Department of Health plans to scrap key NHS performance targets have been described as “risky” by a former NHS Chief Executive.

Lord Crisp, Chief Executive from 2000-2006, said proposals to remove waiting time targets sent the NHS a “very risky message” that “waiting no longer matters”.

But Earl Howe, the DH’s Parliamentary Under-Secretary of State, said the revised NHS Operating Framework would bring an end to central performance management of process targets that have limited clinical justification.

He said the main message, conveyed to NHS bodies by current Chief Executive David Nicholson, was: “Timeliness is important. A great deal has been achieved. We do not want to squander that, but we think that clinicians should now be given the responsibility to prioritise patients and treatments for themselves, not have central performance management dictated from above.”

Howe said the legal duty on commissioners to commission services that comply with operational standards around the 18-week referral time still applies. He also said that guarantees outlined in the NHS Constitution giving patients the right to access services within minimum waiting times had not been diluted.

The revised 2010/11 NHS Operating Framework sets out changes to key priorities for the NHS. It includes the removal of top-down performance management of the 18-week referral target and reduction of the 4-hour A&E target threshold from 98% to 95%, and abolishes targets around access to primary care. Health Secretary Andrew Lansley said that ending performance management targets would allow a more effective focus on patient outcomes.

“The target system isn’t working. We need to get doctors out of a tick box mentality and get them focused on patients,” he said. But Lansley quelled fears that cancer targets would be abolished. “We have made it very clear that we are going to remove those targets that have no clinical justification. But there is a clinical justification to see a specialist in relation to cancer.”

The move has been welcomed by HCPs. Dr Keith Brent, Deputy Chairman of the BMA’s Consultants Committee, said: “Waiting time targets have improved the NHS in many respects, but they have also resulted in pressure on staff to make inappropriate decisions. Patients must always be treated as individuals and we welcome this commitment to allow doctors the freedom to do what is clinically appropriate.”

But patients’ representatives have expressed concern that targets were being scrapped before ways of monitoring treatment outcomes were in place. “This is the right direction and the right idea, but we’re very concerned about how they are approaching making these changes,” said Katherine Murphy, Director, Patients Association. “We have always supported reviewing the targets, but we have never supported abolishing the targets and not putting in place something to replace them.”

David Nicholson said the change in focus should not mean long waiting times were now acceptable. “Standards and quality are also expected to be maintained where existing targets are removed or adjusted pending the development of more outcome-focused measures,” he said. “Patients would not expect a return to long waiting times for operations.”

But policy experts predict that this is inevitable. Dr John Lister, from pressure group London Health Emergency, said: “If anybody felt that the Labour government hadn’t improved anything, they will when they see the waiting list times go up and up. I am not a fan of targets per se, but this is really bad news.”

 
Andrew Lansley

The challenge of clearing the regulatory and procurement hurdles between a bright idea and an innovative product in use may be daunting. However, Martin Goldman argues, it's a challenge that brings out the best in the medical technologies sector.

I have just finished reading a bulletin from the Health Protection Agency, informing me that we may not witness swine flu Armageddon in the immediate future. While governments and big pharma figure out what to do with the millions of vaccine doses left over, it made me think about the great-grandfather of vaccination - Edward Jenner. Today he would be vilified in the press (well, he actually was then) for the use of unlicensed medicines - but he must have had some kind of device to scarify the skin, and it was probably not designed for that purpose. When I was a student, I met a doctor who told me he had specially grown one of his fingernails so that it could rupture the membranes of pregnant women to induce labour. I never saw him do it, and that was probably for the best.

Today, everything used in the delivery of healthcare is regulated to ensure the safety of patients by conformity to predetermined standards. That starts by defining all healthcare products in terms of their therapeutic or diagnostic purpose. Directive 2007/47/ec of the European Parliament and the council of 5 September, 2007 defines a medical device as "any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings." That may be a mouthful, but it is a useful statement. It is basically a 'put up or shut up' if you want to manufacture something and advocate its use for treating patients.

Additionally, it creates an interesting interface between medicines and their delivery systems. With the arrival of devices such as drug-eluting stents, which combine drug delivery and structural device functions, there is a clear need for careful consideration. There have been some well-publicised untoward outcomes with a few devices such as IUDs, prosthetic joints and heart valves, and it is therefore necessary that there should be a regulated process for the development of devices.

Concept to product

For most new devices, there is a process whereby an unmet healthcare need (or an untapped potential profit) is identified - either by an individual or in response to a generally held belief. Often there is an identifiable inventor: an academic or healthcare professional. Given a problem such as the need for a pain-free injection device, where there is an obvious need, a number of possible solutions may come to light in time. Some manufacturers actively court inventive minds, then bring their engineering, electronic and computing skills to bear on a proffered concept. Sometimes the inventor will get into bed with the manufacturer and develop a relationship for the lifetime of a product. The relationship may be driven by financial motives - though if the device bears its inventor's name, that may be a further incentive.

For an embryonic medical device, the only chance of survival into maturity may be the involvement of organisations with sufficient funds to finance the development, testing and initiation of manufacturing and subsequent commercialisation. Much has been written recently about partnerships for the development and commercialisation of medical devices, and the involvement of academia in refining and validating the role of a device is a valued contribution to the commercial organisations.

If a device is an original concept or uses novel processes, it is very important to protect this intellectual property. Failure to do so will prompt copying and ultimately damage the chances of recouping investment, let alone making a profit. Again, this is a reason why funding is needed, as successfully filing and protecting patents is an expensive activity. Fledgling companies may run out of capital before realising their product; the hard side of the business is that there are always vultures circling for opportunities, and acquisitions are so frequent they are not always news.

Having said that, a company in the USA calls itself 'Generic Medical Devices', and its intention is exactly that: to produce cheap facsimiles of products out of patent that represent value for money. If you search on the Internet, a picture of its generic circumcision clamp can be found. Strangely enough, despite its being in the generics market, the company has patents attributed it!

Product to profit

The delivery of healthcare has become a highly regulated activity, especially in the western world. This is true of medicines, devices and the way that services are run (though the latter is regulated more by audit and inspection). For medical devices, unlike medicines, there does not appear to be a legal requirement for appropriately qualified individuals such as physicians and pharmacist to sign off documents and approve processes, so there is a clear need for structured guidance. It can't be a free for all. Those involved in device development and production must have clearly defined responsibilities, be suitably trained, have knowledge of the regulations and have adequate resources to fulfil the directives.

