The NHS Alliance and the National Association of Primary Care (NAPC) have joined forces to create an independent body representing Clinical Commissioning Groups (CCGs).

The coalition will be the collective voice for practising clinicians, CCGs and their leaders to ensure that commissioning bodies are fully involved with the new NHS.

Dr Johnny Marshall, Chairman of NAPC, said: “We are seeing many obstacles, from all quarters of the NHS and elsewhere, being placed to deter and restrain the successful engagement and operation of CCGs.”

Dr Michael Dixon, Chairman of the NHS Alliance, commented: “We will listen to and represent CCGs’ views and concerns without compromise, wherever and whenever necessary. We will be a united voice that will serve to balance the top heavy approach often seen in the NHS.

“As the two organisations that have wholeheartedly championed clinical commissioning over the last two decades, we have a long history of commitment and dedication to the clinical commissioning cause.”

The coalition has agreed a number of shared principles. They include:

• NHS commissioning should be a public function exercised by statutory bodies in the public sector alone. NHS commissioners should be free to choose the support they need from whatever source they feel to be appropriate.
• The NHS should be based on an approach that maximises local responsibility and ownership through local determination rather than central direction, meaning that the NHS Commissioning Board should only take responsibility for things that must be done at national level.
• CCG Boards should have GPs as majority members with a strong primary care focus.  Boards will need to ensure the appropriate involvement of other clinicians and managers and have strong representation from local communities and independent directors.
• NHS provision should be appropriately distributed across the public, third and independent sectors according to the public interest. Those providing NHS services should clearly subscribe to NHS values of openness, transparency and accountability and behave in a manner consistent with those values.
• The NHS should develop integrated care, centred on the needs of the patient rather than the providing organisations, supported by appropriate payment systems.

The coalition has also established a number of priorities it sees as essential. They include:

• To lobby the Government to review the role of the NHS Commissioning Board to ensure that it is set up as an organisation that enables rather than controls CCGs’ work.
• CCGs’ self-determination – Clinical Senates, Clinical Networks, and Local Health and Wellbeing Boards should help not hinder CCGs, who must have the final decision with their patients. 
• Work with the Government to ensure that aspiring CCGs receive the funds intended to support their development.
• Oppose suggestions that CCGs should be constrained in their choice of commissioning support.
• Monitor and CQC to demonstrate that they are acting in the public interest. The coalition will seek to ensure that CCGs have the means of challenging their decisions.
• Transparency - the coalition believes that the payment of any quality premium to reward CCGs which commission effectively should be transparent, represent good value for money and be in the public interest. 

Both forces will contribute to and have ownership of the new initiative, whilst acting as individual identities regarding other functions.

Dr Johnny Marshall added: “Our respective organisations bring their particular strengths to the table to enable us to be bigger than the sum of our parts.

“The strength of our two organisations working in partnership on the same agenda should reassure Clinical Commissioning Groups of our commitment to their cause and that of their patients.

“We will strive to ensure that CCGs are not overburdened with NHS bureaucracy and red tape and are set free to deliver innovative and population focused services.”

A steering group is advancing the coalition's collaborative work.

GSK and the McLaren Group have entered into a long term strategic partnership until at least 2016.

The McLaren Group will share its knowledge in engineering, technology, analytics, and strategic modelling to help improve performance across GSK’s global divisions.

Ron Dennis, Executive Chairman, McLaren Group and McLaren Automotive, says the partnership “engages two great British companies” in a “multi-faceted and ground-breaking way”.

A new state-of-the-art learning facility will also be built as part of the agreement at McLaren’s Headquarters in Woking by 2013.

The partnership will initially focus on GSK’s manufacturing, research and development and consumer healthcare divisions.

Glaxo will evaluate whether it can use McLaren’s engineering and technical expertise to its own manufacturing processes. It’s believed that McLaren’s approach, technology and processes it applies to its Formula 1 team could lead to improvement in GSK’s production line performance and improve cost and customer service.

The pharma company’s R&D organisation is also examining whether McLaren’s expertise and technology could improve their own clinical research processes by increasing the speed of trial design, and allowing for real time patient monitoring and treatment adjustment.

