From the Sector

Der Bundesverband Medizintechnologie (BVMed) hat die gesetzliche Einführung eines Beratungsrechts beim Gemeinsamen Bundesausschuss (G-BA) für Hersteller von sonstigen Produkten zur Wundbehandlung begrüßt. Mit dem Beschluss im Rahmen des Arzneimittel-Lieferengpassbekämpfungs- und Versorgungsverbesserungsgesetzes (ALBVVG) wurde zudem die Übergangsregelung um 12 Monate verlängert. „Damit hat der Gesetzgeber noch rechtzeitig reagiert, um Verbesserungen an der neuen Verbandmittel-Erstattungsregelung vorzunehmen und Nachteile für die Versorgung von Menschen mit chronischen Wunden zu vermeiden“, so BVMed-Geschäftsführer und Vorstandsmitglied Dr. Marc-Pierre Möll. Nun sei es wichtig, „dass der G-BA gemeinsam mit Ärzteschaft, Pflege und Herstellern geeignete und auf die Wundversorgung angepasste Evidenzkriterien entwickelt. Mit dem Beratungsrecht gibt es dafür nun die Grundlage.“

Hintergrund ist, das für sogenannte „sonstige Produkte zur Wundbehandlung“ künftig ein Bewertungsverfahren durchgeführt werden muss, bevor sie durch die GKV erstattet werden. Der Gemeinsame Bundesausschuss (G-BA) hat bislang jedoch keine auf die Wundversorgung angepassten Evidenzkriterien für die erstattungsrelevanten Nutzennachweise definiert. Hierzu gewährt der Gesetzgeber nun – analog zu vergleichbaren Verfahren zur Bewertung des Nutzens von Arzneimitteln nach § 35a SGB V (AMNOG) oder zur Bewertung neuer Untersuchungs- und Behandlungsmethoden nach § 137h SGB V (NUB) – betroffenen Verbandmittel-Herstellern ein Beratungsrecht zur Methodik der für die Nutzenbewertung erforderlichen Studien.

Zur Frage der Evidenzkriterien hatte der BVMed kürzlich im Umfeld des Bremer Wundkongresses eine Umfrage durchgeführt, an der sich über 250 Wundfachkräfte beteiligten. Sie zeigte auf, dass es bei den Behandlungen von 92 Prozent der Teilnehmenden zunächst um die Reduktion klinischer Infektionszeichen geht. 79 Prozent nennen die Reduktion von Wundexsudat, 76 Prozent Reduktion von Schmerzen, 70 Prozent die Verbesserung der gesundheitsbezogenen Lebensqualität der Betroffenen. Die Reduktion der Wundfläche steht bei 58 Prozent im Fokus, die Reduktion der Keimlast in der Wunde bei 55 Prozent. Nur 22 Prozent der Befragten nennen auch den kompletten Wundverschluss als Evidenzkriterium. „Wundauflagen mit antibakterieller Wirkung sind für eine phasengerechte Wundversorgung unerlässlich und müssen auch künftig für die Versorgung chronischer Wunden zur Verfügung stehen“, so BVMed-Wundexpertin Juliane Pohl.

Betroffen von der neuen Regelung ist eine Vielzahl von Produkten wie etwa silber- oder PHMB-haltige Wundauflagen, die bislang erstattungsfähig waren. Nach Einschätzung des BVMed sind rund 400 Produkte betroffen.

The theme for the 13th edition of RISE® (Research, Innovation & Science for Engineered Fabrics) is “A New Era in Manufacturing for Sustainability.” Technology scouts, product managers, senior scientists, development engineers, and business developers will convene September 26-27 at North Carolina State University and The Nonwovens Institute in Raleigh, NC to discover the latest nonwoven innovations.

The RISE conference program features industry leaders from these companies: American Truetzschler, Berry Global, Dilo Incorporated, Evonik Corporation, Indorama Ventures USA, MANN+HUMMEL, the National Renewable Energy Laboratory, NatureWorks, The Nonwovens Institute, Owens Corning, PCI Wood Mackenzie, PolyQuest, Reifenhäuser REICOFIL GmbH, and Simplifyber. These industry experts will discuss the future of nonwoven manufacturing, advances in filter media, rPolymer developments, and sustainable applications.

