Originally Published EMDM October 2005
Analysts forecast healthy growth in the advanced wound-care market despite uncertainties about reimbursement.
Acticoat products are coated with charged 10-µm-wide silver particles, allowing dressings to remain in place for up to a week. A foam version of the product was recently granted marketing approval by US FDA.
If you are in the business of developing and manufacturing advanced wound-care products, you’re in a pretty good spot. According to a report published by international consultancy Frost & Sullivan, Europe’s €900-million wound-care market is projected to grow at an average annual 10–12% rate through 2009. Most of this growth will occur in the advanced wound-management market, which is forecast to reach an annual compound growth rate of 12.4% during the next five years. Continued research and development in the three main product segments—moist, antimicrobial, and biomaterials-based devices—will be a major factor in sustained revenue growth, according to the consultancy.
Europe is the global leader in the use of moist wound dressings. Hydrocolloids and foam dressings account for most of the revenue in this €393.6-million market segment. The continued penetration of these products, however, probably will be compromised by an uptake in the use of antimicrobial and tissue-engineered dressings, say analysts.
Mining Silver’s Healing Properties
When it comes to antimicrobial materials, silver would appear to be a good investment. This element has been shown to reduce healing time and to lower the risk of infection. Several products currently integrate silver in their wound-healing technologies.
Johnson & Johnson’s Ethicon, Bristol-Myers Squibb Co., and Medline Industries all have silver-based wound-care products on the market. Although a smaller player, AcryMed has made a name for itself with its SilvaSorb wound dressings and gel. It is now adapting this technology to invasive devices such as catheters to battle nosocomial infections (see article in this issue’s Industry News section).
A relative newcomer to the silver rush, Nucryst Pharmaceuticals Corp. (Wakefield, MA, USA) recently announced that it had received regulatory clearance for a foam version of its Acticoat technology in the United States. Nucryst and marketing partner Smith & Nephew plc (London) have been selling Acticoat dressing sheets since 1998; US FDA approved a foam version of the product in April 2005. The company reports that foam will allow physicians to treat deeper injuries that sheets can’t reach.
Although silver solutions have been used for wound care in modern medicine since the 1930s, nanotechnology has paved the way for improved formulations. Westaim Corp. (Calgary, AB, Canada), which owns Nucryst, coats polyethylene mesh with charged silver particles that are 10 µm in width (normal silver crystals are 250 µm wide). The smaller crystals allow Acticoat dressings to remain in place for up to a week without being changed.
While the overall market for antimicrobials is relatively small, it is poised for explosive growth, according to Frost & Sullivan. The consultancy estimates a CAGR of 25.9% between 2003 and 2010, with revenues increasing from €28.8 million to €143.6 million.
J&J Leads Charge on Biomaterials-Based Wound Care
Biomaterials-based wound-care products currently account for €20.6 million in revenue, but this sector also may experience substantial growth in the years ahead. “The market is currently being developed,” says Frost & Sullivan programme manager, medical devices, Tanya Pullen. “The major restraining factor is the lack of reimbursement because of the high cost of these products,” she adds. But the outlook may be promising, thanks in part to Johnson & Johnson’s Promogran dressing.
Promogran is said to be the first biomaterial-based dressing to make significant gains in Europe, notes Pullen. The introduction of competing products will further raise the profile of this niche market, culminating in a projected overall market value of €141.1 million by 2010.
Continued growth for tissue-engineered wound dressings, says Pullen, will depend on industry’s ability to establish the efficacy of the products and to educate the medical community on the value of adopting these new technologies. A reduction in treatment costs and effective management of the reimbursement and regulatory processes also will play a key role in promoting their uptake.
Educating practitioners on the value of advanced wound-care technology in general was a key recommendation that emerged from a conference organized by German trade association BVMed in Kassel, Germany, in June. On the theme of “Wound Care in Practice: A Conflict between Cost and Quality of Care,” several speakers challenged the notion that the costs of advanced wound-care technology were exorbitant. In fact, pharmacist Werner Sellmer told attendees, modern wound-care products do not lead to higher costs once you factor in accelerated healing, shorter treatment times, and a better quality of life for patients.
