials used can tolerate the environmental stresses the tool will be exposed to, such as high heat, humidity, and chemical exposure. One significant environmental stress surgical tools must be able to withstand is sterilisation cycles, such as autoclaving, STERRAD Hydrogen Peroxide Plasma, ethylene oxide, E-beam, and gamma. Manufacturers must therefore choose a material that is robust enough to withstand the demands of the healthcare environment, resistant to sterilisation cycles, and meets certifications like ISO 10993-5.
While there are formulated one- and two- part epoxies on the market for the bonding, coating, and encapsulating of medical devices and RFIDs, these carry limitations.
Epoxies typically require specialised mixing systems, have long cure times (up to 60 minutes), short pot life, and may require the use of heat curing equipment. As well as the process disadvantages, the materials have relatively low flexibility and impact resistance, and may require purge cycles that could result in hazardous waste.
To address the process tradeoffs associated with epoxies, a new versatile UV/LED curable adhesive has been developed that can withstand 100+ cycles of autoclave and plasma processes. The material, Dymax 1040-M, exhibits extremely low water absorption (0.5%). This makes it particularly interesting for bonding RFID chips, sensors, and other electronic components found on medical devices, tools, and vials where moisture ingression may be of concern. It features exceptional bond strength to a variety of substrates including stainless steel, aluminium, glass, PP/PE, and PCBs. It is compliant with ISO 10993-5 cytotoxicity and is formulated without IBOA (a known skin irritant).
Compared with epoxies, one-component light-curable adhesives can greatly improve manufacturing productivity, throughput, and efficiency — crucial at a period of high market growth, where manufacturers may be looking to scale up operations. UV curing materials offer fast “on demand” curing
(typically in seconds) when exposed to the correct wavelength of UV light, reducing work in progress, increasing throughput, and reducing costs. A 100% solids, 100% solvent-free, single part formulation simplifies and reduces cost of handling, processing, and dispensing, while minimising environmental impact and improving worker safety.
Also, UV light curing systems help achieve process reliability, repeatability, and validation. UV curable materials are simple to dispense from a simple syringe using anything from time/pressure control, right up to sophisticated volumetric positive displacement pumps. For example, the preeflow eco-PEN, which offers precise, process-stable dispensing as small as 1 μl, and boasts an accuracy of ±1%, >99% of the time. UV curing adhesive processes can be readily automated with a benchtop or gantry robot to improve productivity and remove inconsistencies.
As the market for RFID tagged instruments grows, to improve hospital efficiency and keep patients safe from RISs, the adoption of a UV LED curing adhesive can bring manufacturers process and technical benefits. For best results, work with an adhesives partner who can build a process where all the equipment works together optimally, as this will help deliver efficiency and return on investment.
Make your adhesive and dispensing processes more productive with process-optimising materials & systems
• Improve speed and accuracy of dispensing with dedicated dispensing robots
• Reduce work in progress with fast UV light curing materials
• Improve process simplicity with process-convenient materials packaging
• Get fast, homogenous mixtures of liquids, powders and pastes with mixing and degassing machines
• Achieve more consistent bonding results with plasma surface treatment
Could you reach your productivity potential by improving some of these areas? Read more at intertronics.co.uk/productivity.
01865 842842
info@intertronics.co.uk intertronics.co.uk/productivity
Reliable thermal management. Sensitive & critical liquid cooling.
From supercomputing and data centres to EV charging stations, CPC’s innovative non-spill coupling and connection technologies allow tubing to be quickly and easily connected and disconnected, instilling confidence for thermal engineers and system operators.
Together with
cpc5@tom-parker.co.uk
23 _ 25.5.2023
MedtecLIVE with T4M is the key trade fair for medical technology in Europe – and is also much more. This is where your industry becomes a special experience, knowledge comes to life, trends are addressed, and innovations become real.
The exhibition focuses on the complete manufacturing process in medical technology, from the initial idea to production. Together with the MedtecSUMMIT, you will enjoy a comprehensive programme with top speakers and key players in the industry.
SEE FOR YOURSELF!
secure your ticket now
medteclive.com/en/visit
Honorary sponsors
The development of diagnostic systems has understandably seen a huge rise in recent years:
● The average man on the street now knows the term “PCR”, even if they don’t know what it means.
● They know that lab testing can give better results than a point of need test but is less convenient and more expensive.
● They are also coming round to the idea that lab quality tests don’t need to be carried out in a lab but can be carried out at the point of need at a lower cost.
