GlaxoSmithKline (GSK) plans redundancies in its European sales and administration force to help it cut £1bn from its annual European, R&D and manufacturing costs by 2016.

The London-based pharma giant said it will achieve most of the cost reductions through technical improvements in its R&D and manufacturing processes.

According to CEO Andrew Witty, the cost savings plan has been driven by drug pricing pressures across Europe as the recession continues to worsen.

He also noted that job cuts would primarily affect sales and administration staff across Europe, but did not indicate the likely numbers.

Witty emphasised that GSK has six new drugs (including treatments for HIV, type 2 diabetes, melanoma and asthma) under review by regulatory bodies, with late-stage clinical trial data expected for another nine products within two years.

The company aims to launch up to 15 products within three years, he told business analysts. But given the economic uncertainties affecting Europe, 2013 would be a year of “twists and turns” and “not everything is going to go smoothly”.

According to a company spokeswoman, the technical and staffing changes (including redundancy payments) will have a combined one-off cost of £1.5bn, and will primarily be focused on Europe.

Merck KGaA plans to cut back its biopharmaceutical division Merck Serono, cutting 500 jobs and transferring another 750 as it closes its Geneva headquarters.

The company plans workforce reductions across all global operations, and will

relocate Geneva-based R&D functions to Germany, the US and China.

The cutbacks, a response to falling profits and growing competitive and market pressures, will shift the division’s centre of gravity from Switzerland to Germany.

Stefan Oschmann, the Merck Executive Board member responsible for Merck Serono, said: “The planned measures for Merck Serono’s operations in Switzerland are needed to ensure our global competitive position in a rapidly changing market and to secure the long-term future of the company.

“We are committed to working closely with key stakeholders, especially affected employees, to find socially responsible solutions, including exploring potential entrepreneur partnership programs and redeployment proposals.”

Merck Serono will consolidate all headquarter functions in Darmstadt, Germany, and transfer key R&D positions from Geneva to Darmstadt, Beijing and Boston – taking advantage of the latter’s well-established biotech hub.

Of the division’s 1,250 current positions in Geneva, over 750 will be transferred and the remainder will be lost.

Merck Serono will maintain its manufacturing presence in Switzerland, including its biotech production sites in Aubonne and Corsier-sur-Vevey. Its manufacturing operations in Coinsins will be transferred to Aubonne, and 80 jobs will be lost across the three sites.

A consultation process with employees will start on April 25, and will include attempts to identify redeployment opportunities.

In addition, a dedicated team will try to help employees identify potential spin-off and start-up opportunities. Merck Serono is prepared to commit up to €30m in seed funding to support these projects.

The division plans to commence relocations and workforce reductions in the second half of 2012, to be concluded in the first half of 2013.

The European Medicines Agency (EMA) and the Food and Drug Administration (FDA) in the US will share manufacturing site inspections from January 2012.

The initiative is expected to free up resources for the regulators and reduce the burden of inspections on pharmaceutical manufacturers.

It will apply to inspections of manufacturing sites for human or veterinary medicines in the EU or the US, and will focus initially on sites with a history of good manufacturing practice.

The EMA and FDA currently carry out many inspections in each other’s territories, with much duplication of work.

A further factor is the trend for pharmaceutical companies in Europe and the US to outsource their manufacturing to China or India, making the process global rather than national.

According to the EMA, the changes will mostly affect post-authorisation rather than pre-authorisation inspections.

The initiative follows two pilot projects run by the EMA and FDA to trial the sharing of inspection data:

• An 18-month Good Clinical Practice initiative whereby the two regulatory bodies exchanged more than 250 documents relating to 54 medications.

• A two-year project to cover inspections for joint active pharmaceutical ingredients in the EU, the US and Australia. The participants exchanged nearly 100 inspection reports and nine joint inspections.

The EMA commented that the pilots had increased the shared knowledge of both agencies and identified a number of inspections that would be useful in more than one region.

A new report by the FDA highlights weaknesses in medical device quality in the US over the past decade.

The FDA’s report, Understanding Barriers to Medical Device Quality, stated that while revenues in the medical technology industry have grown over the last ten years, “serious adverse events” have outpaced this growth by 8% each year.

Failures in medical device design and manufacturing process control were found to account for more than half of all product recalls.

“While medical device flaws may vary by device, some sources of error are pervasive throughout the field,” the report reads.

“Identifying and addressing systemic barriers may yield improvements in medical device quality on a large scale.”

