Eucomed leader receives IVEC award

by emma 7. November 2011 12:19

John Wilkinson

John Wilkinson (pictured), Chief Executive of Eucomed, has received a special Career award from the International Vascular and Endovascular Course (IVEC) in Milan.

The award recognises the medtech industry’s contribution to the development of vascular and endovascular surgery.

IVEC Chairman Giorgio Biasi presented the award to John Wilkinson to “honour the excellence of a distinguished scientist and eminent colleague who has contributed enormously in promoting, divulging and spreading culture, development and achievements in the field of vascular and endovascular techniques.”

Following the award presentation, Wilkinson gave the Edmondo Malan Lecture on ‘Development and Achievements in Endovascular Procedures as a Result of a Continuous and Ingenious Co-operation between Physicians and Industry’.

He discussed the long history of collaborative working between clinicians and industry over 200 years, with ideas from doctors and surgeons being developed by companies, culminating in such revolutionary devices as the drug-eluting stent.

Wilkinson also emphasised the need for innovation to be built on a platform of ethical interaction and transparency, and for industry to support education and training in the delivery of new therapies.

Finally, he drew attention to the demographic and economic challenges facing Europe’s health systems, and called for a collaborative approach between all stakeholders to support innovative solutions to these urgent problems.

Eucomed is the leading European medical technology industry association. It represents 4,500 designers, manufacturers and suppliers of medical technologies.

Safe injection system wins Made in Wales Award

by emma 21. October 2011 14:50

Hall Lock system

A medical device that helps to prevent wrong-route injections has won the Medical and Life Sciences Award at the first ever Made in Wales Awards in Cardiff.

The Hall Lock system (pictured) from Flexicare Medical, developed in partnership with clinicians at Cardiff University, is a series of connectors designed to reduce the risk of potentially lethal misconnections.

The system was developed in response to the increasing number of fatalities due to wrong-route injections of intravenous drugs and anaesthetics.

The cross-sectional shapes of the Hall Lock connectors are not compatible with each other or with a standard luer connector, presenting a mechanical obstacle to misconnection.

Hash Poormand, Flexicare’s Business Development Director, commented: “The Hall Lock System is a truly Welsh idea inspired by Cardiff University Hospital and designed by Flexicare in Wales.

“We are proud to be at the forefront of shaping the future of patient safety. This award recognises that innovation can be taken from concept to market with all the expertise required right in the heart of Wales.”

In a keynote speech at the Made in Wales Awards, Cheryl Gillan, Secretary of State for Wales, said: “The innovation recognised at the awards today is inspiring and I want to congratulate each and every winner: they are first-class examples of how Wales can contribute to new technologies and private sector growth.

“SMEs in Wales have a critical role to play in supporting the economy in Wales and I am clear that the UK Government is here to provide support to help companies succeed.”

Based in Mountain Ash, Flexicare Medical manufactures medical devices across a range of product areas including anaesthesia, critical care, breathing systems, suction, resuscitation, continence care and colostomy.

Vernacare highlights innovation through teamwork

by emma 14. October 2011 13:00

Karen Haslam and Maria Sinfield with Queens Award

Bolton-based medical consumables company Vernacare has emphasised the importance of teamwork and partnership for their development of the world’s first pulp wash bowl, which won a Queen’s Award for Enterprise 2011.

The Vernacare wash bowl (pictured) is used by hospitals in more than 270 NHS Trusts and across the globe for patient care, wound and continence care, hand washing and surface cleaning.

In a study reported in the BMJ, Vernacare’s wash bowls were among a package of measures that led to a 50% fall in cases of C. difficile at Salford Royal NHS Foundation Trust over 12 months.

Karen Haslam, Chief Executive of Vernacare (pictured, left), praised the company’s team and the clinicians who had helped them to develop and trial the product. “We developed our single-use wash bowl in response to customer demand,” she said. “Nurses told us they were concerned that re-using plastic wash bowls without properly cleaning and drying was a significant infection risk.

Vernacare’s previous pulp products were permeable to warm soapy water, she added. “This was a major challenge that took our in-house team two years of painstaking research and trial and error to overcome.”

