New Medical Market Country Profiles

The Medical Technology Blog

Hi and welcome back to The Medical Technology Blog.

A short announcement today just to say that we now have a new addition to the blog, which are the Medical Market Focus pages.

The Medical Market Focus tab provides a short introduction to the global medical market reports provided by Espicom Business Inteligence, and if you hover your cursor over the tab, a drop-down menu shows you the current medical device market country profiles featured this month.

This months feature profiles;

Please let me know if you have a specific country you would like to see featured.

Thanks, Paul

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Libyan Medical Market Report

The Medical Technology Blog

In the light of recent world developments, Espicom Business Intelligence has just released a new report entitled The Libyan Medical Market: Status & Post-Conflict Opportunities. This report has been compiled from novel forecasts and original materials to give a complete overview of the Libyan health market. Together with the fall of the Gaddafi regime as well as the expected introduction of a more open-handed democratic government, it is time to scrutinize Libya’s medical market economy in the region, examine the way it may develop, and assess the impacts for medical technology companies.

Libya is a small but oil-rich country in North Africa. Under the personal rule of Muammar Gaddafi from 1969 to 2011, it developed an eccentric mixture of socialism and Islam. The country was largely isolated from the international community due to its terrorist links, although Gaddafi made concerted and largely successful moves to re-engage with the West in the 2001-10 period.

2011 saw a bloody but ultimately successful rebellion against Gaddafi’s rule, caused by declining living standards over the past two years, and inspired by the Arab Spring uprisings in neighbouring countries such as Egypt and Tunisia. Aided by NATO airpower, anti-Gaddafi forces based in Libya’s second city, Benghazi, were able to take Tripoli in August 2011, and the whole country by October.

Libya’s oil wealth has enabled it to create a reasonably comprehensive healthcare system, but spending remains low in comparison with other oil-rich countries of comparable income such as Saudi Arabia. There is therefore considerable scope for expansion and modernisation in the future. There is no private insurance as such, so local people are largely reliant on the public hospital system. There is a well-equipped private sector, which caters for wealthier locals and workers in the oil industry.

The 2011 fighting has caused serious dislocation in the health sector, at the same time as placing great strains upon it. Some facilities have been directly damaged, while others have faced shortages of power, equipment, supplies and personnel. Most services have remained open, however, and the transitional council in Benghazi established a health ministry early on, in order to restore some normality. Shortages have become far less acute in the latter part of 2011, helped by short term overseas aid and the unlocking of public funds for use by the transitional government.

Libya makes some drugs locally, but has no significant domestic production of medical equipment, so all its requirements have to be met by imports. These were boosted by the thawing of relations with the EU and USA in 2003-04, since when direct trade became far easier. Imports peaked at just under US$200 million in 2009, but fell back in 2010 to US$146 million or US$22 per capita. Around three quarters is sourced from the EU, principally Germany and Italy. Despite the fall in 2010, Libya remains by some margin the leading African importer of medical equipment in per capita terms, ahead of larger economies such as South Africa or Egypt.

Understandably, the fighting in 2011 had a severe effect on the Libyan medical market. Imports shrank to almost nothing in the March to July period when trade became difficult, not least due to the freezing of government finance. With the fall of Tripoli in August and the death of Gaddafi in October, some much-needed stability has returned and a rapid rebound to pre-2011 levels of spending can be expected as the new government – and the private sector – restock and re-equip. Looking further forward, Libya has the opportunity to use its oil wealth to create a sophisticated and advanced health sector in the style of the Gulf states, assuming a degree of political will and ongoing political stability. The latter is far from a certainty, but the prospects appear far brighter post-Gaddafi than under his rule.

To purchase, or read more on this new report please click on the link to The Libyan Medical Market: Status & Post-Conflict Opportunities.

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FDA steps up bid to drive innovation in healthcare

The Medical Technology Blog

The FDA has handed over an award of US$2 million…

…to support two regional ‘Centres of Excellence in Regulatory Science and Innovation’ (CERSI) in the US. The centres, which will be located at the University of Maryland and Georgetown University, will focus on strengthening science and training needed to modernise and improve the ways drugs and medical devices are reviewed and evaluated.

