From the Sector

Der Bundesverband Medizintechnologie (BVMed) unterstützt die Medizintechnik-Branche bei der praktischen Umsetzung der neuen Pflichten aus dem Lieferketten-Sorgfaltspflichtengesetz (LkSG) mit einer kostenlosen Handreichung. Sie besteht aus insgesamt sechs Modulen, von denen die ersten drei Module bereits heruntergeladen werden können.

„Unser Ziel ist es, mit den Publikationen zu einem einheitlichen Branchenstandard für die Implementierung des LkSG in Medizinprodukte-Unternehmen beitragen. Damit erreichen wir Harmonisierung, Rechtssicherheit und Effizienz – und nicht zuletzt einen noch bewussteren Schutz der Menschenrechte und der Umwelt“, kommentiert BVMed-Geschäftsführer und Vorstandsmitglied Dr. Marc-Pierre Möll.

Die Module wurden vom BVMed gemeinsam mit der Kanzlei Clifford Chance und der Produktkanzlei entwickelt. Zusätzlich bietet der BVMed entsprechende LkSG-Schulungen an: Am 22. November 2022 exklusiv für seine Mitglieder sowie am 9. Dezember 2022 auch für Nicht-Mitglieder über die BVMed-Akademie.

Die kostenlose BVMed-Handreichung für Medizintechnik-Unternehmen besteht aus den folgenden sechs Modulen:

• Modul 0: Anwendungsbereich
• Modul 1: (Compliance-)Dokumentation
• Modul 2: Ausgestaltung der Governance
• Modul 3: Ausgestaltung des Beschwerdemechanismus
• Modul 4: Risikoanalyse, -priorisierung, -prävention und -abhilfe
• Modul 5: Jährliche Berichterstattung

The Supervisory Board of Lenzing AG, a world-leading provider of sustainably produced specialty fibers for the textile and nonwoven industries, has appointed Nico Reiner as its new Chief Financial Officer. Mr. Reiner will join Lenzing’s Managing Board led by Chief Executive Officer Stephan Sielaff on January 1, 2023. He will succeed Chief Financial Officer Thomas Obendrauf, who is leaving the company of his own volition after seven years.

Nico Reiner has held several positions in his professional career to date, including CFO at globally operating companies such as Schüco Group, AL-KO Group and Pfleiderer Group, as well as management consultant roles. His most recent appointment was as CFO of Vacuumschmelze GmbH & Co. KG, a global player with headquarters in Hanau that specializes in the development, production and marketing of magnetic materials.

From 7 – 9 December 2022, Cinte Techtextil China will welcome visitors sourcing solutions for 12 application areas of technical textiles and nonwovens at the National Exhibition and Convention Center in Shanghai.

A number of countries and regions are represented at the fair’s International Zone, with companies from Austria, Belgium, France, Germany, Hong Kong, Italy, the Netherlands, Spain, Sweden, Switzerland, Taiwan, and the US. Standout international exhibitors include:

• TESTEX, an international, independent Swiss institute which specialises in the testing and certification of textile and leather products. The organisation is a founding member and official representative of the OEKO-TEX® Association, and will present their certification services at the fairground.
• Cotton Council International (CCI) is a non-profit trade association that promotes US cotton fibre and manufactured cotton products, with their COTTON USA™ Mark. At this year’s fair they will showcase cotton spunlace fabric, wipes, kitchen tissues, facial masks, cosmetic removers, and more, with their products particularly applicable to Agrotech, Clothtech, Medtech, and Sporttech.
• Graf + Cie AG is a subsidiary of the Rieter Group, and a leading supplier of clothing for carding and combs for combing machines in the short- and long-staple spinning industry. This year, the Swiss company will showcase stationary flats, and metallic card clothing for roller cards.
• At the returning German Pavilion, buyers can source sought-after technical textiles and nonwovens that are renowned for their quality. The companies and expertise on display at this pavilion are endorsed by the Federal Republic of Germany, with several exhibitors highlighted below:
• Brückner Textile Technologies GmbH & Co KG has developed machinery for the textile industry since 1949. Today, the company offers complete line systems for the dry finishing of both woven and knitted fabric, as well as for technical textiles, glass fibres, and floor coverings.
• Perlon (Zhejiang) Co Ltd is part of a global group of companies that specialises in the manufacture of synthetic filaments, with factories in China, Germany, Poland, and the US. Their products have a diverse range of potential uses, largely categorised in the Agrotech and Indutech application areas.
• IBENA Textilwerke GmbH produces various functional fabrics for Protech. At the fair, the company will be showcasing insulative, flame retardant (FR) textiles for firefighting and search & rescue services. Developed with DuPont™ aramid material, their FR properties will not diminish after washing or repeated use.

