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

A new antimicrobial dressing suitable for severe and highly exudating wounds has been launched in the UK.

Hydrofera Blue (pictured) from Swindon-based company Synergy Health has been developed from blood purification technology.

The dressing is made from poly-vinyl alcohol (PVA) foam that can absorb up to 25 times its own mass in fluids, while binding and eliminating endotoxins.

The foam is combined with two active organic pigments, Gentian Violet and Methylene Blue, which have broad-spectrum bactericidal properties.

The unique construction of Hydrofera Blue means that no antimicrobial chemicals are deposited in the wound.

The combination of pigments was invented by Dr Edward Shanbrom, a pioneer in the use of natural products to cleanse blood.

Hydrofera Blue is effective against the most common pathogens that affect wounds in the UK, including E. coli and MRSA.

The sponge-like foam base of the dressing means that it is both comfortable and durable, and contours easily to the wound bed.

The product has been used extensively in the US since 2003, but until now has not been available to the UK healthcare market. Synergy Health is currently evaluating its use in acute and community settings.

Hydrofera Blue is available in a range of sizes for wounds varying from moderate to heavily exudating. Tunnel and ostomy versions are also available.

Rachel Downham, Woundcare Product Manager for Synergy Health, said: “Hydrofera Blue provides a real step change in advanced wound care management. It has the potential to increase the rate of wound healing and improve pain and odour control, offering big advantages from both a patient comfort and a cost reduction perspective.”

Synergy Health delivers a range of specialist outsourced services to clients in healthcare and health management.

Peterborough-based wound care firm Coloplast has launched a staff wellbeing programme including popular Zumba classes.

The company’s ‘wellbeing week’ included free health checks, a raffle for health products and a session of the popular dance-fitness workout.

The programme continues with presentations for staff on health issues such as cancer awareness, healthy eating and how to maintain energy and concentration levels at work – supported by free daily fruit and weekly onsite Zumba classes.

Olympic athlete Sally Gunnell will join the Coloplast sales and marketing conference later this month to advise on fitness and host a workout for more than 50 employees.

Sam Sedwill, HR Director at Coloplast, commented: “We pride ourselves on listening to what our staff are saying, so when they put forward excellent ideas for ways of helping to improve their work-life balance, we took those ideas and put them together to form a full-scale wellbeing programme.

“The Zumba classes are great fun – fast and frantic, but fun! As well as helping us to get fit it’s a great way of meeting people you don’t normally spend time with at work.”

Zumba is a Latin-inspired dance-fitness programme using international music and rapid-paced steps. Over the last decade it has become vastly popular, with 12 million followers in 125 countries worldwide.

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

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

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

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

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

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

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

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

The FDA has approved MediPurpose’s new range of foam wound care products, MediPlus, containing antibacterial silver.

The products are indicated for use on chronic and traumatic wounds, including ulcers (arterial, diabetic and venous), pressure soles, donor sites, surgical incisions/excisions, and first and second degree burns.

The dressings use antibacterial silver control to provide an effective barrier to bacterial penetration.

Michael Riddle, Vice President of Wound Care at MediPurpose, said: “Our ability to provide cost effective wound care solutions is an integral part of MediPurpose’s value proposition. We can now supply a range of antibacterial dressings at prices that will allow healthcare professionals to offer these beneficial products to a larger population of patients.”

The company also launched its new Foam Ag, Comfort Foam Ag and Super Foam Ag dressings, part of the MediPlus range.

The products are expected to be available in the fourth quarter in the US.

The diversity of wounds and the wounded means that the evidence base for wound care therapies is a complex issue. Professor Richard White of the University of Worcester and Wound Care Alliance UK looks at how companies can best establish the case for their products.

The current situation regarding issues of product evidence and product availability in wound care has been discussed in Medtech Business (May and June 2010). Therapies affected by these issues include silver and other modern wound treatments, such as moist wound healing dressings and topical negative pressure (TNP) devices, which have attracted the scrutiny of those who conduct systematic evidence reviews. Following those commentaries, this article offers some proposals for a way forward.

