The product development cycle

Fig. 2 Once feasibility is established, then developing and evaluating engineering options to create a final product design is undertaken. Engineering options encompass the areas of design concept, custom design creation, and final design approval. Multiple design solutions were considered in developing the micro hip system including hip resurfacing and improving FHO technique. Ultimately, cemented THR was chosen as the best solution for these smaller dogs and cats. Dimensional and stress analyses were undertaken to ensure the implants meet functional requirements. 3-­‐D models of the implants and instruments were then created and used in cadaver evaluations to confirm their function. This process may need to be repeated with design modifications until it satisfies all of the design criteria. Only then are actual prototypes ready to be machined and the custom implant created. Several micro hip custom designs were implanted between 2000 and 2004. Their success and the growing demand for similar custom implants allowed the concept and design to progress into a standard production product. A final design must be then be determined. The original research performed and experience with the custom cases performed help define that final design. The final design of the Micro Hip System consisted of two stems, two 8mm femoral heads, and three acetabular cups (Fig. 3). Instrumentation was also designed for the entire system of implants. Micro Hip System Fig. 3

Production of the implants and instruments can then commence utilizing the manufacturing and quality assurance measures developed. Concurrently, marketing programs are created and implemented. This entails creating educational support material and product information sheets, developing and organizing workshops to teach surgical technique, and recruiting teaching staff for each workshop. The need for custom cases is reviewed with each requesting clinical practice. Many of those custom cases yield complimentary testimonials from patient owners which become part of these marketing efforts. Clinical evaluation of the Micro Hip System is performed in workshops which are scheduled at specific clinical sites where surgeons have been integral in evolving the custom design to a standard product. In this case, Dr. Bill Liska (Gulf Coast Veterinary Specialists) and Dr. Dominic Marino (Long Island Veterinary Specialists) provided the direction for the Micro Hip System. Sales and distribution of the products are managed by customer service. BioMedtrix supplies these products directly to specialty hospitals and universities around the world.