New medical devices take years to reach the market – and many never make it, representing a huge loss of time and investment. Jon Johnson, a researcher at Cambridge’s Institute for Manufacturing, is looking at ways of making the process of commercialisation more efficient.
Like many high-tech industries, the medical sector is strongly motivated to increase the efficiency and profitability of its new product development process.
The industry faces particular challenges. Biotechnology and healthcare developments require huge investment in terms of finance and resources, as well as in-depth research and clinical trials.
According to the Food and Drug Administration, the vast majority of new medical innovations never make it through clinical approval and market adoption. In short, the multiple disciplines required to bring a medical device to market are complex and the process is full of risks and uncertainty.
How can we reduce this failure rate? Focusing on the very early stages of development – when feasibility studies could determine whether a technology will be viable years down the line – seems to offer the greatest potential.
What is needed is improved evaluation at these early stages, before major investment has been committed. If we can establish whether a technology will function as required – meeting user needs, providing genuine health benefits and passing regulatory controls – then industry will have the confidence to take it to the next stage of development. There is currently little guidance for practitioners on this.
At the Institute for Manufacturing we have been working with eight leading medical organisations to track the complex process that a product must follow to go from first concept to commercial adoption.
The output from this study includes an original approach by which companies can better analyse, manage and measure the success of early technology innovation within the healthcare sector. It could also improve regulatory viability, providing significant cost savings and maximising benefits to the healthcare industry.
Jon Johnson is a doctoral researcher in the Institute for Manufacturing, Department of Engineering at the University of Cambridge. He is supervised by Dr James Moultrie.