Therapies on trial

The modern age in wound care, dating from around 1970, has seen a variety of new medical devices come to market – many of which have achieved ‘standard of care’ status. For example, elastic and non-elastic compression bandaging; hydrocolloid, alginate, foam and film dressings; honey as a CE Marked product and many others have become established in the clinical armamentarium.

Countless clinicians, many of them acknowledged experts, have come to rely on these products, knowing that when they are correctly used they work well. This steady supply of products has come from an innovative, dynamic industry that works closely with the clinician.

However, the evidence gathered to support these products does not satisfy the various groups who insist on the Cochrane-style analysis of randomised clinical trials (RCTs). Recent publications have criticised the evidence for moist wound healing, antiseptic dressings and TNP. This criticism, published in the medical literature and the national press, has led to restrictions on product availability.

The key priority, in my view, should be to maintain a regular flow of safe and effective innovations, supported by sufficient evidence for regulatory purposes and for informing the clinician. The introduction of such products should, of necessity, be followed by the ongoing collection and publication of clinical evidence.

Innovation is vital to wound care, as the steady flow of new and improved products leads directly to better patient care. The discipline is still in its infancy – a stage when developments are frequent. The industry is populated by a broad mix of large, established companies and smaller companies, many of them start-up ventures. This affects the level of investment available for expensive RCTs.

Should trials be left to the wealthy companies alone? Or can other, more economical forms of clinical evidence be gathered instead? That would offer the smaller, less affluent companies greater opportunity to develop products, gather evidence and take their treatments to market – and in the past, that has been a significant feature of wound care in the UK.

There is no doubt that evidence in one form or another is essential for the development of wound care – so open discussion of the issues around what makes for effective evidence is needed. In addition, some proactive action on the part of the wound care sector is also essential: companies must, to my mind, take action before further restrictions in product availability are foisted upon them.

Finding the facts

There is a strong case for looking more carefully at what evidence is already available in the public domain. Cochrane analyses have been justly criticised for not taking all of the available evidence into consideration. A preferable method of analysis, with recommendations, is the GRADE system. This well-known and respected system, in my opinion, should be employed to assess the evidence for a number of existing products.

With regard to the ‘quality’ of different types of evidence, the European Wound Management Association (EWMA) has published guidelines for the conduct of RCTs in the May 2011 issue of the Journal of Wound Care.

If a company decides that an RCT is the most appropriate means of gathering clinical evidence, it is important that they avoid the pitfalls which have blighted many previous trials. The Cochrane reviews list the numerous shortcomings in trials, mainly methodological errors, which form grounds for disqualification. These can be avoided!

• At the planning stage, trials should be configured with purchasers in mind: as well as gathering clinical information, the trial should take account of economic factors and quality of life instruments.
• Once the data are published, these should enhance the chances of product uptake or changes in clinical practice. Quality data will make counter-arguments difficult and merit publication in quality journals, and so garner support from opinion leaders.

Case studies are frequently used to provide support for products. However, it is an unfortunate fact that many, probably most, of these studies are of very little value. This is due to their planning and objectives, as well as the information provided. When case study posters and journal reports make products appear to be panaceas, it is no wonder that the whole exercise becomes devalued.

Cohort studies, when properly conducted, can be valuable in many ways. Their merit has been extolled by many influential figures. The GRADE system of analysis gives reasonable weighting to such studies, whereas Cochrane analyses ignore them completely. Their format is less clear than that of RCTs – but when they are conducted in a multicentre setting, with clear objectives and endpoints such as clinical goals, economic factors and quality of life issues, they provide useful data.

Post-marketing surveillance studies, conducted long-term in the ‘real world’ of routine clinical practice, are under-used and under-estimated in wound care. As far as I am aware, they are mandatory in Germany and some quality data have been published from these studies.

Audit of clinical practice is as ‘real world’ as we can get when it comes to clinical (and hopefully financial) data. Efficient clinical settings can audit their practice for long-term outcomes in treatment of wounds. Such studies can provide the most meaningful evidence.

