Managing risk is a vital part of developing medical devices.
We focus on technical risk – reducing the chance of the device not working properly, to avoid harming the patient. It’s also important to manage project risk – things that could go wrong and cost you money or delay your product getting to market. It’s not going to kill anyone, but it could have a big business impact. With good project risk management, you can significantly improve your chances of success. There a lot of similarities between managing the two types of risk, and at eg technology, our product development and project management processes enable us to manage risk effectively.
Here are a few key pointers for effective project management:
We know it’s important to manage technical risks early. As we progress through product development, the options available to solve challenges decrease and the cost of change increases. The same is true of project risks. Successful projects start risk management early and continue to revisit throughout the project.
Early this year, working on a challenging technical problem, we quickly identified a preferred concept. However, this concept required specialist manufacturing, with lead-times likely to be longer than the project timescales. To mitigate this, we engaged with several suppliers, and continued to develop other concepts. We chose to order parts in parallel for more than one concept. The preferred concept was not available in time, and the 2nd concept didn’t work as expected; but we finished the phase with successful prototypes of a 3rd concept. This gave us confidence that our preferred concept will work. The risk also became an opportunity as we have identified a choice of suppliers in manufacturing.
Talk about it
Trust your gut feeling – if you’re worried about something, then talk about it. Many heads are better than one to think of solutions to reduce or mitigate the risk. Sharing project risks with all stakeholders also prevents unpleasant surprises if there are any risks you can’t avoid. Make sure that conversations about risk are part of your regular meetings. This is something we regularly do at eg technology.
On a recent project – where the key milestone was an investor presentation to demonstrate the prototype, we were reliant on one key supplier with a long-lead time. We needed this supplier’s part, so we chose to accept and monitor the risk, keeping a close eye on the schedule as it developed. The supplier was late in their delivery, but we were able to schedule presentation accordingly – avoiding a last-minute change, which would have damaged investor confidence.
Where to start
Just as there are processes and checklists to help identify and manage technical risks, there are many useful tools to identify project risks. We can also learn from each other’s experiences – people who’ve done similar things before will have a good idea of what might go wrong. Identifying risks is just the start though, the real value is in working out what you can do to reduce the likelihood of the risk occurring, or the severity of the impact – and then in doing those things. Tracking the actions, and re-assessing the risks to see the benefit of the actions is all part of the project management.
eg technology have a team of qualified and experienced project managers, who have a proven track record of delivering complex programmes within stringent frameworks. Our approach has been developed and refined to ensure the viability and success of projects, based on our extensive experience.