Heather Dakin, Senior Nurse Infection Control at Colchester Hospital, said of the product: “Nursing staff found that they had more time for patient care and didn’t have to worry about decontaminating plastic bowls. They also found that wards looked much tidier as the pulp can be stacked on racking provided by Vernacare rather than hanging from lockers or beds collecting dust.”

Vernacare provides single-use pulp products for patient waste management and a macerator for disposal. The products are used in over 90% of UK hospitals and more than 50 countries.

The photo shows Karen Haslam and Maria Sinfield of Royal Bolton Hospital with the Queen’s Award.

Blood gas analyser for POC diagnosis

by emma 10. October 2011 11:41

Siemens Rapid Point 500

A new point-of-care analyser for blood gases and other solutes, launched worldwide, promises quicker and easier diagnosis in the critical care environment.

The RAPIDPoint 500 Blood Gas System (pictured) from Siemens Healthcare Diagnostics delivers reliable results in 60 seconds and allows rapid identification of the patient and operator.

The new system aims to meet the growing demand for POC blood tests that can be used rapidly and easily by a wide range of clinicians.

The RAPIDPoint 500 analyser has a cartridge that lasts up to 28 days, with a full complement of critical-care tests for blood gases, pH, electrolytes, glucose and lactate-1, as well as full CO-oximetry, from a single whole-blood sample.

Features to enhance ease of use include:

  • fully automated calibration and quality control
  • a self-contained Automatic Quality Control cartridge that operates without manual intervention
  • an integrated bar code reader with a wide scanning area for patient and operator identification.

The new medical device can be integrated with the Siemens RAPIDComm Data Management System to enable centralised management of multiple Siemens blood and urine analysers in critical care monitoring.

“The RAPIDPoint 500 system is designed to satisfy the unique demands of testing at the point of care,” said Dr. David Stein, CEO, Point of Care Business Unit, Siemens Healthcare Diagnostics.

“In addition to being easy to use, the analyser leverages proven and reliable cartridge-based technologies to deliver fast, accurate, laboratory-quality results, helping clinicians feel confident in making critical decisions.”

Diary of a self-confessed NHS budget-holder

by emma 29. September 2011 15:21

diary budget holder

How well do you understand the various priorities of a key element of your customer-base: the payer? Omar Ali pens Part II of a typical day in the life of a Formulary Pharmacist.

10AM : GP REFUSED PRESCRIBING OF A PAIN DRUG/ACTION ASAP
OK, we have been here before – this product is non-formulary. It has never been applied for. The GP is well within rights to refuse prescribing. The consultant knows it is non-formulary and has ‘requested’ via a letter – actually stating it is non-formulary, so would the GP kindly prescribe it.

The GP is irate, and the patient is now confused and unhappy: “why wont you prescribe what the expert/consultant has asked for?” There is a stalemate. Not a great scenario – this call is backed up with emails going back with two PCT advisers, a commissioner, a GP and a pain nurse. This will mean going to see the consultant and being firm: these are the rules of engagement, this is the financial framework, this is how I can help you manage your patient.

Thoughts for pharma

We call this ‘lockdown’. It’s a process by which redundancy is built into the formulary processes to ensure compliance, limited loopholes and consequential policing. What’s crazy is I know the brand, and I know the rep. Every month she asks: “when is the next D&T?” I tell her – and nothing happens. Next month, she asks again. So what’s happening?

The representative knows she needs a consultant to bring her brand to the D&T but can’t/won’t affect it. The representative then considers ways around the D&T; KOL to find loopholes, write to the GP, prescribe on FP10(HP), do a non-formulary request, try IFR, etc. In fact, exhaust all opportunities except the one that is needed: D&T approval.

Sometimes the pharma company has a brand philosophy which doesn’t press the right buttons: they have representatives calling the wrong people, the quality of the representative is not good enough, the seniority/decision-making-abilities are lacking.

This ‘lockdown’ effect will usually mean that the company goes round in circles. It focuses on new materials and a wonderfully articulated campaign – usually around ‘Edith’, a 50-year-old patient who is suffering from constipation and can’t enjoy her grandchildren. “If only you would prescribe the brand for her. You would if it was your own grandmother”.