Also its Consumer Healthcare business will work alongside McLaren’s Formula 1 unit which analyses team performance during a Grand Prix to enable GSK to respond quicker to competitor activity and customer needs, and inform decision making on various issues. Analytical and performance management tools developed and used by the Group will also be utilised to improve GSK’s ability to come to faster decisions around longer term investments.

Andrew Witty, GSK, CEO, says the partnership highlights the company’s innovative thinking which continues to look for “inspiration and fresh perspective” from outside the sector on how to achieve its strategic goals.

“I am delighted to announce this partnership with McLaren which brings together two British companies whose continued success hinges on the ability to innovate and rapidly respond to change and competitor activity,” said Mr Witty. “McLaren has an unparalleled reputation for innovation built on rigorous analytics and fast decision making.”

McLaren boss Ron Dennis says the agreement is the first between the Group and a major pharmaceutical corporation. “Specifically, our intention is that GSK will harness McLaren’s world-beating Formula 1-bred technology, processes and operational dynamism, in order to enhance its performance across a wide variety of its divisions in a way that none of its competitors can match,” he added.

The global market for telehealth services will pass $1 billion by 2016, a new business report has claimed.

In the 2011 edition of its report The World Market for Telehealth, medical electronics market research group InMedica forecasts that the telehealth market could reach $6 billion by 2020.

The report highlights the growing use of home monitoring systems to monitor vital signs, improving the control of long-term conditions such as diabetes, heart failure and COPD.

The leading market for telehealth systems is the US, the report notes, but there have been some large-scale trials in Europe – most notably in the UK, where more than 2,000 patients have received telehealth services.

“Many public healthcare systems now have targets to reduce both the number of hospital visits and the length of stay in hospital,” said Diane Wilkinson, Research Manager at InMedica. “This has led to a growing trend for healthcare to be managed outside the traditional hospital environment, and as a result, there is a growing trend for patients to be monitored in their home environment using telehealth technologies.

“What is apparent is the convergence of many different industries in this space, including telehealth companies, device manufacturers, healthcare agencies, service providers and telecommunication companies.”

The World Market for Telehealth – a Quantitative Market Assessment, 2011 Edition” provides an overview of the global telehealth market, analysing the sector’s business models, technologies, peripheral devices, major suppliers and market drivers/inhibitors.

InMedica is the medical research group of IMS Research, a leading supplier of market research and consultancy to the electronics industry.

The revised Health and Social Care Bill remains contentious, but appears likely to pass into legislation. Simone Carron-Peters of Frost & Sullivan analyses its probable impact on the UK healthcare market.

The Government’s contentious Health and Social Care Bill has raised many concerns among the various stakeholders. The eight-week NHS listening exercise conducted by the NHS Future Forum has resulted in the proposal of multiple changes to the Bill, whose passage towards legislation is summarised in Figure 1 below.

This article evaluates the planned NHS reforms for impact on the health system and the life science industry.

Overview of the Bill

The Health and Social Care Bill proposes to create an independent NHS Board, promote patient choice and reduce NHS administration costs.
Its key focus areas are:

• To establish an independent NHS Board to allocate resources and provide commissioning guidance.
• To increase GPs’ powers to commission services on behalf of their patients.
• To strengthen the role of the Care Quality Commission.
• To develop Monitor, the body that currently regulates NHS Foundation Trusts, into an economic regulator to oversee aspects of access and competition in the NHS.
• To reduce the number of health bodies, including abolishing PCTs and SHAs, in order to help the Government cut NHS administration costs by one-third.

More power (and money) to the GPs

In its initial form, the reform aimed to improve the quality of service delivery by devolving NHS commissioning powers and responsibility into the hands of GPs. The GP consortia would receive budgetary allocations from the new NHS Commissioning Board, which would be responsible for managing and allocating about £80 billion of the health budget. The consortia would, in turn, devolve the funds to the various practices under them.

The new GP consortia would replace the 302 PCTs in England, which would be abolished by 2013. All NHS trusts were set to become Foundation Trusts by April 2014. It was anticipated that the consortia would require significant assistance, including support from the private sector, in exercising these new commissioning functions.

Medical organisations and NHS trusts were immediately sceptical about the implementation of this reform, saying that the changes could have negative effects on NHS services. Some trusts argued that it is risky to reduce the central grip on commissioning at a time where urgent savings are being made. Others agreed that GPs are well positioned to make decisions on the use of resources for their patients.

