Failure is expensive, very expensive

And it gets even more expensive when you’re developing a medical device.

Like me, you’d probably like to avoid the pitfalls where you can, avoid the pain.

Abut 10 years ago, being naturally curious people, we chose to investigate the things that were common to successful projects, and the traits of projects that failed, either on resource, budget, or time. Our research uncovered the causes of failure, and the resulting costs to businesses and individuals. It also revealed the things that made projects successful.

The results of our research still hold true today, they’re supported by experience of working on over 50 medical device and combination products since then.

So, how does this apply to developing a medical device, or for that matter, a drug/device combination product?

There are 5 things you should know, to avoid the painful bite of failure; we’re going to cover them now. And, as an added bonus, you’ll see that these 5 things can be applied to any project, in any organisation, even at home.

At the heart of every successful project are 5 things:

  1. Begin with the end in mind“. That’s all about understanding where you’re going to, listening to your user or customer actually needs your device to do for them
  2. Having a well thought through, realistic project plan.  You’ll want to ensure that compliance and regulatory are covered, as well as the key disciplines/activities.  A plan that allows you to get to where you now know you need to get to
  3. Risk based approach to your project activities and action (not doing too much, or  too little, doing just the right amount, of the right things) – rather than just rolling the dice and keeping your fingers crossed
  4. Making decisions based upon evidence. Evidence that you can trust.  Making those decisions at the right points in your project
  5. Measuring what you’ve done, so you can check you’re still on the right path and make small course corrections, as you need to

It’s fair to say that, miss out on one of these, and you’re massively increasing the chances of failure. But take care of all 5 elements and you’re minimising the chance of things going expensively wrong.

So, maybe now it’s time to measure your project against these 5 things.  Things that you know make the difference between failure and success.

Doing nothing really isn’t an option.

That’s why, next time, we’ll look at the 7 steps you’ll want to take to find out how your project stacks up, and then fix the things you’re not happy with.