Diagnostics & Imaging Weeks

The German cabinet has taken a small step toward relieving an acute shortage of medical and information technology workers that is hamstringing future growth of the country's med-tech sector.

Ministers last week agreed to lift restrictions on the immigration of highly qualified workers from 10 new member states of the European Union (EU), beginning in November if the cabinet's recommendations are approved by parliament in August. Restrictions also were eased for foreign applicants who demonstrate proficiency in speaking German.

In response to the accession of 10 European nations to the EU in 2004, Germany closed its labor markets while Britain, Ireland and Sweden opened access to these foreign workers. The German restrictions were imposed for a three-year period and then extended to 2009.

Meanwhile, the German medical technology sector, Europe's largest at €46 billion ($72.75 billion) in estimated annual sales, has pleaded with the Labor ministry for years to lighten the barriers to make up for the shortage of engineers needed to sustain growth.

Verein Deutscher Ingenieure (VDI; Düsseldorf), the German engineering association, in its annual med-tech survey reported that more than 30,000 job postings are going wanting in the sector due to a shortage of qualified personnel.

The Association of German Engineers says that there are 96,000 jobs available for information technology workers alone, twice as many as four years ago, according to Deutsche Welle, and in the IT sector every second company reports business is lower because vacant positions cannot be filled.

Executives responding to the VDI survey said the shortage is at a dramatically high level, and the German Industry Association for Optical, Medical and Mechatronical Technologies reports 64% of its members rate the lack of technical personnel as the top issue facing the German sector, ahead of global competition (32%) and costs and capital requirements (23%).

According to a study published by the economics ministry in June, the skills shortage in Germany will cost the country more than €20 billion ($31 billion) in 2008.

Under measures approved by the cabinet German employers, in order to hire a candidate from one of the newer member country, will no longer be required to prove there are no suitably qualified applicants from Germany or the original EU nations.

Restrictions will remain in place on less qualified workers from countries that joined the EU in 2004, such as the Czech Republic, Estonia, Hungary, Latvia, Lithuania, Poland, Slovakia and Slovenia, and this restriction was even extended through 2011.

Business leaders welcomed the modest changes by the cabinet as a step in the right direction while saying they fall far short of recognizing the seriousness of the crisis.

The conditions spelled out by the cabinet require proof that a candidate is already earning a salary in excess of EUR 85,000 ($134,500) and are so highly qualified that they effectively are free to choose among opportunities more attractive than moving to Germany, such as English-speaking countries where they would encounter less cultural resistance.

Carola Feller of the German engineering federation, VDMA, said some of the eastern European countries that Germany is blocking actually have "a much better image than Germany" and recruitment efforts do not always appear especially attractive.

"The German labor market is only opening up for those who don't have to work in Germany," concluded an editorial in Deutsche Welle.

Japan approves cardiac monitor

Medtronic (Minneapolis) reported receiving Japanese regulatory approval for the Reveal DX Insertable Cardiac Monitor (ICM). The device has been designated by the Japanese government as a high-priority medical device, and the company says it is the first insertable cardiac monitor to be introduced in Japan.

The Reveal DX ICM provides insight into syncope, unexplained fainting episodes. Syncope is difficult to diagnose as episodes are often too infrequent and unpredictable for detection with conventional monitoring techniques such as ECG Holter monitors or external loop recorders. These tests are limited to 24 hours and one month, respectively; combined with the constraints placed on the patient's daily life and the limited likelihood of an event occurring during the monitoring period, the testing may fail to determine the cause of the episodes, according to Medtronic.

Causes of syncope can be heart rhythm disturbances or abnormalities in the structure of the heart. Syncope can lead to serious injury or can be a precursor to sudden cardiac death. Roughly 1.5 million people worldwide suffer from unexplained syncope. In almost 10% of patients, syncope has a cardiac cause.

Inserted just under the skin of the chest area, Medtronic said the Reveal DX ICM is about the size of a memory stick and is capable of monitoring patients for up to three years, allowing for long-term, continuous cardiac monitoring. Records of arrhythmias are automatically recorded and saved, and patients may prompt the device to record any events at any time. If the patient experiences a syncopal episode, the information collected by the device may help the physician determine if the episode is attributable to an arrhythmia.

Since no similar device has been available in Japan, the Ministry of Health, Labor and Welfare designated the Reveal DX as "high priority" for approval in Japan. The device was subject to a fast-track evaluation by the Japanese government, and received regulatory approval this month.

Medtronic Japan will begin marketing the Reveal DX ICM once it has attained reimbursement approval for the device. The company will partner with Asahi Kasei for exclusive sales distribution rights for the device in Japan; Medtronic Japan will serve as the device's designated marketing authorization holder.

The Reveal DX ICM is commercially available in the U.S., Western Europe and Canada.