As the global medical device field continues to expand (currently >$330 Billion), a paradigm shift has focused on the creation of resorbable medical devices. This movement has been driven by the desire of final device manufacturers to replace current non-degradable implants along with the application and creation of resorbable devices (and scaffolds) in the emerging fields of tissue engineering and regenerative medicine. The fields of tissue engineering and regenerative medicine seek to replace and repair damaged tissues with a temporary (resorbable) scaffold that can allow new tissues to form within the body. Resorbable polymers that can degrade into natural metabolites (e.g. H2O and CO2) can create this temporary scaffold and support structure through a variety of manufacturing processes.
Beyond traditional manufacturing methodologies, processes that can produce implants that closely mimic the native properties within our tissues (skin, ligament, bone, cartilage, blood vessels) are on the forefront of improving medical device design. By having medical devices that can replicate the appropriate architecture of the tissues they are meant to replace, innate healing mechanisms including cellular growth, development, and maturation can occur accelerating the healing process and forming new tissues. Of the manufacturing tools available at Poly-Med, Inc., electrospinning enables the use of a wide variety of resorbable materials allowing for different physical, mechanical, and degradation rates to be achieved through a unique fiber formation process.
Electrospinning is an electrostatic fiber fabrication method, which uses electric force to draw a charged extension of a polymer solution into fiber diameters on a submicron scale. Using strong electric fields to generate submicron fibrous scaffolds, electrospinning has the capability to be used in a variety of indications ranging from fibrous coatings on implants to entire stand-alone devices or constructs.
Fibrous materials created by electrospinning are comprised of a plurality of fibers resulting from an infinite number of fiber-fiber contacts and layers upon layers of fibers. Engineering criteria for electrospun products revolve around fiber size, pore size, fiber orientation, intermixed fiber populations, and layered constructs comprised of different types of fibers and materials. Based on these criteria, standard surgical mesh specifications including basis weight (areal density), thickness, and mechanical properties can easily be tuned and measured.
Beyond control of the physical dimensions of an electrospun mesh, electrospun devices also allow for the easy incorporation of medical grade additives or active pharmaceutical ingredients (APIs). As electrospinning does not typically require elevated temperatures, sensitive materials like APIs can easily be incorporated into the bulk fiber during the electrospinning process. Besides inclusion of APIs inside fibers, physical adsorption is also possible as constructs often exhibit very high surface area to volume ratios. Electrospun products can have varied porosities greater than seventy (70) percent!
At Poly-Med, we specialize in novel processing of biomaterials and know first-hand what it takes to manufacture electrospun medical products on a commercial scale. Beyond standard engineering practices of equipment qualification and process validation, we have been able to establish our own standards for tight manufacturing and process controls to allow highly capable medical grade electrospinning processes for desired outcomes and high quality products.
To summarize, medical-grade electrospinning provides an innovative tool for medical device development and has shown great promise in enabling new and exciting products. With the ability to provide industrial scale electrospinning services, PMI can help you develop your next medical device! Contact us to learn how our electrospinning expertise can help you advance your next bioresorable medical device!