New funding for medical technology research by companies, clinicians and academics aims to promote innovative approaches to the prevention, diagnosis and treatment of diseases in the NHS.

The National Institute for Health Research (NIHR) Invention for Innovation (i4i) programme has allocated up to £13m for research projects, and has launched a call for proposals.

The NIHR i4i programme funds projects through prototype and commercial development until a technology is ready for clinical testing, bringing together academic or clinical researchers and technical experts from industry.

The programme has been updated in two ways:

• Research projects in Wales, as well as in England, are now eligible for i4i.
• Instead of being divided between early- and late-stage product development awards, applications will all be submitted through a single route.

As well as looking for technologies that will benefit NHS patients, the NIHR i4i programme supports collaboration between researchers in industry, the NHS and the academic field. Each approved proposal will bring together researchers from at least two of these sectors.

NIHR particularly welcomes proposals from SMEs and from teams that have previously succeeded in developing and commercialising new technologies.

Martin Hunt, NIHR i4i Programme Director, said: “In the present economic climate, it is becoming increasingly difficult for medtech companies to secure funding for new, innovative technologies. The NIHR i4i programme provides a valuable funding opportunity for the medtech sector.”

This year’s i4i funding covers a “much broader” range of projects than last year’s, he noted. “The amount of funding awarded is determined by the nature and scale of the proposed research activity and we are considering projects seeking larger funding amounts than before.”

Outline research proposals must be submitted by 5pm on Wednesday 7 December 2011. Further details are available at www.i4i.nihr.ac.uk.

The ruling by a European court banning patents on inventions derived from stem cell research has been described as ‘devastating’ for biotech researchers and life science companies that depend on their findings.

The Court of Justice of the EU has ruled that inventions requiring the use of human embryos (at whatever stage of development) as base material are excluded from patentability, even if the patent does not itself refer to such use.

The ruling could see an end to UK investment in stem cell research and life science companies that rely on it, including medtech companies developing diagnostics and therapies relating to this area of biotechnology.

The regenerative properties of stem cells from human embryos is a key discovery of the biotech sector, and the new ruling excludes Europe from what has been hailed as the medical breakthrough of the new century.

Researchers have predicted that stem cell research could deliver effective therapies for degenerative diseases such as Alzheimer’s.

“This is a devastating decision that will stop stem cell therapies’ use in medicine,” said Pete Coffey, a researcher at UCL. “The potential to treat disabling and life-threatening diseases using stem cells will not be realised in Europe.”

Patent attorney Dr. Richard Gibbs, Associate at Marks & Clerk, noted: “This decision may do serious damage to stem cell research and technology in Europe. Those with existing patents will be uncertain of their enforceability; those intending to apply may need to reconsider their options.

“The potential for successful commercialisation is the major pre-requisite for attracting much-needed funding and investment in the arena of stem cell technology, and this decision significantly impacts that potential.”

Religious campaigners against stem cell research have praised the ruling as a victory for their view that individual life begins at conception.

In the US, the current administration has overturned the previous ban on stem cell research – but if a future government restores the ban, a medical breakthrough at the heart of a new life science industry sector could be lost to the Western world.

The idea that ‘any qualified provider’ can deliver NHS services may be contentious, but it has roots in existing policy. Thoreya Swage examines the opportunities for industry in the changing health provider landscape.

Successive governments have tried in recent years to shake up the healthcare system in the UK, with England probably being subject to the greatest number of changes. A key element of these shake-ups has been various attempts to expand the healthcare market in order to include the private or independent sector.

This widening of the doorway started in earnest with the deployment of the waiting list initiative in the 1990s, using the spare capacity of independent hospitals to reduce the queues for elective procedures that had built up in the NHS.

The baton was then taken up by the independent sector treatment programme under the last administration: the range of work done by private providers expanded to diagnostic procedures and screening programmes, as well as the construction of bespoke independent hospitals to take on hip, knee and cataract operations from the NHS.

It was at this stage that the concept of patients choosing which healthcare institution to go to for treatment or diagnostic procedures started to take off, with some of those options being in the independent sector. The idea of an ‘any willing provider’ began to take shape, with NHS care being delivered by any appropriate healthcare body as long as it had reached identified quality and safety standards.

However, before the recent change of government this initiative began to cool under external political pressure and at one time even seemed likely to fade away.

What AQP means

Despite opposition, the coalition Government has renewed the ‘any willing provider’ policy, calling it this time ‘any qualified provider’. In July of this year the Department of Health in England issued ‘operational guidance’ to the NHS providing further details to PCT clusters and the emerging Clinical Commissioning Groups (CCGs) – the renamed, modified GP consortia.

This policy has come under the guise of improving the quality of care by widening patient choice for specific services.

The intention is to permit the patient to choose from a list of qualified providers when they require a referral for a specific community or mental health service. To meet the ‘any qualified provider’ (AQP) requirement, a healthcare organisation needs to fulfil the quality, price and contractual obligations for NHS services. This process, as we have seen, is already in place for elective care.

