From the Sector

Long-standing BTMA member James Heal is celebrating its 150th anniversary this year, the company’s formation dating back to 1872, when it was listed as an oil and tallow merchant and mill furnisher in Yorkshire, UK.

Today, as a testing equipment manufacturer for textiles and nonwovens, James Heal continues to expand its range, with a focus on making testing simple – most notably with the introduction of its Performance Testing collection of instruments, most recently the AirPro and HydroView systems.

AirPro
The new James Heal AirPro air permeability tester is used to test the resistance of the flow of air through woven, knitted and nonwoven textiles. Its software offers flexibility with standards and  comprehensive reporting options and different test head sizes are available, making it suitable for a range of applications and standards

HydroView
The HydroView hydrostatic head tester is meanwhile designed to measure the penetration of water in materials which have an end use that requires water resistance, such as those in the medical, geotextiles and nonwovens sectors. It is also proving essential in the testing of end-use applications for technical textiles, such as in protective gloves, diving dry suits and winter sports apparel, to fishing waders, roofing, tenting, ground sheets and more.

Der Bundesverband Medizintechnologie (BVMed) unterstützt den Vorschlag des GKV-Spitzenverbandes, die Mehrwertsteuer auf Arznei- und Hilfsmittel einheitlich abzusenken.

Aufgrund der unterschiedlichen Besteuerung bei Medizinprodukten sei es notwendig, mit einem einheitlichen Steuersatz für Klarheit bei allen Beteiligten zu sorgen. Als Beispiele nannte der BVMed Herzschrittmacher und Elektroden, die unterschiedliche Mehrwertsteuersätze hätten. Für Hüft- und Knieimplantate gelte der ermäßigte Mehrwertsteuersatz nur bei Bestellung von kompletten gelenkbildenden Komponenten. Für einzelne Teile und Zubehör, wie beispielsweise einem Hüftkopf, zähle dagegen der volle Mehrwertsteuersatz. Auch bei Wirbelsäulenschraubensystemen gebe es in der Praxis immer wieder Abgrenzungs- und Definitionsprobleme. „Wir sollten die jetzige Diskussion nutzen, um hier endlich Klarheit und Rechtssicherheit zu schaffen“, so Möll.

Die BVMed-Expert:innen verweisen in diesem Zusammenhang auf die Änderung der EU-Mehrwertsteuerrichtlinie (Richtlinie [EU] 2022/542) vom April 2022, die bis spätestens Ende 2024 national umgesetzt werden muss. Die EU-Richtlinie eröffnet die Möglichkeit für einen ermäßigten Mehrwertsteuersatz nicht nur „für Arzneimittel, die für ärztliche und tierärztliche Zwecke verwendet werden, einschließlich der Erzeugnisse für Zwecke der Empfängnisverhütung und der Monatshygiene sowie absorbierende Hygieneprodukte“, sondern auch „für medizinische Geräte, Vorrichtungen, Produkte, Artikel, Hilfsmittel und Schutzausrüstung, einschließlich Atemschutzmasken, die üblicherweise für die Verwendung in der Gesundheitsversorgung oder für den Gebrauch von Behinderten bestimmt sind, Gegenstände die wesentlich sind um eine Behinderung auszugleichen oder zu bewältigen, sowie die Anpassung, Instandsetzung, Vermietung und Leasing solcher Gegenstände.“

„Die EU ermöglicht einen ermäßigten Mehrwertsteuersatz auf Arzneimittel und Medizinprodukte. Der Vorschlag ist sinnvoll, denn er entlastet die Krankenkassen und Krankenhäuser und sorgt für Klarheit und Rechtssicherheit bei den Herstellern. Ein einheitlicher Mehrwertsteuersatz muss endlich umgesetzt werden!“, so BVMed-Geschäftsführer Möll.

International technology group ANDRITZ has received an order from Jasztex Fibers Inc., Canada, to supply a crosslapper to its site of Pointe Claire (Quebec province).
The line will be dedicated to the production of polyester blends for a wide range of applications, including home furnishing, filtration, blankets, architectural, fire retardant, transportation. Start-up is planned for the second quarter of 2023.

ANDRITZ has been a regular supplier of Jasztex. Over the last years, ANDRITZ provided crosslappers for previous investments in Toronto (Ontario) and Pointe Claire (Quebec).

Jasztex’s nonwoven products are sold throughout the bedding, furniture, filtration, acoustic and thermal insulation, transportation and medical markets.

Pincroft announced the adoption of an innovative precision spray technology that allows the application of many finishes for textiles, including permethrin for vector protection, to the face of the fabric to avoid contact with the skin.