Integrated-care concepts and a therapeutic package that encompasses the complete treatment of an illness would produce a more balanced picture of the benefits of advanced wound-care technology, noted several speakers. BVMed board member and medical director of Bristol-Myers Squibb Co. Friedhelm Bartels advocated improved coordination between hospitals and the outpatient sector. To this end, he called for wound treatment guidelines, the establishment of a defined wound-care specialization, and a collaborative effort involving the health insurance funds, healthcare providers, and industry.
Contract Manufacturer of Adhesive Components Can Make a Name for Its Customers
A manufacturer of custom wound dressings and plasters has augmented its range of services by investing in a flexographic printing capability that allows the company to differentiate its customers’ products through the incorporation of a printed brand logo. Establishing itself as a one-stop shop offering everything from artwork generation through the finished product, InteliCoat Technologies (Wrexham, Clwyd, UK) can now print high-resolution logos, grids, text, and other end-user aids in a choice of colours, all of which are US FDA approved and conform to BgVV and European directives. The service is part of the Inspire range of services for medical component manufacture.
The versatile printing press, which has been installed in a positive-pressure HEPA-filtered environment, can print over an area 1.6 m wide. It prints in a single colour onto substrates that include both clear and coloured films. In addition, print can be encapsulated within the film or at the film-foam interface, thereby removing it from the upper film surface and eliminating the chance of subsequent removal by chemical or mechanical means.
The printing service is flexible, responsive, and cost-effective because it does not require the large runs commercial printers may. The company offers film and foam manufacture, lamination, adhesive coating, and slitting, in addition to printing.
Nonwoven Fabrics Are Designed to Absorb, Not Adhere
A company specializes in the manufacture of nonwoven fabrics for use in such wound-care applications as adhesive plasters, surgical dressings, bandages, and swabs. Resintex Industriale S.r.l. (Milan, Italy) customizes its products to answer customer requests for, perhaps, several materials in a multilayer construction, slitting, or impregnation with antiseptics and powders.
Running production in a controlled-climate environment, the ISO-certified firm supplies nonadherent pads to manufacturers worldwide. Nonadherent wound pads for surgical dressings have absorption rates of 120 to 320%. The full range of products available includes nonadherent pads for eyepads and ocular occlusers, aluminium- and silver-coated nonwovens, haemostatic wound pads, antimicrobial wound pads containing silver fibres, antibacterial nonwovens, nonadherent nonwovens for swabs, and padding for immobilization casts.
Thermoplastic Laminates, Nets, and Nonwovens Offer Healthcare OEMs a Choice
An R&D-focused manufacturer that emphasizes its eagerness to partner with medical device companies in designing components for cutting-edge projects offers several distinct lines of products for applications ranging from blood filtration to advanced surgical-wound care. Available from DelStar Technologies Inc. (Bristol, UK) are Stratex engineered composites, Delnet apertured film, Naltex extruded netting, and DelPore melt-blown nonwoven media. The DelPore thermoplastic laminates, nets, and nonwovens are suitable for incorporation into surgical disposables such as face masks, drapes, and gowns; for pad stock in wound-care products; and for spill-safety applications, including chemotherapy drug-preparation pads.
Stratex composites for finger bandage pad stock can be built from as many as five layers of facings and substrates without chemical adhesives. Supplied in widths to 173 cm, the structures meet defined absorbency, loft, wicking, repellency, release, and barrier characteristics. The line includes alginate pads and impregnated antibacterial pads.
Elastic Delnet films are engineered to achieve precise rates of permeability. The fine mesh provides a flexible, breathable barrier layer that does not adhere to skin. Offered in thicknesses of 0.05 to 0.3 mm and with a hole size between 100 and 140 µm, films from this product family can serve as a scrim or support for hydrogels, electrodes, and nasal strips. In addition, like the DelPore media, they can be a face mask component.
Open-mesh Naltex, available in numerous configurations, is designed to enhance air and liquid flow in face masks and filters, to protect delicate medical devices during cleaning and storage, and to serve as disposable protective packaging.
DelStar is always flexible, ready to respond quickly to special or evolving needs.
Versatility of Skin-Contacting Adhesives Invites OEM Creativity
Adhesives for medical applications involving both direct skin contact and the construction of skin-contacting devices are commonly enhanced by their specialist manufacturer to lend new properties to materials and thus spur both new product development and the enhancement of existing products. Collano AG (Sempach-Station, Switzerland) formulates its adhesives to provide not only the features required by wound-care applications but also convenience, safety, and attractiveness. The company uses only synthetic raw materials that are latex and solvent free and meet ISO 10993 standards.
