Assistive technologies: what’s going on?

August 13th, 2010

In a time of upheaval, it’s easy to get confused about the commercial side of the assistive technologies sector. There is no ‘business as usual’. Rob Chesters, Division Manager of Alvolution, looks at the opportunities for assistive technology companies as the UK’s healthcare landscape changes.

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The public spending cuts will block the uptake of new technologies for electronic healthcare, as community-based health services will be the first thing to be cut back. True or false?

False – the public spending cuts may in fact present a significant turning point for the adoption of technology. Technology deployed in the community has the potential for a reduced workforce to ‘do more with less’. In particular, telecare and telehealth technologies can reduce the costs of care by reducing ‘man hours’.

There may be a period of time where it does create some difficulty, but I think ultimately the reality is that technology can make the savings. Medtech companies are working with SHAs and PCTs to build business cases that allow technology to be an intervention that cuts down the cost of care. I think the cuts may hit them initially, within the next six to twelve months – but that will refocus the minds of those in commissioning who are being pushed in terms of care costs and staff costs to try and make savings, helping them to recognise how new technology can really support them.

Where digital healthcare technologies succeed in UK healthcare, it will only be via major telecommunications companies that have the capacity for large-scale market penetration. True or false?

True – but there’s an important role for specialist SMEs within that. Over the past 18 months there has been a significant shift, with large companies taking a greater interest in digital healthcare technologies. Many of the large telecommunication companies see a growing market for healthcare services delivered via mobile devices. The processing power, connectivity, network capability and prevalence of mobile phones make them ideal for telemedicine applications. Large mobile providers have the capability to market digital health services to the mass market. They are seeking partnerships with smaller companies, recognising that many SMEs are at the cutting edge of innovation in this sector.

The increasing emphasis on local control of commissioning and service design means that companies developing new technologies for assisted living can become active partners in changing healthcare at a local level. True or false?

Variable – many of the most proactive companies will work closely with commissioners in their locality. Much of this tends to focus on getting new technologies into pilots and evaluations, which are then used to support sales to other regions if they are successful. Many companies will start by looking for local services and specialists – if they draw a blank, they will seek contacts in other regions.

If companies have a product and find some kind of ‘champion’ in the NHS or social care, that can help them get into the system and do piloting and evaluation. That will provide the evidence and the confidence that the product is marketable elsewhere. In telehealth or telecare, a company may have developed a new product but need access to service users and patients for the testing process – so a kind of partnership is key. In some instances they’ll find a regional champion, but in other instances they’ll have to trawl the UK to find somebody to support it.

There are real opportunities at this time for medtech companies to help the NHS save money and improve public health by shifting its emphasis from providing care to enabling independence and self-care. True or false?

True – across both the NHS and social care, there is a real push for greater independence and preventative healthcare. Telecare provides technologies that can aid an individual to live safely and independently. Telehealth offers users the opportunity to monitor their own vital signs on a daily basis. Evidence from trials suggests that these technologies give the individual greater buy-in terms of their own care.

There’s a similar effect with the new system of personalised budgets, which will give purchasing power to the patient or the service user. When the individual can choose to either buy a piece of technology to monitor their health or to spend that money on more carers coming into their home, they are gaining ownership of their healthcare.

The pilots for personalised budgets tend at the moment to be dealing more with aids and adaptations: the kind of resources a community equipment store would be issuing, such as walking frames and stairlifts. It’s only a matter of time before more advanced technologies such as telehealth solutions come into that space as well.

Rob Chesters is Division Manager of Alvolution, an independent organisation for the discovery, collaboration and promotion of technological advances in the assisted living sector.

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Medtech Business events

August 13th, 2010

Assisted Living Special Interest Group: Digital technologies for home-based healthcare

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With the increasing Government focus on the preventative and community-based care of long-term conditions, assisted living has become a market-forming sector of healthcare.

Assisted living is the area of health and social care dedicated to helping people with long-term health problems or disabilities to live independently and manage their own well-being. This requires a network of support services within which new technologies can play a crucial role.

With the new Government looking to roll out the personal health budget system currently being trialled, suppliers of technologies for assisted living are not just finding a new market: they are building that market through their partnerships with the NHS and Social Services and their interaction with consumers, establishing new forms of healthcare delivery.

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The digital future

A recent meeting of the Assisted Living Special Interest Group (SIG) in Warwickshire had the theme ‘Digital technologies for home-based healthcare’. Hosted by Alvolution, the new assisted living division of industry specialist MedilinkWM, the event brought together people from industry, the NHS and Social Services, the Technology Strategy Board (TSB) and elsewhere.

A key issue identified by Graham Worsley of the TSB was how to break down the barriers between new technology and healthcare. He identified three kinds of barrier: the resistance of the NHS as a market; patient resistance arising from lack of experience; and issues to do with establishing common standards and device interoperability.

Rob Chesters, Division Manager of Alvolution, explained why digital technologies are an important focus for assisted living. Firstly, they offer powerful solutions in terms of remote monitoring, activity tracking, prompts and alerts. Secondly, they enable the integration of healthcare into the everyday communications of the user. Thirdly, they are a focus of collaboration between providers, users, academics and industry, who need to work together to ensure that the new systems are effective.

Rob also discussed the value of demonstrator models such as the Alvolution Demonstrator House in providing a showcase for new technologies that places them in a real context, thereby enabling all stakeholders to see how these solutions function for the user, the carer and the service provider. What is being demonstrated is not just a new healthcare solution but a new model for commercial engagement, using real and specific examples.

