Research and Development
As part of our growth strategy, we develop new market-oriented products and enhance existing ones as well as improving dialysis treatments. Our R & D teams benefit from our vertically integrated business model. As we also operate dialysis clinics, they have acc ess to the opinions and experience of patients, physicians, and nurses at all times.
Rise in R & D expenses
In the reporting year, Fresenius Medical Care spent a total of around $112 M on research and development (2011: $111 M). Similar to previous years, R & D expenditure corresponded to approximately 3% of our dialysis product revenue and slightly less than 1% of our total revenue. At the end of 2012, our patent portfolio comprised some 4,850 property rights in approximately 850 patent families, i. e. groups of patents linked to an invention. Our development work in the reporting year produced around 80 additional patent families.
Expenditures for research and development
|in $ M|
Number of patents
In 2012, a total of 530 highly qualified employees (full-time equivalents) worked for Fresenius Medical Care in R & D worldwide (2011: 530). They come from various backgrounds: Physicians work side by side with software specialists, business economists and engineers in interdisciplinary teams. Our largest R & D unit with around 350 employees is in the EMEA region (Europe, Middle East and Africa); charts 2.4.4 and 2.4.5 provide information on their levels of education and professional backgrounds. Most of our R & D colleagues work at our German facilities in Schweinfurt and Bad Homburg. Smaller teams work in St. Wendel ( also in Germany), and in Bucharest (Romania), where an R & D competency center specializing in software developments has been set up. In addition, we have specialist teams for research and development in the North America and Asia-Pacific regions.
Number of employees in R&D
Effective March 1, 2013 Fresenius Medical Care has appointed a new member to the Management Board, who is responsible for our R & D activities. This underscores our aspiration to constantly improve our products, develop new solutions for treating patients on dialysis, and at the same time increase the efficiency of our processes in general and control them at a global level – see “Subsequent events”.
In Krems in Austria, we operate our own R & D department for sorbent technology see Glossary as well as manufacturing products for various sorbent therapies. In Krems, we are also in close contact with local universities – see section „Cooperation in research extended” in this chapter. Over the next few years, we intend to expand our unit in Krems into a competency center for sorbent technologies, as we believe that these technologies hold considerable potential for new blood purification applications and treatments.
As part of our innovation culture, we also strive to carry out research and development responsibly. For more information on this, see the “Responsibility” chapter.
Four trends characterize our research and development
Our R & D work was again particularly influenced by the following four trends in 2012:
- Advances in medicine and technology: Dialysis is still a relatively young discipline. It has only been available as a standard treatment for chronic kidney failure for about 50 years. However, research on the complex interactions and concomitant effects that occur with kidney failure is increasing. At the same time, the technological possibilities for treating patients are also improving. Our R & D is geared towards quickly turning new findings into market-ready products, enabling us to offer patients gentler, safer and more individual treatment. Major technological trends in this area include new developments in information technology, technologies to gradually reduce the size of products and simplify their use, and the integration of various treatment elements to create holistic therapy systems. We are also working on promising methods such as sorbent technology for recycling tap water, as large quantities of water are required for hemodialysis treatment.
- Sustained growth in patient numbers: More people than ever suffer from chronic kidney failure. It is estimated that by 2020, there may be around 3.8 M kidney patients worldwide. This development is exacerbated by the increase in the number of people suffering from diseases such as high blood pressure and diabetes – typical precursors of kidney failure that are becoming more and more common due to factors such as a lack of exercise, an unhealthy diet, or obesity. For this reason, a key focus of our research and development is also on home therapies such as peritoneal dialysis and home hemodialysis along with related technologies and products. Treatment at home provides patients who are suited to it with greater freedom in their daily lives. It also helps to free up the limited capacity in dialysis clinics and gives people who live in areas with a weak healthcare infrastructure access to treatment that may not have been available otherwise.
- The increase in concomitant diseases: Patients with chronic kidney failure are getting older. This is partly because society is aging overall and the risk of suffering from end-stage renal disease increases with age. Another reason is that advances in medicine are raising the life expectancy of kidney patients. The older patients get, however, the greater the likelihood of concomitant diseases occurring, for example severe cardiac and vascular conditions. Based on their growing prevalence and new scientific insights, these are increasingly becoming a focal point of our research and development as diagnostic and therapy systems that go beyond dialysis itself.
- Rising cost pressure in healthcare: An aging population, the spread of chronic illnesses, and the aspiration to offer new or improved technologies in patient care all present major financial challenges to healthcare systems. Even more reason for Fresenius Medical Care to abide by a principle that is also specified in our internal research guidelines: Innovations not only have to be of high quality, but must also be affordable so that patients can benefit from them. Based on our experience in operating our own dialysis clinics, we do not consider these to be incompatible demands.
