|
|||||||
|
|||||||
|
A1 Posting Certificate: SPECTARIS Calls for Business-Friendly RegulationsIn a letter to the responsible Federal Ministry of Labor and Social Affairs (BMAS), SPECTARIS criticized the strict requirements for A1 posting certificates. The A1 certificate serves as proof that an employee is insured in their country of original employment when traveling to an EU country. It must be applied for through the responsible social security agency. SPECTARIS points out to the BMAS that this procedure has proven to be a stumbling block in cross-border business: Processing by government agencies currently takes about one week. As a result, last-minute client visits abroad are virtually impossible to arrange, which damages the relationship with the client. Furthermore, a significant bureaucratic burden arises because a four-page form must be filled out for every employee’s assignment abroad. In addition, the methods of verification vary from country to country. To ensure that cross-border business activities are not hindered by the practice of A1 certificates, SPECTARIS has called on the BMAS to advocate for waiving the requirement to carry these certificates for short business trips to EU member states. Furthermore, the national procedures of the European member states should be harmonized. |
SPECTARIS General Meeting and Industry DaysThe next SPECTARIS General Meeting will take place on September 12, 2019. This year, the association will meet at the Aesculap Academy (Luisenstraße 58, 10117 Berlin). The General Assembly will be held in the morning. After a group lunch, the industry days organized by the professional associations will take place in the afternoon. The annual reception in the evening, including a social gathering, will round out the event. Federal Minister of Health Jens Spahn has been invited to deliver the keynote address. We will inform you about registration options soon. |
The optical industry is undergoing a major transformationThe optical industry performed well in 2018. Industry revenue on the retail side rose by 2.2 percent to 6.26 billion euros (including VAT). 12.84 million pairs of prescription glasses were sold, which is 180,000 more than in the previous year. Contact lens (CL) sales at optical retailers stagnated in 2018, remaining at 415 million euros. By contrast, CL sales generated online rose by 13.4% to 159 million euros. Overall, however, the optical retail sector still ranks among the retail industries with the lowest share of online sales. Because online providers in the industry have had to recognize that they cannot operate without in-store refraction and fitting, hybrid sales models continue to grow. Purely online business is therefore increasingly giving way to omnichannel sales. The ten largest optical retail chains, in turn, accounted for just under 50 percent of the industry’s revenue in 2018, despite representing only about 20 percent of all stores in Germany. To secure or expand their market position, large retailers are currently engaging in concentrated acquisitions of well-established traditional specialty stores. These consolidation processes will ultimately affect all market participants in the coming years. An industry in transition. |
Revenue in the German photonics industry rose by 7 percent in 2018The photonics sector in Germany continues to experience strong growth: According to calculations by the industry association SPECTARIS, revenue for the German photonics industry in 2018 totaled 37.1 billion euros, up 6.7 percent from the previous year. Overseas revenue increased by 7.1 percent, reaching 26.6 billion euros. Domestic business also performed well, recording a 5.6 percent increase to 10.5 billion euros. As a result, 72 percent of revenue is now generated abroad—and the trend is upward. “The top five target countries for German companies in 2018 were the U.S., China, the Netherlands, France, and Italy, which together accounted for 42 percent of total exports,” commented Dr. Bernhard Ohnesorge, Chairman of the SPECTARIS Photonics Division. The United Kingdom ranked sixth, where German photonics exports declined by nearly 7 percent, primarily due to the debate surrounding Brexit. “Even though there are uncertainties against the backdrop of a looming slowdown in the global economy and a possible expansion of trade barriers, we expect sales to grow again by six to seven percent in 2019,” explains Ohnesorge. Strong international demand is expected to contribute significantly to this result, while a slight slowdown in domestic growth is anticipated. Since photonics is used as a key technology in many growth sectors, SPECTARIS continues to expect positive economic development for the photonics industry. The approximately 1,000 German photonics manufacturers employed around 138,000 people in 2018, five percent more than in the previous year. For 2019, another increase of about three percent is expected, bringing the total number of employees to 142,000. More |