The delegates heard success stories from three of the region’s medtech SMEs:

• Sero Solutions, whose near field communication technology enables users and carers to transfer data wirelessly from a range of devices, assisting real-time monitoring and continuity of care.

• Halliday James, whose i-Cue Smart Care system supports people with cognitive disabilities by guiding their use of household appliances. The technology allows components to be added or removed over time.

• Safe Patient Systems (SPS), whose IT solutions for safer patient tracking, surgery and triage in hospitals and remote monitoring at home offer web-based data handling linked to mobile communications.

The spreading network

David Morgan of SPS identified the mobile phone as “the ubiquitous device for healthcare monitoring in the future”. This was a key theme of the event.

Michael Reilly of Orange Healthcare described how the company is working with SME technology partners to position solutions within the “complex ecosystem” of healthcare. This level of technology, he argued, can rise to such long-recognised challenges as dealing with patient comorbidities, while the commercial scope and experience of Orange means it is well placed to integrate new medical technologies in the NHS value chain – “You cannot just go in with the technology.”

In breakout sessions, the challenges of developing a wireless healthcare culture were discussed. New medical technologies may impress experts, but do they make sense to end users and consumers? How can complex IT systems be made inclusive enough for people with cognitive impairments to use them effectively? Can a product designed for use in the NHS be adapted for a consumer market? Can wireless healthcare solutions overcome widespread public mistrust of Internet service providers?

A final question was posed by Rob Chesters at the end of the day: how can the industry make sure that new digital technologies are used to their best effect? For example, will people use remote monitoring systems not just to monitor their vital signs, but to adapt their behaviour? The question reminded us that the industry is looking at nothing less than a revolutionary change in the culture of healthcare.

Towards the new horizon

August 11th, 2010

The emerging innovation landscape of the NHS offers fresh opportunities for medical technology sales – if you can keep one step ahead. Andy Beech of OTD examines the dynamic relationship between innovation and key account management.

Televison programmes showcasing new performance talents are nothing new. Half a century before Britain’s Got Talent or The X Factor, there was Opportunity Knocks – which started life as a radio programme in 1949, before it ran on TV from 1956 to 1990. Along the way, changes were made in terms of format and style to keep the audiences engaged. That’s an example of incremental innovation: the gradual updating, improving and refreshing of existing products and services. Breakthrough ideas that provide new solutions, such as the invention of colour television, are termed radical innovation.

The two types of innovation are closely linked. A focus on continuous improvement produces what is termed an S curve: numerous small improvements followed by a major change. Incremental changes provide the groundwork for radical steps forward, which in turn call for new incremental changes. Innovation provides a step change that quickly transforms a process, product, system or service.

Another notable feature of innovative and creative thinking is that we are geniuses at it as children. For many of us, little by little it is discouraged until we give up. At school, did you ever hear “Stop looking out of the window and day-dreaming” or “That drawing looks nothing like an elephant”? In the workplace, do you hear “We’ve already tried that and it didn’t work” or “You must be joking”?

The really good news about innovation and creativity, however, is that with the right leadership, good facilitation, a simple methodology and a little change in mindset and culture, we can all become geniuses again. It is that simple. The important thing is to take time to step out of the operational world of means to a familiar end and into the innovation world of new horizons.

Innovation workshops of the kind that OTD provides encourage divergent thinking and support people in making new mental associations and connections. Ideas are the starting point, but a key output from such a workshop is a list of actions. An individual or team then takes responsibility for achieving each of these actions.

Innovation: an unmet need

Opportunity is knocking for us as medtech industry professionals, and innovation is at the heart of that opportunity. The need for fundamental changes in healthcare service delivery to meet the growing healthcare need within the constraints of the health economy is recognised as a driver for the uptake of innovative medical technologies – and new systems for integrating these technologies into NHS commercial and clinical practice are becoming active.

The NHS innovation agenda offers us a huge and immediate opportunity to engage with our customers at a level, and in specific ways, that may not have been possible before. The NHS has Quality, Innovation, Productivity and Prevention (QIPP) at the heart of its strategy – which means that it is likely to be at the heart of many individuals’ and teams’ strategies. The NHS has its own dedicated Institute for Innovation and Improvement, which is trying to help it build a culture of continuous innovation and a mindset focused on improving results.

This mindset change will not happen overnight. It will need a concerted effort from people at all levels within the NHS to make it a reality. That is where the medtech industry can make a difference – not just by supplying products, but by assisting change at operational and commercial levels.

The NHS Innovation and Improvement Survey 2009 provides us with some key insights into the current situation and the needs for the future:

• Current innovation and improvement practice has improved in the last year from 5.4 on a 10-point scale to 6.3.

• The most useful tools that the NHS Institute could develop are education, training and assessment workshops related to improvement and innovation.

• The resourcing of innovation and improvement is insufficient – only 25% and 19% of NHS staff respectively expressed a positive view. This was identified as an area of weakness by the report.

An open door

So while innovation is a key strategic feature for the NHS, the people working in it realise they still have some way to go. In essence, this is likely to be a huge unmet and high-priority need for many of your customers. Where there is a big unmet need, there are also big opportunities. But how can we identify them?

A key feature of successful sales people and account managers is their ability to engage meaningfully with their customers and uncover business opportunities. They take the time to step into their customer’s shoes and see the world from their perspective. What are their goals, what issues do they face, what resources do they have or lack, what keeps them awake at night?