In the UK, the Medicines and Healthcare Regulatory Agency (MHRA) conducts the regulation of medicines and medical devices (the latter having been added to its remit more recently). Lots of information about the regulation of devices can be found on the MHRA website at www.mhra.gov.uk/Howweregulate/Devices/index.htm. The rules are subject to the European Directive on Medical Devices - but as that is less easy to get your head round than the UK information, we will limit ourselves to the local context.

Many documents, regulations and guidelines are available here, but there is no one place where all the relevant information for developing and registering can be found: it is necessary to wade through many separate documents. There are independent consultancies that can assist device virgins with their first experience of putting a device on the market. The regulatory environment is fluid (because technology advances rapidly), and this means that sections of the guidelines and regulations are constantly being updated. The MHRA has undertaken, in line with the recommendations of the Hampton Report (2005), to keep its guidance documents under constant review.

A good starting point is Bulletin 8, which provides information about the European Medical Devices Directive (from the MHRA viewpoint). It explains the intentions of the directive and covers topics such as the classification of devices, the CE Mark and the competent authority and notified bodies. Bulletin No. 2 covers CE Mark approval, which means that a device may have access to the whole of the European Community market without any further need for compliance with national approval systems. This is leagues away from the complex ways in which medicines are centrally approved and are handled within the community.

Bulletin 10 covers the classification of devices covered by the Directive into 4 areas: Class I (low risk), Classes IIa and IIb (medium risk) and Class III (high risk). The bulletin outlines a number of rules, e.g. that any non-invasive product belongs to Class I if other rules do not apply. For a supplier of devices, being able to claim Class 1 means it is subject to the least obligation for supply of information and documentation. At the other end of the scale, a Class III device may require clinical investigation before marketing. This is the subject of a document, 'Guidance for manufacturers on clinical investigation to be carried out in the UK' (updated September 2009).

One of the most useful documents is Bulletin 17, which sets out in broad terms the regulation of specific products and helps to clarify the distinction between medicines and medical devices. A device (such as a drug-eluting stent) whose function involves a medicinal content falls into a more highly-regulated division of devices. The bulletin offers a helpful annex listing areas of doubt and offering guidelines as to whether something is a device or a medicine. This can be confusing to the uninitiated, and the arbitrary-seeming division of dentistry products may serve as an object lesson.

Talking cure

One of the things that make the medtech industry attractive in this country is that a company may make promotional claims about a device and not be subject to the same level of legal restriction as for medicines. That is not to say a company would advertise a new hip prosthesis in the Daily Express - but the relationship with healthcare professionals is less constrained, and there is less need for an approval process that prolongs the time from agency concept to printed materials.

The ABHI Code of Business Practice is like a very watered-down version of the guidelines for medicines, and relies on self-regulation rather than sanctions. For this reason, some companies that have been hindered by legislation and guidelines on medicines are now looking at whether their products could be classified as medical devices. Similarly, the pricing issues and regulatory schemes do not apply in the same way; and for a class I device, arguably, there is no need for the involvement of a healthcare professional if a patient purchase is intended.

A bright future

The role of medical technologies in our healthcare is increasing all the time. Their development and provision need to follow an agreed structure and set of regulations in order to protect the public. There are many regulations, but it is difficult to round them up in one place.

Even so, the regulations are easier to deal with than those governing medicines - and once they are negotiated, the commercial possibilities in Europe are great. The medtech industry has a bright future, as long as its activities transparently reflect the fact that the wellbeing of patients is the highest priority.

Dr Martin Goldman qualified in medicine and practised initially in hospitals. He has worked in the pharmaceutical industry for over 25 years, and has been involved in a wide variety of medical department activities - including the recent development of a dry powder inhalation system to deliver antibiotics to the lungs.

The role of medical technologies in our healthcare is increasing all the time. There are many regulations, but it is difficult to round them up in one place. Once they are negotiated, the commercial possibilities in Europe are great.

Michael Cadman is General Manager of CODAN Ltd, a leading supplier of disposable devices for infusion therapy based in Wokingham, Berkshire. CODAN Ltd is a member of the International CODAN Companies group, which employs more than 1500 people.

What are your main priorities as General Manager of CODAN Ltd? How do you divide your time?

The priority, of course, is to maintain the excellent growth we have seen over previous years, and in the current climate to maintain profitability. As part of a multinational European-based parent company, we buy in euros and US dollars, so this is proving particularly challenging - as I am sure is the case for many suppliers to the NHS.

The strategic direction of the company also focuses a lot of my attention, as does the day-to-day running of a large healthcare business with all that encompasses. The key to all of it, though, is maintaining an enjoyable and positive culture within the company.

What are the main routes by which CODAN does business with the NHS - clinicians, local procurement specialists, NHS Supply Chain, etc? How do you build relationships with these customers?

We have always believed that the best way to be a successful supplier of any healthcare product to the NHS is to be able to communicate effectively with the clinicians who decide whether our products meet their requirements. In this context, we always try to employ sales people and product specialists who have a relevant clinical background.

The route to supplying the NHS is an ever-evolving entity! So it is important that we keep abreast of how it needs to be approached. We are fortunate to enjoy good and positive relationships with the NHS Supply Chain, and I think having an understanding of what they are trying to achieve and vice versa makes doing business more straightforward for both parties.

Many of our products have been developed through close co-operation with clinicians who have approached us with ideas to improve products and develop new ones.

The key to any successful business is the customer, and ultimately in our case that is the patient. Having recently been on the receiving end of major surgery, I can assure you that it has given me an even stronger insight into how we need to approach the clinicians and how our products can make a greater difference.

How has CODAN's experience of the global market affected its strategy?

As part of my role I have regular contact with colleagues worldwide, and it is interesting to see not only how differently the countries approach healthcare provision, but also the different priorities in clinical practice. Our international experience enables us, I feel, to take all this information and apply it to how our products are developed for use throughout the world healthcare market.

How do you see the market for disposable infusion devices changing in the coming years?

The market for disposable infusion devises - as well as delivery systems such as infusion pumps, which are also an important part of our business - suggests that there is an ever-increasing demand. All manufacturers are challenged to meet this future demand with high-quality and cost-effective products.