The system is a more versatile and environmentally friendly alternative to the traditional application method of padding and offers the possibility of applying the chemistry on either face side or both sides of the fabric across the full width.

The benefits of this new equipment are countless not only for the end user but also for the environment. The system allows for a reduction of energy, water and wet pick up of up to 50%, while 100% of the chemistry is recycled. Thanks to the equipment’s precision application technology, less water and chemistry are needed, and its no immersion system means the fabric would require less saturation and a shorter drying time.

Mike Collins, Pincroft’s Managing Director: “This innovative equipment can be used in two ways. The single sided spray finishing can be used where the full effectiveness of the finish is only required on the face side of the end item, for example, vector, fluorocarbon and antimicrobial protection. The dual spray finish may be used to simulate the traditional padding method where full effectiveness of the finish is required dependant on end use, for instance, crease recovery, fabric softening, soil release and moisture management.”

This vector protection solution provided by Pincroft is ACTIGARD®, a branded technology developed by Sanitized AG, with long lasting active ingredients that have proved highly effective against mosquitoes and ticks. This product endures a high number of washes, is suitable for military uniforms and conforms to Standard 100 by Oeko-Tex®.

In cooperation with Platte Berlin, deadHYPE, Visionary Services and the Fashion Council Germany, The Ground invited to the Studio2Retail block party in Mitte. 950 guests, including creatives, influencers and the young Gen-Z Berlin fashion scene, came together for the first time since The Ground premiered in July to exchange and celebrate change.

The community had the exclusive opportunity to buy the limited pieces of the MUST-HAVE PEACE charity collection, which the Premium Group team initiated to support the people suffering from the war in Ukraine.

The collection includes 22 special items of clothing and accessories from 11 brands and designers from the Premium Group cosmos, of which 100% of the proceeds go to Be an Angel.

Be an Angel e.V. is an initiative of people from creative industries who are committed to the sustainable integration of people with a refugee background. Under the direction of Chairman Andreas Tölke, the team has been working intensively for the people from Ukraine for weeks, organising trips to Germany for refugees from Moldova, activating a nationwide network for accommodation and supplying hospitals in Odessa, Kyiv and Lemberg with medicine.

• Values from the past 30 years more relevant than ever and are reflected in recent growth

During its 30^th anniversary, the international OEKO-TEX^® Association is still seeing positive business development despite numerous global challenges. In total, OEKO-TEX^® issued more than 36,000 certificates and labels in the past financial year – an increase of 14% compared to the previous year. The STeP by OEKO-TEX^® facility certification recorded the strongest growth, almost doubling compared to 2020/2021. The number of labels and certificates issued increased from 31,696 to 36,084 between July 1st, 2021, and June 30th, 2022.

"Since OEKO-TEX^® was founded in 1992, our business practices have been aligned with our core values," says OEKO-TEX^® Secretary General Georg Dieners. “Sustainability, trust and safety build upon each other and are the basis of transparent and sustainable action. We underpin responsible action with our independent scientific methods and are valued in the industry as an effective, solution-oriented partner.” In the past financial year, this was reflected in the new Impact Calculator, with which STeP by OEKO-TEX^®-certified companies calculate their CO₂ emissions and measure their water consumption to ultimately reduce both. For OEKO-TEX^®, a sustainable future is inextricably linked to a transparent status quo. "By setting the highest standards and communicating them openly, we encourage companies and consumers to do the same," says Dieners.

To maintain trust and credibility, OEKO-TEX^® includes external perspectives. The International Advisory Board reviews proposals of the OEKO-TEX^® Working Groups and provides important impetus for continuous optimization of the standards. Additionally, a Public Stakeholder Consultation was conducted in March 2022 to gain comprehensive insights from all interest groups. These are now being integrated into the further development of the standards and services. The investments of the past financial year reflect how important quality assurance and product control are for the OEKO-TEX^® Association: Almost 40% of the total expenditure flowed into these two items.

In the meantime, the basic business continues to progress successfully. The number of STANDARD 100 by OEKO-TEX® certificates issued in the 2021/2022 financial year exceeded 25,000 for the first time. More than 15,000 chemicals, colorants and auxiliaries were certified with ECO PASSPORT by OEKO-TEX^®.

In autumn 2022, OEKO-TEX^® will launch a certification to help companies comply with upcoming due diligence laws. With RESPONSIBLE BUSINESS by OEKO-TEX^®, OEKO-TEX^® is responding to the increasing global expectations of compliance with due diligence requirements in companies. The new standard is based on the EU proposal for due diligence, the German Due Diligence Act, which will come into force from 2023, and numerous other international legislative proposals.