As our key account management and selling skills workshops have shown us consistently, asking effective questions that uncover clinical, personal and organisational needs is the most powerful and effective part of the customer interaction. To be interesting to the customer, you have to be interested!

In addition to what we learn directly from our customers, there is a wealth of information sources out there that can help us identify opportunities. NHS Trust surveys and business plans can help us to identify their priorities and goals. Journals such as the Health Service Journal can also be a mine of information.

How to add value

As an account manager in the medtech industry, you will select your tactics and strategies according to your targeting and prioritisation of accounts. You will have some ‘service’ accounts where the investment of time and resources is low. These are ‘quick win’ business relationships. You will also have some ‘key’ accounts where you will invest a lot more time and resources to grow the business and build long-term partnerships, offering bespoke added value services and resources.

Medtech is a very competitive industry: we are all searching for new value added services that our customers need. Ideally, we want to identify needs that are at the top of our customers’ priorities – and are aligned to our needs as well.

Value added products and services can be a bit like Christmas presents: offered with good intentions, but sometimes completely missing the mark in terms of what is really wanted. How many presents have you never used, or worn? Services can only be called ‘added value’ if they are recognised as adding value from the perspective of the customer. It’s not the thought that counts: it’s the concrete benefit.

There is now an important opportunity to provide your key account customers with the innovation and creativity tools they need to create improved patient experience and more efficient patient pathways. This in turn should improve patient access to your products, increase your business and build long-term loyalty within the account.

Discussions with these customers will establish whether this is an important area of unmet need for them, or would be an unwanted Christmas present. If it is important, then hurry – because your competitors will be asking the same questions.

Planning your service

There are two general ways of providing key account customers with innovation tools as an added value service: by building their internal expertise, and by providing external expertise when needed.

Which route you choose will depend on many factors, but could include the importance of the account, your available resources and priorities, and your customer’s resources and capabilities.

If you are planning to provide a value added service for your key accounts, you may need to choose an appropriate company to work with. The criteria you may want to consider include:

• How broad is their innovation expertise?

• Do they have transferable innovation methodologies and materials?

• How well do they understand the medtech industry?

• How well do they understand the NHS?

Conclusion

The NHS innovation landscape requires clinicians and commissioners to find new solutions to the problems of modern healthcare. That means not only being receptive to new medical technologies that can help them achieve their goals, but also using new ideas in their service provision and commercial engagement.

Key points to keep in mind are:

• We can all be innovative and creative given the right leadership, culture, methodology and tools.

• Most of your customers are desperate for innovation tools.

• Provide value added services for your key accounts that are aligned to your mutual goals and needs.

• You can gain competitive advantage and build loyalty by moving quickly to provide the innovation tools your customers need.

So are you heading towards the new horizon… or are you just waiting for it to come to you?

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Andy Beech is Director of Business Development at OTD, learning and development specialist for the pharmaceutical and healthcare industries.OTD delivers KAM consultancy and development programmes for the life science industries worldwide. OTD’s new Team Innovation & Creativity programme dovetails the priorities of the NHS with the priorities of the industry in providing value added services through key accounts. For more information, visit www.otd.uk.com.

 

There is now an important opportunity to provide your key account customers with the innovation and creativity tools they need to create improved patient experience and more efficient patient pathways. This in turn should improve patient access to your products, increase your business and build long-term loyalty within the account.

The science of compliance

August 11th, 2010

Part five: The travel grant

Steve Gray answers your questions about compliance with the ABHI Code of Business Practice and other industry codes that govern commercial activity.

Thank you for the suggestions we have received regarding future articles. Do please keep sending in your questions and comments.

Dear Steve:

How can I make sure that my target doctors are the ones who attend overseas conferences? It used to be easy, but now I understand that we are not able to select delegates directly any more. Can you please explain how it works?

Steve says:

Imagine that Lakeshore Diagnostics is intending to attend the European Urology Society meeting in Barcelona next year.

Lakeshore’s management has decided to allocate sufficient funds to enable the marketing team to take 10 Key Opinion Leaders as sponsored delegates of the company. Lakeshore will pay for their flights, accommodation, registration and meals. The ABHI and Eucomed Codes of Business Practice are very clear as to what the company needs to do.

The first consideration is that the visit to the EUS event must meet all the standards of hospitality that we have discussed in previous articles. The attendance at the event must meet the principle of separation. This means that it cannot be linked to any attempt to sway the KOL to use or recommend any particular product as a result of receiving hospitality. However, in these circumstances the requirement goes further. The hospitality includes the entire package for the event, including the flights, accommodation, meals and registration fee.

The new process indicated by the ABHI and Eucomed codes contains strict regulations regarding the offer of places to attend medical congresses. To begin with, the offer of a place cannot be conditional on any support for the company’s product. Lakeshore Diagnostics must write to the person to whom they wish to offer a place, making it clear that the offer is independent of product usage. The letter can be based on a template supplied by the ABHI if required. However, it is in effect a contract between the recipient and the company, and meets the requirements of the principle of documentation.

The letter must also inform the intended recipient that a copy of the letter has been sent to their employer. This is where the Eucomed and ABHI codes differ in their requirements. To comply with the Eucomed code, the letter must inform the hospital management that a place has been offered. To comply with the ABHI code, the letter must do that and must give the invitee’s organisation the absolute right to refuse to send the nominated KOL but retain the place and offer it to another individual.

