The process of medical device development : how it represents a challenge to traditional product development methodologies : a thesis presented in partial fulfilment of the requirements for the degree of Master of Technology in Product Development at Massey University

Abstract

Medical Devices [MD] represent special challenges to the designer and manufacturer. They range from disposable, single use articles to extremely complex and expensive technologies. While single use devices may be simple in concept and easily manufactured, they nevertheless may be invasive or could threaten human life if inappropriately used. For consumables packaging to maintain sterility from factory output to the operating tray is an important requirement. Such devices, in common with far more sophisticated equipment, may be assigned a classification requiring tightly controlled manufacturing and inspection systems that may vary between different jurisdictions. Quality management systems increase overheads to the already considerable investment incurred during R & D. Audit trails required by these systems become tortuous and difficult to validate as components are sourced increasingly from low cost base countries. The increasing use of microprocessor controlled wireless network technology increases radio frequency clutter and electromagnetic interference between medical devices can result in injury or death. Most countries now insist on guarantees that toxic substances cannot be released by a product into the environment during it's lifecycle or when disposed of. International protection of intellectual property presents challenges for New Zealand manufacturers with limited resources. Frequently the designer/manufacturer needs an in depth understanding of the clinical context for the equipment including a knowledge of human physiology and anatomy for the application. Current literature about allied technology must be reviewed and a business plan developed that exploits the opportunity presented by the proposed advances in the development of a new MD applying current theoretical knowledge. Many developments supercede historical technology, introducing challenges for the practitioner/operator to understand it's operation and optimise it's performance. Factoring patient & practitioner education into the distribution of MD's significantly increases the cost of marketing. To gain access into international markets MD's must comply with stringent standards for safety and performance. A case study examines these issues in relation to the development by the author of MD's to enhance vision and conduct tests of visual performance, the Librus 300 & 600. This study illustrates many of the difficulties the New Zealand Manufacturer faces and suggests management structures, processes and development systems that would facilitiate the process and an infrastructure to support it.