Turkish company, Makroser Tekstil specialises in manufacturing digitally printed carpets and over the years has become one of the leading suppliers in the sector. Utilising Mimaki’s high-performance TS300P-1800 sublimation transfer printer since 2020, the company has optimised their production potential to meet increasing customer expectations in this growing digital textile carpet market.

Alongside carpets, the company also offers other solutions to the carpet industry by producing backing and other materials

Acting as both a seller and a supplier, Makroser Tekstil has an approximate monthly output of 150,000 square meters of final product and sells about 70-80,000 square meters of intermediate goods per month. “Our market has four main pillars, including chain market groups, export, e-commerce and our own retail network. We have gained serious momentum in the sales of our final products in recent years, and we attach great importance to our sales and marketing processes, in addition to production, so to increase our profitability. We are currently exporting 35-40% of our production, and our branding and e-commerce activities show that we are making significant improvements”, says Makroser Tekstil’s co-founder, Talha Güldest.

Makroser Tekstil decided to invest in a Mimaki TS300P-1800 sublimation transfer printer back in August 2020, with the aim to strengthen their position in the digitally printed carpet market. “The investment in the TS300P-1800 has enabled us to have the capacity to respond quickly to e-commerce orders,” Güldeste commented. “Product quality is the main criterion in the supplies we provide to both online and retail outlets. We made this investment because we saw that we would increase our quality and customer satisfaction in the carpets we print. The Mimaki printer met our expectations, providing the results we wanted from the very first print after installation.” Considering the increased demand, Güldeste aims to further boost their printing capacity with investment in several more Mimaki printers.

A new fabric inspection technique for accurately detecting the most subtle of defects on patterned fabrics during high speed production has been developed by BTMA member Shelton Vision, of Leicester, UK.

The patent-pending system has been integrated into the company’s WebSpector platform and validated through factory trials on a purpose-built full scale in-house demonstration system with sophisticated fabric transport capabilities. As a result, a first system has already been ordered by a manufacturer of both plain and patterned fabrics, including camouflage, in Colombia. This follows the successful conclusion of a 21-month Innovate UK project in which techniques for the resolution of complex pattern deformations were developed by machine vision and computer scientists in the company, backed up by the machine vision and robotics department at Loughborough University.

Restrictions
Traditional methods for defect detection rely on human inspection which is ineffective, with detection rates under 65%, while the Shelton WebSpector machine vision system offers a sophisticated platform for automated defect detection of over 97%, but until now has been restricted to plain textiles.

While pattern matching and neural network approaches have previously been tried for patterned textiles, they have failed to provide a practical solution due to the extreme complexity associated with pattern matching on deformable substrates like textiles, as well as the time required to train a neural network for each pattern type.

Challenges
The challenge is that fabrics are not rigid and can be creased or stretched and are also subject to local distortion,” says Shelton Vision Managing Director and CEO Mark Shelton. “As a result, inspection without the technique we have developed, would lead to thousands of false positives. Our sophisticated pattern inspection software techniques ensure a clean image, allowing the detection of faults on fabrics running at speeds of up to a hundred metres a minute.”

The full system consists of:

• A camera and lighting system for optimum image capture at high speed and associated image processing hardware.
• Self-training software utilising statistical analysis to automate the system configuration for new textile products.
• An advanced suite of defect detection algorithms for the detection of all textile defect types.
• An AI-driven defect classification system which learns and automates defect naming in real time, as well as a real time defect grading capability based on client decision rules.
• A system for recording and retrieving complete roll map images for subsequent review and quality control.

The generation of textile roll maps with complete defect data allows for an optimised textile cut plan, improved downstream processing and quality assurance.

Freudenberg Performance Materials Apparel (Freudenberg) is pleased to announce the establishment of the Apparel Technical Solution Center – Asia at its Nantong factory in China to expand the company’s innovation capabilities. With floor space of 900 m2, the new center offers technical expertise and innovations to apparel customers from nearly all apparel segments in Asia and around the world.

New capabilities with the Apparel Technical Solution Center – Asia
Committed to bringing enhanced technical support and services tailored to customers’ needs, the dedicated Apparel Technical Solution Center – Asia (ATSC) is equipped with cutting-edge technology. This includes a wide variety of fusing and bonding machines, laser and ultrasonic cutters, specialized sewing machines for sportswear applications, fiber filling machines for insulation applications, and washing and dry-cleaning machines that meet GB and AATCC standards.

The ATSC offers technical know-how to help customers design complex apparel solutions. In particular, it furthers Freudenberg’s dedication to joint innovations with sportswear customers and to finding technical solutions for performance applications.