The report was launched by the FDA’s Center for Devices and Radiological Health in order to understand and improve gaps in device quality, and outlines recommendations for both industry and federal regulators.

The analysis found that “nearly 60% of the adverse event reports” involved cardiovascular, in vitro diagnostics and general hospital/surgical equipment.

“Our efforts revealed that there are systemic gaps within the medical device industry's quality approach that result in these issues,” said the report. “Attempts to improve quality are hindered by challenges within the industry as well as specific aspects of the agency's regulatory approach.”

According to the FDA, medtech manufacturers are facing a series of challenges which are impeding device quality, such as the increasing complexity of devices, time to market competition, and cost pressures.

Identified opportunities for improvement include postproduction monitoring and feedback, creating quality incentives, and improving design and engineering.

The report also cited steps for the FDA to incorporate, such as clarifying Agency requirements and learning from regulators of similar high-tech industries.

A similar initiative is underway in Europe to improve medical device regulatory assessment processes, with support from Eucomed.

What level of medical device failure is acceptable? Brad Abbey argues that the industry needs to arm itself against the threat of litigation – not with lawyers, but with the right kind of evidence.

I was somewhat taken aback by a letter in the British Medical Journal last December, where under the unlikely-sounding title ‘FDA is gold standard of review’, Mark B. Leahy, president and CEO of the US Medical Device Manufacturers Association, while singing the praises of the industry, said that a recent study of FDA-approved medical devices from the past 5 years showed that fewer than 1% had been recalled.

Most recalls, he said, were due to manufacturing and design problems in a post-marketing setting. This was in response to an article that had been highly critical of the safety surveillance of medical devices in the US and the low hurdles that have to be jumped to get a device approved (seemingly true on both sides of the Atlantic).

I am a generalist in the healthcare industry, mainly involved with medicines, but to say I was surprised by that figure is an understatement. I realise that the number of car recalls may be higher – but with a surgically implanted device, the owner cannot check it in at the service centre and pick it up at the end of the day.

I know that MHRA gives daily warnings about medical devices, from wheelchairs to drug-eluting stents; but given that the level of adverse event risk that is acceptable to the public for a medicine is somewhere between 1 in 10,000 and 1 in 100,000, the 1% risk seems difficult to accept.

A lead article in the May 2011 BMJ, by Peter Wilmshurst of STARFlex fame, opened with the comment that the regulation of medical devices is (in his opinion) unsatisfactory, unscientific and in need of a major overhaul. Pretty damning stuff.

 

Duty of care

The registration of medicines requires data on the safety, efficacy and quality of products, and the numbers of patients needed to demonstrate an acceptable risk/benefit profile can be dauntingly high. The same level of scrutiny does not happen in Europe for medical devices, where a single approval can trigger cross-community acceptance.

With the increasing complexity of devices and the high levels of patient expectation, it is hardly surprising that when seemingly good devices go wrong the patients want compensation – and, where there is a suitable arena, for punishment to be meted out.

In the US, where many complex medical devices are developed and initially marketed, the ‘learned intermediary’ doctrine has been used by healthcare product manufacturers in recent times to protect themselves in the event of something going wrong. This doctrine, used in the US legal system, states that the manufacturer of a product has fulfilled their duty of care when they provide all the necessary information to a ‘learned intermediary’, who then interacts with the consumer.

This doctrine has been used primarily by pharmaceutical and medical device manufacturers in defence against tort suits. In a majority of American states, the courts have accepted this as a liability shield for pharmaceutical companies.

However, drug and medical device manufacturers sustained an unexpected blow in August 2008 in Rimbert v Eli Lilly and Company: in a federal court decision, for the first time, there was a rejection of the learned intermediary doctrine in its entirety. The decision rejected the notion that the manufacturers of drugs and medical devices do not have to make the patient fully aware of the risks associated with them and that this can be delegated to the prescriber.

The idea underlying the ‘learned intermediary’ doctrine is that the prescriber, who has expert knowledge and skill, should make the decision about risk. But changes in the consumer environment whereby prescription products can be advertised directly to potential patients have rendered this justification obsolete, and so it was predictable that for medical devices – some of them traditionally never coming ‘into the hands’ of the patient – the risk scenario would be influenced by the lesser amount of risk/benefit information needed before approval for marketing. While the doctrine has not been used in Europe, the risk information relating to devices is lagging behind that for medicines.

In order to be vigilant about the risks of medical devices, companies will be best served by surveillance systems that monitor the risk/benefit profile of products from the moment they are first evaluated (even if that takes place in animal models). This is not always easy.

