MTI Issue 66 by Med-Tech Innovation Magazine

www.med-technews.com Issue 66 | Oct/Nov/Dec 2023

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MED-TECH INNOVATION | NEWS MED-TECH

innovation

Revolution in the

Red Medtech on how the digital revolution in quality management and emerging technologies, is redefining medical devices

PLUS

Compamed/Medica Previews Avoiding deficiencies in submissions with use-related risk analysis The importance of regular cleanroom maintenance

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CONTENTS regulars

From the editor Ian Bolland comments on notified body capacity following the update to approved UK bodies

Making medtech

A round-up of some of the latest industry news

Expo News

The latest news on Med-Tech Innovation Expo

14.

On the Cover

Professor Laurie Rowe from Red Medtech analyses the digital revolution in quality management and emerging technologies

22.

Digital Health

Zühlke UK explores attitudes UK consumers have towards apps and other digital services

30.

Real World Medtech

Ian Bolland reports from the 40th anniversary celebrations of Micrometric

THE TEAM editor | ian bolland ian.bolland@rapidnews.com group portfolio sales manager | caroline jackson +44 (0)1244 952 358 caroline.jackson@rapidnews.com portfolio sales manager | helen hickey +44 (0)1244 952 374 helen.hickey@rapidnews.com

features

18.

MED-TECH

Cleanrooms

INNOVATION | NEWS

Guardtech outlines the importance of regular cleanroom maintenance for medical device manufacturers

21.

IP & Patents

Finnegan provides important considerations for wearable IP

24.

Leading Ladies

We profile some of the leading ladies in the medical technology sector

27.

Human Factors Engineering

BlackHägen Design explains how to avoid deficiencies in submissions with use-related risk analysis

28.

Robotics & Automation

EMS comments developments in manufacturing and robotics technologies in prosthetics

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from The editor A new route to clearance? Whenever I have had the opportunity to discuss regulation of medical devices with those who know their stuff on the issue, there have been several consistent themes: Changing regulations in the United Kingdom postBrexit, grappling with the new European Medical Device and In-Vitro Diagnostic Regulations, and Notified Body capacity. The UK has made what seems to be a welcome step forward on the latter of late with a notable increase in Notified Body capacity with TÜV SÜD, Intertek, and TÜV Rheinland UK receiving Approved Body status. Prior to this approval in August, the UK had a total of four approved bodies in BSI, Dekra and SGS, with UL International only certified to approve IVDs. While the MHRA welcomed approved body capacity almost doubling, and the increase in capacity is undoubtedly welcome as we try to get more life-saving innovations on the market to improve quality of life across the world, one thing to consider is the capacity that the individual companies have. This is likely to be an unknown until someone enquires about their services, but their presence might well break a bottleneck for approvals though there is still more to be done.

Elaine Gemmell from InnoScot Health wrote for the Med-Tech Innovation News website calling for more resources and effort to be provided:

wouldn’t bit sitting here writing this column and I’d be putting those proceeds into trying and failing at another career as a professional golfer.

“There’s no doubt in my mind that these additional Approved Bodies are much needed and will bolster UKCA certification capacity following Britain’s legislative cut-off from Europe during Brexit. It is also positive that EU Notified Bodies TÜV SÜD, Intertek, and TÜV Rheinland UK are being designated as UK Approved Bodies, demonstrating confidence in our system.

It's positive news but there is more that must come along for the clearance process to be smooth as possible for any innovators.

“But with CE marking still being allowed for device submissions to the British market, three new Approved Bodies is not yet enough to bolster UKCA certification capabilities ahead of the CE mark transition deadline, and the focus on that will only continue to intensify. “It is simply not sufficient to support manufacturers who are trying to bring their products to the UK.” As you can tell from Gemmell’s comments – the big issues are all linked and need addressing. If I had a pound for every time I’ve heard there needs to certainty about the outlook for regulation in the medical device sector, I probably

Capacity, of course, isn’t just a UK issue, it’s something that is grappling the European system too, with the new notified bodies also operating in Europe (much like the existing bodies) maybe some crossborder collaboration might be the next step in easing the processes for everyone. While capacity may have increased, and it remains one of the biggest challenges facing device innovators getting their product to market, keeping track of all of the regulatory changes in the current environment remains a big challenge. Indeed when attending a session at Medilink Midlands Innovation Day, delegates suggested it remains the biggest, but approved body capacity was mentioned. This area is going to be challenging for some time yet, but at least there are signs that innovators lives may get easier in one aspect.

Making medtech

PainCheck reports strong year-on-year growth

ainChek, the company behind an AI-powered pain assessment tool, has reported a 150% year-on-year increase in the number of beds in UK residential care homes using the PainChek technology, with 20,000 now contracted. The company, which started out in Australia, has conducted over 3,000,000 digital pain assessments worldwide, with 70,000 aged care beds now contracted worldwide, representing a 96% increase on the previous year. PainChek is a regulatory cleared medical device for the assessment of pain, enabling best-practice pain management for people living with pain in any environment. Recent adopters of the PainChek technology in the UK include the London Borough of Enfield, which will be funding PainChek across 80 care homes consisting of 1,900 beds, Exemplar Healthcare, TLC Care,

Angel Care, and Royal Star & Garter. This year, PainChek partnered with Quality Compliance Systems (QCS) to support the 2023 review of a national pain management policy designed to help improve pain assessment and management in those who cannot reliably self-report their pain. PainChek’s Tandeep Gill says: “Our latest figures reﬂect the value of the PainChek technology in UK care homes as well as worldwide. Reaching over three million pain assessments is a real milestone for us – each

individual assessment brings more objectivity and consistency to evaluating and managing pain, whilst making a real difference to the lives of those suffering from pain. “In the UK, we have been rapidly growing our network of clients and technology partners. To support rapid growth and increasing demand for PainChek, the UK team has built further capacity for customer education and training by partnering with Ark Assessment Limited. Through the partnership, pharmacists will deliver dementia education and pain management training using PainChek as part of their medication management service for aged care homes. We look forward to continuing to work closely with our partners in the UK and around the world to support bestpractice pain management for more people around the globe.”

Partnership aims to tackle cardiovascular ‘ticking time bomb’

emote patient monitoring provider Inhealthcare has partnered with FibriCheck, the medically certified app for heart health, to help the NHS combat cardiovascular disease in the UK. The collaboration between the companies aims to save lives, reduce health inequalities, and ease pressure on the NHS through the scaling up of preventative checks. Cardiovascular disease affects seven million people and is a major cause of disability and death, especially among disadvantaged communities. Inhealthcare and FibriCheck will offer NHS organisations the ability to monitor heart health across integrated care systems and transform detection and condition management for people with atrial fibrillation, high blood pressure and high cholesterol, the main causes of the disease. The NHS Long Term Plan identifies cardiovascular disease as a clinical priority and the single biggest opportunity to save lives. Inhealthcare has worked with the NHS for more than a decade and has developed more than

100 clinically designed digital health services, which have been used by three million patients across the UK. FibriCheck enables mobile heart rhythm monitoring with medical grade accuracy and has been used by more than 2,000 clinicians and hospitals in 43 countries worldwide. FibriCheck users can measure their own heart rhythm by placing a finger on the camera of their smartphone, which captures data about their cardiovascular system. All measurements are analysed by a medically certified1, AI-powered algorithm. The results of the measurements are immediately available and can be shared with the involved physician. Inhealthcare users can share their readings remotely with healthcare systems via a choice of communication channels. If readings fall out of range, alerts are generated, and clinicians intervene as necessary with medical treatment and advice. Bryn Sage, chief executive of Inhealthcare, said: “Cardiovascular disease is a ticking time bomb and a major cause of morbidity, disability, and

mortality in the UK despite being largely preventable. “Our partnership with FibriCheck gives integrated care systems the ability to detect and manage risk factors in their populations and reduce avoidable deaths and disease. We are excited at our potential to improve heart health at scale and ease pressure on the NHS and wider economy. “This is another excellent example of how healthtech companies with innovative and complementary services can come together to confront the challenges facing the NHS and the nation as a whole.”