The ‘payer avoidance’ strategy will not work. Lockdown is getting tighter. With Clinical Commissioning Groups it will be even more so. The financial framework will be more akin to trying to prescribe a non-formulary drug whilst working for BUPA, who would neither tolerate nor reimburse because the formulary is under a financial restrictions.

Indeed, the pain market has also intensified. This means numerous brands shouting for a louder voice in an intense market. Neuropathy, Opioids, Fentanyl/breakthrough Ca pain – add these up and you have pharma running around competing for a slice of the pie. Given all the warnings we had with COX-IIs, now we have them with NSAIDS, and of course even the weak Opioids have ‘addictive warnings’ all over them.

It is not surprising we are caught in the headlights of where to go in the name of safety and analgesia. Please someone, be it a brand manager or someone with payer access, see the bigger picture. Help us with the whole pathway. See our needs and work in partnership with us.

11AM : MEETING WITH PHARMA BRAND MANAGER
It’s not often I get a visit from a brand manager! We have been struggling for some time attempting to commission a funding pathway for an osteoporosis product – see earlier Matrix Revolutions. However, we may have a solution now with a variety of process mapping models.

I have finally received a number of options and interestingly the applicable HRG codes for activity within this domain. This has been a headache, despite a NICE TAG within the context of this ongoing saga. A resolution is long overdue. After a lot of liaising and a lot of technical HRG work-up, we may end up up with a streamlined prescribing pathway which lines up the PCT, the GPC, the acute trust, and fracture liaison service.

Thoughts for pharma

There is an intriguing change of paradigm when I am sat having an adult conversation with a brand manager compared to a ‘rep-call’. I realise that brand managers can’t go and see all their customers face-to-face.

But the paradigm shift is palpable. Why? Here we have it: The representative is ‘detailing me’ – that is never going to compare with an adult conversation with a brand manager who gets the bigger picture.

But something else, potentially more devastating: the brand manager is able to vocalise the ‘brand story’ in a far more compelling way than the ‘local rep’. That’s interesting, because the local rep is trained in the ‘brand messages’.

Even if you put aside that the brand manager has a ‘big picture understanding’, the fact that the value of the brand was unbelievably clear means that somewhere along the factory chain of sales force effectiveness and tier upon tier of managers, the message is lost in Chinese whispers. Why? I don’t actually know.

The representatives that are sent to see me are not in the same locator of food chain as I am. In effect, pharma is sending people of a certain authority that doesn’t fit with where I am. Even with account management. Remember, I talk clinical, I talk financial, I do commissioning maps, I do total drug budgets – I still have a boss.

However, pharma send people to see me with the following authority: “I need to get my medic to answer that…I need to get my line-manager to answer that…I need to call in my health economics person to see you…I need to call my regional account manager to approve that…”

When will I see all these people? Why do I need to see them all? Is it all ABPI, is it internal compliance, or is it sales force design? I’m not all for it, but I do see where some industry leaders are coming from in proposing authorised account managers answerable to MDs with budgets run at their own liability and expertise.

I recently did a ‘Payer Process Mapping Day’ for a pharma company/team of Executive Healthcare Development Managers. It fascinated me. Pharma has spoon-fed even higher NHS teams to such a level, that if you clear the playing field and ask them to come up with solutions to landscapes, they go blank. at day, the summarising  suggestions was simply: “we need a toolkit from head-office”. It was worrying. My conclusion?

We need to innovate within the NHS. Pharma companies are stakeholders. We should be asking you to help us innovate, but the people you are sending me… while I’m wanting them to look at the traffic jams I have ahead of me, and help navigate local influencing factors, they are waiting for a tool-kit from head-office!

11.30AM : CARDIOLOGY CONSULTANTS FORUM
Cardiology prescribing has so many focal features right now, I’m struggling to keep up with payer issues. This is due to a mixture of NHS demands, D&T processes, a sizable shift in coronary intervention work – and the drugs required within such units) and recent launches of new products that are proving challenging to implement within our health economy.

