January 2019 Issue: U.S. Ambassador, Optometry Report, and much more.

FOCUS

SPECTARIS Discussion with U.S. Ambassador Grenell on Trade Issues

In late November, SPECTARIS met with U.S. Ambassador Richard Grenell in Berlin in a small group setting to discuss trade issues. The focus was on regulatory matters—but the topics of tariffs and sanctions were also addressed. The U.S. side was particularly interested in how we can achieve uniform approval procedures for medical devices in the U.S. and Europe, or, as a first step, how we can facilitate market access through FDA recognition or CE marking. SPECTARIS has launched a survey on this topic within the committee responsible for regulatory matters—the Technical Commission for Medical Technology—and agreed to remain in contact with the U.S. Embassy on this issue. In addition, the Embassy offered to assist SPECTARIS members in addressing challenges related to the U.S. market by contacting the Trade Section. The SPECTARIS Foreign Trade Department is happy to assist in contacting the Embassy and is available to answer any questions. Contact: goldenstede@~@spectaris.de

New: The Essential Reference Guide for the Optometry Industry

Get a comprehensive overview of the vast world of optical retail—all in one place: This is made possible by the comprehensive report “Germany and the World—Markets, Consumers, and Trends 2017/18.” With its 100-page compilation of available industry data, this publication—which has been in print for ten years—has become the industry’s standard reference work. The report is published by the industry association SPECTARIS and the Central Association of Opticians and Optometrists (ZVA). In addition to the latest figures on the industry, opticians, and people with vision impairments, the new edition also features a comprehensive section on international markets. “In 2017, the German optical market generated more than six billion euros in sales for the first time. Growth in brick-and-mortar retail was 2.7 percent,” emphasizes SPECTARIS Chairman Josef May. The report’s nearly 50-page international section provides a comprehensive overview of optical markets outside Germany and also lists all import and export figures for individual product groups for each country. The industry report, with its nearly 250 charts and tables, is available only in print. The price is 269 euros for SPECTARIS members and 539 euros for non-members (plus VAT in each case). Interested opticians should contact the SPECTARIS office. Further information and ordering details can be found on the SPECTARIS website.

PHOTONICS Trade Show in Moscow to Feature a German Joint Booth Once Again

After a five-year hiatus, there will once again be a German joint pavilion at the “PHOTONICS – World of Lasers and Optics” trade show in Moscow from March 4 to 7, 2019. The joint pavilion is supported by the Federal Ministry for Economic Affairs as part of its international trade show program. Eight German companies are participating in this relaunch. The companies will showcase products that are not affected by the sanctions against Russia. Other companies in the German photonics industry are still hesitant to participate again in this leading photonics trade show in Russia. Difficulties with the Federal Office for Economic Affairs and Export Control (BAFA) in obtaining export licenses and uncertainties regarding potential impacts on their U.S. business were cited by the companies as the most common reasons.

Economic Barometer for Analytical, Biotech, and Laboratory Technology: Fill It Out and Reap the Benefits

In cooperation with the GIT laboratory trade journal, SPECTARIS provides a straightforward tool for a quick market assessment. The brief survey, conducted quarterly, offers participants insights into current trends regarding order intake in the fields of analytical, biotechnology, and laboratory technology in Germany and regions worldwide. The survey takes no more than five minutes to complete. The results are published in the print edition of GIT six weeks after they are evaluated. Survey participants receive the results digitally immediately after evaluation. If you would like to register to receive the survey link, please send an email to Harald Hartmann.

Germany as an eHealth Hub: 2019 Is the Year to Set the Course

Germany is set to become a pioneer in digital health. In addition to SPECTARIS, seven other trade associations in the industrial healthcare sector are committed to this goal. However, for this catch-up effort to succeed, stakeholders need a shared vision—an eHealth roadmap—and political coordination. Working toward this goal was the focus of a discussion evening between policymakers and industry representatives on December 13, 2018, in Berlin, organized by BIO Deutschland, Bitkom, the German Association for Health IT, BVMed, SPECTARIS, VDGH, vfa, and ZVEI.  SPECTARIS was represented by Martin Braecklein (Linde Group), Michael Scherf (Getemed), and SPECTARIS Managing Director Jörg Mayer. Federal Minister of Health Jens Spahn spoke at the event: “Without digitalization and with overly restrictive data protection, our healthcare system will fall short of its potential. That is why I am driving digitalization forward—in the areas of electronic health records, mobile access, and e-prescriptions.” In an international comparison, the healthcare systems that are most successful in mastering digital progress in care are those that have a clear and jointly defined eHealth strategy. This is demonstrated, among other things, by the current study “#SmartHealthSystems” by the Bertelsmann Foundation, in which Germany ranks 16th out of 17. Other critical success factors include alignment with health policy goals and implementation by a neutral yet accountable body. The recently published SPECTARIS study on “Health 4.0” can be found here.