The BMA: a critical response

The reform plans have also not gone down well with the British Medical Association (BMA), who expressed concerns about the level of responsibility being bestowed on GPs. One of the BMA’s major concerns was the lack of clarity in the Bill with regard to the roles that the GP consortia would be expected to perform. The BMA also believes that it is important to ensure the funding for GP practices remains distinct from other budgets, as it would cause significant complications if GP consortia were to be made responsible for amalgamated budgets that included the management of standard GP contracts.

Currently there are about 177 GP ‘pathfinders’ (pilot groups of GPs testing the system’s concepts and functions) who are taking the lead in implementing the new commissioning roles.

In May 2011, the BMA’s Health Policy and Research unit conducted a national survey of GP opinion that received a response rate of 39%. The survey findings revealed an alarming 55.8% of the respondents citing NHS reforms as a reason for their intention to retire in the next two years. That figure was composed of 59.4% of the 688 principal or contracted GPs, 41.1% of the 30 employed salaried GPs and 35.8% of the 39 freelance GPs who participated in the survey.

The survey also asked GPs how confident they were that the GP commissioning consortia would be appropriately skilled and supported. 65.6% were ‘not confident’ that the consortia would be appropriately skilled, while only 15.8% were ‘confident’ that they would be. In addition, 70.9% of the respondents stated that they were ‘not confident’ that the consortia would be supported, while just 10.2% were ‘confident’ that they would be.

Amendments to the Bill

Based on the recommendations of the NHS Future Forum, the Health Secretary announced changes to the Health and Social Care Bill in June 2011. The Bill is due for its third reading on the 6th and 7th September 2011.

The role and functions of GP consortia are now better-defined. The consortia – now called Clinical Commissioning Groups (CCGs) – would be required to publish details on their constitution and how the allocated budgets have been used. They would also be required to follow guidelines from, and be accountable, to the NHS Commissioning Board. GPs are also bestowed with a responsibility to promote research and innovation.

The plan for all NHS trusts to become Foundation Trusts by April 2014 has been amended. NHS trusts would become Foundation Trusts by 2016, based on their clinical readiness for transition. They would be given the liberty to make use of private health treatments, and would compete among themselves for patients.

The role of the National Institute for Health and Clinical Effectiveness (NICE) would increasingly focus on giving authoritative advice to clinicians on when and how the most effective treatments can best be used, and also on the development of quality standards for the NHS to aim for in the treatment of certain conditions.

Value-based pricing (VBP) would replace the Pharmaceutical Price Regulation Scheme (PPRS), which has existed since 1957. The purpose of VBP is to improve NHS patients’ and clinicians’ access to effective and innovative drugs and medical technologies by ensuring they are available at a price that reflects their value, based on an assessment of the outcomes they can achieve.

Impact assessment of the health reforms

The implementation of the Health and Social Care Bill will witness an increase in private sector and voluntary involvement in the delivery of healthcare. GP commissioning will allow the use of private healthcare for NHS patients. Healthcare vendors and providers can capitalise on this shift by offering products and services best suited to patients’ needs in order to influence GP commissioning.

The aim of value-based pricing is not to achieve the lowest price possible, but to encourage the development of new therapies and promote innovation. The principle of linking the price of innovations to their value has already received support from a broad range of stakeholders.

The priorities of the health reforms are ambitious; if instituted, they will have far-reaching effects on the way the British public accesses the health system. It will also affect the role of the private sector in the UK healthcare system, increasing opportunities for private providers of both clinical and support services to become involved in providing healthcare to NHS patients.

According to the Government’s calculations, the reforms will bring about a huge cost saving for the NHS. However, negative consequences such as redundancy for administrative staff in the health authorities will pose a huge socio-economic threat.

How will the savings affect the prospects for innovative medical technologies? The adoption of such products has always been necessary for medical professionals, predominantly because new technology aims to provide healthcare at a quicker rate – minimally invasive technologies being a major example. The Government has vowed to ensure the system delivers effective and appropriate healthcare to all who need it. Moreover, GPs have a greater understanding of patients’ needs than the managers or PCTs who at present make funding decisions. Thus the demand for innovative devices will arise regardless of the allocated NHS budgets.

One of the main objectives of the reforms is to put patients and public first by implementing a ‘no decision about me without me’ policy. National standards and independent inspection will continue to assure patients that all NHS-funded services are safe and of a high quality. Patients will have much more information about individual services and their performance, enabling them to choose the services that best meet their needs.

