The disposable medical nonwoven market is projected to reach $20 billion by 2017, according to a comprehensive report from market researcher Global Industry Analysts (GIA), San Jose, CA1. Growth is being influenced by demographics, as well as three significant health conditions—obesity, diabetes and an aging population.
These health trends typically increase surgical procedures, and hence the demand for disposable medical products (e.g., protective apparel). There is an additional influence on sector growth arising from the demands of developing world economies where there is an ongoing overhaul not only in healthcare per se, but also in the expectations of a system and the ability to finance a higher level of care. These global factors offset the potential reduced usage of nonwovens from medical advancements related to natural orifice as well as non-invasive procedures. This group of factors influencing growth has not changed significantly from that proposed by Mironov in 20042.
In healthcare, nonwovens are utilized to a large extent in products that are designed to provide barriers (e.g., barriers between patients and themselves, barriers between the patient and the physician/caregiver and also barriers between patients). The spread of infections—whether it is Hospital Acquired Infections (HAIs) or Surgical Site Infections (SSIs)—continues to rise3. Sporadically, numbers do fall, but this is then followed by an ever-increasing ramp up. This situation is a concern both for the patient and for healthcare establishments.
Nonwoven products remain the component of choice for providing appropriate protection due to their ability to create barriers either from the structure of the nonwoven itself or from an additional active coating for personal protective apparel. However, less invasive surgeries and procedures being carried out remotely by more efficient robots may ultimately impact the overall design needs of these products in the future, along with other performance factors for protective apparel, such as absorption levels, due to a lower volume of any Other Potentially Infectious Fluids (OPIF) or the remoteness of the physician to immediate exposure.
Developing economies, where the demand for healthcare is beginning to increase, are expected to help sustain growth of nonwovens use. These countries will undoubtedly provide alternative markets for new penetration models with disposable protective apparel. This expansion also extends to some markets in Europe where single use, disposable protective apparel is not typically the norm. Generally, in global demographics, the aging population is an important component and plays a significant role. Product innovations are necessary and will be expected for this user group in order to enhance quality of life4.
Asia Pacific is fast growing in its use of nonwovens. China, in particular, is in the midst of overhauling its approach to healthcare, supported by its buoyant economy. The penetration of single use medical nonwovens is linearly related to the country’s Gross Domestic Product (GDP) and is a helpful, leading indicator for the market5. GDP in China expanded 1.8% in the first quarter of 2012 over the previous quarter, yet as such represented a three-year low position6.
Currently, although the manufacturing footprint for nonwovens is one that straddles many continents, China is now the leading global exporter of nonwoven roll goods; 51% of U.S. imports are coming from either the European Union or China5. “China has a strong converting industry that is prepared to supply finished goods. So the key question that remains unanswered currently is: how will the change happen, gradually?” says Valeria Erdos, product manager, Drape, Gown and Apparel, at Ahlstrom. “Will it be sudden? Convert by product segment? And most importantly, what kind of regulations will be put in place in these new markets?’”
In the future, manufacturing, converting and use of nonwovens in the “home” market are considered potential opportunities for growth. They certainly make use of the footprint of nonwoven equipment already deployed in Asia and eliminate navigating the tortuous supply chain process to place products for sale in the U.S. market. There are numerous factors that need to be overcome by U.S. distributors, namely, navigating the geopolitical instabilities, increasing regulations, remote suppliers and the challenges with labor and currency issues and, most significantly, unpredictable fuel costs7.
Key Definitions in Medical & Hygiene Markets
Nonwovens used in medical products are designed for two purposes: firstly, to be low cost to aid in one-time use scenarios; and secondly, to perform 100% of the time8. The design and performance characteristics are driven by their end use, the need to meet the desired functionality, barrier, absorption, strength and the fact that any chemical additives need to be biocompatible; these products will come into close contact with the human body.