Interoperability in Lab 4.0: Industry Standards Continue to Take ShapeOn April 11 and 12, ten SPECTARIS members met in Berlin to further advance the development of an industry standard for analytical, bio, and laboratory technology. The goal is to achieve interoperability and connectivity among analytical and laboratory instruments—a request that numerous users have conveyed to manufacturers. It has already been decided that the standard will be based on the OPC UA protocol, which originated in the process industry, and will be developed to be device-agnostic. The current tasks include developing the information model, creating exemplary industry use cases, and assessing the funding landscape. An initial meeting with those responsible for information integration at BASF will take place at Lab.Vision to develop the industry standard in close alignment with user needs. All SPECTARIS members are cordially invited to participate in this important process. Simply send an email to ladwig@~@spectaris.de. |
Cybersecurity: Researchers Manipulate Cancer DiagnosesThe issue of cybersecurity, particularly for medical devices, is becoming increasingly important. Manufacturers of network-enabled medical devices must take special care to ensure that their devices implement information security to the best of their ability. The following example illustrates why this issue is rapidly gaining importance: IT experts from Israel have developed a method for falsifying computed tomography (CT) scans. Using this method, they can, for example, indicate the presence of cancer where none exists—or make real cancer cells disappear from images. The researchers cite several reasons why attackers might target this method. In their publication, they mention political influence. The method could also be used to falsify research results, defraud insurance companies, carry out terrorist acts, or even commit murders. According to Spiegel ONLINE, the researchers identify the system used to transfer files from the CT scanner to radiologists’ computers as a key vulnerability. Since this transmission path is usually unsecured—meaning the data is not encrypted—it can be intercepted and altered. SPECTARIS has been involved since February 2019 in the Alliance for Cybersecurity, an initiative founded by the Federal Office for Information Security (BSI) that aims to strengthen Germany’s resilience against cyberattacks. You can find the full article on this topic here. |
New Junior Staff Member at the SPECTARIS Medical Technology AssociationIn March, the SPECTARIS Medical Technology Association gained a new, dynamic member. Effective immediately, Jana Mallok will be joining the team as a junior editor. Her responsibilities include, among other things, developing the concept for the MedTech Letter and the Medical Technology Yearbook. She succeeds Madeleine Wendt, who has now moved full-time to the Regulatory Affairs department at SPECTARIS. Previously, Mallok worked in an online editorial office and at a trade journal. |
Comprehensive Training Program on the New European Medical Device Regulation LaunchedOn April 10, a new partnership between SPECTARIS and senetics healthcare group was launched in Tuttlingen. Together, they will now offer the training course “Market Access for Medical Devices in Europe” nationwide throughout Germany. “The topic of the Medical Device Regulation (MDR) is a pressing concern for companies,” emphasizes SPECTARIS Managing Director Jörg Mayer. “Many small and medium-sized enterprises have to travel to major German cities for training on this topic. We’re going to remedy that situation. We’re pleased to have found a powerful and well-established partner in senetics so that we can offer training to all medical device manufacturers in Germany—practically right on their doorstep.” Senetics Managing Director Dr. Wolfgang Sening adds: “The one-day introductory training sessions cover the most important aspects of the MDR. During the sessions, we will address, among other things, the new classification rules, changes to the conformity assessment procedure, and updates to the technical documentation.” In the coming months, training sessions will take place in Bielefeld (June 9), Kempten (Sept. 25), Wiesbaden (Sept. 18), Schwerin (May 7), and many other locations. The participation fee for the one-day training session is 680 euros. SPECTARIS member companies receive a 25 percent discount. More |
Information Session on “The Healthcare Industry in Chile” on May 23, 2019, in BerlinThe consulting firm “enviacon international” is organizing a full-day informational event on the topic of “The Healthcare Industry in Chile” on behalf of the Federal Ministry for Economic Affairs and Energy (BMWi) and in cooperation with the German Chamber of Commerce in Chile (AHK). SPECTARIS is a partner of the event, which will take place on May 23, 2019, at the VKU Forum in Berlin. The event will focus on market developments, framework conditions, and business opportunities for German small and medium-sized enterprises in Chile. The goal of the event is to prepare interested companies for their actual market entry. To this end, participants will receive country- and industry-specific information about Chile. Particular emphasis will be placed on market access and sales opportunities for German companies in the healthcare industry. More |