A letter in the BMJ (in the same issue as Leahy’s letter) from a Welsh group of doctors highlights the problems of post-marketing surveillance for medical instruments, and in particular the use of single-use devices for tonsillectomy from 2001 in the wake of the variant Creuzfeldt-Jakob disease that followed the ‘mad cow’ scare of the 1990s.

Widespread adverse events were associated with these non-reusable instruments despite their CE marking, and they were deemed not fit for purpose. The case for reform of medical device regulation therefore seems a given.

 

Hip or lame?

In the meantime it seems that the visible portion of the iceberg of device regulation-related problems is giving rise to a stream of litigation that could possibly become a tide. Recent Medtech Business news reports have followed the fate of orthopaedic company DePuy and its ASR hip replacement.

Hip replacement is one of the clinical successes of the marriage between orthopaedic surgeons and the medical device industry, and it was estimated (before this year’s NHS rationing) that about 70,000 patients were undergoing total hip replacement each year in the UK.

I remember metal-on-metal hip replacements from the 1970s (I have one in a drawer at home that came to me as a result of its breaking), and they became popular again in the 1990s. However, the most recent generation have not fared so well, with higher than expected rates of failure and concerns about excessive levels of metal ions (cobalt and chromium) in the blood of patients.

According to 2010 data from the National Joint Registry of England and Wales, the DePuy ASR Hip Resurfacing System has a revision rate of 12% at 5 years after surgery and the DePuy ASR XL Acetabular System has a revision rate of 13%.

That means that during the first 5 years after a hip replacement with the DePuy ASR hip, at least 1 in 8 patients will experience hip failure requiring painful and expensive revision surgery. With more than 90,000 DePuy ASR hips in patients worldwide, over 11,000 people could require additional surgery due to the defective design of this implant and DePuy’s failure to remove it from the market earlier.

One of the questions that remains unanswered was whether there were potential conflicts of interest between the supplier and the healthcare professionals who developed and were involved in promoting these devices. The key issue in litigants’ minds is that the device did not perform as well as such a device might be expected to, and it seems that the device’s registration in the US was obtained without clinical trials to prove its long-term safety and efficacy. In a litigious society such as the US, where someone must pay for any mistake, the supplier appears to have suffered with the rolling of heads and the decision to remove the offending brand from the market.

Don’t get the idea that this case is a one-off: the recent history of medical devices suggests that arrivals on the market may sometimes be premature, as real risks may not have become apparent. Whether this is related to inappropriate endorsements from the medical profession is difficult to judge, but there are known examples of high-level payments to medical inventors who ‘sell’ their developments to industry and subsequently endorse them.

On the other hand, everyone is aware of what happened to Peter Wilmshurst when he took the opposite stance against a device manufacturer: there was a serious attempt to punish his critical views (which seemed to be well founded) and personally break him through the English court system.

 

Evidence is strength

Litigation against medical device companies is nothing new. However, in an age when people with problems can readily find lawyers willing to take on their problems, and some lawyers (particularly in the US) go looking for people who did not even know they had problems, access to litigation seems to be easier – and it is oiled by the possibility of compensation (which may be deserved when devices turn out to be inadequate or unsafe).

A Google search for the term ‘medical device litigation’ returned 640,000 hits; most of the leading ones were to do with lawyers offering their services in the pursuit of such litigation, or training sessions for lawyers who want to become involved in such cases, or training for companies who want to avoid them. I don’t believe a wake-up call about the risks of being sued is necessary, but what is well worth thinking about is the possible root causes of the current danger, which can ruin a company that believed it had a good product.

The message I am offering is consistent. The products of the healthcare industry must be subject to close and continuous scrutiny for their risk/benefit profile, and this should be done prior to marketing and continue in a structured manner post-marketing. NICE advisory policy on the best devices to use is still in its early stages.

There seems to be a raft of opinion supporting the idea that the regulation of medical devices (in Europe, and probably also in the US) needs to be overhauled to eliminate the placing of devices on the market with inadequate safety and efficacy monitoring.

Rather than finding ways of avoiding expenditure during a product’s development and launch by minimising the collection of such data, companies need to embrace the need for resilient data sets and continual risk/benefit signal monitoring. The competent authorities will wake up to this need, and those with effective systems in place will withstand the culture change best.

Brad Abbey is an industry observer, or the pen-name of an industry observer. The views expressed in this article are those of Brad Abbey, and do not necessarily reflect the views of Medtech Business.