The cost of nonwovens, since they are typically polypropylene based, is highly dependent on the cost of raw materials (e.g., oil) and the manufacturing process itself, primarily its productivity. In addition, since much of the protective apparel market has to meet given standards in terms of performance, the products need to meet the regulations stipulated by the local approving body (e.g., FDA in the U.S. or the CE—European Conformity mark—in Europe) to achieve the appropriate approvals for sale.
The claims surrounding the final end product need to be approved, not the input materials. This fact alone has resulted in slow moving improvements to nonwovens; the suppliers alone cannot manage or steer the approval process. The convertors need to seek the required approval, and appropriate classification for labeling of the final product.
Opportunities for Material Advancements
New manufacturing processes lead to improved and enhanced finishing processes. The nonwoven process itself allows for a great deal of manipulation and creativity in the way in which the outputs can be delivered. Process changes are not limited to only one variable. They include combinations of resin type and mixture, as well as fiber size, shape, morphology, density and thickness, including spatial formation together with fillers and topical or embedded treatments that can in combination deliver a variety of performance characteristics designed to meet a range of final end user product specifications9,10.
Nanotechnology has been a technology on the horizon, waiting for an opportunity for many years, with the premise that it would have a significant and positive impact in the field of nonwovens. The expectation has been the ability to add topical coatings with active nanoparticles or to add active nanoparticles to the melt so as to embed them subsurface (in both cases producing equivalent activity from reduced concentrations). Alternatively, others have considered creating nanofibers with more surface area, leading to an increase in overall density of a nonwoven without increasing raw material usage or adding additional weight.
There has been some advancement in this field, yet the cost of production (often due to slower line speeds) and limited increases in performance characteristics have been strong delimiters to accelerating progress. However, recently, Polymer Group Inc. (PGI) announced the commercialization of its Arium technology, which results from submicron size fibers that do not necessitate utilizing any more resin and do not slow the production rate11. This technology offers much promise for controlling levels of performance and other key characteristics of nonwovens. It also offers the capacity to manipulate the overall modular structure of a nonwoven in a variety of different ways, for example, by using the submicron fibers in combination with nonwovens derived from the various process technologies that are already available and fully commercialized.
Another technology investigated routinely is the use of plasma. This technology provides a means to modify the surface chemistry characteristics of nonwovens and thereby eliminate the need for additional topical surface coatings. In addition, such treatments have been shown to improve breathability of a nonwoven by up to as much as 95%. Recent advancements in this space include the ability to carry out the treatment at atmospheric pressures; the previous need for a vacuum prevented widespread use and made it necessary to install complex processes with associated costs that exceeded those related to simple in line coating12.
Challenges for Product Advancements
Nonwovens already dominate the market in hygiene products, in incontinence pads, diapers and feminine hygiene products; Colleen Ward, vice president, global marketing for Avery Dennison highlights the fact that nonwovens are also used to provide the body facing side of ostomy products. One of the largest growing segments in current medical markets, and one where there has been much activity and investment to date, is the incontinence products market. There is a desire to improve quality of life for those suffering from all forms of incontinence; their expectation is to lead as active a life as possible. Market demand is for superior products that meet three key criteria: simplicity, comfort and security/confidence. New enhanced, absorbent, odor neutralized undergarments and body shields will see the fastest gains in demand among incontinence products due to the advantages associated with comfort and protection they present for users13.
The advantage afforded by nonwovens is the disposable one time philosophy, eliminating the potential for cross contamination, the transmission of infections due to ineffective recycling processes and the risk of impaired performance due to unforeseen degradation, yet this practice also adds to the growing waste stream14. Class IV surgical drapes and gowns will post the strongest sales gains among nonwoven medical textiles as surgical infection prevention safeguards are upgraded by hospitals and ambulatory surgery centers. Disposable face masks will also fare well in the marketplace, benefiting from routine use by medical providers in virtually all direct contact patient procedures.
Moving forward, nonwovens will face issues related to reimbursement and coverage provided by the payers, as well as the potential for “bloodless surgeries” if natural orifice and non-invasive surgeries become the norm. Hence there would be a need to transition from the typical surgical drape, yet with the ever-present issues focused on waste and waste streams.