R & D projects in the reporting year
To meet the challenges described and achieve the best possible therapeutic performance, our R & D teams continued to enhance our dialysis products and therapy systems in 2012. The focus was on further improving clinical results and the quality of life of patients as well as minimizing cardiovascular risks while keeping therapy costs under control and making sure that our products are easy and safe to handle.
Therapy systems continuously enhanced
In the past year, we introduced a new therapy system, the 5008 CorDiax. We also provided care teams in the U.S. with new modules for the 2008T therapy system.
Introducing the new 5008 CorDiax therapy system
In the reporting year, we launched the new 5008 CorDiax therapy system in the EMEALA (Europe, Middle East, Africa and Latin America) region. It combines proven and new functions to offer top-quality therapy and maximum patient safety as well as being easy to use and making sustainable use of available resources. This enables us to attain optimum treatment results and further minimize the risks of cardiovascular diseases.
The outstanding functions of the 5008 CorDiax are:
- Venous Access Monitor (VAM):
A rare but dangerous occurrence is the loss of blood during dialysis. This can happen if there are leaks in the bloodline system or if the fixture of the venous needle that connects the patient’s vascular access with the bloodline system comes loose, for example. The software-based monitoring system VAM detects such problems and reacts with an alarm that activates the necessary safety responses in the dialysis device. VAM has been available for the 5008 therapy system since 2011 and is already well established on the market. We work constantly on its optimization.
- AutoSub plus:
Current data shows that ONLINE HDF treatment see Glossary – mit unserem with our 5008 therapy system is particularly gentle and efficient if the volume of blood replaced during dialysis is as high as possible. However, if this level is too high, adverse side-effects can occur. As the maximum replacement volume can be different for individual patients and even for individual dialysis treatments, we developed the Auto- Sub plus software for the 5008 CorDiax in the reporting year. It enables optimized, fully automatic regulation of the volume of blood to be replaced, tailored to each patient’s needs.
- FX CorDiax dialyzer:
The new FX CorDiax dialyzer, which we introduced in Europe in 2011, is particularly effective. It contains the high-performance Helixone plus membrane, which selectively filters toxins with a medium molecular size and low molecular weight, such as phosphates, out of the blood, thus reducing the risk of cardiovascular diseases. The membrane also ensures that beneficial substances for the patient, such as the essential blood component albumin, are not flushed out at the same time.
- 5008 CorDiax HD-Paed:
Children suffering from kidney failure need special care when undergoing dialysis treatment. With this in mind, we launched the 5008 CorDiax HD-Paed in the reporting year. It is the first hemodialysis (HD) device in the world to be approved for children with a body weight of ten kilograms or more.
New modules added to our therapy system
We also improved our 2008T therapy system for the U.S. market in the reporting year. It is the first hemodialysis machine to be approved on the U.S. market with an integrated software platform for entering and managing clinical treatment data directly at the treatment room. The module helps physicians and clinic staff to record data efficiently and promptly as required by the authorities for billing services pursuant to the new reimbursement system in the U.S. The 2008T can be connected to various data management systems used in U.S. dialysis clinics. The advantage for care staff is that they can access dialysis treatment data and data from the medical information system (MIS), which were previously recorded and stored in a variety of sources, in the treatment room, enabling them to adjust the treatment and treatment plans directly.
In the reporting year, we added an infusion pump for intravenously administered iron compounds to the dialysis device and tested it at several dialysis centers. Studies have shown that the pump makes it easier for clinic staff to prepare and administer the exact dosage of iron products, thereby further increasing patient safety as well. We continue to establish the infusion pump on the market as a component of the 2008T in 2013.
- bibag system:
A further module to be launched in 2013 for the 2008T is the bibag system. It contains dry bicarbonate concentrate as a pure substance. This dispenses with the need for storing the water contained in liquid concentrates, reducing the amount of packaging and the corresponding waste to a minimum.
In the reporting year, we also enhanced and compacted our Crit-Line analysis device so that it can be integrated in our 2008T dialysis machine. Crit-Line is used to control the fluid balance of patients with chronic and acute kidney failure – and therefore also to detect and treat attendant symptoms. We expect to launch the enhanced analysis device, called CLiC (Crit-Line in a clip) on the U.S. market in 2013 following approval from the U.S. Food and Drug Administration (FDA).
Innovations in home dialysis offer additional safety for patients
One way of treating the rising number of dialysis patients outside of dialysis centers is home hemodialysis. In the reporting year, we enhanced two home hemodialysis machines – the 2008K@home in the U.S. and the 5008 S CorDiax home HD in the EMEALA region – that adapt treatment to patients’ individual medical needs and daily lives.
The 2008K@home is one of only two devices specifically for home hemodialysis with FDA approval in the entire U.S. market. The user interface has been simplified to enable patients to operate the machine intuitively. We also improved other products in the reporting year. A new wireless wetness detector will be launched in 2013 that features a new alarm function, providing additional safety. A signal sounds as soon as a leak occurs at the vascular access during dialysis, which, if it were to go unnoticed, could be fatal.