The reforms will ensure that services are easier to access and more responsive. Shorter patient waiting times, one-stop clinics for diagnostics, and increased provision of healthcare in patients’ homes are some examples of services that are likely to develop in response to new incentives. Patients will be able to gain access to healthcare in new ways that are more flexible. This is likely to mean more services delivered in local communities, such as urgent, preventative and rehabilitative care, thus helping to avoid unnecessary hospital admissions. Better information will help patients to understand and make the best use of the options available.

The reforms will also support services to become more integrated. Improved information systems will play a key role, enabling healthcare providers to exchange clinical data more easily and so gain a complete view of the patient’s condition. Increasingly, there will be opportunities for patients to influence the pattern of services within their locality. Local practices will have incentives to provide locally-based health improvement and health protection services. Patients will be in a better position to manage their own health.

Financial goals

The Government is confident that the health reforms will allow it to save billions. Figures from the Impact Assessment published alongside the Health and Social Care Bill earlier this year claim that the structural reforms to the NHS will save £5 billion per year, though this is a gross rather than net figure. The Bill promises to reduce NHS administrative costs while promoting patient choice. However, time alone will tell whether these reforms prove to be economic.

 

Simone Carron-Peters is a Research Analyst for growth consultants Frost & Sullivan.

The FDA has approved Lupin Pharmaceutical’s generic version of UCB’s Keppra XR tablets for the treatment of epilepsy in patients aged 16.

The levetiracetam drug is indicated for adjunctive therapy to treat partial onset seizures following final approval from the FDA for its abbreviated new drug application (ANDA) to market the treatment option in the US.

The 500mg and 750mg extended release tablets are the AB-rated generic equivalent of Keppra XR.

Lupin Ltd said in a statement that commercial shipments of the product have now commenced.

Keppra’s annual sales were estimated at $161 million for a twelve month period ending in June 2011, based on IMS Health sales data.

The India-based pharmaceutical company produces a range of generic and branded formulation and APIs for distribution worldwide, involving market shares in cardiovasculars, diabetology, asthma, paediatrics and anti-infectives.

A monitoring technology used in hospitals has helped the GB Rowing Team to train for the current World Championships in Bled, Slovenia.

As the team’s High Performance Partner, Siemens Healthcare has provided them with a RAPIDPoint 350 Blood Gas analyser (pictured), which helps to monitor the athletes’ adaption to intense training.

By monitoring their blood gases, the team can identify any imbalance that might lead to loss of breath or development of a stitch.

The RAPIDPoint analyser is small, lightweight (less than 8kg) and easy to use in a wide range of environments. It delivers results in just 2 minutes.

David Tanner CBE, the GB Rowing Team’s International Manager, commented: “The use of the Siemens RAPIDPoint 350 is a very good example of the partnership between Siemens and the GB Rowing Team. There is no question that this has helped the GB Rowing Team to improve performance on the water.”

According to Chief Coach Paul Thompson, “Using this analyser allows coaches and support staff better to monitor, direct and individualise the rowers’ programme to maximise the training effect and their race readiness.”

Helen Glover, World Cup winner 2011, offered a user’s view: “The testing involved with the RAPIDPoint 350 is painless and non-invasive. The results have been very helpful to me in understanding how my body reacts to intense periods of training.”

“Our RAPIDLab300 is a small, low-maintenance and easy-to-use system, making it ideal for hospital critical care environment and a huge range of other testing environments, including sport,” said Afia Boamah, Blood Gas and Stratus CS Product Manager at Siemens Healthcare Diagnostics.

A new technology that relieves the symptoms of chronic migraine by sending electrical pulses to the occipital nerves has received CE Mark approval.

The Genesis neurostimulation system from US company St. Jude Medical is the first such device to be approved for the treatment of intractable chronic migraine (ICM) in the EU.

The approval means that ICM sufferers in Europe will gain a proven alternative option for management of a painful and disabling condition.

ICM is defined as headache lasting at least 4 hours per day for at least 15 days per month, causing at least moderate disability and not responding to 3 or more preventative drugs.

The new system delivers peripheral nerve stimulation (PNS) of the occipital nerves in the back of the head, using small electrical leads placed under the skin.