Potential countervailing duties imposed in response to EU subsidies in the aircraft industry could also affect SPECTARIS sectorsOn April 12, 2019, the U.S. Trade Representative (USTR) issued a preliminary list of EU products worth US$21 billion that could potentially be subject to additional tariffs. In addition to goods from the civil aviation industry, the list includes, among other items, laboratory glassware (HTC 7017.10.60), prisms (HTC 9001.90), lenses, and other camera accessories. The reason for the USTR’s action is that the World Trade Organization (WTO) has repeatedly found that EU subsidies for the aircraft manufacturer Airbus have had adverse effects on the United States. The USTR estimates the resulting damage at US$11.2 billion. The U.S. has therefore initiated proceedings under Section 301 of the Trade Act of 1974 , which is intended to determine possible countervailing duties on EU products. The amount of the additional duties and the timing of their implementation are not yet known. A public hearing on this matter will take place on May 15 in Washington. Affected companies are welcome to contact the SPECTARIS Foreign Trade Department (Anne-Kathrin Schmalz, schmalz@~@spectaris.de), which also plans to comment on the list and is already in dialogue with the relevant divisions in the federal ministries. |
Workshop: Development Banks as Partners and ClientsSPECTARIS, ZVEI, and the Agency for Economy & Development are hosting a workshop on May 20 in Frankfurt am Main to show export-oriented companies opportunities for participating in tenders issued by international development banks. The background to this is that, as the need for high-tech medical devices grows in many developing and emerging economies, the demand for high-quality products from Germany is also increasing significantly. There are increasingly frequent calls for greater participation by German companies in relevant tenders issued by the World Bank and other development banks. With a good understanding of the procedures, the effort involved is manageable, and the chances of success are very good. At the workshop, proven experts in development bank tenders will offer specific information and advice. Learn more. |
Innovation Day on May 9 Showcases Projects Funded by the BMWiOn May 9, 2019, innovative small and medium-sized enterprises and research institutions from all over Germany will once again gather at the outdoor grounds of AiF Projekt GmbH (Association of Industrial Research Organizations) in Berlin-Pankow for the traditional exhibition organized by the Federal Ministry for Economic Affairs and Energy (BMWi). More than 300 companies, research institutions, and cooperation networks from across Germany will present new products, processes, and services spanning a wide range of technological fields and industries, the development of which was financially supported by the BMWi’s technology-neutral innovation funding program. This year, SPECTARIS’s cooperation partner F.O.M. will have a booth at the event and will, among other things, present the new AiF Medical Technology Research Alliance (FAM). Invitation flyers, the event program, the exhibitor directory, and further information can be found here. |
Call for Research Participation: Smart Dressings for Chronic Open WoundsThe treatment of chronic open wounds requires a hydroactive wound dressing that ensures optimal conditions during every phase of healing. However, such a product is expensive and not widely available in Germany. As part of the project “Wound Dressings with Smart Moisture Balance,” scientists now aim to develop a hydroactive wound dressing based on microfibrillated cellulose (MFC) as a drug-free medical device. The goal is to synthesize an MFC with an optimized moisture balance by specifically modifying its molecular composition. The project proposal is scheduled to be submitted for review in fall 2019 by SPECTARIS’s cooperation partner F.O.M., with the project set to begin in early 2020. A grant of approximately 475,000 euros is being requested from the Joint Industrial Research (IGF) program fund of the Federal Ministry for Economic Affairs and Energy. Anyone wishing to contribute to making this project a reality—whether by participating in the project’s accompanying industry committee or by providing a financial contribution—is welcome to contact F.O.M. More. |
Place your ad on our websiteEstablish your presence in our growth sectors and benefit from reaching your target audience with an ad on our website. Our website serves as a showcase for the German high-tech industry and is therefore the first port of call for information about innovation-driven small and medium-sized enterprises in the fields of consumer optics, medical technology, photonics, and the laboratory industry. You can find advertising listings and prices here. |
May 29, 2019 | Berlin | WissenraumStrategy Meets Content We would like to draw your attention to an event organized by SPECTARIS GmbH. In this workshop, you will learn the key aspects of developing a digital marketing strategy and how to identify the essential factors for success in creating perfect content. More |
Privacy at SPECTARIS: We Keep You InformedThe protection of your personal data is important to us. You can find out how we handle your personal data in accordance with the GDPR of May 25, 2018,here: . |
What Our Members SaySPECTARIS is a key partner in a challenging environment "In times of rapid and far-reaching changes in the medtech industry and a challenging regulatory environment, SPECTARIS is an important partner for our company and indispensable as an advocate for our interests in Berlin and Brussels. It’s worth getting involved!" Bert Sutter, Managing Director, Sutter Medizintechnik GmbH |
|
|
|