Innovations that advance the nonwovens industry will be recognized with the 2023 RISE® Innovation Award. Three finalists will present their innovative products or technologies to RISE participants, Tuesday, September 26th. The 2022 award winner was DiaperRecycle, cat litter made from recycled diapers.

RISE participants have the option of touring The Nonwovens Institute’s $65 million-plus, 60,000 square-foot facilities featuring state-of-the-art equipment, pilot lines, and analytical laboratories, as well as attending an evening reception at the Lonnie Pool Golf Course Clubhouse. During the evening reception, graduate students and faculty from North Carolina State University will feature their research and technical advances with poster presentations. The tour and reception will take place Tuesday, September 26th and the tour is limited to 40 attendees.

• The A+A Expert Talks head into their third round

On 20 June 2023 between 10.00 am and 11.30 am experts from the fields of sustainability, circular economy, environmental protection as well as corporate fashion and product management will be presenting lectures and discussing the topics of sustainability in supply chains, standardisation and quality seals as well as the associated challenges and solutions in cooperation with German Fashion. They will thereby provide a platform for the exchange of knowledge, experience and innovative approaches.

The focus on sustainability and the circular economy reflects the growing relevance of these topics in the world of work. More and more companies recognise the need to make their business practices more sustainable and optimise the use of resources.

This Expert Talk will be presented by Irina Olm, In-House Lawyer & Counsel of GermanFashion Modeverband Deutschland e.V. and Expert for Circular Economy and CSR, who will contribute her know-how on the European level.  

Benjamin Helfritz, Head of Quality in Digital and Green Transformation, DIN – German Institute for Standardisation, will introduce participants to the new standards for the Green Transition.  
The Digital Product Passport (DPP) is needed for both the green and digital transition. However, it will only achieve its full added value if interoperability is ensured between existing and emerging systems. The use of the DPP promotes more sustainability and digital progress.

Henk Vanhoutte, Secretary General, European Safety Federation (ESF) and Lucia Mendori, Regulatory Affairs Associate / Chair ESF Working Group Sustainability will present practical examples and concrete application factors for sustainable PPE as well as solutions for sustainable jobwear. They will provide an overview of survey results from their members regarding various sustainability aspects – pointing to how the industry is treating this important topic but also flagging up the limits to the sustainability of PPE.

Lena Bay Høyland, Product Director of the Swedish workwear manufacturer Fristads Kansas will share the sustainability strategy of her company which has committed to minimise its environmental impact by targets and effective measures. The progress made by Fristads Kansas was measured using concrete figures and audits. This is a use case highlighting the innovations and challenges associated with sustainable jobwear.

By organising the Expert Talks the leading international trade fair A+A jointly with its strategic partners from the German Federal Association for Occupational Safety and Health (Basi), Fraunhofer IPA, German Fashion (Modeverband Deutschland e.V.), DGUV (Germany Statutory Accident Insurance), BAuA (Federal Agency for Occupational Safety and Health), BMAS (Ministry of Labour and Social Affairs), IVPS Interessenverbund Persönliche Schutzausrüstung e.V. (PPE Stakeholder Association) as well as IFA (Institute for Occupational Safety) will provide its community with a networking and information platform.

2XL Corporation, Avgol Nonwovens, and Yowel to compete for Award
INDA, the Association of the Nonwoven Fabrics Industry, announced the three finalists for the World of Wipes Innovation Award®. The Award will be presented at the 17th annual World of Wipes® (WOW) International Conference, July 17-20, at the Atlanta Marriott Marquis in Atlanta, Georgia.    

The three products vying for this Award are a cleaning and disinfecting device from 2XL Corporation, a wipe utilizing biotransformation technology from Avgol Nonwovens, and a reusable towel dispensing system from Yowel.

The winner will be announced on July 20th at 11 am. The three companies competing for the Award are:

Windup by 2XL Corporation
Meet the Windup: a groundbreaking new device that can clean and disinfect your home using a self-advancing microfiber roll that you never have to touch. Just one roll will clean your kitchen over 50 times. An innovative one-touch revolving roll and a versatile spray system that allows use of your favorite floor cleaner or our specially formulated disinfecting solution. No more stopping to change expensive pads or change filthy water. Get wound up for Windup.