Something we are particularly focused on at present is the environmental consequences of how disposable products are disposed of. To demonstrate our commitment to addressing this issue, we have recently introduced a new, more environmentally friendly plasticiser into our products: we have replaced DEHP with high-grade TOTM. This has clinical benefits as well as reducing the environmental consequences of disposal. Sustainability and environmental safety issues are increasingly important for the global medical device market.

The new era of community-based and technology-enabled healthcare requires joined-up thinking across the industry, as well as across global health systems. Continua Health Alliance is bringing together major players in medical technology to change the world of healthcare.

There is no more potent example of the impact of Web 2.0 technology on our lives, whether at work or at home, than the current evolution of a global network of wireless healthcare devices. As specialist companies work to develop wireless monitoring and diagnostic technologies that can help clinicians in track patient welfare in the community, spreading the new healthcare paradigm throughout modern society, the question remains: what links it all together?

Continua Health Alliance is part of the answer. It describes itself as "a non-profit, open industry coalition of the finest healthcare and technology companies joining together in collaboration to improve the quality of personal healthcare". Its long-term goal is to establish "a system of interoperable personal health solutions" - building the technological foundation for a new era of healthcare when people with long-term health needs will remain independent and in control of monitoring and supporting their own well-being.

The Alliance has more than 230 member companies around the world. Its members range from global healthcare corporations (Baxter, GE Healthcare, Medtronic, Philips) and specialist providers of electronic healthcare systems (Cambridge Consultants, Omron, St Jude Medical, Tunstall Healthcare) to health provider organisations (NHS Connecting for Health) and major technology corporations (IBM, Nokia, Panasonic).

World of Health IT

In March 2010, Continua Health Alliance shared its ideas about developing a standards-based interoperability approach to personal health systems with the 3,000 attendees at World of Health IT (WoHIT), a leading forum for e-health in Europe.

"Continua is dedicated to supporting connected health initiatives worldwide," said Chuck Parker, the Alliance's Executive Director. "We feel WoHIT is an excellent fit for our priorities and brings together leaders from both Europe and around the world, resulting in incredible momentum and synergy for the connected health movement."

Recently, Continua has strengthened its engagement with the European Union through its receipt of funding from the European Commission for a 12-month project, Smart Personal Health (see interview below). The project aims to develop understanding of the need for interoperability among personal health systems and other e-health systems across Europe.

The first in a series of workshops in conjunction with Smart Personal Health, 'Enabling Integrated Care: Harnessing personal health systems for better outcomes across the care continuum', took place as part of WoHIT 2010. The workshop provided a forum to explore opportunities and identify solutions for integrating personal health systems in routine healthcare, placing their use in the practical context of the work of clinicians and underlining the cost and patient outcome benefits of personal health systems.

Continua has also formed a partnership with Renewing Health, a major project co-funded by the EU with funding of over $19 million. The project aims to aid the implementation of connected health technology in homecare systems to assist patients suffering from cardiovascular or respiratory illnesses or diabetes.

Bring it home

The number of quality Continua-certified devices from the Alliance's member companies has now reached 15. Recently certified products include:

• Omron BP792IT Home Blood Pressure Monitor. This monitor, which uses Bluetooth wireless technology, allows users of Omron blood pressure monitors to easily transmit data to electronic health applications.

• Omron HBF-206IT Body Composition Monitor. This monitor, which also uses a Bluetooth chip, enables users to gain a comprehensive view of their health level through several fitness indicators and transmit data easily to electronic health applications.

• Omron HJ-721IT Pedometer with HHX-IT1 Docking Station. This system enables a family to use individual pedometers and transmit their data easily to electronic health and fitness applications through one simple device.

• Toshiba Bluetooth Stack for Windows. This Bluetooth-enabled device links to a PC and records your vital data automatically, without any need for further user intervention.

• Texas Instruments MSP430 USB Agent Platform. This hardware and software platform enables companies to develop Continua-compliant portable medical devices (such as a blood pressure monitor, blood glucose meter, digital thermometer or pulse oximeter) more quickly and easily.

The bite of Bluetooth

A key medtech player in the Continua Health Alliance strategy is Cambridge Consultants. A world-leading technology product development firm based in London and Boston, Cambridge Consultants has played a crucial role in the emergence of wireless healthcare through its creation of the Bluetooth technology and its medical applications.

Among the company's innovations is the Vena platform, launched in March 2008: a versatile and affordable Bluetooth chip (priced at $10) that allows medical devices such as blood pressure monitors to transmit data wirelessly. The Vena platform embeds both the emerging IEEE11073 standard, which ensures the compatibility of data exchanged between different types of devices, and the emerging Bluetooth Medical Device Profile, optimised for the secure transport of medical data, in a single chip.

The Vena platform can be used to connect multiple devices, providing a link to online records through a computer system. Vena has been adopted by Continua Health Alliance as a global platform for a network of interoperable wireless healthcare devices.

Paul Williamson, Head of Wireless Medical at Cambridge Consultants, spoke to Medtech Business about Vena's significance for the emergent global wireless healthcare network: "Cambridge Consultants' Vena platform has been specifically developed to be easily integrated into wireless healthcare devices at any stage of the design or production process, which has made it possible for companies to rapidly bring Continua-certified products to market.

"For example, it is this ease of implementation that enabled A&D Medical to commercialise its Vena-enabled blood pressure monitor and weighing scales last August. Our knowledge of Bluetooth technology, which Cambridge Consultants originally helped bring to the commercial market, has allowed us to think outside the box and embed Bluetooth-related technologies such as the Health Device Profile (HDP) for the secure transport of medical data onto a single chip at an affordable price.

"Current solutions in the telehealth space are often expensive, so Vena represents a disruptive low-cost technology for the medical home market. Vena provides consumers with tools they can use effectively at home, and with minimal effort and expense, to manage chronic conditions like diabetes or congestive heart failure as well as interact with their healthcare network."

Unity is strength

Chuck Parker, Executive Director of Continua Health Alliance, spoke exclusively to Medtech Business and explained the significance of the Continua Health Alliance for the global medtech industry.

What are the main objectives of Continua Health Alliance? What are its primary implications for healthcare systems and for public health?

Continua Health Alliance represents more than 230 leading technology and healthcare companies dedicated to establishing a robust ecosystem of interoperable and connected personal health solutions that empower organisations and individuals to better manage health and fitness.

