The French medical device market is ready for expansion with US products. Despite tight budgets and a strict regulatory process, a growing elderly population demands advanced medical devices.
Medical Device Market: France Is Ready for US Products
For American medical device manufacturers, entering the French market can seem like a tricky move. The French healthcare system operates differently than the US healthcare system, and the opportunities for growth in the medical device market are different in Europe. However, analysts agree that the French market, with the second largest European population after Germany, is ripe with possibility for manufacturers who are looking to expand into Europe. According to a 2015 GlobalData report, the medical devices market size in France was about $14.7 billion in 2012. Also, it was expected to reach approximately $20.8 billion by 2020.
More and more, the current French market relies on medical device imports from manufacturing operations located abroad. Imports amounted to more than 50% of the overall market in 2015, according to the US Department of Commerce. So, what does this mean for US exporters? A growing medical devices market with an increasing reliance on products that are manufactured abroad. But first, let’s step back and define the product and US and French markets.
Large US and French Medical Device Manufacturers
The US Department of Commerce defines a medical device as “any piece of equipment or apparatus used to treat or diagnose an illness and comes into direct contact with the patient.” The major US medical device companies include: Baxter, Beckman Coulter, Becton Dickinson, Boston Scientific, GE Healthcare Technologies, Johnson & Johnson, Medtronic, St. Jude, and Stryker Corp. Large European medical device companies include Siemens Healthcare, Hoffmann-La Roche, Medtronic, Essilor International, and GlaxoSmithKline.
Importantly, the United States is the world’s leading producer of medical devices, and it is also the world’s largest consumer of medical devices. France ranks ninth in the top ten countries for the size of its medical device market for exports in 2016 by the US Department of Commerce, and the country ranks fifth worldwide in similar surveys. When looking at the medical equipment market in general in France, 33% of its medical equipment imports came from the United States in 2015, with growth expected at 3% into 2017.
Health Care System in France Compared to the United States
As in the United States, France has a rapidly aging population that will push spending on health care ever higher in the coming decades. An increasing demand for health care services and rising costs for those services will challenge budgets. The biggest way that the United States and France differ is that the United States does not offer universal health insurance coverage as in France. The French social security system covers about 75% of its citizens’ health care costs, equaling 35% of French social expenditures.
In contrast, many in the United States, despite the Affordable Care Act, pay a large amount of their income on health care. However, the United States as a whole spends more than twice as much per person on health care each year than France. This is partly because French doctors make about twice the average salary in France, whereas US physicians make more than five times the average wage in the United States. Doctors’ educational expenses and insurance costs are much lower in France than that found in the United States. The government heavily subsidizes medical school tuition. Also, the French legal system discourages legal action against health care providers.
Health Care Cost Reduction Solutions
Despite the relative low cost of French health care, the French health care system is looking to reduce growth in health care costs. This is exactly where medical device manufacturers can find opportunities, such as medical devices that can help cut the number and length of hospital stays and devices that provide or add to home care solutions. Other areas of interest include devices for non-invasive surgery, orthopedics, and disposable medical equipment. Diagnostic medical imaging systems are especially in demand in France.
Telemedicine, mobile health, and electronic medical records are likely to become more common in future care. As the interconnected ecosystem of health care becomes a reality, purchasing offices will seek out connected medical devices to help meet the demand for instant, accurate information. France is consistently among the top markets in the world for health care spending on medical devices. Therefore, although budgets will shift to promote more economical health care solutions, spending will likely remain at comparable levels.
French Regulatory Environment
The regulatory environment in France is driven by patient health and safety concerns. Payment transparency and the confidentiality of client records are important considerations for the management of billing systems and privacy. However, the French government scrutinizes medical devices through the EU list of competent authorities and the National Agency for Medicines and Health Products Safety (ANSM). What is the regulatory path for getting a medical device approved in France?
Medical devices are classified according to risk into Classes I, IIa, IIb, III, and IV. An authorized representative located in the European Union is necessary to register a medical device in France. In order to access the French market, it might make sense to work with a French company to meet regulation requirements. It might also be good to link up with a distributor in France to sell medical devices in the French market.
Medical Device Marketing in France
The marketing specialists at ADEXMA can tailor these options to a medical device manufacturer’s particular needs. Accessing the French market might mean adjusting a product so that it meets French regulations or adding features that will make the device more valuable to healthcare systems with strict budgets. The French health care system may be primarily funded by the government, but it is still expected to meet the high standards set by regulators. This includes having the most advanced medical devices in stock for its doctors and the patients that they serve. US medical device manufacturers should see great interest in their products once they are marketed to French customers as indispensable additions to their medicine cabinets.
By Mary Le Rouge
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