Final NICE diagnostic guidance on the EOS 2D/3D X-ray imaging system calls for the system’s health benefits to be further investigated in clinical research settings.

The new system (pictured) from US company EOS Imaging uses low-dose radiation imaging to produce 2D X-ray images and 3D reconstructions for bones.

Its innovative slot-scan technology, scanning a line at a time rather than taking the entire image at once, enables it to produce upright and weight-bearing whole-body images.

By showing relationships between the spine, hip, pelvis and knees, the EOS system could particularly benefit the monitoring and treatment of patients with spinal deformities or alignment problems.

The system’s reduced dose also offers potential safety advantages in the repeated imaging of patients with spinal deformities, especially children.

The new guidance encourages the use of the 2D/3D imaging system in specialist research settings to collect evidence about clinical benefits associated with weight-bearing whole-body imaging and 3D reconstruction.

Professor Carole Longson, Director of the NICE Health Technology Evaluation Centre, said: “The EOS 2D/3D imaging system was identified by the Diagnostics Advisory Committee as an important emerging technology. There is evidence showing comparable or better images and radiation dose reduction associated with using the EOS system to image patients with spinal deformities.”

However, she said, there is currently no evidence that compares the diagnostic accuracy of the EOS system with that of conventional radiological examinations. “NICE will follow up the Diagnostics Advisory Committee’s research recommendations on the EOS 2D/3D system and will assess the feasibility of this research with a view to facilitating the development of further relevant evidence.”

Full data sets evaluating the system’s benefits will trace the outcome of its use from planning through to complex surgeries such as hip replacements.

Marie Meynadier, CEO of EOS Imaging, said: “The EOS 2D/3D imaging system is subject to an extensive programme of research associating radiologists and orthopaedic surgeons. We will provide data to NICE as they are established to determine when a cost-effectiveness review based on this evidence would be appropriate.”

The new external assessment centres recently announced by NICE will help to develop and facilitate research products to assist suppliers when NICE medical technology or diagnostics guidance recommends it.

Despite huge investments into CRM systems some pharma companies still struggle to get all of their staff to embrace and fully interact with them. Pf’s Iain Bate explores why, and what the future holds for technology in the industry.

There’s no doubt that technological developments have changed the way we live and work from year to year – maybe even from month to month in the 21st Century. But has the world of healthcare been travelling in the slow lane of the intergalactic highway?

The potential that technology offers to pharma, and the general world of healthcare, is enormous. But is the pharmaceutical industry, and its staff in particular, using it to maximise the returns of billion-dollar investments?

It would seem that technology is the ‘buzz word’ on the lips of a few of healthcare’s major players at present. The DH recently invited people to nominate their favourite health-related mobile phone ‘app’ – be it for keeping fit, to locate a hospital or chemist, or helping to manage an illness. Creative minds were also asked to design their own health app with a panel of DH judges deciding on their favourite from the most popular entries.

Health Secretary Andrew Lansley says it’s the Government’s intention to give people better access to information using modern technology and the exercise is a “unique opportunity for the NHS and those who develop apps to not only showcase their work, but to bring to life new ideas and realise true innovation in healthcare”.

As part of the DH’s technology revolution, patients may also soon be offered online consultations with their GPs using programmes such as Skype. Clearly the Government is embracing the convenience technology offers to patients, but are other sectors in healthcare as interested? It would seem there is still some way to go.

 

In two minds

Pf ’s 2010/11 annual Company Perception, Motivation and Satisfaction Survey suggests that not all respondents are completely convinced by the power of technology in the workplace. Although the Survey – which relates to 2010 and the early part of this year – found that nearly 90% of respondents have access to a CRM system, only 43% find time to use it in the field and more than a fifth of people fail to accurately record post-call reports with important clients.

Questions have to be asked as to why, despite multimillion pound investment and training by pharma companies, there remains a percentage of staff that still ignore the power and potential of the technology at their finger tips.

Results from the Survey reveal there’s no difference in uptake by key account managers, primary and secondary care representatives, those in primary care roles only, firstline sales managers and secondline sales managers and the use of CRM technology between differing age groups – although surprisingly 10% of respondents in these positions with less than two years of experience said they did not have a CRM system, compared to just 5% more experienced colleagues.