Hot-melt adhesives and water-based dispersions for direct skin contact are the manufacturer’s core competencies. Ultraviolet-light-curable hot-melt adhesives with high moisture vapour permeability and a variety of adhesion values are well suited for use in antimicrobial incision films and as a basis for subsequent active wound treatment. Collano adhesives are a key element of hydrocolloid dressings that can absorb up to three times their weight in moisture and are used in blister tapes and wound treatments.
Skin-friendly adhesives for wound dressings can be given additional functionality. Components that stimulate the healing process may be included. The adhesives may contribute to shaping or stabilization of the dressing as well.
The company’s full range of medical adhesives includes formulations for tapes that hold dressings, catheters, and intravenous tubes in place and adhesives used in the manufacture of electrocardiography electrode systems as well as others that attach the electrode to the skin. It has the resources to assist customers in exploring new applications for adhesives and developing new products.
Hydrogel-Based Wound Dressings Kill Bacteria on Contact
A European hydrogel designer and private-label manufacturer has added antimicrobial gels to its range of patented hydrogel products for advanced care of moist wounds. First Water Ltd. (Marlborough, Wilts, UK) develops, manufactures, and converts wound dressings and medical devices based on a proprietary hydrogel technology. Removing the need for preservatives or such antimicrobial agents as silver, the new gels provide a skin-friendly environment that kills a wide spectrum of species. First-aid dressings both protect a wound from external contamination and absorb blood and other fluid exiting the wound. The First Water systems are designed to ensure that any bacteria coming in contact with the gel or contained in the wound exudate are absorbed and contained by the dressing and killed. The gels have shown their ability to kill C. albicans, A. niger, P. aeruginosa, S. aureus, and E. coli on contact when independently challenged by these microbes.
In addition to minimizing the incidence of infection, the gel systems provide an optimal moist healing environment for wounds ranging from cuts and grazes to major injuries. They are available in the form of dressings 75 × 45 mm to 200 × 200 mm in size. The gels are backed with a breathable polyurethane bacterial barrier in adhesive-bordered and nonbordered versions.
Cellulose Esters Enable Nonwoven Products to Be Fine-Tuned
Cellulosic materials, in the form of viscose filaments, are used in many nonwoven applications to enhance the breathability or fibre performance of nonwoven materials, or to promote the delivery of functional additives. Cellulose esters are critical components in nonwovens manufacture, playing a role in fibre production, material enhancement, converting, and finishing. Eastman Chemical B.V. (Capelle aan den IJssel, Netherlands) offers a range of cellulose esters that are distinctively tunable: their composition can be adjusted to allow manufacturers to vary the flexibility, softness, water resistance, breathability, or other functional property of polymeric nonwovens to suit a range of applications.
The cellulose acetate, cellulose acetate butyrate, cellulose acetate propionate, and cellulose triacetate supplied by Eastman are semisynthetic polymers prepared from the natural plant polymer cellulose. These biopolymer derivatives are formulated into a fibre, film, or coating or a nonwoven composition by means of melt- or solvent-based processes. They are compatible with a variety of resins, augmenting the appearance and functionality of absorbent products, wipes, and filtration devices based on advanced composite structures.
Cellulose esters lend toughness, chemical resistance, and high clarity to films, and provide them with controlled-release capability. Their breathable barrier properties make them suitable for incorporation into such medical applications as disposable gowns and drapes. Many of the esters are nontoxic, and some grades are hypoallergenic in skin-contact situations. The latter have been given GRAS—generally regarded as safe—status by US FDA.
Specialized Equipment Can Put Bandage and Dressing Manufacturers on Fast Track
With a core competence in the high-speed processing of semirigid materials, a company provides machinery installations for manufacturers of nonwoven, woven, and cotton medical and hygiene products. IVF Technology AG (Neuhausen, Switzerland) is an independent subsidiary and a supplier for a major equipment manufacturing group. Its full range of capabilities includes on-site and online maintenance and repair services, analysis of existing installations for the purpose of optimization, machine and installation validation, and support for the development of customers’ products.
