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
To mitigate risks, first there has to be an understanding of the potential risks in the development process and secondly a plan to minimise their impact and mitigate them as far as is practical and cost effective.
Controlling spending is not just about spending wisely and getting best value, but also about making informed investment decisions (based on sound data and experience) to reduce risk by investing proactively in key areas. Sometimes, money spent in the right areas early on in the development process can save significant sums later on – the cost of quality effect.
Optimising project timescales
Optimising project timelines involves identifying key decision points and ensuring you have the data you need to make robust decisions when and where they’re needed, preventing unnecessary work or racing down a flawed development path. Creating the least impact on project timescales steps back from the fallacy of planning a “best case” project timeline, which almost inevitably falls apart at the first hurdle and ends up costing far more than budgeted and taking years longer to deliver (if at all). Instead, it looks in detail at the individual project elements and avoids the temptation of cutting corners to create a more robust, realistic, affordable and achievable plan for development through to launch and beyond.
That’s a lot to consider, no matter what development stage you’re at.
How to ensure medical device development goes smoothly
To ensure things go as smoothly as possible, when we’re brought into a project to deliver a specific piece of work we offer clients the option of a scoping day, assessing collaboration prerequisites and risk factors in a pre-collaboration checklist.
This builds the foundation for a successful working relationship, with no surprises, and enables us to help you avoid the pitfalls that can stop, stall or even derail a project completely.