Value and cost

Cost-effectiveness, or health economics, has been a high priority in healthcare for many years, yet it does not figure in enough wound studies. Rather naively, claims of ‘cost-effective’ based on the unit price of a product still appear.

Health economics is a defined and refined science and must be recognised, and used, as such. In this respect there is vast room for improvement in company-sponsored wound treatment studies.

For the future, it is important that the evidence for wound care therapies is of better quality than it generally has been over recent decades. This is achievable through awareness of the literature and close liaison with experts – it does not necessarily need to incur substantially greater costs!

The whole dynamic of selling has changed over the past twenty years. No longer is it sufficient to demonstrate the product to a nurse or doctor and wait for the orders to flow in. Other key groups are now involved, and liaison with them to facilitate product uptake has become essential.

Everyone involved in wound care in the UK must now be aware of, and recognise the important role of, pharmacists, medicines management, formulary committees etc. Companies must do more to involve these groups.

The transition or evolution of standards for medical devices from the days of the first modern ‘moist wound dressings’ is remarkable. Following the enactment of the Medical Device Directives in the mid-1990s, the system has become more ordered and bureaucratic.

However, this process is far from complete. The recent furore over failing hip implants has shown that the current regulations are not adequate to prevent major clinical catastrophes involving medical devices. In the USA, the FDA is taking a very close look at device regulation.

As the standards for evidence become more sophisticated, better reflecting the realities of clinical practice, the medical device industry – and in particular, the sector supplying wound dressings and associated products – has the opportunity to address the need for change and adapt accordingly.

 

 

Richard White is Professor of Tissue Viability at the University of Worcester.

US biomedical scientist Dr Robert Langer (pictured), whose work led to the use of artificial skin to repair burns, has been named the winner by The Economist in the bioscience category of its tenth annual Innovation Awards.

The award, sponsored by Astellas Pharma Europe Ltd, recognises Dr Langer’s exceptional contribution to tissue engineering and drug delivery.

A pioneer of biomedical engineering, Dr Langer is the David H. Koch Institute Professor at Massachusetts Institute of Technology, where he leads the world’s largest biomedical engineering laboratory.

The polymer-based artificial tissues developed by Dr Langer are now used as a basis for replacement skin, as well as the controlled administration of drugs and hormones.

“Robert Langer is one of the most innovative and influential biomedical engineers of our time,” said Tom Standage, Digital Editor at The Economist and chairman of the judging panel.

“His proven successes in drug-delivery and tissue engineering have made possible new forms of medication and treatment. He is a worthy recipient of our bioscience award.”

Ken Jones, CEO of Astellas Pharma Europe Ltd, commented: “Robert Langer has made an extraordinary contribution to the field of biomedical engineering and has been responsible for true breakthroughs in the global quest to discover better ways to manage diseases.”

To mark the tenth year of its Innovation Awards, The Economist is inviting all past winners to attend awards ceremony on 21 October. Those attending include Hermes Chan, developer of rapid HIV diagnostic testing, and Mikkel Vestergaard Frandsen, developer of low-cost medical devices for the developing world.

A test originally designed to predict cancer prognosis could save the NHS millions of pounds in treating patients with chronic wounds, scientists have said.

The test, developed by two Welsh life scientists, is set to be commercialised by Fusion IP and promises to improve wound care by analysing the genetic signature of a wound.

Chronic wounds, such as those caused by leg ulcers and pressure sores associated with diabetes, currently cost the NHS £180m a year in Wales alone.

Keith Harding, Professor of Rehabilitation Medicine and Wound Healing at Cardiff University, said: “At a time when we can cure many cancers and transplant organs at will, we still can’t get a patient in front of the right person at the right time when they have a wound. A majority of patients will be seen in routine clinical practice for many months or even years before the clinician will say someone else needs to see the patient.”

It can currently take up to 12 weeks to determine whether a leg ulcer wound is responding to treatment, but Professor Harding said in one case he came across, a patient had had his dressings changed weekly for 57 years with no improvement in his wound.