The launch of the iPad in March 2010 promised to revolutionise the way sales representatives, and those in similar roles, use CRM systems in the field. However, nearly three-quarters (70%) of respondents from the Survey are still presently sent out with laptops containing their customer-relationship systems.

When quizzed on what they’d change about the hardware which houses their system, the majority of respondents said that their CRM was too awkward to carry, with poor running systems an issue and that batteries ran out too quickly. Apple claims its second-generation iPad now enjoys ten hours of use away from a plug socket in the field.

Yet the switch to the latest convenient tablet devices may not necessarily be about high levels of investment, it may be down to maximising value for money as Paul Shawah, Vice President, Multi Channel Strategy, Veeva Systems explains. “I would say the life cycle of devices within the industry is generally about three years, sometimes a little bit longer,” he said. “When a company invests in new technology they typically depreciate that over that period, so they don’t want to replace it in the field for that time to maximise their investment.

“However, with the introduction of game changing technology like the iPad, this has changed. We see a number of our pharmaceutical customers are justifying the business case to move to the iPad even before their tablets are fully depreciated. This speaks to the business benefit that pharma expects to achieve from the iPad and the related applications only available on that device.”

A convenient shield

Despite technology eliminating mundane process in the workplace and offering the potential to assist employees and improve their efficiency at work, it has historically been used as a shield to mask poor performance and abused as a means to waste company time – a recent online survey by AOL found that nearly half of Americans (44.7%) rank surfing the web as their primary activity during the two hours they ‘waste’ each day at work.

But it would seem that a high number of respondents do value the opportunities CRM offers. Almost two-thirds (64%) said they always enter correctly the amount of customer sales they make into their CRM. But 21% admitted they fail to always report face-to-face meetings with clients. More surprisingly, over a fifth of participants said they do not always record the number of products they had sold to clients.

The lack of honest accuracy is surprising considering the amount of time spent using CRM systems each day. A third said they spend between one and two hours a day on their system with a fifth spending three hours or more on their CRM. During their time using the management system, more than half (55%) said that call reporting was the most useful feature.

Although respondents were less impressed with the KAM abilities of their software with only 19% believing it to be the most useful facility. When questioned about what they would change given the chance, 45% said they wanted an improved database, over a quarter (28%) called for their system to be overall more useful, and 18% said they would prefer their CRM to be easier to use.

 

The next level

But what of the future of CRM systems? Will they be easier to use and have improved customer databases? David Round, General Manager, UK, Cegedim Relationship Management, says the regular interaction we now have with technology means we’ve all come to expect the latest developments.

“End users are significantly more ‘technology-savvy’ than their counterparts of even five years ago,” he explained. “If anything, the challenge for companies is to ensure that they provide their end users with the types of technology that they use as consumers. It’s also important to focus on the usability of your software to ensure maximum use. Technology companies – and pharma – must work together to develop a better understanding of the interaction, to ensure it meets users’ needs in the field.”

One main reason that users have become more ‘savvy’ is down to the use and interaction with social media. Whether at home or at work, websites such as Twitter, Facebook, LinkedIn and most recently Google+ have driven an increased use of various forms of technology – especially on devices such as smartphones or tablet devices which reps are calling for in the field.

Pharma companies, both in the US and UK, have flirted with the idea of fully embracing the power social media harnesses, but at present are restricted by the PMCPA’s Code of Practice and by the FDA – who has again delayed the publication of its guidance.

The FDA says it is “difficult to provide a timeframe... due to the extensive work and review process, or ‘Good Guidance Practices’, which ensures that FDA’s stakeholders are provided well vetted guidances articulating FDA’s current thinking on a topic”.

Although the FDA may be unsure on how to direct healthcare companies, David Round believes the introduction, both professionally and personally, of social media has had an impact on staff and their expectations.

“For the modern professional person, much of their everyday life is conducted online – for example on shopping, utilities, insurance or booking a holiday – and many users then want the same level of capability from the tools they use in their job,” he added.

Dan Goldsmith, General Manager, Veeva Europe, agrees there has been a significant shift in the way we operate and interact due to our experiences online through tagged posts or hash-tagged searches. But although the 800 million users on Facebook – more than half which ‘log-on’ every day – and 175 million people on Twitter have no problem saying hello to friends, pharma finds it more difficult reaching out to people.