By harnessing technology to augment healthcare delivery, these personal connected health solutions can help address some of our most pressing healthcare challenges. Today's providers are struggling to optimise patient care, improve clinical outcomes and enhance access, while reducing the skyrocketing costs associated with an ageing population, chronic diseases and unhealthy lifestyles. As the demand for medical services accelerates, the growing shortage of physicians and other healthcare professionals adds to these pressures.

Personal connected health solutions provide an important way to help meet some of these challenges. Consider that expenditures for individuals with chronic diseases in some countries consume more than 75% of total medical care costs. Remote observation can help by giving care teams easy access to accurate, ongoing trend data for vital patient information. Healthcare professionals are empowered to address potential health problems early on and provide solutions more quickly and easily as needed, which can reduce the number of consultations, unnecessary emergency room treatments or even critical situations.

Interoperability is crucial to spur the widespread adoption of connected personal health solutions and realise their full promise. Last year, Continua released its first Design Guidelines, a milestone toward establishing a diverse ecosystem of interoperable healthcare devices and solutions. The guidelines provide the framework for development, certification testing and implementation of interoperable, connected health devices. During the second quarter of 2010, Continua will issue the next generation of guidelines to enable an increased array of features and benefits.

Continua's rigorous certification program provides consumers and healthcare providers with increased confidence that certified products will work together. More than a dozen Continua Certified devices are now available, and many more are poised to join the Continua ecosystem in the coming months.

Continua's name suggests a broad-based systems approach. How can a 'personal health ecosystem' be most effectively supported by healthcare providers and medical technologies?

Personalised connected health solutions offer individuals the power to better manage their own health and fitness. By engaging patients, their loved ones and their caregivers as full partners and active participants in their care, these systems can help make health knowledge an integral part of daily living, encouraging healthier lifestyles. For those coping with chronic conditions or the limitations imposed by ageing, these systems can provide greater freedom and independence while also monitoring their safety and adherence to desired outcomes.

Hospitals and clinics will benefit by gaining easy access to necessary immediate information, enabling faster diagnoses and treatments with a diminished chance of error. The deployment of connected healthcare systems helps to eliminate gaps in the flow of patient data, providing a richer view of the overall health of an individual and ultimately enhancing efficiency, access and medical outcomes.

The ability to remotely manage a person's health is becoming increasingly important, particularly for those coping with chronic conditions. Even as the shortage of healthcare professionals becomes more marked, they are responsible for an ever-increasing number of individuals. The effective use of connected health technology offers healthcare teams and physicians the ability to more efficiently manage the healthcare of multiple patients. Information gathered during consultations can be augmented with invaluable, ongoing trend data. Software that manages the flow of this information and provides high-level analysis will play an important part in connected health solutions by providing the ability to constantly monitor each patient's data and send alerts for any significant changes that may require intervention.

Continua has a wide range of member companies. Given that innovation and product differentiation are essential for a company's success, how is working within the Continua framework beneficial to members?

Although some of our members are direct competitors, they understand it will take industry-wide collaboration to develop a market for connected health devices and services. Continua Health Alliance and its members work together to define design guidelines for connected health solutions. By providing common design guidelines based upon some of the most widely-accepted technology standards in the industry, Continua's members are able to shape the direction of the connected health industry while developing a larger market for solutions. These guidelines free member companies to focus on the specific features and functionality of their own solutions, rather than having to devote time and resources to the development of an entire networking and data transmission chain. The guidelines provide a common framework for each company to build upon to add value through specialisation and differentiation.

What new developments does Continua have planned for 2010?

Continua plans to issues its next generation of design guidelines during the second quarter of 2010. Two low-power radio standards have already been selected for incorporation in the next iteration of technology design guidelines for Bluetooth low-energy wireless technology and ZigBee Health Care technology. These guidelines will bring an increased array of features and benefits as additional devices join the Continua ecosystem.

As an international organisation dedicated to fostering personalised connected health solutions worldwide, Continua has a strong presence in the UK and Europe, as well as North America and Asia-Pacific. In 2010, Continua will remain active internationally. In the upcoming months, Continua plans to participate in key industry events in Spain (Mobile World Congress and World of Health IT), Japan (the key governmental launch of Continua) and Germany (third in a series of Smart Personal Health programmes). Additionally, the organisation hosts several summits a year throughout the world. Continua's Summer Summit in June will take place in Belfast, Northern Ireland, and the Fall Summit will be held in Seoul, South Korea.

An important initiative for Continua in 2010 is the Smart Personal Health project. Continua recently announced the receipt of funding from the European Commission (EC) for this 12-month project. Smart Personal Health aims to promote awareness and a deeper understanding of the need for interoperability among personal health systems (PHS) and devices across Europe.

Continua is joined by European health standards groups such as the European Telecommunications Standards Institute (ETSI) and Integrating the Healthcare Enterprise (IHE) in building the Smart Personal Health project. Other project partners include Empirica and The Centre.

The project will culminate in a report to the European Commission in Brussels highlighting the current status, concerns, barriers and viable incentives to accelerate the development and adoption of interoperable personal health systems. The report will include recommendations to the European Commission, national governments, stakeholder groups and the industry at large for promoting interoperability.

Continua will also be participating in several European conferences and exhibitions in 2010, including NHS Smart Home, Ambient Assisted Living Forum, Medica and the Mobility Forum.

'The deployment of connected healthcare systems helps to eliminate gaps in the flow of patient data, providing a richer view of the overall health of an individual and ultimately enhancing efficiency, access and medical outcomes.'

NICE has today issued negative draft guidance on imatinib (Glivec) at doses of 600 or 800mg/day for patients with unresectable and/or metastatic gastrointestinal stromal tumours (GIST) whose disease has progressed after treatment with 400mg/day imatinib.

NICE recommended imatinib at 400mg/day to treat GIST in October 2004, but ruled earlier this month that it was unable to recommend the drug as an adjuvant treatment.

Andrew Dillon, Chief Executive of NICE, said: “Since the appraisal was published in October 2004, there has been no new good quality clinical and cost effectiveness data produced on doses of 600 or 800mg/day. On this basis, we cannot recommend these higher doses of imatinib for use on the NHS.

“NICE has already recommended sunitinib (Sutent) as a treatment option for patients with unresectable or metastatic malignant gastrointestinal stromal tumours for whom treatment with 400mg/day imatinib treatment has not worked or was not suitable.”

