Helping medical device Sponsors improve healthcare since 1967, NAMSA is the world’s leading MedTech CRO offering global end-to-end development services. Driven by its global regulatory expertise and in-depth therapeutic knowledge, NAMSA is dedicated to accelerating medical device product development, offering only the most proven solutions to move Clients’ products through the development lifecycle efficiently and cost-effectively. From medical device testing, regulatory, reimbursement and quality consulting, and clinical research services, we are the industry’s premier, trusted partner for successful development and commercialization outcomes.
AST Products, Inc. develops and manufactures a range of ophthalmic surgical products used by physicians to treat patients with cataracts. Our ophthalmic product line includes: the Asqelio™ series of intraocular lens and their Preloaded IOL Delivery Systems (monofocal, trifocal, EDOF and multifocal, and related toric versions), and our premier intraocular lens (IOL) delivery devices, the bioli™, pioli™ and lioli™ IOL Delivery Systems, which are designed for the implantation of a single-piece foldable intraocular lens into the human eye through a surgical procedure. All our Asqelio™ series of Preloaded IOL Delivery Systems and the IOL Delivery Systems are pretreated with our innovative LubriMATRIX™ technology which offers a safe, simple and effective lens delivery. AST also provides environmentally-friendly medical coatings for a variety of industries, along with analysis equipment and specially engineered plasma reactors that facilitate the application of our advanced surface treatment technologies.
Bausch & Lomb
Biocoat, Inc. develops and licenses biomaterial coatings for medical devices that are custom engineered to meet specific clinical parameters. The company specializes in supplying lubricious hydrophilic coatings for medical devices to original equipment manufacturers and contract manufacturers. Biocoat is also able to provide coating services to aspiring medical device companies that require assistance with manufacturing.
Carmeda is a medical coating company that develops, manufactures, and markets biocompatible coating technologies. CARMEDA® BioActive Surface (also known as CBAS® Heparin Surface) is the clinically most proven heparin coating technology commercially available. This technology provides a lasting thromboresistance that actively prevents platelet adhesion and thrombus formation on medical device surfaces. GORE® PROPATEN®Vascular Graft is one of many products featuring this heparin technology, which in numerous of clinical studies has shown to improve clinical outcome and to reduce overall healthcare costs. Carmeda is certified to ISO13485 and has state-of-the-art cGMP-compliant facilities for contract coating of Class III products according to both European and US requirements
School of Biomedical Engineering
Evonik, a global leader in specialty chemicals, provides drug delivery technologies, API manufacturing, intermediates, biomaterials for medical devices, ingredients for nutraceuticals, amino acids and derivatives.
For over 30 years, Evonik Health Care has empowered medical device companies to create next-generation devices that enable a healthier more active lifestyle. Our biomaterials have tunable properties to make medical procedures better and more patient friendly. With real scientists behind our products, we provide a one-stop-shop from concept to commercialization, helping you to bring your devices to market faster.
Our integrated portfolio includes RESOMER®, the world’s leading portfolio of bioresorbable polymers, for use in implantable medical devices via various processing technologies, including 3D-printing. Another highlight is Evonik’s clinically proven ENDEXO® surface modification technology, which is based on low-molecular-weight fluoro-oligomers to enhance the biocompatibility of medical devices in cardiovascular, neurovascular, and renal applications.
Driven by continuous innovation, Evonik launched the innovative non-animal derived collagen platform VECOLLAN® in 2020. In 2021, Evonik acquired the German biotech company JeNaCell, complementing its offering with biosynthetic cellulose that is ideally suited to medical applications such as wound care, implant materials and scaffolds for tissue engineering.
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We develop coatings to reduce protein and cell adsorption or mineral deposition on surfaces allowing devices to retain their functions longer. Our medical device coating products control the surface properties to minimize harm to the body and to the medical device from those biological interactions.
Our medical technologies help make it possible for millions of people to resume everyday activities, return to work, and live better, longer. We're able to do this with the help of some very special people around the world: 38,000 dedicated employees who share a passionate purpose to improve lives, thousands of medical professionals who share their insights and ideas, and hundreds of advocacy associations that help us share information so people with debilitating diseases know relief is possible.
Northern Arizona University (NAU) and its Bioengineering Program, affiliated through the Mechanical Engineering Department, is a multidisciplinary collaboration between researchers and faculty in Engineering, Biology, Biomedical Sciences, Chemistry, Physics and the Center for Materials Interfaces in Research and Applications (¡MIRA!). The program is affiliated with Barrow Neurological Institute (BNI – Phoenix, AZ) and Northern Arizona Healthcare (NAH - Flagstaff, AZ) to collaborate on translational medical device research. The Bioengineering Program includes biomaterials testing, state-of-the-art multi-material 3D printing, computational and benchtop flow modeling (with particle tracking), stroke research, biomechanics, and medical device development. Undergraduate and graduate students actively collaborate with small start-ups and large-industry leaders in medical device development, publish in internationally renowned journals, and attend annual conferences to present their work.
While we may be best known for our GORE-TEX® fabrics, all our products are distinguished in their markets. Our technologies and fluoropolymer expertise are unsurpassed. We create next-generation cable assemblies and components for the electronics industry, set the standard for outerwear comfort and protection, solve difficult industrial problems with innovative materials and technology, and Gore medical products work in harmony with the body's own tissues to restore normal body function.