International standards such as ISO 62366, ISO 14971 compliance gurus and journals all talk about taking a risk based approach to elements of your development project.
As with many things in life, the strategy you choose to achieve this becomes a matter of how much risk you are prepared to live with;
- How comfortable are you with the risk of meeting a costly surprise if you choose to test late in development?
- How much risk are you prepared to pass onto your customers, your users?
Lets take a look at two strategies for a medical device development project.
The dare devil approach. It’s a high risk strategy that is often seen as the fast way of getting down the mountain.
For this strategy to succeed, the device manufacturer has to be super confident in their design, either because it is very similar either a design they have already done or it is very similar to what’s already on the market. The design will also use existing production and assembly processes, without modification.
In this scenario most device testing and process validation activity is done at the last possible stage, when the design is frozen and the company is ramping up for launch.
Sometimes, testing is even done after launch when the regulators ask for the documented evidence.
To take on this strategy you have to have a lot of confidence that you know how to repeatably and reliably manufacture your product, your customers (and ultimate users) know how to work your device as well as you do.
After all, “Its not the fall that kills you”.
This approach is often perceived as slowing down a fast track project. Yet, the strategy includes the right development activities, at the right times throughout the various stages of product development.
It’s the more conventional way of getting down a mountain.
“The sooner [you] get involved, the quicker, cheaper development is” Vicki R Lewis, AAMI/FDA summit 2013.
In reality, adding development activities to a project at the right time should not impact on time-lines, as activities can run in parallel. Indeed, these activities will greatly reduce the likelihood of expensive re-designs or fire-fighting as you get closer to scale-up and launch preparation.
Of course, development activities need to be budgeted for, but;
- How much expensive is unfreezing a design to start developing new mould tools?
- How much more expensive is a product recall because of a foreseeable use error?
Taking this approach should not end messily, as you descend your mountain.
Which of these two strikes a chord with you, feels like the usual one for development? Perhaps you can see the differences in likely outcomes from the two strategies.