The guidance states that the implementation of AQP will be conducted in phases from April next year. However, some work needs to be done before that. PCT clusters and their associated CCGs need to have decided which community or mental health services they wish to identify for the implementation of AQP locally by October, so that their patients can begin to have access to that care between April and September next year. Three or more services from the following list, drawn up by the DH in conjunction with patient groups, should be identified:

• musculo-skeletal services (neck and back pain)
• audiology services in the community (adults)
• continence care (adults and children)
• diagnostic services (e.g. imaging and heart and lung investigations)
• wheelchair services (children)
• podiatry services
• wound healing and management of leg ulcers
• primary care psychological therapies (adults).

The guidance also says that PCT clusters and CCGs can choose alternative services for AQP in different priority areas if these are supported by local patients – for example, as identified through the shadow health and wellbeing boards (the new joint health and social care joint commissioning boards) – and effective gains in quality and access can be made by doing so.

Getting involved

How can independent provider organisations participate in this process? The principles of the AQP approach are as follows:

• Organisations can qualify and register to provide NHS services as long as they meet NHS assurance requirements.
• Referral pathways and protocols set by CCGs must be accepted by the providers wishing to be on the AQP list.
• Patients are offered a choice of services from the list of qualified providers.
• There will be a fixed price based on a national or local tariff, to ensure that the provider is chosen by quality.

A national qualification process for all AQP providers is currently being developed by the DH in order to minimise bureaucracy and reduce transaction costs. The proposed principles for qualification are that providers:

• must be registered with the Care Quality Commission to demonstrate that they meet the essential standards for quality and safety (or equivalent assurance requirements if providing services not covered by CQC registration)
• are licensed by Monitor (from 2013) so that they are authorised to deliver NHS care
• can meet the terms and conditions of the NHS Standard Contract, including having regard for the NHS Constitution, appropriate guidance and legal obligations
• deliver care at NHS prices
• can meet the service specifications developed by commissioners and comply with referral protocols
• agree with the commissioners on any supporting schedules to the NHS Standard Contract, e.g. on activity levels.

More details of the qualification process will be published this autumn.

The providers that have successfully achieved the national qualification process will be listed in a directory available to GPs later this year.

By November 2011, lead PCT clusters will have produced detailed implementation packs for each service on the AQP list that will include service specifications, contract currencies, tariffs and information models.

It is anticipated that AQP for the services identified above will begin to be implemented from April 2012, with all CCGs having this in place for their patients by September 2012.

What happens next?

AQP will continue to expand: for 2013/14 a further list of services has been identified by the DH for discussion with commissioners, patient groups and providers. The list is not finalised, but will probably include:

• maternity care, e.g. antenatal education and support for breastfeeding
• speech and language therapy
• supporting patients to self-manage long-term conditions
• chemotherapy in the community setting and at home
• primary care psychological therapies for children and adolescents
• wheelchair services (adults).

Opportunities for medtech

The most obvious opportunity for medtech in relation to AQP is in the sphere of direct access diagnostic services, where many investigations such as non-obstetric ultrasound, echocardiography, cardiac physiology, MRI, X-ray, endoscopy and phlebotomy can be provided in the community setting, as indeed some already are (e.g. via Inhealth). These direct referrals can enable GPs to obtain rapid investigations and help to manage their patients in primary care, without having to refer to a hospital consultant.

Another key area is adult hearing services, including audiology and hearing aid fitting. Telehealth and telecare also have a part to play in supporting some of these services by monitoring people with long-term conditions at home. The services identified for the initial phase of AQP have traditionally had poor information systems. Better data collection on activity and health outcomes will be vital for the success of the providers delivering services under this initiative.

The key challenge for medtech companies is to get onto the recognised list of AQP that the DH is drawing up, or to work with partners who will be applying to go onto the list. Rather than regarding independent providers simply as customers, medtech suppliers can work with them to achieve AQP success.

Potential providers need to get up to speed on a number of areas, such as ensuring that they are registered with the CQC, have a good understanding of the standard NHS contract, offer services in keeping with the CCGs’ requirements and can manage within NHS financial envelopes.

The aim should be to identify the lead commissioner(s) within the local PCT cluster and associated CCGs and find out which community services they are planning to include on their local AQP. Alternatively, contacting the local shadow health and wellbeing board (if it is sufficiently developed) may indicate other priority areas for AQP. This is an opportunity for marketing medtech services that can be shown to improve patient care and are aligned with the local health economy’s priorities.

Medtech providers should also be clear about whether they can meet (or help their partner organisations meet) the qualification requirements for AQP. They should look closely at the details of these when they are published by the DH later this year.

Companies should also start doing their homework now on pricing and the care outcomes that can be achieved through their services, bearing in mind that the NHS commissioners will be looking at how the five high-level domains of the NHS Outcomes Framework will be achieved.

Another key milestone to look out for is the implementation packs due in November on service specifications, contract currencies, tariffs and information models. These will require close examination by potential providers seeking to ensure that they are fully prepared for AQP.