Medical device outsourcing company Vention Medical has acquired ATEK Medical Group, a leader in medical device assembly, packaging and injection moulding.

Dan Croteau, CEO of Vention Medical, said, “Our partnership with the ATEK Medical Group management team will allow Vention to provide an enhanced customer experience. Like Vention, ATEK Medical Group aspires to continually satisfy customers through intense focus on services that improve quality, innovation, and cost.”

The acquisition will incur a variety of combined capabilities and services, including product design and development, innovative component technologies, along with the manufacturing space of 175,000 square feet at its Costa Rica campus.

ATEK recently opened a second facility in Grand Rapids, Michigan, to support customer demands in the US.

Chris Oleksy, President of ATEK Medical, and Tom Houdeshell of ATEK Plastics, said that Vention’s experience and capabilities in design, components and assembly makes Vention “a very appealing partner for us”.

Vention Medical specialises in components and services used in interventional and minimally-invasive products, including medical balloons, advanced extrusions and heat shrink tubing, clean room injection moulding, assembly and packaging services.

Nephron Pharmaceuticals plans to build a $313 million plant in Cayce, South Carolina, creating 707 new pharmaceutical jobs.

The generic respiratory treatment specialist will build its new facility on a 60-acre site to help expand its market and develop a pipeline of products.

Nephron currently employs more than 400 people at its manufacturing and distribution facility in Orlando, Florida.

The state will contribute $4.5 million to the facility’s preparation and construction costs, which is set to be up and running within the next couple of years.

France is Europe’s biggest importer and exporter of medical devices. However, current reforms are driving cost reduction and efficiencies. Medtech Business in association with Espicom takes a look at the French market for medical technologies.

France is one of the top five medical device markets in the world, accounting for around 3.9% of the global market.* Within Europe, the market ranks behind Germany and is a similar size to that of the UK.

The country has a well-developed healthcare system, combining public hospitals with commercial clinics that are the main providers of elective surgical treatment. While the public sector is the largest purchaser of most diagnostic and therapeutic equipment, the private sector is the dominant purchaser of surgical equipment and supplies.

The high level of healthcare expenditure (11.8% of GDP) and the substantial health deficit are major concerns that have prompted various reform programmes aimed at curtailing costs and improving efficiency in the healthcare system. For this reason, the medical market is only likely to see moderate growth, rising from US$8.3 billion in 2011 to US$9.8 billion by 2016.

Despite several high-profile investment programmes, France continues to lag behind its European neighbours in some high-technology fields, most notably imaging and radiotherapy equipment. A second five-year cancer plan has now been launched which aims to increase the numbers of scanners.

With flagging domestic production in several sectors the French medical device market is increasingly reliant upon imports, which now account for around 80% of consumption. However, many imported products are re-exported to other countries.

 

The market in 2011

In 2011, the French medical device market (see Figure 1) is valued at US$8,280 million. Consumables is the largest product category, accounting for 20.9% of the overall market, followed by diagnostic imaging (19.8%).

Espicom estimates that the medical device market will grow at an average annual growth rate of 3.5% between 2011 and 2016 – bringing the total market value to US$9.8 billion by 2016.

Orthopaedic and prosthetic devices are expected to continue to be the most dynamic sector of the market, with growth forecast to be more than double the rate for the overall market. Conversely, diagnostic imaging is forecast to have the lowest growth during the 2011–16 period.

 

Predictions for market segments

Figure 2 shows Espicom’s predictions for the major segments of the medical device market.

1. Consumables. The market for medical consumables is estimated at US$1,729 million. The consumables market grew at an annual rate of 5.1% in US dollar terms between 2006 and 2010. Imports supply the greater part of the market. Espicom estimates the consumables market will continue to grow by an average of 3.5% over the next few years.

The wound care products market is forecast to grow at an average annual rate of 2.9% in US dollar terms during the 2011–16 period. Syringes, needles & catheters has been the fastest growing sector of the consumables market and will continue to be, with a CAGR of 4.1% to 2016.

2. Diagnostic imaging apparatus. The market for diagnostic imaging is estimated at US$1,636 million. The market grew at an annual rate of 2.8% between 2006 and 2010. France lags behind its European neighbours in the diagnostic imaging field, though the second cancer plan aims to increase provision of MRI, CT and PET scanners.

Imports supply the greater part of the market, though their market share is lower for radiation apparatus due to the strength of the domestic manufacturing industry. The USA and Germany are the major sources of supply. Espicom estimates that the imaging market will grow by an average of 2.1% between 2011 and 2016.