This is driving a need to develop high quality, inexpensive, easy-use single use diagnostics. As these devices get smaller to reach that point of need, they need to incorporate microfluidics. Rapid Fluidics has a technique to produce fully functional microfluidic prototypes in a matter of hours, rather than weeks. Following a PhD at Newcastle University, we have developed a method of relatively inexpensive 3D-printing microfluidic prototypes, offering a 24hour turnaround of bespoke designs. This allows customers to try multiple iterations of early-stage designs in a very short space of time, reducing the time and cost of product development.
There are various traditional methods for producing and sealing microfluidics such as CNC machining; hot embossing; and injection moulding. These all require secondary bonding such as adhesives; solvent diffusion bonding; laser and ultrasonic welding.
Rapid Fluidics focuses on 3D-printed microfluidics. We can produce open channels very simply using our highresolution printers, which could be enclosed through any of the conventional methods listed. But we can avoid the time, expense, and risk of all those techniques by simply 3D-printing a lid directly on to the microfluidic layer. This has many advantages: the key one being time, but also the lid itself can include additional features such as more channels with vias linking the layers. External connectors can simply be incorporated, from mounting features for manifolds, barbed tube fittings or threaded holes.
The microfluidic market has only been around for a few decades and is small but there are several companies around the world providing prototyping and production services, each with their own processing niche. While they all have their respective strengths, Rapid Fluidics offers a short turnaround. We use modified commercially available 3D
printers with lower overheads to cover. Representatives from the industry agree that offering prototyping as an outsourced service is a growth industry, derisking product development for our clients. From our market research, 95% of our customer base are SMEs favouring lowCAPEX outsourced prototyping.
We’ve worked closely with Kromek, in Sedgefield, County Durham since we started in 2020. Kromek’s background is in radiation detection, working with the medical, power and defence industries. Through this connection, they are working with DARPA, part of the US department of defence, on a system for detection of airborne pathogens, which uses microfluidics to analyse samples.
Early in the development, to translate a particular process to a lab-on-a-chip, they had to mix small volumes of four different liquids. Using a chain of proprietary components, they simply couldn’t do this. We discussed the process one afternoon in the lab. Sketched it on a whiteboard, modelled it in CAD and 3D-printed it that evening, to be tested the following morning. It didn’t work. But the next one did. We also sent the design out for quotation from other suppliers, and nothing was available within 7-8 weeks, and at a considerable cost.
Jamie Marsay, head of biotech, described it as a game changer. After all, if you are in the situation of developing a diagnostic system, trying to detect a virus that is threatening to wipe out half the population of the planet, would you rather test it in eight weeks? Or tomorrow?
So where do we go from here?
As well as the more standard customer requests for batches of 1-off, 5, 20 parts, we’ve recently been approached by several companies enquiring about larger batch production volumes up to tens of thousands. So, we can scale up to meet the potential market, we are engaging in processes to improve efficiency by automating our manufacturing and developing our own specific and exact materials. We’ve started down this route with an Innovate UK Smart Grant, along with angel investors backing it. We’ve recently moved into new, larger facilities and the next step is to source more people and upgrade our manufacturing equipment. With our scaled-up production capabilities, we can then expand into ever larger markets.
Rapid Fluidics will be exhibiting at Med-Tech Innovation Expo on 7-8 June 2023 on Stand C20. For more information, please visit med-techexpo.com.
After researchers from The Centre for Additive Manufacturing at the University of Nottingham were awarded a £6 million grant from the EPSRC, Ian Bolland spoke to Ricky Wildman, professor in chemical engineering, to find out the effects this could have for medical device manufacturers.
The project itself will allow the development of a toolkit which will act as an instruction manual to improve the pathway from research all the way through to development and clinical adoption; identifying how medical technology companies can develop personalised and tailored medical devices.
Wildman began by outlining that the project is being driven by industry needs and finding out why companies had – or in some cases hadn’t – adopted additive manufacturing.
“One of the things that we found out is there's a lot of desire for 3D printing, but there are bottlenecks, some real problems with uptake. One of the major problems around that is the availability of materials.”
Although there is a need for personalised, tailored, and effective medtech devices, the materials have not been available, product development, along with route to market, can be long. The Centre for Additive Manufacturing, a multidisciplinary research group at The University of Nottingham, feels it can addressing this problem with its toolkit, and that it will help to unlock a bottleneck that prevents the bringing of new innovative engineering to the NHS.
Among the toolkit’s armoury will be its ability to provide advice to manufacturers regarding what materials can be used for specific devices, or what materials are available that can be 3D printed.