J&J announces brand identity refresh

ohnson & Johnson is updating its brand and uniting both its medtech and pharmaceutical segments under the Johnson & Johnson brand name to demonstrate its collective power in healthcare. The announcement marks the next era for Johnson & Johnson, which is leveraging its expertise in innovative medicine and medical technology to prevent, treat and cure complex diseases and introduce solutions that are smarter, less invasive, and more personalised. Joaquin Duato, chairman of the board and chief executive officer, said: “Our exclusive focus on Innovative Medicine and MedTech solutions enables us to innovate across the full spectrum of healthcare in ways no other company can. Uniting our diverse businesses under an updated Johnson & Johnson brand reﬂects our unique ability to reimagine healthcare through transformative innovation, while staying true to Our Credo values and the level of care that patients and doctors expect of us.” Over time, Janssen, the company’s pharmaceutical segment, will be named Johnson & Johnson Innovative Medicine, and the medical technology segment will continue to be named Johnson & Johnson MedTech. Vanessa Broadhurst, executive vice president of global corporate affairs, added: “Our Johnson & Johnson brand identity communicates our bold approach to innovation in healthcare, while staying true to the care we have for our patients around the world. We take immense pride in leading healthcare for more than a century and are seizing on our scientific momentum to profoundly impact health for humanity.”

Expo News

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.

Call for Papers opens for Med-Tech Innovation 2024 Applications are now open for speakers to take part in the world-leading conference programme which runs alongside Med-Tech Innovation Expo, on 5th-6th June 2024, at the NEC, Birmingham. Med-Tech Innovation is seeking speakers who can share inspiration and thought-leadership on the current status of the medical technology industry. Speakers will have the opportunity to be part of the CPD-accredited conference at Med-Tech Innovation Expo, the perfect platform to share expertise and market knowledge, increase visibility of projects and research and start new conversations with stakeholders. Ian Bolland, group content manager of Med-Tech Innovation and Medical Plastics News, said: "The conference in 2023 was very well received and we want to provide another programme that is just as, if not more, engaging in 2024. “This is a really exciting time to be involved in medtech, but there are also many challenges that our sector faces. There is this appetite for innovation but how do you get things approved quickly in an ever-changing regulatory environment? And how do you go about doing it in a socially responsible manner?

“There is a clear appetite for medtech to be at the heart of industrial strategy in the UK, while neighbouring Ireland is renowned for its strength in the sector, there arguably isn’t a better time to get involved.” Last year’s conference alone saw speakers from the Office for Life Sciences, Department for Health and Social Care, Department of Business and Trade, Boston Scientific, Johnson & Johnson MedTech UK & Ireland, Barts Health NHS Trust, the Medical Technology Group and Stryker. The 2024 conference will address key industry issues, and is accepting submissions across, but not limited to: ■ Supply chain strategy ■ Adoption of minimally invasive devices ■ New manufacturing practices ■ AI use in medical devices ■ Medical device outsourcing ■ Overcoming manufacturing challenges ■ Recruitment and retention of new skills and talent ■ Effective partnership with the NHS and market access ■ Sustainability strategy ■ Securing financial backing ■ Manufacturing for miniature (smaller) medical devices

■ Regulation including (but not limited to) CE, UKCA & FDA clearance ■ Diversity in MedTech Global innovation will only achieve its fullest potential by embracing individuals from all backgrounds. We are calling on the entire medical technology industry to help ensure we have full representation and a diversity of voices for the programme in 2024. Barbara Harpham, chair, Medical Technology Group, a speaker at the 2023 Expo, said: “It was wonderful to see a celebration of the UK medical technology industry. The ongoing success of the Med-Tech Innovation Expo is

testimony to the important role the sector plays in our economy, in improving the NHS, and delivering better outcomes for the patients it serves.” Dr Paul Bhogal, consultant interventional neuroradiologist, Royal London of Barts Health NHS Trust, who was part of a keynote session, said: “My experience at the Expo was fantastic and I had several very interesting conversations following my talk. The audience was engaging and enthusiastic and open to challenging the status quo and looking for novel solutions to the various problems that exist within healthcare within the UK but also further afield.”

- HOW TO APPLY -

Speakers are invited to submit presentation title, abstract (200 words), biography (200 words), and a high resolution headshot here, or by emailing ian.bolland@rapidnews.com.

Deadline: Monday 15th January 2024. 7

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MEDILINK

£33m investment unlocked for ‘green’ inhalers K indeva Drug Delivery, a drug delivery device contract development and manufacturing organisation, has received a £33 million grant from the Life Sciences Innovation Manufacturing Fund. The funds enhance Kindeva’s capability to manufacture the next generation of green inhalers and to deliver ever-evolving therapies for respiratory diseases worldwide. Kindeva’s Global CCO David Stevens, said: “This joint investment of public and private funds creates myriad new opportunities for Kindeva colleagues within the U.K., as significant technical and regulatory expertise is required in the development and manufacturing of complex inhalation products. This investment provides Kindeva with a springboard

to expand our capabilities and capacity, while simultaneously partnering with leading pharmaceutical companies around the world to bring the next generation of green inhalers to market — with a common goal of safeguarding access to necessary therapies for patients and reducing our impact on the planet.” Charnwood Campus Science, Innovation and Technology Park, Loughborough, where the R&D arm of Kindeva is based is also making strides in its decarbonisation efforts to further reduce their carbon emissions in the march toward achieving net zero. Gosia Khrais, commercial director, Charnwood Campus, said: “As an organisation that

Leeds Children’s Hospital installs BEAMS

O is becoming more and more important to the success of the life sciences sector in the region, we take our ESG responsibility very seriously. All construction projects that involve recommissioning of existing or design and build of new buildings prioritise decarbonisation and net zero. The labs and offices available for rent on Charnwood Campus offer great credentials in terms of progress made towards net zero. I would like to encourage anyone who is currently looking for space within a thriving and innovative environment to reach out to us. We will be thrilled to offer a tour round this fantastic science park.”

Oxford and Pioneer Group plan to convert Victoria House O xford Properties Group, a real estate investor, and Pioneer Group, a company combining laboratory development and operation with venture building, have launched plans to convert Victoria House in Bloomsbury Square, London, into a sciences hub. The project has secured planning approval and Oxford and Pioneer Group have also announced that Victoria House will be the new home of the BioIndustry Association (“BIA”), the trade association for UK life sciences. The project will deliver new lab space to the London market amid a shortage of

commercially available lab space in the city, which, according to Savills, has reached functional full occupancy with a sub 1% vacancy rate as of Q1 2023. Victoria House is a GradeII listed building, which has a neo-classical façade with internal Art Deco features. It was designed and constructed in the 1920s for its former owner-occupier the Liverpool Victoria building society and served as its as head office until 1996. Oxford and Pioneer Group plan to convert 220,000 sq ft of the building’s 300,000 sq ft internal area into Grade A wet lab-enabled life sciences space. The development will

have customer wellbeing and sustainability at its core, with the project on track to achieve BREEAM ‘Excellent’ certification. Richard O’Boyle, CEO of Pioneer Group, added: “This announcement is an important milestone for our plans with Oxford Properties at Victoria House. London is a renowned global life sciences hub and together we look forward to joining and supporting the local community by not only meeting growing demand from life sciences organisations that seek the ideal combination of amenities and location to attract talent and drive the future of scientific discovery, but also by creating strong, long-term relationships with local organisations working to maintain London’s unique identity as a major player on the international stage. Victoria House will be a premium offering which help further our goal of helping homegrown and international businesses solve the greatest unmet medical and healthcare needs of our time.”

