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single-market regulation and innovation in europe medical devices industry

er sucht sie anzeigen köln H Steg, N Thumm

International Journal of Technology Assessment in Health Care 2001, 17 (3): 421-32

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In this article we analyze the influence of the legal regulatory framework in Europe, established by the two directives on medical devices and active implantable devices, on the performance of innovation in a single European market. First, we describe in general the possible influence of a single European market on innovation and the institutional features of the particular harmonization approach ("New Approach") we are looking at here. The empirical results presented derive from a survey investigation involving 150 firms that we defined as best innovators in the European medical devices industry from a pre-survey. The results confirm that the total impact of the New Approach regulation on firms' innovation in the long term is positive. However, it also becomes clear that the impact of regulation on innovation is limited if the factors are looked at individually and that there is a clear difference regarding short-term effects. To improve the regulatory framework, several policy actions are recommended.

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Most people use least one medical device every day.

Ranging from high-tech MRI machines and surgical robots to contact lenses or condoms, there are currently over products available that fall under this category, according to the European industry association Eucomed. According to MedTech Europearound 7. Single-market regulation and innovation in europe medical devices industry medical technology sector is known to be one of the most innovative industries.

Medical technology is regularly at the top of the list of technology fields with the most patent applications. According to the European Patent Officemore patent applications were filed for medical technology in 11, applications than for any other type of technology, including digital communication 10,biotechnology 5, and pharmaceuticals 5, Medtronic have already done it, moving to Ireland.

Across Europe, there are roughly 25, medical technology companies employing more thanpeople. In the USabout single-market regulation and innovation in europe medical devices industry, people work for 6, medical device companies. This shows how the industrial structure differs between the two continents. The European industry is single-market regulation and innovation in europe medical devices industry by small and medium-sized companies SME.

Many of those European medtech champions are part of big industrial conglomerates, such as Siemens or Philips, or pharmaceutical companies, such as Novartis and Roche.

More patent applications were filed for this field in than for any other type of technology. But emerging countries, such as China or Brazil, are catching up fast with growing middle classes demanding better healthcare. While the Western markets are pretty mature by now, in future most of the growth for medical device companies will probably come from emerging countries.

Despite the fact that many hospitals are running deficits, the demand for medical equipment is comparable stable in Germany. Over the last few years, the French government has implemented a number of cost-cutting measures including more demanding requirements for reimbursement for medical devices. Hospitals hope to reduce spending by pooling their procurement in big purchasing groups.

Faced with a huge national deficit, the Italian government curbed public medical device expenditure in Additionally, companies currently struggle with delayed payments from public bodies. Here too, the Spanish National Health System had to cut spending significantly. BMI assumes that most European markets will grow again in with the exception of some Southern states that have been hit hard by the ongoing economic crisis, such as Italy and Spain.

Since the global CAGR is expected to be around 6. The US are the biggest single market for medical technology. European medical technology clusters While medical technology companies can be found all over Europe, a number of regional industrial clusters have emerged. Those regions have a high concentration of medical device companies, component suppliers, clinics and research facilities with focus on medical research. The companies in those clusters benefit not only aubrey plaza dating 2014 from the opportunities of joint research and the proximity of experts in many medical areas, but often also from collaboration in areas, such as lobbying and of components.

At the center of such medical clusters are often global medical device companies or world-renowned universities attracting talent, capital and supply industries.

Single-market regulation and innovation in europe medical devices industry, the area is home to medical technology companies with over Additionally, 40 hospitals treating more than One of the biggest clusters in Europe er sucht sie anzeigen köln is the located around the small town Tuttlingen in the Southwest of Germany.

With more than medtech companies employing over After Ireland started in the s to attract foreign companies with low corporate tax rates and research incentives, many of the big US companies settled in the area around Galway. After that, an indigenous medical technology industry quickly established itself followed by a highly innovative research landscape. The BioRegion of Catalonia single-market regulation and innovation in europe medical devices industry, in Spain, is also increasingly becoming one of the hotspots for innovation in medical technology with its over life science companies.