Nonwovens are already used in a variety of products, and market opportunities continue to grow15. They are routinely featured in protective apparel, surgical drapes and gowns, infection control apparel like isolation gowns and are also a major component in facial protection.
One of the biggest challenges to overcome in the apparel market is limitation on fit and conformability in nonwovens, so a major issues to address in the future is the development of two-way stretch and more conformable nonwovens. Stephanie Earley, marketing development manager, Elastic Nonwovens for Kraton Performance Polymers Inc. has seen increased customer focus on this issue with demand created by specialty applications of nonwovens that come into direct contact with skin. On the other hand, Sterile Barrier Systems (SBS)—which include sterilization wrap, overwrap and pouches—use a significant amount of nonwoven materials. SBS are designed to protect the integrity of sterilized products/instruments in the hospital environment and are used during transportation of surgical instruments from room to room. However, in this product group, there is less demand for comfort and more for strength and durability.
Nonwovens are also turning up in smaller niche applications, where the volume component will be less, yet cost pressures will also be less since they represent higher valued targets. Product offerings in this category are those supporting Advanced Wound Care (AWC), as well as traditional bandages, pressure garments and prosthetics. In addition, nonwovens are being deployed for implantable devices such as sutures, vascular grafts and artificial ligaments. Nonwovens are also beginning to play a role in extracorporeal devices, such as artificial lungs, hearts and kidneys, as well as ligament repairs and other skeletal scaffolds, yet these are still rare compared with their other uses16.
Within the wound care industry, the goal is to create thinner dressings that have similar absorption to the properties of foam dressings. Thinner dressings are less bulky and more comfortable for the patient. Due to the absorption properties of nonwovens, there is potential to replace foams as the material of choice for the absorption layer. “At the moment, foams continue to be used as the reservoir layer for multilayer moist wound care dressings,” says Anne Havens, marketing/sales from Creative Foam Medical Systems, Bremen, IN. “However, as the market develops, the desire for a thin, absorbent material with improved physical properties, and superior to foam, is growing. Absorbent materials with physical properties such as vertical wicking, low-to-no swelling, increased wet physical properties such as tear and tensile strength, are desirable for AWC, and will be increasingly in demand.”
Remote surface monitoring technologies incorporated into future medical products, specifically those utilizing nonwoven materials, would be advantageous and provide opportunities for improved patient care longer term. For example, if monitoring technologies were included in advanced wound care dressings, in addition to antimicrobial agents currently used to minimize the potential for infections, it would provide the ability to assess the speed and progress of wound healing; these are key performance indicators for the nursing staff. Similarly, if antimicrobial components are embedded into materials used to manufacture hospital bed mattresses, covers and linens, the potential for infection transmission would be reduced too. Furthermore, there are opportunities to include other “smarter” technologies in nonwoven materials resulting in “active” surfaces that prevent the occurrence of pressure ulcers; pressure ulcers are considered a “NEVER” event in the healthcare space, and as such reportable and non-reimbursable. Finally, developing alarm alert systems for the incontinence market, including antimicrobial agents in all products, would minimize the potential for infections, and diminish other common issues linked to this condition17,18.
Areas of opportunity for growth in nonwoven products exist even within the U.S. market, for example, in Home Health and Ambulatory Care Centers. These segments present a set of unique, unmet needs. Avery Dennison proposed the idea for soft and comfortable nonwoven bed sheets that function as cotton but are disposable and are at a lower price point than current bed sheets. In aging populations, there is a higher risk of incontinence, which leads to increased opportunities for infections, unless appropriate laundering takes place; hence disposable sheets would have a key role to play. More Voice of the Customer (VOC) is required to establish the exact product requirements. There is, however, speculation that the home healthcare market will continue to grow beyond simple bandages and pain management, as healthcare protocols and treatments are aligned closer to the Point of Care (POC).