This year’s fair also sees the return of the Taiwan Zone. With support from the Taiwan Nonwoven Fabrics Industry Association, the area will showcase a range of industry leading nonwoven products and services, by brands such as KNH Enterprise, Nan Liu Enterprise, Unique Pretty Ind, and Web-Pro Corporation.

As a world’s largest manufacturer of technical textiles, China is home to a vast array of companies responsible for innovative products. Some domestic exhibitors to look out for are:

• CTA Hi-Textiles Co Ltd, a high-tech enterprise controlled by China Textile Science Research Institute. In recent years, the company has developed several new textile composite materials, and their products are widely used in sectors such as national defence, policing and public security, medical protection, and engineering and manufacturing.
• Sateri is one of the world’s largest producers of viscose fibre, with an annual capacity of 1.8 million metric tonnes. At their mills, they make yarn and fibre products applicable to sectors such as beauty, hygiene and personal care, medical, wipes, and protective wear.

To help international buyers stay connected with the Chinese market, Match Plus, the fair’s online business matching platform, will support foreign buyers achieve their sourcing goals despite travel limitations. Further information on Match Plus will be available at a later stage.

The fair’s product categories cover 12 application areas, which comprehensively span a full range of potential uses in modern technical textiles and nonwovens. These categories also cover the entire industry, from upstream technology and raw materials providers to finished fabrics, chemicals and other solutions.

Orbus Exhibit & Display Group® has continued its substantial and longstanding relationship with digital print technology provider Electronics For Imaging, Inc., choosing the premium-quality capabilities of the EFI™ VUTEk® FabriVU® 340+ soft signage printer to meet surging demand for dye-sublimation soft signage graphics. The new printer now running at Orbus’s Las Vegas facility marks an important milestone for EFI, as it is the 300th EFI VUTEk FabriVU printer installed worldwide.

Orbus is North America’s top trade manufacturer of soft signage and flag graphics for tradeshow exhibits, promotional displays, experiential retail and corporate interiors. The company is one of the largest users of EFI soft signage printers worldwide. The newly installed FabriVU 340+ model joins two additional FabriVU printers at Orbus Las Vegas. The company has its fourth FabriVU printer at its headquarters facility, along with a pair of high-volume EFI industrial printers used exclusively for dye-sublimation production.

The upgraded performance comes courtesy of the VUTEk FabriVU 340+ printer’s new, eight-printhead, CMYK x 2 array, along with new electronics for reliable and consistent premium-quality output of exhibit graphics, backlit graphics, retail fixture wraps, front lit graphics, block-out banners and fabric interior decor. A flag printing kit on the printer easily handles porous media in high-penetration applications by collecting inks without touching the rear side of the media.
 
As with all VUTEk FabriVU printers, it prints both transfer paper and direct-to-fabric.

The launch of the third edition of the Imagining Sustainable Fashion Award started on October 27, 2022. The Imagining Sustainable Fashion Award (ISFA) is the international competition born out of the collaboration between Connecting Cultures, the foundation that guides the Out of Fashion platform, and C.L.A.S.S., an international eco-hub that since 2007 has been advocating for a new generation of fashion in which the union of design, innovation, communication, and responsibility shapes a conscious and competitive business, capable of playing both an economic and social role.

The Imagining Sustainable Fashion Award invites stylists, photographers, designers, illustrators and artists to create visual imagery, a project that highlights awareness, respect for people and the planet that define the values of sustainable fashion in the fashion system.

Award submissions will be examined by an international jury composed of:

• Anna Detheridge, Founder and President, Connecting Cultures
• Giusy Bettoni, CEO and Founder, C.L.A.S.S.
• Rita Airaghi, Steering Advisor, Gianfranco Ferré Research Center
• Paola Arosio, Head of New Brands & Sustainability Projects, Camera Nazionale della Moda Italiana
• Jeanine Ballone Managing Director, Fashion 4 Development
• Evie Evangelou, Founder and President, Fashion 4 Development
• Sara Kozlowski, Vice President of Program Strategies, Education, and Sustainability Initiatives, Council of Fashion Designers of America
• Dio Kurazawa, Founding Partner, The Bear Scouts
• Renata Molho, journalist, former editor-in-chief of L'Uomo Vogue and former editor-at-large of L'Uomo Vogue, Vogue Italia, Casa Vogue
• Stefania Ricci, Director, Museo Salvatore Ferragamo
• Jovana Vukoje, Senior New Brands Specialist, Camera Nazionale della Moda Italiana

The winning projects of past editions were Take a Walk on the Green Side by Emma Scalcon (2021 - Italy) and Fashion Affair by Vishal Tolambia (2022 - India), two very different works that highlighted how challenging sustainability issues are in the contemporary communication landscape.

