Bringing a medical device to market requires significant investment of time, money and resources.
In our experience, the precise amounts of all three needed to successfully complete development, industrialisation and launch varies, depending on the nature, complexity and risk associated with the product.
It is not unusual for a low to moderate risk device to take 3-4 years to reach the market, supported by development investment of up to around $30million. As the device risk and/or complexity increases, so does the investment; by comparison, a complex, high risk device may take upwards of 6 years and $90 million to bring to market. There are no guarantees, of course, that the device will ever make it to the market or, if it does, that it will be commercially successful but for those that are, the rewards can be significant.
So the medical device development process can often be a perfect storm —high risks, high costs, lengthy development timelines that can eat into the revenue generation window, and potentially relatively modest returns—has created a difficult environment for medical device innovation. If you’re in this challenging environment, you’ll want to focus on strong management of process to mitigate risks and minimise time and investment, whilst ensuring your development roadmap doesn’t cut any corners.
In our experience, gained from over 25 years in device development, you stand the best chance of success if you focus on three critical factors;
• Mitigating Risks
• Controlling spend
• Optimising project timescales
Read the full article by Medilink member Three Circles here.