The Medical Technology Blog

Sony eyes growth in medical fields as company swings the axe in its higher profile electronics businesses

Welcome back to the Medical Technology Blog, we have a great post today provided by our medical newsletters team-leader, Lawrence Miller, Lawrence is all the editor Medical Industry Week, please read on…

Sony’s newly-installed management team have unveiled plans to cut a further 10,000 jobs in a bid to revitalise and grow the struggling electronics business to generate new value.
The plans, which will see the Japanese company focus on core areas of digital imaging, games consoles and mobile devices, aim to increase sales to ¥8.5 trillion, and provide a return on equity of 10 per cent, by the year ended 31st March 2015 (FY 2014). Sony’s 2011 sales were ¥7.2 trillion and have already been lowered for 2012 to ¥6.4 trillion.

Sony to grow medical equipment field - ¥50 billion sales by 2014?

Somewhat surprisingly, the turmoil in its high-profile electronics business, particularly with regards to televisions, is set to open doors for the company’s comparatively less profile medical peripherals division. In keeping with many of Japan’s electronic giants, Sony has been taken gradual steps into the medical field, particularly within the areas of medical-use printers, monitors, cameras and recorders. By the end of FY 2014, Sony is targeting sales of ¥50 billion (approximately US$630 million).

In a clear sign of its intention to grow the business, Sony also plans to enter the market for medical equipment components, where it believes its strength in various core digital imaging technologies offer significant competitive advantages in applications such as endoscopes. The latter has inevitably led to talk that the company may ultimately be interested in a tie-up with the scandal-ridden Olympus group, which is struggling to deal with a massive accounting fraud. Olympus’s diagnostic endoscopes dominate the worldwide market in this area. However, with Sony’s eye on other parts of its empire, and Sony’s less than impressive financial performance itself, a tie-up with Olympus seems a bit of a hefty deal to take on.
Such a takeover, however, cannot be entirely ruled out as Sony has also restated its determination to “aggressively pursue” other merger and acquisition deals that can expand its medical business, with the aim of developing the business into a key pillar of Sony’s overall business portfolio. The company recently entered the life science industry, where the company can apply technologies such as semiconductor lasers, image sensors and microfabrication, by purchasing iCyt, a manufacturer of cellular analysis equipment, and Micronics, a company that makes medical and diagnostics equipment.

It remains to be seen if three years from now the name Sony is regarded with more recognition than at the present time. However, given the current commentary coming out of the Japanese company, it seems at least one group of employees in the struggling company will be significantly more relaxed as the cost cutting programme swings into action.

Article Source: Medical Industry Week

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The Medical Technology Blog

Welcome back to the Medical Technology Blog. Today’s post is taken for Espicom’s business publication Drug Delivery Insight, which is edited by Sophie Braacken, please read on…

Prosonix has presented new research showing that a combination of two inhaled respiratory drug molecules in a pre-determined ratio within Multi-component Particles (MCP) significantly improved co-localisation of the active drug components in the lung. The presentation was made by Prosonix’ Dipesh Parikh at the Drug Delivery to the Lungs 2011 (DDL2011) conference in Edinburgh, UK.

In the presentation, Prosonix describes how its Umax technology has enabled the development of one such example of MCP, which combines budesonide (BDS) and formoterol fumarate dihydrate (FFD) in a single particle, in a pre-determined ratio with “exquisite” control and consistency. The combination of BDS and FFD forms the basis of AstraZeneca’s multi-billion dollar respiratory drug product Symbicort. Combining multiple active drug components into a single particle using Umax® technology is shown, using Raman chemical imaging, to result in optimal co-association and co-localisation of the drug molecules at the correct sites in the lung and respiratory tract.

The concurrent delivery of inhaled corticosteroids (ICS) and long-acting B2-adrenergic bronchodilators (LABA) is a key treatment for asthma and chronic obstructive pulmonary disease (COPD) with mutual synergy of action cited as important for clinical performance. Previous analysis by Prosonix of currently marketed suspension-based MDI and DPI combination product formulations, which consist of individual drug components in a simple mixture, has shown limited co-localisation. Compared with these combination products, the improved co-localisation of MCPs to targeted parts of the lung is expected to achieve more pronounced synergy and additive efficacy on the key target cells directly from the solid state, improving outcomes and leading in turn to lower doses and improved safety and compliance.

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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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Researchers create human heart cells that can be paced with light

The Medical Technology Blog

This weeks artice on the Medical Technology Blog is taken fromEspicom’s business publication, Cardiovascular Device Business, please read on…

In a paper published in the September issue of the Biophysical Journal, lead author Dr Oscar Abilez, a postdoctoral scholar and PhD candidate in bioengineering, and a multidisciplinary team from Stanford University, describe how they have, for the first time, engineered human heart cells that can be paced with light using a technology called optogenetics. In the near term, the researchers say the advance will provide new insight into heart function. In the long term, however, the development could lead to an era of light-based pacemakers and genetically matched tissue patches that replace muscle damaged by a heart attack.