Both the ABHI and Eucomed code requirements are more stringent than those in other industries, such as the pharma industry. The ABHI code in particular virtually guarantees that the offer of a place cannot be seen as inducing an individual. This protects the medtech company, the clinician and the hospital from accusations of inappropriate influence, and therefore also provides a measure of protection for all concerned in respect of the UK’s new Bribery Act.

So the best way to get the KOL you want is to give a clear set of educationally-based reasons why that KOL should be chosen. Warn them personally that the offer is en route and that there is a new process to follow. This will enable the KOL to work with their own internal system and explain why they are the best person to attend the medical congress.

Remember: forewarned is forearmed.

Steve Gray is an experienced compliance specialist and Managing Director of Compliance Hub Ltd. The company supplies training and materials to support all codes of conduct, including Eucomed, and is an accredited training provider to the ABHI. For details, see www.compliance-hub.com.

Do you have a compliance query for Steve Gray? If so, e-mail your question to us at joel.lane@medtechbusiness.co.uk. Your anonymity is guaranteed.

My Medtech Business

August 11th, 2010

Philip Yates is the Managing Director of Otto Bock UK, a supplier of innovative products and services for people with restricted mobility, including prosthetics, orthotics, rehabilitation and neurostimulation devices. Based in Egham, Surrey, the company is part of the global Otto Bock Healthcare group.

Philip Yates

What are your main priorities as Managing Director of Otto Bock UK? How do you divide your time?

We’re a family-owned German business, 90 years in the making, and have been established in the UK for 34 years. We have 12 locations and 250 people in the UK and Ireland. When you’ve got such a wide variety of units and clinics in different places, it’s important from a Managing Director’s point of view that we have a clearly communicated vision and planned business objectives.

The difficulty of being in various locations across the UK is communication, which I believe affects a number of companies. Another crucial element to the role is to motivate staff and ensure that we have the right people in the right jobs. An important element from my side is to constantly look for business opportunities, ensuring that we continue to drive the business forward and meet our goals and objectives over the next three to five years.

In terms of how I divide my time, it’s important that I meet with my teams on a regular basis. I also spend time meeting with and listening to our customers, attending conferences such as those led by BHTA and NHS Confederation, and meeting with the wider group of industry leaders.

What customer groups do you identify within your market? Which customer group are you most concerned to develop in the coming years?

The main customer, I would say for 95% of our business, is the NHS – which is a B2B relationship. We engage with many people within the NHS: the management, the medical teams, the buyers and engineers. We also have a commercial sector in terms of the mobility dealerships that we partner with. In terms of development over the next three to five years, we’re focused on training right across the spectrum of healthcare providers and our products. However, the orthotics and mobility markets hold huge potential for us over the next three to five years, because of our investment into technically advanced products.

Is this a good time to be selling innovative mobility products in the UK? How is Otto Bock responding to the challenges of the market?

It’s always important to push the boundaries with technically advanced products. In terms of timing for the UK, I think it does make sense – especially as we are very much focused on driving new, technically advanced products and improving quality of life for users. At the same time, it’s also important that we understand the needs of the NHS and develop products to suit its requirements. Currently we have a small market share in the UK for orthotics and mobility products, but we now have a full complement of products that will suit the needs of customers and end users. I feel it’s important when you’re talking to your customers that you listen to their needs, as that can generate great opportunities.

To meet the needs of the NHS and the current economic environment, we need to keep our costs under control by ensuring that we are a lean organisation: we look at things such as direct delivery and shared services, and utilise IT such as online ordering to keep our costs down. The next few years will be a challenge, but with the right structures, cost control and investments we will be successful.

Our recently launched neurostimulation implantable device is a new area for Otto Bock, as it involves dealing with surgery. We have the full complement of medical and technical teams to support this market introduction: it’s not just a case of selling a product into the market. It will be interesting to see how this important area develops over the next three to five years, because there are numerous offshoots that will come from the huge investment that Otto Bock has already made into this area.

Patients, prescribers and politicians: a new coalition for the NHS

August 11th, 2010

The coalition’s recently unveiled Programme for Government and proposals for a new Health Bill promise significant change for the NHS. Patient power and clinical leadership will take centre stage, while politicians will take a back seat. Chris Ross examines the rhetoric.

A devolution of power and responsibility within the NHS will see patients and doctors given more control in a clinically-led health service, the coalition Government has announced.

The new approach, outlined by Cameron and Clegg in their Programme for Government and expanded upon within the subsequent Queen’s Speech, aims to bring an end to the “bureaucracy, top-down control and centralisation” it claims has “diminished the NHS”.

Health Secretary Andrew Lansley said the new NHS will be one in which patients enjoy a prominent voice. “Decisions must be taken with patients, closer to patients and with clinical leadership to the fore,” he said.

The BMA has welcomed the pledge to develop a clinically-led health service following an increase in NHS management in recent years, but urged the coalition to deliver beyond rhetoric. “Doctors want to work constructively with the new Government and we are pleased with plans to prioritise clinical engagement with the medical profession. But it is essential that this dialogue is meaningful and does not just pay lip service to the notion of involving clinicians in proposals for the health service,” said BMA Chairman Dr Hamish Meldrum.

Plans to introduce a Health Bill that cements the coalition’s vision for the health service were unveiled in last month’s Queen’s Speech. The Bill, which will be put before Parliament in around 18 months’ time, will propose an NHS run by clinicians and free from political interference. A flagship component will be the creation of an independent NHS Board, which will be responsible for apportioning resources and providing commissioning guidance. It will also give GPs power to purchase services for their patients.