“In the simplest terms it’s giving them a recipe saying, ‘here are the materials you want to use and here is the way to put it together.’
“We are driven by this idea that 3D printing can be used to make these personalised devices. It is very difficult for those who are used to traditional manufacturing to be able to jump to 3D printing.”
In sum, it’s a 3D printing guide for those who are unfamiliar with it. There are many examples of how it has been used in the medical sector, whether that has been for the casing of devices, prosthetics, or indeed developing new dummy organs that can be used in the field of medical education such as laparoscopic surgery training.
While 3D printing plays a very important role in the development of these medical
products and its packaging, Wildman highlights that the process has probably not yet realised its potential in medtech, and in its sister sector of pharmaceuticals.
“What we are imagining are devices that have these other functions in there that we can perhaps maybe bio function, or have some other function other than just structural, like you would get in packaging or prosthetics.
"We've imagined three products in this project to begin with, at least to be able to drive this toolkit because you have to set yourself the goal of making these sorts of game-changing products to really pull out what that toolkit is going to be able to achieve.”
The £6 million grant will help the researchers create a platform by which industry can deliver,
on demand, the materials and processes needed to 3D print medical technology and devices. Additive Manufacturing will help create highly functional, smart products for (bio)pharma, cell therapy/regenerative medicine, (bio)catalysis and more, that until now have been impossible to create using traditional manufacturing.
The goal is the toolkit will help identify how medical technology can develop personalised, tailored medtech devices.
To see widespread uptake across hospitals, pharmacies and the wider NHS, manufacturing products embedded with advanced functionality need the capability to quickly and reliably ‘dial up’ performance, to meet sector specific needs and specific advanced functionalities. It is hoped the toolkit can help
develop technology such as prosthetic limbs, ‘smart pills’ and intestinal patches to rebuild tissues damaged through chronic disease.
Wildman continued: “A real problem with trying to get complex therapeutics delivered to patients is that you've got tablets, you have to have injections or really high loadings of peptides, and so on. First of all, we're imagining a tailored pill that can help get a biologic into people. What we imagine is that instead of having vaccines via injection where you have to queue up at a local GP, you can package them up and send them out as pills. Now, how much easier would it have been in the pandemic?”
This is an example of how the intestinal patches could be used. Wildman also cited examples of those who suffer from chronic intestinal diseases where stem cells could replace tissue – and 3D printing would be needed to replicate it, along with some more important parts of the chemistry for the tissue.
“A third product is a mini reactor. When we are producing medicines, we have to be very specific. Some medicines are very difficult to produce in high specificity. At the moment we have very big what I guess you call the traditional pack beds with enzymes that are located on beads that are placed in there. But it's a very random process. You fill a cylinder full of beads and you run the reactions through, and you get a very
uncontrolled set of conditions. We're envisaging these very small mini reactors; highly designed, highly specific, and to be able to dial that up to manufacture medicines.”
The project involves working with Johnson & Johnson, Pfizer, AstraZeneca, and some of the main players in the 3D printing industry; particularly Boston Micro Fabrication, Xaar and Formlabs.
So, what would make the project a success?
“If we are able to show our industrial partners that this toolkit will help product generation, and we can have that adopted within their manufacturing workflows, that will be a real mark of success.
“I think it's fair to say that the 3D printing companies and 3D printing printer vendors are excited by the idea of having materials, and better materials, available for their systems.”
If we are able to show our industrial partners that this toolkit will help product generation, and we can have that adopted within their manufacturing workflows, that will be a real mark of success.
Not only does Industry 4.0 deliver medical equipment manufacturers flexibility and speed to market, but it also enables hyper-personalisation as individualised mass production becomes possible without compromising on cost, quality and speed. However, manufacturers face multiple challenges, including:
● Unfamiliarity with Industry 4.0 concepts.
● Lack of global uniform standards, regulations and certifications.
● Inability to identify and measure opportunities.
Traditionally, manufacturing machinery has been disconnected and these isolated systems meant that safety could be assessed in a static environment. Current regulations are also set up to address this - where the variables can be easily understood, and control measures applied to minimise the known hazards. However, smart factories are based on modular architectures, with standardised interfaces and state-of-the-art information technology that permit highly flexible, automated ‘plug and produce’ manufacturing.
While Industry 4.0 is a growing reality, much of it remains a concept as the shift to this method of working requires significant investment, and many brownfield factories do not have the necessary infrastructure to support it. As manufacturers become more aware about Industry 4.0, the realisation will become apparent that it is a route that must be taken for their business to thrive and survive.