Previously, Fresenius Medical Care’s ONLINE HDF treatment method was restricted to dialysis in clinics. Thanks to the 5008 S CorDiax home HD, which we introduced in 2012, this therapy method is now also available as a standard feature in home hemodialysis. Functions such as cable-free remote control, an intuitive user interface designed with patients in mind, and innovative safety functions have been developed for the special needs of home hemodialysis patients.
New dialysis machine gives patients maximum independence and mobility
Our home hemodialysis systems already give some of our patients greater flexibility in their daily lives. The Portable Artificial Kidney (PAK), which we aim to launch on the North American market following approval from the U.S. Food and Drug Administration (FDA), is another device that should provide even more dialysis patients with even greater independence in future.
The key advantages of the Portable Artificial Kidney are:
- It can be quickly and easily dismantled into two portable sections that are easy to transport. In addition, it is simple to assemble and take apart without the help of a technician and is easy to use.
- Thanks to innovative sorbent technology, the PAK needs just six liters of potable tap water for hemodialysis treatment. By comparison, conventional hemodialysis requires 120 to 200 liters of specially treated warm water per treatment. Consequently, the PAK no longer needs to be connected to the water supply for dialysis treatment.
This means that the PAK is extremely resource-efficient, flexible and can be used almost anywhere, giving dialysis patients maximum independence and mobility.
Clinical research delivers positive results
In addition to developing new products and procedures and continuously enhancing existing ones, a process known as sustaining engineering, we are also active in relevant areas of clinical research such as chronic kidney failure in the broadest sense and technologically related blood purification procedures.
In the reporting year, we undertook clinical studies to examine the automatic regulation of the electrolyte balance. The overall electrolyte balance of the human body and the individual electrolyte concentrations in the various bodily fluids and tissues are hugely significant for the function of the entire organism. In healthy people, the natural kidney assumes the complex task of regulating this; in patients with end-stage renal disease, dialysis performs this function. Particularly in hemodialysis, where the dialysis solution is continuously prepared by a dialysis machine, it is possible to influence these processes favorably by adapting the dialysis solution accordingly. As the underlying issues are complex, we need to test these thoroughly in clinical studies before we can offer an automated method of this kind as a routine procedure to aid physicians. We are currently performing clinical tests on such a procedure.
Another focus of our clinical studies at present is peritoneal dialysis (PD) and especially overhydration, which affects over half of PD patients. Active fluid management can offer patients numerous benefits: It could increase the survival rate, reduce the number and duration of hospital stays, diminish the occurrence of an enlarged left ventricle of the heart, improve patients’ quality of life, and better maintain residual renal function. In the area of hemodialysis, our Body Composition Monitor analysis system is already an integral part of therapy, enabling us to determine the individual fluid status and body composition of each patient. We are currently conducting a study to show that the Body Composition Monitor can also be used to improve fluid management in PD patients.
In a study started in 2011, we are accompanying 1,000 adult patients over a three-to-four-year period, who were about to have their first PD treatment after diagnosis when the study began. Data is recorded regularly on each patient including their current medication, typical laboratory results and fluid status. In this way, we aim to track the status and development of fluid levels before and during PD treatment in relation to residual renal function, nutrition levels and the treatment prescribed by the physician. We also intend to obtain information on the best time to switch treatment from PD to HD.
In another study, we are assessing a low-sodium PD solution for patients with high blood pressure compared to a conventional solution already available on the market. The aim is to reduce high blood pressure and improve sodium and water management. High blood pressure and sodium and water deposits are typical concomitant diseases in PD patients with end-stage renal disease.
Cooperation in research extended
We work with universities and research institutes around the world that operate in our specialist field. One example is the Danube University Krems in Austria, whose research into extracorporeal blood purification processes with sorbents has been funded by us for about 20 years. This long-standing partnership with an excellent team of specialists was ultimately one of the reasons why we decided to invest further in our Krems facility.
We also maintain close contact with research institutes in the U.S., where our cooperation partners include renowned universities as well as the Renal Research Institute (RRI). The RRI was founded in 1997 as a joint venture between Fresenius Medical Care North America and the Beth Israel Medical Center, a hospital in New York. It is a leading institute in the field of clinical treatment and research into chronic kidney failure. Together, we are working on some fundamental issues related to dialysis treatment. These include the complex causes of kidney disease, particular aspects of treating children with kidney disease, or issues such as fluid management in dialysis patients or the effects of kidney disease on the natural acid-base balance in the human body.
Our R & D projects are mainly carried out by our own employees and research departments. To date, we have only used third-party services for these purposes to a small extent. When cooperating with national and international universities and other scientific institutions, we use various financing models. Some of our research alliances are also publicly funded.