Other measures include increasing the responsibilities of the Care Quality Commission and giving new powers to Monitor to act as an economic regulator “to oversee aspects of access and competition in the NHS”. Further attempts to improve efficiencies within the service will see a reduction in the number of health quangos in a bid to cut administration costs in the NHS by a third.

The Health Bill – at a glance

Purpose:

To build a sustainable national framework for the NHS.

To support a patient-led NHS focused on outcomes.

To reduce bureaucracy.

Benefits:

An NHS led by clinical decision-makers that is more responsive to patients.

A system that drives up standards of care, eliminates waste and achieves outcomes.

A service where patients have greater choice and control in decisions about their care.

Policy:

The establishment of an independent NHS Board to allocate resources, provide commissioning guidance and allow GPs to commission services.

Strengthening the Care Quality Commission and developing Monitor into an economic regulator to oversee access and competition in the NHS.

A reduction in the number of health quangos, cutting the cost of NHS administration by a third.

Targeting key priorities

The Queen’s Speech followed hot on the heels of the coalition’s Programme for Government, which was unveiled by Prime Minister David Cameron and Deputy Prime Minister Nick Clegg shortly after the new Government was formed. The Programme guaranteed a “real term” increase in health spending in each year of the parliament and an end to “top-down reorganisations of the NHS” that it said had “got in the way of patient care”. The Government pledged to stop the “centrally dictated closure of A&E and maternity wards” and give people better access to local health services.

Other measures outlined in the Programme include:

• NICE reform and a move to value-based pricing, so that all patients can access the drugs and treatments their doctors think they need.

• Establishing a Cancer Drugs Fund.

• Strengthening the power of GPs as “patients’ expert guides” through the health system by enabling them to commission care on their behalf.

• Prioritising dementia research within the health R&D budget.

• Setting health targets in key areas such as cancer and stroke survival rates and reducing hospital infections.

• £10 million a year from 2011 to support children’s hospices.

• A new per-patient funding system for all hospices and providers of palliative care.

• An extension of best practice on improving discharge from hospital –maximising the number of day care operations, reducing delays prior to operations and enabling community access to care and treatments.

• Helping elderly people to live at home for longer through home adaptations and community support programmes.

• The development of a 24/7 urgent care service throughout England.

• Giving every patient the power to choose any healthcare provider that meets NHS standards, within NHS prices. This includes independent, voluntary and community sector providers.

Local decision-making

The Programme’s commitment to end an era of top-down NHS reconfigurations and instead give power back to local communities has been highlighted as a key component of change. Health Secretary Andrew Lansley said: “We are committed to devolving power to local communities – to the people, patients, GPs and councils who are best placed to determine the nature of their local NHS services. Local decision-making is essential to improve outcomes for patients and drive up quality.”

Lansley said he expects decisions on NHS service changes to:

• focus on improving patient outcomes

• consider patient choice

• have support from GP commissioners

• be based on sound clinical evidence.

Local NHS organisations that have started to look at changing services will need to ensure their plans match these criteria. Lansley had said he was looking to NHS London, the biggest authority in the health service, to lead the way in working with GP commissioners in their reconfiguration of NHS services. However, the head of NHS London, former GSK Chairman and CEO Sir Richard Sykes, resigned from his position late last month following the new government’s decision to halt a wave of hospital reorganisations. Sykes was said to be furious at the Health Secretary’s decision to scrap a review of healthcare in the capital. The review included the possible closures of some A&E and maternity units.

A mixed reaction

Commenting on the new Programme for Government, ABHI said that the coalition appeared to have dropped the Conservative pledge to scrap NHS targets such as the ‘18 week wait’ but questioned its pledge to stop top-down reorganisations. “The programme does contain significant changes in the shape of an NHS Board and GP commissioning – measures which could have serious implications for NHS structures,” it said.

ABHI highlighted the appointment of Earl Howe as Parliamentary Under Secretary of State for Quality as being significant for industry. The position gives Howe responsibility for medicines, pharmacy and industry, NICE, R&D and innovation. ABHI recently met with Earl Howe to discuss the medical technologies industry and says it looks forward to continuing its dialogue.

Reaction to the recent announcements has been varied. Anna Dixon, Director of Policy at think tank The King’s Fund, said the proposals confirm that the NHS is embarking upon a period of significant change. “Strengthening the role of doctors and the voice of patients will create some difficult dilemmas,” she said. “In setting up an independent NHS board, careful thought will need to be given to the relationship between its responsibilities and those of ministers, who will remain accountable to Parliament for NHS expenditure.

“We welcome the acknowledgement of the critical role played by GPs within the NHS and the clear signal that changes are needed to improve the quality of general practice. If, as expected, these changes include transferring budgets to GPs, it will be important to learn from the previous experiences of GP-led commissioning in the United Kingdom and other countries to ensure it delivers benefits for patients and efficiency savings across the health system while ensuring accountability for public expenditure.”

But analysts have warned of the dangers of giving financial accountability to clinicians. Dean Arnold, Head of Healthcare Practice at Deloitte, said: “Putting patients first is always a positive thing to do, so too is empowering clinicians. However, this requires some caution as clinicians are not specialists in cost management – a skill that will become increasingly important. With power comes greater accountability. Patients should be able to hold clinicians to account. It can be argued that today healthcare managers and executives are far more accountable to patients than clinicians. It will be vital to get the right ‘checks and balances’ if we are to put the NHS in the hands of clinicians.”