ne of the largest Children’s Hospitals in the UK, Leeds Children’s Hospital, has recently installed the BEAMS (Bedside Equipment Alarm Monitoring System) on one of its wards, to enhance patient safety and improve nursing efficiency and conditions. BEAMS at Leeds Children’s Hospital has reduced the number of alarms taking more than five minutes to respond to by 57%, more than 30 minutes by 100%, and average response by 43% to one minute 42 seconds. BEAMS is a monitoring system developed for and with Sheffield Children’s Hospital by Tutum Medical to improve response times for critical bedside alarms. It listens for medical device alarms and notifies staff of the source, device, and type of alarm. This allows staff to prioritise the most critical alarms. Jenni France, ward manager at Leeds Children’s Hospital, said: “We had heard from other children’s hospitals how this simple and easy system was significantly improving response times to critical equipment alarms. We saw great results from a trial on Ward L30. Patient safety and reassurance for nursing staff markedly improved. We know immediately which patient’s device has raised an alarm and the urgency of the alarm so we can prioritise alarm responses in seconds. A quiet and calm children’s ward, who would have thought!” Paul Rawlinson, managing director of Tutum Medical, added: “We are delighted Leeds Children’s Hospital have installed BEAMS and are seeing significant improvements in response times to alarms. Patient safety and better working conditions for nurses are vital especially at a time of nurse shortages and increased alarm fatigue. We are proud to be making a difference not just at Leeds Children’s Hospital but on wards across the country with our unique system.”

COMPAMED/MEDICA

ABHI UK explores the innovations and key exhibitors that visitors can expect to see at MEDICA from 13-16 November in Hall 16 on Stand J48.

he world of health technology is rapidly evolving to meet the demands of an ageing and growing global population. Recognised as a leader in the field, the UK healthtech industry is set to showcase its expertise at MEDICA 2023. SHOWCASING UK EXPERTISE Across the globe, healthcare systems are facing increasing demands driven by ageing populations, a rise in chronic diseases, and higher expectations for quality care. From Artificial Intelligence (AI) to wearables, robotics to telehealth, genomics to 3D printing, the healthtech landscape is rapidly evolving to address these challenges. Known as a global hub for life sciences, trailing only behind the United States for life sciences inward investment, the UK has long been recognised as a world leader in this space. The healthtech industry continues to play a significant role in the UK's economic growth and is now the largest employer in the broader UK life sciences sector, employing 127,400 people across 3,860 companies. In healthcare, a wave of exciting new technologies is being used to fight illness, develop vaccines, and help people to look after their

own health. Both in the UK and globally, there is a clear drive for healthcare systems to embrace technologydriven solutions, enhancing efficiency, reducing costs, and freeing up valuable resources. In a world grappling with shared challenges, trade shows like MEDICA provide a stage for UK companies to showcase their expertise and demonstrate how they can make significant contributions to addressing global healthcare issues through technology and innovation. As the show makes its return to Düsseldorf, the Association of British HealthTech Industries (ABHI) will return with another line-up of UK healthtech companies who together will spotlight the remarkable prowess of the UK's industry. From world-first product launches to exciting demonstrations, visitors to the

ABHI UK Pavilion will discover a wide array of innovative services, technologies and innovations in key areas such as digital health, diagnostics, and critical care, and surgery. The platform will offer visitors a chance to see some of the best healthtech innovations from the UK up close and in action; and offer UK companies the opportunity to showcase the latest pioneering solutions to help hospitals cut costs, achieve greater sustainability, and empower patients to take better care of their health. THIS YEAR’S KEY EXHIBITOR HIGHLIGHTS INCLUDE: ■ Adtec Healthcare will demonstrate its SteriPlas Cold Plasma medical device, known for treating chronic wounds, surgical site infections, and dermatology conditions. ■ GlucoRx, an NHS supplier, will display its blood glucose monitoring devices, including the GlucoRx BioXensor and GlucoRx AiDEX CGM, providing realtime data and integrated app functionality. ■ Haemoband Surgical will showcase its band ligation and endoscopic products, including the HB-SleeveLUX Proctoscope, designed for enhanced patient comfort and convenience. ■ IMed Consultancy will present their UK

Responsible Person (UKRP) offering, assisting businesses entering the UK market for medical devices. ■ Innovia Medical will feature new product launches in various specialties, including their DTR Medical Oral Rotating Biopsy Punch and Summit Medical ENT Product Line. ■ Neurovalens will showcase the Modius Sleep, a noninvasive wellness device clinically proven to treat insomnia. ■ PolyNovo UK will present its NovoSorb Biodegradable Temporising Matrix technology for tissue repair. ■ Seating Matters will launch Sydney GoFlat, a lie-ﬂat chair for critical care patients. ■ Surgical Holdings will be demonstrating how hospitals can manage and care for their surgical instruments in a sustainable and cost-effective way. ■ TestCard will demonstrate its at-home testing solutions, including the ClearScreen testing app for COVID-19 and inﬂuenza testing. UK PAVILION PRESENTATION THEATRE Following last year’s success, ABHI will again host the 'UK Pavilion Presentation Theatre’, providing UK companies a platform to showcase their technologies to international audiences. This will run for the duration of MEDICA 2023, offering exhibiting UK companies enhanced opportunities for partnerships. VIRTUAL ACCESS TO UK HEALTHCARE PAVILION All UK activity from MEDICA 2023 will be available on the UK Healthcare Pavilion virtual platform, enabling visitors to discover and connect with innovative UK life sciences companies, hospitals, clinics, and key organisations.

COMPAMED/MEDICA

Medilink partners with Department for Business and Trade

ver the last 21 years, Medilink UK’s presence at MEDICA has continued to grow and as the Lead UK Partner of Messe Düsseldorf, Medilink UK will be supporting companies of all sizes from across the UK on their pavilion, building on the success of the 2022 exhibition as it delivers a large pavilion at this year’s exhibition in Düsseldorf. As the world’s largest medical trade fair, MEDICA attracts over 6,000 exhibitors and more than 120,000 visitors. For companies wishing to connect with potential investors, buyers, distributors and clients from around the world attendance at the event is a must. This year, Medilink UK is the exclusive partner of the Department for Business and Trade (DBT), supporting DBT’s regions and nations from across the UK in one location on the Medilink UK pavilion. DBT will be supporting delegations of companies, increasing the visibility of UK innovation at the world-leading MEDICA trade fair whilst offering unique opportunities for companies to build ties with key decision-makers and innovators around the world. Mark Oakes, head of life sciences (exports) at the Department for Business and Trade said: “I am excited to be attending my very first MEDICA in Düsseldorf this November where I will be leading a team from DBT to showcase UK innovation and expertise in medtech. DBT’s team will comprise of staff from London, Germany, the UK regions and nations, and commercial officers from across the globe. We will be directly supporting around 50 UK companies covering the full range of UK strengths in a sector which delivered £4.1 billion of exports in 2022. I am delighted we are partnering with Medilink this year and I am confident we will deliver an impactful presence and engaging programme of events and presentations.”