The deadline for submissions is Wednesday, January 25, 2023.
The winner will be announced in March 2023 and will receive a cash prize of €3,000.00.

Neue Zahlen der Europäische Kommission zur Implementierung der EU-Medizinprodukte-Verordnung (MDR) zeigen nach Ansicht des Bundesverbandes Medizintechnologie (BVMed) zwar Tendenzen in die richtige Richtung, „nach mehr als fünf Jahren der Umsetzung verfügt das MDR-Regulierungssystem aber immer noch nicht über ausreichende Zertifizierungskapazitäten“, so BVMed-Geschäftsführer und Vorstandsmitglied Dr. Marc-Pierre Möll. Die europäische Medizintechnik-Branche fordert daher in einem Schreiben an die EU-Kommission und Gesundheitsminister:innen der EU-Mitgliedsstaaten, zusätzlich zu den bisher durchgeführten untergesetzlichen Lösungen, „legislative Maßnahmen“ auf dem EPSCO-Meeting im Dezember 2022 zu beschließen. Dazu gehören die Verlängerung der Übergangsfristen nach einem risikobasierten Ansatz oder die Abschaffung der bestehenden Abverkaufsfrist.

Die EU-Kommission hat Ende Oktober 2022 unter anderem folgende aktuelle Zahlen zur MDR vorgestellt:

• Von 80 unter den alten Richtlinien designierten Benannten Stellen haben 62 Stellen MDR-Anträge gestellt.
• Mittlerweile gibt es 34 Benannte Stellen unter der MDR.
• Rund 23.000 Zertifikate müssen noch in die MDR überführt werden.
• Über 75 Prozent (17.000) dieser Zertifikate laufen im Mai 2024 aus.
• Bislang – Stand: Oktober 2022 – wurden 8.120 Anträge angenommen und 1.990 MDR-Zertifikate ausgestellt. Im April 2022 waren es 1.069 Zertifikate.
• Die Bearbeitungszeit liegt bei keinem einzigen MDR-Zertifikat (QMS und Produktprüfung) unter einem Jahr. 82 Prozent der Zertifikate dauern zwischen 13 und 18 Monaten, 18 Prozent zwischen 19 und 24 Monaten.

„Die Zahlen zeigen, dass zwar seit April 2022 mehr Zertifikate ausgestellt wurden, die Kapazitäten aber weiterhin bei weitem nicht für die Gesamtheit der Zertifikate ausreichen werden, um negative Folgen für die Patient:innenversorgung und die Markteinführung von Innovationen zu verhindern“, so BVMed-Geschäftsführer Möll. In einem vom europäischen Dachverband MedTech Europe koordinierten Schreiben an die EU-Kommission und die Gesundheitsminister:innen der EU-Mitgliedsstaaten haben deshalb über 300 Verbände und Unternehmen der Medizintechnik-Branche kürzlich „dringenden Handlungsbedarf für den Gesetzgeber“ bei der Umsetzung der MDR angemahnt.

Der vom Bundesgesundheitsministerium (BMG) begonnene Dialogprozess und die Vorschläge der Medical Device Coordination Group (MDCG) auf EU-Ebene seien zwar gute Ansätze, aber es sind weitere Schritte notwendig. „Wenn nicht unverzüglich Maßnahmen ergriffen werden, steht Europa vor einem Szenario, in dem eine große Anzahl bestehender Medizinprodukte, auf die sich Patient:innen, Krankenhäuser und andere Gesundheitseinrichtungen verlassen, nicht rechtzeitig rezertifiziert werden und daher Gefahr laufen, dauerhaft vom Markt zu verschwinden“, heißt es in dem Schreiben. „Gleichzeitig verzögert sich die Zertifizierung neuer und verbesserter Produkte, was dazu führt, dass die Patient:innen erst mit Verzögerung von den Vorteilen der Innovation profitieren.“ Die anhaltende COVID-19-Pandemie und die Folgen des russischen Angriffskrieges gegen die Ukraine hätten diese Situation durch Unterbrechungen der Lieferketten, deutliche Erhöhung der Energiepreise und Probleme bei der Durchführung von Audits vor Ort sowie bei klinischen Prüfungen noch verschärft.