Coalition health team

The Government’s new Health Ministers and their portfolios are as follows:

Minister of State for Health – Simon Burns

Responsible for: Legislation, NHS Performance, Health Services, Reconfiguration of Services, Patient Safety, Application of Quality Regulation and Connecting for Health.

Minister of State for Care Services – Paul Burstow

Responsible for: Long Term Care Reform, Carers, Personal Health Budgets, Safeguarding Vulnerable Adults, End of Life Care, Long Term Conditions (including cancer and diabetes), Dementia, Physical Disabilities and Learning Disabilities.

Parliamentary Under Secretary of State for Public Health – Anne Milton

Responsible for: Public Health, Blood and Transplants, Fertility and Embryology, Children’s Health, Maternity Services and Nursing and Midwifery.

Parliamentary Under Secretary of State for Quality – Earl Howe

Responsible for: NHS Constitution, NHS Commissioning Reform, Primary Care, NICE, R&D, Finance, Innovation and Medicines, Pharmacy and Industry.

Silver wound dressings: a topical issue

August 11th, 2010

A recent report in the Drugs and Therapeutics Bulletin argued that the routine use of silver dressings for wounds is not cost-effective. Professor Richard White of the University of Worcester and the professional association Wound Care Alliance UK argues that this medical devaluation of silver is potentially dangerous.

Silver-containing wound dressings are under close scrutiny after recent publications in scientific journals and the national press have cast doubt on their clinical value. It is apparent that the use of wound dressings containing the antimicrobial silver is being restricted across the UK. This is happening ostensibly because the clinical evidence for their use is weak. However, that may be just a smokescreen for cost-cutting.

The evidence in favour of silver dressings is, importantly, sufficient for two major regulatory bodies: the MHRA (following European Medical Device directives) and the FDA. There can be no reasonable doubt that in vitro, silver is a proven broad spectrum antimicrobial that is active against a wide range of pathogens, including resistant organisms such as MRSA and VRE. While the Cochrane Systematic Reviews claim there is insufficient evidence to support the use of these dressings, the most recent of these acknowledges 26 RCTs incorporating 2066 patients (Storm-Versloot et al 2010).

Flawed study

The VULCAN Trial publication (Michaels et al 2009) has been cited as a scientific rationale for removing silver dressings from wound formularies, based on a demonstrated lack of healing efficacy. However, serious methodological flaws in this study have been highlighted (White et al 2009). The central flaw is the use of silver dressings for prolonged periods of time (up to 12 weeks) without clinical justification, contrary to current best practice.

The authors thus present the use of topical silver products in a manner that is inappropriate, but seek to draw serious conclusions from the outcomes observed. This has led to the mistaken belief that silver dressings performed in a similar manner to dressings that did not contain silver and were at a lower unit cost.

As with all antimicrobials, silver dressings must to be used in an appropriate and structured manner for short periods with clear clinical objectives in mind – which was not the case in the VULCAN study.

Careful assessment

A Best Practice Statement in the use of Topical Antimicrobials/Antiseptics has been drafted by a panel of experts in the field, and is currently out for consultation. It states that products such as silver wound dressings should be used in a timely and appropriate manner which is tied to accurate assessment and regular re-assessment.

This is a responsible attempt by those active in the field of wound healing to address concerns that have been raised regarding the use of silver dressings. The panel are mindful of the potential catastrophe that could lie in wait for those vulnerable patients with infected wounds denied access to silver dressings.

Wound care products companies must now respond by making sure that their instructions for use are clear and in accord with best clinical practice. In particular, restrictions must be put on the duration of use. The use of products in neonates and paediatric cases must also be carefully considered and appropriate advice given.

To withdraw silver without adequate justification and/or without clinical advice on alternatives will compromise care, increasing morbidity and mortality. The latter has been established through audits showing that the arbitrary withdrawal of silver has led to increased incidence of septicaemia and death (Newton 2010).

Those responsible for wound formularies should be mindful of the potential human costs associated with decisions based on poor science, and should be held professionally accountable in the event of a documented increase in septicaemia based on the withdrawal of silver dressings.

Conclusion

Responsible clinicians will continue to use silver dressings in the fight against wound infection as part of a co-ordinated and comprehensive method of reducing infection rates in the UK. The risks associated with arbitrary restriction or removal of products should be borne in mind by all who have responsibility for the prevention and management of wound infection.

1. Storm-Versloot MN, Vos CG, Ubbink DT, Vermeulen H. Topical silver for

preventing wound infection. Cochrane Database Syst Rev. 2010 17;3:CD006478.

2. Michaels JA, Campbell B, King B, Palfreyman SJ, Shackley P, Stevenson M.

Randomized controlled trial and cost-effectiveness analysis of silver-donating

antimicrobial dressings for venous leg ulcers (VULCAN trial). Br J Surg. 2009

96(10):1147-56.

3. White R, Cutting K, Ousey K, Butcher M, Gray D, Flanagan M, Donnelly J,
McIntosh C, Kingsley A, Fletcher J, Chadwick P, Gethin G, Beldon P. Randomized
controlled trial and cost-effectiveness analysis of silver-donating antimicrobial
dressings for venous leg ulcers (VULCAN trial) (Br J Surg 2009; 96: 1147-1156).
Br J Surg. 2010 97(3):459-60; author reply 460.

