From the Sector

In der im Frühjahr 2022 gestarteten Datenbank „BVData“ des Bundesverbandes Medizintechnologie (BVMed) sind mittlerweile über 400 Bewertungsverfahren für über 200 innovative Untersuchungs- und Behandlungsmethoden mit Medizintechnologien abgebildet. Die BVMed-Datenbank bereitet aus der Medizintechnik-Perspektive die Methodenbewertungs-Verfahren des Gemeinsamen Bundesausschusses (G-BA) und weiterer beteiligter Organisationen strukturiert auf.

Die Anforderungen an die sichere und leistungsfähige Behandlung von Patient:innen mit Medizinprodukten wachsen stetig. Mit geeigneten Datenquellen können wichtige Erkenntnisse aus dem Versorgungsalltag gewonnen werden, um die Behandlungsqualität zu verbessern. Ein wichtiges Instrument für Medizintechnik-Hersteller, um den Nutzen von Medizinprodukten zu belegen, sind Verfahren der Methodenbewertung, beispielsweise die Erprobungsverfahren.

Ein Methodenverfahren erfordert die Teilnahme vieler unabhängiger Institute. Hier ist allerdings die Kommunikation der Untersuchungsergebnisse und Beschlüsse nicht einheitlich geregelt. Einen vollständigen Überblick über die Methodenbewertung und Analysen gibt die herstellerorientierte digitale Bewertungsverfahren-Datenbank „BVData“ des BVMed. Dort werden Verfahren von der Eröffnung bis zur abschließenden Bewertung strukturiert hinterlegt. Mit den vollständig recherchierbaren Datensätzen zur Erprobung und Bewertung von Medizinprodukten können Medizintechnik-Unternehmen alle Daten schnell und aussagekräftig analysieren.

Der Bundesverband Medizintechnologie (BVMed) trauert um seinen langjährigen Geschäftsführer und Vorstandsmitglied Joachim M. Schmitt. Er verstarb am Neujahrstag 2023 im Alter von 71 Jahren.

Schmitt kam 1985 zum BVMed und war von 1990 bis 2019 Geschäftsführer des deutschen Medizintechnik-Verbandes. Unter Führung von Schmitt wurde der Vertretungsbereich des Verbandes kontinuierlich ausgebaut, eine proaktive politische Arbeit etabliert und mit dem Umzug nach Berlin 2001 konsequent intensiviert. Weitere Meilensteine waren die Erarbeitung des Kodex Medizinprodukte in den 90er Jahren und der Aufbau der BVMed-Eventtochter MedInform (heute BVMed-Akademie) zu einem stetig wachsenden Informations- und Seminar-Service.

„Wir verlieren mit Joachim M. Schmitt eine prägende Gestalt des Verbandes und das jahrzehntelange Gesicht der deutschen MedTech-Branche. Wir verneigen uns vor einer großen Persönlichkeit und seiner unternehmerischen Leistung. Sein Wirken und sein menschliches Vorbild werden unvergessen bleiben“, so der BVMed-Vorstandsvorsitzende Dr. Meinrad Lugan sowie BVMed-Geschäftsführer und Schmitt-Nachfolger Dr. Marc-Pierre Möll.

• Potential loss of competitiveness, caused by the EU’s inaction of the energy crisis, and Chinese and US subsidies to domestic industry

Following yesterday’s European Council summit and its conclusions on the measures to tackle the energy crisis, the European textiles industry is extremely concerned about the fast loss of competitiveness of Europe and demands urgent action to save the industry.

The chain of factors determining this sharp decline in competitiveness is twofold. First, the energy cost in Europe is more than 6 times higher than in the US, China, and neighbouring countries. This factor alone has almost erased the business case for producing in the EU. At present, many textiles and clothing companies are producing at net loss or have shut down production. The industrial conditions have worsened in such a way that there is no business case to invest in Europe or buy products produced or processed in the EU. It is only the sense of responsibility of the entrepreneurs towards the European society that is keeping the plants and production running.

Secondly, while the EU is passive and extremely slow in articulating a credible and effective response to the energy crisis, the main international competitors and trade partners (China, India and the US respectively) have developed comprehensive state-aid frameworks for their domestic industry despite not being affected by this crisis at all. The latest example is the 369-billion-dollar scheme of the Inflation Reduction Act rolled out by the Biden administration.