Out of these, over work in the field of medical technology, employing more than 11, people. The industry benefits from cooperation with 41 research centers, 15 university hospitals, 13 science and technology parks and eleven universities offering life sciences studies the region.

The high concentration of research institutions focusing on life science and healthcare in the area facilitates the emergence of medical technology start-ups. Other important healthcare clusters are in the area between Stockholm and Uppsala Sweden with companies including pharmaceutical and biotechnology firms employing 20, people, and the Alsace Biovalley in France with over medtech companies.

The City of London started several initiatives to bring together medical researchers, hospitals, medtech and biotech companies, the NHS and venture capital firms. Catalonia is becoming one of the hotspots for innovation in medical technology in Europe. Over the last ten years, 48 medtech companies were founded in the BioRegion of Catalonia. Changes ahead The medical technology industry is undergoing a period of fundamental change. On the one hand are changing demographics in most parts of the world and the increasing prevalence of chronic diseases driving the demand for high-quality medical devices, diagnostic and imaging equipment, and innovative eHealth solutions.

On the other hand healthcare expenditure is increasingly curbed by strained public budgets and austerity measures, especially in Southern Europe. As a consequence, hospitals are often reluctant to invest in expensive medical equipment or pool their purchases in procurement groups in order to push prices down. Healthcare insurances increasingly require medical technology companies to prove that new treatments are not only medicinally effective but also help to take costs out of the system before agreeing to pay for them.

Medical technology companies are trying to adapt to the changing conditions by introducing cost-saving technologies, such as mobile health solutions, and new business models.

For example, some companies started to offer comprehensive services on a pay-per-procedure basis instead of just selling devices. The US gi-ant Medtronic, for instance, operates entire cath laboratories for hospitals. One of the motivations for the deal was probably to save corporate taxes by being able to move the company headquarter from the US to Ireland. But size in itself increasingly matters in the medical device industry.

Companies seek to increase their scale in order to counter the greater bargaining power of purchasing groups. Additionally, they hope that sizes helps to achieve synergy effects. On the other hand, increasing cost pressures force er sucht sie anzeigen köln companies to concentrate on their strategic core business and sell peripheral units.

The Swiss company Roche, for examples, has invested heavily over the last years to acquire molecular diagnostic companies which are important for both its medtech and its pharmaceutical arm.

Covidien acquired the Israeli firm Given in for its minimally invasive capsule endoscopy technology. The ubiquity of mobile technology in to the desire of patients to have more say single-market regulation and innovation in europe medical devices industry the management in their own health could be indicators that the medtech industry is ripe for digital disruption.

Google made the headlines with some of its moonshot projects, such as smart contact lenses for diabetics or swallowable pills that detect various illnesses at an early stage. Apple released its Healthkit app to improve patient doctor communication and facilitate clinical trials.

Watson initially became famous beating human contest-ants in the game show Jeopardydemonstrating the ability to understand natural language. In Junethe company announced that it would er sucht sie anzeigen köln cooperate with Medtronic to develop mobile diabetes apps.

While the activities of those newcomers matthew gray gubler dating aubrey plaza is unsettling for many of the traditional medtech companies given their track record of disruption and their vast resources, it is unlikely that the IT giants single-market regulation and innovation in europe medical devices industry sweep away their established competitors overnight.

It takes long years of experience to bring single-market regulation and innovation in europe medical devices industry products to market in a sector as regulated as medical technology. Therefore, it is more probable that the IT companies will seek to cooperate with more experienced medtech firms to market their ideas.

Google, for example, announced in that it teamed up with Swiss Novartis to develop smart contact lenses to market maturity. Since the wellbeing and sometimes the lives of patients depend on the proper functioning single-market regulation and innovation in europe medical devices industry medical devices, a new device has to undergo a stringent regulatory process before it is ready to hit the market.

While in the US a single regulatory body, the Food and Drug Administration FDAis responsible the approval and monitoring of medical devices, this task is performed in Europe by the so-called notified bodies.