Approximately 60% of chronic wound cases are unresponsive to the current traditional treatment. The new test, however, has been shown to be 98% accurate in initial research.

The test is the result of a four-year collaboration between Professor Harding and Wen Jiang, also a professor at Cardiff University, and examines the genetic signature of the wound.

Professor Jiang, Professor in Surgery and Tumour Biology at Cardiff University, said: “The very close correlation between the genetic signature and the future outcome of the wound healing process gives us confidence this test will deliver real benefits to patients.”

The collaboration has been granted £150,000 from the Welsh Government’s Academic Expertise for Business (A4B) programme to validate the new wound test.

Both professors hope to set up a company to commercialise the product, with support from Fusion IP, Cardiff University’s commercial partner.

“The idea is to give the average clinician the opportunity, at almost the first appointment, to tell whether a patient is going to be easy-to-heal or hard-to-heal,” commented Professor Harding.

Ernest Waaser, new CEO of global wound care company Systagenix, talks to Medtech Business about the importance of helping clinicians to address the challenge of wound healing across a range of care environments.

Ernest Waaser is the recently appointed CEO of wound care company Systagenix, based in the UK. Formed in 2008 through a buyout of Johnson & Johnson’s advanced wound care business, Systagenix supplies wound dressings to over 100 countries. The recent launch of its ‘Let’s Heal’ brand shows the company addressing the wound management and healing process proactively across primary, secondary and home-based care environments.

What prompted the launch of Systagenix in 2008: what opportunity did the company’s founders identify?
When our investors looked at the business back in 2008 they saw a strong existing business that, with the right focus and strategic investments, had a terrific opportunity to grow. The business had a 75-year heritage, a world-class R&D capability, and a strong reputation in wound care – a clinical area that’s continuing to grow with the ageing population and the increase in diabetes and obesity. It was part of a very large diversified company where it had to fight for investment and resources against other businesses. So by creating a stand-alone company that’s solely focused on wound care, we can be much more responsive to the needs of the market, make those strategic investments and bring real innovation to the world of wound care.

What is the thinking behind the ‘Let’s Heal’ brand?
What has it achieved for the company and for the industry? There are two basic beliefs behind the brand. First, we believe passionately that the goal is wound healing, not wound management. And in today’s practice, too often companies focus on managing individual symptoms in isolation from each other, rather than tackling the whole wound healing process as a continuum. Second, we recognise that there’s no single product or device that will heal every wound. Each patient and each wound is different, and there may be many reasons why a wound is not healing: the patient may have an infection or a high protease level, or a venous insufficiency, or any one of several other underlying illnesses or complications.

So our objective is to take a more holistic approach, to put a system in place, starting with diagnostic tools and leading on to the proper treatment for that wound in that patient. ‘Let’s Heal’ is our approach to providing a range of treatment options and a systematic approach to when to use each product. The huge innovation here is to start that whole process with point of care diagnostics that will provide immediate feedback on the status of the wound, which the clinician then uses to help select the appropriate treatment. ‘Let’s Test’ is our Systagenix umbrella for future wound diagnostics and assessment products, and that’s the entry point for our overall system of care.

Systagenix has particularly focused on treating hard to heal acute and chronic wounds. How are you trying to change the way these wounds are perceived?
The first perception we’re trying to change is that some patients must live with a wound. Our objective is that every wound should be healed, and we think every patient deserves that. Managing life with a wound is not in our vocabulary.

The second thing we’re trying to bring visibility to is that hard to heal wounds are not only affecting the patient’s quality of life, but are very expensive for the healthcare system. In many countries wound care is done partly in hospital, partly in an outpatient setting and partly at home, so the costs are spread around and the total cost tends not to be visible to healthcare administrators. The product that’s used to treat the wound is a small part of the cost: there’s hospitalisation, physician time, multiple home nurse visits, and the very real cost of complications ranging from infections to amputation.