While a smart factory will see reduced risk in several areas, the range and flexibility of connected interfaces introduces a new set of machinery safety risk issues. Industry 4.0 will therefore necessitate a move from a human-led static risk assessment approach to a machine-led dynamic risk assessment approach, with an ever-increasing reliance on multiple layers of functional safety. As Industry 4.0 becomes ever more agile and automated, so the approach to machinery safety must reflect and support that. For many, Industry 4.0 therefore raises more questions about machinery safety than can currently be answered.
To address these challenges, Deutsche Akademie der Technikwissenschaften (acatech), a German National Academy of Science and Engineering, developed the Industry 4.0 Maturity Index. The index was developed by a consortium of research institutions working under the umbrella of acatech, and we also contributed our knowledge in industrial IT security.
The objective was to create a tool that enabled Industry 4.0 to be introduced in manageable steps. The tool provides manufacturers of automation systems with a solid basis and certainty for their investments and planning. The model covers the entire value chain and focuses on the defined individual benefits for the company.
The Maturity Index has a modular structure and covers five functional areas: development, production, logistics, services, and marketing and sales. However, Industry 4.0 is more than the mere connection of cyber-physical systems (CPS), as a company’s corporate culture is equally important to its organisational structure. To address this, the index therefore defines four structural areas:
1. Resources - include a company’s workforce and their competencies, equipment, facilities, tools and products.
2. Information systems - refer to socio-technical systems in which people and technology provide and process data.
3. Organisational structurecovers rules and structures which control a company’s
While the use of IT and process automation has already become the standard, companies still use insular information systems at this stage
Once the individual components are connected, companies have reached the maturity stage of connectivity and implemented digitalisation as defined in this guideline. However, they have not yet achieved full integration between information and operational technologies.
internal and external relationships.
4. Corporate culture - refers to a company’s value system, such as its workforce’s willingness to accept and actively shape change.
Application of the Maturity Index covers three phases. The first phase is to analyse a company’s current maturity stage, using questionnaires, on-site factory inspections and workshops to provide an overview of the current state of digitalisation.
Phase Two involves the definition of specific goals, including consideration of both the use of digital processes and corporate strategy. A gap analysis then identifies the capabilities and resources that are still needed to achieve these objectives.
The final phase sees the experts develop a digital roadmap to build up these capabilities, with actions being
prioritised based on a costbenefit matrix.
The expectations of Industry 4.0 are that it will increase efficiencies and enable product developers and manufacturers to tailor products to customers’ needs faster. However, the connected world of Industry 4.0 adds a new and significant dimension of complexity in terms of machinery safety challenges, and many still do not have a coherent plan for Industry 4.0 implementation. The solution to this could be the Maturity Index, as it delivers a step-by-step goal-based approach, so that every single action delivers measurable benefits, and the process is always traceable.
VISIBILITY:
At this stage, companies start to use sensors for real-time recording of conditions and processes. They produce a digital model of production, a “digital shadow” that shows what is happening at any given point in time.
TRANSPARENCY:
Once companies use the digital shadow to identify and understand interactions, they have reached stage 4. To do so, they need to interpret the recorded data in the relevant contexts by applying engineering knowledge. Big data applications are deployed in parallel to business application systems, such as ERP – or MES – systems, to provide a common platform for extensive data analysis.
PREDICTIVE CAPACITY:
To simulate scenarios and evaluate them in terms of their likelihood and consequences, the digital shadow is projected into the future. As a result, companies can anticipate future developments and make the necessary decisions.
ADAPTABILITY:
At the highest stage of maturity, the IT systems will make these decisions independently. At this stage, Industry 4.0 has been realised in full. IT systems initiate the necessary alignment measures automatically and without delay. The extent to which IT systems will be allowed to act autonomously depends on two aspects: first, on the complexity of the decision, and second, on the cost-benefit ratio of automated versus human actions.
While Industry 4.0 is a growing reality, much of it remains a concept as the shift to this method of working requires significant investment.
The walls and shelves of the company are decorated with iconic designs and examples of innovation but one that stands out is the Sinclair C5 – an example of a remarkable innovation but a commercial failure. Hall provided some insight into the C5’s flop, that it was down to Sinclair’s failure to engage with the user enough, whether that was when it came to focus groups, or not showing prototypes to people or asking for critical analysis and to be challenged
So why does PD-M have a 1980s innovation on the wall that cost a lot of money with only 483 made?
“It ticks a lot of boxes as a pure innovation, but when you bring an innovation to market and don’t align it to your audience – which could be a surgeon, a patient, clinician, or a user –then it will spectacularly bomb.