The annual incidence of GISTs is estimated to be 14.5 per million population – approximately 791 new cases per year in England and Wales (mid-2008 population). Of these, the manufacturer of Glivec estimates that two thirds are considered to be resectable.

The EMA has granted a new indication for GSK’s oral breast cancer treatment Tyverb (lapatinib).

Approval was given for Tyverb, in combination with an aromatase inhibitor (AI), to treat post-menopausal women with hormone receptor (HR)-positive, ErbB2 (HER2) over-expressing metastatic breast cancer, based on evidence that it can increase progression-free survival (PFS) by more than five months in this indication.

Professor of Breast Cancer Medicine, Stephen Johnston, Royal Marsden NHS Foundation Trust & Institute of Cancer Research, commented: “Lapatinib plus an AI offers an effective, chemotherapy-free and well-tolerated option for patients with a distinct disease profile. As a first line option for these patients it offers a choice to delay the need for more aggressive and toxic therapies, such as chemotherapy. Importantly as an all-oral treatment option it allows patients to take their medication at home, relieving precious hospital resources.”

As an oral treatment, Tyverb has the potential to relieve hospital resources, but also to allow patients more time at home with their families.

Around 50% of patients with ErbB2-positive metastatic breast cancer are also HR-positive. A phase III trial in over 1200 patients demonstrated that ErbB2-positive patients given lapatinib plus letrozole experienced a median 8.2 months of PFS, compared with 3 months without lapatinib.

Lapatinib is already indicated (in combination with Xeloda/capecitebine) for patients with ErbB2-positive metastatic breast cancer, pretreated with anthracyclines and taxanes, who have progressed following treatment with trastuzumab in the metastatic setting. NICE, however, recently ruled that the drug is not a cost-effective use of NHS resources in this indication.

Tyverb in combination with letrozole is currently being considered by the NICE work programme as part of a Multiple Technology Appraisal (MTA) – guidance is expected in the first half of 2011.

The coalition’s recently unveiled Programme for Government and proposals for a new Health Bill promise significant change for the NHS. Patient power, value-based pricing and clinical leadership will be take centre stage. But what will it mean for pharma? Chris Ross examines the rhetoric.

Plans to review NICE and introduce value-based pricing have received a cautious welcome from the UK pharmaceutical industry in the wake of the new coalition government’s first announcements on health.

The ABPI has said it supports an assessment of NICE’s remit and the way in which it assesses value, but warned that the move towards value-based pricing faces some significant design issues.

The two proposals formed part of a series of new initiatives unveiled by the new government, design to facilitate a devolution of power and responsibility within the NHS and give patients and doctors more control in a clinically-led health service.

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, MP 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 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 the establishment of a Cancer Drugs Fund to enable patients to access the cancer drugs ‘their doctors think will help them’, an increase in the responsibilities of the Care Quality Commission, and awarding 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 which 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 to 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

Programme for Government

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. Key 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 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

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.

Reaction

Reaction to the recent announcements has been varied. The ABPI said that the UK is slow to allow patients’ access to innovative new medicines, despite having the lowest prices compare to other countries – and therefore was pleased to see the proposed review of NICE. A spokesman told Pf: “We would welcome a review of NICE, its remit and the way it assesses value, so that British patients get better outcomes and access to medicines available to patients in other countries, and the NHS spends its total budget as wisely as possible.”

Its views on value-based pricing, however, were more cautious – with its successful implementation being dependent upon collective responsibility between the industry, government and the NHS. “The ABPI strongly supports the principle that NHS patients should receive faster access to innovative new medicines. Industry needs to be accountable for demonstrating the full value of medicines, while NICE and the NHS must put in place systems commensurate with evaluating this full value,” it said. “Value-based pricing (VBP) is clearly a priority for the new coalition government, but faces some significant design issues – and we look forward to a dialogue with government on these issues. No other country has yet implemented a full VBP system and its design will be critical in order to avoid unintended consequences for patients, government, the NHS and industry alike. The current PPRS runs until 2014 and, under this scheme, the UK enjoys the lowest prices in Europe.”

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 health care 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 becomes greater accountability. Patients should be able to hold clinicians to account. It can be argued that today health care 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.”

Market access has for some years been one of pharma’s most widely used buzzphrases. But now it is one of its highest priorities. New data shows the industry know it can no longer pay lip service to the notion of market access. It can, and must, do better. Chris Ross reports.

An overwhelming majority of pharmaceutical companies across Europe have conceded the need to make improvements to their market access strategies, a new report has shown.

The Cegedim Dendrite Market Access Industry Report, based on a survey of almost 200 sales and marketing executives from across Europe, says that 88% of organisations acknowledge the need to change their approach to market access, and that 75% have earmarked resources to invest in its improvement in 2010/11.

The vast majority of pharmaceutical companies have already moved to a Key Account Management (KAM) model as they seek to align sales and marketing methodologies with the demands of the modern marketplace. This is borne out by the Cegedim Dendrite survey which shows that 83% of companies have taken the KAM approach. The poll, conducted last month, indicates that many companies believe the shift towards KAM will deliver the greatest benefit to market access strategies. But, faced with a future without blockbuster drugs and with a European-wide reduction in healthcare spending having a major impact on marketing budgets and sales operations, successful market access will require much more than a restructured field force.

According to the research, the industry has a number of current concerns. The most fundamental fear is, of course, the global economy –with 24% of survey respondents citing it as the most significant challenge facing market access. The tough economic climate has, in turn, been the catalyst for a whole raft of other concerns for pharma. Primarily, companies are worried by the growing influence of HTA bodies and the increasing shift in influence from prescribers to payers. Likewise, the fragmentation of decision-making across regional bodies with increasing influence on pricing and reimbursement locally is a further cause for concern. The developing trend towards the globalisation of pharmaceutical strategies is another major worry for market access managers; while reinforcing brand image may work at a global level, the report says that successful market access cannot be achieved in an increasingly fragmented market if organisations do not take into account that local market differences will cause problems.

A cross-functional responsibility

So how is pharma responding? Well, companies are deploying a variety of approaches (see figure 1), as indicated by the Cegedim Dendrite survey. Examination of the respondent profile (see ‘Survey Methodology’) shows that market access responsibilities now extend across the pharmaceutical organisation. Historically, market access has been considered the preserve of roles in health outcome research, but as the concept has evolved, the involvement of sales and marketing executives has grown considerably. The fact that market research, business intelligence and business development roles are also represented in the survey demonstrates the extent to which market access strategies are now a cross-organisational concern.