Recent trade data  already indicate a loss of global competitiveness: imports to the EU have grown tremendously in 2022 (+35% year-to-date). It is also evident that the surge in imports goes in parallel with the surge of natural gas price. It is expected that energy prices will remain high and volatile, opening the door for imports to gain substantial market shares in the EU.

The chart indicates the development of the Title Transfer Facility (TTF) until September 2022 since Eurostat data for Q4 2022 has not been published yet. Euratex is aware that the market situation has eased somewhat since in the past months, but the crisis remains because gas prices are still extremely high in comparison to last year. This suggests that the current loss of competitiveness of the EU manufacturing will not be recovered even with lower energy prices, unless measures are taken to correct the unlevel playing field on which the EU industry has to operate in the international markets. Only with an ambitious and comprehensive relaunch plan at EU level, Europe will be able to restore its credibility as a global manufacturing powerhouse and investments.

If the status quo is maintained, not only the EU will not be able to recover its competitive position on the global business stage, but it will also fail its plans to reach zero-net emissions and achieve circularity. It is evident that these ambitions - that the industry is passionately supporting - need massive capital investments. However, in the current scenario an investments diversion can only be expected to markets where governments are actively supporting those investments and energy costs are much lower – regardless of their fossil- or non-fossil origin.

The European textiles industry – the whole value chain, from fibres, nonwoven, to fabrics, clothing manufacturers - are facing unprecedented pressure deriving from the current geopolitical situation, the new macroeconomic conditions and unfair competition from third states. The situation is going to worsen if no emergency action is taken, especially because a recession is expected in the coming months.

The main structural component of the EU manufacturing are SMEs: these are economic actors that are particularly exposed to the current crisis as they do not have the financial leverage to absorb the impact of energy prices for much longer. Urgent EU action is needed to ensure their survival.

EURATEX calls on the EU political leaders in the Commission, in the European Council and in the national capitals to:

1. Raise the ambition and adopt a comprehensive approach at EU level: energy, state-aid and trade policy must be brought together in a single strategy with concrete emergency solutions and with a clear SME dimension;
    
2. Let all hesitations aside and adopt a meaningful price cap on natural gas wholesales, that should be ideally no higher than 80 euro/MWh. In parallel, it should also be ensured that electricity prices are brought to a sustainable price level;
    
3. Change the European posture on state-aid, even temporarily. An ambitious plan of investments and state-aid in green technologies to support the industrial transition should be rolled out.

Such a plan, however, should not be conceived as a retaliation against our most necessary and like-minded trade partners. Access to finance and markets must be safeguarded for all those actors who are capable and willing to invest in Europe, on the basis of reciprocity. In   these challenging times for geopolitical stability, ensuring strong trade ties with our traditional allies and partners is of utmost importance. The roll-out of an investment and state aid plan should not interfere, but rather support, the dialogue with the US (and other partners) and the deepening of our trade and investment partnership. Such a dialogue should be accelerated in the context of the TTC as well as at WTO level.

INDA, the Association of the Nonwoven Fabrics Industry, has named MaryJo Lilly as its new Market Intelligence Leader. Lilly brings more than 20 years of nonwovens & engineered materials expertise with a background in the disposable, medical and specialty materials industries.

Before starting a consulting firm two years ago, Lilly was Regional Commercial Director of North America for Tredegar Film Products and before that, spent more than a decade as Vice President of Sales at Berry Global in the Health, Hygiene, and Specialties Division growing the personal care and medical markets.

Additionally, Lilly’s leadership experience includes Global Business Director at Clopay Plastic Products and Director of Sales and Marketing for Absorbent Materials at Rayonier Performance Fibers. Lilly holds a Ph.D. from the University of Pittsburgh.

With her industry knowledge and extensive network, Lilly will develop, issue and present reports, presentations and data to support INDA, member decision-making and the industry. She will, through collaboration with market participants and subject matter experts, develop and maintain relevant industry statistics, reports and surveys on the North American and worldwide markets by major segments and processing technologies.

INDA’s 17th annual World of Wipes® (WOW) International Conference is accepting abstracts through December 2, 2022, on innovative, inspiring, and informative wipe products, markets and technologies to be presented in Atlanta, GA, July 17-20, 2023.

Experts in the areas of dry and wet wipes, sustainability, end-use markets, substrate formation, raw materials and fibers, liquid ingredients, packaging, machinery, and market trends and data are encouraged to submit a brief abstract of one or two paragraphs detailing the relationship of their presentation to wipes or wipe manufacturing. Along with a brief abstract summary, professionals should also submit a speaker’s photo, and biography. Information may be submitted online via the WOW website before December 2nd.