Managing director at Medilink North of England, Tom Elliott, explains why the Medilink UK pavilion continues to see success at MEDICA. “For companies that are looking to increase or launch into new international markets, find distributors, develop partnerships or present their medical solutions to a global audience, MEDICA is the perfect platform to engage face-to-face with potential clients and collaborators. “The support that Medilink UK provides gives companies on the UK pavilion access to a team of specialists with sector-specific understanding of international markets, their regulatory landscapes and market entry requirements. This represents exceptional value for exhibitors which would not be available elsewhere. In addition to this, exhibitors are also supported by the UK-based advisors from the Department for Business and Trade. We are especially pleased to be the exclusive partner of DBT this year and

look forward to working with them on the Medilink UK pavilion.” In partnership with DBT, Medilink will be running a series of pre-event briefings on the run up to MEDICA, which are open to any UK company to attend. There is also a schedule of inmarket seminars that exhibitors and visitors are invited to attend. These will run across all four days of the event on the Medilink UK pavilion and will include presentations such as ‘Navigating International Markets’ by Phil Jennings from Santander Navigator, ‘Future UK Medtech Regulatory Framework’ by Neil Ebenezer from DBT, ‘Support to Accelerate MedTech evidence generation in the NHS’ presented by NIHR plus many others. MEDICA 2023, takes place from November 13th to 16th in Düsseldorf, Germany. Medilink will be located in Hall 16 Booth H03 / J16-8. www.medica-tradefair.com

Sponsored

Do you have a communications strategy? Thomas Averre, Director at Tarleton Communications, a specialist life sciences public relations agency, breaks down the basics of a communication strategy. Over my career I have found that the businesses that don’t have a communications strategy are usually the ones drifting in the wind, struggling to build momentum with investors or gain traction with customers. Communicating well is difficult, but especially if you don’t have a strategy that identifies who you really need to inﬂuence and how you’re going to do it. Medtech leaders are intelligent, logical people who value expertise and experience, yet many don’t prioritise communications and haven’t appointed a professional to manage their external reputation. If you want to make sure your business communicates effectively, but don’t yet have a strategy in place, I’m hoping this gives you some food for thought. WHAT IS A COMMUNICATIONS STRATEGY? Essentially, it’s a document that diagnoses the situation (where you’re currently at), sets a direction (what you want to achieve) and explicitly charts a path for getting there (who you need to inﬂuence, with what message and how you’re going to do it).

Every strategy should start with a situation diagnosis. This is the part most nonmarketers recognise as it includes a SWOT analysis, establishes the conditions the business finds itself in and develops insights that help set objectives. The segmentation and targeting sections are an opportunity to look at the potential markets and prioritise which are attractive and feasible. This is extremely useful for boards that feel their business lacks a clear direction, as it imposes discipline and determines which markets to focus on. Think of it as a checklist that gives you the confidence to reject opportunities that could prove a distraction. Positioning and messaging are perhaps the most crucial sections, where a communications professional can draw on expertise and experience to advise you how to craft a distinctive position capable of creating and reinforcing memory structures through long-term brand building. This provides the guidelines for messaging (what you should actually say) – many get this the wrong way around and start with messaging, which leads them to frequently pivoting as they discover it lacks rationale.

Finally, a strategy should set out the tactics by which it will be implemented (PR, thought leadership, social media etc), and how success will be measured. While every strategy should contain these basics, this is not an exhaustive list. I have developed bespoke communications strategies for spinouts and for mature SMEs selling into complex OEM networks, and while all contain some version of the above recipe, they vary in length and complexity. WHY HAVE A COMMUNICATIONS STRATEGY? There are few questions more important than who should we inﬂuence, and how will we do it? Communicating with healthcare stakeholders is challenging because decision makers are sophisticated and quick to reject those without credibility or a clear proposition. Businesses that struggle to make progress are often terrible at communicating because they don’t recognise the importance of a strategy and don’t delegate implementation to experienced professionals. Ironically, the same businesses wouldn’t dream of not having an R&D timeline in place or not hiring patent attorneys to protect their IP! I have never met a chief executive or senior leader who has regretted investing in a proper strategy.

Every company should have one, but a strategy can be truly transformational for those who feel their business is lacking direction or messaging discipline because their marketing activity is an occasional LinkedIn post, odd article and a trade show. I’ve spent my career working in life sciences and manage the public relations and communications activity for some of the UK’s most innovative start-ups and SMEs. Many clients are looking to attract investors, build industry partnerships or grow their existing market share. In each of these situations, creating awareness, building momentum and demonstrating credibility are critical to success, but you can’t do any of that without a plan to help determine if you’re being strategic or just bouncing around and wasting money. If you feel like there is a void between where you want to be, and where you currently are, it’s almost certain improving the way you communicate would help close it. If you’d like to discuss how a communications strategy could help you or need advice on how to professionalise your public relations, feel free to get in touch. Thomas Averre can be contacted via thomas@tarletoncomms.com.

cleanrooms

Maintaining high standards Joe Shackley, marketing manager at Guardtech Group, outlines the importance of regular cleanroom maintenance for medical device manufacturers along with insight from the company’s experts.

hey say that ‘if it ain’t broke, don’t fix it’ – but when it comes to cleanrooms and laboratories, sometimes waiting for a problem to arise before you act can have devastating results. Suffolk-based cleanroom construction specialist the Guardtech Group has been providing controlled environments to the life sciences industry for more than 20 years, meaning and a long history working with the medical device industry and wider life sciences community in cleanroom servicing & maintenance. The company offers a package of controlled environment solutions, including programmes in Cleanroom Service Plans. In the past 12 months, they’ve designed and constructed controlled environment solutions for the likes of JEB Technologies, Advanced Medical Solutions, Sherlock Biosciences, Biocomposites and Medical Moulded Products.

continue to drop over subsequent validations, you recognise there’s a problem that needs addressing. “The sooner you’re able to identify these issues the better – especially given that some HEPA filters have an 8-10-week lead time. “Identifying appropriate spares can be critical – in terms of reducing potential cleanroom downtime to a minimum and therefore saving lost process time, which can be very costly. If that doesn’t put a smile on a client’s face, nothing will!” It’s evident that any business’ controlled environment is given the regular TLC it needs to continue to operate at peak performance – as anything less could risk product and process and, ultimately, cost time and money, and even risk potentially crippling sanctions. As well as commissioning new-build cleanrooms, Crisp and compliance manager Chris McGinn lead the Group’s service, maintenance,

testing, validation, and decontamination programmes for existing controlled environments. The Guardtech Group Service Department supports ongoing compliance in all cGMP & ISO14644 classified cleanrooms, ensuring facilities are audit-ready and compliant with regulatory bodies. They also provide documentation on all their construction projects, including a Design Qualification (DQ), Installation Qualification (IQ) and Operational Qualification (OQ) as part of its Commissioning and Compliance offering. Compliance manager McGinn adds: “All cleanrooms need regular service and maintenance to ensure they continue to meet standards and function at optimum levels – and it’s recommended that you have at least two programmes per year to go over the necessary checks and processes to confirm that nothing is amiss.

New services manager Glen Crisp is a former air conditioning installation engineer and senior manager at Adcock with 30 years’ experience in the industry. He knows how critical it is for applications in the medical device industry to feel they can entrust the Planned Preventative Maintenance (PPM) of their process rooms, plant, utilities, and devices to specialists. “Regular servicing and maintenance is vital,” Crisp says. “The risk of a major fault developing diminishes significantly when you have a cleanroom that operates efficiently.

“Our testing helps to spot problems before they cause serious issues. When, for example, you conduct a cleanroom validation, you need to check airﬂows. If you notice these

All cleanrooms need regular service and maintenance to ensure they continue to meet standards and function at optimum levels

Cleanrooms

“At Guardtech, we’ve built up an impressive amount of knowledge, resource and expertise to ensure our clients’ cleanrooms get the best support available – we’re here to take away the burden of managing a controlled environment, so clients can focus on delivering the product or service they specialise in.”

This includes Builders’, Pre-Validation and Biocidal/Sporicidal cleans through to Hydrogen Peroxide Fogging and Microbiological/bioburden testing with TSA & SDA plates.