To create the light-responsive heart cells, the researchers first inserted DNA encoding a light-sensitive protein called channelrhodopsin-2 (ChR2), into human embryonic stem cells. ChR2 controls the flow of electrically charged ions into the cell. For heart cells, the primary ion is sodium, which initiates an electrochemical cascade that causes the cell to contract. They then transformed the optogenetically engineered stem cells into cardiomyocytes those that respond to light.

The key protein for the experiment is ChR2, which is sensitive to a very specific wavelength of blue light and regulates tiny channels in the cell surface. When ChR2 is illuminated by the right wavelength of blue light, the channels open to allow an influx of electrically-charged sodium into the cell, producing a contraction. After creating the cells in a laboratory dish, the researchers tested their new cells in a computer simulation of the human heart, injecting the light-sensitive cells in various locations in the heart and shining a virtual blue light on them to observe how the injections affected contraction as it moved across the heart.

In a real heart, the pacemaking cells are on the top of the heart and the contraction radiates down and around the heart. With these models, the researchers say they can demonstrate not only that pacing cells with light will work, but also where to best inject cells to produce the optimal contraction pattern.

The long-term goal is the development of a new class of pacemakers. At present, surgically-implanted electrical pacemakers and defibrillators are commonplace, regulating the pulses of millions of faulty hearts around the world. However, Abilez adds that neither is without problems – pacemakers fail mechanically and the electrodes can cause tissue damage. Defibrillators, on the other hand, can produce tissue damage due to the large electrical impulses that are sometimes needed to restore the heart’s normal rhythm. In the future, the researchers envision that bioengineers will use induced pluripotent stem cells fashioned from the recipient’s own body, or similar cell types that can give rise to genetically matched replacement heart cells paced with light, circumventing the drawbacks of electrical pacemakers.

Co-author, Dr Christopher Zarins, professor emeritus of surgery and director of the lab, speculates the the work could result in a pacemaker that is not in physical contact with the heart. Instead of surgically implanting a device that has electrodes poking into the heart, engineered light-sensitive cells would be injected into the faulty heart and used to pace the heart remotely with light, possibly even from outside of the heart. The leads for such a light-based pacemaker might be placed outside the heart, but inside the pericardium, the protective sack surrounding the heart. Another concept to be explored is a pacemaker placed inside the heart chambers, as with traditional pacemakers, whose light can travel through the intervening blood to pace light-sensitive heart cells implanted inside. Since the new heart cells are created from the host’s own stem cells, they would be a perfect genetic match.

The authors conclude that optogenetics could also lead to advances beyond the heart. It might lead to new insights for various neuronal, musculoskeletal, pancreatic and cardiac disorders, including depression, schizophrenia, cerebral palsy, paralysis, diabetes, pain syndromes and cardiac arrhythmias.

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US joint replacement registry gets fully under way

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Hi and welcome back to the Medical Technology Blog, and today’s post come from Espicom’s excellent news publication, Orthopaedic Business News, please read on…

Like the National Joint Registry of England & Wales before it, the American Academy of Orthopaedic Surgeons (AAOS) has been busy with the task of establishing the American Joint Replacement Registry (AJRR) – a project designed to collect data on all primary and revision total joint replacement procedures in the US. The registry’s mission is to improve patient safety and quality of care, as well as reducing the associated cost. With that mission in mind, the AJRR has recently completed its pilot programme of data collection.

Dr John Callahan, Vice President of AAOS and team leader of the AJRR project, said that past medical registries have been shown to help reduce the cost of medicine and, in particular, the burden of joint replacement. Callahan believes that decreasing revision surgeries by half would save millions anually for healthcare payers as well as for the US government. “Because of this, US Congress is interested in including registries in healthcare reform. The AJRR will be able to provide information in a timely manner, where it can be analysed by orthopaedic surgeons”, he said.

Short-term, the registry aims to establish an infrastructure and a uniform system for the collection of information and monitoring outcomes of total joint replacement in the US, as well as identify patients who may need follow-up evaluation, thereby increasing patient safety. Long-term, the registry’s goals are to create a real-time feedback mechanism in order to detect “sub-optimal” performance, and establish a uniform system that can be used to expand understanding of total joint replacement for research to improve patient care.

AAOS statistics show that in 2006 alone, more than one million hip and knee replacement took place in the US. Of these, around 7.5 per cent were revision surgeries, resulting in 77,000 procedures, at a cost of over US$3.2 billion. The AAOS has projected that the AJRR will reduce healthcare costs by around US$1.3 billion over the next 20 years. The AAOS believes that even a 2 per cent decrease in revision rates could potentially save US$65.2 million a year. Similar registries in Sweden, England & Wales, Canada and Australia have seen up to a 10 per cent reduction in revision rates as a direct result of their own registries.

However, the registry is not all about saving cash. Explaining the registries main aims and focus points, Dr David Lewallen, Chair of the AJRR Board of Directors, said there is a national interest in registries, particularly how patients will benefit. In the past, national data collection of hip and knee implants has helped to improve care by allowing surgeons, device manufacturers and hospitals to better understand what aspects of joint replacement is successful, and what needs to be improved. Lewallen said that the AJRR will enable surgeons, hospitals and device manufacturers to review their own data and compare their performance with similar institutions, in order to understand where opportunities for improvement may exist. The registry will also be a resource for patients, who will be able to contact the registry to find out what methods and devices were used at the time of their surgery.