Further innovation at the Nantong factory
The factory was moved to the Nantong Economic and Technological Development Area to meet increased production demand with state-of-the-art technological capabilities. Covering an area of nearly 50,000 m² with cotton interlining, bi-elastic fusible interlining, and preformed materials production lines, the new site went into operation in 2021.

Dedicated to continuously improving production quality, the new factory also includes an innovative online defect detection system. This system enables defect information to be captured in real time and sent to operators for immediate adjustments, increasing the rate of bi-elastic interlinings and shirt interlinings. Furthermore, the online weft density automatic adjustment system helps improve the stability of the drying process and the quality of semi-finished products.

Der Bundesverband Medizintechnologie (BVMed) unterstützt den im Juli 2022 begonnenen „Dialogprozess“ des Bundesgesundheitsministeriums (BMG) und das aktuelle Papier der „Medical Device Coordination Group“ (MDCG) auf EU-Ebene, um die Probleme bei der Implementierung der EU-Medizinprodukte-Verordnung (MDR) durch pragmatische Lösungen anzugehen.

Die „Medical Device Coordination Group“ hat am 26. August 2022 ein Papier veröffentlicht, das Maßnahmen zur Verbesserung der Kapazitäten der Benannten Stellen, zum Zugang zu Benannten Stellen und zur Vorbereitung der Hersteller enthält, um die MDR-Implementierung zu unterstützen und Versorgungsengpässe mit Medizinprodukten zu vermeiden.

Der BVMed begrüßt zahlreiche der vorgeschlagenen Maßnahmen. So wird empfohlen, hybride Audits wo immer möglich durchzuführen sowie vorgeschlagen, bei der Überwachung von „Legacy Devices“ (Bestandsprodukten) die „Flexibilität voll auszunutzen“. Zudem sollen MDCG-Guidances überarbeitet werden, um unnötigen Verwaltungsaufwand zu beseitigen. Außerdem sollen vor und während der Konformitätsbewertungsverfahren strukturierte Dialoge zwischen Benannter Stelle und Hersteller aufgenommen werden. Viele der sinnvollen Ansätze sind jedoch wenig konkret und es fehlen mögliche legislative Maßnahmen. So beispielsweise ein Durchführungsrechtsakt zu Art. 97 (3), um die Anwendung europaweit zu harmonisieren.

„Das MDCG-Papier hilft, aber wir brauchen schnell weitere, konkrete und vor allem pragmatische Maßnahmen, um die Warteschleifen im Zertifizierungsstau aufzulösen. Wir müssen Tempo machen und brauchen weitere Schritte“, so BVMed-Geschäftsführer und Vorstandsmitglied Dr. Marc-Pierre Möll.

Der BVMed setzt sich unter anderem für folgende Maßnahmen ein:

• Der Fokus bei MDR-Zertifizierungen muss auf dem Delta zu den Richtlinien liegen („GAP Review“): Die Benannte Stelle sollte bei „Legacy Devices“ das Review auf die Forderungen der MDR, die über die bereits bekannten Forderungen der alten Richtlinien hinaus gehen, fokussieren. Dabei sollten bereits bekannte Alt-Nachweise verwendet werden, bei denen sich die Anforderungen von denen der MDR nicht unterscheiden.
• „Zertifikate unter Auflagen“ sollten nicht auf klinische Daten limitiert werden: Zertifikate unter Auflagen gab es bereits unter den Richtlinien. Diese dürfen nicht rein auf klinische Daten limitiert werden, wenn keine Zweifel an der Sicherheit oder Performance des Produktes bestehen.
• Aussetzen von „Scope Extension Audits“: Hersteller, die eine langjährige Geschäftsbeziehung mit ihrer Benannten Stelle haben, sind mit ihren Prozessen, Fertigungsanlagen, größtenteils auch Mitarbeitern bei den Auditoren und Reviewern bekannt. Ein Verschieben dieser Audits in das nächste Überwachungsaudit würde Kapazitäten für andere wichtige Reviews und Audits freigeben.
• Lösungen für Hersteller ohne Benannte Stelle: Es werden dringend Lösungen für Medizinprodukte-Hersteller benötigt, die trotz großer Aufwände und Bemühungen noch immer keine Benannte Stelle gefunden haben.

„Schnelligkeit ist jetzt wichtig. Alle Anstrengungen, die erst am Ende des Jahres greifen, kommen zu spät. Denn die MedTech-Unternehmen müssen jetzt schwierige Entscheidungen darüber treffen, welche Produkte im Markt gehalten werden können. Deshalb brauchen wir jetzt eine europaweit abgestimmte Strategie mit pragmatischen Lösungen“, so Möll.