4. Newton H (2010) Reducing MRSA bacteraemias associated with wounds, Wounds UK 6(1); 56-65.

Richard White

Richard White is Professor of Tissue Viability at the University of Worcester, WR2 6AJ.

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The science of compliance

August 4th, 2010

Part four: The exhibition table

Steve Gray answers your questions about compliance with the ABHI Code of Business Practice and other industry codes that govern commercial activity.

This article is based on a query recently received from one of our readers. The names and other specifics have been changed. Please keep sending in your questions!

Dear Steve:

As a local representative for MK Continence Devices, I have been asked to sponsor an educational meeting organised by a local group of healthcare professionals. The meeting is in a syndicate room in a local hotel. We are exhibiting our products on a promotional table – which, due to the layout of the venue, has to be in the same room as the presentation screen used for the educational content of the meeting.

What protocol should I follow regarding the promotional display table? Should I leave the room and cover the table from view during the educational meeting, then unveil it during refreshment breaks in the meeting?

Steve says:

Let’s consider the options and implications. The primary guiding principle here is that of separation, but what does that mean in this context?

MK Continence Devices is allowed to promote its products by buying advertising space – in this instance, the advertising space takes the form of an exhibition stand. Consider what expectations would apply if the advertising space were a page in a medical journal: would the company have to find a way of covering the advertising page while the reader was reading the educational text? Of course not, that’s just silly. So there is no reason to apply any different rules for advertising at a meeting – under normal circumstances. There is no requirement in the ABHI (or any Code) to hide the exhibition stand as a matter of course.

So when could the exhibition stand be a problem? Let’s consider its potential location. It is most likely to be at the back of the room (behind the audience as they face the speaker). Or it might be at the side of the room, but not directly in the line of vision for the vast majority of the audience. In both cases, the only time the audience will look at the stand is when they are meant to, i.e. during the breaks.

However, if the stand is at the front of the room next to the screen, I can see how that might be a cause for concern. The audience will be able to see the promotional display constantly during the presentation, and any references that are made to company products will naturally result in eyes being drawn to the display stand. That is distracting for the audience and unfair to the speaker. It also subtly changes the perceived relationship between the product and the meeting: MK Continence Devices could be seen as having a much greater influence on the meeting and the content of the talk than is actually the case. Common sense and courtesy suggest that the most appropriate thing might be to cover the stand during the talk – or not to put it in that place to start with.

The other principle in the ABHI Code to consider is that of transparency. As with all meetings, MK Continence Devices needs to consider the expectations of the audience. A company should never be present at an event unless the audience knows before they are arrive that the event is sponsored by industry.

All that remains is the acceptance of the organizers: you must respect their wishes. Assuming that the event organiser is happy for the stand to be in the room, then I foresee no issues. However, you must abide by their wishes.

In this example, we have used a room in a local hotel. The venue is irrelevant: it is the purpose of your presence at the meeting that determines what is acceptable here, not the venue. It is also appropriate to consider that individual companies may apply different rules: ABHI defines the minimum standards that apply to its members, but a company can choose to apply stricter standards.

Steve Gray is an experienced compliance specialist and Managing Director of Compliance Hub Ltd, an accredited provider of training services to the ABHI. For details, see www.compliance-hub.com.

Do you have a compliance query for Steve Gray? If so, e-mail your question to us at joel.lane@medtechbusiness.co.uk. Your anonymity is guaranteed.

Naidex 2010

August 4th, 2010

Birmingham NEC, 20–22 April 2010

N4

Assistive technologies for disability, homecare and rehabilitation are a rapidly growing sector of the medtech industry, due to a combination of factors: the ageing population, the shift of healthcare from the hospital to the community, and the involvement of a wider range of stakeholders in care provision.

However, a crucial issue for assistive technology companies is how to access this growing and diversifying market through the channels of NHS and social care procurement, which remain resistant to innovation. A proactive approach to market access is driving much of the change in this sector.

The Naidex 2010 exhibition reflected the fundamental changes taking place in this sector of healthcare. The event was bigger than ever before, with over 380 exhibitors spread across three halls. Part of the reason for the event’s success is that it targets all stakeholders: disabled people and their families; healthcare, social care and education professionals; and trade representatives.

Key themes of the three-day event were inclusive technology, enabling access and independence, and developing products and services to meet the needs and preferences of individuals.

Access all areas

Naidex 2010 was opened by the TV presenter, model and actress Shannon Murray. Over the three days, ‘Naidex TV’ broadcasts kept visitors up to date with developments in the field of homecare, disability and rehabilitation.

Mel Clarke, British archer and Paralympic bronze medallist, was presented with a scooter painted with the Union Jack, donated by dealers ACL Mobility and Mobility Carestore and the manufacturer, Danish company Mini Crosser.

The KidEquip Zone presented resources to assist children with disabilities, including a wheelchair skills training space run by Go Kids Go! – a charity dedicated to improving children’s mobility and independence. The new Communication Village featured a range of communication aids and educational resources.

Among the Lifestyles Seminars was a compelling talk from Shannon Murray about her success in building a show business career despite the effects of a major spinal injury. Murray said she’d been surprised at how many products she’d seen at Naidex that she hadn’t known she needed!

The CPD Professional Seminars included a presentation from the Health Design & Technology Institute in Coventry on how it brings assistive technology companies and occupational therapists together to design effective products. A specialised bra and a walk-in bath were used to illustrate the principles of ‘inclusive design’.