“The whole point is when people visit us and say they’ve got a great idea, we ask if they have spoken to a user. If they think, ‘well, John think’s it’s great’ then we ask again, ‘have you actually spoken to your user?’
“There are a lot of people that innovate that say they have got an innovation, it’s a great piece of technology, and everyone is going to love it.
“We say your audience is not interested in what it is, it’s interested in what it does. They just want to know what the value is to them, and how they are going to engage with it.” Though the company is a design
consultancy, talking to users is front and centre of what PD-M offers, and its expertise allows it to lead the client through the innovation journey.
When a product is presented to PDM, though it may sound brutal, the consultancy is required to pick holes in it to improve that innovation before too much investment goes into it, and so it can be tailored towards a more commercially viable product.
Hall explains that innovation is not a straightforward path.
“You don’t go, ‘I’ve got the idea,’ then make a prototype to show people and go into production. There’s so many twists and turns along the way, it’s far from a linear path. What we’re good at is leading clients through the innovation journey, navigating them, avoiding the pitfalls.”
A lot of PD-M’s work is with high growth start-ups, academics, SMEs, public companies as well as some research work alongside the NHS.
Many consultancy style companies in this space tend to have teams of 40 or 50 people. Though there might not be as many in the PD-M team, the company is bullish about its offering and states it has the capacity to work on big projects. The critiquing of innovations that are brought to them, along with the experience and skill to assemble and modify them, allows Hall to describe PD-M as the ‘thinkers’ and the ‘doers’.
Examples of the work undertaken includes providing thousands of face shields to the NHS during the COVID-19 pandemic, an example of its 3D printing capabilities, and an Acetone Breath Analyser with the University of Durham.
“What we’ve realised is that we’re equally as good and potent as those organisations.
“We could easily go off and do a lot of crazy stuff but what drags us back is being commercially aware and we have
an obligation to the client to get it right first time. Just because you can doesn’t mean you should.
“People are now talking about user centred design, human-centred design, behavioural design, we’ve been doing this for years.”
So, what makes a good innovation? And how does it eventually get to market and become a viable commercial product?
“Every project should have a viable trigger. Either it's disruptive, more cost effective, it optimises new technology, it opens up a new market. Every project has got to have a trigger; a viable, legitimate trigger, and a reason why you should do it.
“What we’re good at doing with the innovations is everything that hangs off it. The business case, the commercial case, the usability, intellectual property, cost of manufacturing. It’s really asking those questions, otherwise people tend to have a bias and continue until someone tells them to stop what they’re doing, usually at a point where it’s too late. It comes down to having the right strategy, and this is something we’re really focused on.
“What we do is try to get all of the stakeholders on board to give them that objective view.”
PD-M summaries its mission for 2023 as ‘taking clients further’.
PD-M will be exhibiting at Med-Tech Innovation Expo on 7-8 June 2023 on Stand D48. For more information, visit www.med-techexpo.com.
Design advanced touch solutions with our medical product portfolio. We deliver excellent customer support and a one-stop shop experience that reduces complexity, cost and design time in your medical applications. Our robust medical and touch devices are additionally certified to IATF 16949 standards ensuring a high level of quality and customer satisfaction.
Our brand-new maXTouch® Knob-on-Display™ (KoD™) family of touchscreen controllers, for example, can increase your design flexibility while reducing system costs. This innovative, new technology allows you to smoothly apply various knob counts, shapes and positions to accommodate a variety of end-user products. You can also keep the comfort of a rotary encoder input device combined with an innovative design using multi-touch displays that can be developed into your modern-day ultrasound imaging equipment, patient monitors, electrocardiogram (ECG) machines and more.
We also offer a large portfolio of power management devices for your system, including Linear Low-Dropout (LDO) Regulators. LDOs can provide desired voltage levels with a constant and stable output. LDOs are the ticket to low power consumption and high-power efficiency and achieve a significantly smaller footprint compared to other types of regulators.
Ultimately, you can design an application with a display that relies on LDOs to attain higher resolution and a KoD controller for a simpler and more tactile manipulation of the settings in a water-resistant display. You can also create handheld medical equipment that uses LDOs to optimize battery life while using KoD controllers to provide traditional knob controls that are easily manipulated by a gloved hand.
Med-Tech Innovation News: the magazine for professionals working in the UK and Irish medical device industry.
SUBSCRIBE for the latest industry insights on innovation and technical intelligence. www.med-technews.com/subscribe