The Guardtech Group Service Department’s Testing programme includes filter integrity and separative devices – such as biosafety cabinets and laminar ﬂow benches – as well as Performance Testing, including Temperature, Humidity and Lux levels. Validation features measurements for Air Velocity, Volumetric Flow Rate and Room Differential Pressure, as well as Particle Counting – all in accordance with ISO 14644-1. The service & maintenance remit is wide ¬– from HVAC, compressor and generator repairs and upgrades to filter replacements, gauge calibration and environmental monitoring (EMS) and Building Management System (BMS) Servicing. The company also highlights the need for rapid rise door or central vacuum system inspection, process air handling unit filter testing, crane servicing, fall protection systems or transfer hatch servicing. Services manager Crisp says: “HVAC can often be a really tricky area to deal with. Whether it’s refrigerant leaks, F-gas checks, or ensuring efficient operation conditions – you don’t use want to be using more power than you need to be. So, a big part of our offering is to ensure everything is working as it

Working to GMP standards, the team conduct cleanliness verification tests with full reporting and are certified to work at height (as IPAF PAL card holders). should be – be that compressor checks or ensuring evaporator and condenser coils are clean, confirming that the system is drawing the correct number of amps. And all of these HVAC matters tend to lead directly on to filtration issues. “That’ll be ensuring the filters in our Fan Filter Units (FFUs) are clean and operating effectively. If things aren’t right, you’re going to be overworking motors and there’s more chance of a breakdown.” The Group also has a dedicated Decontamination Team on hand to complete its Cleanroom Service Plans. The two most senior members have 30 years’ experience in decontamination, offering tailored cleaning programmes to suit the needs of all applications, following client SOPs and using specific validated chemicals and equipment as and when required.

Crisp continues: “Keeping the cleanroom working within the design specification and keeping spaces as clean as possible is obviously critical in meeting compliance and adhering to the regulations which govern the work our customers conduct in their controlled environments.” For Crisp, efficient programming is as important as any aspect of a solid overall Cleanroom Service Plan. “To really keep on top of all the maintenance required in a cleanroom environment, you need to be organised. A lot of goes on in there that needs to be done at certain times – for example, HEPA filter changes need to be co-ordinated with a deep clean and validation afterwards. “You will often need to plan ahead with the client to schedule in the downtime or programme shutdown to facilitate the cleanroom maintenance that’s required.”

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IP & Patents

Winning IP strategies for wearables I

James Bell, of counsel, Finnegan and Darren Jiron, partner, Finnegan outline the considerations to be made for wearable medical electronic devices.

n 2022, the market for wearable medical electronic devices (WMEDs) was $27 billion in the U.S. alone, and according to Future Market Insights this market is expected to grow at a compound annualised rate of over 28% between 2023 and 2032. Sales relating to WMEDs include hardware-based products such as watches, rings, belts, etc., but also extend to associated applications configured to provide monitoring, diagnostics, analysis, and reporting of medically useful biometric data to medical practitioners. Revenue streams further rely upon “server” based applications and communication between such servers (e.g., smartphones, cloud devices, etc.) and wearable units. Such a multi-faceted eco system presents significant opportunities for companies to build corporate value through a strategically developed, diversified international patent portfolio designed to protect the underlying features and innovations of its WMEDs.

jurisdictions have different rules regarding the availability of claims directed to therapeutic and diagnostic methods carried out on human or animal bodies. The United States and Australia are two of the few jurisdictions not explicitly prohibiting patent claims directed to such methods. Indeed, patent regulations in China, Japan, and even Europe expressly prohibit such method claims, while permitting patenting of devices carrying out such methods.

WHY PATENTS? Granted patents provide a territoryspecific, exclusive right to exclude others from practicing an invention claimed in the patent. Claims that impact competitors can generate huge value as tools for offense (e.g., litigation, licensing) and/ or defence (e.g., deterrents to litigation or market entry). Regardless of company size, strong, international patents can support an array of corporate interests, from enhanced investment opportunities to leverage over competitors.

2) Hardware and/or software claims Claims focused on hardware should be the first to consider, especially

CONSIDERATIONS WHEN PATENTING WMEDS 1) Therapeutic claims Choosing where to patent typically depends on factors such as competitor activity, market size, location of R&D activities, etc. Patenting WMEDs raises additional considerations. For example, various

In view of such variation, patents applications for WMEDs should include different types of claim sets tailored to a particular jurisdiction. Claims should focus on WMED products configured to execute therapeutic and/or diagnostic methods and/or any corresponding server devices configured to cooperate with the WMED. Patentees should also consider claims in at least the U.S. directed to diagnostic and/or therapeutic methods.

as infringement of such claims does not require actual use of the product. Merely manufacturing or selling of products can constitute infringement. But what about the software that drives the WMED features? While claims directed to software per se may be problematic from patentability and detectability perspectives, claims directed to software-driven techniques for collecting, analysing, and presenting data, including how the device interacts with a user, are often patentable and can be highly valuable. Here, a proper definition of claim scope within the context of the device performing the innovative techniques, as well as a statement of a resulting technical effect within the description are key factors to consider. Further, WMEDs may cooperate with a server device to perform operations, and claims focused on this relationship should be considered. For example, system features may be claimed from the perspective of the WMED or the server device and may include combinations of the WMED with the server device. This strategy may provide options for enforcement, while remaining within claim limits set by various patent jurisdictions. 3) Timing Patent applications protecting developed IP should be filed as early as possible, and before discussions with third parties. Most patent jurisdictions follow a “first-to-file” system, and with rapid innovation in the WMED space, there is elevated risk that another party may win the race while others hesitate. CONCLUSION As the WMED market grows, so too does the number of companies competing in this space. Those with strategically developed patent portfolios may earn and maintain their seat at the table, while those without proper IP protection may be relegated to the side lines.

DIGITAL HEALTH

Medical Apps and pat

Can pay, won't Dr James Graveston, a senior medtech specialist at Zühlke UK and former NHS hospital doctor, explores research UK consumers have towards apps and other digital services, why they are the future - but with insights on the problems B2C firms will need to overcome if they are planning to scale successfully with sales to consumers.

here is some good news for medtech CEOs and entrepreneurs from our research this year into UK adults and their attitudes towards medical apps and other digital treatments... but sadly a lot of cautionary news too. Much of the UK population is raring to go when it comes to getting digital apps. We commissioned a research agency to question a representative 1,000-person sample and half of all adults said they would feel “comfortable” or “very comfortable” with being prescribed an app for treatment by their healthcare provider, and of the 25% who were uncomfortable with this, half only mildly objected.

Also, the people who are most likely to be interested in medtech apps are younger or more aﬄuent adults, although there is strong demand for them across all working-age adults. In short, at first glance there seems to be a very large, very keen, aﬄuent, and very under-served market. However, there is a lot to be cautionary about from our research before launching down the B2C route and selling directly to the public. Firstly, people really don’t want to pay for medical apps in the UK! Half of the population will point-blank not pay anything for a medical app. While the other half will pay up to £10 per month, their willingness to pay quickly drops with only 9% willing to pay £21 or more per month, and only 3% more than £30. A big part of this is because many don’t trust the technology yet. Over half of people felt apps and digital devices could not measure their health accurately, with only 19% comfortable (to some extent) that they could. This was similar across all age groups with, perhaps surprisingly, mobile phone-loving millennials in their 30s the most sceptical. Another part of this is their huge trust for the NHS. Their trust for the NHS means people will use medical apps prescribed through the NHS but are much less trusting of other providers.

Dr James Graveston, a senior medtech specialist at Zühlke UK

A whopping 74% of all adults cited the NHS as their “most trusted” provider for medical apps. This contrasts with only 8% for Big Tech firms like Apple, Amazon & Google, and 10% most trusting established or start-up medtech companies. It is worth saying at this point that while data protection is a big concern, our research shows it is not the blocker. Although 20% of people say they would not want to share their health data at all, the rest of the population would do so under certain conditions. So, the dilemma facing medtech providers going down the B2C route is that while there is a huge and unmet demand for medical apps and devices... but the market in the UK wants free prescription apps from the NHS, is hugely sceptical about other providers and is not willing to pay much either! Our conclusion for medtech providers going down the B2C route with a purely digital solution is they must be very cautious indeed about revenue expectations. There really isn’t a clear remuneration pathway, and a look at the accounts of many existing wellness and fitness app providers also shows that many are struggling to monetise even high usage. For investors, they need to make sure that there are sufficient funds to last the course should sales prove much slower than hoped for – which is highly likely. Otherwise, they will have the unwelcome prospect of being diluted by further fundraising and, worse, little chance of exiting at all. But before concluding that the NHS is clearly a better bet and going down that route instead, caution here is also required!