The CE Mark approval was supported by the findings of a study of 157 chronic migraine sufferers carried out by St. Jude Medical. At 12 weeks, the active group (using Genesis) reported an average of seven fewer headache days a month, compared to one day fewer in the control group. The active group showed a 41% improvement in disability, compared to a 13% improvement in the control group.

Dr. Stephen D. Silberstein, Director of the Jefferson Headache Center and principal investigator in the clinical trial, said: “Through my participation in this study, I have observed the life-changing potential this therapy offers chronic migraine patients.”

According to Headache UK, over 5 million people in the UK suffer from chronic migraine, with women more than twice as likely to suffer from it as men. The cost of the condition, including lost working days, had been estimated at £2.25 billion per year in the UK.

St. Jude Medical’s neurostimulation systems for treatment of chronic pain have been used with more than 75,000 patients worldwide.

ViroPharma’s Buccolam has been specifically licensed for infants, children and adolescents to treat severe convulsions and epileptic seizures in Europe.

It is the first children’s medicine to be granted the Paediatric Use Marketing Authorisation (PUMA), delivering an age-specific dose in the right form for the child.

Dr June Raine, Director of Vigilance and Risk Management of Medicines, MHRA, said: “They are not simply ‘small adults’ and they respond differently to medication”.

The midazolam and oromucosal solution comes in a pre-filled syringe indicated for patients aged three months to 18 years of age.

The dose is administered via the cavity between the cheek and gum, a less invasive method than its current treatment option, which is rectally-administered diazepam.

The marketing authorisation is based on data gathered from four clinical trials testing Buccolam against diazepam, where Buccolam proved to be either comparable to, or better than the existing treatment.

“Children should have access to medicines that have been especially designed for them,” added Dr Raine.

The medicine previously received a positive opinion in June from the Committee for the Medicinal Products for Human Use (CHMP) and will now be available across the EU as well as Norway, Iceland and Liechtenstein.

Thierry Darcis, Vice President and General Manager of ViroPharma Europe, said: “We look forward to working closely with physicians across Europe as we launch Buccolam into the European markets”.

The marketing authorisation for Zytiga (abiraterone acetate) has been approved by the European Commission after an accelerated regulatory review process by the EMA.

The androgen biosynthesis inhibitor has been approved for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) whose disease has progressed.

Professor Karim Fizazi, Department of Cancer Medicine, Institute Gustave Roussy, France, says its approval “gives new hope to men” suffering from the disease across Europe.

The fast-track review by the EMA followed a positive opinion by the CHMP in July.

Zytiga demonstrated in a pivotal Phase III study a 35.4% reduction in the risk of death and an improvement of almost four months in median overall survival.

“The efficacy, safety and ease of use of abiraterone acetate, a medicine that can be taken at home, will address an important unmet medical need for many patients, helping them to live longer with a better quality of life and less pain,” added Professor Fizazi.

Prostate is the third most common cause of cancer deaths in Europe. An estimated 370,000 new cases were diagnosed across Europe, resulting in the deaths of nearly £90,000 men.

Ernest Waaser, new CEO of global wound care company Systagenix, talks to Medtech Business about the importance of helping clinicians to address the challenge of wound healing across a range of care environments.

Ernest Waaser is the recently appointed CEO of wound care company Systagenix, based in the UK. Formed in 2008 through a buyout of Johnson & Johnson’s advanced wound care business, Systagenix supplies wound dressings to over 100 countries. The recent launch of its ‘Let’s Heal’ brand shows the company addressing the wound management and healing process proactively across primary, secondary and home-based care environments.

What prompted the launch of Systagenix in 2008: what opportunity did the company’s founders identify?
When our investors looked at the business back in 2008 they saw a strong existing business that, with the right focus and strategic investments, had a terrific opportunity to grow. The business had a 75-year heritage, a world-class R&D capability, and a strong reputation in wound care – a clinical area that’s continuing to grow with the ageing population and the increase in diabetes and obesity. It was part of a very large diversified company where it had to fight for investment and resources against other businesses. So by creating a stand-alone company that’s solely focused on wound care, we can be much more responsive to the needs of the market, make those strategic investments and bring real innovation to the world of wound care.