3. Dental products. The market for dental products is estimated at US$859 million, equal to 10.4% of the total medical device market. The dental products market grew at an annual rate of 4.2% between 2006 and 2010. It is forecast to grow at an annual rate of 3.5% over the next few years, taking the total to US$1,020 million by 2016.

4. Orthopaedic & prosthetic devices. The market for orthopaedic & prosthetic devices is estimated at US$1,336 million, equal to 16.1% of the total medical device market. The orthopaedic & prosthetic devices market grew at an annual rate of 9.2% between 2006 and 2010.

Imports have seen particularly high growth in recent years, though a corresponding increase in exports in this sector indicates that not all imported products are destined for the domestic market. The majority of orthopaedic imports are supplied by Switzerland and the USA.

The orthopaedic & prosthetic devices market is forecast to grow at an annual rate of 6.1% in US dollars over the next few years, taking the total to US$1,794 million by 2016.

5. Patient aids. The market for patient aids is estimated at US$1,131 million, equal to 13.7% of the total medical device market. The patient aids market grew at an annual rate of 4.5% between 2006 and 2010.

French imports of patient aids far exceed the value of the domestic market due to a high level of re-export activity, particularly for pacemakers. Switzerland and the USA are the leading suppliers of portable aids, whilst the USA and China are the major sources of supply for therapeutic appliances.

The patient aids market is forecast to grow at an annual rate of 3.9% over the next few years, taking the total to US$1,367 million by 2016.

 

Imports

The value of French medical device imports has recorded a steady rise over the past decade, reaching US$10.4 billion in 2008 before falling back to US$10.3 billion in 2009.

Imports of consumable items amounted to US$1,780.6 million in 2009. Imports fell by 1.0% over 2008 in US dollar terms (though they increased in euro terms). Syringes, needles, catheters & cannulae are the largest subcategory.

Diagnostic imaging imports totalled US$1,564.0 million in 2009, equal to 15.2% of the total. This was the weakest performing category in 2009, with a fall of 16.4%.

Imports of orthopaedic & prosthetic devices were worth US$1,549.1 million in 2009, equal to 15.1% of total medical device imports. This was the fastest growing category in 2009, with a rise of 26.6%. All three subcategories – artificial joints, orthopaedic appliances and other artificial body parts – recorded strong growth.

Patient aids are the largest import category, with imports worth US$2,624.1 million in 2009, equal to 25.5% of total medical device imports. Pacemakers accounted for 54.7% of imports in this category in 2009, but also accounted for more than half of patient aid exports.

The leading suppliers of French medical imports in 2009 were the USA, Switzerland and Belgium, with the UK ranking eighth as a supplier with imports worth US$288,964 (2.8% of the total).

 

Exports

In 2009, medical device exports registered a 3.0% fall in value to US$9.2 billion, having recorded steady growth in previous years with a CAGR of 6.8% for the 2005–2009 period.

In 2009, 69.5% of all French medical device exports were sent to the rest of the EU, with the Netherlands taking a 17.6% share, followed by Germany with 14.4%. The UK took 6.6% of French medical device exports.

Outside Europe, the leading destination is the USA, which accounted for 9.1% of exports. The USA is the leading destination for French exports of diagnostic imaging apparatus.

Next month, Medtech Business will look at the medical technologies market in Germany.

This article is based on information from Medical Market Outlook reports published quarterly by Espicom Business Intelligence. *All figures are in US $. For further details of the 66 markets covered, please visit www.espicom.com/outlookm1

Nanotechnology holds the key to a new generation of medical devices and diagnostics. Mike Fisher of the Nanotechnology KTN looks at how miniaturisation is changing the face of healthcare.

Over the past decade there has been significant interest in the promise that micro and nanotechnology holds for life sciences.

An estimated 40% of US nanotechnology venture capital is being allocated to life science start-ups – and over 2008 and 2009, according to a study carried out by Lux Research, healthcare and the life sciences saw an increase in investment of 42%, while other areas such as manufacturing and materials saw a decline.

Europe has a number of leading biotechnology companies, as well as world-renowned R&D facilities. Traditionally the emphasis of these companies has been exclusively on biotechnology – but more recently the lines between biotechnology and the electronics industries have become blurred, creating a new and exciting field of new applications and markets using techniques acquired in the semiconductor world.

The electronics industry has been transformed by the strategy that ‘smaller is better’, and using these same techniques and applying them in medical and pharmaceutical contexts has opened exciting new market opportunities. The next level of miniaturisation, into nanoscale dimensions, is a booming area of R&D with significant funding being invested worldwide.