Folding machines for wound-care devices, nursing pads, and disposable medical bed covers feature high production speeds and flexibility. Units are available to convert small webs 1200 mm wide and large webs 2500 mm wide. Automated machines for individual processes or for producing complete plasters can be supplied. Customers may view installations in the manufacturer’s production facility. System efficiency and compatibility with other production processes results from the company’s process know-how; installations are designed with a full understanding of the nature of upstream and downstream production stages, as well as peripheral operations.
Also produced are installations for the manufacture of gauze swabs, which are available in a wide range of quick-change formats. Installations for the manufacture of elastic bandages consist of a machine for thermal pretreatment, a winding machine, and, for the production of elastic-cohesive bandages, a coating machine.
Production-Line Expertise Can Be Applied to Wound Dressings
Product-specific production and packaging lines are built for medical and pharmaceutical device manufacturers according to need. Total modularity in design enables the complete lines available from Medicon GmbH (Schwäbisch Hall, Germany) to be flexibly adapted to the production of items with distinctive features that give them a high added value. Process engineers and clients work together to develop and implement innovative production processes.
With the assistance of qualified partners, the company creates turnkey lines made up of machines that meet GMP requirements. It can integrate web-processing, lamination, folding, embossing, sealing, liquid- and solid-dosing, labelling, stacking, pick-and-place, primary and secondary packaging, and palletizing modules into a specialized system. A line for the manufacture and packaging of adhesive wound dressings consists of units for unwinding raw materials, high-frequency and ultrasonic sealing and laser cutting, placing dressings on foil, transferring the product to the pouch-packing system, joining different web materials to make multilayer products, packaging in primary pouches, stacking and counting products for secondary packing, and cartoning.
An integrated master control system enables the line to be operated centrally and facilitates gathering of production statistics and preparation of batch reports. The control system can be built to conform to the US FDA requirements of 21 CFR Part 11.
Perforated Wound-Care Films Are Tailor Made
A company that announces its mission as the provision of solutions in film and fibre offers a wide range of nonwoven and film products for medical and hygienic applications. Cast and blown polyethylene and polypropylene films are central to the product line of RKW AG Rheinische Kunststoffwerke (Worms, Germany). These are produced in breathable and nonbreathable forms, include elastic versions and perforated films for wound-care and adhesive plaster applications, and can be printed in up to eight colours.
Driven by customer requirements, the manufacturer analyzes trends as it develops new disposable products and works closely with clients to provide cost-effective custom systems. The company has 17 business units and a worldwide distribution network through which flexible local teams are compiled that have the aim of supplying customers with exactly the nonwoven or film required for an application. Its full range of services runs from R&D to bulk production, delivery, and after-sales service.
The manufacturer is technologically equipped to produce carded and spunbonded nonwovens, cast and blown films, lamination via ultrasonic bonding, bonding by adhesive and thermal means, extrusion coating, and perforation through in-line and off-line equipment. All of its component units are certified to ISO 9001, all raw materials are tested in in-house laboratories, the production equipment is permanently monitored, and computer-aided technologies are employed to ensure that precision and very fine tolerances are maintained.
Specialist Can Quickly Produce the Double-Sided Tape That Is Needed
A specialist firm that develops custom products in collaboration with its clients produces adhesive tapes for medical, technical, and personal hygiene applications in large and small volumes on a contract basis. Its flat hierarchy and wide range of production equipment enable Koester GmbH & Co. KG (Altendorf, Germany) to take new concepts into series production quickly and flexibly. The company has an active R&D department. It uses nonpolluting raw materials and processes and employs only solvent-free siliconized backing material and environmentally friendly adhesives in its finished products.
Among the medical adhesive tapes offered are double-sided tapes for disposable operating-theatre drapes or use on human skin. These are available with a paper or film liner, which may be extended or not, on one side or both sides. One side of the tape is permanently adhesive to the drape, while the other is coated with non-skin-irritating adhesive. Double-sided adhesive tapes for attaching absorbent medical devices to the skin also are available, with a construction analogous to the drape tapes.
ISO 9001:2000– and ISO 14001:1996–certified, the company has additional capabilities. It can add elasticity to a variety of materials by means of sophisticated extrusion techniques, and it is also able to coat and laminate various materials.
Copyright ©2005 European Medical Device Manufacturer