Technology Early Stage Funding: We are constantly reviewing and investing in novel early stage biomedical technologies for performance feasibility studies, market studies, preliminary development costs, and team strength that have commercial potential, attractive ROI, and that align with our company mission/vision.
Fundamental R&D, Animal Clinical GLP Studies, and Strategic Formation: Chosen technologies with appropriate injection of capital will undergo Phase I/II technology R&D and design and pilot manufacturing following ISO 13485 for animal and clinical studies, prior to processing FDA 510k and PMA approvals.
ISO 13485 GMP Manufacturing: Our team bring past experiences ranging from developing medical devices following ISO 13485 requirements for Ethicon Endo Surgery, Dupont, Covidien, Biomet, Medtronic, Abbott, Boston Scientific, BWTek, Synthes, and others in the fields of implants, catheters, nephrostomy balloons, spinal cord development, stem cell technologies, hemo point-of-care devices, spectroscopy/optics, and Raman based technologies. In addition, the team has had direct exposure to more than 70 medical device parts/assemblies in FDA approved manufacturing sites, to more than 15 medical device R&D and NPD projects in industry, and most importantly experience in transfering medical production lines from site to site within the USA.
Continuous Lean Operations: We bring in the understanding of how different company cultures can build or break a business, and while culture is critical for a success of a company, we believe that enforcing a lean operation mentallity is the most basic prerequisite for long term global success. We have experience implementing continuous improvement on production lines to maintain high quality production levels that is necessary for biotech and medical device manufacturing, sterilization, and packaging.
Sales/Customer Service: We have helped various high tech companies train their international central/south american and asian suppliers to expand and strenghthen their sales channels to allow a seamless customer service around the globe.