Breaking down barriers

The New Product Gallery displayed 83 pictures of innovative technologies next to an interactive voting station. Following two days of voting by visitors and exhibitors, Mangar International was awarded the New Product of the Year Award for its Back Saver: a product to assist with putting a wheelchair in the boot of a car.

“We are absolutely ecstatic to have won this prestigious award for the Back Saver,” commented Andrew Barker, Managing Director of Mangar International.

Etac UK came second with its E800 range of powerchairs, which improve user independence. In third place was SpaceKraft with its Interactive BubbleWall Panel, a visual resource with bright LED colours that phase automatically, used for developing sensory and communication skills.

MyBility Ltd launched its All Terrain Standing Wheelchair, whose 4-wheel drive enables the user to cross challenging surfaces (such as railway sleepers or heavy snow) without discomfort or loss of control. The chair offers a range of positions for the user, from standing to lying down. Director Chris Christou said the MyBility wheelchair offered liberation to many people “trapped in traditional chairs”.

Through the hourglass

Medtech Business spoke to a range of companies at Naidex 2010 and heard – in areas as far apart as communication aids and wheelchairs – that their innovation was challenged by an ‘hourglass effect’: there was successful R&D and unmet consumer need, but the limiting factor was the ability or willingness of purchasers to try new technologies.

The industry’s response to a changing market was reflected by the launch of the Wheelbox on-location wheelchair rental service: a self-service automated system with a card-operated user interface. The hospital version uses patient ID cards, while a version for shopping centres uses chip and pin technology.

Another example of the industry’s adaptation to changing models of care provision was Go Independent, a provider of bathroom and shower solutions that works with local authorities to install top-quality existing brands, providing a one-stop shop for the client or contractor.

Naidex 2010 showed the assistive technologies sector breaking the hourglass open, finding new ways to reach the people who need its products and services.

My Medtech Business

August 4th, 2010

James Urie is Sales and Marketing Director of Mediplus Ltd, a manufacturer of medical devices for urology, gynaecology and other therapy areas based in High Wycombe, Buckinghamshire.

James Urie

What are your main priorities as Sales and Marketing Director of Mediplus Ltd? How do you divide your time?

My number one priority is to maintain our philosophy of developing high-quality products at fair prices backed by high levels of service. Mediplus is a family company, so I wear many hats: developing and delivering our global sales and marketing strategy through our sales function; business development of the Americas: marketing communications, such as a total redesign of our website; research and development of our next product; Key Account Management of NHS Supply Chain, SHAs, PCTs and the DH; and identification of innovation routes such as the NHS National Technology Adoption Centre. When I have a spare moment, I am Vice-Chair of the CIM Medical Marketing Group.

Who are your main customers? How do you access them and build relationships with them?

Essentially our end customer is the patient being treated by heathcare professionals, and these are the people we have most contact with. In the UK we are selling to the NHS, but internationally we sell to our network of 40 distributors – or partners, as we prefer to call them.

Three years ago, Mediplus purchased a French company to sell our Anaesthetics and Urology range. Elsewhere, we have a comprehensive network of partners for whom we provide training and high-quality support. Sales in the USA are growing nicely and our next target market is Mexico, which will be an excellent long-term business opportunity for us.

We spend lots of time engaging with clinician and patient groups in order to understand what improvements we can make to our products and services, reducing costs by reducing waste or changing clinical practice. We are all about offering a better value proposition, not just offering a similar product at a cheaper price.

For the UK, we have a sales team of seven and a marketing team of two, whose focus is to understand how we can deliver cost savings to the NHS – not just by negotiating large contracts to secure prices, but by fundamentally changing clinical practice to release significant cost savings.

How are new communication technologies affecting your approach to sales and marketing?

The world is a very small place now, with lots of enthusiasm for things like FaceBook, Twitter and LinkedIn. A number of companies offer training on how to make the most of these. Some pharma companies have done well out of using these media, but as an SME we have to think differently.

We have been looking at how we can use these closed loop media to communicate directly with patients and clinicians, but have not yet found the key to it without remortgaging the house. However, we have experimented with one or two ideas that must be working, as the CIM thought they were good enough to be in the final of the Marketing Excellence awards against some very large pharmaceutical companies. We were the only medical device company in the final. That shows that with a bit of innovation, you can use the Internet to get your message across.

The success of our SPC video on YouTube, where we have had over 50k hits in six months, has shaped our strategy by giving us the confidence to submit a 510K for our Suprapubic catheter, as we receive several leads a week from hospitals in the USA that we have never visited.

How is the current shift in the focus of healthcare from the hospital to the community affecting your business and its commercial strategy?

The secret of successful marketing is to change your product and service offering as the market changes. The move from acute to community is a dramatic change, and we are trying to move with the times.

Historically, Mediplus has only focused on the acute sector. Three years ago we started promoting The Osbon ErecAid vacuum therapy device, which crosses both acute and community sectors as it is available on FP10. We wanted to gain an insight into how community selling works.

Within our Pelvic Floor division, some products are already there, some will be there one day, and some are being pushed there – so it makes for an interesting challenge!

At the beginning of this year, we started active dialogue with the DH, SHAs and PCTs to try and influence the services they commission. It’s a completely different approach, engaging with these groups rather than the people we deal with on a daily basis – so we have had to change our mindset, understand the terminology they use and change our marketing strategy and sales pitch accordingly.