Over 450 wipes business leaders are expected to convene at the Atlanta Marriott Marquis Hotel July 17-20, 2023 to hear premium content in market research, product innovations, sustainability issues, new materials and substrates for all wiping products and their components.

The last WOW event held in Chicago connected more than 450 participants from 18 countries representing the entire wipes supply chain to explore issues and advancements in the growing multibillion-dollar wipes sector. WOW is targeted exclusively for wipes brand owners, converters, manufacturers, and their entire supply chain.

The WOW Committee is developing content for a timely and relevant program that targets such areas as energy consumption, digitalization, global supply chain challenges, the plastics issue, ingredient transparencies, market intelligence, substrate developments, converting systems, material science, packaging, and circularity advances in personal and industrial wipes.

Training at the WOW 2023 Conference
The WIPES Academy, the industry’s first and only comprehensive wipes training for the entire supply chain, will occur prior to the conference start, July 17-18. Participants will gain a strong foundation of fundamental wipes knowledge, covering the basics of wipes design, manufacturing and applications, market trends, and opportunities in new product areas. At least two years of basic nonwoven fabrics knowledge or completion of the INDA Elementary Nonwovens Course are the recommended prerequisites.

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.

After the DOWNPASS Standard entered into force as a zero-tolerance standard on 1 January 2017, its first major revision is due in 2022/23. The stakeholder-based approach has again sought feedback from professional and relevant public communities for its first major revision, as it did originally when it was first developed: In addition to animal welfare organisations, veterinarians and agricultural scientists, many trade partners and consumers have also contributed to the discussion with their wishes and requirements.

A central aspect of the DOWNPASS standard is the exclusion of all goods from live animals. Down and feathers may neither come from moulting nor from live plucking. Accredited independent auditing organisations are responsible for monitoring and inspecting the manufacturers' supply chains on site worldwide. Intensified monitoring of high-risk areas is mandatory, but its frequency is left to the discretion of the auditors, who inspect farms both announced and unannounced.

Down and feathers, which are used as filling material for DOWNPASS labelled finished products, may only be obtained after slaughter. This must be clearly verifiable. In this respect, all poultry farms that have animals slaughtered for the purpose of food production are covered - regardless of whether these come from parent or rearing farms or from farms that both rear ducklings and goslings besides keeping parent animals.

Parent vs. rearing farms - new mandatory requirement
The vast majority of all poultry farms raise chicks themselves for food or to keep them later as adults for egg laying. So, when the current DOWNPASS speaks of rearing farms or rearing, the term always covers both variants.
Pure parent farms that do not raise chicks themselves but buy in the adult ducks and geese to lay eggs are rare. For this, the standard had an optional additional module that referred to waterfowl, i.e. jointly to ducks and geese.

Since live plucking of ducks is not known and this has been confirmed by veterinarians and agronomists, the DOWNPASS 2019 had enabled the optional auditing of pure goose parent stock farms, being no rearing farms, via an annex. This hitherto voluntary option has been tested in practice over the past three years and met with consistently positive feedback from both producers and trade partners. Therefore, the auditing of goose farms will be a mandatory part of the new version of the DOWNPASS standard in the future. The option for the voluntary goose parent audit will be dropped as well as the one for the simultaneous auditing of duck and goose parent farms.

Die im Bundesverband Medizintechnologie (BVMed) organisierten Hersteller von aufsaugenden Inkontinenzprodukten schlagen aufgrund explodierender Rohstoff-, Transport- und Energiepreise Alarm. Der steigende Preisdruck wird durch sinkende Monatspauschalen in den Hilfsmittel-Versorgungsverträgen mit Krankenkassen noch verstärkt. „Die Schere zwischen sinkenden Erstattungspreisen und steigenden Produktionskosten nimmt stetig zu. Dieser Kosten-Tsunami gefährdet die medizinische Versorgungsqualität der Betroffenen“, so BVMed-Expertin Juliane Pohl, Leiterin des Referats Ambulante Versorgung. Der BVMed sieht dringenden Handlungsbedarf, um die qualitätsgefährdenden Mechanismen der bestehenden Pauschalsystematik zu überwinden.