Although this initiative seems small in scale it looks set to grow in the future, and further opportunities will present themselves for 2013 and beyond as AQP continues to expand. For more information, visit the Department of Health website.

Dr Thoreya Swage was formerly an NHS clinician and a senior manager in various NHS organisations covering acute and primary care. She has expertise in commissioning health services and is currently working for a number of NHS organisations, including DH agencies, to develop a more commercial approach to the commissioning of healthcare.

UK-based telehealth and telecare leader Tunstall Healthcare Group is to acquire remote health monitoring and 24/7 communication provider American Medical Alert Corp (AMAC).

Jack Rhian, President and CEO of AMAC, said: “Tunstall’s longstanding culture of engineering excellence, technological innovation and commitment to providing seniors with the tools to live independently is perfectly aligned with AMAC's mission.”

New York-based AMAC has two business divisions. Health and Safety Monitoring Systems (HSMS) includes a portfolio of remote patient monitoring devices and services including personal emergency response systems (PERS), mobile PERS, medication management and telehealth.

The company’s second division is Telephony Based Communication Services (TBCS), AMAC’s contact centre services group, which provides quality communication services to all types of healthcare departments, including physicians, hospitals, homecare and the pharmaceutical industry.

Gil Baldwin, CEO of Tunstall, said: “AMAC will support our ambitious growth plans in the United States.”

AMAC is “one of the largest providers of PERS in the US with 75,000 subscribers nationwide and a strong reach within hospital systems, home healthcare, government agencies and senior living facilities,” Baldwin noted, adding: “I believe there will be far reaching benefits for all of our customers, partners and employees of the Group.”

Tunstall will obtain all of the outstanding common shares of AMAC for $8.55 cash per share.

The deal is expected to close at the end of the fourth quarter of 2011.

Based in North Yorkshire, Tunstall Healthcare is a leading global supplier of telehealth and telecare systems.

The only solution to the NHS funding crisis is “radically re-orienting services to reduce hospital stays and offering new forms of care,” according to NHS Confederation head Mike Farrar (pictured).

Farrar, a long-term supporter of medtech innovation as a facilitator of NHS service redesign, has said in a Guardian article that shifting healthcare services into the community and centralising surgery provision is the only way to avoid wholesale loss of NHS service provision.

He noted that the imperative of achieving £20 billion of savings by 2015 was already increasing NHS waiting times and raising the threat of the health service cutting services to “salami slice its way out of financial trouble”.

Farrar also said that there was a danger of the NHS reducing access to “less effective treatments”, though in fact this is already taking place in most Trusts.

To avoid financial disaster on the one hand or disastrous loss of services on the other, he argued, the only way forward is to shift the focus of services into the community – and immediately to cash in on the benefits of service redesign by closing down much of the existing in-patient hospital provision.

Surgery can be relocated to major centres and out-patient services to primary and home-based care, he said, with hospitals ceasing to be the main providers of secondary care.

Farrar’s argument echoes the emphasis of Lord Darzi’s NHS Review (2008), but with the crucial further twist of a serious funding crisis.

His stark message is that without this reconfiguration of services – which will only be possible if funding is made available for service redesign – healthcare in the UK “faces a bleak future”.

The medtech industry has argued for years that the use of new technologies to shift more diagnosis, monitoring and treatment into the community is essential to the future of the NHS. Now, a leading NHS figure has said there is no other option.

The FDA has approved Calgary Scientific’s medical imaging device, ResolutionMD Mobile, as a mobile diagnostic app for use in the US.

The new technology gives physicians remote access to patient images and reports stored within any healthcare facility, enabling clinical diagnosis of the patient from any location.

Dr James A. Brink, Professor and Chair of the Department of Diagnostic Radiology at Yale University School of Medicine, said: “The ability to view diagnostic quality images on mobile devices promises to speed healthcare delivery, particularly for urgent conditions or after hours.”

The mobile app promises complete security and advanced capabilities through minimal bandwidth, even on 3/4G wireless. The technology also ensures that patient image data cannot be lost or stolen, and no highly sensitive or confidential patient data is ever retained on the device.

Dr Byron Osing, CEO and Chair of Calgary Scientific, said: “Lost or stolen patient data is a critical issue in the medical IT sector, with regular announcements of significant HIPAA compliance fines being levied and legal settlements in the tens of millions of dollars.”

“The FDA clearance of the ResolutionMD solution is a key strategic step forward for the Medical IT sector in enabling a high performance and secure ‘mHealth’ paradigm, as well as ensuring that vast regions of the world that are currently dependent upon wireless connectivity can now leapfrog directly into the realm of advanced medical solutions," added Dr Osing. 

Non-diagnostic versions of the app are already licensed under OEM agreements with global leaders in medical imaging and information technology.

The software has also been approved by Health Canada, has acquired the CE Mark for distribution in the EU, and is available on Apple iPhone and iPad devices. 

Calgary Scientific is a provider of accessible, advanced visualisation solutions in medical imaging and web, mobility and collaboration enablement technologies, used to help industries achieve secure access with their existing technology.