Nonwoven wipe using biotransformation technology by Avgol Nonwovens
This innovative spunlace wipe utilized advanced biotransformation technology developed jointly by Indorama Ventures and Polymateria. Meeting the BSI PAS 9017 specification, this wipe in the event it becomes fugitive, and exposed to heat, sunlight, air and moisture will transform into a harmless, bioavailable wax at its end-of-life, eliminating microplastic pollution. Compatible with mechanical recycling and combatting ‘fugitive’ waste, this wipe represents a significant leap towards eco-friendly, sustainable nonwoven hygiene products.

The Yowel™ System by Yowel
Ready to help the earth and save money…every day? Yowel is a patented system for dispensing reusable towels. Instead of a roll of paper towels, place a Yowel full of reusable towels into your paper towel holder – or choose the countertop model, and you’re immediately reducing your paper towel consumption.  The Yowel System has 40 reusable towels and a mesh bag for used towels. Save money and help Mother Nature.

INDA’s Technical Advisory Board selected the finalists based on the creativity, uniqueness, and technical sophistication employed in finding novel ways to expand the utilization of nonwovens. Categories considered for the award were wipes related raw materials, roll goods, converting, packaging, active ingredients, binders, additives, and end-use products.

Nice-Pak’s SecureFLUSH® Technology Flushable Wipes received the 2022 World of Wipes Innovation Award for their unique, 100% cellulose nonwoven that is strong enough to clean, yet break apart rapidly, when flushed. A specialty “lock and key” design of plant-based fibers and formula leverages patent-pending technology to break apart five times faster than the leading brand of two-ply toilet paper and ensure responsible care of plumbing and wastewater. SecureFLUSH® Technology Flushable wipes are available in Walmart, Amazon, and at Nicencleanwipes.com.

On the occasion of EURATEX’ General Assembly held in Milan on 7 June, the European textile industry  discussed the relationship between innovation, sustainability and people in the industry of tomorrow. EURATEX members welcomed the Textiles Transition Pathway, released on 6 June by the Commission, as a valuable roadmap to ensure a successful green and digital transition. The meeting in Milan was also the occasion to strengthen links with textile machine manufacturers, gathering at ITMA 2023.

Hosted by Sistema Moda Italia (SMI), EURATEX meetings addressed the crucial issue of how to develop new competitive business models for the future, following the Industry 5.0 concept. In 2021, the European Commission launched “Industry 5.0”, which puts the wellbeing of the worker at the centre of the production process and the use of new technologies to provide prosperity beyond jobs and growth, while respecting the production limits of the planet.

The keynote speakers, Francesco Pinto (Chairman, Yamamay) and Claudio Cavacini (Director of Retail Industry Solutions & Strategy, Salesforce), presented how the digital transformation is affecting companies in the retail industry and how they should adapt to maintain their competitive edge. A panel session of textile machinery manufacturers debated how their companies can help delivering this transformation through state of the art machineries. They all agreed that it requires common efforts by all actors and stakeholders along the textile value chain and public support to make the necessary investments. According to Enzo Maurer, ITMA President, ITMA 2023 in Milan will exactly showcase excellence in innovation and new available technologies to make a leap forward in sustainability.

According to Sergio Tamborini, "we are particularly honored to host this event organized by Euratex, the association which is the voice of the European textile industry and its demands, especially those concerning the circular economy. Sistema Moda Italia wants to play its part and there are priorities, from legislation on extended producer responsibility (EPR) in Italy to eco-design, where textiles and clothing will act as a testing ground. SMI's goal will be to continue to encourage the debate on circularity  promoting it in all institutional settings aiming to a growing sustainable  supply chain.”

Alberto Paccanelli, EURATEX President added: “Today’s discussions showed that we are ready to take up new challenges. Nevertheless, this  transition towards a textiles 5.0 can only happen with the support of all actors, from policy makers to retailers. Today’s meeting was also the occasion to review the EU transition pathway for the textiles ecosystem, published yesterday by the European Commission. The pathway is the perfect example of a co-creation process between the European institutions and the stakeholders. We hope that other EU initiatives or legislative proposals will follow the same co-creative process.”