In August 2011, the agency released the strategic plan for “Advancing Regulatory Science at FDA”, the main focus of which was to accelerate delivery of new medical treatments to patients, improve paediatric health, protect against emerging infectious diseases and terrorism, enhance safety and health through informatics, protect the food supply, modernise safety testing and meet the challenges of regulation. More recently, in October, the agency announced a related initiative, “Driving Biomedical Innovation: Initiatives for Improving Products for Patients”. This plan focuses on “continuing dialogue with companies, innovators, patients and other stakeholders to identify barriers to progress and better define what steps need to be taken to overcome any obstacles to innovation”.

Working with FDA scientists, CERSI researchers will assist the FDA in driving innovation in medical product development as well as in advancing laboratory, population, behavioural and manufacturing sciences. The agency chose to pilot the CERSIs in Washington, DC, to allow for the greatest possible face-to-face collaboration and training with FDA staff.

Thanks to Sophie Bracken for this article, Sophie is editor of Espicom’s business publication Drug Delivery Insight.

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Medica 2011

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Visit Espicom Stand 16F-24-2 in the UK Pavillion for your chance to win an iPad 2!

Is medical market and business intelligence critical to your company? Then let us invite you to visit and review the latest class-leading products from Espicom – the choice of leading executives in 50 countries worldwide.

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Also…we would really like your feedback – We are demonstrating our new feature rich delivery platform – come and see its facilities and tell us your opinion, the things you like and what you would like to see more of.

Finally…that iPad2 – We will be holding a draw to win an iPad 2 at the show. To enter, all you have to do is leave your business card with us. Could there be a better way to view Espicom’s excellent content?

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Biologic Therapies bursts onto orthobiologics scene

The Medical Technology Blog

Welcome back to the Medical Technology Blog. We start off the week with an article from the orthopaedics business, please read on…

A new company has been propelled into the orthobiologics industry as the result of a joint venture between device firms Scorpion Medical and Monet Medical. Dubbed Biologic Therapies, the new company will focus on the design, development and manufacture of components for the biologics sector of the medical device industry.

Orthobiology is the inclusion of biology and biochemistry in the development of bone and soft tissue replacement materials for skeletal and tissue healing. Biologic Therapies  will  attempt to take this process to a new level by creating ‘Autologous Orthobiologic Therapy’. The company believes it can use the body’s own stem cells to increase the healing potential and provide quicker restoration of function within muscle, tendon, ligament, bone and cartilage, said Dr R Wade McKenna, owner and operator of Monet Medical and  by an orthopaedic surgeon. Biologic Therapies will be led by President Steve Bales, a former employee of DePuy and Encore Medical.

McKenna’s autologous biologic therapy (bone marrow aspirate stem cells) treatments are designed to augment overall healing and improve surgical and non-surgical results. The treatments are for ligamentous injuries involving the knee, ankle and elbow. Treatments in the knee include ACL, MCL and LCL injuries. In the elbow, stem cells are used successfully to treat acute and chronic medial and lateral epicondylitis. Ligamentous injuries around the ankle are referred to as sprains but can often represent significant tears to the stabilising structures of the ankle. Autologous biologic therapy is used around the ankle in chronic and acute sprains to shorten the recovery time and improve the quality of healing tissue.

As its first product offering, Biologic Therapies is actively working to bring to market a new, patented device for accessing a patient’s own stem cells through the safe and painless harvest of bone marrow. This device is scheduled for market release during the first quarter of 2012. The company believes this device is unlike anything currently available and expects it could become the “gold-standard” for use in stem cell harvesting procedures.

Closely following the stem cell harvesting device will be a range of implant systems for fracture fixation, which will include the ability to introduce stem cells precisely at the fracture site. In addition, Biologic Therapies intends to create a strategic initiative to broaden the training and product support by offering an educational element to surgeons and healthcare professionals. The educational programme will aim to enhance the awareness and efficacy of this emerging technology as well as share Biologic Therapies’ surgical protocols designed to increase the success rate of autologous orthobiologic therapies.

Thanks to Sophie Bracken for providing this article, Sophie edits Espicom’s business publication Orthopaedics Business News.

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NICE delivers its verdict on next-generation cardiac CT scanners

The Medical Technology Blog

cardiac catheterization: my own heart, visible...