Mobile diagnostics

Using miniaturisation, medical diagnosis equipment can now be used outside of the lab: in doctor’s surgeries, remotely, and even on mobile phones. The applications are endless.

Imagine a world where all you need is your smart phone to detect any disease through blood analysis, without the need for costly and lengthy analysis in the lab. That could be real in five or ten years’ time.

Ten years ago the ‘lab-on-chip’ was a concept without a viable market entry point, but now point-of-care diagnostic systems are starting to show clear benefits in disease detection and cancer therapy.

By using these applications to analyse samples of blood, interstitial fluid, urine and saliva, medics are able to use minimally invasive techniques to obtain quick results that are easily collected, with minimal stress and discomfort to patients.

Using miniaturisation in diagnosis means that the size and cost of equipment can be reduced dramatically. Sensors can be made available at the point of care, in many cases providing a diagnosis while the patient is with the doctor. Providing early diagnosis means that the right treatment can be given early, avoiding complications caused by delays.

Micro and nano diagnostic devices can also provide closed-loop systems that continuously monitor patients and respond immediately to physiological changes. This is particularly important in the intensive care unit, where simple parameters such as oxygen levels can be critical.

In the future, as medical systems become fully integrated with semiconductor technology, we can expect lab-on-chip devices that measure information on disease markers, cell count or DNA-RNA from a very small quantity of blood or other biological fluid sampled by pain-free needles, and ways to receive and transmit real-time information from sensors located inside the human body.

With applications such as point-of-care diagnostics already emerging with huge benefits to patients, there is no doubt that the next generation of healthcare technology will be enabled by the use of miniaturisation.

Taking a simple and effective concept from the semiconductor world has already delivered a dramatic effect on medical diagnostics and is now moving into drug discovery, creating new and exciting applications across a wide variety of markets.

Chain reaction

Getting these applications to market has been hindered by a lack of potential investors and early adopters willing to take a leap of faith. However, there are now a significant number of international companies developing these new application technologies, as they have begun to see the clinical effectiveness offered by nanotechnology and miniaturisation.

The current interest in the use of miniaturisation in the life sciences has been driven by the many advances this new concept promises. Individuals, companies and funding bodies are looking for ways to invest in this newly commercialised technology. To ensure success, nano-companies need to secure support from venture capitalists and other funding bodies, which can be difficult in the current economic climate.

However, despite the advanced developments in miniaturisation in the life sciences, the industry is still relatively new and there are a number of gaps in the supply chain that prohibit products from getting to market in an effective manner. It is crucial with any new technology to ensure that all parts of the supply chain interact and keep each other informed of developments and capabilities.

One of the Nanotechnology KTN’s main remits is to analyse this supply chain, determine where the gaps are and encourage companies to recognise the commercial gains that can be reaped from bridging them.

Connecting members of the supply chain with one another means that academics, research specialists, industrial practitioners and funding sources can meet to discuss ideas and business opportunities, thus ensuring the developments in this application of nanotechnology continue.

Clearly, many of the applications in these new markets are novel and as a result have yet to be fully developed and become economically viable. In the quest to make these technologies and applications available to a wider market, clinical efficacy and value to the healthcare payer are ultimately the deciding factors.

Increasingly, products need to be cost-effective – and the materials used to produce each device represent a significant part of the cost. It can be expected that as the use of miniaturisation in life sciences becomes more widespread, the associated costs will reduce and the applications will expand much more widely.

Given the economic benefits it promises, it is inevitable that the use of miniaturisation in the life sciences will continue to be adopted and supported.

Mike Fisher, PhD, is Theme Manager – Life Sciences & Healthcare at the Nanotechnology Knowledge Transfer Network (KTN).

Sanofi Pasteur has invested $300 million in plans to open a new vaccine manufacturing plant in India by March 2012.

The new plant aims to help expand the company’s vaccine capabilities, following the acquisition of India’s Shantha Biotech for $784 million in 2009.

However, the deal carried manufacturing defects forced by the WHO to cancel pre-qualification of the vaccine Shan5, costing Sanofi hundreds of millions of dollars.

But Chris Viehbacher, CEO of Sanofi, said to the Business Standard: “We have implemented all the corrective measures. And we are quite positive about the relationship with Shantha and will be participating in global tenders once the pre-qualification process is completed for low-cost and high-quality vaccines.”

By 2015, Sanofi expects 30% of its total sales to come from the US, 33% from Europe and the rest from emerging markets.