DIGITAL HEALTH

ients:

pay

For investors, they need to make sure that there are sufficient funds to last the course should sales prove much slower than hoped for - which is highly likely. Otherwise, they will have the unwelcome prospect of being diluted by further fundraising and, worse, little chance of existing at all From the outside the NHS appears a big central organisation - sell once to someone at the centre and you’re in. Nothing could be further from the truth! There is no central delivery system for apps and other medtech in the NHS. Things like the NHS App and the NHS COVID App (which Zuhlke created and ran) are rare exceptions. Without going into painful detail, NHS budgets are split regionally and ultimately between trusts covering primary and secondary healthcare, mental health, and ambulances. There are by 229 trusts and 1,250 Primary Care Networks (PCNs) in England alone, and in their areas, they collaborate with each other and decide how budgets are spent through 42 Integrated Care Boards (ICB’s). If you have an app that does something very simple (such as a reminder app for GP’s patients to take their pills) then you will need to sell it through each Trust or PCN or GP practice individually, vastly increasing costs of sale.

However, if your app provides an “integrated medical pathway” for a disease or condition, spanning primary and secondary care, you will require alignment across the Integrated Care Systems (the partnerships the ICBs look after), effectively requiring agreement amongst multiple trusts and PCNs to be procured. Only well-funded and determined organisations can stay the course for such a protracted and uncertain process, especially when the sales effort needs to be duplicated across each of NHS England’s Trusts, ICBs or PCNs.

Instead, the medtech industry and patient groups need to successfully lobby the government to step in and introduce a centralised market for digital health that the ICB’s, trusts and GP’s practices can buy from without the current rigmarole. Personally, I’d turn the very popular NHS App into a gateway for prescription medical apps. All NHS approved apps would be available through it... with the patients GP or consultant “switching it on” when prescribed. One point of sale for the medtech providers, one delivery platform (a bit like the NHS’s own App Store for patients), and medical grade apps available to all patients that need them simply and conveniently.

Given that both the B2C route and trying to sell into the NHS are both high cost and potentially low reward, and especially off-putting for startups, what is the solution?

Such a straightforward approach would unleash the innovation of the UK’s medtech sector to dramatically improve the fortunes of both the NHS and millions of patients, rather than the current situation of the sector being shackled by the NHS’s byzantine structure.

The case for the widespread introduction of prescription apps is clear, and the lag in their introduction is harming patients and the NHS itself. Sadly, I cannot see it happening easily within the existing NHS structure.

Zuhlke’s full research – Health Study 2023 – is available to download at: https://www.zuehlke.com/en/ insights/future-of-the-nhs

FEATURE

LEADING LAD ES OF MEDTECH As part of a new feature Med-Tech Innovation News profiles some of the leading ladies currently working in the medical technology sector.

Preeti Choudhary PBC is a forward-thinking consultancy, providing regulatory and quality support to the medtech and pharmaceutical industry. PBC helps manufacturers get their innovative, products from conception to market. We understand the challenges of navigating the ever-changing regulatory landscape and that developing a robust quality management system can be daunting. However, with experience of working with new start-ups to global giants, we provide a holistic service to

our clients, and tailor our solutions to meet their individualised and specific requirements. We are a team of experienced consultants, who are passionate, committed and thrive off the challenges that medtech can bring. We endeavour always to always fulfil our professional promises, provide realistic guarantees, and follow our business ethos, of truth, integrity, and honesty. www.pbc-uk.com

Dr Amy Russell I am the managing director of Russell Regulatory Consultants. With a team of experienced and knowledgeable consultants, we provide exceptional services in various device therapeutic areas. Our expertise encompasses: regulatory strategy and device classification; technical document preparation, gap analysis and updates in compliance, technical document preparation, gap analysis and updates in compliance to UKCA and CE marking

requirements; clinical evaluation document writing; QMS standards; internal auditing and external audit support, training. Our mission is to streamline regulatory processes and expedite product approvals, allowing companies to focus on innovation and growth. By leveraging our expertise, clients can confidently navigate the ever-evolving medical device market and meet regulatory obligations. www.russellregulatoryconsultants.com

Annmarie Nicolson

Annmarie, founder of We Are Human, has built an all-female team of human factors consultants and user researchers, dedicated to developing life-changing products. With experience collaborating with global companies and start-ups across femtech, medical, and healthcare, the team empowers organisations to achieve optimal outcomes aligned with regulatory expectations.

implements technical proficiency, regulatory expertise, and creative methodologies to uncover invaluable insights and deliver datadriven results. Annmarie feels strongly about the underfunding and insufficient research into female-related health issues. We Are Human continues to provide support to femtech startups, assisting in securing funding, navigating product development, and user testing.

We Are Human prioritises user needs throughout product development. The team

www.wearehmn.com

FEATURE

Lucy Lehane Establishing Lehane Consulting Ltd. in 2023, has been a dream come true - I have always loved the world of science and technology! Beginning as a biomedical scientist in the NHS, I gained first-hand knowledge working in a busy lab and understanding how diagnostic tests are vital to guide treatment and improve outcomes. I have over 25 years’ experience in medical diagnostics, having worked in global diagnostic roles representing women’s health, cardiology, oncology and respiratory disease. I am also

an accredited marketing and PR professional, highly skilled at translating scientific messages into clear communications, particularly for media management of products and brands. Lehane Consulting Ltd. combines my unique skillset across medical marketing, scientific affairs, healthcare comms and product strategy to help companies take their products from concept to launch and beyond. www.lehaneconsulting.co.uk

Jo Belshaw I hold a degree in Chemistry, part of a pioneering class with a 50:50 gender balance.

supporting healthcare worldwide with our team of eight BDMs in Europe and China.

Since 1997, my career has been dedicated to plastics. Beginning in the lab, I transitioned to Application Development Healthcare in 2002.

ALBIS boasts a premier portfolio of medicalgrade plastics from renowned producers, spanning standard, engineering plastics, and high-performance polymers. I’m excited to contribute to healthcare innovation through plastics at ALBIS, driving positive changes in the industry.

With 21 years of experience in Polyolefins and dedicated Healthcare Teams, I joined ALBIS in 2018 as business development manager healthcare for the UK and Ireland. Currently, I lead the Global BDM healthcare team,

www.albis.com

Bethlehem Araya Sigma Connectivity has been pioneering the development of connected devices for leading global tech companies for many years. Leading this transformative work is Bethlehem Araya, the CEO of Sigma Connectivity MedTech which can meet the specific needs of bringing advanced medical devices to market. Before her current role as CEO, Bethlehem Araya held various key positions within Sigma Connectivity, including Imaging expert, senior

project manager, and manager. She played a pivotal role in establishing the medtech business unit within Sigma Connectivity in 2018, ultimately leading to the spin-off of Sigma Connectivity MedTech in 2022. Bethlehem's professional background also includes extensive experience in product development for mobile phones in Sweden and Taiwan during her years at Sony Ericsson and Sony Mobile. www.sigmaconnectivitymedtech.com