“Social media create a new avenue for healthcare dialogue and will only continue to pervade our lives,” said Dan. “Consequently, I believe that pharma faces two challenges. The first is to decide how to participate in the online dialogue with stakeholders and then to create those interactions through the channels we’re all familiar with, such as Facebook and Twitter.

“The second is to figure out how to leverage the model of social dialogue internally to support stronger collaboration and more focused communication among employees. Already, we see some companies taking advantage of the latest social business tools to connect employees with one another and to access and share information in real time.”

Clearly CRM solution providers understand the potential modern technology and social media platforms offer to companies. Whether pharma and its workforce get fully up to speed on the intergalactic highway sooner or later remains to be seen.

AstraZeneca’s Brilique (ticagrelor) has been recommended in final guidance, in combination with aspirin for up to a year, as an option to treat adults with acute coronary syndromes (ACS).

NICE has also recommended the treatment as a treatment option for people admitted to hospital with unstable angina.

Professor Carole Longson, NICE Health Technology Evaluation Centre Director, says that evidence shows Brilique is “effective at reducing myocardial infarction (MI) and deaths from cardiovascular causes”.

Every year in England, around 200,000 people are diagnosed with ACS, of whom approximately 75% have unstable angina or Non-ST-segment-elevation myocardial infarction (NSTEMI).

The medication works by reducing or preventing blood clots, so that the flow to the heart muscle can be maintained to prevent further damage. It is licensed for the treatment of people with ACS who are managed medically or who are to undergo percutaneous coronary intervention (PCI) – a procedure to widen narrowed arteries in the heart.

The guidance recommends the use of anti-platelets treatment, in combination with aspirin, as a treatment option in people with STEMI who are to undergo PCI and in people with NSTEMI.

“Today’s guidance, in recommending the use of ticagrelor where clinically appropriate, is an affirmation of that effectiveness and good news for patients with ACS, wherever they live in England and Wales, because it increases the number of treatment options available to them,” said Professor Carole Longson, NICE Health Technology Evaluation Centre Director.

The BMA has set out eleven areas of continuing concern with the Health and Social Care Bill.

The Association says that a series of further amendments to the Bill are necessary in “order to mitigate damage” to the NHS.

Its recommendations include giving Clinical Commissioning Groups (CCGs) the freedom to commission the most appropriate services, and ensuring the Secretary of State retains ultimate responsibility for the NHS.

Dr Hamish Meldrum, BMA Chairman, says although the Association would prefer the Bill to be withdrawn, “there is scope for further significant change to be made” during its passage through the House of Lords.

In its latest briefing paper, the BMA also calls for an amendment which makes it explicit that patient choice will not be given priority over fair access for all. It also wants further safeguards which prevent providers of care or services ‘cherry-picking’ more profitable services.

On incentives for commissioning, the Association “continues to have serious concerns” about conflicts of interest with the link of financial incentives to the performance of CCGs.

Dr Meldrum hopes that peers in Lords will agree with the suggested amendments and change the controversial legislation before it progresses any further.

“Because so much of the detail won’t appear on the face of the Bill and will instead be left to secondary legislation and guidance, it is essential to have firm assurances now about the government’s implementation plans, for example, we continue to have serious concerns about the ethics of the current proposal to incentivise commissioners,” he said.

“Other areas where the BMA is seeking amendments relate to public health; the private patient income cap; the foundation trust failure regime; increasing bureaucracy and complexity, and information and confidentiality.”

Members of the BMA have previously expressed “major concerns” about the Health Bill on various occasions, calling for the Government to amend the plans back in June 2011.

A new childcare product designed to improve posture and assist spinal development has been launched by a UK company.

The PosturePadJunior wedge cushion (pictured) from Derby-based Jolly Back Enterprises was developed with support from the Healthcare and Bioscience iNet, which is part-financed by the European Regional Development Fund (ERDF).

Designed by physiotherapist Lorna Taylor, the product was launched during National Back Care Awareness Week.

Taylor received an iNet Innovation, Advice and Guidance grant, which enabled her to design and test the wedge cushion prior to commercialisation. She is working on a DVD to train teachers and nursery managers in manual handling and back care.

The same company launched the Jolly Back chair earlier this year, using the same wedge-shaped cushion technology to prevent or reduce back pain. The product has 23 UK distributors and has sold worldwide.

“As a children’s physio, I am concerned at how child development is being adversely affected by current lifestyles,” said Taylor, who noted that correct positioning of babies can “allow core strengthening of the back and neck”.