The evolution mirrors progress within the industry’s customer-base. The vastly expanding range of stakeholders now involved in health provision and able to influence decision-making, which includes charities and patient bodies at national level as well as pharmacists and nurse practitioners locally, has underlined the importance of market access strategies that span the entire product lifecycle. With the emphasis now so heavily focused on cost, it is becoming increasingly important to communicate with HTAs earlier in the product development lifecycle, to gain insight into a product’s marketing potential. At the other end of the product lifecycle, ongoing communication is essential since the pricing and reimbursement rates can be reset at any time, while pressure from generic prescribing is ever present.

Key Account Management

Research demonstrates that companies are embarking upon health outcome measurement in development and post-launch (61%), leveraging physician peer networks and interactions (61%) and the promotion of health and well-being over treatment of illness (43%). But the most common response has been the move to key account management. Across the industry, companies have responded to the shift from prescriber to payer and the declining influence of local clinicians by dramatically cutting their field forces and implementing smaller, more strategic sales teams. But, say Cegedim Dendrite, creating a new workforce is only the starting point. Market access teams need new skill sets and the ability to communicate with a range of individuals - from commissioners to formulary managers in regional authorities and directors of local healthcare units, as well as hospital doctors and, in some regions, primary care physicians. “These individuals expect business-led discussions about a product’s efficacy, its ability to deliver a financial return and its role in the overall care pathway,” notes the report. “In addition to new communication skills and a very different cultural approach, KAMs must be supported with excellent information that identifies the relevant stakeholders in these regional and local authority organisations.”

The most notable example of the growth of ‘payer influence’ in the UK is, of course, NICE – which has frequently led the way in European HTA. The disparate nature of European healthcare markets has so far prevented the development of a pan-European NICE, but despite regional differences, the wider market faces common health economic challenges that are driving the need for market access strategies. “"The fundamental Market Access driver for all markets is the need to demonstrate real value to the Care Pathway,” says Thibaut de Lataillade, Global Marketing VP, Cegedim Dendrite. “Even though European markets are at different levels of maturity, all of them are implementing Health Technology Assessment bodies, with a similar key driver to ensure that the cost of new treatments delivers acceptable ROI to the local Health Service."

In the UK, the rapid increase in payer influence has propelled a steady decline in the number of sales representatives targeting traditional clinicians. The new coalition government says it aims to design a ‘clinically-led NHS’ that will give power back to prescribers – but, in a marketplace constrained by considerable economic imperatives, it seems highly unlikely that the high-volume, high-frequency model of sales will ever return. Instead, the smarter, leaner KAM approach will establish itself as the norm. “Of course, there will always be a role for the ‘traditional’ primary care field force to educate and inform healthcare professionals,” says David Round, General Manager, UK, Cegedim Dendrite. “However, the current shift towards Key Account Management teams will continue and these KAM teams will rely on specific and increasingly detailed knowledge of their local health economies, as they seek to influence the key market access stakeholders."

Identifying stakeholders

While pharmaceutical companies have undoubtedly identified many of the key changes required to address a new, complex healthcare environment, the question remains as to how effective their responses have been to date. The key to success is the effective identification of market access stakeholders. According to Cegedim Dendrite’s survey, while pharma companies appear fairly happy with their ability to identify key stakeholder, only 7% strongly agree that they can identify them. This raises questions about the type and quality of information the industry gathers about its key customers. Does it support the complex, multi-dimensional market access strategies that are now required? Critically, how much information do companies collect to determine stakeholder roles within the fragmented, multi-tier regional health environment?

So what do pharma companies need to do to ensure they respond to market needs more effectively? "Based on our experience, and the detailed results of the survey, the most important thing that pharma can do is the implementation of an organisation-wide Key Account Management strategy, with a CRM tool which shares information effectively across the whole organization,” says Stefan Janssens, President EMEA, Cegedim Dendrite. “This must be built on a detailed understanding of the key drivers of the market access stakeholders that pharma seeks to influence."

The future: KAMs at the centre

Pharmaceutical companies face an even tougher marketplace across Europe in the future. A combination of the increasing influence of non-clinical stakeholders and the vagaries of the global economy means that companies face huge challenges to create and deliver effective market access strategies. Success will depend upon building strong relationships with every stakeholder across national and regional health organizations, as well as the growing number of associated stakeholders such as patient groups, charities and pharmacists. But, says Cegedim Dendrite, identification of these clinical and non-clinical stakeholders is just the beginning. Robust segmentation and targeting that reflects peer networks of influence and tailored messaging can only enable effective market access if backed up by strong communication across a highly motivated and skilled KAM teams.

Therefore, the role of the field force, as part of a cross-functional organization-wide effort, remains ever crucial. The effective consolidation of market access activities across organizations is key to supporting a drug throughout its lifecycle, from initial pricing and reimbursement decision-making, to delivering access to regional markets. As the Cegedim Dendrite report concludes: “it is those organizations that understand the new stakeholders and their networks of influence, that create the 360 degree customer view and then leverage that information to deliver innovative service that truly reflect the underlying drivers, that will create the most successful market access strategies.”

Key account managers will sit at the centre of these strategies. At present, progress is being made as companies begin to prioritise market access. But for now the industry, in the words of my fifth form geography teacher, ‘could do better.’ Sadly, I couldn’t. But you must.

For a copy of the full white paper, The Cegedim Dendrite Market Access Industry Report, visit www.cegedimdendrite.com/ma-report.

 

Survey methodology

The Cegedim Dendrite survey was based on online interviews with 194 individuals from countries across Europe. The respondent group worked for companies across the pharmaceutical sector, with 23% in organisations employing fewer than 100 people, 38% in companies with between 100-500 staff, 20% in the 500-2000 category and 19% in companies with more than 2000 employees. Respondents were executives from marketing, market access, market research and sales departments.

Research has shown that peer opinion is one of the most significant influences on doctors’ prescribing behaviour. So how can you maximise the impact of your customer meetings? Matthew Butcher investigates.