There haven’t been many large-scale economic studies, but the evidence is pretty clear that the faster you get a wound healed, the lower the overall cost to the health system. That really is the focus of our ‘Let’s Heal’ approach: to eliminate trial and error, using point of care diagnostics to get the right treatment started immediately and shorten the overall healing time and cost.

How does that strategy work at the sales and marketing level?
Wound care is a clinical process that is spread not only across different care settings –  hospital, home, clinic – but also across a number of clinical specialties that treat wounds: vascular surgeons, podiatrists, general surgeons and others. One leading international clinician told me that wound care is a team sport. So part of what we do from a sales and marketing point of view is to try and bring these various clinical specialties and different types of clinicians together, to take a look at how the overall care process can be improved.

For example, we recently brought an international group of key opinion leaders together who issued an international consensus document on the use of a diagnostic in wound care to detect high protease levels, which are a known inhibitor to wound healing. They are putting the ground work in place to establish the need for that diagnostic test and determine how it should be used in clinical practice. This element of bringing the clinical community together to look holistically at how we can help them and provide them with the right tools to diagnose and heal wounds is an important part of the marketing effort for us.

How are current changes in the NHS landscape affecting the UK market for wound care companies?
We really haven’t seen the major impacts just yet. Obviously the NHS will be incredibly focused on delivering high-quality care at the lowest possible cost. I think our challenge as a sector is to demonstrate very clearly that our products and services can materially lower the cost of wound care: faster healing, fewer visits and fewer complications. I think as we go forward and the landscape continues to change, we’ll monitor that carefully and adjust as we need to.

What are the major business challenges facing UK wound care companies seeking to export to global markets?
I’d point out three challenges. The first is regulatory. Our products are covered under medical device and/or pharmaceutical regulations in every country they’re sold in, and once you get outside the EU they’re all different. The second is reimbursement. Just because you have regulatory approval doesn’t necessarily mean you can get paid for the product. The reimbursement systems are different in literally every country in the word. So those two issues, regulatory and reimbursement, require the combination of a fairly sophisticated infrastructure with the right skills and expertise and good local partners in your export markets. And finally, you really have to tailor your offering to local needs, taking into account local clinical practice and pricing expectations.

What do wound care companies need to do to address the clinical and commercial challenges of healthcare in the 21st century?
21st-century healthcare is all about finding more cost-effective ways to deliver high-quality care to a growing population of patients. As an industry we need to help clinicians in wound care get the right treatment to the right patient quickly and avoid much of the costly trial and error process that exists today. That requires thinking about innovation in a different way, looking not only at your product but at the overall process for treating a patient.

Major wound care company Kinetic Concepts, Inc. (KCI) is to be purchased by a finance consortium comprising Apax Partners, the Canada Pension Plan Investment Board (CPPIB) and the Public Sector Pension Investment Board (PSPIB) for approximately $6.3 billion.

Based in the US, KCI manufactures and markets products for the wound care, tissue regeneration and therapeutic support markets that are used in a range of settings: hospitals, nursing homes, specialist clinics and the home.

The consortium plans to work in partnership with the management of KCI to expand the company’s core medical products business, developing new products and extending into new geographies.

Buddy Gumina, Co-head of the Apax Healthcare team, said: “We are highly impressed by the culture of innovation at KCI and are excited to work with a business that produces solutions that dramatically improve the lives of many people around the world.

“Over the years, we have reviewed multiple investments in the medical devices and products industry, having originally identified it as a key growth sector within our overall healthcare investment practice. Based on this experience, we possess a deep understanding of KCI’s business and the markets in which the company operates.

“We are delighted to have the opportunity to partner with CPPIB and PSP Investments to support the company’s continued growth.”

Apax Partners is a leading global private equity investment group that operates across the US, Europe and Asia. Canada Pension Plan Investment Board (CPPIB) is a professional investment management organization. The Public Sector Pension Investment Board (PSPIB) is a Canadian Crown corporation.

The acquisition is expected to close in the second half of 2011, subject to shareholder and regulatory approvals.