What is the thinking behind the ‘Let’s Heal’ brand?
What has it achieved for the company and for the industry? There are two basic beliefs behind the brand. First, we believe passionately that the goal is wound healing, not wound management. And in today’s practice, too often companies focus on managing individual symptoms in isolation from each other, rather than tackling the whole wound healing process as a continuum. Second, we recognise that there’s no single product or device that will heal every wound. Each patient and each wound is different, and there may be many reasons why a wound is not healing: the patient may have an infection or a high protease level, or a venous insufficiency, or any one of several other underlying illnesses or complications.

So our objective is to take a more holistic approach, to put a system in place, starting with diagnostic tools and leading on to the proper treatment for that wound in that patient. ‘Let’s Heal’ is our approach to providing a range of treatment options and a systematic approach to when to use each product. The huge innovation here is to start that whole process with point of care diagnostics that will provide immediate feedback on the status of the wound, which the clinician then uses to help select the appropriate treatment. ‘Let’s Test’ is our Systagenix umbrella for future wound diagnostics and assessment products, and that’s the entry point for our overall system of care.

Systagenix has particularly focused on treating hard to heal acute and chronic wounds. How are you trying to change the way these wounds are perceived?
The first perception we’re trying to change is that some patients must live with a wound. Our objective is that every wound should be healed, and we think every patient deserves that. Managing life with a wound is not in our vocabulary.

The second thing we’re trying to bring visibility to is that hard to heal wounds are not only affecting the patient’s quality of life, but are very expensive for the healthcare system. In many countries wound care is done partly in hospital, partly in an outpatient setting and partly at home, so the costs are spread around and the total cost tends not to be visible to healthcare administrators. The product that’s used to treat the wound is a small part of the cost: there’s hospitalisation, physician time, multiple home nurse visits, and the very real cost of complications ranging from infections to amputation.

There haven’t been many large-scale economic studies, but the evidence is pretty clear that the faster you get a wound healed, the lower the overall cost to the health system. That really is the focus of our ‘Let’s Heal’ approach: to eliminate trial and error, using point of care diagnostics to get the right treatment started immediately and shorten the overall healing time and cost.

How does that strategy work at the sales and marketing level?
Wound care is a clinical process that is spread not only across different care settings –  hospital, home, clinic – but also across a number of clinical specialties that treat wounds: vascular surgeons, podiatrists, general surgeons and others. One leading international clinician told me that wound care is a team sport. So part of what we do from a sales and marketing point of view is to try and bring these various clinical specialties and different types of clinicians together, to take a look at how the overall care process can be improved.

For example, we recently brought an international group of key opinion leaders together who issued an international consensus document on the use of a diagnostic in wound care to detect high protease levels, which are a known inhibitor to wound healing. They are putting the ground work in place to establish the need for that diagnostic test and determine how it should be used in clinical practice. This element of bringing the clinical community together to look holistically at how we can help them and provide them with the right tools to diagnose and heal wounds is an important part of the marketing effort for us.

How are current changes in the NHS landscape affecting the UK market for wound care companies?
We really haven’t seen the major impacts just yet. Obviously the NHS will be incredibly focused on delivering high-quality care at the lowest possible cost. I think our challenge as a sector is to demonstrate very clearly that our products and services can materially lower the cost of wound care: faster healing, fewer visits and fewer complications. I think as we go forward and the landscape continues to change, we’ll monitor that carefully and adjust as we need to.

What are the major business challenges facing UK wound care companies seeking to export to global markets?
I’d point out three challenges. The first is regulatory. Our products are covered under medical device and/or pharmaceutical regulations in every country they’re sold in, and once you get outside the EU they’re all different. The second is reimbursement. Just because you have regulatory approval doesn’t necessarily mean you can get paid for the product. The reimbursement systems are different in literally every country in the word. So those two issues, regulatory and reimbursement, require the combination of a fairly sophisticated infrastructure with the right skills and expertise and good local partners in your export markets. And finally, you really have to tailor your offering to local needs, taking into account local clinical practice and pricing expectations.

What do wound care companies need to do to address the clinical and commercial challenges of healthcare in the 21st century?
21st-century healthcare is all about finding more cost-effective ways to deliver high-quality care to a growing population of patients. As an industry we need to help clinicians in wound care get the right treatment to the right patient quickly and avoid much of the costly trial and error process that exists today. That requires thinking about innovation in a different way, looking not only at your product but at the overall process for treating a patient.