Challenges for Nonwovens Suppliers
Surprisingly, based on input from a number of well known and well recognized suppliers in the nonwovens industry, the challenges in the medical nonwovens field have not changed significantly from those presented in 20042,19. The issues, then and now, remain much the same, namely:
• Rising/fluctuation of raw material costs
• Environmental sustainability
• Life Cycle Analyses (LCA)
• FDA challenges for new products with, surface actives, especially antimicrobial treatments
• Public/patient perceptions
• Need for new uses and users to extend the U.S. market, as well as penetration into new emerging markets
• Need for improved comfort and functionality
• Sterilization—the reliance on ETO as opposed to gamma technology
• Reusable vs. disposable products
• Innovation to offset impacts in an aging population
Issues involving sustainability and waste stream management will continue to be high priority topics; increased focus on the Life Cycle Analysis (LCA) of products will become imperative. The requirements in place for high performance barriers in medical products combined with the challenges of cost are almost mutually exclusive parameters when sustainability issues are also included.
Ahlstrom’s Erdos notes, “Sustainability is a complex issue and it can be impacted from several angles, from the way current products are manufactured, to products made with renewable resources, what are the comparisons and how are products then disposed. There are several published studies that present conflicting results as to the impact of single use nonwovens on the environment versus that of reusable products. We believe that single use causes less burden overall on the environment with the advantage of consistent, high quality performance, uncompromising integrity and better economics.”
Recent in-depth assessments of several key studies comparing the environmental impact of reusable with disposable medical products concur with this view and show how the basis of any study needs to be thoroughly examined to ensure “like conditions” before extracting conclusions20.
Impacts of the recent and ongoing changes in healthcare point to an era where evidence-based research will soon become the norm, and the resulting focus on individualized payments. Hence, there will be a clear link between the performance of products and the overall outcome of a medical procedure. This approach will clearly drive compliance within the medical markets since products will become standardized and less customized.
If nonwoven suppliers are thinking proactively and developing advanced materials with active surfaces that lead to better outcomes (e.g., reduced HAIs and SSIs) in preparation for these future challenges, they will be well positioned for the change21. In addition, it is well known and accepted that hygiene products are experiencing tremendous growth in the emerging markets and are less challenging to manufacture than medical products, with lower demands when it comes to accreditation and the need to seek approval from regulating bodies.
Balancing demands of the convertor and the distributor with the capabilities of the raw materials suppliers will be essential in order to sustain and grow markets. In this way, it will be possible to control costs, to ensure products are specified appropriately, and not over-engineered and not over-customized. Unnecessary features that are unrelated to surgical outcomes, require more materials or lead to slower line speeds, must be minimized or eliminated since they ultimately contribute to higher costs.
Key questions highlighted for those associated with nonwovens in medical products during the Smart Fabrics meeting, organized by Smithers Apex, in Miami, FL, in April, included18:
What protective apparel will be required if…?
• All surgeries become non-invasive
• Point sterilization is possible
• Robots carry out all surgeries
• Wounds can be sterilized prior to closure
• The “landscape” of the Operating Room (OR) changes
• ORs no longer exist; where will surgery be performed
• Polypropylene is no longer available, or becomes too costly
Vicki Barbur works with leading edge companies in their efforts to spur, track and manage innovation through portfolio management and technology partnering. She is based in Chicago, IL, and can be reached at firstname.lastname@example.org.
Soft, lightweight, flexible fabric offers precise absorbency control, fluid retention and porosity.
In a burgeoning medical nonwovens market with end product manufacturers seeking new, innovative concepts, Super Absorbent Fibre (SAF) technology from Technical Absorbents, a division of U.K.-based Bluestar Fibres Company Limited, has opened up new possibilities for the future of wound care.
Technical Absorbents has developed SAF-based medical fabrics for use in advanced moist wound care dressings. Such products provide a therapeutic effect and aid healing, especially when used in the treatment of wounds with high exudates (e.g., chronic wounds and burns).