Notified bodies are independent institutions accredited by national authorities of EU member states. They evaluate technical documentation and quality systems of manufactures and test if the devices operate as expected.

Inafter the French manufacturer of breast implants PIP fraudulently used cheap silicone instead of medical-grade material harming thousands of patients, the system came under fire and politicians argued for stricter regulation. The EU institutions and the member states are currently working on a new legislation that will overhaul the EU medical device directives.

The main objective is to improve the quality of the work of notified bodies and the security of medical devices.

Medtech manufacturers fear that more stringent regulatory rules will drive up costs to market new products and discourage innovation. One new requirement that is already felt by the industry are unannounced audits. Emerging and future technologies Hardly any industry implements new technologies as fast in its manufacturing processes and products as the medical device industry.

For example, medtech companies are among the pioneers in finding applications for 3D printing technology. Because of the need to tailor many medical products to individual patients, 3D printing single-market regulation and innovation in europe medical devices industry become the standard process already in the manufacturing of certain devices, such as hearing aids or dental implants.

It is expected that 3D-printed hip and knee replacements will be in mainstream use within er sucht sie anzeigen köln two to five years. One major trend in healthcare is personalized medicine where physicians are able to suit treatments to the patient. As mentioned above, the digitalization of healthcare is progressing. Patients use cell phones and wearable single-market regulation and innovation in europe medical devices industry to monitor their health.

In the research labs, scientists are working on even more futuristic technologies. In the future, nano sized devices will travel through blood vessels searching for biomarkers of diseases, delivering drugs and attacking cancer cells. Researchers are also working on technologies that are able to interpret electrical currents in the brain.

Such brain-device interfaces might one day help quadriplegic patients to operate motorized exoskeletons. Scientist are also trying to take 3D Printing to the next step. They are replicating human tissue with the help of 3D printers. Inresearchers at Chinese Hangzhou University even claimed to have produced a small kidney. Currently, the major challenge for Bioprinting is to supply the printed structures with blood so that they can survive. While it is still probably decades away that companies will be able to print fully functional replacement organs, the technology might in the nearer future be used to produce tissue for clinical trials.

Public payers and health insurances will demand that new medical devices not only improve the treatment but also help save money. Conclusion The medical device industry faces challenges in many areas. Regulatory changes are looming, new contenders are entering the market, and public healthcare budgets are ever decreasing.

However, the prospects for the industry are still promising. Ageing populations and a globally growing middle class are indicators that the demand for medical will only increase in the future. Medical device companies will have to employ new technologies in order to adapt to changing conditions, as public payers and health insurances will demand that new medical devices not only improve the treatment but also help to save money.

We make a device that had never been seen before. Our device measures ocular mobility precisely and objectively, facilitating diagnosis and monitoring of the condition and, indirectly, improving the results of surgery.


Innovation & Industry – date.ditz-recycling.de Single-market regulation and innovation in europe medical devices industry

This article is part of our special report Medical devices regulation. It warns especially that small and medium-sized enterprises SMEs could disappear with the proposed new system.

The industry said SMEs will not benefit from the proposed system, warning that they are the ones most of the groundwork when it comes to inventing new cutting-edge technologies which can save the life of patients. The European Commission has tabled new rules for the approval of medical devices following a health scandal in France involving faulty breast implants.

But Serge Bernasconi, chief executive of Eucomed, the European medical technology industry association, told EURACTIV that independent research has shown that the proposed EU approval system would delay patient access to life-saving medical devices by 3 to 5 years without adding additional safety.

This technology is already saving the lives of patients in Europe while an estimated 7 million Americans with the condition are still waiting for this treatment to be approved. Other examples cited by Bernasconi include two cardiovascular treatments Cardiac Resynchronisation Therapy and Transaortic Valve Implantationwhich have already provided patients across Europe with an additional 50, life years in the period between EU regulatory approval and US approval.

It underlined that recent health scandals involving faulty breast implants and toxic replacement hips have illustrated the need to strengthen safety checks on medical devices in the EU. Safety first in new medical devices regulation. Goyens supports calls for a centralised pre-market single-market regulation and innovation in europe medical devices industry system and said the industry was not focusing on the right issues.

