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Wound management is challenging; both public and private partners have been working tirelessly to find novel and advanced solutions. The ever-growing prevalence of chronic diseases such as diabetes has driven demand for care, particularly in developing nations. Unhealthy lifestyles and a deskbound work culture are expected to further increase the prevalence of chronic diseases, enhancing the call for a variety of new wound care products.1 This is luring many researchers and medical companies to develop innovative products or improve existing options.
An increasing understanding of wounds at the molecular level, the availability of technological devices that help visualize unreachable anatomical areas, and enhanced microscopic analysis of live tissues are leading to the development of better and more innovative wound care products that efficiently promote healing with minimal-to-no side effects. Novel solutions include, but are not limited to, different combinations of advanced drug delivery systems (from nano to macro scale) that are loaded or imbued with small drug molecules to large biomolecules, gene and cell therapies, and 3- dimensional, multilayered regenerative skin substitute models.2
Simple consumables such as gauzes, bandages, cleaning or cleansing solutions, and the like have less stringent regulations from health authorities and hence are widely available in different forms in the market. Complex decellularized extracellular matrix scaffolds (derived from a variety of mammalian sources), electrospun nanofibrous scaffolds (made of biodegradable polymers), hydrogels, wafers, sponges, films, nano/micro drug delivery systems, and other dressings/devices have been loaded with healing agents, growth promoters, and/or biologicals (eg, growth factors, DNA) and tested for wound healing in animal models. Cell therapy strategies (eg, autologous macrophages, cultured skin cells, stem cells), skin graft techniques, live skin equivalents, bioengineered live skin equivalents (eg, dermal substitutes, bilayered skin substitute), and advanced medical devices also have been explored.3-5
From the pharmaceutical and medical device industrial (commercial) perspective, which are highly regulated industries, key questions to be addressed include: 1) Do the protocols and designs follow current good clinical/manufacturing practices and device design regulations, respectively? 2) Are the materials used or administered during the product approved by health authorities under current pharmaceutical or medical device regulations? 3) Do these products or devices permit further pharmaceutical or medical development in terms of safety, efficacy and stability? 4) Is the production process robust and reproducible? 5) Is it possible to scale-up the process for bulk manufacturing? 6) Is the product patient-friendly and/or should practitioners be involved? 7) Is the product/device applicable for different types of wounds? 8) Is the product or device commercially viable to produce to sustain, considering the competitive market and insurance coverage regulations? Answers to these questions require strong scientific data in order to get a green light from both health authorities and manufacturers. Many effective models and studies of advanced prototypes with exotic features and/or a high degree of complexity do not withstand unsurmountable hurdles to complete their clinical trial journey.6
Clinical trials not only provide the needed data for commercial approval and reimbursement, but they also provide valuable insights on how the wound care product interacts with wound physiology and overall on product safety. Researchers and medical companies realize the need for quality study designs and for joining forces to develop and test wound care products. In addition, huge investment in patient support programs is occurring that includes education and practical training to enhance the overall effectiveness of the wound care product or device. In the end, what developers, researchers, patients, and providers aim for is to find an effective, safe, and easy-to-use product. It is heartening to know that all involved parties are striving to ensure “novel” wound care is practical and available. The hope is that in the years to follow, more and more novel and efficient wound care prototypes developed by public-private partnerships will become viable, approved products and devices that fulfill patient and practitioner needs.
Affiliations
Dr. Chereddy is a Project Manager, Process Unit Project Management Office, Cell & Gene Technical Development & Manufacturing, Novartis Pharmaceutical Corporation, Morris Plains, NJ. The opinions and statements expressed herein are specific to the respective authors and not necessarily those of Wound Management & Prevention or HMP. This article was not subject to the Wound Management & Prevention peer-review process.