Jens Spahn Receives the Yearbook “The German Medical Technology Industry”

On November 19, SPECTARIS Managing Director Jörg Mayer, together with Dr. Rainer Kalamajka (Chair of TKMT, Regulatory Affairs at Miele & Cie. KG) and Marcus Kuhlmann (Head of the SPECTARIS Medical Technology Association), presented a copy of the latest Medical Technology Yearbook to Federal Health Minister Jens Spahn. The book opens with a foreword by the minister. The official launch of the eleventh edition of the yearbook took place in early November at MEDICA 2018, the world’s leading trade fair for the medical industry in Düsseldorf. The yearbook provides all industry stakeholders with key national, European, and global market data on medical technology.  The approximately 120-page SPECTARIS Yearbook, “The German Medical Technology Industry,” can be downloaded .

2019 Foreign Trade Day Highlights the Trending Topics of Free Trade and Digitalization

German companies in the medical technology, pharmaceutical, and laboratory technology sectors operate worldwide. A key pillar of their success is building networks in foreign markets. In the Federal Foreign Office, SECTARIS has an excellent partner for gathering market intelligence and securing political support for important projects. At the Foreign Trade Day on March 20, 2019, export-oriented companies can establish important contacts, raise issues regarding specific target markets, and obtain exclusive market information from a strong network of partners. The framework for these discussions is provided by the 2019 theme, which brings together two key concerns of the SECTARIS industries: the defense of free trade and appropriate framework conditions for digital products and processes. Participation in the Foreign Trade Day is free of charge for manufacturing companies from the target sectors, members of the participating associations, and public officials (from the Bundestag, ministries, embassies, etc.). Registration here (Photo: Fotolia.)

Participation in a Political Exchange – Thai-German Business Forum

On November 28, a high-level business delegation led by Thai Prime Minister H.E. General Prayut Chan-o-cha met with German business leaders at the Thai-German Business Forum in Berlin. Also in attendance were several representatives from the industry association SPECTARIS, who learned about current developments in the region and opportunities for deeper cooperation. The focus was on future-oriented topics such as Thailand 4.0 and the opportunities presented by reforms in the ASEAN region. For example, an e-customs system (ASEAN Single Window—ASW) is currently being established, which is expected to lead to savings in transaction costs for companies by 2020. Digitalization is also a top priority on the agenda in ASEAN countries. This area is set to play a key role in the countries’ long-term strategies to address the challenges of technological disruption—including at the political level—through appropriate training initiatives, research priorities, and regulatory reforms. If you are interested in participating in political delegations or high-level forums such as the Thai-German Business Forum, please contact Jennifer Goldenstede.

IGF Budget Cap Blocks Urgently Needed Health Research

Experts from the Association of Industrial Research Organizations (AiF) cite an urgent clinical need: antibiotic-resistant pathogens are leading to an increasing number of deaths. The indiscriminate use of antibiotics also accelerates the development of resistance, so that, according to projections, approximately 10 million deaths worldwide are expected annually due to multidrug-resistant pathogens starting in 2050. This has prompted Prof. Dr. Hans-Peter Deigner, Prof. Dr. Matthias Kohl, Prof. Dr. Markus Egert, and their team at the Institute for Precision Medicine at Furtwangen University to develop a research project with a single goal: rapid and reliable diagnosis of bacterial infections, particularly those caused by (multi)resistant pathogens. To this end, F.O.M. has applied to the Federal Ministry for Economic Affairs and Energy (BMWi) for approximately 250,000 euros in funding through the “Industrial Collaborative Research” (IGF) program. The project proposal, titled “Microresonators for Point-of-Care Diagnostics of Pathogenic Germs” (InfektResonator) submitted by Furtwängler received a very good score of 33 points (out of a maximum of 40). However, the funding allocated in the 2019 federal budget is insufficient. In March 2017, the German Bundestag decided to increase the IGF budget from 169 million euros to 200 million euros. To date, this plan has not been implemented. As a result, it is expected that in 2019, only projects rated 34 points or higher by the reviewers will be able to get underway. Urgently needed research is thus on hold!

New Members

We warmly welcome Satisloh GmbH, DKW Life Sciences GmbH, MAICO diagnostics GmbH, and infoteam Software AG! Satisloh is a leading global manufacturer of machinery for the production of eyeglass lenses and precision optical lenses. DKW Life Sciences is a leading international manufacturer of laboratory glassware, consumer glass products, and packaging and storage solutions for a wide range of scientific and technical applications. infoteam Software AG is a long-standing provider of software solutions subject to regulatory standards. These include, for example, software for use in medical and laboratory devices (IVDR, MDR, FDA, etc.) as well as functionally safe software (IEC 61508, DIN EN 50128, DIN EN ISO 13849, etc.) up to the highest safety level. For over seven decades, the name MAICO has stood for reliable, advanced, and high-quality hearing diagnostic devices. Whether for hearing screening or diagnostic applications, MAICO offers a comprehensive product range to meet a variety of requirements. You can find more information about our members here.