Taylor described the PosturePadJunior wedge cushion as “a simple means of naturally supporting the spine for comfort and physical development”.

iNet advisor Dr Ros Graves commented: “Lorna has shown incredible resourcefulness by coming up with simple but effective products and bringing them to market so efficiently. The potential impact of all her ideas is enormous so we are delighted to have been able to help.”

The Healthcare and Bioscience iNet is an initiative delivered by Medilink East Midlands that assists companies and inventors in the healthcare sector to develop new technologies, products and services. It brings together firms, academics and public service representatives.

NICE has appointed a new external assessment centre to support its Medical Technologies Evaluation Programme.

The new assessment centre, developed by Newcastle upon Tyne Hospitals NHS Foundation Trust Medical Physics Department in partnership with York Health Economics Consortium, will provide independent assessment of the clinical and health economic evidence for medical technologies.

It will also develop and facilitate independent research to assist suppliers when NICE guidance recommends that further research should be carried out on a medical device or diagnostic.

The new assessment centres were selected for their knowledge and expertise in the evaluation of medical technologies.

To date, one more external assessment centre, CEDAR – part of Cardiff and Vale University Local Health Board – has been commissioned.

Professor Carole Longson, Director of the Centre for Health Technology Evaluation at NICE, said: “We’re delighted to welcome the new joint external assessment centre based at Newcastle and York. Their input to the production of NICE medical technology guidance will be essential, providing independent assessment of the evidence available for devices going through the NICE evaluation process.

“Where the relevant NICE advisory committee identifies that a technology has considerable potential but insufficient evidence to support widespread adoption across the NHS, it may make recommendations for further research. In such cases, the external assessment centre will play a key role in facilitating the development of further relevant evidence.

“We look forward to working with the centre, and benefitting from their combined technical and economics expertise in supporting the development of robust guidance for the NHS.”

Established by NICE in 2009, the Medical Technologies Evaluation Programme is focused specifically on innovative medical technologies. Seven NICE medical technology guidance documents have been published to date.

Anti-bee or wasp venom treatment Pharmalgen has been recommended in preliminary draft guidance by NICE.

It has been recommended as a treatment option for those who have had a severe systemic reaction to being stung or a moderate reaction with additional complications.

Professor Peter Littlejohns, Clinical and Public Health Director at NICE, says Pharmalgen is an “effective, preventative treatment”.

Less than 0.5% of the population in the UK who are stung by a bee or wasp experience a severe reaction, known as anaphylaxis. Each year in the UK, up to nine people die as a result of anaphylaxis.

Pharmalgen works by gradually increasing doses of the allergen by injection, which over a period of time, desensitises a person with the allergy by altering their immune system. It is carried out in two phases: the first initial phase after a sting and the maintenance phase which last for three years.

“The reactions that some people experience to stings from bees and wasps can be distressing, frightening and sometimes life-threatening,” said Professor Littlejohns. “People who have had a serious reaction to a sting can often experience extreme anxiety about possible future stings, and this can affect their daily lives.”

Final guidance is now expected to be issued to the NHS in February next year.

It’s everybody’s worst nightmare isn’t it? You’re in an interview for a job you really want and it all starts going wrong. Whether it’s your phone ringing or you’re giving the longest, most irrelevant answer to an interview question ever, once things start going wrong it feels like there’s no way back. However, it is possible to get things back on track and limit the damage during the actual interview. You can also follow up with certain steps that can help to rectify the situation afterwards so do not fear, some tips are here.

Whilst in the interview

• Try not to panic: Even if you’re convinced you’ve made a massive mistake in the middle of your interview, keep calm and carry on. The interviewers may not have even noticed, or if they have, they may be willing to allow it depending on how the rest of the interview goes.
• Don’t try too hard: Ok, so you’ve been had. You made a mistake and it hasn’t quite gone to plan but don’t overcompensate by trying too hard. If you do so, you’ll tighten up, get stressed and probably go on to make many more mistakes and then comes a downward spiral. Instead, focus on executing your original game plan for the interview and try to keep your breathing even.
• Don’t dwell on the mistake – move on: Yes, you may have made a mistake, but if you keep thinking about it for the rest of the interview, you’ll be distracted and that will make matters worse. Move this mistake to the back of your mind by listening carefully to what the interviewers are saying. This will help you remain in the moment instead of thinking about what just happened.
• Control those emotions: Even if you feel like bursting into tears because the interview is going so badly, try to keep yourself in check. Keep things in perspective—it’s a job interview, not a fight to the death. If you really are emotional, excuse yourself to the bathroom so you can take a moment.

