You’ll probably remember our discussion about 5 key things that successful device development projects take care of, to minimise the risk of failure and the harm and expense that results?
I’d like to share with you an approach to looking at a project, to see how mature your development methods and their results are, comparing them with a recognised benchmark. You’ll probably find this helpful to make sure you’re giving your device the best possible chance of reaching the market, to answer that nagging concern about some parts of your development plan.
So, one approach to getting an objective, realistic assessment of how risky your project is, looks like this (it has 6 steps):
1. Identify what your business needs, to successfully develop this product. This will probably include some specific standards, like ISO 13485, ISO 14971 and ISO 62366. Remember too, to identify which regulations you need to conform with.
A tip here – it’s not enough to simply say “ok we’ll comply with 13485”, you should work out which parts of the standard or regulation are actually relevant to the product you’re developing.
2. And this step is key. Take an honest, objective look at how well your activities, documents and procedures stack up against the business needs we’ve just been talking about. To make it more manageable, you may choose to do this by looking at each clause of a standard or regulation, in turn.
3. Write down the observations (to give you the complete picture). They’ll probably be either;
- Things that aren’t up to scratch, but won’t hurt you badly, right away
- Clear gaps that you must address, otherwise they’ll kill your medical device
- Things that are actually working well and don’t need to be changed
4. Plan how you’ll address these first two, perhaps tackling the most pressing ones first. Remember to plan the what, how and who for each action.
5. Work through the plan. Do check back often to make sure you’re closing the gaps, making adjustments to the plan as you need.
6. When you think you’re all done, look over everything, to confirm that what you’ve achieved really does fit the bill.
It’s really important, and I can’t stress this enough, to make sure that whoever you get to make this appraisal, has the knowledge, capabilities and experience to give you a complete picture, warts and all, along with pragmatic ways to close gaps.
They’ll be independent of the project, so they can see through assumptions and around blind spots.
Thank you for reading and please keep sending us your questions and feedback.