Optimum global regulatory approaches for in-vitro diagnostic (IVD) instrumentation product development /
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The foundation and interest for this dissertation is the complexity associated with the development and release to market of In-Vitro Diagnostic (IVD) Medical Device Instruments. The instruments used in diagnostics are complex with multiple technologies used such as microfluidics, pneumatics, AC/ DC power supplies, Optical analysis methods, data processing and complex electronics. Global trends in the industry include the progression and growth of developing markets and the move towards the manufacture of medical devices in lower cost regions. Within this, the complexity and changes within the regulatory framework have added extra hurdles in bringing new diagnostic instrumentation to market. Despite this complexity the area of IVDs is an attractive market for manufacturers to operate within. This market is expected to grow globally at a compound annual growth rate of 5.5% between 2016 and 2021. The global market is estimated to grow to reach $78.74 billion in revenues by 2021. Despite the global economic challenges in other segments the medical device industry has one of the highest growth areas with IVDs being a major area within this segment. The aim of this research was to analyse the IVD medical device global regulatory framework, to review the product development processes used and to identify efficiencies that can be gained in the regulatory approach to product development. This dissertation presents the regulatory approach used for IVD instruments in the primary global markets. The product development process is reviewed and the options that can be used to develop products within this regulatory framework are reviewed. Finally recommendations are made on how best to progress global product development in the coming years. The research approach used has analysed the IVD global market and identified the largest markets. For these markets available data has been found and used to analyse the regulatory structure in place, the specific regulation of IVD devices and identify applicable market trends. North America and Western Europe are the most understood and largest markets in terms of revenue. However these are not the largest growing markets and the fastest growing markets such as the BRIC countries (Brazil, India, Russian Federation and P. R. China) have also been researched. The product development processes currently used in the viii industry are analysed. The development approaches used in other industries are also reviewed for potential application. The context for this research are the trends globally in the IVD medical device industry and the continuing increasing demand for these diagnostic devices generally. The research results and analysis indicate that while there are regular changes in the regulation of IVD medical devices there are similarities and attempts at harmonisation which are assisting manufacturers in the standardisation of approaches to product development. The driving factors for these moves towards harmonization can be explained by international governments desire to reduce regulatory costs and the in-country pressures to free up the supply of healthcare. For the IVD sector there is an understanding that the use of screening and testing to identify health problems early before they progress is an effective preventative approach as well as a way to reduce costs. The patient costs associated with long term care in hospital can be minimized using screening and diagnostics methods more extensively to reduce the time of stay in hospital which is a large element in the increase of healthcare costs more particularly in developed countries. The research found that In-Vitro medical device industry is not significantly affected by global economic fluctuations. In looking at the development process of devices it does seem that the medical device industry has held to traditional development approaches which have been significantly dictated by regulatory requirements. There are efficiencies to be gained in development processes which will not reduce compliance to regulatory requirements. This will reduce time to market and contribute to global requirements for higher quality healthcare.
- Theses - Science ITS 
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