Laurie Rowe Red Medtech was founded by Professor Laurie Rowe, building on her 20+ years of industry specific experience working in engineering design and manufacturing. Her career has focused on developing medical devices and healthcare systems, leading cross-functional teams, and delivering successful new product development, quality, and regulatory projects across a range of technologies. Laurie is a serial inventor qualified in engineering design & innovation with a

passion for supporting next-gen, she applies her expertise to help spinouts, start-ups and established companies with their international device development and compliance projects. As a Notified Body trained MDSAP ISO 13485 lead auditor, she covers all device types and classifications with a wide and varied portfolio including implants, drug delivery, patient data management, rehabilitation, and wearables. www.redmedtech.co.uk

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Risk Adverse

Human Factors Engineering

Renée Bailey, senior manager, human factors engineering, BlackHägen Design explains how to avoid deficiencies in submissions with use-related risk analysis.

or companies seeking approval of their medical device in the U.S., the Food & Drug Administration (FDA)’s expectations often come as a surprise. While it is commonly known that the FDA applies serious rigor and scrutiny to their review of premarket submissions, many companies face challenges meeting these expectations and face delays or budget overages for several reasons. One deficiency area frequently identified is the Human Factors Engineering/Usability Engineering (HFE/UE) submission. In a 2020 presentation by Medical Human Factors Network UK, the FDA reported that pre-market HFE submissions to FDA were deficient at an alarming rate. For example, of 228 submissions for 510(k) clearance, only 11 were ready for review upon first submission to FDA. Overall, FDA’s analysis showed that of 542 total HFE submissions, only 23, or 4%, were what FDA considered ready for the first time for review. Expectations for including HFE during medical device development have been communicated since 2011 by FDA and since 2007 by international regulatory authorities. It may be tempting to think best practices integrating and executing the HFE process are a routine part of most medical device development programs; however, the statistics tell a different story. And an even bigger story is the costs manufacturers face due to these deficiencies. When HFE submission deficiencies occur, the cost of course correction can be staggering. Costs may include go-to-market delays translating to a loss of projected sales revenue and repeating a full or partial HFE validation to collect data requested and expected by FDA. If the deficiency cannot be corrected within the time designated by the FDA (typically 180 days), additional user fees associated with the pre-

market application may be required. Repeating an HFE validation or partial validation can introduce other complexities, such as exhausting a limited pool of hard-to-find end-users, like patients with rare conditions or healthcare providers within specific specialties. USE-RELATED RISK ANALYSIS SUPPORTS HF OUTCOMES Several decisions or strategies implemented in an HFE program increase the likelihood of experiencing HFE submission deficiencies. If the HF strategy is not integrated into the Regulatory Affairs (RA) submission strategy, or an HF validation is conducted as the only HFE activity without prior formative evaluations. Another contributor to deficiencies is making major modifications to the user interface or other integral HFE elements, such as intended users or use environments without formative testing prior to an HFE validation. However, the most common issues revolve around the Use-Related Risk Analysis (URRA). To avoid the most common (and costly) HFE submission deficiencies, integrating risk management and development of a URRA with the HFE process early in product design and development stands out as the most important HF strategy. This is because the URRA is fundamental to the HFE process and ultimately helps demonstrate how the device user interface has been optimised for safety and effectiveness. The integration of HFE and Risk Management as a part of device design and development is a main tenet of the FDA’s expectations. INCLUDE A URRA AND START EARLY Per the FDA’s analysis, URRA issues contributed to 80% of the HFE submission deficiencies generated. Issues cited included not providing a URRA as part of the submission, using an unknown URRA process, and inappropriate selection of tasks evaluated based on the severity of associated harms, to name a few.

The FDA is clear in their HFE Guidance that use-related risks are a focus and priority related to HFE submissions. The FDA Guidance states that for “devices where an analysis of risk indicates that users performing tasks incorrectly or failing to perform tasks could result in serious harm, manufacturers should submit human factors data in premarket submissions.” Use-related risks are identified and assessed through an integrated HFE and risk management approach. HFE analyses support risk management activities by identifying and documenting tasks and potential use errors that could lead to harm and the severity of the potential harm. HFE formative and validation evaluations are critical methods used to understand if the design of the user interface effectively reduces or eliminates use-related risks. This approach may also uncover new or unforeseen use errors or use-related hazards. When Risk Management is implemented early as an integral part of the HFE process, opportunities exist to iteratively improve the design of the user interface and implement risk control measures. Risk control measures implemented to reduce use-related risks are tested through additional HFE evaluations ensuring risks during use are reduced or eliminated to the extent possible. Because risk-based HFE activities are integrated early in product development, the cost and effort to implement design changes are incremental compared to late-stage design changes. The integrated, iterative approach to HFE and risk management is the most effective way to reduce the potential of deficiencies in a premarket submission to the FDA. Thus, avoiding the previously mentioned costs of late-stage design changes, or worse, the added costs to resolve HFE deficiencies identified by the FDA after submission.

Robotics & Automation

An artificial helping hand

Dave Walsha, sales manager at DC motor supplier EMS, explains how developments in manufacturing and robotics technologies are offering patients a prosthetic experience like never before.

pper limb prosthetics are abandoned by some 18% of patients, though some studies cite this figure as high as almost one in two. Evidently, replicating the complexity of human design in a comfortable, easy-to-use prosthetic is no easy feat. Crutches, walkers, and wheelchairs offer some leg amputees additional support for movement. But these types of aids do not grant the same freedom as two working limbs, and the problem is amplified for those also missing hands or arms. Simple tasks such as opening a jar or tying a pair of shoelaces become difficult and time-consuming. Extensive efforts have been made to create prosthetics that grant amputees more freedom and independence. Prosthetic principles There are two main types of prosthetics: passive and active. Passive devices are for aesthetic purposes, offering no additional movement. Active or powered devices are those that provide functionality to the limb.

Electrically powered prosthetics, or ‘myoelectric’ prosthetics contain electrodes to receive electromyographic (EMG) signals from the muscles or nerves above the amputation. It’s these

electrical signals that are transmitted to the prosthetic’s control electronics, where the signals are amplified and used to direct the motors to move accordingly. Prosthetic problems Despite the benefits prosthetics can offer, the technology still faces problems. Poor fit is a common problem, which can lead to discomfort, skin irritation and even causing some patients to abandon their prosthetic altogether. The highly individualised nature of humans, whether it’s their body proportions or the nature of the amputation means that no two users are the same — and therefore, neither should their prosthetics be. This makes component manufacturing hard to standardise, while also increasing the cost per prosthetic. Another common concern is the lack of functionality. The human hand can grip objects of a variety of shapes, sizes, and textures. This includes fragile items, which can be held tight enough to keep them secure but without damaging or breaking the object. Most commercially available bionic hands struggle to offer a comparable level of movement or sensory feedback and can therefore be a source of frustration more than an aid.

Improving design These issues represent a major challenge for designers, but there are ways to address them. Tackling fit and customisation issues is possible by making use of 3D printing technologies. In recent years, advancements in 3D printing have made it more commercially viable to produce highly customisable products. With no minimum order or the need to create specific moulds, prosthetics can be prototyped and developed on an individual basis for an improved fit. This also allows for aesthetic personalisation for a less obtrusive prosthetic.

the iron contained in traditional DC motors reduces the minimum moment of inertia, allowing for rapid acceleration and deceleration rates and cogging-free running. Additional benefits include low noise, a compact design, and low power consumption, particularly at no-load conditions.

To address functionality concerns, miniaturisation of the electronics within the prosthetic is essential. The DC motors that facilitate the movement of artificial joints must be small enough to fit within a housing built to replicate human limbs. However, these size restrictions should not come as a detriment to the rest of the specification. It’s important that these motors offer a high torque, and can quickly change direction to account for quick or sudden movements.

Implementing more sophisticated technology unlocks further benefits, such as prosthetics that can adapt to the individual’s gait. High-power microprocessors and miniature precision sensors working alongside these motors allows for a system that can respond in real-time to patient movement. These offer a more natural walking experience and mean that the prosthetic can react quickly in the case of a stumble or loss of footing.