“The basic functionality of SAF is its ability to absorb up to 200 times its own weight in water, and 60 times its own weight in saline, at an extremely fast absorption rate,” explains Dave Hill, business development manager at Technical Absorbents. “Being fiber-based, SAF can be precisely tailored to a diverse range of medical fabric formats that offer the potential for enhanced design and performance. It is the basis for soft, flexible wound care dressings, which absorb and retain wound exudates—creating the optimum environment to aid the healing process and prevent further bacterial growth.”
Since wound care dressings are mainly fibrous based, SAF can be integrated exceptionally well throughout the final product, resulting in excellent conversion, minimum wastage and consistent performance, he adds.
As an absorption component, SAF affords significant benefits to medical device producers, patients and caregivers. Its fibrous form creates lightweight, soft and flexible fabrics, offering precise absorbency control, fluid retention and porosity, with low dust and shedding performance. Enhanced absorption and retention levels also mean dressings need changing less frequently, reducing time pressures on clinicians and helping to enhance patient comfort.
Moist wound care dressings are designed to present proper moisture conditions around the wound, without actual wetting. The integration of an SAF-based fabric results in the rapid uptake and retention of exudates from the infected area. These conditions are essential for creating an optimum environment to aid the healing process and prevent further bacterial growth.
“SAF-based medical fabrics are available in a wide range of formats and can also provide different levels of anti-microbial and anti-inflammatory performance,” Hill notes. “SAF can also be used in other medical-related products such as disposable mats for use in operating theaters. It can also be incorporated into diagnostic transportation solutions, such as packaging for medical testing kits and blood and bodily-fluid testing materials—thus ensuring any potentially spilled fluid is locked away within the fabric for safe disposal.”
Many companies have realized potential in the medical nonwovens field, and developing countries are beginning to follow suit. “Countries such as China and India are looking to develop higher quality products for the advanced wound care market,” says Hill. “This can only mean further growth for nonwovens within this field.”
For the future, Technical Absorbents is working on a range of development projects and has received many inquiries about the possible integration of SAF into new products, says Hill.
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2. Advances in Biomedical Textiles and Healthcare Products, Mironov, A.V., IFAI Expo, Pittsburgh, 2004
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12. Atmospheric plasma, Wolf, R.A., Enercon Industries, PFFC, February 2003
13. What’s new and what’s coming soon?, Cottenden, A. and Fader, M., Innovating for Continence, The Engineering Challenge, The Simon Foundation, Illinois, April 2011
14. The 3R’s: retrieve and reuse vs. replace, Barbur, V.A., Marcus Evans Medical Device R&D Summit, Florida, 2010
15. Scalpel….suction……nonwoven, Frei, C.E., Nonwovens Industry, September 1999
16. Growth factor-rich plasma increases tendon cell proliferation and matrix synthesis on a synthetic scaffold: an in vitro study, Visser, L.C., Arnoczky, S.P., Caballero, O., Kern, A., Ratcliffe, A. and Gardner, K.L., Tissue Engineering, Part A, 16, 1021-1029, 2010
17. Ending extra payment for ‘never events’ – stronger incentives for patients’ safety, Milstein, A.N., Engl. J. Med., 360, 2388-2390, 2009
18. Materials in medicine: the need for smart, high performance textiles, Barbur, V.A., Smithers Apex Smart Fabrics Conference, Florida, 2012
19. Industry technology road-mapping of nonwoven medical textiles, Amir, A, MS Thesis, NC State, Raleigh, 2006
20. The case for ‘green’: the debate about recyclable vs. disposable medical devices continues, Barbur, V.A. , Marcus Evans Medical Device R&D Summit, Florida, 2011
21. A cost-benefit analysis of Gown use in controlling VRE transmission; is it worth the price? - Puzniak, L.A., Gillespie, K.N., Leet, T., Kollef, M. and Mundy, L.M. – Infection Control & Hospital Epidemiology, 25, 5, 418-424, 2004