Zusätzlich zu untergesetzlichen Lösungen seien daher so bald wie möglich legislative Maßnahmen erforderlich, heißt es in dem Schreiben, das unter anderem an den deutschen Gesundheitsminister Prof. Dr. Karl Lauterbach ging. Die europäische Medizintechnik-Industrie fordert darin:

1. Verlängerung der Gültigkeit der Richtlinienzertifikate (Richtlinie über Medizinprodukte und Richtlinie über aktive implantierbare medizinische Geräte), um Bestandsprodukte verkehrsfähig zu erhalten. Diese Verlängerungen sollten analog zur Änderung der Verordnung über In-vitro-Diagnostika im Januar 2022 anhand eines risikobasierten Ansatzes erfolgen, also mit unterschiedlichen Fristen je Risikoklasse der Produkte.
2. Zertifikate unter Auflagen für Bestandsprodukte sowie wesentlich geänderten und neuen Produkten, um beispielsweise mehr Zeit für die Zusammenstellung weiterer Daten und Nachweise zu schaffen, die zur Erfüllung der MDR-Anforderungen erforderlich sind.
3. Abschaffung der in Artikel 120 Absatz 4 der MDR festgelegten Abverkaufsfrist, um die Bereitstellung bereits in Verkehr gebrachter Medizinprodukte über das Enddatum Mai 2025 hinaus zu ermöglichen. Auf diese Weise lässt sich die unnötige Entsorgung oder der Rückruf von bereits in Verkehr gebrachten sicheren Medizinprodukte vermeiden.

„Wir müssen diese gesetzgeberischen Maßnahmen zügig umsetzen – und gleichzeitig daran arbeiten, die Rolle Europas als attraktive Region für Investitionen in medizintechnische Innovationen zu stärken“, so der Appell von BVMed-Geschäftsführer Dr. Marc-Pierre Möll.

• European textile industry needs to prepare for a paradigm shift, and become global leader in sustainable textiles

Organised by EURATEX in partnership with the Portuguese Textile Association (ATP), the Porto Convention – Sustainability meets Competitiveness: How to Square the Circle? – took place on 13-14 October in Porto, Portugal, with nearly 250 entrepreneurs attending from all over Europe. They discussed the current challenges of the European textile industry and set the grounds for a bright future, based on some strong foundations: innovation, creativity, quality and sustainability.

In his keynote speech, Mr. Pedro Siza Vieira, Former Minister for the Economy and Digital Transition of Portugal, assessed the geopolitical and macroeconomics changes, and how this will impact on the future of the textile industry: nearshoring and friend-shoring, independence from foreign gas through the use of European sustainable energy, as well as circular and automated production lines. While the current turbulence causes uncertainty, he sees a better future for our industry.

The first CEO Panel, addressing the theme of How to Measure and Communicate about Sustainability, focused on the challenges to translate “sustainability” towards the consumers. The panel addressed the issue of greenwashing and the role of brands in communicating about sustainability. It looked at how the new European Commission regulations on eco-label, digital product passport (DPP) and product environmental footprint (PEF) will create a new framework.

The second CEO Panel, discussing Financing Sustainability, looked at the cost of sustainable investments, and how this cost should be managed within the entire supply chain, including the brands and retailers.

Four workshops with industry experts followed in the afternoon, addressing the themes of Extended Producer Responsibility (EPR) in Textiles, Digital Product Passport (DPP), Recycling Textile Waste and Labelling Textiles (Product Environmental Footprint). As these initiatives will roll out in the coming years – as part of the EU Textile Strategy – participants got a better understanding of the future framework for our industry.

Dirk Vantyghem, Director General of EURATEX, commented on this: “to prepare for a brighter future requires a new regulatory framework, where quality and durability become the norm, where transparency and sustainability is rewarded, where free riders – who do not comply with rules and standards – are kept outside the market. The EU Textile Strategy aims at creating such a framework, which must be fair and balanced, and requires a close and constant dialogue between the regulator and the industry.”

During the 2nd day of the convention, participants had the opportunity to visit state of the art textile companies (Têxteis J.F. Almeida, RIOPELE, and TMG Automotive) and the Portuguese textile  research centre CITEVE. They showcased how the Portuguese textile industry is making this transition, while remaining globally competitive.

Alberto Paccanelli, President of EURATEX, concluded: “We need to attract creative people in our companies, we need to produce top class quality products, and we need to become more sustainable. That is the recipe for our success in a globalised and highly competitive industry.” Paccanelli is positive about the future: “While we face very tough times, I am optimistic about the future of our European textile industry. The rest of the world is watching us, as we move forward with our strategy. We should become their benchmark and Europe should become a global leader in sustainable textiles.”