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Medical Industry Week News

It’s good news this week for some of the biggest medical imaging companies

GE Healthcare, Siemens Healthcare, Philips Healthcare and Toshiba Medical Systems – with all four receiving tentative backing for their respective next-generation cardiac CT scanners in draft guidance drawn up by the National Institute for Health and Clinical Excellence (NICE) in its latest draft guidance on the subject.

Now available for a period of public consultation, the draft guidance specifically applies to the use of the Somatom Definition Flash CT scanner (Siemens), Aquilion One (Toshiba), Brilliance iCT (Philips) and Discovery CT750 (GE) in the NHS in England for people with suspected or known coronary artery disease (CAD) in whom imaging is difficult with earlier generation CT scanners. A review team looked at 24 studies, with the vast majority (20) using Siemens’ Somatom Definition Flash (1) or an earlier model, Somatom Definition (19). Interestingly, despite its glowing endorsement only two of the studies referenced actually used the cutting edge CT scanner technology. In 2007, CAD was estimated to have claimed 91,000 deaths in the UK.

CT scans are performed to evaluate the arteries of the heart, and can also be used to assess the function of the heart, the anatomy of the heart, and the degree of coronary calcification in the heart. The technology survived a review of five recognised models for assessing the cost effectiveness of next-generation cardiac CT scanners, including the Europa model, for the prognosis of people with CAD, and the York Radiation Model, which estimates the impact of imaging in terms of radiation dose on cancer mobidity and mortality.

The recent NICE clinical guideline on chest pain recommends CT coronary angiography and invasive coronary angiography to assess the state of arteries and identify significant narrowing in people with an estimated probability of coronary artery disease of 10 to 29 per cent and a calcium score of <400 or less. People with a calcium score >400 are considered difficult to image using earlier generation CT technologies. Other reasons that make CT imaging difficult are obesity, arrhythmias (irregular heart beat), high heart rates (above 70 beats per minute) or previous coronary stents or bypass grafts.

The latest generation cardiac CT scanners have technical features that aim to overcome these difficulties, including the ability to acquire images much faster than earlier generation CT scanners, better image quality and reduced radiation doses. The NICE guidance recommends the use of these scanners for first line imaging of the coronary arteries in people with suspected stable coronary artery disease who are difficult to image with earlier generation CT scanners and whose estimated probability of having CAD is 10 to 29 per cent. In addition, the draft guidance recommends their use in people with known CAD for first line evaluation of disease progression to establish the need for revascularisation where imaging with earlier generation CT scanners is difficult.

Imaging companies will not quite be celebrating at the moment as final guidance on this topic is not expected until the new year, but they will be quietly confident that there is now a recognised need for the technology within the National Health Service in the UK.

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Non-Surgical Treatment for Varicose Veins

The Medical Technology Blog

As the NHS cuts start to bite, could a treatment for varicose veins provide one of the answers?

Maybe not! But Medical Industry Week this week highlighted the rather grand suggestion that a non-surgical treatment for varicose veins could save the UK’s National Health Service over £17 million annually in healthcare costs, and help 7,000 patients avoid further treatment due to unsuccessful alternative treatments. It’s not going to solve all our problems, but if it’s true then it’s a good start!

All medical device companies like to big up their respective device and technologies from time to time, particularly when one considers that regulatory authorities from across the country are tightening the budgets.  So it remains to be seen whether VNUS’ claims are just marketing puff, but it’s interesting to see how companies are increasingly using costing as a sale push, in addition to all the stated benefits of improving healthcare.

Developed by US-based VNUS Medical Technologies, the VNUS Closure Procedure involves a hospital stay of a couple of hours, treatment under local, rather than general anaesthetic, and claims a much faster recovery time with most patients able to walk out of the treatment room unaided. The procedure is also much less resource-intensive than surgery to the NHS, particularly compared to conventional varicose vein stripping, which takes up a great deal of operating theatre time.

For the same costs, the company said this week that a further 25,000 patients could be treated earlier and avoid pain, or discomfort. Further savings are on offer as the procedure can be carried-out in a treatment room so it has the potential to free-up theatre-time, enabling the NHS to treat other serious conditions more quickly and to reduce those all-important waiting-times.