Die Bewältigung der COVID-19-Pandemie und der Ukraine-Krieg haben die Verfügbarkeit von Rohstoffen und Energie, die globalen Lieferketten sowie das Transportwesen stark beeinträchtigt. Diese Veränderungen führen zu immensen Preissteigerungen, die sich unmittelbar auf die Herstellung von Medizinprodukten auswirken – darunter die Produktion von Hilfsmitteln zur aufsaugenden Inkontinenzversorgung. Ein paar Beispiele zu den Auswirkungen:

• Die Kosten für Superabsorber haben sich mehr als verdreifacht.
• Die Kosten für Zellstoff, Polypropylen und Polyethylen haben sich mehr als verdoppelt.
• Zusätzlich treibt die Verfünffachung der Energiepreise die Herstellkosten in ungeahnte Höhen.
• Die nationalen und weltweiten Logistikkosten sind zudem aufgrund fehlender Transportkapazitäten und höherer Preise für Kraftstoffe, Verpackungen, Container und Paletten massiv gestiegen.

Zum Hintergrund der Versorgungsproblematik erläutert der BVMed, dass die Versorgung von Patient:innen mit Hilfsmitteln zur aufsaugenden Inkontinenzversorgung durch entsprechend qualifizierte Hilfsmittelleistungserbringer wie Sanitätshäuser oder Homecare-Versorger erfolgt. Diese vereinbaren mit Krankenkassen eine Erstattung für die monatliche Versorgung mit den Produkten sowie den dazu gehörigen Dienstleistungen wie die Auswahl des individuell erforderlichen Produkts, die Einweisung sowie die Unterstützung bei Komplikationen.

Das Problem: Die besondere Systematik bei der Vereinbarung dieser Erstattungsbeträge führt zu Vergütungen im sehr niedrigen zweistelligen Bereich. Die durchschnittliche Monatspauschale liegt aktuell bei unter 17 Euro für Versorgungen in der Häuslichkeit. Diese Pauschale umfasst alle individuell erforderlichen Produkte und Dienstleistungen sowie Logistik und sonstige Administration. Alle an der Versorgung Beteiligten seien nun aufgefordert, geeignete Antworten auf diese dramatischen Entwicklungen zu finden und Gegenmaßnahmen einzuleiten.

Sustainable Chemistry for the Textile Industry (SCTI™) has appointed Dr. Isabella Tonaco as Executive Director, effective November 1, 2022. With a mandate to inspire and trigger action at a global level, she will lead SCTI to drive transformational change in the textile and leather industries.
 
Launched two years ago by seven of the world's leading chemical companies, the SCTI Alliance aims to enable brands, retailers and manufacturers to apply cutting-edge sustainable chemistry solutions that enhance the well-being of factory workers, local communities, consumers and the planet.
 
Dr. Tonaco will oversee SCTI activities to implement this mission. Based in Germany, she will work with SCTI member companies and stakeholders across the textile and leather value chain to help the industry achieve the highest levels of sustainability. Dr. Tonaco will report to the SCTI Executive Committee.
 
Dr. Tonaco has more than a decade of experience in sustainability and has held various strategic and commercial roles in the chemical industry. Most recently, she was Vice President of Strategy Execution and Marketing for Renewable Polymers & Chemicals at Neste, a global leader in renewable and circular solutions. Previously, Dr. Tonaco worked for BASF, where she established and executed the company's global leadership position in certified sustainable palm-based ingredients for the Personal Care industry.

Der Geschäftsführer des WifOR-Instituts, Prof. Dr. Dennis Ostwald, hat auf der BVMed-Jahrespressekonferenz am 13. Oktober 2022 die Nachhaltigkeitsstudie „SEE-Impact-Study der deutschen MedTech-Branche“ vorgestellt, die vom BVMed-Institut in Auftrag gegeben wurde.

Die SEE-Impact-Study untersucht die gesamte Wertschöpfungs- sowie vorgelagerte Lieferkette der Medizintechnik-Branche und zeigt neben dem ökonomischen auch den ökologischen und sozialen Fußabdruck der Produktionsseite auf. Damit wird erstmalig eine Standortbestimmung einer Branche für die sozialen und ökologischen Faktoren geschaffen, die die Herausforderungen identifiziert und quantifiziert. Hiermit schafft der BVMed für die Branche und seinen Mitgliedsunternehmen einen Orientierungsrahmen für die Entwicklung einer Nachhaltigkeitsstrategie.

Weitere Informationen finden Sie hier.