At the recent CAMX 2022 Composites and Advanced Materials Expo in Anaheim, California, The Heat Sealing Module – HSM from Zünd was recognized with an Unsurpassed Innovation Award. The HSM significantly facilitates the processing and handling of dry fiber materials with thermoplastic content. This new tool is Zünd’s answer to a demand in the composites industry for wider-spread use and easier processing of these types of materials.

The American Composites Manufacturing Association, ACMA, proclaimed the Heat Sealing Module – HSM the winner of the ACE Award for Unsurpassed Innovation in the “Manufacturing: Equipment and Tooling” category. This award is presented annually to equipment, tooling, a production aid, or software designed to improve manufacturing production, environmental sustainability, or product quality and performance in composites manufacturing.

During processing, dry fiber materials are prone to fraying along the edges. Using hot air, the HSM seals the fabric along the cut path in advance of the Zünd Power Rotary Tool – PRT cutting it. Because of this sealing process, the cut can then be performed at full speed, in any direction, and produces both higher-quality parts and greater production efficiencies.

The HSM helps create clean, sealed edges when cutting fiber-reinforced thermoplastic composites. It benefits not only the cutting process itself, but other production processes downstream. Cutting this way leaves behind no loose or uncut fibers and maintains a clean cutting surface and uncontaminated production environment. At the same time, it ensures that cut parts maintain their shape, and this increased stability makes them much easier to handle, especially in fully automated production workflows.

Der Bundesverband Medizintechnologie (BVMed) hat ein wissenschaftliches Institut gegründet, das sich unter anderem der Versorgungs- und Gesundheitssystemforschung sowie methodischen Fragen der Nutzenbewertung und des Health Technology Assessments (HTA) von Medizinprodukten widmen wird. „Zielsetzung des Institutes ist die Aufbereitung und methodische Diskussion von Evidenz zur Stärkung und Sicherung der Patientenversorgung mit Medizinprodukten“, so die Leiterin des BVMed-Instituts, Anne Spranger, auf der Jahrespressekonferenz des deutschen Medizintechnik-Verbandes.

Das BVMed-Institut wird dazu mit den relevanten Institutionen, beispielsweise den wissenschaftlichen Instituten der Krankenkassen, anderen Forschungseinrichtungen und auch Fachgesellschaften in Dialog treten sowie eine Übersicht zu Datenquellen und -methoden erarbeiten. Dazu sind eigene Auswertungen und Publikationen geplant. Zu den weiteren Aufgaben gehört die Organisation von Informations- und Fortbildungsformaten und die Erstellung von Leitfäden.

During an awards ceremony on Monday, October 17, the Society for Human Resource Management (SHRM) Foundation awarded Barry-Wehmiller CEO Bob Chapman its preeminent recognition in people leadership, the Tharseō CEO of the Year Award.

SHRM is the world's largest HR professional society, representing more than 300,000 HR professionals across the globe, impacting 115 million workers and their families. The Tharseō (thar-seh'-ō)—derived from the Greek word for "courageous, confident and bold"—awards are given to those who demonstrate innovative and impactful business practices leading to better workplaces and a better world by serving as visionaries, innovators and change agents.

Chapman has been the CEO of Barry-Wehmiller since 1975. Since then, he has applied a blend of strategy and culture to create a thriving global organization. Chapman’s work is chronicled in his 2015 Wall Street Journal bestseller Everybody Matters: The Extraordinary Power of Caring for Your People Like Family, co-authored by Raj Sisodia, founder of Conscious Capitalism. In 2016, Harvard Business School released a case study about Barry-Wehmiller’s approach to business that is now taught at 80 business schools. A non-profit, Chapman Foundation for Caring Communities, and a leadership consulting firm, Chapman & Co. Leadership Institute, bear Chapman’s name and share some of the foundational learnings that helped transform the culture of once-traditional Barry-Wehmiller into a caring, dignity-honoring, fulfilling place to work.

In recent years, Chapman has focused on creating caring leaders of tomorrow by sponsoring programs in K-12 schools and universities. In 2021, Chapman and his team partnered with Fordham University and other Jesuit business schools to launch the Humanistic Leadership Academy which helps professors and students become more human-centered.

A sought-after global speaker, Chapman recently addressed the United Nations PRME conference on transforming education, the China Organizational Evolution Forum, Brazil’s Virtuous Leadership Conference, Vizient CEO Network, and the Healthcare Burnout Symposium, to name a few.