June 1, the European Parliament has adopted its Report on an EU Strategy for Sustainable and Circular Textiles. The Report wants to step up the EU’s ambition towards sustainability and circularity even further, but it has failed to recognise the strategic role of the European textile industry to scale up sustainability, nor to appreciate the global competitive threat which our companies are facing.

Director General Dirk Vantyghem commented on the MEP Report: “We welcome the strong interest of the European Parliament in the textile and fashion industry, but encourage MEPs to develop a balanced vision which reconciles sustainability and competitiveness. Developing a new business model for our industry requires carefully crafted legislation at global level, and an open dialogue between the industry, the brands and the consumer.”

EURATEX supports the EU Textile Strategy, as it was presented over a year ago by the European Commission. The 160.000 European textile companies are committed to invest in sustainability, develop new circular business models and produce high quality textile products – not just in fashion, but also in home and medical textiles, construction, agriculture or cars. To do so, indeed a new regulatory framework is needed, with clear definitions, coherent rules and effective controls. But also, the companies should be able to comply with these rules and remain globally competitive.

The EP Report has failed to respect that balance between sustainability and competitiveness. Instead, it suggests even more rules and restrictions, totally disregarding the current economic challenges caused by high energy prices, loss in consumer confidence and assertive trade partners. Putting the bar even higher will simply mean that the European textile industry will be pushed out of the market, resulting in a bigger environmental footprint and increased dependency on foreign supplies. Quite the opposite of what the EU wants to achieve with its open strategic autonomy plans.

The Report also fails to differentiate between textile products. There is a mix up between fashion and technical textiles, between products made in Europe and outside, between high quality and durable products and low-quality items. It is regretful that the European Parliament did not make that distinction and simply refers to “textiles” as a general cause of concern, without acknowledging e.g. the high quality products, made by European textile and fashion companies.

The Report puts a strong responsibility on the supply side – the industry and the brands – and does not sufficiently address the role of the consumer. Initiatives therefore are essential to create a stronger demand for sustainable textiles, which includes better communication and transparency (avoid greenwashing), fiscal measures, green public procurement and better control of online marketplaces.

On a positive note, the EP Report does recognise the importance to invest in research and innovation, to support reskilling and upskilling, the need of scaling up circular economy and pay attention to the needs of SMEs. EURATEX has always insisted that such massive transition can only be successful if accompanied by significant and dedicated support programmes. The EU Textiles Transition Pathway should offer a clear perspective in this regard.

• Flame Retardancy for Composites Applications in the Transport Sector

On 10-11 May 2023, the AVK - Industrievereinigung Verstärkte Kunststoffe e. V. in cooperation with the FGK - Forschungsgesellschaft Kunststoffe e.V. in Berlin organised for the first time an international, English-language conference on flame retardancy.

In 18 compact lectures, more than 20 experts informed nearly 80 participants about new developments, requirements and innovations regarding specific flame retardant properties of components made of fibre-reinforced plastics/composites for the transport sector.

Among others, there were presentations by industry representatives from Saertex, BÜFA, Clariant, Diehl Aviation and Airbus, but also from institutes such as the Fraunhofer Institutes or the Federal Institute for Materials Research and Testing. Presentations on the topics of standardisation, raw materials, automotive or recycling were on the agenda, but also flame retardants for connectors and battery housings for electric vehicles or fire-retardant systems for rail vehicles or fire-retardant CFRP made from recycled CF nonwoven were presented.

INDA, the Association of the Nonwovens Fabrics Industry, announces the publication of a new study, North American Nonwoven Materials Annual Study 2022.

Based on actual surveys and interviews with producers, enhancing the accuracy and relevance, this study tracks machine additions, closures, and productivity improvements. This study is the industry benchmark for capacity and production information for North America and the only publication that provides an estimate of operating rates, based on nameplate machine capacity, through the year 2022. The 72-page study contains 43 figures and 11 tables.

“An element of INDA’s mission is to provide credible statistics to the nonwovens and engineered materials industry,” said Tony Fragnito, INDA President. “Our objective is to continually improve the quality of data and industry information. We feel the industry will greatly benefit from this in-depth resource for strategic planning and investment purposes,” Fragnito added.