On its own, the VNUS procedure may not represent a significant dent in the £20 billion of spending cuts that the NHS is faced with securing over the next four years, but getting on top of some of these, arguably less glamorous treatments could collectively make a positive impact on meeting this ambitious target. Medical Industry Week argues that it is time to take a closer look at these sort of treatments in a bid to meet a target that even the NHS Confederation says is unlikely to be achieved with the timescale.

This article was provided by Lawrence Miller, editor of Medical Industry Week, and the medical newsletters teamleader.

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Introducing Espicom Business Intelligence

The Medical Technology Blog

Introducing Espicom Business Intelligence

Our first video on Youtube;

Please check it out and leave a comment or if you’re in a good mood, give us a thumbs up!

Thanks, Paul.

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The Medical Technology Blog

Diagnostics Focus in The Medical Technology Blog this week – Scientists call for UK medical centres to adopt pulse oximetry test for identifying heart defects in newborns

The largest UK investigation into screening newborns for congenital heart defects has found that pulse oximetry is able to identify babies with life-threatening congenital heart defects, a major cause of infant mortality in the developed world. Researchers from the University of Birmingham and Birmingham Women’s Hospital have published data from the study, called PulseOx, in The Lancet medical journal.

More than 20,000 mothers and babies from throughout the West Midlands took part in the trial. Midwives used pulse oximetry to measure oxygen levels in newborns’ blood via a small sensor placed on the skin of hands or feet. Babies with low oxygen levels soon after birth may be at increased risk of heart defects. Current screening for heart defects involves ultrasound before delivery and routinely examining all newborns in the first 24 hours after birth. However, these examinations often miss babies with serious heart defects. PulseOx is carried out as an additional test on the postnatal ward, before discharge from hospital.

In six maternity units in the UK, asymptomatic newborn babies (gestation >34 weeks) were screened with pulse oximetry before discharge. Infants who did not achieve predetermined oxygen saturation thresholds underwent echocardiography. All other infants were followed up to 12 months of age by use of regional and national registries and clinical follow-up. The main outcome was the sensitivity and specificity of pulse oximetry for detection of critical congenital heart defects (causing death or requiring invasive intervention before 28 days) or major congenital heart disease (causing death or requiring invasive intervention within 12 months of age).

Out of the 20,055 newborn babies that were screened, 53 had major congenital heart disease (24 critical), a prevalence of 2·6 per 1,000 live births. Analyses were done on all babies for whom a pulse oximetry reading was obtained. Babies who failed the PulseOx test were given a heart ultrasound. Of 195 babies with an abnormal result following the test, 26 had a major congenital heart defect and a further 46 had other important problems which required urgent treatment brought to attention by the test.

Lead investigator Dr Andrew Ewer says that sufficient evidence exists for all babies to be routinely tested using pulse oximetry and, in conjunction with other tests, could help identify cases of critical congenital heart defects that go undetected with antenatal ultrasonography. Funding for the UK study was provided by the National Institute for Health Research Health Technology Assessment programme.

Thanks to Sophie Sanderson, editor of Diagnostics Focus for providing this article.

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The Medical Technology Blog

The weekend’s nearly here and we finish off with an article from Orthopaedic Business News by Espicom’s medical news editor Sophie Bracken.

CellSonic Medical, an India and UK-based developer and manufacturer of machines and consumables for wound healing, orthopaedic, urology and skin care in the medical, veterinary and cosmetic markets, is looking for worldwide distributors for its products, which span the areas of lithotripsy, urology, surgery, laparoscopy and dermatology, and also include cosmetic creams and gels. All of CellSonic’s products possess CE mark approval.

The CellSonic medical device is a lithotripter with variable power for use in hospitals and clinics to treat bones, wounds and sports injuries. The device produces a shockwave that is focused by the parabola in the head. According to CellSonic, the company has miniaturised the lithotripter, making it “safe, reliable, easy to use and reduced to price to reach a worldwide market for wound healing”. Calcified shoulder is the most commonly treated condition with shockwaves. Tennis and golfer’s elbow are also commonly treated with the technique. A power boost can be provided for machines that require a bone-healing facility.

According to CellSonic, its system can cost half that of electro-magnetic machines and claims to be cheapest in the medical, veterinary and cosmetic markets. The distributor will exclusively offer CellSonic’s full range and undertake all sales functions.

Have a great weekend, thanks for reading, Paul.

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