Opting for a coreless or ironless DC motor is preferable for many medical applications, and prosthetics is no exception. Eliminating

Other considerations to make include the choice of commutation. Graphite and precious metal commutation types are available, though the latter is best suited to compact, battery-powered applications.

The design and manufacture of prosthetics maintains a challenge, but with the continued need for artificial limbs, it’s an area that’s important to develop further.

Sustainability

Carbon-free healthcare:

Are you ready for the journey?

Daniele Fazio, vice president of business development, Flex Health Solutions, EMEA, reﬂects on the recent MedTech Forum in Dublin

he healthcare sector faces a looming challenge: driving innovation to deliver better patient care while minimising environmental impact. The World Economic Forum says the sector accounts for over 4% of all global carbon emissions. Recently, we hosted a panel of industry experts moderated by MedTech Europe at The MedTech Forum 2023 conference to discuss the trends driving sustainability and to provide a focus for discussion on the future of sustainable innovation. Under the banner: Advancing Towards Carbon-Free Healthcare with Circular Economy: Ready for the Journey? experts explored specific issues around sustainability and the steps companies can take to improve medical device sustainability. Some common areas of focus emerged including an increase in demand for sustainable solutions from customers, an evolving demand from patients, anticipated growth in regulation, and new developments in design and manufacturing that can support sustainable goals. GROWING EXPECTATIONS In Europe, providers are raising their expectations of suppliers when supporting net-zero objectives. One notable trend is the transition of therapies and diagnostics from hospitals to point-of-care settings and patients' homes. This sees a disruption of the product-as-a-service model, where medical devices

are managed by hospitals and sometimes owned by healthcare solutions companies responsible for maintenance. Patients can take a more active role in managing their health and blur the line between medical and consumer devices. Establishing the infrastructure to extend the lifespan of these products, including their retrieval from the field to facilitate repair, refurbishment, and recycling of the plastics, batteries, and electronics, will depend on the adoption of intelligent usage models, and effective strategies for engaging patients in the circular economy. ANTICIPATING REGULATION More specific sustainability regulation is inevitable. The European Green Deal for example, will bring about radical changes and place new demands on the industry to align with the legislation. With common challenges, the need for intense industry collaboration on sustainability standards is obvious. Healthcare solutions companies can collaborate to inspire industry-wide change in several ways: establishing sectorial key performance indicators (KPIs), environmental, social, and corporate governance (ESG) reporting standards, and sharing best practices. TWO APPROACHES Many companies have taken steps to improve their manufacturing practices by setting clear science-based environmental targets for reducing emissions, water usage and achieving zero waste. This can be achieved through generating and

purchasing renewable energy, optimising site infrastructure, and partnering with customers and suppliers on energy and emissions reduction strategies. Partnering can accelerate sustainability across the value chain. By incorporating environmental requirements from the early stages of product design, customers can reduce their environmental impact. BETTER BY DESIGN We work closely with customers to address the challenges and opportunities with medical device sustainability and the practicality of delivering circular economy solutions. One key pillar of sustainable transformation is integrating sustainability principles into product design and development. This involves using sustainable materials, optimising energy efficiency, improving product durability to extend lifespan and designing for easier disassembly and reassembly for maintenance and repair. Also, opting for platforms that work to environmental design guidelines to reduce environmental impact and address areas of improvement for product sustainability is beneficial. PRODUCT ARCHITECTURE IS KEY Given the long product life cycle of some devices, it is not uncommon for companies to focus on redesigning existing products. This can be a more difficult path. An assessment to redesign a product begins with an analysis carried out against a set of best practice

guidelines to identify where improvements can be made. Each product characteristic is evaluated for potential redesign based on the impact and likely environmental benefits it can deliver, as well as the time, complexity, and scope of effort required. Ideally the environmental requirements are set at the early stages of product development, in the ‘User Requirements Specification’ document. The specifications will guide your engineer’s work on system requirements, architecture, and sub-system requirements including hardware, firmware, and mechanical design. You must also consider: ■ Material Selection This can be challenging as biocompatibility requirements set a high bar. Sourcing components need investigation, planning and testing to ensure materials meet certain requirements. ■ Power - Lower power consumption is an important factor, particularly for portable and batteryoperated devices. ■ Repair - If you want the option to repair a product, you need to be able to open it using screws or snaps. Gluing and welding, commonly used as the most cost-effective solutions, are more suited to disposable products. ■ Reliability - Extending a product’s life can have obvious sustainable benefits. Designing for reliability can help avoid the need to repair and refurbish the product altogether. The healthcare industry has a unique opportunity to drive sustainable innovation and become a catalyst for positive change.

ON THE ROAD WITH

Laser focus:

Behind the scenes at Micrometric

Precision engineering and laser manufacturing company Micrometric has been celebrating its 40th anniversary this year. Ian Bolland went along to the company’s Lincoln HQ to ﬁnd out more as it marked this milestone.

aser is at the heart of everything Micrometric does, whether that’s cutting, marking or welding, across multiple industries. As well as the medical device sector, Micrometric serves electronics, oil and gas, instrumentation, aerospace, automation and many other industries. As part of the 40th anniversary celebrations guests were given a tour of the workshop by Neil Main, cofounder, and commercial director Chris Waters. The company’s repertoire of machinery includes a CO2 laser which allows for the cutting of organics like plastics and ceramics – one of its oldest machines which has been inside the factory since 1988. But the old combines with the new to cater for companies who are in demand for Micrometric’s more established services as well as it’s more recently acquired capabilities.

We were given some insight into the full repertoire of laser cutting and drilling across the sectors it operates in, including in medical devices. Many of the medical parts manufactured by the company involve tube cutting to create small windows, slots, holes and spirals for different pieces of equipment. With the specialism in cutting smaller components, a lot of them form part of the smaller devices people are

accustomed to in a healthcare setting, including small tubes, endoscopes and injection needles. As well as the smaller tubes, larger tubes are also cut to form parts of MRI machines, while its laser capabilities allow Micrometric to provide marking services for the creation of Unique Device Identification (UDI) codes.

short amount of time when first starting to cut a part, which is very useful for cutting highly reﬂective materials like brass, copper and silver as well as other metals like titanium, tantalum and iridium. Once the initial cut is made then it has up to 3kw of power available.”

As part of the tour, we were given some insight into how the laser machine works that is used for tube cutting – as mentioned already used to a great degree in the manufacture of parts for medical devices. Waters said: “The tube cutting laser is used a lot in the medical industry; cutting things like stents and it can cut tubes from 0.5mm diameter up to 30mm diameter. If you think of someone who has a stent in their heart, that’s the kind of thing this laser cuts. “A large hub for medical device manufacturing is in Ireland. These companies are focused on production of existing parts and may not have a lot of time on their lasers for developing new parts, and that’s where we can help. We can cut their development parts on our lasers.” While the majority of the machinery within the factory may be laser-based, Waters also highlighted the wire eroder: "An electrical current is passed through a wire that is brought close to the part being made and it can remove very small amounts of material. With this machine we are working to a few microns of accuracy.” Addressing the capabilities of the powerful lasers in the factory, Waters explains: “Ours is around 4.5 kilowatts so we can cut up to 20mm thick stainless steel and 15mm aluminium. We can also cut large thick parts very quickly and, therefore, very economically. “Another laser in the factory has the capability to use 5kw of power for a

As well as the laser manufacturing services provided, there was also a strong emphasis on the company being rooted in the community with partnerships with the local colleges, allowing young people to work for one day a week as part of their qualifications with the potential for employment upon completion. Waters added: “When we recruit, not all new employees have all the skills we require but if we see a passion and ability for the work we do, then we will support them with training and by sponsoring them to gain formal qualifications.”

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