The complete study is provided to producers who supplied key metrics. The Executive Summary, an overview of the findings and implications, will be offered to current INDA members on a complimentary basis.

The detailed study is available for purchase, with members receiving a discount.

Findings from this year’s study include:

• North American capacity continues to increase with investments being made across all the processes and for a variety of end-uses. The industry’s nameplate capacity utilization has increased year-over-year, for the fifth consecutive year.
• In 2022, capacity of nonwovens in North America reached 5.565 million tonnes, an increase from the previous year of 2.4% (net growth of 128,700 tonnes) and an improvement over the previous year’s growth rate of 1.8%.
• North American imports, in tonnage, decreased 24.3% in 2022 and exports decreased 16.3% due to market stabilization after COVID. Nonwoven production tends to stay within the region, so the net trade balance (imports less exports) accounted for less than 5.5% of the region’s capacity.

“2022 was a period of economic adjustment and stabilization,” said Mark Snider, Chief Market & Industry Analyst. “We’re seeing a controlled and consistent transition back to pre-pandemic levels of nonwoven growth.”

Der Bundesverband Medizintechnologie (BVMed) fordert in einem 5-Punkte-Plan Maßnahmen für die im Koalitionsvertrag vorgesehene Stärkung des Medizintechnik-Standorts Deutschlands. Zu den Forderungen des deutschen Medizintechnik-Verbandes gehören eine beauftragte Person der Bundesregierung für die industrielle Gesundheitswirtschaft, eine Stärkung der Resilienz und der Lieferketten, ein Belastungsmoratorium und Entbürokratisierungs-Offensive für die KMU-geprägte Branche, Fast-Track-Verfahren für Innovationen mit klaren Fristen sowie einfache Anerkennungsverfahren für benötigte Fachkräfte.

Der BVMed-Vorstandsvorsitzende Dr. Meinrad Lugan bezeichnete die Medizintechnik-Branche als „Aushängeschild für die deutsche Wirtschaft“: „Wir sind Innovationstreiber. Wir sind Jobmotor. Wir haben Hidden Champions und sind Exportweltmeister. Wir haben 93 Prozent Mittelstand. Für Deutschland steht viel auf dem Spiel. Denn: Der Medizintechnik-Standort Deutschland ist stark gefährdet.“ Das liege neben den massiv gestiegenen Kosten für Energie, Rohstoffe und Logistik sowie Inflation und steigende Löhne vor allem an „hausgemachten Problemen“: Sehr kompliziertes regulatorisches System für Medizinprodukte, überbordende Bürokratisierung und Regulierungswut sowie schleppende Digitalisierung im Gesundheitssystem und mangelnde Datennutzung. „Wir senden damit keine Signale für einen innovationsfreundlichen Standort aus“, so Lugan. Er fordert: „Um Top-Talente im Land zu halten und Innovationen hier zu entwickeln, brauchen wir bessere Rahmenbedingungen!“.

Der 5-Punkte-Plan des BVMed sieht unter anderem vor:

1. Beauftragte Person der Bundesregierung für die industrielle Gesundheitswirtschaft
Für eine gut koordinierte MedTech-Branchenstrategie „aus einem Guss“, muss die ressortübergreifende Zusammenarbeit verbessert werden. Der BVMed fordert daher die Benennung einer beauftragten Person der Bundesregierung für die industrielle Gesundheitswirtschaft sowie die Stärkung der Abteilung Gesundheitswirtschaft im Bundeswirtschaftsministerium.

2. Resilienz und Lieferketten stärken
Der BVMed spricht sich für einen „systemischen und strategischen Ansatz“ aus, um die Resilienz des deutschen Gesundheitssystems und die Lieferketten zu stärken. Dazu gehören eine bessere Einbeziehung der MedTech-Branche in die Erarbeitung von Lösungen, die Unterstützung des Aufbaus von Produktionskapazitäten in Deutschland in Produktbereichen, in denen eine strategische Unabhängigkeit erreicht werden soll, sowie die Einrichtung einer digitalen Bestandsplattform versorgungskritischer Medizinprodukte, um Transparenz in Echtzeit zu erreichen.

