Ä¢¹½tv

Capabilities

• Biologics

  Most biologics are complex structures or mixtures that are not easily identified or characterized, and as a result, they are more challenging to manufacture, process, store, distribute, and deliver. Ä¢¹½tv has multidisciplinary expertise in biologics used with medical devices and pharmaceuticals, and we can assist in characterizing and developing combination products that contain cells, scaffolds, and bioactive drug entities.

• Spine

  Developing and evaluating therapeutic options for treating spine diseases requires extensive research into potential causes and the complexity of the underlying biomechanics. Ä¢¹½tv specializes in providing rapid, focused, market-sensitive solutions to technical challenges for spinal treatments, ranging from non-operative approaches to implantable devices.

• Endoscopy

  Although most endoscopic procedures are performed without complications, these potentially lifesaving instruments carry the risk of infection if not designed, used, or reprocessed properly. Leveraging biomedical engineering, human factors, epidemiology, microbiology, regulatory affairs, and clinical knowledge, Ä¢¹½tv provides expertise in all aspects of endoscope design, testing, and development, including materials selection and innovation to improve or eliminate the impact of reprocessing.

• Vascular Therapies

  Developing and evaluating cardiovascular, neurovascular, and peripheral endovascular implantable and non-implantable technologies presents a variety of challenges in device design, performance, and interaction with the surrounding environment. Leveraging our experience in device performance testing, implant retrieval analysis, finite element analysis, computational fluid dynamics (CFD), and other specialties, Ä¢¹½tv's multidisciplinary experts assist clients in addressing challenges arising from complex vascular therapeutics.

• Combination Products

  Combination product manufacturers face numerous hurdles bringing new products to market, including performing appropriate preclinical and clinical testing to evaluate safety and effectiveness, preparing compelling regulatory submissions, and developing comprehensive post-marketing strategies. Ä¢¹½tv specializes in providing rapid, focused, market-sensitive insights to complex challenges for our combination products clients with the highest-quality engineering, regulatory, safety assessment, epidemiological, and health economics expertise.

• Women's Health Products

  Developing and evaluating women's health products requires an integrated, multidisciplinary approach that considers gender-specific influences, unique anatomy and physiology, lifestyle, and economic impacts on health and wellness. Ä¢¹½tv helps clients address the complexities of women's health product development with a wide range of expertise in biomedical engineering, human factors, health economics, epidemiology, toxicology, health risk assessment, and medicine.

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• Regenerative Medicine

  Key challenges in the regenerative medicine market include navigating complex regulatory pathways, coordinating animal and clinical testing, and the need for a multidisciplinary approach. Ä¢¹½tv is uniquely qualified to address regenerative medicine development challenges through characterizing devices and therapies in vitro and in vivo, providing technical assistance for existing products, and conducting regulatory and risk assessments pre- and post-market, as well as providing solutions to demonstrate clinical and cost effectiveness.