Aristotle said it first, or at least best: “Man, by nature, is a social animal.” You just have to look to the success of websites like MySpace or Facebook for proof that social networking is an integral part of our lives. And, further, that the act of socialising influences our behaviour.

Peer pressure

That holds true even for groups of people we usually think of as highly rational and data-driven – doctors. This has been known since 1954, when Herbert Menzel and Elihu Katz conducted the first major study on the impact of physicians' social networks. By examining the social process by which doctors influenced each other to adopt a new drug, tetracycline, they found that the diffusion of information was a social process. Funded by Pfizer, the study was originally intended to assess the impact of medical journal advertisements. Surprisingly, Menzel and Katz discovered that while promotional materials enabled knowledge and awareness of the drug, it was not sufficient to convince physicians to adopt the product. The more significant factor impacting a physician's prescribing rate was the subjective assessment of his or her peers.

Since then, numerous studies have confirmed Menzel and Katz's findings and further expanded the level of detail to track the specific diffusion paths by which physicians influence each other. A 2006 study conducted at the Brigham and Women's Hospital evaluated the network of influential discussions regarding women's health issues among 33 primary care physicians across four separate clinics in a six-month period. Again, the findings confirmed the impact of peer interactions, and supported the concept that efficient dissemination of information can be achieved through peer influence.

Interaction equals action

With these results in mind, how can pharmaceutical representatives optimise their communication with healthcare professionals to support their products? In rating the effectiveness of practices designed to promote behavioural change among physicians, Dr Jeremy Grimshaw conducted a meta-analysis in 1998 that evaluated 1,139 references. Grimshaw, Director of the Clinical Epidemiology Program of the Ottawa Health Research Institute and Director of the Centre for Best Practice at the University of Ottawa's Institute of Population Health, found interactive educational meetings (participation of healthcare providers in workshops that include discussion or practice) were among those consistently most effective in promoting behavioural change among health professionals. Among interventions of variable effectiveness was the use of local Key Opinion Leaders (practitioners identified by their colleagues as influential) presenting their case experiences followed by interactive discussion. And among the interventions that had little or no effect were theoretical lectures, for example.

In short, interactive educational meetings in which healthcare providers could engage in active dialogue offered greater impact than traditional instructive educational meetings with no interaction and relevance to day-to-day experience. And yet, most medical communications programs today such as audio visual lunch meetings or medical education meetings still rely on presentations in the theoretical format without interaction.

This might suggest a possible reason why such medical educational programmes are not delivering the expected results. The value of key opinion leaders is not in question; rather, it is the nature of the format in which they present. A format that allows for maximum peer-to-peer interaction and day-to-day relevance may well mean the difference between a high-influence and a low-to-moderate-influence programme.

Like attracts like

Another method of optimising the effectiveness of medical educational meetings is by choosing your audience wisely. It has been found that the dialogue between an audience of healthcare professionals who professionally resemble each other tends to provide an even greater effect than interactions between those individuals without similarity.

For example, a primary care physician may look to a professor for updated information on disease states or therapeutic choices, but a primary care physician may be influenced more readily by another primary care physician when learning best practices based on clinical experience.

“Interpersonal communication is usually more effective when there is a high degree of professional resemblance between the individual attempting to introduce the innovation and the recipient,” states Robert Sanson-Fisher in a recent report in the Medical Journal of Australia.

Therefore, the choice of delegates depends greatly on the topic of the meeting, as well as the representative’s aim of the meeting, for example, do they wish to enhance disease state knowledge, do they wish to challenge day-to-day practice, etc?

Keeping to the Code

Delegate choice must also be considered when choosing a venue to host such meetings. For example, a large number of key opinion leaders might require a hotel as it has a larger capacity, as opposed to a meeting with a small number of nurses possibly requiring a small private function room in a local restaurant. A presentation topic that is relevant to a local trust would be more likely to require a venue very local to the target audience, as opposed to a topic relevant to a national audience, which would probably require a venue in a location off a motorway, or near a train station, in a central part of the UK.

These factors must be taken into consideration at all times when organising a medical educational meeting to ensure that the venue choice is “appropriate and conducive to the main purpose of the meeting”, as stated by the PMCPA, as well as ensuring that the meeting is compliant with the ABPI Code of Practice. It is also fundamental that, in order to organise a meeting that is ABPI Compliant, the venue should not be luxurious, or recognised for its sporting facilities, for example, and a private function room must be available to ensure that no members of the public are able to hear or see the contents of the presentation.

In summary, it is clear that the era of medical education and peer-to-peer influence tactics is upon us. However, with the pressure of smaller field forces and fewer resources and stricter codes of practice, representatives need to be more innovative and targeted in their approach, and spend their time and money wisely. Evidence suggests that discussion and interaction during such medical educational meetings enhances peer influence as opposed to non-interactive presentations, and delegate choice is key.

Matthew Butcher is Managing Director of CompliantConferences.co.uk, which offers an online search engine to assist in the organisation of meetings by locating venues with private function rooms, caterers, takeaway and delivery services by postcode, as well as additional resources to help towards reducing workload when arranging a successful medical educational meeting. Visit the website or contact enquiries@compliantconferences.co.uk for more information.

Just been promoted or seeking promotion to regional management? Ama Verdi-Ashton shares the benefits of her experience in the industry to ensure you get the best start in the job.

“We are delighted to offer you the position of Area Manager….” I can still recall those words being said to me when I achieved my first manager’s position. They were words that evoked emotions of happiness, a sense of accomplishment and excitement. I also recall, however, a few days later when reality bore through my soul that I was now a bona fide manager of a real live team. I would be expected to develop business for a major pharmaceutical company on an area that currently had a £2.5 million turnover! The feeling of fear came to visit along with trepidation. The need to scream loudly would bubble at the back of my throat quite often in those days. My thoughts were always: “What should I do?” “Will this work?” “What is right?”

I wished, at the time, that there was a Manager’s Guide for our industry. Something that could direct me when I did not know something and a guide that would confirm when I got something right.

Now, years later, as I approach a major birthday, I am delighted to be writing such a guide. It is based on my experiences as a manager who built many teams successfully. I hope you find it useful and that the strategies work as well for you as they did for me.

This will be a simple, step-by-step guide for the first four harrowing, yet exciting, weeks of becoming a manager in pharma.