3. Belastungsmoratorium und Entbürokratisierungs-Offensive
Der BVMed fordert eine Entbürokratisierungs-Offensive, die den deutschen Mittelstand im Blick hat, konsequent Überregulierungen abbaut sowie in Brüssel für standortfreundliche Regulierungen kämpft. Dazu gehört, dass die Verantwortung für Lieferketten auf die unmittelbaren Zulieferer beschränkt bleibt. Der BVMed fordert zudem einen einheitlichen ermäßigten Mehrwertsteuersatz auf Medizinprodukte sowie mehr Geschwindigkeit und bessere Förderung von klinischen Studien. Wichtig seien zudem adäquate Mechanismen, die die ambulante Hilfsmittelversorgung auch im derzeitig starren Vertragskonstrukt sicherstellt.

4. Fast-Track für Innovationen mit klaren Fristen
Der BVMed setzt sich für flexiblere und schnellere Bewertungsverfahren mit klaren Fristenregelungen beim Gemeinsamen Bundesausschuss (G-BA) und beim Bewertungsausschuss ein. Forschende Medizinprodukte-Unternehmen benötigen zudem einen besseren Datenzugang und ein Antragsrecht beim Forschungsdatenzentrum. Außerdem sollte sich Deutschland dafür einsetzen, dass die EU-Medizinprodukte-Verordnung (MDR) strategisch weiterentwickelt wird und „mehr Berechenbarkeit und Schnelligkeit“ beim Marktzugang von Medizinprodukten bietet. So spricht sich der BVMed unter anderem für Fast-Track-Verfahren für innovative Medizinprodukte aus, die den Stand der Technik erheblich verbessern oder einen bislang ungedeckten medizinischen Bedarf betreffen. Hier gebe es bereits etablierte Regelungen zu FDA-Programmen oder Arzneimittel-Verfahren.

5. Fachkräfte gewinnen
Um dringend benötigte internationale Fachkräfte für die Medizintechnik-Branche zu gewinnen, fordert der BVMed einfache Anerkennungsverfahren, Integrationsangebote und Internationalisierung der Verwaltungsverfahren. Außerdem sollten die Arbeitsbedingungen insbesondere in der Pflege verbessert werden, beispielsweise durch den geförderten Einsatz von digitalen Lösungen und pflegeunterstützenden Technologien.

The textile machinery orders index for the first quarter of 2023, as processed by the Economics Office of ACIMIT, the Association of Italian Textile Machinery Manufacturers, declined markedly compared to January-March 2022 (-35%). In absolute terms, the index stood at 84.8 points (basis: 2015=100).

This result is mainly due to a reduction in the orders intake recorded by manufacturers on foreign markets. Indeed, foreign orders dropped by 40%, whereas the domestic market showed a 14% increase. The absolute value of the index settled at 78.3 points abroad, while it measured in at 148.1 points in Italy. During this year’s first quarter, booked orders stood at 4.2 months of guaranteed production.

ACIMIT president Alessandro Zucchi stated that, “The order index for the first quarter confirm a trend of the past few quarters, where uncertainty still predominates in global markets, both in terms of a macroeconomic framework that is characterized by a penalizing inflationary trend and ongoing geopolitical tensions. This is a scenario that this does not facilitate investment plans for businesses.”

However, this uncertainty does not appear to affect the sector’s operators, who are nonetheless permeated by a sense of optimism, as is also testified by the positive data drawn from a comparison with orders from the previous quarter (October-December 2022), for which total orders had been slightly on the rise at +3%. Indeed, the president of ACIMIT confirms that, “Manufacturers in our sector don’t lack for work, having filled up on orders last year and are now busy fulfilling them. The forecasts for 2023 remain positive”. Zucchi concluded, “I expect this confirmation of a healthy manufacturing sector to come from ITMA Milan, the world’s premier trade show dedicated to textile and clothing technologies, slated to open on June 8th at the Rho Fiera exhibition spaces. The exhibit will feature over 400 Italian manufacturers, taking up approximately 30% of the entire exhibition space. This figure is in itself a result that confirms the leadership role of Italy’s textile machinery manufacturers”.