Key follow-ups after the interview

• Say ‘thank you’ in a note / email: No matter how embarrassed you are because of a bad interview, still email a ‘thank you’ note to the interviewers. It can’t logically make matters worse and is a simple sign of acknowledgement and politeness. If you are really convinced there’s no way you’ve gotten the job, just think of sending a ‘thank you’ note as an act of closure.
• Get in touch with new thoughts: The last thing you may want to do after a disastrous interview is to email the interviewers with new thoughts or ideas about the interview topics. However, by emailing them with things that have occurred to you after the event, you may be salvaging the situation. In the clear light of day, your thoughts will be more lucid and will give the interviewers a more accurate idea of who you really are.
• Don’t be tempted to vent online: Don’t dismiss your opportunity to get this job because you think it didn’t go well. There is no excuse to jump on Facebook and rant about the bad experience. You never know exactly how you came across. There is always a chance that the interviewers will consider you seriously for the role and wouldn’t it be awful if they come across you online to see a negative display of your experience with them? Also don’t forget that other employers you’ve applied to may also be checking your online profiles.
• Be sure to move on: Speaking of your other applications, if you genuinely think the bad interview is a lost cause even after you’ve followed the above steps, don’t give up on your job search completely. Focus on the other applications you’ve made and how you’re going to improve upon your interview technique. If learning from your interview mistakes helps you to ace the next interview you get, the bad interview will at least have been worth something.

For further reading and advice on interviews you may find this “How to ace the interview” eGuide helpful.

About the author:

Nisa Chitakasem, co-founder of Career Change Specialists Position Ignition, which helps people with their career change, job search and career direction.

NICE has published guidance supporting the use of a patient warming mattress from a Yorkshire company to prevent hypothermia during surgery.

The Medical Technologies Advisory Committee (MTAC) assessed the use of the Inditherm mattress (pictured) from Inditherm Medical, which is designed for use with patients having surgery involving an anaesthetic.

The evidence considered suggests that the device is as effective in maintaining a patient core body temperature above 36°C as forced air warming, which NICE continues to recommend.

MTAC also estimated that the Inditherm mattress offers the NHS an average annual cost saving of £9,800 compared with forced air warming (where heated air is blown into a specially designed blanket).

In addition, MTAC concludes, the Inditherm mattress may have further practical advantages: it is re-usable and can be cleaned in the same way as a normal operating table mattress, as well as minimising waste of energy.

Professor Carole Longson, Director of the NICE Centre for Health Technology Evaluation, said: “We are very pleased to publish guidance today advising that the Inditherm patient warming mattress should be considered for use in patients at risk of inadvertent hypothermia. The evidence examined indicates that as well as benefiting patients by reducing a range of serious complications associated with inadvertent hypothermia, it also benefits the NHS by saving money.”

Longson also noted that the new guidance did not supersede the recommendation of forced air warming – rather, it suggested “that when considering new investment in warming devices, consideration should be given to whether use of Inditherm would be beneficial with respect to local circumstances.”

NICE estimates that there are 2700 theatres in England not currently using any type of patient warming, of which 40% might be expected to purchase the Inditherm mattress.

Inditherm Medical is based in Rotherham.

The FDA has issued its first draft guidance detailing how decisions are made during premarket approval applications (PMAs) of medical devices.

The document outlines that safety data and effectiveness data are initially gathered, weighing the benefits of the technology against the probable risks associated with the device.

The guidance intends to “provide more clarity to manufacturers” about the factors considered when reviewing a PMA, stated Jeffrey Shuren, Director of the FDA’s Center of Devices and Radiological Health.

Mr Shuren said that many factors must be taken into account, “as medical devices grow increasingly complex”.

For example, the severity of the disease the product diagnoses or treats and whether or not alternative tests or treatments are already available are taken into account.

The guidance also proposes that FDA medical device reviewers use a worksheet to demonstrate how they make benefit-risk determinations.

In some cases, this worksheet could be made public post-approval to make the FDA's process even more transparent.

Visit the FDA website for more information.