CardioFocus manufactures products to treat atrial fibrillation, a very common hearth rhythm defect. Its product are implanted inside the heart and for this reason, they are classified as Class III device, meaning that risks associated with them is highest, receiving a great deal of approval scrutiny. Sagon, who runs CardioFocus, said his company has tried to get its products on both the US and EU markets and experienced how the two different approval systems work.

CardioFocus brought the device to Europe in early and achieved a CE mark within a relatively short period of time. In the US a feasibility trial began in lateand CardioFocus finally received permission to begin a clinical trial at the beginning of Probably closer to 1, The product is working quite well.

As SMEs usually perform better when it comes to innovation within healthcare, according to Sagon, a stricter EU system with larger requirements of capital available to continue the efforts would result in the smaller companies scanning the globe for places with less commitment of resources.

He warned there could be a potential backlash on innovation, for SMEs in Europe, on jobs and patients as well. Bertholet said Europe is one of the world-leading centres for medical technologies with a great medical community, very innovative, ready to single-market regulation and innovation in europe medical devices industry new technologies. The medical doctors are innovative in Europe and there is a strong engineering as well.

It also means the most recent and innovative procedures are currently not available to US patients medical doctors. He said companies will go bankrupt because if it takes five years to get market approval, it will be difficult to get financing as no one want to lend to a company for five years without revenues.

There are other issues at stake, not only patient safety. They would have to turn global very quickly. What we see today is that devices that are approved for our clinical application are reporting less successful results than we are.

Because trying to do the best job possible job can always involve the risk that you might fall short. It has helped European physicians be at the forefront of their field, helped European patients received the best therapy and European universities and medical centres now offer the best therapies.

It has also provided a boost for the industry and to economies. Medical devices are defined broadly and can include anything from sticking plasters to contact lenses, pregnancy tests, dental filling materials, X-ray machines, pacemakers, breast implants, hip replacements and HIV blood tests. Following a huge health scandal involving faulty implants sold around Europe, the European Commission published proposals in late for a new regulatory regime for medical devices.

A new regulatory landscape. Henriette Jacobsen updated: Background Medical devices are defined broadly and can include anything from sticking plasters to contact lenses, pregnancy tests, dental filling materials, X-ray machines, pacemakers, breast implants, hip replacements and HIV blood tests. The new regulations are scheduled for adoption later in Parliament will vote to accept or reject the report in a plenary session. Further Reading European Commission Public health: Medical devices Industry Eucomed: Towards a regulation that guarantees patient safety, single-market regulation and innovation in europe medical devices industry patient single-market regulation and innovation in europe medical devices industry and keeps innovation in Europe CardioFocus: By continuing to browse the website, you are agreeing to our use of cookies I agree.


Medical devices: Better regulation for Europe

Some more links:
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New Medical devices regulations single market (drugs, medical devices, tobacco control), New Regulation on medical devices.
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THE IMPACT OF SINGLE MARKET REGULATION ON INNOVATION: on innovation in the medical devices industry. they in the medical device industry in Europe.
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Single Market Forum; Industry. Industrial Policy; The medical devices industry is a major employer in Europe, Competitiveness and innovation.
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New Medical devices regulations single market (drugs, medical devices, tobacco control), New Regulation on medical devices.
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Changes to the way In VitroDiagnostics medical devices are Regulated in Europe. The IVD Directive will soon be replaced by the IVD Regulation single-market.
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Zahra Doejune 2, 2017
Morbi gravida, sem non egestas ullamcorper, tellus ante laoreet nisl, id iaculis urna eros vel turpis curabitur.
Zahra Doejune 2, 2017
Morbi gravida, sem non egestas ullamcorper, tellus ante laoreet nisl, id iaculis urna eros vel turpis curabitur.
Zahra Doejune 2, 2017
Morbi gravida, sem non egestas ullamcorper, tellus ante laoreet nisl, id iaculis urna eros vel turpis curabitur.

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