The AJRR aims to gather data on all replacement and revision surgeries, including younger patients who are not recipients of Medicare – with the ultimate goal of achieving 90 per cent participation. The AJRR was set up in June 2009, and enrolment began in 2010. Participating hospitals have been submitting data for only a few months, but already information on over 3,600 primary and revision replacements has been assembled from eight different reporting sites, marking the culmination of the pilot stage.

Following an updated report on the pilot project, covering lessons learned and data analysis, the AJRR Board of Directors have begun formulating strategies for outreach recruitment, expanding resources and efficient data collection methods as the registry moves to full production. The AJRR’s timeline for 90 per cent participation in the registry is for October 2013.

At the moment, the AJRR is focused on collecting so-called “level-one” data, which includes a number of core data elements, such as patient, surgeon, procedure and hospital data. Each patient, surgeon and hospital has a unique identifier, which enables index procedures to be linked to subsequent events, permits patients to access their own information, allows data to be linked to other databases and helps maintain confidentiality.

Level-two data include variables that could enhance the value of the data analysis and allow risk adjustment, such as the patient’s body mass index and any comorbidities, as well as process of care data such as antibiotic prophylaxis. Level-three data will focus on outcomes and patient satisfaction, while level-four data (such as radiographs) provide more in-depth analysis of why and how implants or procedures fail.

Lweallen said the next step of the AJRR is to recruit a Medical Director to supervise operations. The registry is also moving toward implementing systems that will enable a wide range of hospitals and systems to submit data.

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DePuy, A Johnson & Johnson Company logo
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A warm welcome back to The Medical Technology Blog.

Newcastle University’s bioengineering team has made a bid for some of the credit in helping to persuade Johnson & Johnson‘s DePuy Orthopaedics unit to recall its Articulating Surface Replacement (ASR) hip prosthesis from the market.

The researchers,  led by Dr Tom Joyce, began investigating the ASR hip prosthesis as far back as February 2008, and discovered a number of failings in the design of the implant and offered an explanation into how and why the metal joint was being worn away, releasing high levels of toxic metals into the patient’s bloodstream. The subsequent recall means that thousands of patients – estimated at 93,000 worldwide, are being recalled in an effort to determine the extent of the problem and offer support to those who have been left with the crippling side-effects. According to DePuy, “very few” of the ASR devices remain on the worldwide market, following the company decision in 2009 that it would be discontinuing the ASR system as a result of “declining demand and the intention to focus on the development of next generation hip replacement and resurfacing technologies that best meet the needs of surgeons and patients.”

Joyce explained: “The thinking was that a metal-on-metal ball and socket joint should be far more effective and hard-wearing for patients than the older style metal-on-polymer system where the softer polymer tended to wear away quite quickly, releasing particles and eventually causing the artificial joint to fail. What our research showed was that if the ball and socket were not perfectly aligned then the metal wore away quite vigorously – the initially ultra-smooth surfaces roughening and then grinding away against each other – to release nano-sized particles into the body that were then absorbed into the bloodstream and tissues, causing far greater damage.” According to Joyce, only in a minority of cases were the joints actually functioning correctly.

Concerns first began to arise when a number of patients reported groin pain, some not long after their arthritic hips had been replaced with ASR prostheses. Working with orthopaedic surgeon David Langton, based at North Tees University Hospital and now working towards a PhD in Bioengineering under the supervision of Joyce, the NU team studied over 100 explanted hip joints sent to them from across Europe. Blood tests revealed high levels of cobalt and chrome ions in the blood stream of ASR patients. The ASR is made from cobalt-chrome alloy so this implicated the artificial hip. Using a “state-of-the-art” machine, the team studied the surface of the artificial hip joints and found that instead of being highly polished with a mirror-like surface, the failed devices had become roughened. This caused the lubrication of the joint to fail so that, with each step, the patient was producing relatively high volumes of metallic wear debris.

The ASR device formed part of a class of large diameter, monoblock hip resurfacing and replacement devices often selected by surgeons for younger patients who may benefit from a more stable device that can reduce the chances of dislocation after surgery. The DePuy ASR hip resurfacing system was introduced in 2003 and is only approved for use outside of the US, whilst the ASR XL acetabular system was first launched in 2004 and has been available worldwide.

DePuy, like its peers in the industry, will look back on this chapter in the history of hip replacement and hope to learn its lessons. For one thing, sometimes a development that appears to be successful and the answer to a major problem may not necessarily work out all so wonderful in reality over time. The industry has also had to trade off the benefits of technology with its failings, but recalls such as those from DePuy and Zimmer are inevitably going to make it much more difficult to convince surgeons and and potential patients that future technologies won’t suffer the same fate in the future. It is also likely to lead to much more stringent and expensive clinical trial programmes, and further regulatory scrutiny.

Thanks to Lawrence Miller for this post, Lawrence is the medical newsletters team leader and managing editor of Medical Industry Week and Orthopaedics Business

More to come this week, drop back soon, thanks, Paul.

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