The right foundation

We need to first consider what the foundation of our role is and, in my opinion, there are three key plates that you need to spin. Consider these and decide the percentage of time you will spend in each. Make your foundation strong by doing your homework and be embroiled in what is on these plates.

- THE BUSINESS

· What are the sales doing on the area and individual territories?

· What are your sales targets?

· What projects are happening to drive the sales?

· What’s the business plan look like?

- YOUR PEOPLE/THE TEAM

Your people are the richest resource you have available to you to help drive sales. You will need to identify who are your high achievers, who are your ‘cash cows’, who are weakest links, who needs more support. This will take time, however, the task will be infinitely easier if you set your stall right from the start as set out in this article and be a visible and proactive boss.

- INFLUENCERS

Who are the people internally and externally that influence your business and team? In this article I have not the space to discuss external customers. For internal customers, build a relationship with them and network, network, network. This will gain you more credibility as a manager and can even lead to extra budget!

Internal influencers are:

· Product managers in Marketing

· NHS liaison personnel

· Secondary or Primary Care

· Your manager

External influencers are:

· Policy makers (for guidelines protocols)

· Key consultants, GPs, GPSIs, pharmacists

· Any other decision maker

If you ever feel lost in a mire of ‘too much to do’, self-coaching around these three key areas will usually bring clarity.

So let’s look at what we do with in those first crucial weeks.

Week 1-2

1. Contact team members individually by phone

This is an introduction to you and should be done on Day 1 or before if possible. Let the individual know how excited you are to be working with them. Offer support if needed. The outcome of this call should be an individual business meeting booked in week two and to let them know about the first area meeting you will be organising.

1. Contact internal influencers

Mobilising the internal influencers for your business is key to success. Regular contact with, for example, your NHS liaison person, will give lots of benefits for the business. Spread that net wide to find these key people. The outcome of this call should be an appointment to see them with an agenda agreed as to what you will discuss.

1. Organise your first area meeting and send out date

I urge you to refer to my previous article about Area Meetings to help you make the most of this important resource.

Week 2 – 3

You will now begin to have the meetings you have planned. Here is a suggested agenda for meeting with your representative:

• Complete a coaching contract. This is where you lay out what is important to you on a daily basis, e.g. you might hate it when people are late and you expect them to be on time, you might only like people to ring you before 6pm and not after. The representative may like forms filled at the end of the field visit not at lunch time, they may prefer you to remain quiet in calls, for example. It includes anything you both deem important to ensure your relationship is on sturdy ground right from the start and can be reviewed as often as you wish.
• Talk about their take on their business and customers.
• Talk about their last appraisal.
• Talk about their career aspirations and how you will help them.
• Engage them personally. Remember they work for YOU, you are the company to them, and so getting to know and understand them will always help.

You should also start field visiting with the team. If they see that you are positive and enthusiastic, that is exactly what they will be. Your organisation will probably have its own guidelines on what to do and how to behave on field visits, but the most important thing is to keep upbeat and enthusiastic. You want to leave the representative feeling energised to go out the next day and perform for you and for them to look forward to future field visits. Keep the feedback objective and not subjective.

Here is a suggested agenda for a meeting with your internal customers:

• The Business on the Area including customers
• Their business plan
• Successes
• Contract how you will work with them
• Establish what they need from you and your team to help drive success
• Always invite them to future business meetings, as they are imperative to you hitting your sales target.

Week 4

It is time to hold your first area meeting. You will need to cover the following:

Sales summary

• Research your sales. Complete a SWOT analysis with the team to better understand what is going on.
• Where are you now? Graph the data, as a region, territory and per individual area. Graph the competitors, talk about potential for the area.
• Graph the targets for the year. Breakdown to quarters and even down to individuals. Asking a representative to achieve a yearly target of £200,000 is a lot more daunting than breaking it down to 12 scripts a week, for example.
• Use the graphs to coach the group based on the good performance of individuals, share best practice etc.

Activity report

• Research your face-to-face calls. What is the team achieving for meetings and contact rates? What do you need the team to achieve? Graph the data.
• Again, coach and brainstorm around individual performances to help leverage the best practice that will drive sales.

Create a vision

• Creating a team vision together helps establish a framework for significant strategic success.
• Please see my previous article on Area Meetings on how to create a vision with your team (or contact me via Facebook).

Expectations

• Here is where you can begin the contracting process by sharing your expectations with your new team, for example, that you expect a fair day’s work for a fair day’s pay.
• You could also use this session to talk about field visits and what you expect from them.
• Always let the team know what they will get in return for honoring your expectations. For example, you will be an ambassador for them and their careers, selling them just as hard as they are selling the products for you.
• Give them an opportunity to voice their expectations of you as their new boss.

At the end of week four, take stock and contemplate what you have done so far. What went well, what needs readjustment?

Table: Your first four weeks’ actions

TIME	ACTION
WEEK 1	Contact all representatives individually
	Contact internal influencers and make appointments to see them
	Ensure you have individual meetings set up with team members
WEEK 2	Organise area meeting for week 4
	Understand your business by sales, success factors, activity and projects
	Practice how will create a vision with your team
	Write your 'Expectations' slide for your area meeting
WEEKS 3	Hold individual meetings with representatives
	Hold individual meetings with internal influencers
	Start field visiting
WEEK 4	As above
	Hold your first area meeting for the team
	Review your first four weeks

Tips for the future

1. Understand your team better by carrying out Belbin, which highlights the strengths of each individual. This will help you delegate tasks to your team members that are right for their natural style and ability.
2. Hold regular team meetings or ‘buzz sessions’. For example, if the team activity is sliding, a quick ‘buzz session’ for a couple of hours may be all that is needed to re-motivate them or find out what the issues are.
3. Take a leaf out of Management Consultant Tom Peters’ fantastic book In Search of Excellence’ where he shares with us a technique known as ‘management by walking about’, which was popularised by Tom Peters and Robert Waterman in the early 1980s because it was felt that managers were becoming isolated. At Hewlett-Packard, where the approach was practiced from 1973, executives were encouraged to know their people, understand their work and make themselves more visible and accessible. Management by walking around emphasises the importance of interpersonal contact, open appreciation and recognition. It is one of the most important ways to build civility and performance in the workplace.

In short, spend time with your richest resource – your team, and your sales and your activity will be superhuman! Most of all, enjoy yourself, inspire your team, and have fun in this most vital and wonderfully rewarding role. Good Luck!