The format takes place as follows: I basically ‘gatecrash’ the forum and hijack a section of the agenda to use the opportunity for both information flow – in both directions, buy-in – to various prescribing initiatives, D&T processes and budgetary issues, and input to a number of shared-care-prescribing guidelines.

The aim is to open GPC/CCG cluster prescribing. A lot of this is about supportive communications; managing up – to my Chief and Director of Finance, and managing down – to pharmacy team on formulary policing. I need to take the consultants from ‘one place to another place’ within each micro-managed sub therapy. It’s a give-and-take scenario.

Thoughts for pharma

Cardiology has never really left the ‘priorities’ list. Right now, although there are some exciting and challenging implementations, I foresee a rocky road ahead. Antiplatelets. With the onset of generic clopidogrel’s price suddenly dropping like a stone – Plavix was £40 pcm, generic clopidogrel is now £2.50pcm, the Director of Finance is looking at the cost savings that we have built into our financial planning.

But here’s the catch – not only do we have branded prasugrel, we also now have branded ticagrelor, both pushing upward of £50pcm+. So how do we manage this? I have potential new pipleline antiplatelets which have offerings to interventional cardiology versus a savings plan that I will need to explain if I renege on. Tough. After much consternation, we’d put prasugrel onto our formulary, and now we have displaced this with ticagrelor.

We still have the generic clopidogrel as first line – but we always, always need a second line drug. Interestingly, neither company appears to have come forward with a QIPP line yet. One of them have thought about patient access schemes. NICE looks like it will be happy to support either. Cardiac networks play an important role – the cardiologists just want somewhere else to go after generic failure.

This was a learning curve for me. Whilst the clinical ‘story’ for either brand never really did magical wonders for the payers, the cardiac network is influential, and I think the companies are now maybe reconciling a ‘payer value story’.

There was a scary moment for one of the companies – a serious hospital discount nearly had us giving away one of the brands as a 12-month supply on the rucksack of a patient discharged from the angio suite – with a cost-saving share with the PCT. The company in question quickly made that disappear! It’s fascinating and like a game of chess sometimes…

Dronedarone. Even with a NICE TAG behind it, this has not been easy to implement. It really does take some serious ‘heads-together’ and I have never seen such fierce debate between clinicians and payers. Affordability and the increasing prevalence of AF makes for a great D&T discussion.

The next meeting I have with the directorate is to implement the use of this agent in young patients – outside NICE who recommended in 75yr+ – as the clinicians see greatest benefit here. This is where the payer’s approach needs serious consideration. All being well, I’ve managed to create an amber/shared care with PCT funding to keep all happy – let’s see what happens at the formalisation and authorisation meeting.

NICE chest pain implementation. There are significant stakeholders here with a number of large meetings across the PCT – payers, consultants, commissioners, coronary care units, etc. The implementation involves a number of small ‘mini-projects’, putting different drugs into the formulary for specific uses to help implement NICE.

That’s the way proper process mapping occurs. It’s more about the drug assisting the pathway, not about the drug per se. I see a lot of work to be done here. But I also expect to see consistency across the PCT.

Read Omar’s previous article in this series on Account Management in pharma.

Omar Ali

Omar Ali is the Formulary Development Pharmacist for Surrey & Sussex Healthcare NHS Trust and sits on the External Reference Group for Cost Impact Modelling for NICE. He may be reached on omar.ali@sash.nhs.uk

Pain therapy device approved in US

by emma 27. September 2011 16:52

MB product news

The FDA has granted US approval to Zynex for NexWave, a medical device to be used in electrotherapy treatment.

The next generation medtech system combines three modes of medical technology to provide a wide range of pain and muscle rehabilitation therapies: traditional TENS, interferential and neuromuscular electrical stimulation – through one non-invasive device.

Thomas Sandgaard, CEO of Zynex, said: “The combined modalities of our NexWave provide doctors and clinicians a more comprehensive pain therapy solution for their patients. This device was designed with the patient in mind, as it is compact and easy to use.”

US-based Zynex Medical engineers and manufactures its own design of electrotherapy medical devices for pain relief, pain management and stroke and spinal cord injury rehabilitation.

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